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CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
1
An international multi-centre appraisal of
the management of acute CHOLEcystitis
during the COVID-19 pandemic The
CHOLECOVID Audit
Study Protocol Version 121
25th June 2020
CHOLECOVID Collaborative
Website wwwcholecovidorg
General email cholecovidgmailcom
REDCap queries redcapcholecovidgmailcom
Twitter CHOLECOVID
Key Study Dates
Study Registrations Opens 1 May 2020
Retrospective Data Collection Period 1 12 Sep 2019 to 12 Nov 2019 (+ 30 day follow-up)
Retrospective Data Collection Period 2 12 Mar 2020 to 12 May 2020 (+ 30 day follow-up)
New Site Registration Deadline 12 August 2020
REDCap Database Entry Deadline 12 September 2020
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
2
Table of Contents
CHOLECOVID Steering Group 3
Collaborative Partners 4
Study Delivery Timeline 6
Introduction 7
Methods 8
1 Summary 8
2 Study Aims 8
3 Project Timeline 9
4 Design 9
5 Setting 9
6 Patients 10
7 Definition of Acute Cholecystitis 10
8 Eligibility Criteria 10
9 Data Collection 11
10 Local Project Registration and Ethics 12
11 Analysis Plan 12
12 Authorship 13
13 Expected Outputs 15
Appendix A Case Report Form 16
Appendix B Data Dictionary 17
Appendix C CHOLECOVID Site Survey 27
Appendix D Tokyo Guidelines Audit Standard Adaptation 28
Appendix E Charlson Comorbidity Index Score 29
Appendix F KDIGO Clinical Practice Guidelines for AKI 30
Appendix G Tokyo Guidelines for Severity Grading of Acute Cholecystitis 31
Appendix H Clavien-Dindo Grading of Surgical Complications 32
Appendix I CHOLECOVID PI REDCap Guide 33
Appendix J NHS Health Research Authority Outcome 40
Appendix K References 41
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
3
CHOLECOVID Steering Group
Name Organisation Twitter
Dr Harry V M Spiers Manchester University NHS
Foundation Trust UK
Harryvmspiers
Miss Rebecca Varley Manchester University NHS
Foundation Trust UK
Varley_RJ
Waheed-Ul-Rahman Ahmed University of Oxford UK WaheedURAhmed1
Dr Omar Kouli Greater Glasgow and Clyde
NHS Foundation Trust UK
Kouli_omar
Mr Daniel Ahari University of Manchester UK AhariDaniel
Miss Leah Argus University of Manchester UK Leahargus
Mr Kenneth McLean University of Edinburgh UK Kennethmclean92
Mr Sivesh Kamarajah Newcastle Upon Tyne Hospitals
NHS Foundation Trust UK
Siveshk
Dr Matthew Goldsworthy Manchester University NHS
Foundation Trust UK
MattGoldsworthy
Mr Peter Coe Leeds Teaching Hospitals NHS
Trust UK
Petecoe1
Mr Majid Rashid NHS Fife UK -
Mr Ewen Griffiths University Hospitals Birmingham
NHS Foundation Trust UK
EwenGriffiths
Mr Anthony Chan Manchester University NHS
Foundation Trust UK
Anthonykcchan
Mr Christian Macutkiewicz Manchester University NHS
Foundation Trust UK
SurgeryHPB
Mr Saurabh Jamdar Manchester University NHS
Foundation Trust UK
Saurabh_Jamdar
Mrs Catherine Fullwood University of Manchester UK -
Mr Michael Wilson NHS Forth Valley UK WilsonMSJ
Professor Giles Toogood Leeds Teaching Hospitals NHS
Trust UK
-
Professor Ajith Siriwardena Manchester University NHS
Foundation Trust UK
-
Key Contacts
For guidance relating to mini-team setup and audit registration please contact your local principal investigator (PI)
If you would be interested in signing up as PI for a new centre not currently involved or for any general enquiries
regarding the protocol please contact us via email (cholecovidgmailcom) or Twitter (CHOLECOVID)
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
4
Collaborative Partners
Association of Upper Gastrointestinal Surgery of Great Britain and Ireland wwwaugisorg Twitter augishealth Great Britain and Ireland Hepato-Pancreato-Biliary Association wwwgbihpbaorguk Twitter GBIHPBAnews
Americas Hepato-Pancreato-Biliary Association wwwahpbaorg Twitter AHPBA
Asian-Pacific Hepato-Pancreato-Biliary Association wwwa-phpbaorg Association of Surgeons of Great Britain and Ireland wwwasgbiorguk Twitter asgbi
Royal College Surgeons of England wwwrcsengacuk Twitter RCSNews Scottish Surgical Research Group wwwscottishsurgeonscom Twitter ScotSRG
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
5
Kent Surrey amp Sussex Surgeons Research Collaborative wwwksssurgeonscom Twitter kssresearch The Roux Group wwwrouxgrouporguk Twitter roux_group London Surgical Research Group wwwlsrgorguk
The University of Manchester wwwmanchesteracuk Twitter OfficialUoM
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
6
Study Delivery Timeline
Dates Description
1st May 2020 CHOLECOVID Study Launched
8th June 2020 First Principal Investigator (PI) REDCap Accounts Generated (then on a rolling twice-weekly basis for all new PIs ndash Tuesday and Fridays)
12th June 2020 First Collaborator REDCap Accounts Generated (then on a rolling twice-weekly basis for all new collaborators ndash Tuesday and Fridays)
18th June 2020 ndash 12th September 2020
REDCAP Data Collection Database Active Period
12th August 2020 Recruitment of New Sites closes
12th September 2020 REDCap Database Locked Final Data Submission Deadline
September 2020 Data Analysis
October 2020 Planned Dissemination of Results
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7
Introduction
Acute cholecystitis is inflammation of the gallbladder typically due to gallstones [12]
Internationally accepted guidelines provide information on standards for diagnosis and
optimum management [34] In patients without major co-morbidity laparoscopic
cholecystectomy during the index admission is the recommended treatment for acute
cholecystitis [567] A meta-analysis of randomized trials demonstrated that delayed
laparoscopic cholecystectomy increased the total hospital stay compared to an early
laparoscopic cholecystectomy after acute cholecystitis [8] Treatment with antibiotics
may be used as a temporising option or as an attempt to control symptoms in patients
who are unfit for surgery Radiologically guided percutaneous cholecystostomy can
also be a treatment option in patients who are unfit for surgery [9] Percutaneous
cholecystostomy is a recognised alternative treatment to cholecystectomy in high-risk
patients and can be used as a definitive option [101112] Although evidence is
limited this option is supported by international guidelines [13] The only randomised
controlled trial to compare laparoscopic cholecystectomy to percutaneous
cholecystostomy reported complications in 44 of the 68 patients (65) in the
percutaneous drainage arm compared to 8 of the 66 patients (12) in the group
undergoing surgery [14]
The outbreak of the novel coronavirus Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2 or COVID-19) has posed a significant challenge to
surgical healthcare systems across the world [15] The World Health Organization
declared a global pandemic due to SARS-CoV-2 on 12th March 2020 [16]
To cope with this unprecedented pandemic healthcare systems across the world cut
back or completely stopped elective surgery reduced non-elective surgery and
adopted non-surgical modes of treatment In the United Kingdom the Royal College
of Surgeons of England advised that non-operative treatment options should be
considered wherever possible for emergency presentations [17] In the case of acute
cholecystitis recommended non-operative management constitutes antibiotics alone
with percutaneous cholecystectomy in select patients [17] Similar guidance was
provided by the American College of Surgeons [18] and the Royal Australasian
College of Surgeons [19]
This study is an audit of the hospital management of patients with acute cholecystitis during the time of the COVID-19 pandemic The audit assesses treatment options and compares outcome to the reference standard of the Tokyo guidelines [34]
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8
Methods
1 Summary
CHOLECOVID is an international multi-centre audit regarding the management of
acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will
participate at each hospital with members ranging from medical students and
traineesresidents to supervising consultantsattending will participate at each
hospital They will retrospectively collect data on patients admitted to hospital with
acute cholecystitis during two separate data periods (a specified pre COVID-19
pandemic period and a specified period during the COVID-19 pandemic) Each centre
will be required to complete a survey detailing their local acute cholecystitis
management practices
Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and
up-to four additional collaborators (data collectors) ndash all five members will be involved in the data
collection at each site supported by a supervising consultant where appropriatepossible No more
than one mini-team will be collecting data at any one hospital site All collaborating members will be
listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met
(discussed in Authorship section)
2 Study Aims
Primary aim
To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the
management of acute cholecystitis
Secondary aims
bull To characterise severity of acute cholecystitis admitted to hospital during the
COVID-19 pandemic
bull To explore changes in management and outcomes associated with acute
cholecystitis during the COVID-19 pandemic
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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2
Table of Contents
CHOLECOVID Steering Group 3
Collaborative Partners 4
Study Delivery Timeline 6
Introduction 7
Methods 8
1 Summary 8
2 Study Aims 8
3 Project Timeline 9
4 Design 9
5 Setting 9
6 Patients 10
7 Definition of Acute Cholecystitis 10
8 Eligibility Criteria 10
9 Data Collection 11
10 Local Project Registration and Ethics 12
11 Analysis Plan 12
12 Authorship 13
13 Expected Outputs 15
Appendix A Case Report Form 16
Appendix B Data Dictionary 17
Appendix C CHOLECOVID Site Survey 27
Appendix D Tokyo Guidelines Audit Standard Adaptation 28
Appendix E Charlson Comorbidity Index Score 29
Appendix F KDIGO Clinical Practice Guidelines for AKI 30
Appendix G Tokyo Guidelines for Severity Grading of Acute Cholecystitis 31
Appendix H Clavien-Dindo Grading of Surgical Complications 32
Appendix I CHOLECOVID PI REDCap Guide 33
Appendix J NHS Health Research Authority Outcome 40
Appendix K References 41
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3
CHOLECOVID Steering Group
Name Organisation Twitter
Dr Harry V M Spiers Manchester University NHS
Foundation Trust UK
Harryvmspiers
Miss Rebecca Varley Manchester University NHS
Foundation Trust UK
Varley_RJ
Waheed-Ul-Rahman Ahmed University of Oxford UK WaheedURAhmed1
Dr Omar Kouli Greater Glasgow and Clyde
NHS Foundation Trust UK
Kouli_omar
Mr Daniel Ahari University of Manchester UK AhariDaniel
Miss Leah Argus University of Manchester UK Leahargus
Mr Kenneth McLean University of Edinburgh UK Kennethmclean92
Mr Sivesh Kamarajah Newcastle Upon Tyne Hospitals
NHS Foundation Trust UK
Siveshk
Dr Matthew Goldsworthy Manchester University NHS
Foundation Trust UK
MattGoldsworthy
Mr Peter Coe Leeds Teaching Hospitals NHS
Trust UK
Petecoe1
Mr Majid Rashid NHS Fife UK -
Mr Ewen Griffiths University Hospitals Birmingham
NHS Foundation Trust UK
EwenGriffiths
Mr Anthony Chan Manchester University NHS
Foundation Trust UK
Anthonykcchan
Mr Christian Macutkiewicz Manchester University NHS
Foundation Trust UK
SurgeryHPB
Mr Saurabh Jamdar Manchester University NHS
Foundation Trust UK
Saurabh_Jamdar
Mrs Catherine Fullwood University of Manchester UK -
Mr Michael Wilson NHS Forth Valley UK WilsonMSJ
Professor Giles Toogood Leeds Teaching Hospitals NHS
Trust UK
-
Professor Ajith Siriwardena Manchester University NHS
Foundation Trust UK
-
Key Contacts
For guidance relating to mini-team setup and audit registration please contact your local principal investigator (PI)
If you would be interested in signing up as PI for a new centre not currently involved or for any general enquiries
regarding the protocol please contact us via email (cholecovidgmailcom) or Twitter (CHOLECOVID)
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4
Collaborative Partners
Association of Upper Gastrointestinal Surgery of Great Britain and Ireland wwwaugisorg Twitter augishealth Great Britain and Ireland Hepato-Pancreato-Biliary Association wwwgbihpbaorguk Twitter GBIHPBAnews
Americas Hepato-Pancreato-Biliary Association wwwahpbaorg Twitter AHPBA
Asian-Pacific Hepato-Pancreato-Biliary Association wwwa-phpbaorg Association of Surgeons of Great Britain and Ireland wwwasgbiorguk Twitter asgbi
Royal College Surgeons of England wwwrcsengacuk Twitter RCSNews Scottish Surgical Research Group wwwscottishsurgeonscom Twitter ScotSRG
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Kent Surrey amp Sussex Surgeons Research Collaborative wwwksssurgeonscom Twitter kssresearch The Roux Group wwwrouxgrouporguk Twitter roux_group London Surgical Research Group wwwlsrgorguk
The University of Manchester wwwmanchesteracuk Twitter OfficialUoM
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6
Study Delivery Timeline
Dates Description
1st May 2020 CHOLECOVID Study Launched
8th June 2020 First Principal Investigator (PI) REDCap Accounts Generated (then on a rolling twice-weekly basis for all new PIs ndash Tuesday and Fridays)
12th June 2020 First Collaborator REDCap Accounts Generated (then on a rolling twice-weekly basis for all new collaborators ndash Tuesday and Fridays)
18th June 2020 ndash 12th September 2020
REDCAP Data Collection Database Active Period
12th August 2020 Recruitment of New Sites closes
12th September 2020 REDCap Database Locked Final Data Submission Deadline
September 2020 Data Analysis
October 2020 Planned Dissemination of Results
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7
Introduction
Acute cholecystitis is inflammation of the gallbladder typically due to gallstones [12]
Internationally accepted guidelines provide information on standards for diagnosis and
optimum management [34] In patients without major co-morbidity laparoscopic
cholecystectomy during the index admission is the recommended treatment for acute
cholecystitis [567] A meta-analysis of randomized trials demonstrated that delayed
laparoscopic cholecystectomy increased the total hospital stay compared to an early
laparoscopic cholecystectomy after acute cholecystitis [8] Treatment with antibiotics
may be used as a temporising option or as an attempt to control symptoms in patients
who are unfit for surgery Radiologically guided percutaneous cholecystostomy can
also be a treatment option in patients who are unfit for surgery [9] Percutaneous
cholecystostomy is a recognised alternative treatment to cholecystectomy in high-risk
patients and can be used as a definitive option [101112] Although evidence is
limited this option is supported by international guidelines [13] The only randomised
controlled trial to compare laparoscopic cholecystectomy to percutaneous
cholecystostomy reported complications in 44 of the 68 patients (65) in the
percutaneous drainage arm compared to 8 of the 66 patients (12) in the group
undergoing surgery [14]
The outbreak of the novel coronavirus Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2 or COVID-19) has posed a significant challenge to
surgical healthcare systems across the world [15] The World Health Organization
declared a global pandemic due to SARS-CoV-2 on 12th March 2020 [16]
To cope with this unprecedented pandemic healthcare systems across the world cut
back or completely stopped elective surgery reduced non-elective surgery and
adopted non-surgical modes of treatment In the United Kingdom the Royal College
of Surgeons of England advised that non-operative treatment options should be
considered wherever possible for emergency presentations [17] In the case of acute
cholecystitis recommended non-operative management constitutes antibiotics alone
with percutaneous cholecystectomy in select patients [17] Similar guidance was
provided by the American College of Surgeons [18] and the Royal Australasian
College of Surgeons [19]
This study is an audit of the hospital management of patients with acute cholecystitis during the time of the COVID-19 pandemic The audit assesses treatment options and compares outcome to the reference standard of the Tokyo guidelines [34]
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8
Methods
1 Summary
CHOLECOVID is an international multi-centre audit regarding the management of
acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will
participate at each hospital with members ranging from medical students and
traineesresidents to supervising consultantsattending will participate at each
hospital They will retrospectively collect data on patients admitted to hospital with
acute cholecystitis during two separate data periods (a specified pre COVID-19
pandemic period and a specified period during the COVID-19 pandemic) Each centre
will be required to complete a survey detailing their local acute cholecystitis
management practices
Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and
up-to four additional collaborators (data collectors) ndash all five members will be involved in the data
collection at each site supported by a supervising consultant where appropriatepossible No more
than one mini-team will be collecting data at any one hospital site All collaborating members will be
listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met
(discussed in Authorship section)
2 Study Aims
Primary aim
To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the
management of acute cholecystitis
Secondary aims
bull To characterise severity of acute cholecystitis admitted to hospital during the
COVID-19 pandemic
bull To explore changes in management and outcomes associated with acute
cholecystitis during the COVID-19 pandemic
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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3
CHOLECOVID Steering Group
Name Organisation Twitter
Dr Harry V M Spiers Manchester University NHS
Foundation Trust UK
Harryvmspiers
Miss Rebecca Varley Manchester University NHS
Foundation Trust UK
Varley_RJ
Waheed-Ul-Rahman Ahmed University of Oxford UK WaheedURAhmed1
Dr Omar Kouli Greater Glasgow and Clyde
NHS Foundation Trust UK
Kouli_omar
Mr Daniel Ahari University of Manchester UK AhariDaniel
Miss Leah Argus University of Manchester UK Leahargus
Mr Kenneth McLean University of Edinburgh UK Kennethmclean92
Mr Sivesh Kamarajah Newcastle Upon Tyne Hospitals
NHS Foundation Trust UK
Siveshk
Dr Matthew Goldsworthy Manchester University NHS
Foundation Trust UK
MattGoldsworthy
Mr Peter Coe Leeds Teaching Hospitals NHS
Trust UK
Petecoe1
Mr Majid Rashid NHS Fife UK -
Mr Ewen Griffiths University Hospitals Birmingham
NHS Foundation Trust UK
EwenGriffiths
Mr Anthony Chan Manchester University NHS
Foundation Trust UK
Anthonykcchan
Mr Christian Macutkiewicz Manchester University NHS
Foundation Trust UK
SurgeryHPB
Mr Saurabh Jamdar Manchester University NHS
Foundation Trust UK
Saurabh_Jamdar
Mrs Catherine Fullwood University of Manchester UK -
Mr Michael Wilson NHS Forth Valley UK WilsonMSJ
Professor Giles Toogood Leeds Teaching Hospitals NHS
Trust UK
-
Professor Ajith Siriwardena Manchester University NHS
Foundation Trust UK
-
Key Contacts
For guidance relating to mini-team setup and audit registration please contact your local principal investigator (PI)
If you would be interested in signing up as PI for a new centre not currently involved or for any general enquiries
regarding the protocol please contact us via email (cholecovidgmailcom) or Twitter (CHOLECOVID)
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Collaborative Partners
Association of Upper Gastrointestinal Surgery of Great Britain and Ireland wwwaugisorg Twitter augishealth Great Britain and Ireland Hepato-Pancreato-Biliary Association wwwgbihpbaorguk Twitter GBIHPBAnews
Americas Hepato-Pancreato-Biliary Association wwwahpbaorg Twitter AHPBA
Asian-Pacific Hepato-Pancreato-Biliary Association wwwa-phpbaorg Association of Surgeons of Great Britain and Ireland wwwasgbiorguk Twitter asgbi
Royal College Surgeons of England wwwrcsengacuk Twitter RCSNews Scottish Surgical Research Group wwwscottishsurgeonscom Twitter ScotSRG
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Kent Surrey amp Sussex Surgeons Research Collaborative wwwksssurgeonscom Twitter kssresearch The Roux Group wwwrouxgrouporguk Twitter roux_group London Surgical Research Group wwwlsrgorguk
The University of Manchester wwwmanchesteracuk Twitter OfficialUoM
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6
Study Delivery Timeline
Dates Description
1st May 2020 CHOLECOVID Study Launched
8th June 2020 First Principal Investigator (PI) REDCap Accounts Generated (then on a rolling twice-weekly basis for all new PIs ndash Tuesday and Fridays)
12th June 2020 First Collaborator REDCap Accounts Generated (then on a rolling twice-weekly basis for all new collaborators ndash Tuesday and Fridays)
18th June 2020 ndash 12th September 2020
REDCAP Data Collection Database Active Period
12th August 2020 Recruitment of New Sites closes
12th September 2020 REDCap Database Locked Final Data Submission Deadline
September 2020 Data Analysis
October 2020 Planned Dissemination of Results
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7
Introduction
Acute cholecystitis is inflammation of the gallbladder typically due to gallstones [12]
Internationally accepted guidelines provide information on standards for diagnosis and
optimum management [34] In patients without major co-morbidity laparoscopic
cholecystectomy during the index admission is the recommended treatment for acute
cholecystitis [567] A meta-analysis of randomized trials demonstrated that delayed
laparoscopic cholecystectomy increased the total hospital stay compared to an early
laparoscopic cholecystectomy after acute cholecystitis [8] Treatment with antibiotics
may be used as a temporising option or as an attempt to control symptoms in patients
who are unfit for surgery Radiologically guided percutaneous cholecystostomy can
also be a treatment option in patients who are unfit for surgery [9] Percutaneous
cholecystostomy is a recognised alternative treatment to cholecystectomy in high-risk
patients and can be used as a definitive option [101112] Although evidence is
limited this option is supported by international guidelines [13] The only randomised
controlled trial to compare laparoscopic cholecystectomy to percutaneous
cholecystostomy reported complications in 44 of the 68 patients (65) in the
percutaneous drainage arm compared to 8 of the 66 patients (12) in the group
undergoing surgery [14]
The outbreak of the novel coronavirus Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2 or COVID-19) has posed a significant challenge to
surgical healthcare systems across the world [15] The World Health Organization
declared a global pandemic due to SARS-CoV-2 on 12th March 2020 [16]
To cope with this unprecedented pandemic healthcare systems across the world cut
back or completely stopped elective surgery reduced non-elective surgery and
adopted non-surgical modes of treatment In the United Kingdom the Royal College
of Surgeons of England advised that non-operative treatment options should be
considered wherever possible for emergency presentations [17] In the case of acute
cholecystitis recommended non-operative management constitutes antibiotics alone
with percutaneous cholecystectomy in select patients [17] Similar guidance was
provided by the American College of Surgeons [18] and the Royal Australasian
College of Surgeons [19]
This study is an audit of the hospital management of patients with acute cholecystitis during the time of the COVID-19 pandemic The audit assesses treatment options and compares outcome to the reference standard of the Tokyo guidelines [34]
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8
Methods
1 Summary
CHOLECOVID is an international multi-centre audit regarding the management of
acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will
participate at each hospital with members ranging from medical students and
traineesresidents to supervising consultantsattending will participate at each
hospital They will retrospectively collect data on patients admitted to hospital with
acute cholecystitis during two separate data periods (a specified pre COVID-19
pandemic period and a specified period during the COVID-19 pandemic) Each centre
will be required to complete a survey detailing their local acute cholecystitis
management practices
Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and
up-to four additional collaborators (data collectors) ndash all five members will be involved in the data
collection at each site supported by a supervising consultant where appropriatepossible No more
than one mini-team will be collecting data at any one hospital site All collaborating members will be
listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met
(discussed in Authorship section)
2 Study Aims
Primary aim
To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the
management of acute cholecystitis
Secondary aims
bull To characterise severity of acute cholecystitis admitted to hospital during the
COVID-19 pandemic
bull To explore changes in management and outcomes associated with acute
cholecystitis during the COVID-19 pandemic
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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4
Collaborative Partners
Association of Upper Gastrointestinal Surgery of Great Britain and Ireland wwwaugisorg Twitter augishealth Great Britain and Ireland Hepato-Pancreato-Biliary Association wwwgbihpbaorguk Twitter GBIHPBAnews
Americas Hepato-Pancreato-Biliary Association wwwahpbaorg Twitter AHPBA
Asian-Pacific Hepato-Pancreato-Biliary Association wwwa-phpbaorg Association of Surgeons of Great Britain and Ireland wwwasgbiorguk Twitter asgbi
Royal College Surgeons of England wwwrcsengacuk Twitter RCSNews Scottish Surgical Research Group wwwscottishsurgeonscom Twitter ScotSRG
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5
Kent Surrey amp Sussex Surgeons Research Collaborative wwwksssurgeonscom Twitter kssresearch The Roux Group wwwrouxgrouporguk Twitter roux_group London Surgical Research Group wwwlsrgorguk
The University of Manchester wwwmanchesteracuk Twitter OfficialUoM
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6
Study Delivery Timeline
Dates Description
1st May 2020 CHOLECOVID Study Launched
8th June 2020 First Principal Investigator (PI) REDCap Accounts Generated (then on a rolling twice-weekly basis for all new PIs ndash Tuesday and Fridays)
12th June 2020 First Collaborator REDCap Accounts Generated (then on a rolling twice-weekly basis for all new collaborators ndash Tuesday and Fridays)
18th June 2020 ndash 12th September 2020
REDCAP Data Collection Database Active Period
12th August 2020 Recruitment of New Sites closes
12th September 2020 REDCap Database Locked Final Data Submission Deadline
September 2020 Data Analysis
October 2020 Planned Dissemination of Results
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7
Introduction
Acute cholecystitis is inflammation of the gallbladder typically due to gallstones [12]
Internationally accepted guidelines provide information on standards for diagnosis and
optimum management [34] In patients without major co-morbidity laparoscopic
cholecystectomy during the index admission is the recommended treatment for acute
cholecystitis [567] A meta-analysis of randomized trials demonstrated that delayed
laparoscopic cholecystectomy increased the total hospital stay compared to an early
laparoscopic cholecystectomy after acute cholecystitis [8] Treatment with antibiotics
may be used as a temporising option or as an attempt to control symptoms in patients
who are unfit for surgery Radiologically guided percutaneous cholecystostomy can
also be a treatment option in patients who are unfit for surgery [9] Percutaneous
cholecystostomy is a recognised alternative treatment to cholecystectomy in high-risk
patients and can be used as a definitive option [101112] Although evidence is
limited this option is supported by international guidelines [13] The only randomised
controlled trial to compare laparoscopic cholecystectomy to percutaneous
cholecystostomy reported complications in 44 of the 68 patients (65) in the
percutaneous drainage arm compared to 8 of the 66 patients (12) in the group
undergoing surgery [14]
The outbreak of the novel coronavirus Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2 or COVID-19) has posed a significant challenge to
surgical healthcare systems across the world [15] The World Health Organization
declared a global pandemic due to SARS-CoV-2 on 12th March 2020 [16]
To cope with this unprecedented pandemic healthcare systems across the world cut
back or completely stopped elective surgery reduced non-elective surgery and
adopted non-surgical modes of treatment In the United Kingdom the Royal College
of Surgeons of England advised that non-operative treatment options should be
considered wherever possible for emergency presentations [17] In the case of acute
cholecystitis recommended non-operative management constitutes antibiotics alone
with percutaneous cholecystectomy in select patients [17] Similar guidance was
provided by the American College of Surgeons [18] and the Royal Australasian
College of Surgeons [19]
This study is an audit of the hospital management of patients with acute cholecystitis during the time of the COVID-19 pandemic The audit assesses treatment options and compares outcome to the reference standard of the Tokyo guidelines [34]
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8
Methods
1 Summary
CHOLECOVID is an international multi-centre audit regarding the management of
acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will
participate at each hospital with members ranging from medical students and
traineesresidents to supervising consultantsattending will participate at each
hospital They will retrospectively collect data on patients admitted to hospital with
acute cholecystitis during two separate data periods (a specified pre COVID-19
pandemic period and a specified period during the COVID-19 pandemic) Each centre
will be required to complete a survey detailing their local acute cholecystitis
management practices
Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and
up-to four additional collaborators (data collectors) ndash all five members will be involved in the data
collection at each site supported by a supervising consultant where appropriatepossible No more
than one mini-team will be collecting data at any one hospital site All collaborating members will be
listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met
(discussed in Authorship section)
2 Study Aims
Primary aim
To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the
management of acute cholecystitis
Secondary aims
bull To characterise severity of acute cholecystitis admitted to hospital during the
COVID-19 pandemic
bull To explore changes in management and outcomes associated with acute
cholecystitis during the COVID-19 pandemic
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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5
Kent Surrey amp Sussex Surgeons Research Collaborative wwwksssurgeonscom Twitter kssresearch The Roux Group wwwrouxgrouporguk Twitter roux_group London Surgical Research Group wwwlsrgorguk
The University of Manchester wwwmanchesteracuk Twitter OfficialUoM
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6
Study Delivery Timeline
Dates Description
1st May 2020 CHOLECOVID Study Launched
8th June 2020 First Principal Investigator (PI) REDCap Accounts Generated (then on a rolling twice-weekly basis for all new PIs ndash Tuesday and Fridays)
12th June 2020 First Collaborator REDCap Accounts Generated (then on a rolling twice-weekly basis for all new collaborators ndash Tuesday and Fridays)
18th June 2020 ndash 12th September 2020
REDCAP Data Collection Database Active Period
12th August 2020 Recruitment of New Sites closes
12th September 2020 REDCap Database Locked Final Data Submission Deadline
September 2020 Data Analysis
October 2020 Planned Dissemination of Results
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7
Introduction
Acute cholecystitis is inflammation of the gallbladder typically due to gallstones [12]
Internationally accepted guidelines provide information on standards for diagnosis and
optimum management [34] In patients without major co-morbidity laparoscopic
cholecystectomy during the index admission is the recommended treatment for acute
cholecystitis [567] A meta-analysis of randomized trials demonstrated that delayed
laparoscopic cholecystectomy increased the total hospital stay compared to an early
laparoscopic cholecystectomy after acute cholecystitis [8] Treatment with antibiotics
may be used as a temporising option or as an attempt to control symptoms in patients
who are unfit for surgery Radiologically guided percutaneous cholecystostomy can
also be a treatment option in patients who are unfit for surgery [9] Percutaneous
cholecystostomy is a recognised alternative treatment to cholecystectomy in high-risk
patients and can be used as a definitive option [101112] Although evidence is
limited this option is supported by international guidelines [13] The only randomised
controlled trial to compare laparoscopic cholecystectomy to percutaneous
cholecystostomy reported complications in 44 of the 68 patients (65) in the
percutaneous drainage arm compared to 8 of the 66 patients (12) in the group
undergoing surgery [14]
The outbreak of the novel coronavirus Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2 or COVID-19) has posed a significant challenge to
surgical healthcare systems across the world [15] The World Health Organization
declared a global pandemic due to SARS-CoV-2 on 12th March 2020 [16]
To cope with this unprecedented pandemic healthcare systems across the world cut
back or completely stopped elective surgery reduced non-elective surgery and
adopted non-surgical modes of treatment In the United Kingdom the Royal College
of Surgeons of England advised that non-operative treatment options should be
considered wherever possible for emergency presentations [17] In the case of acute
cholecystitis recommended non-operative management constitutes antibiotics alone
with percutaneous cholecystectomy in select patients [17] Similar guidance was
provided by the American College of Surgeons [18] and the Royal Australasian
College of Surgeons [19]
This study is an audit of the hospital management of patients with acute cholecystitis during the time of the COVID-19 pandemic The audit assesses treatment options and compares outcome to the reference standard of the Tokyo guidelines [34]
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8
Methods
1 Summary
CHOLECOVID is an international multi-centre audit regarding the management of
acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will
participate at each hospital with members ranging from medical students and
traineesresidents to supervising consultantsattending will participate at each
hospital They will retrospectively collect data on patients admitted to hospital with
acute cholecystitis during two separate data periods (a specified pre COVID-19
pandemic period and a specified period during the COVID-19 pandemic) Each centre
will be required to complete a survey detailing their local acute cholecystitis
management practices
Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and
up-to four additional collaborators (data collectors) ndash all five members will be involved in the data
collection at each site supported by a supervising consultant where appropriatepossible No more
than one mini-team will be collecting data at any one hospital site All collaborating members will be
listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met
(discussed in Authorship section)
2 Study Aims
Primary aim
To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the
management of acute cholecystitis
Secondary aims
bull To characterise severity of acute cholecystitis admitted to hospital during the
COVID-19 pandemic
bull To explore changes in management and outcomes associated with acute
cholecystitis during the COVID-19 pandemic
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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6
Study Delivery Timeline
Dates Description
1st May 2020 CHOLECOVID Study Launched
8th June 2020 First Principal Investigator (PI) REDCap Accounts Generated (then on a rolling twice-weekly basis for all new PIs ndash Tuesday and Fridays)
12th June 2020 First Collaborator REDCap Accounts Generated (then on a rolling twice-weekly basis for all new collaborators ndash Tuesday and Fridays)
18th June 2020 ndash 12th September 2020
REDCAP Data Collection Database Active Period
12th August 2020 Recruitment of New Sites closes
12th September 2020 REDCap Database Locked Final Data Submission Deadline
September 2020 Data Analysis
October 2020 Planned Dissemination of Results
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7
Introduction
Acute cholecystitis is inflammation of the gallbladder typically due to gallstones [12]
Internationally accepted guidelines provide information on standards for diagnosis and
optimum management [34] In patients without major co-morbidity laparoscopic
cholecystectomy during the index admission is the recommended treatment for acute
cholecystitis [567] A meta-analysis of randomized trials demonstrated that delayed
laparoscopic cholecystectomy increased the total hospital stay compared to an early
laparoscopic cholecystectomy after acute cholecystitis [8] Treatment with antibiotics
may be used as a temporising option or as an attempt to control symptoms in patients
who are unfit for surgery Radiologically guided percutaneous cholecystostomy can
also be a treatment option in patients who are unfit for surgery [9] Percutaneous
cholecystostomy is a recognised alternative treatment to cholecystectomy in high-risk
patients and can be used as a definitive option [101112] Although evidence is
limited this option is supported by international guidelines [13] The only randomised
controlled trial to compare laparoscopic cholecystectomy to percutaneous
cholecystostomy reported complications in 44 of the 68 patients (65) in the
percutaneous drainage arm compared to 8 of the 66 patients (12) in the group
undergoing surgery [14]
The outbreak of the novel coronavirus Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2 or COVID-19) has posed a significant challenge to
surgical healthcare systems across the world [15] The World Health Organization
declared a global pandemic due to SARS-CoV-2 on 12th March 2020 [16]
To cope with this unprecedented pandemic healthcare systems across the world cut
back or completely stopped elective surgery reduced non-elective surgery and
adopted non-surgical modes of treatment In the United Kingdom the Royal College
of Surgeons of England advised that non-operative treatment options should be
considered wherever possible for emergency presentations [17] In the case of acute
cholecystitis recommended non-operative management constitutes antibiotics alone
with percutaneous cholecystectomy in select patients [17] Similar guidance was
provided by the American College of Surgeons [18] and the Royal Australasian
College of Surgeons [19]
This study is an audit of the hospital management of patients with acute cholecystitis during the time of the COVID-19 pandemic The audit assesses treatment options and compares outcome to the reference standard of the Tokyo guidelines [34]
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8
Methods
1 Summary
CHOLECOVID is an international multi-centre audit regarding the management of
acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will
participate at each hospital with members ranging from medical students and
traineesresidents to supervising consultantsattending will participate at each
hospital They will retrospectively collect data on patients admitted to hospital with
acute cholecystitis during two separate data periods (a specified pre COVID-19
pandemic period and a specified period during the COVID-19 pandemic) Each centre
will be required to complete a survey detailing their local acute cholecystitis
management practices
Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and
up-to four additional collaborators (data collectors) ndash all five members will be involved in the data
collection at each site supported by a supervising consultant where appropriatepossible No more
than one mini-team will be collecting data at any one hospital site All collaborating members will be
listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met
(discussed in Authorship section)
2 Study Aims
Primary aim
To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the
management of acute cholecystitis
Secondary aims
bull To characterise severity of acute cholecystitis admitted to hospital during the
COVID-19 pandemic
bull To explore changes in management and outcomes associated with acute
cholecystitis during the COVID-19 pandemic
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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7
Introduction
Acute cholecystitis is inflammation of the gallbladder typically due to gallstones [12]
Internationally accepted guidelines provide information on standards for diagnosis and
optimum management [34] In patients without major co-morbidity laparoscopic
cholecystectomy during the index admission is the recommended treatment for acute
cholecystitis [567] A meta-analysis of randomized trials demonstrated that delayed
laparoscopic cholecystectomy increased the total hospital stay compared to an early
laparoscopic cholecystectomy after acute cholecystitis [8] Treatment with antibiotics
may be used as a temporising option or as an attempt to control symptoms in patients
who are unfit for surgery Radiologically guided percutaneous cholecystostomy can
also be a treatment option in patients who are unfit for surgery [9] Percutaneous
cholecystostomy is a recognised alternative treatment to cholecystectomy in high-risk
patients and can be used as a definitive option [101112] Although evidence is
limited this option is supported by international guidelines [13] The only randomised
controlled trial to compare laparoscopic cholecystectomy to percutaneous
cholecystostomy reported complications in 44 of the 68 patients (65) in the
percutaneous drainage arm compared to 8 of the 66 patients (12) in the group
undergoing surgery [14]
The outbreak of the novel coronavirus Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2 or COVID-19) has posed a significant challenge to
surgical healthcare systems across the world [15] The World Health Organization
declared a global pandemic due to SARS-CoV-2 on 12th March 2020 [16]
To cope with this unprecedented pandemic healthcare systems across the world cut
back or completely stopped elective surgery reduced non-elective surgery and
adopted non-surgical modes of treatment In the United Kingdom the Royal College
of Surgeons of England advised that non-operative treatment options should be
considered wherever possible for emergency presentations [17] In the case of acute
cholecystitis recommended non-operative management constitutes antibiotics alone
with percutaneous cholecystectomy in select patients [17] Similar guidance was
provided by the American College of Surgeons [18] and the Royal Australasian
College of Surgeons [19]
This study is an audit of the hospital management of patients with acute cholecystitis during the time of the COVID-19 pandemic The audit assesses treatment options and compares outcome to the reference standard of the Tokyo guidelines [34]
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8
Methods
1 Summary
CHOLECOVID is an international multi-centre audit regarding the management of
acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will
participate at each hospital with members ranging from medical students and
traineesresidents to supervising consultantsattending will participate at each
hospital They will retrospectively collect data on patients admitted to hospital with
acute cholecystitis during two separate data periods (a specified pre COVID-19
pandemic period and a specified period during the COVID-19 pandemic) Each centre
will be required to complete a survey detailing their local acute cholecystitis
management practices
Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and
up-to four additional collaborators (data collectors) ndash all five members will be involved in the data
collection at each site supported by a supervising consultant where appropriatepossible No more
than one mini-team will be collecting data at any one hospital site All collaborating members will be
listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met
(discussed in Authorship section)
2 Study Aims
Primary aim
To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the
management of acute cholecystitis
Secondary aims
bull To characterise severity of acute cholecystitis admitted to hospital during the
COVID-19 pandemic
bull To explore changes in management and outcomes associated with acute
cholecystitis during the COVID-19 pandemic
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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8
Methods
1 Summary
CHOLECOVID is an international multi-centre audit regarding the management of
acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will
participate at each hospital with members ranging from medical students and
traineesresidents to supervising consultantsattending will participate at each
hospital They will retrospectively collect data on patients admitted to hospital with
acute cholecystitis during two separate data periods (a specified pre COVID-19
pandemic period and a specified period during the COVID-19 pandemic) Each centre
will be required to complete a survey detailing their local acute cholecystitis
management practices
Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and
up-to four additional collaborators (data collectors) ndash all five members will be involved in the data
collection at each site supported by a supervising consultant where appropriatepossible No more
than one mini-team will be collecting data at any one hospital site All collaborating members will be
listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met
(discussed in Authorship section)
2 Study Aims
Primary aim
To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the
management of acute cholecystitis
Secondary aims
bull To characterise severity of acute cholecystitis admitted to hospital during the
COVID-19 pandemic
bull To explore changes in management and outcomes associated with acute
cholecystitis during the COVID-19 pandemic
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
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17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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9
3 Project Timeline
Collaborators at each participating site will retrospectively collect data covering all
admissions with acute cholecystitis over two pre-specified 2-month periods
1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)
2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)
Each patient will be followed up for 30-days from the first day of index admission If
the patient undergoes cholecystectomy within that 30-day follow up period they will
be followed up for 30-days post-operatively This will allow comparison between the
management and outcomes of patients with acute cholecystitis before and during the
COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th
September 2020
4 Design
CHOLECOVID is an international multi-centre audit
5 Setting
CHOLECOVID is open to any hospitalsite in the world that treats patients with
acute cholecystitis In order to describe local processes and resources each site will
be asked to complete an online site survey questionnaire to understand local
management of acute cholecystitis (Appendix D) All participating centres will be
required to register the study according to local regulations evidence of which will be
uploaded onto REDCap prior to commencement of data collection from each
respective site
Clarification Note
Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
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17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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10
6 Patients
Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute
the study population
7 Definition of Acute Cholecystitis
Acute inflammation of the gallbladder with pain for over 24 hours often with systemic
upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive
protein (CRP) and at least one imaging modality with findings characteristic of acute
cholecystitis [34]
8 Eligibility Criteria
Inclusion criteria
bull All adult patients (greater than or including 18 years of age)
bull Admitted to hospital within the pre-specified data collection periods
bull Clinical features of acute cholecystitis including local signs of inflammation
(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised
inflammatory markers (WCC CRP)
bull Documented diagnosis of acute cholecystitis as demonstrated by at least one
radiological test (USS MRCP or Computed Tomography (CT))
Exclusion criteria
bull Patients less than 18 years of age
Completion of the short site survey can be done by a PIsupervising consultant (preferred) or
trainee that is familiar with the acute cholecystitis management practices at your site Completion
of the site survey is necessary before the site is granted access to the CHOLECOVID Data
Collection form on REDCap
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9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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11
9 Data Collection
Data will be collected and stored online via the Research Electronic Data Capture
(REDCap) web application [2021] hosted and managed by the University of
Manchester United Kingdom No patient identifiable data will be uploaded or stored
on the REDCap database A designated local principal investigator (PI) and a
maximum of four additional collaborators will be identified per site making a total of
five collaborators at each participating site Additional collaborators may be allowed
in certain cases such as at particularly high-volume centres only after discussion
with and at the discretion of the CHOLECOVID Steering Group
Data will be collected in the following categories
1 Demographics
2 Diagnosis
3 Intervention
4 COVID-19 status
5 Follow Up
Data will be collected on audit standards and confounding factors for management
and outcomes related to acute cholecystitis to permit accurate risk adjustment of
outcomes This will include COVID-19 status on admission and during in-patient
course Without appropriately adjusting for risk factors it is likely that any findings
would be biased and unable to be appropriately analysed on a national and
international scale Data will be collected according to the case report forms and
data dictionary outlined in Appendix A and B
Top tip
Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form
(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible
patients
You should collect data on all patients meeting the inclusion criteria All eligible patients must be
included All four inclusion criteria must be met for all patients uploaded onto the REDCap
database
CHOLECOVID Study Protocol Version 121 25th June 2020
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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12
10 Local Project Registration and Ethics
All participating centres will be required to register the study according to local
regulations evidence of which will be uploaded to REDCap prior to commencement
of data collection It may be necessary to obtain formal research ethics approval in
some participating countries In the United Kingdom this project should be
registered as a clinical audit or service evaluation (as per NHS Health Research
Authority Guidance ndash Appendix J)
The principal investigator at each site is responsible for obtaining necessary local
approvals (eg audit approval service evaluation research ethics committee or
institutional review board approval) Principal investigators should discuss with their
head of department to expedite the approval process wherever possible in view of
the urgency of the global pandemic Regardless of the approval pathway chosen it
should be stressed that this is an investigator-led non-commercial study which
requires no changes to normal patient care and only routinely available non-
identifiable data will be collected No patient identifiable data will be uploaded or
stored on the REDCap database
Seek advice from PIsupervising consultant on how you may register the study at your hospital
and what approvals would be required These must be added to the REDCap database as
evidence by the PI You may also seek advice from your local audit department or get in touch
with the CHOLECOVID Collaborative should you require any further advice
11 Analysis plan
A full data analysis plan will be written Initially data will be reported using
descriptive analyses Comparisons between groups and to reference standards will
be undertaken using appropriate non-parametric analyses There will be no
comparison of data between individual sites
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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13
12 Authorship
All research outputs from the CHOLECOVID study will be authored as per the
National Research Collaborative (NRC) authorship guidelines [24] All collaborators
will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative
in accordance with the roles defined below (so long as the minimum requirements for
authorship are met)
A designated principal investigator (PI) hospital lead and a further four collaborators
(data collectors) will be identified per site making a total of five collaborators at each
participating site
bull Local Principal Investigator (hospital lead) A single lead point of contact
for data collection at each site who has overall responsibility for site
governance registration and supporting data collection PIs are recommended
to be either a consultant or trainee at each site and only one person can fulfil
this role Minimum requirements for authorship include
o Primary person responsible in obtaining local approvals for conduct of
the CHOLECOVID audit (eg registration of the audit seeking
Caldicott guardian (or equivalent) permission to upload data to
REDCap)
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Coordination of presentation of local results at their centre from the
CHOLECOVID audit (or otherwise arranges another collaborator to
present on their behalf)
bull Local collaborators (data collectors) A team of up to four data collectors
per centre although this should be appropriate to the anticipated case load)
To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI
(httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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14
Minimum requirements for authorship on CHOLECOVID outputs include
o Compliance with local audit approval processes and data governance
policies
o Active involvement in data collection over at least one data collection
period at a centre which meets the criteria for inclusion within the
CHOLECOVID dataset
o Collaboration with the hospital lead to ensure that the audit results are
reported back to the audit office clinical teams
bull Supervising Consultant Where the Principal Investigator at the centre is not
a consultant data collection in each hospital must be supervised and
supported by a named consultant Minimum requirements for authorship on
CHOLECOVID outputs include
o Sponsorship of local study registration and responsibility to ensure
local collaborators act in accordance with local governance guidelines
o Successful completion of data collection at a centre which meets the
criteria for inclusion within the CHOLECOVID dataset
o Facilitation of local result presentation and support of appropriate local
interventions
o Completion of workplace-based assessments for data collectors if
requested
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
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15
Centres who do not upload patients meeting the eligibility criteria OR with gt5 of
missing data uploaded will be excluded from the analysis and the contributing data
collectors excluded from authorship Sponsorship through the audit approval project
registration process by a consultant does not constitute authorship nor does
inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship
Criteria for site inclusion within CHOLECOVID
bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study
bull Have completed the short site survey
bull Successful data collection of at least one eligible patient per period for each site
bull Individual sites must also ensure
1) They obtain gt95 data completeness for all required field
2) All data has been uploaded by the specified database closure deadline
Should these criteria not be met the contributing mini-team and any data they contribute may not be
included in the final study and they may be removed from any authorship lists You are advised to get
in touch with us as soon as possible so we may support you with ensuring your site is able to
successfully collect data towards the CHOLECOVID Study
13 Expected Outputs
All data will be reported as a whole cohort Unit level data for comparison will be fed
back to collaborators to support local service improvement This project will be
submitted for presentation at national and international conferences Manuscript(s)
will be prepared following close of the project
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
PRIVATE AND CONFIDENTIAL PATIENT INFORMATION
16
Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID
Section 1 Baseline Demographics
Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)
Inclusion Criteria (All four must be met)
Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)
One or more radiological tests confirming AC
Age (years) _ _ _ Gender Male
Female Pregnant
Yes No
BMI (kgm2)
lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40
Underlying Co-morbidities (Tick all that apply)
MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue
Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS
If T1DM T2DM Severity
Diet-controlled Uncomplicated End-organ damage
If Solid Tumour Spread Localised Metastatic
If Liver Disease Severity Mild Moderate Severe
Total Charlson Comorbidity Index Score (Calculator
bitlycci_calc) _ _ points
Section 2 Diagnosis
Admission Blood Tests (Please complete all)
Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3
ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)
Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3
Radiological Investigations Performed During Index Admission (Tick all that apply)
Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)
MRCP (if yes day post-admission ______)
If US Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
First Investigation Performed During Index Admission
US CT MRCP
If CT Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
If CBD stone ERCP at Index Admission
Yes No
If MRCP Findings
(Tick all that apply)
Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening
No acute findings
HDU or ITU Admission During Index Admission
Yes No
Day of First HDU or ITU Admission Day _ _
Tokyo Severity Grade
Grade I (mild) Grade II (mild) Grade III (severe)
If HDU or ITU Total Duration
_ _ days
Section 3 Intervention
Trial of Conservative Management
(During Index Admission)
Yes No
Antibiotics Given
Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)
Yes ndash oral only (days given______)
Intervention Tried During Index Admission Cholecystostomy Cholecystectomy
Conservative Management Only Palliative Care Only
Cholecystostomy
Inserted During Index Admission
Yes (days post-admission ______) No
Approach Transhepatic Transperitoneal
Tube size _ _ Fr
Tubogram
Yes (days after insertion ______) No
Complications (Tick all that apply)
Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection
Viscus Perforation None
Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No
Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No
Cholecystectomy
Performed During Index Admission Yes (days post-admission ______) No
Surgical Details
Cholecystectomy Subtotal Cholecystectomy
Abandoned Intraoperatively
Surgical Modality
Minimally-invasive Minimally-invasive Converted to Open
Open
Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)
IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days
Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications
Pulmonary Complications
Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)
Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)
IF unexpected ventilation day of start _ _ days
Section 4 COVID-19 Status To be completed for Period 2 patients
COVID-19 Status 7-days Prior to Index Admission
Positive Negative Unknown If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index
Admission
Yes No If Positive
Method of Diagnosis (Tick all that apply)
Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis
Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable
Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No
Section 5 30-day Follow-Up
Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No
Unplanned readmissions within 30-days follow-up of index admission
_ _ readmissions
IF No Cholecystectomy During Index admission Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
CHOLECOVID Study Protocol Version 121 25th June 2020
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
17
Appendix B Data Dictionary
Baseline
Demographics Data
Fields
Required data (definition comment)
1 Data collection
period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)
2 Inclusion Criteria
1) Age 18 or over
2) Admitted to hospital during the study period
3) Clinical features of acute cholecystitis
4) One or more radiological tests confirming acute cholecystitis
Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period
3 Age Years (Whole number at time of admission)
4 Gender Male Female
5 Pregnant Yes No
6 Body Mass Index
(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)
7 Underlying co-
morbidities
(select all that apply)
Myocardial Infraction (MI)
Congestive Heart Failure (CHF)
Peripheral Vascular Disease (PVD)
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)
Dementia
Chronic Obstructive Pulmonary Disease (COPD)
Connective Tissue Disease
Peptic Ulcer Disease
Must have all four patients not meeting all four criteria must not be included
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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18
Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-
Controlled diabetes scores 0 points)
Moderate to Severe Chronic Kidney Disease (CKD)
Hemiplegia
Leukaemia
Malignant Lymphoma
Solid Tumour If yes Localised Metastatic
Liver Disease If yes Mild Moderate Severe
Acquired Immunodeficiency Syndrome (AIDS)
None of the Above
Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD
defined as on dialysis status post kidney transplant uraemia
Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage
Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate
defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal
hypertension with variceal bleeding history
8 Total Charlson
Comorbidity Index
Score
Number (Whole number minimum 0 points - maximum 37 points)
We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc
Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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19
Diagnosis Data
Fields Required data (definition comment)
1 Admission Blood
tests
(Please complete
all)
Haemoglobin (Hb) (record in gramLitre (gL))
Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)
White Cell Count (WCC) (record in x 109Litre to one decimal place)
Normal range 40 to 110 x 109Litre
C-reactive Protein (CRP) (record in milligramLitre(mgL))
Normal range lt 4 milligramLitre
Platelets (record in cubic milli-meter(mm3))
Normal range 150 to 450mm3
Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))
Normal range 44 to 147 IUL
Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))
Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)
Bilirubin (record in micromoleLitre (μmolL) to one decimal place)
Normal range lt 210 μmolL)
Internationalised Normal Ratio (INR) (record to one decimal place)
2 Acute Kidney
Injury (AKI) at
index admission
(As per KDIGO
Guidelines)
No AKI Stage 1 Stage 2 Stage 3
Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F
3 Radiological
Investigations
performed during
index admission
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
(tick all that apply)
Please include only those radiological investigations performed during the index admission
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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20
4 Which radiological
investigation was
performed first
IF more than one radiological investigation selected
Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance
cholangiopancreatography (MRCP)
5 If Abdominal
Ultrasound Scan
(US) performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
Ultrasound
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
6 If Computed
Tomography (CT)
preformed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
CT
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
7 If Magnetic
resonance
cholangiopancreat
ography (MRCP)
Performed
Days after
index
admission
Number (Whole number where 0 = same day as index admission 1 = first day after index admission
etc)
MRCP
findings
Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)
Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)
No acute findings
(tick all that apply)
8 Endoscopic
Retrograde
Cholangio-
Yes No
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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21
Pancreatography
(ERCP) for CBD
stone during index
admission
Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone
9 Tokyo Severity
Grade
Grade I (mild) Grade II (moderate) Grade III (severe)
Tokyo Severity Grading system guide is detailed in Appendix G
10 Critical care (ie
HDU or ITU)
admission during
index admission
Yes No
Please record if patient was admitted to HDU or ITU during their index admission
11 Day of first critical
care admission
Number
Number of times patient was admitted to HDU or ITU during their index admission
where 0 = same day as index admission 1 = first day after index admission etc
12 Total length of
stay in critical care
Number (Whole number of days)
If appropriate this should include combined duration from multiple admissions to HDU or ITU
Intervention Data
Fields Required data (definition comment)
1 Trial of
conservative
management
(during index
admission)
Yes No
2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No
3 Total duration of
antibiotics from
index admission
(days)
If antibiotics used
Duration antibiotics given (whole number of days)
If patient is on antibiotics at the end of the 30-day follow-up period please enter 31
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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22
4 Outcome of trial of
conservative
management
IF trial of conservative management lsquoYesrsquo selected
Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only
5 First intervention
IF trial of conservative management lsquoNorsquo selected
Cholecystostomy Cholecystectomy Palliative Care
If yes to Cholecystostomy
6 Cholecystostomy
inserted during
index admission
Yes No
7 Days after
admission Number (0 = same day as index admission 1 = first day after index admission etc)
8 Approach Transhepatic Transperitoneal
9 Tube size Number (Whole number in French (Fr) scale)
10 Tubogram Yes No
11 Tubogram
performed days
after insertion of
cholecystostomy
If yes to Tubogram
Days after insertion of cholecystostomy
(where 0 = same day as index insertion 1 = first day after index insertion etc)
12 Complications
Bleed
Bile Leak
Dislodgement
Occlusion
Intra-abdominal collection
Viscus perforation
None
13 Duration of
cholecystostomy
Number (Whole number of days)
If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
CHOLECOVID Study Protocol Version 121 25th June 2020
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
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41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
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42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
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23
14 Discharged with
cholecystostomy Yes No
15 Further
intervention
required
Yes No
16 Further
intervention type Further Cholecystostomy Cholecystectomy
If yes to Cholecystectomy
17 Cholecystectomy
during index
admission
Yes No
18 Days after index
admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)
19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively
20 Modality
Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)
Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the
decision was made to change to an open approach)
Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)
21 Highest 30-day
post-operative
complication
grade (Clavien-
Dindo
classification)
None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery
death occurred)
Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H
22 Postoperative
biliary
complications
IF postoperative complications (ie Clavien-Dindo 1 or higher)
Bile leak
Bile duct injury
No Biliary Complications
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24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
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25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
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39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
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40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
24
(tick all that apply)
23 Pulmonary
complications
Pneumonia (IF selected Day of Diagnosis of Pneumonia)
Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)
Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)
Pulmonary Embolism (IF selected Day of Diagnosis of PE)
No Pulmonary Complications
(tick all that apply)
24 Type of ventilation
IF Unexpected Ventilation
Non-invasive Invasive
COVID-19 Status
(Period 2 Only) Data
Fields
Required data (definition comment)
1 COVID-19 status
7-days prior to
index admission
Positive Negative Unknown
2 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
3 Was patient
considered to be
positive for
COVID-19 at any
point during 30-
days following
index
admission
Yes No Unknown
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
CHOLECOVID Study Protocol Version 121 25th June 2020
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic
General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
25
4 Method of
diagnosis (tick all
that apply)
Positive nasooropharyngeal swab or bronchoalveolar lavage
Chest X-Ray
CT Chest
Clinical diagnosis
5 Tested positive
for COVID-19
during index
admission after
an initial
negative screen
Yes No Not applicable
6 Was patient
tested for
COVID-19 (ie
swab) prior to
surgery
Yes No
7 Number of days
testing
performed prior
to surgery
Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)
30-Day Follow-Up
Data Fields Required data (definition comment)
1 Index admission
length of stay
Number (Whole number of days)
If patient has not been discharged by the end of the 30-day follow-up period please enter 31
2 Did this patient die
within 30-days of
index admission
Yes No
3 Days after index
admission
Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission
etc)
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26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic
General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic
General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
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32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
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34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
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35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
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37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
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38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
26
4 Number of
unplanned
readmissions
within 30-days of
index admission
Number (Whole number of times)
5 Cholecystectomy
plan at discharge
Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy
Unclear
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic
General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic
General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
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43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic
General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
27
Appendix C CHOLECOVID Site Survey
Please note a supervising consultant trainee (preferably) at your site must complete
this survey as a pre-requisite to register your site to partake in CHOLECOVID
Period 1 Survey
Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2
(120320- 120520 ie during COVID-19 Pandemic)
Number of consultants at site
routinely performing laparoscopic
cholecystectomy
1 2 3 4 5 ge 6
Daily lsquohotrsquo emergency
gallbladder operating list available
Yes (number of sessions per week _________)
No
On-site interventional
radiology service able to perform
cholecystostomy
Yes No
If no daily lsquohotrsquoemergency
operating list access to emergency
operating list for emergency gall bladder surgery
Yes No
On-site Endoscopic Retrograde
Cholangiopancreatography (ERCP)
service
Yes No Specialty or non-
specialty emergency on-call
Specialty (ie separate UGIHPB and colorectal on-call
Non-specialty (ie non-separated on-call)
Has your hospital site been affected by
COVID-19 Yes No
Have you adopted new guidance for the management of acute
cholecystitis as a result of COVID-19
Yes No
Has a lack of PPE prevented you from
performing cholecystectomy at
any point
Yes No
If new guidance has been adopted which guidance have you
most closely followed
International National
Regional Local (ie your hospital)
Collegiate Intercollegiate Organisation (eg ASGBI)
CHOLECOVID Study Protocol Version 121 25th June 2020
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28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
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General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
CHOLECOVID Study Protocol Version 121 25th June 2020
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30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
28
Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)
Standard
1 Early laparoscopic cholecystectomy is
recommended for mild AC
Tokyo Guidelines (2018)
bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the
CCI score suggests the patient can withstand surgery
2 For moderate AC laparoscopic
cholecystectomy should be performed if
the patient can withstand surgery
otherwise conservative therapy or biliary
drainage
Tokyo Guidelines (2018)
bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if
the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical
center If the patient cannot withstand surgery conservative treatment and biliary drainage should be
considered
3 For severe AC early laparoscopic
cholecystectomy can be performed in a
setting where ICU management is
available otherwise conservative
treatment should be performed or
biliary drainage where possible
Tokyo Guidelines (2018)
bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic
cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that
allows for intensive care management If it is decided that the patient cannot withstand surgery
conservative treatment including comprehensive management should be performed Early biliary
drainage should be considered if it is not possible to control the gallbladder inflammation
Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic
General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
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CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic
General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
29
Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc
Co-Morbidity Scoring
Age
0 Points (lt50 years)
1 Point (50 ndash 59 years)
2 Points (60 ndash 69 years)
3 Points (70 ndash 79 years)
4 Points (ge 80 Years)
Previous Myocardial Infarction (MI) 1 Point
Congestive Heart Failure (CHF) 1 Point
Peripheral Vascular Disease 1 Point
Previous Cerebrovascular Accident (CVA) or Transient
Ischaemic Attack (TIA) 1 Point
Dementia 1 Point
COPD 1 Point
Connective Tissue Disease 1 Point
Peptic Ulcer Disease 1 Point
Liver Disease 1 Point (Mild)
3 Points (Moderate to Severe)
Diabetes Mellitus
0 Point (None or diet-controlled)
1 Point (Uncomplicated)
2 Points (End-Organ Damage)
Hemiplegia 2 Points
Moderate to Severe Chronic Kidney Disease
Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis
status post kidney transplant uremia
2 Points
Solid Tumour
0 Point (None)
2 Point (Localised)
6 Points (Metastatic)
Leukaemia 2 Points
Lymphoma 2 Points
Acquired Immunodeficiency Syndrome (AIDS) 6 Points
Total Charlson Comorbidity Index (Max score 37 points)
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
30
Appendix F KDIGO Clinical Practice Guidelines for
Acute Kidney Injury
Grade Serum creatinine Urine output
I 15 ndash 19 times baseline OR
03 mgdl ( 265 moll) increase
lt 05 mlkgh for 6 - 12 hours
II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours
III 30 times baseline OR
Increase in serum creatinine to 40 mgdl
( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2
lt 03 mlkgh for 24 hours OR
Anuria for 12 hours
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
31
Appendix G Tokyo Guidelines for Severity Grading
of Acute Cholecystitis
Grade I (mild) No organ dysfunction and mild inflammatory changes in the
gallbladder
Grade II (moderate) Associated with any one of the following conditions
(1) Elevated WBC count (gt18000mm3)
(2) Palpable tender mass in RUQ
(3) Duration gt72h
(4) Marked local inflammation (gangrenousemphysematous cholecystitis
pericholecystichepatic abscess biliary peritonitis)
Grade III (severe) Associated with dysfunction of any one of the following
organssystems
(1) Cardiovascular hypotension requiring treatment with vasopressors
(2) Neurological decreased level of consciousness
(3) Respiratory PaO2FiO2ratio lt300
(4) Renal dysfunction oliguria creatinine gt20 mgdl
(5) Hepatic dysfunction PT-INR gt15
(6) Haematology
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
32
Appendix H Clavien-Dindo Grading of Surgical
Complications
Grade Definition
Grade I Any deviation from the normal post-operative course not requiring
surgical endoscopic or radiological intervention This includes the
need for certain drugs (eg antiemetics antipyretics analgesics
diuretics and electrolytes) treatment with physiotherapy
and wound infections that are opened at the bedside
Grade II Complications requiring drug treatments other than those allowed
for Grade I complications this includes blood transfusion and total
parenteral nutrition (TPN)
Grade III Complications requiring surgical endoscopic or radiological
intervention
bull Grade IIIa - intervention not under general anaesthetic
bull Grade IIIb - intervention under general anaesthetic
Grade IV Life-threatening complications this includes CNS complications
(eg brain haemorrhage ischaemic stroke subarachnoid
haemorrhage) which require intensive care but excludes transient
ischaemic attacks (TIAs)
bull Grade IVa - single-organ dysfunction (including dialysis)
bull Grade IVb - multi-organ dysfunction
Grade V Death of the patient
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
33
Appendix I CHOLECOVID REDCap Guide for PIs
Setting up your REDCap account
1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will
take you to the password setup page in REDCap
2) You will see your username in the dialog box Select the password field to
set your password
3) The requirements for the password are that it should be AT LEAST 9
CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case
letter one upper-case letter and one number
4) Click lsquoSubmitrsquo after you have entered and confirmed your password
5) This takes you to the REDCap welcome page shown below which gives you
all the details of REDCap
6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will
ask you to set a security question This question helps with recovering your
password if you forget it so it is advisable that you select a security
question and set an answer and save it
TOP TIP
Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data
collection it is vital that collaborators set their security question as soon as they are given access to
their account
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
34
How to Add Collaborators on to REDCap
Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk
Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
35
Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home
Screen
Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new
recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo
drop-down menu
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
36
Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of
the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project
Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott
Approvals as required at each centre or any evidence from ethical departments
waiving the need for ethical approvals
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
37
Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the
screen Add details of the collaborators including First amp Last name Grade a valid
E-mail and ORCIDs
IMPORTANT NOTE
To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the
Collaborator Details Form (Collaborators can register an ORCID identifier at
httpsorcidorgregister)
bull The ORCID digital identifier is free-of-charge and widely administered and used within
research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-
7824)
bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by
downloading the name of the collaborator using their individual ORCID (and so this is
mandatory for collaborators to be credited with compulsory)
bull The only compulsory information you are required to provide on your ORCID profile is your
name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility
settings set to Everyone
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
38
TOP TIP
Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid
delays with them receiving their REDCap account
Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be
generated for all collaborators at a site
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
39
Frequently Asked Questions (FAQs)
1) When do collaborators get REDCap access
After you have filled in the site data (and uploaded evidence of ethical or
auditCaldicott approvals) collaborator details and completed the site survey on
REDCap they should get login details to access the project after we run the next
round of approvals internally through REDCap (usually every couple of days)
2) I do not have ethicalaudit approval yet can we still collect data
No data collection can only start once appropriate approvals have been granted and
uploaded on to REDCap
3) I have not completed the site survey can our site still collect data
Yes however REDCap accounts will only be generated for collaborators once the
site survey has been completed and uploaded onto REDCap To aid you with having
(often busy) consultants complete the site survey the site survey CRF is attached in
Appendix D this may be printed off and provided to consultants in person
Alternatively you may have a trainee complete the CRF or yourself as PI providing
you are familiar with the sitersquos practices
4) I do not have Caldicott approval yet (UK centres only) can we still
collect data
Yes data collection can be started given that you have ethicalaudit approval (but
not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need
to be collected and stored on a secure NHS device It can then be transferred on to
REDCap once Caldicott approval is granted
5) In centres where the audit department has waived registration what
proof do I need to put on REDCap
You can upload a screenshot of the email demonstrating this on REDCap
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
40
Appendix J NHS Health Research
Authority Outcome
The NHS Health Research Authority questionnaire (httpwwwhra-
decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was
not research as the participants are not randomized to different groups there is no
change in treatment or patient care and the findings cannot be regarded as wholly
generalizable
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
41
Appendix K References
1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across
Europe Final report United Eur Gastroenterol J 20142539-543
2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med
20083582801-2811
3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the
management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72
4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute
cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7
5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic
cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev
20136CD005440
6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed
cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest
Surg201519(5)848-857
7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed
laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-
1313
8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy
increases the total hospital stay compared to an early laparoscopic cholecystectomy
after acute cholecystitis an updated meta-analysis of randomized controlled trials
HPB(Oxford) 201517(10)857-862
9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic
cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg
2010 80 280ndash283
10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous
cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary
sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash
101
11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous
cholecystostomy for acute cholecystitis a single-center experience J Gastrointest
Surg 2012 16 1860ndash1868
12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for
acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
42
13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary
drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20
71ndash80
14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy
versus percutaneous catheter drainage for acute cholecystitis in high risk patients
(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363
15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute
respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it
SARS-CoV-2 Nature Micobiol 2020 5 536ndash544
16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-
19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st
May 2020]
17 Royal College of Surgeons of England Updated Intercollegiate General Surgery
Guidance on COVID-19 London Royal College of Surgeons of England 2020
[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-
guidance-for-surgeons-v2 [accessed 1st May 2020]
18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency
General Surgery Patients Chicago IL American College of Surgeons
2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-
surgery [accessed 24th April 2020]
19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery
East Melbourne Royal Australasian College of Surgeons
2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-
2920COVID-1920Guidelines20for20General20Surgery_FINALpdf
[accessed 24 April 2020]
20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a
metadata-driven methodology and workflow process for providing translational
research informatics support J Biomed Inform 200942(2)377ndash381
21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building
an international community of software partners J Biomed Inform 201995103208
22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre
prospective population-based cohort study of variation in practice of
cholecystectomy and surgical outcomes (The CholeS study) BMJ Open
20155(1)e006399
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-
CHOLECOVID Study Protocol Version 121 25th June 2020
CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom
43
23 CholeS Study Group West Midlands Research Collaborative Population-based
cohort study of outcomes following cholecystectomy for benign gallbladder diseases
Br J Surg 2016103(12)1704-1715
24 National Research Collaborative amp Association of Surgeons in Training Collaborative
Consensus Group Recognising contributions to work in research collaboratives
guidelines for standardising reporting of authorship in collaborative research Int J
Surg 201852355-360
- An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit
- Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of
-