met-repair: screening - inclusion form met : reevaluation for perioperative cardiac risk met-repair

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  • MET : REevaluation for Perioperative cArdIac Risk

    MET-REPAIR Appendix 5A Screening / Inclusion form – Final Version 1.0 dated 6 Feb 2017 Page 1 of 1

    Appendix 5A

    MET-REPAIR: Screening - Inclusion Form

    Inclusion criteria

    - Planned as inpatients after surgery Yes No

    - Non-cardiac surgery Yes No

    - Age (at time of operation) ≥ 45 years AND NSQIP MICA percentage ≥ 1%

    OR

    - Age (at time of operation) ≥ 45 years AND Revised Cardiac Risk Index ≥ 2

    OR

    - Age (at time of operation) ≥ 65 years AND intermediate or high risk procedure

    Yes No

    - Consent Mandatory?  Yes  No

    Mandatory unless the centre has an explicit and written exemption from IRB

    If consent mandatory - Consent obtained

    Yes

    No

    Exclusion criteria

    - Non-Elective surgery planned to occur ≤ 72 hours after diagnosis of the acute condition that makes the procedure necessary

    No Yes

    - Acute coronary syndrome or uncontrolled congestive heart failure within the last 30 days of planned day of surgery

    No Yes

    - Stroke within the last 7 days of planned day of surgery No Yes

    - Long-standing inability to perform ambulation

    e.g. paraplegics, polio, etc.; NOT joint or pain problems

    No Yes

    - Unable to complete the questionnaire No Yes

    - Unable to consent or unwilling to participate No Yes

    - Previous enrolment in MET-REPAIR No Yes

    IF all items confirm patient can be included,

    THEN, Paper CRF and electronic CRF should be completed.

    IF patient does not comply with any inclusion criteria,

    THEN, DO NOT INCLUDE patient in the study

    Paper CRF and electronic CRF should NOT be completed.

  • MET : REevaluation for Perioperative cArdIac Risk

    MET-REPAIR Appendix 5B CRF Confidential Identification Coversheet – Final Version 1.0 dated 6 Feb

    2017

    Page 1 of 1

    Appendix 5B

    MET-REPAIR: Patient Confidential Identification CRF Coversheet

    This coversheet is intended to help site staff and local investigator link local patient data to the study-specific study patient code. This sheet is used to facilitate this task for investigators; it can be filled to your convenience. After completing follow-up, this coversheet should be saved separately from the CRF and filed in a secure place. The information on this coversheet will NOT be collected in the CRF. It is for local use ONLY.

    IDENTIFYING DATA

    A Date paper CRF created |__|__| / |__|__|__| / |__|__|__|__| (dd/Mmm/YYYY)

    B Date of birth |__|__| / |__|__|__| / |__|__|__|__| (dd/Mmm/YYYY)

    C1 Patient Code (OpenClinica eCRF ID number) |__|__|__|-|__|__|__|-|__|__|__| (xxx-xxx-xxx 3 digit code for the

    country, 3 digit code for the hospital and 3 digit individual patient number)

    C2

    Identification

    fill in with available data – only for local follow-up use:

    Patient Hospital/local Identification Number (handwritten or sticker):

    First name:

    Last name:

    Completion progress of the study forms: Paper CRF OpenClinica electronic CRF

    CRF1: PREOPERATIVE CHARACTERISTICS - Patient Data and Planned Surgery (1.1-1.10) - Preoperative Comorbidities (1.11-1.28) - Functional Capacity Questionnaire (1.29-1.35)

    CRF2: ANAESTHESIA DATA - Intraoperative data (2.1-2.5)

    CRF3: POST SURGERY DATA - Postoperative Data (3.1-3.7) - Adjudicated Outcomes (3.8-3.15)

    CRF4: NTproBNP SUBSTUDY (4.1-4.3) (only for centres participating to this substudy)

    CRF5: PREOPERATIVE CARDIOLOGY CONSULTATION AND PREOPERATIVE CARDIAC TESTING - 5.1. Preoperative Cardiology Consultation - 5.2. Preoperative Ergometry - 5.3. Preoperative Echocardiography (rest) - 5.4. Preoperative Stress-Echocardiography - 5.5. Myocardial perfusion study

    - 5.6. Coronary Angiogram (within 12 months prior to surgery)

  • MET : REevaluation for Perioperative cArdIac Risk

    MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 1 of 10

    Appendix 5C

    MET-REPAIR Case Report Form

    CRF 1: PREOPERATIVE CHARACTERISTICS

    PATIENT DATA AND PLANNED SURGERY

    1.1

    Study Subject ID: |__|__|__|-|__|__|__|-|__|__|__| Enter Study Subject ID in this format xxx-xxx-xxx 3 digit code for the country, 3 digit code for the hospital and 3 digit individual patient number

    1.2

    Informed consent applicable?

    Yes No choose no only if consent process has been confirmed in writing as not needed by local Ethics

    1.2.1 If yes, was consent obtained? Yes No

    1.2.1.1 If obtained, date of informed consent |__|__|- |__|__|__| -|__|__|__|__| in this format dd-Mmm-YYYY (Month in English starting with capital letter)

    1.3 Year of birth:

    |__|__|__|__| (e.g. 1971)

    patient must be ≥ 45 years of age on the inclusion date

    1.4 Gender: Male Female

    1.5 Weight:

    |__|__||__| kg [40-120]

    1.6 Height:

    |__|__||__| cm [140-210]

    1.7 Preoperative functional status

    ☐ fully independent ☐ partially dependent ☐ fully dependent

    1.8 Planned type of surgery Low risk Moderate risk High risk

    see Appendix 5D CRF Instructions

    1.9

    Planned intrathoracic, intra-abdominal, or suprainguinal vascular surgery?

    Yes No

    1.10

    Planned procedure site (as per NSQIP MICA)

    Anorectal Aortic Bariatric Brain Breast ENT (not thyroid/parathyroid) Foregut/Hepatopancreatobiliary Gallbladder, appendix, adrenal and

    spleen Hernia (ventral, inguinal, femoral) Intestinal

    Neck (thyroid/parathyroid) Obstetric/Gynecologic Orthopedic and non-vascular

    extremity Other abdominal Peripheral vascular Skin Spine Non-esophageal thoracic Vein Urology

  • MET : REevaluation for Perioperative cArdIac Risk

    MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 2 of 10

    PREOPERATIVE COMORBIDITIES

    1.11 ASA Physical Status: I II III IV V

    Choose single most appropriate

    1.12

    Diabetes mellitus

    diagnosis of diabetes mellitus reported in preoperative clinical documentation or corresponding medication

    No Diet Oral antidiabetics Insulin

    1.13 History of Hypertension

    Yes No

    yes, if diagnosis reported in any preoperative clinical documentation of if history of correspondent treatment

    1.14 History of Congestive Heart Failure

    Yes No

    yes, if diagnosis reported in any preoperative clinical documentation of if history of correspondent treatment

    1.15 History of Coronary Artery Disease

    Yes No

    yes, if diagnosis reported in any preoperative clinical documentation or if history of myocardial infarction (1.16), correspondent interventions (1.17-1.18), or medical treatment

    1.16 Previous Myocardial infarction?

    Yes No

    1.16.1 If yes, date of last MI: |__|__| - |__|__|__| - |__|__|__|__|

    1.17

    Previous percutaneous coronary intervention?

    Yes No

    1.17.1 If yes, date of last PCI: |__|__| - |__|__|__| - |__|__|__|__|

    1.18

    Previous coronary artery bypasss grafting?

    Yes No 1.18.1 If yes, date of last CABG: |__|__| - |__|__|__| - |__|__|__|__|

    1.19 History of peripheral vascular disease

    Yes No yes, if diagnosis reported in any preoperative clinical documentation of if Hx of correspondent interventions (e.g. PTA, vascular surgery)

    1.20 History of Stroke or TIA

    Yes No yes, if diagnosis reported in any preoperative clinical documentation of if Hx of correspondent interventions

    1.21

    Creatinine Preop:

    preoperative creatinine (closest to operation date and ≤3 months)

    |__|__|__|__|.|__| 1.21.1 μmol/L [1.0-3000.0]

    mg/dL [0.1-30.0]

    1.22 Preoperative Dialysis Yes No

    yes, if diagnosis reported in any preoperative clinical documentation

    1.23

    History of severe valvular stenosis

    if reported in any preoperative clinical documentation or refer to CRF Instructions (App. 5D) for echocardiographic definitions

    Yes No

    1.23.1 If yes, check all that apply : Mitral valve Aortic valve Tricuspid valve Pulmonary valve

    1.24

    History of severe valvular regurgitation

    if reported in any preoperative clinical documentation or refer to CRF Instructions (App. 5D) for echocardiographic definitions

    Yes No

    1.24.1 If yes , check all that apply : Mitral valve Aortic valve Tricuspid valve Pulmonary valve

  • MET : REevaluation for Perioperative cArdIac Risk

    MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 3 of 10

    1.25

    Chronic Obstructive Pulmonary Disease ?

    COPD diagnosis reported in preoperative clinical documentation or corresponding medication

    Yes No

    1.26

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