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TRANSCRIPT
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Methods For Identifying Surgical Wound Infection
After Discharge From Hospital
Emily Petherick, Jane Dalton and Nicky Cullumª
Department of Health Sciences
University of York
ªCorresponding Author: Professor Nicky Cullum, Department of Health Sciences, Univeristy of York, Area 2, Seebohm Rowntree Building, Alcuin College, York YO10 5DD. Email: [email protected]
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Table of Contents
Abstract .......................................................................................................4
Background .......................................................................................................8
Definition of Surgical Site Infection (SSI)................................................................................9
Aims ......................................................................................................11
Methods ..................................................................................................... 12
Literature Review..................................................................................................................12
National Audit ......................................................................................................................13
Results ..................................................................................................... 15
Literature Review..................................................................................................................15
Discussion .....................................................................................................29
Audit of current surveillance practice: Results.......................................................................30
Telephone Interviews with Survey Respondents....................................................................31
Other relevant research currently being undertaken or planned within the United Kingdom.36
Conclusions .....................................................................................................37
Question 1: What are the features of existing post discharge surveillance systems in terms of
coverage; denominator data; diagnostic criteria; other data collected; methods of data
collection?.............................................................................................................................37
Question 2: What is the current evidence for the validity, reliability and practicality of
different methods of post-discharge surveillance of SSIs? .....................................................38
Question 3: What research is needed to fill knowledge gaps?................................................39
Appendix A Search strategies used in the report..........................................44
Strategy no. 1. Surgical wound infection: prospective studies.................................................44
Search strategy no. 2. Surgical wound infection: measurement and validation studies............47
Search Strategy no. 3. Surgical wound infection: surveillance and monitoring studies............51
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Appendix B Critical Appraisal of Included non-comparative PDS studies....
.....................................................................................................55
Appendix C Example of audit sent to Infection Control lead within Trusts .
.....................................................................................................90
Appendix D Telephone interview 1st contact................................................92
Appendix E Telephone interview 2nd contact...............................................93
APPENDIX F Individual components of wound definition systems not
previously described in Bruce et al (2001). ...........................................................................95
Appendix G Excluded Studies.......................................................................96
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Acknowledgements
We would like to thank the following for their assistance in the production of this report:
Ms Lisa Mather, Centre for Reviews and Dissemination, University of York, for literature
searching; Mr Peter Moore, Consultant Surgeon, Northern Lincolnshire and Goole Hospitals
NHS Trust for his expert clinical advice; and Sandi Newby and Corinna Petre for their secretarial
assistance.
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Abbreviations
ASEPSIS Additional treatment, Serous discharge, Erythema, Purulent exudate,
Separation of deep tissues, Isolation of bacteria, and duration of
inpatient Stay – a system for scoring wound infections
CABG Coronary artery bypass graft
CDC Centers for Disease Control
HPA Health Protection Agency
ICD International Classification of Disease
NINSS Nosocomial Infection National Surveillance Service (UK based)
NNIS National Nosocomial Infections Surveillance System (USA based)
NS Not Stated
PDS Post discharge surveillance
SSI Surgical site infection
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Abstract
Background: Most surgical site infections are thought to occur after patients are discharged
from hospital, therefore accurate methods of detecting infection post-discharge are important in
order to monitor surgical performance and evaluate interventions aimed at reducing surgical site
infections.
Objectives: To establish
(i) the features of existing post discharge surveillance systems;
(ii) the current evidence for the validity, reliability and practicality of different
methods of post-discharge surveillance of SSIs;
(iii) what research is needed to fill knowledge gaps and
(iv) possible study sites where evaluations of methods of detection of SSI post-
discharge might be incorporated into current activity.
Methods: Update of previous systematic review and national audit of current surveillance
practices.
Results: Only 5 studies (3 new to this review) were identified which compared alternative
methods of post-discharge surveillance for surgical wound infection. These studies were unique
comparisons; there is no consensus as to the gold standard reference method of detection –
candidates include direct observation of patient wounds by health professionals and data capture
from primary care (including of routine data). A promising method for comparison would be
CDC-criteria driven patient self-diagnosis but an appropriate tool has yet to be developed. The
audit identified a wide range of surveillance programmes in operation in England, Scotland and
Wales. Some of these involve direct observation of patients’ wounds and some primary care
data capture. National SSI surveillance programmes currently do not require post-discharge
surveillance.
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Conclusions: More research on methods to measure surgical site infection rates after hospital
discharge is needed. Preliminary work should develop an appropriate reference (gold standard)
system that is sufficiently accurate. This should then serve as a comparison to alternatives such
as patient self-diagnosis. It is likely that some of the centres currently undertaking PDS SSI
could host new research.
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Background
Surgical site infections (SSIs) have been estimated to occur in up to 15% of elective surgical
patients and approximately 30% of patients whose surgical procedure was classed as
contaminated or “dirty”(Bruce et al, 2001). The proportion of SSIs which is preventable is
unknown however there are wide variations in infection rates and an international drive to
minimise them (Bruce et al, 2001). Accurate, standardised methods of defining and monitoring
SSIs are essential in order to detect and treat infections (treatment), compare the performance of
different surgical services (performance monitoring) and of different interventions (research). Some
investigators have viewed SSI surveillance itself as an intervention aimed at reducing SSI through
an audit and feedback mechanism.
Recent figures from Scotland completed as part of the Scottish Surveillance of Healthcare
Programme (SSHAIP) found that infections occurring after discharge from hospital accounted
for 65.3% (range: 26-89%) of all SSIs in those sites that include post-discharge surveillance
(Scottish Centre for Infection and Environmental Health, 2003).
Bruce et al (2001) completed an extremely helpful review of the measurement and monitoring of
surgical adverse events in 2001. This review (the search for which covered only the years 1993 –
1999) identified 41 different definitions of SSI and 13 different grading scales, of varying
complexity. The review emphasised the importance of post-discharge surveillance for SSI (PDS
SSI) since the mean duration of post-operative stay is reducing (including an increase surgical day
cases). It has been suggested that between 50% and 70% of SSIs occur after the patient is
discharged from hospital (Holtz & Wenzel, 1992). Ascertainment of SSI after discharge presents
its own methodological challenges however. Methods which have been studied include direct
observation of patients’ wounds by health care professionals in different settings; questionnaires
and diaries completed either by patients or health care professionals; telephone surveys to
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patients. The interpretation of these data to date has presented challenges however which can be
summarised as:
• The lack of an agreed gold standard method of PDS SSI
• Paucity of studies comparing different methods in a consistent way (large variations in
definition of SSIs; staffing, setting and timings used in existing studies).
Definition of Surgical Site Infection (SSI)
The previous systematic review (Bruce et al, 2001) described the most current definition of
surgical wound infection as that produced by the Centers for Disease Control and Prevention
(CDC) in 1992. The CDC has since produced updated guidelines for the prevention of surgical
site infections, however the definitions provided of surgical site infections have not changed
(Mangram et al, 1999). Full details of this definition are provided in Box 1.
BOX 1 Definition of surgical site infection: CDC (Horan et al 1992).
For surveillance classification purposes, SSIs are divided into incisional SSIs and organ/space SSIs. Incisional space SSIs are further classified as involving only the skin and subcutaneous tissue (superficial incisional SSIs) or involving deep soft tissues (e.g. fascial and muscle layers) of the incision (deep incisional SSIs). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than the incision opened or manipulated during the operative procedure.
Superficial incisional SSI Superficial incisional SSIs must meet the following criteria: infection occurs within 30 days after the operative procedure and involves only skin or subcutaneous tissue of the incision, and at least one of the following is present: • Purulent drainage from the superficial incision. • Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. • At least one of the following signs or symptoms of infection: pain or tenderness, localised swelling, redness or heat and superficial incision is deliberately opened by a surgeon, unless culture of incision is negative. • Diagnosis of superficial incisional SSI by the surgeon or attending physician. The following are not reported as superficial incisional SSIs: • stitch abscess (minimal inflammation and discharge confined to the points of suture penetration) • infection of an episiotomy or a neonate’s circumcision site* (episiotomy and circumcision are not considered NNIS operative procedures) • infected burn wound* • incisional SSI that extends into the fascial and muscle layers (see deep incisional SSI).
Deep incisional SSI Deep incisional SSIs must meet the following criteria: infection occurs within 30 days after the operative procedure if no implant† is left in place or within 1 year if an implant is left in place and the infection appears to be related to the operative procedure and infection involves deep soft tissues (e.g. fascial and muscle layers) of the incision and at least one of the following is present: • Purulent drainage from the deep incision but not from the organ/space component of the surgical site. • A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever (> 38°C), localised pain, or tenderness, unless culture of the incision is negative.
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BOX 1 Definition of surgical site infection: CDC (Horan et al 1992). (Continued)
• An abscess or other evidence of infection involving the deep incision is found on direct examination, during re-operation, or by histo-pathological or radiological examination. • Diagnosis of a deep incisional SSI by a surgeon or attending physician. Organ/space SSI An organ/space SSI involves any part of the anatomy (e.g. organs or spaces), other than the incision, opened or manipulated during the operative procedure. Organ/space SSIs must meet the following criteria: infection occurs within 30 days after the operative procedure if no implant is left in place or within 1 year if an implant is left in place and the infection appears to be related to the operative procedure and infection involves any part of the anatomy (e.g. organs or spaces) other than the incision opened or manipulated during the operative procedures, and at least one of the following is present: • Purulent drainage from a drain that is placed through a stab wound‡ into the organ/space. • Organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space. • An abscess or other evidence of infection involving the organ/space on direct examination, during reoperation, or by histopathological or radiological examination. • Diagnosis of an organ/space SSI by a surgeon or attending physician. * Specific criteria are used for infected episiotomy and circumcision sites and for burn wounds. † An implant is defined as a non-human-derived implantable foreign body (e.g. prosthetic heart valve, non-human vascular graft, mechanical heart, hip prosthesis) that is permanently placed in a patient during operation. ‡ If the area around a stab wound becomes infected, it is not an SSI. It is considered a skin or soft tissue infection, depending on its depth.
Specific sites of organ/space surgical site infection • Arterial or venous infection • Breast abscess or mastitis • Disc space • Ear, mastoid • Endometritis • Other infections of the lower respiratory tract • Other infections of the urinary tract • Other male or female reproductive tract • Intra-abdominal, not specified elsewhere • Intracranial, brain or dural infections abscess • Joint or bursa • Mediastinitis • Meningitis or ventriculitis • Myocarditis or pericarditis • Oral cavity (mouth, tongue or gums) • Osteomyelitis • Endocarditis • Eye, other than conjunctivitis • Gastrointestinal tract • Spinal abscess without meningitis • Sinusitis • Upper respiratory tract, pharyngitis • Vaginal cuff
SSI involving more than one specific site Infection that involves both superficial and deep incision sites is classified as a deep incisional SSI . Occasionally an organ/space infection drains through the incision. Such infection generally does not involve re-operation and is considered a complication of the incision. It is therefore classified as a deep incisional SSI.
The CDC guidelines concluded that, with respect to post-discharge surveillance;
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‘At this time no consensus exists on which post-discharge surveillance methods are the most
sensitive, specific and practical. Methods chosen will necessarily reflect the hospital’s unique
mix of operations, personnel resources, and data needs.’
The guidelines also examined the evidence for surgical site surveillance in the
outpatients department and concluded that;
‘At this time, no single detection method can be recommended. Available resources and
data needs will determine which method(s) should be used and which operations should be
monitored. Regardless of which detection method is used, it is recommended that the CDC
NNIS definitions of SSI be used without modification’.
We have taken as the starting point for this review (and in agreement with the NCCRM) the
CDC definition of surgical site infection and recommend that this should be used in all future
studies unless evidence arises to suggest the definition is unsatisfactory or that a more valid or
reliable definition is developed.
Aims
This brief review aims to answer the following questions:
1. What are the features of existing post discharge surveillance systems in terms of
coverage; denominator data; diagnostic criteria; other data collected; methods of data
collection?
2. What is the current evidence for the validity, reliability and practicality of different
methods of post-discharge surveillance of SSIs?
3. What research is needed to fill knowledge gaps?
4. Are there possible study sites where evaluations of methods of detection of SSI post-
discharge might be incorporated into current activity?
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Methods
Existing surveillance systems were identified and described using a combination of literature
review and a national audit.
Literature Review
The literature search undertaken for the Bruce review was updated. The search strategy is
outlined in Appendix A and the databases searched are shown in Table 1.
Table 1 Electronic databases searched for this review
Database Period/Issue covered
Medline (OVID) 1999-02/2004
EMBASE 1999-03/2004
CINAHL 1999-03/2004
The Cochrane Library 1999-2004 Issue 1
In order to be eligible for inclusion, studies had to:
- Describe a method of post discharge surveillance for surgical site infection
OR
- Compare at least two methods of post discharge surveillance for surgical site infection
OR
- Describe an economic evaluation of post discharge surveillance for surgical site infection.
Papers were excluded if they met any of the following criteria;
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- Paper gave no indication that post discharge follow up was performed
- Post-discharge follow up was carried out for reasons other than for surveillance of
surgical wound infection
- Appeared to be routine patient follow up post operation with no methodological detail
provided of how any post-discharge follow up was achieved.
National Audit
The answer to Question 1 was further supplemented by an audit of current post-discharge
surveillance across the UK. The audit involved two phases in an effort to gain a high response
rate. For the first phase, a brief audit form was sent to Infection Control Personnel within all
primary care trusts and hospital trusts within the UK National Health Service. The aim of this
national audit was to identify those Trusts that were undertaking any post-discharge surveillance
for surgical site infection. A database of infection control personnel was purchased from
Binley’s (http://www.binleys.com/default.asp) current to January 2004. Audit forms were sent
to multiple contacts within the Trusts, where the database listed more than one infection control
staff member. A sample of Trusts that identified themselves as undertaking surveillance
participated in a telephone interview in order to collect more detailed information.
A copy of the audit form sent to Infection Control teams can be found in Appendix C.
Telephone Interviews
Sample selection Of the 42 respondents who indicated that their Trust was currently carrying out post discharge
surveillance for surgical site infection, nine were selected in line with the following criteria:
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(a) respondents had indicated their willingness to be contacted for further discussion
(only 20 out of 42);
(b) the Trust’s post discharge surgical site infection (SSI) surveillance appeared to extend
beyond the provision of routine follow up;
(c) to reflect a variety of methods of surveillance in a range of surgical specialities.
The resulting sample comprised a range of surgical specialities: general, gynaecology,
orthopaedics, neurosurgery and cardio-vascular. A range of surveillance methods was also
evident within the identified programmes. These included patient telephone surveys (n=4),
patient questionnaire (for example delivered at an outpatient visit) (n=3), GP/health professional
surveys (n=2), surgeon survey (n=1), direct observation (n=5) and others (n=2) in connection
with the use of hospital information systems.
Development of interview schedule
Broad categories of questions were identified with close reference to issues arising from the
systematic review and others contained within the research brief. The interview schedule was
constructed to cover the following:
(a) descriptions of the practice setting, population and surgical speciality
(b) methods of surveillance (including any previously tried and discarded)
(c) the operational definition of surgical site infection in use
(d) perceived practicality of methods currently employed
(e) any evaluation and linkage of data (see 2nd contact - Interview Schedule: Appendix E).
A draft interview schedule was prepared and a final version agreed by the investigators.
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Procedure for contacting prospective interviewees
Prospective interviewees were contacted by telephone to arrange a convenient time for interview.
Their agreement was ascertained in relation to (a) the tape recording of the interview and, (b) the
identification of their Trust in the write up of results (see Telephone interview – 1st contact
sheet: Appendix D). A copy of the interview schedule was faxed or e-mailed to the prospective
interviewee in advance of the interview date where possible.
Nine Trusts were initially contacted to arrange an interview. Seven responded and
representatives from six were interviewed (one cancelled the appointment and was unable to re-
arrange a suitable time).
Results
Literature Review
Our literature search overlapped with the Bruce et al (2001) search by one year (1998). The
search yielded a total of 3, 548 article titles and/or abstracts. Two abstractors assessed these
articles independently applying the inclusion and exclusion criteria previously stated. Any
disagreements were agreed by consensus.
Full text versions of research reports were obtained if they potentially met any one of the criteria.
A total of 130 papers were ordered for full text assessment. Of these 74 met the eligibility criteria
and were abstracted in full. Of those that did not meet inclusion criteria 13 were narrative
reviews, 26 did not perform post discharge surveillance in the study, 3 were editorials, 9
contained information that had been published in duplicate, 1 study was systematic review that
was not limited to studies of post-discharge surveillance (references were checked for relevant
articles although none were located) and 1 study was unable to be translated (sufficient details
confirmed that this was not a study comparing methods of post discharge surveillance), 2 were
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unable to be retrieved and in 1 study the authors were unable to separate the results for the post-
discharge period that was included in the study. Full references of the excluded studies are
included in Appendix G.
A study assigned as Level I evidence is considered the most rigorous and least susceptible to
bias, while a study deemed to contain Level IV evidence is considered the least rigorous and
most susceptible to bias (see Table 2). Systematic reviews of Level I studies of diagnostic tests
were also considered Level I evidence.
Table 2 Levels of evidence for diagnostic test studies (primary research)
Level of Evidence Criteria
I Independent blind comparison of an appropriate spectrum of consecutive patients, all of
who have undergone both the diagnostic and the reference standard
II Independent, blind or objective comparison but in a set of non-consecutive patients, or
confined to a narrow spectrum of study individuals (or both), all of whom have undergone
both the diagnostic test and the reference standard.
III Independent blind comparison of an appropriate spectrum but the reference standard was
not applied to all patients
IV Any of: reference standard was not applied blinded or not applied independently.
No reference standard was applied (case series).
The QUADAS tool (Whiting et al, 2003) was used to assess the validity of the studies comparing
different methods of post discharge surveillance methods.
A total of 75 papers were found that referred to post discharge surveillance for surgical site
infections. Of these, 3 papers not included in the previous review, reported research that
compared different surveillance methods. The remaining 72 papers described a single
surveillance programme. No studies were located that attempted to validate or compare wound
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classification systems, nor were any studies found that looked at the impact on patient outcomes
of having post discharge wound surveillance programme.
Methods of post-discharge surveillance for surgical site infections in the literature
In the previous review by Bruce et al (2001) a total of 82 studies were found that had some
mention of post-discharge surveillance. Of these the majority were single arm studies, with only
2 that looked at a comparison of different methods of post discharge surveillance.
This review update identified a total of 72 studies that described a single system of post
discharge surveillance for surgical site infection. These studies did not use a reference standard
and as such can be designated level IV studies (Table 2). All but one study looked at non-
objective testing methods such as patient or physician assessment of surgical wound status. One
study looked at blood testing for diagnosis of mediastinitis in a population of patients who had
undergone CABG. As in Bruce et al (2001), the majority of papers found monitoring systems
that undertook intermittent and selective rather than continuous or hospital wide surveillance.
These studies can be further differentiated into three categories based on the primary aim as
reported by the author. These being;
1) Studies undertaken to test a method of post-discharge surveillance without a
comparison group (11 studies identified).
2) Studies undertaken to report the effect of an intervention (surgical or other) and
report on the complications (SSIs or other) experienced by patients undergoing the
therapy. These studies may compare methods of an intervention but the method of
post-discharge surveillance is uniform between the two groups (i.e. a randomised
controlled trial comparing two surgical techniques). Or alternatively these studies
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may have been undertaken to examine the prevalence of surgical site infections post
discharge within a particular ward or hospital using one method of post discharge
surveillance (45 studies).
3) Studies undertaken with an alternate aim or aim not specified (16 studies).
The majority of studies were undertaken in Western Europe and North America, with 9 studies
having been undertaken in the United Kingdom, in a wide variety of surgical specialties including
general, cardiac, orthopaedic, obstetrics amongst others.
All papers were abstracted irrespective of stated primary aim if it appeared that some attempt
had been made by the authors to describe their post-discharge surveillance programmes. The full
details of all abstracted single arm studies can be found in Appendix B.
This section gives an overview of the methods and duration of surveillance of the 72 studies
included.
The methods used to detect post-discharge SSI were:
• direct observation of the wound by health professional (n=31)
• telephone interviews with patients (n=17)
• patient questionnaire (n=13)
• other methods (n=21). Other methods used included review of operating logs to
examine surgical revisions, cards being given to patients to give to their general
practitioners to return to the hospital should a surgical site infection have been detected,
examination of hospital readmission data, review of pharmacy data and using a mixture
of methods amongst others.
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• not stated (n=9)
• staff questionnaires (n=8).
It should be noted that more than one method was used in some studies however in these
studies the methods were not compared with each other.
Full details of each surveillance method, duration, study sample size and response rate can be
found in Appendix B.
The CDC definition was the most commonly used definition of surgical wound infection and
was applied in more than 38% (n=28) of studies included. Other definitions used included
authors’ own (n=8, 11% of studies) and other methods or methods unclear (n=10, 14% of
studies). No formal definition of surgical wound infection was provided in 26 (36%) of studies.
Appendix F presents a summary.
The duration of follow up within the post discharge surveillance programmes identified varied
from 3 days post-discharge to several years, with 30 days being the most common duration
(n=34, 50%). The use of a thirty-day follow up point was associated with use of the CDC
definition of surgical wound infection (30 days is stipulated by the CDC as the required duration
of follow up). In many cases the time at which follow up assessments took place was probably
chosen to reflect other outcomes of interest such as functional assessments but this was not
explicitly stated. Only one study stated the CDC criteria as the rationale for following patients up
for a year after they had received a prosthetic implant.
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These wound infection criteria are provided in Appendix F for descriptive purposes as evidence
does not exist to determine the comparability or validity of these compared to other definitions
e.g., CDC. It should further be noted that these other definitions provide no guidance as to
optimum duration of follow up.
Studies comparing the validity of alternate methods of post-discharge surgical site
infection surveillance.
Bruce et al (2001) categorised the body of literature related to the accuracy and validity of
surveillance of surgical wound infections in four ways. Firstly, there are attempts to compare
different processes of case ascertainment, including case ascertainment by different health care
professionals. Second, these are assessments of patients’ own ability to self diagnose wound
infection, compared with health professional diagnosis. Third, there are validation reports of data
capture methods, in particular, manual versus automated data entry. Finally, there are studies of
the validity of systems and examination of the feasibility of using existing data-collections
systems (e.g. feasibility of antibiotic utilisation as a measure of surgical site infections).
In order for validation studies to be eligible for inclusion in this review, studies had to compare
alternative ascertainment techniques, preferably in consecutive patients. In addition patients had
to receive both methods of surveillance regardless of the results of either method.
Validation of case ascertainment
We regarded studies of case ascertainment as being those which compared an alternative method
of surveillance with a reference standard which involved a purposeful patient examination by a
health care professional with the goal of identification of infection. We found none of these
studies.
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Validity of systems and existing data collection systems.
Only one study was found that compared the validity of using an existing data system to capture
patients with surgical site infections (Sands et al, 2003). This study did not focus exclusively on
post discharge surveillance.
In this study, Sands et al, (2003) included all patients who were members of the Harvard Pilgrim
Health Care (USA) who underwent CABG surgery between March 1, 1993 and June 30, 1997, if
their algorithm derived probability of postoperative wound infection was = 0.1 or greater were
entered into the study. This resulted in 388 eligible patients from a total of 1352 CABG patients.
The study compared two different surveillance methods; ascertainment of SSI by the capture of
data from existing systems (claims and pharmacy dispensing data, medical records) and
prospective hospital based surveillance using NNIS criteria. One hospital within this study also
used automatic screening of antibiotic use. The study attempted to capture SSIs that occurred
both during the inpatient and post-discharge phases. Patients whose probability of infection was
calculated to be 0.1 had their patient records reviewed by a trained abstractor to determine
whether they had experienced an SSI as defined by the criteria of the CDC National Nosocomial
Infections Surveillance (NNIS) system. No information was provided regarding how the
probability of infection was calculated.
Patients were then classified as infected, or not, according to hospital-based surveillance, claims
based surveillance or neither. The denominator used for the calculation of sensitivity and
specificity was the combined total of infected patients irrespective of method of diagnosis.
Surveillance based on health plan data identified approximately 50% more infections than did
hospital-based surveillance and more than twice the number of infections occurring post
discharge.
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There are considerable methodological problems inherent in this study; not least the lack of gold
standard comparison and therefore no sense of the extent of misclassification by either system,
neither of which involved purposeful patient examination. Rather the authors have taken the
combined figure of positive results of infection irrespective of method of diagnosis to be the true
positive rate. Whilst this may have increased the reported sensitivity of the tests, the ratio of
difference between the two tests would remain the same. Sufficient detail was not available to
calculate the specificity of either of the methods.
Therefore whilst this study suggests that, in the USA, administrative data were able to detect
more patients with SSIs than hospital based surveillance, its applicability in the UK is low due to
the amount, type and quality of routine data capture in the UK health system. Furthermore, the
study is uninformative regarding post-discharge SSI detection.
Validation of patient self-diagnosis
Four studies were identified that looked at the validation of patient self-diagnosis as a method of
post discharge surveillance (Martini et al, 2000; Mitchell et al, 1999 Seaman & Lammers, 1991 and
Whitby et al, 2001). Two of these studies (Mitchell et al, 1999 and Seaman & Lammers, 1991)
were included in the Bruce et al (2001) review and were re-extracted for this review for
completeness.
In the first study Seaman & Lammers (1991) compared standardised patient interview by health
professional (nurse, nurse practitioner, physician’s assistant, physician, or medical interpreter)
with medical examination (physician, nurse practitioner, or physician’s assistant). Patients in this
study were those whose lacerations had been previously sutured in the emergency department
thus whilst these were not strictly surgical wounds we felt the information was likely to be
generalisable to surgical wounds.
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The authors of this study calculated patients’ ability to detect infection. This study found that
patients were unable to recognise infections in their own wounds. Of the 21 wound infections
that were identified by health care professional assessment only 11 were detected by patients
themselves, equating to a false negative diagnostic rate of 48%. However the paper did not
detail the questions asked of the patients.
A second study Mitchell et al (1999) compared patient identification of wound infection using
postal questionnaire with a postal questionnaire to surgeons requesting information on the
wound status of the patient obtained at their postoperative review. Patients were chosen to
represent the major elective procedures performed by cardiothoracic, vascular, abdominal,
orthopaedic and gynaecological surgeons at the hospital and covered both clean and
contaminated classes of surgery. Infection was diagnosed and classified on the basis of modified
CDC criteria modified.
Response rates to the questionnaire ranged from 50% to 65% for patients and 42% to 61% for
surgeons. Forms relating to 641 wounds were returned by both the patients and the surgeon; the
total number of eligible wounds is not clear but since there were 1360 eligible patients there is
clearly a high proportion of missing data. Both patients and surgeons agreed that wound
infection was absent in 565 cases. Surgeons classified infection as present in 59 wounds whilst
patients classified infection as present in 74 wounds; the researchers on further investigation
then re-classified 23 wounds regarded as not infected by surgeons as infected – in other words
they rejected the gold standard in favour of patient assessment! Reasons for misclassification
were given as surgical wound assessment preceding the development of infection and patients
having reported their infection to someone other than their surgeon. False negative rates for
patient assessment were also very low. Overall the agreement between surgeon and patient
assessment was fair, with a Kappa of 0.73.
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The results of this study would appear to suggest that patients may be able to self diagnose
wound infection with a good level of agreement with the surgeon’s routine post-operative
review. The interpretation of these results is slightly hampered by the relatively low response
rates from both the patients and surgeons, which may bias the estimates.
In a third study, Whitby et al (2001) analysed the validity of post-discharge self-diagnosis in
Brisbane, Australia. Patients were chosen from a variety of surgical specialties sampled to contain
a high proportion of patients undergoing ‘contaminated’ and ‘dirty’ procedures; specifically
cardiac, breast, laparotomy, upper gastrointestinal tract, lower gastrointestinal tract, hepatobiliary,
hernia repair, orthopaedics, urology, gynaecology and vascular surgery.
Self-diagnosis including recall of antibiotic prescribing by General Practitioners was compared
with diagnosis by one of two research nurses (the standard method of surveillance in that
hospital and regarded as the reference standard). These two methods were also compared with
diagnosis from wound photographs by a Surgeon and a Medical Microbiologist. One Infection
Control Nurse visited the patient and assessed for the presence of infection or no infection.
Patients were blinded as to the purpose of the post-discharge visits in an effort to eliminate the
potential bias that a weekly visit by the nurse may engender.
Nurse assessment was then compared with self-diagnosis that comprised a postal survey at four
and six weeks postoperatively (the second survey to establish inter-rater reliability the patients
being told it was to assist in rectifying computer problems associated with the initial recording of
questionnaire responses). A third questionnaire was then sent to patients who had replied to the
questionnaire sent at week 4 but not at week 6.
Patients were questioned in the survey as to whether they had noticed or remembered any of the
following events;
25
1. Presence or recall of yellow discharge (with the appearance of pus) alone or
2. a) Presence or recall of fever and
b) Redness or swelling and/or
3. Recall by the pa tient of antibiotics prescribed by a General Practitioner for
suspected SSI.
These criteria were also used for nurse diagnosis. The results of both the patient self diagnosis by
questionnaire and the gold standard of Infection Control Nurse diagnosis were compared with
independent assessment of the photographs the doctors and were then classified as being an SSI
or not. Medical diagnosis was based only on the presence of discharge and/or swelling as visible
from the photographs.
Insufficient details are provided as to judge how well these patients were representative of a full
spectrum of disease and risk.
The authors calculated the correlation of all methods with the gold standard of infection control
nurse diagnosis. Unfortunately correlation is inappropriately applied here since the correlation
co-efficient measures the strength of a relation between the two variables, not the agreement
between them and it is possibly to have poor agreement but a high correlation (Bland & Altman,
1986). In this case there was poor correlation between each of patient recall, surgeon diagnosis
and infection department physician/microbiologist with the gold standard of infection control
nurse assessment (correlation coefficients of r=0.37, 0.39 and 0.38 respectively). Correlation
between the surgeon and physician proved only moderate (r=0.50; 95% C.I. 0.41-0.62). The
greatest correlation with the gold standard was the patients’ recall of General Practitioner
antibiotic prescription (r=0.76; 95% C.I. 0.66-0.87). P values were not reported for the values of
correlation. Inter-rater reliability was not provided for the two research nurses that undertook
the evaluation that formed the gold standard of the study.
26
It is unclear whether having a nurse visit on weekly visit, even if intended only to judge the
cosmetic appearance of the wound, may have altered the perception of the patient with regards
to taking action that they may have felt was appropriate to treat the wound (i.e. would they be
more or less likely to visit their G.P. with concerns about the infection in a wound if they knew
there was a nurse coming to visit regardless).
All patients received the reference tests (i.e. questionnaires and surgeon/physician assessments)
regardless of the findings of the gold standard.
This study found that patients were unable to effectively self assess surgical site infections post
discharge (positive predictive value of 29% - in other words only 29% of people who assessed
themselves as having an infection actually had one). However the negative predictive value for
patient assessment was high (98% of patients who assessed themselves as not having an
infection did not have one). The results of this study suggest that patient recall of antibiotic
prescriptions by General Practitioner warrants further research to test whether it is a viable
alternative to visits by infection control nurses for the detection of surgical site infections that
occur post discharge. This requires further confirmation since correlational data only were
presented. Data presented in the publication were not sufficient to allow for the calculation of
the sensitivity and specificity of any of the methods compared to the gold standard which is the
information required to make an assessment of the validity of the methods being studied.
Furthermore both the positive and negative predictive values that are reported in this study are
highly dependant upon the prevalence of infection in the population and as such cannot be
generalised to other populations.
In the fourth study, Martini et al (2000) compared the results of a patient questionnaire with
outpatient clinic records for the surveillance of post discharge surgical wound infections. The
27
study participants were all patients (n=1664) who had undergone orthopaedic surgery over a 20
month period at a hospital in Tubingen, Germany.
Patients were sent a questionnaire 3 months post discharge asking them to report any wound
infection or inflammation that had occurred post surgery. The results of this survey were then
compared with the patient records in the outpatient clinic where patients had been routinely
followed up post discharge. In additional patients’ general practitioners were contacted to
confirm if a diagnosis of surgical site infection had been made. It was not stated at what time
point/s patients attended an outpatient clinic.
Of the 92% of patients who responded, 64 reported having had an infection or inflammation of
the wound. When this was compared with clinic and general practitioner data the number of
confirmed cases was 9, and in all of these cases the wound infection had been captured at the
outpatient clinic. No a priori definition of wound infection was described. It is unclear if all
practitioners were using the same criteria by which a judgement of wound infection could be
objectively and consistently made.
The authors of this study felt that results of this study showed that patients who were regularly
followed up in outpatient clinics did not require additional questionnaires to capture post
discharge wound infections, however it is not clear that routine outpatient follow up is a robust
enough method of detection to be regarded as a reference method.
No studies were found that compared a “gold standard” reference method with an existing data
collection system only although there was some component of this in one of the studies found
and described above.(Sands et al, 2003)
All studies were then assessed for then assessed for quality using the QUADAS tool. The result
of this assessment is shown below in Table 3.
28
Table 3 Assessment of comparative studies using the QUADAS tool
QUADAS Item Sands (2002)
Whitby (2002)
Seaman & Lammers (1991)
Mitchell (1999)
Martini (2000)
Was the spectrum of patients representative of the patient who will receive the test in practice?
No. CABG patients only.
No. Chose moderate to high risk patients only.
No. Only included patients with lacerations treated at A & E
Yes Unclear. Not enough information presented
Were the selection criteria clearly described?
Yes No No No No
Is the reference standard likely to correctly classify the target condition.
No. Relies on reporting; no observation.
Unclear* Yes Unclear No
Is the time period between the reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests?
Unclear Unclear No Unclear
Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis?
Yes Yes Yes No. Only those whose surgeon completed the questionnaire
Yes
Did patients receive the same reference standard regardless of the test result?
Yes Yes Yes Yes Yes
Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)?
No Yes Yes Yes Yes
Was the execution of the index test described in sufficient detail to permit replication of the test?
Yes Yes Yes Unclear Yes
Was the execution of the reference test described in sufficient detail to permit replication of the test?
No Yes Yes Yes Yes
Were the index test results interpreted without knowledge of the results of the reference test?
Unclear Yes Yes Unclear Yes
Were the reference standard results interpreted without knowledge of the results of the index test?
Unclear Yes No Unclear Yes
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?
No. The information available in this standard would not be available in the UK.
Yes Yes Yes Yes
Were uninterpretable/ Intermediate test results reported?
Unclear Unclear Unclear Unclear Unclear
Were withdrawals from the study explained?
Unclear Unclear Yes Unclear Unclear
Overall, methodological weaknesses were observed in all 5 comparative studies and the quality of
reporting was also poor, as evidenced by the frequency of “unclear” responses to the QUADAS
questions.
29
Discussion
Only five studies comparing alternating methods of surveillance for SSI were located. In brief
these studies compared;
• ascertainment of SSI by the capture of data from existing systems (claims and pharmacy
dispensing data, medical records) with prospective hospital based surveillance using
NNIS criteria (Sands et al, 2003). This study found that data from existing administrative
systems were better able to detect surgical site infections than routinely collected data.
• Surgeon questionnaire-based assessment of patient wound status compared with patient
self-assessment of wound status by postal questionnaire (Mitchell et al, 1999). This study
found that there was fair agreement between surgeons and patients regarding the status
of their wounds however data were missing for the surgeon assessment in 50% of
patients.
• Patient self diagnosis by interview compared with health professional diagnosis and
found that patients were unable to diagnose infection or recognise signs of inflammation
producing false negative rates of 48% (Seaman & Lammers, 1991).
• Infection control nurse diagnosis compared with patient self-assessment, surgeon
diagnosis, infection department physician/microbiologist and patient recall of general
practitioner antibiotic prescription (Whitby et al, 2002). This study found that patients
were not able to adequately identify infected wounds (i.e., a high false negative rate).
Further results in this study are uninterpretable since analysed as correlation rather than
agreement, although it is noteworthy that correlation between methods was poor.
• Patient reported symptoms of infection with outpatient clinic physician diagnosis
(Martini et al, 2000). This study found that similar rates of infection were detected via
patient report and outpatient clinic follow up.
30
Two main issues arose from the comparative studies. Firstly variations in data collection
procedures and classification systems between countries limits the comparability and synthesis of
the post discharge surveillance data. As will be further described many studies do not provide
clear descriptions of the criteria by which a diagnosis of infection was made. Secondly, the
source of data affects the external validity of the study as information collected in one country
may not be readily available in another. Together these two factors limit the applicability of the
available evidence to the United Kingdom where vastly different systems are in place. In addition
methodological limitations are evident in these studies that make the conclusions drawn difficult
due to interpret in light of the limited internal and external validity that is apparent in these
studies.
Audit of current surveillance practice: Results
In total 361 Infection Control personnel were sent an audit form (Appendix C) and asked to
return the form irrespective of whether they were performing post discharge surveillance.
Overall 46% (n=146) of trusts returned the audit form (only one response was counted in the
numerator where multiple responses were received from single institutions). Of those trusts that
responded n=42, 29% reported performing some form of post-discharge surveillance and n=104
(71%) said they were not.
Orthopaedics was the specialty most commonly involved with obstetrics (post-caesarean section)
also being common (23%, n=10). In a small minority of trusts that reported performing PDS,
14% (n=6/42) reported doing so in all surgical areas. Other surgical procedures that were
followed in smaller numbers were vasectomies, craniotomies, CABG, large bowel surgery, breast
surgery, general surgery, hernia repair, vascular surgery and day surgery.
31
The most common methods of PDS reported in the audit was that of routine clinical follow up
45% (n=19/42) and direct observation of the wound in 41% (n=17/42) of positively responding
trusts. An even greater number of respondents 50% (n=21) reported using another method or a
combination of methods. These included; giving forms to patients or primary care providers to
return in 30 days; looking at hospital readmission data at 30 days post discharge; writing letters to
or telephoning General Practitioners to ask if the patient had any signs of infection post
hospitalisation or a combination of these and other methods. Other methods such as surgeon
surveys, patient telephone or postal questionnaires were less frequently undertaken. Consent to
pass on details of Trusts was only obtained from Trusts who participated in telephone
interviews.
Telephone Interviews with Survey Respondents
Nine Trusts were initially contacted to arrange an interview. Seven responded and six were
interviewed.
Summary of findings of telephone surveys of current practice of post-discharge within
the NHS
Interviews were conducted with representatives from the following NHS Trusts:
- Nottingham City Hospital
- University College London Hospitals Trust
- Bedford NHS Hospital Trust
- South Glasgow University Hospitals Trust
- Ayrshire and Arran Acute Hospitals Trust
32
- Poole Hospital NHS Trust
All post discharge surveillance (PDS) systems discussed below represent activity that was
considered to be beyond routine follow up. Four locations (Nottingham City Hospital NHS
Trust, University College London Hospitals NHS Trust, Bedford NHS Trust and South
Glasgow University Hospitals Trust) were operating a system in more than one surgical
speciality.
The surgical specialities involved in post-discharge surveillance amongst the five locations that
were available for interview were obstetrics, orthopaedics and neurosurgery. Methods of post
discharge surveillance included patient telephone survey (n=3), patient questionnaire completed
at outpatient visit (n=1), patient questionnaire sent to patients’ residence (n=1), GP/health
professional survey (n=2), direct observation (n=3) and others (hospital re-admissions data)
(n=2). Two locations (Ayrshire & Arran Acute Hospitals Trust and South Glasgow University
Hospitals Trust) were using more than one method in the same surgical speciality.
Centres using patient telephone survey as the method (or part method) of PDS
Systems in operation at Ayrshire & Arran Acute Hospitals NHS Trust and South Glasgow
University Hospitals Trust and University College London Hospital in London included the use
of a patient telephone survey as part of their PDS system. At Ayrshire & Arran, all caesarean
section patients received a telephone call from a midwife (at day 28 post surgery) to confirm
wound status. SSHAIP criteria (Scottish Surveillance of Healthcare Associated Infection
Program – issued by SCIEH) were used to classify SSI. The system, established since October
2002 in conjunction with direct observation (see below), was deemed to work well as part of an
established after-care pathway in this surgical speciality. No additional resource requirements
had been identified due to its perceived ease of incorporation within the community midwife
role. Data regarding patients with surgical site infection were fed back within the hospital (to
33
clinical staff, surgeons, anaesthetists, Infection Control Committee) and at national level (to
SCIEH). A previous telephone survey system (without community midwife involvement) had
been tested at this location and constituted the pilot for the current procedure.
At South Glasgow, all patients with primary hip/knee replacements were monitored using CDC
guidelines. Due to some patients often being discharged to outlying areas (with no routine
follow up appointment made at the treatment location), telephone contact was made by
surveillance nurses during the first year after discharge in order to assess wound status with the
patients. No costings had been undertaken for this part of the PDS procedure. This system was
accompanied by checks on routine hospital data (see below). Again, data regarding post
discharge infections were fed back both locally (to clinicians, multidisciplinary teams and allied
health care professionals) and nationally to SCIEH and the Pan-Celtic Collaboration.
At University College London hospital post-discharge surveillance programmes have been in
place since 2000. Telephone surveillance is undertaken over one 6 month period each year
capturing all patients who have undergone surgery in that institution within that time period. In
addition patients are also asked to complete a postal questionnaire. Patients are asked a series of
questions so that the infection control team are able to assess and classify the patients’ wounds
using a comparison of four methods; ASEPSIS, CDC, NNINS and the definition provided by
Cruse & Foord (1973). They have found that the range of systems is more informative than any
single definition of wound infection, however the questionnaires have not been compared with
direct observation of the wound. The questions that are asked relate to each patient’s condition
for the entire period post-discharge (i.e. not solely at the time of survey completion). The average
response rates for the two methods of surveillance have been estimated at 88 to 90%.
34
The cost of this programme has been estimated at approximately £90,000 per annum (the
respondents claim a large proportion of these costs are offset by cost savings due to the
surveillance programme).
Centres using patient questionnaire as the method (or part method) of PDS
The PDS system at Nottingham City Hospital NHS Trust consisted of a patient questionnaire
administered at outpatient visits following all orthopaedic surgical procedures. This system was
provided as an extension to the mandatory inpatient surveillance after orthopaedic surgery
(Department of the Communicable Disease Surveillance Centre at the Health Protection Agency
- April 2004) and data were fed back at national level.
Centres using GP/health professional survey as the method (or part method) of PDS
Two centres used reports from GPs or other primary health care professionals as the basis of
surveillance. At Bedford NHS Trust, infection control nurses surveyed GPs 2 to 2.5 years after
surgery, using NINSS guidelines (cases identified from the hospital register). GPs were asked for
a simple “Yes/No” answer as to whether any of their patients had been referred back to an
orthopaedic surgeon for an “important” infection (defined as “deep”, not “superficial”) during
that time period. A good response rate was reported from GP surgeries (generally over 85%).
The system was considered to be easy to set up and run, although costs to Primary Care were
unknown. Feedback of data was given at local level (within hospital).
A new system of PDS was established at Poole Hospital NHS Trust in January 2004 involving
follow up of all patients with repair of fractured neck of femur. A standard leaflet regarding
wound care was issued to patients upon discharge; at the same time GPs, district nurses and
practice nurses are advised (by letter) regarding the purpose of the proposed PDS system. They
were advised to report any wound problem occurring in patients during at least the first year after
surgery. Regular telephone contact with GPs was made (the timing and frequency of this was
35
reported to be variable and dependent upon resources) in order to identify whether the patient
has represented to the surgery. Given that the hospital would subsequently follow up the patient
(this time using modified CDC definitions of wound infection), the resource impact of this
procedure upon GPs was considered to be minimal. Despite this, the practicality of this system
was often hindered by low GP response rates. There was some internal (within hospital)
feedback of data, but no link to any national audit.
Centres using direct observation as the method (or part method) of PDS
Three of the five locations (Nottingham City Hospital NHS Trust, Ayrshire & Arran Acute
Hospitals Trust and Bedford NHS Trust) were using direct observational techniques during the
process of post discharge surveillance on all caesarean section patients. All systems were
conducted in the community setting, with one (Bedford Trust) maintaining a linkage of data
between hospital and community recording systems. Patient information on wound self-
assessment was given in one location (Ayrshire & Arran). This was delivered in the form of a
letter, which also contained instructions for the patient to contact their GP or midwife as and
when required. Established surgical wound classification systems were in operation across the
three sites (CDC/NINSS and SSHAIP). Surveillance after caesarean section was considered
practically feasible since regular home visits by midwives and health visitors is standard practice.
However, it was pointed out (by the representative of Nottingham Trust) that stronger data links
should be forged with primary, secondary and community care services in order to utilise
established communication channels more effectively. Although no formal economic evaluation
had been carried out at any of the locations, no significant extra costs were perceived for
community services. One location (Ayrshire & Arran) reported that feedback was directed at
national level (SCIEH), the other two reporting formally on an internal (within hospital) basis
only.
36
Centres using other methods for PDS South Glasgow University Hospitals Trust was using hospital re-admissions data for the
monitoring of surgical site infections in both orthopaedic and neurosurgery specialities. The
system in orthopaedics was used in conjunction with telephone follow up (reported above). The
system in neurosurgery was of a limited nature. The programme (which comprised checks on re-
admissions data) was reported to be a difficult procedure to administer, mainly due to the
dispersal of patients returning to regional care centres after discharge from South Glasgow. Such
a method of surveillance will only identify the most severe cases of infection and depends on
having adequate record flagging or linkage.
Other relevant research currently being undertaken or planned within the United
Kingdom
Complementary work is being currently or about to be performed in a number of relevant areas.
Risk factors for surgical wound infections
Dr Barney Reeves of the London School of Hygiene and Tropical Medicine is undertaking work
to investigate risk adjustment methods for surgical wound infection by (a) systematic reviews and
(b) statistical modelling using existing databases.
First, systematic reviews will be carried out on: (a) risk factors; (b) stratification by procedure
type; (c) evidence about the effect on risk-adjustment models of post-discharge surveillance.
Second, data contained in each database, methods of data collection and potential biases arising
will be described. Third, statistical modelling will be carried out: (a) uni-variable analyses of
individual risk factors and potential two-way interactions between risk factors; (b) multi-variable
modelling, initially without and subsequently with consideration of the data hierarchy (clustering
37
patients within surgeons and centres); (c) exploration of alternative definitions of SSI. This work
was due to be completed by March 2004.
Determining diagnostic characteristics without a gold standard
This work also commissioned by the National Co-ordinating Centre for Research Methodology
seeks to commission an analytical piece that will give guidance to researchers as to the best
methods to use in the absence of a gold standard. This is relevant to detection of surgical
infection in that there is no consensus as to what the precise components of a gold standard
method of detection are, and no objective measure of the presence of infection.
Clinical Practice Guideline on Surgical Site Infection: prevention and treatment
This work has been commissioned by the National Institute for Clinical Excellence and is being
undertaken at the National Nursing and Supportive Care Collaborating Centre (RCN Institute).
The guideline will be restricted to incisional procedures, in people at risk of SSI. Diagnosis,
classification and surveillance of infection are all within the scope of this guideline. Guideline
development was reported as being due to begin June/July 2004.
Conclusions
Question 1: What are the features of existing post discharge surveillance systems in
terms of coverage; denominator data; diagnostic criteria; other data collected; methods
of data collection?
There is great variation in the methods of PDS SSI and particularly in the sources of data used.
Multiple methods are commonly used including routine clinic follow up plus data from primary
care providers. Orthopaedics and obstetrics are the most frequently observed surgical
specialities undertaking PDS SSI. Importantly whilst there are na tional policies to capture SSIs
38
(for example the Health Protection Agency’s mandatory orthopaedic surgical site infection
surveillance which began on April 1st 2004), these schemes does not require post-discharge
surveillance and do not give guidance as to how this could be undertaken.
Question 2: What is the current evidence for the validity, reliability and practicality of
different methods of post-discharge surveillance of SSIs?
Only five studies have compared alternative methods of PDS SSI and none of these is a proper
study of diagnostic test accuracy comparing an alternative method with a gold standard or
reference method of surveillance. The five studies identified represent five unique comparisons
in varied and sometimes highly selected populations. The following methods have been studied
at least once in a comparison:
- capture of routine data (insurance claims, pharmacy data, records)
- prospective hospital based (including outpatient visits) surveillance (3 studies)
- patient interview by health care professional
- patient postal questionnaire (3 studies)
- surgeon questionnaire
- general practitioner questionnaire
- home based infection control nurse assessment
- doctors’ assessment using photographs
There is no uniformity of gold standard or reference method; in at least one study the surgeons’
assessment was over-ridden by the patient assessment. The diagnostic accuracy of routine
outpatient follow up as a method of surveillance has not been proven. Methods of routine data
capture which have performed well in the USA are not applicable to the UK.
39
The studies of patient self-diagnosis gave conflicting results (and used varied methods of aiding
self-diagnosis that were not usually described in sufficient detail to permit replication). The only
study which suggested patients’ assessments were accurate had so much missing data as to
completely undermine the findings.
The survey of national practice gives some impression of which methods are feasible and
practical. It is noteworthy that routine outpatient follow up is the most commonly used method
but probably what constitutes routine follow up varies between sites, and the research literature
does not provide evidence of its reliability as a method. The data suggests that at least in some
locations, patient telephone survey is feasible and this may be a good method of capturing data
from patients who do not attend for routine follow up. Some centres are routinely capturing
data from primary care – a method that shows promise in some of the research.
Question 3: What research is needed to fill knowledge gaps?
• Criteria to be used to define and classify surgical site infection
The international standard is the CDC definition (Mangram et al, 1999) and this should be used
as the basis for patient and professional assessment.
There are those who believe that alternative methods of wound assessment (e.g., ASEPSIS) have
benefits over the CDC criteria (particularly the fact that CDC criteria allow for physician or
surgeon impression of infection alone to be sufficient evidence) and comparison with an
alternative system could be undertaken within any surveillance study.
40
• Evaluating alternative methods of post-discharge surveillance
The crucial decision to be made relates to what the appropriate “gold standard” or reference
surveillance method will be for comparative purposes. The best candidate for this is not clear
but given the absence of data supporting alternatives it should probably be health professional
assessment at around 30 days post-op (timing dictated by CDC criteria). It appears from our
survey that there are centres where this currently occurs (Bedford for caesarean section patients
for example) and which might be candidates to host further comparative research. If health
professional assessment proves prohibitively expensive or impractical then use of primary care
data (antibiotic prescriptions, GP survey, primary care data capture) may be a valuable
alternative. Again Bedford NHS Trust use this method and report good response rates from
GPs whilst Poole NHS Trust complains of poor response rates.
The first step in any research to explore the use of patient self-diagnosis will be the development
and pilot of a suitable instrument for use by patients, and it should be fairly straightforward to
use CDC criteria as the basis for this.
• Can patients self-diagnose surgical wound infection at an acceptable level of
accuracy?
The identification of a sufficiently valid, reliable and cost-efficient method of post-discharge
surveillance for surgical site infection is essential given the need for, and expansion in, this
activity. It is probably fair to say that the reference standard method of surgical site surveillance
is currently the direct observation of the surgical site by a health professional for up to 30 days
for a standard operative procedure and up to a year where a prosthesis has been implanted.
However the precise components of this reference standard are impossible to define at this time.
To what extent does the type of health professional assessing the wound make a difference?
41
Could health care assistants be trained to undertake this role effectively (probably)? How
frequently should wounds be assessed in order to optimally capture clinically important infection
(no studies comparing different time periods have been identified)?
An alternative method to health professional assessment, for detecting surgical site infections
after discharge, should be developed and evaluated. Such a method would trade off sensitivity
and specificity in favour of efficiency. Unfortunately the existing evidence does not give clear
direction as to what the components of this new method should be but an important method to
evaluate would be CDC criteria-based patient self-assessment. The diagnostic validity of the new
method should then be compared with professional assessment (see desirable features of future
studies, below).
As regular home visits by health care professionals or health care assistants are expensive to
undertake, consideration could be given to researching self-diagnosis in patient groups already
receiving follow up after discharge. Women who have had a caesarean delivery; people who
have undergone coronary artery bypass grafting or hip surgery (it will be important that a range
of ages is represented) are potential groups in whom feasibility could be explored. An economic
evaluation should also be incorporated in order to weigh the costs and benefits of the new
method of surveillance.
• What is the most reliable method of detecting surgical site infection post discharge
using patients as informants?
It is not clear whether patient generated detection is best achieved via questionnaires or
telephone interviews at fixed time points. Telephone interviews are likely to give better response
rates but are far more resource intensive therefore the obvious candidate for initial comparison
42
with professional assessment would be patient completed postal questionnaire. Telephone
interviews would be an alternative only if response rates were inadequate via postal
questionnaire.
Desirable Features of Future Studies
a) The spectrum of patients chosen should be representative of those patients who will
receive the surveillance in practice and include a wide spectrum of underlying risk
and co-morbidities. The inclusion of a wide spectrum of patient means that the
clinical applicability (generalisability) is increased.
b) It is likely that future studies will use multiple raters and it is essential that all raters
are fully trained for their role; are using the same criteria for assessment; and that
inter-rater reliability (or agreement) is periodically measured within the study (and
reported).
c) The time period between the application of the reference standard and the
comparator method of surveillance should be sufficiently short to ensure stability in
the wound status. Furthermore there is a need for both tests to be undertaken at a
time period by which a surgical site infection should be reasonably expected to have
occurred (i.e. surveillance carried out one week post-discharge may be less likely to
capture surgical site infections than one carried out at 30 days).
d) Patients need to have both the new and the reference method of surveillance in order
to calculate the predictive validity of the new surveillance method. In addition both
methods need to be applied irrespective (and independently) of the results of either
test.
e) Description of both the reference and alternate method should be described in
sufficient detail to permit replication.
43
f) Interpretation of the data from alternative surveillance methods should occur
independently.
g) The clinical information that health professionals access when judging whether a
surgical wound infection has occurred during the study should be the same as is
available in routine clinical practice within the United Kingdom.
h) Any withdrawals from the study should be clearly explained so as to reduce any bias
that may occur due to systematic differences between patients who withdraw and
those who remain can be examined.
i) Future studies should integrate mechanisms for dealing with equivocal or ambiguous
assessments.
• Does post-discharge surveillance make a difference to patient outcomes?
The evidence currently suggests that audit and feedback has only modest effects on professional
practice (Grimshaw et al, 2004) therefore a simple evaluation of the impact of PDS SSI (e.g., in a
randomised controlled trial) does not seem sensible (since audit and feedback alone would not be
likely to change professional practice and impact on patient outcomes). Any new method of
PDS SSI should be used to measure outcomes of other interventions aimed at reducing surgical
site infection and as part of ongoing performance monitoring once an adequate method of risk
adjustment has been identified.
44
Appendix A Search strategies used in the report Strategy no. 1. Surgical wound infection: prospective studies
Medline search strategy 1 exp surgical wound infection/ 2 exp wound infection/ 3 (postoperative wound infection$ or post operative wound infection$).tw. 4 surgical wound infection$.tw. 5 wound infect$.tw. 6 (wound infect$) adj10 surgery.tw. 7 surgical site infection$.tw. 8 (nosocomial infection$) adj10 surg$.tw. 9 or/1-8 10 exp prospective studies/ 11 exp cohort studies/ 12 exp longitudinal studies/ 13 exp follow-up studies/ 14 prospective stud$.tw. 15 cohort stud$.tw. 16 longitudinal stud$.tw. 17 (follow-up stud$ or followup stud$).tw. 18 panel stud$.tw. 19 or/10-18 20 9 and 19 21 animal/ not (animal/ and human/) 22 20 not 21
45
EMBASE search strategy 1 exp surgical infection/ 2 exp wound infection/ 3 exp surgical wound/ 4 (postoperative wound infection$ or post operative wound infection$).tw. 5 Surgical wound infection$.tw. 6 wound infect$.tw. 7 (wound infect$) adj10 surgery.tw. 8 Surgical site infection$.tw. 9 (nosocomial infection$) adj10 surg$.tw. 10 or/1-9 11 exp prospective studies/ 12 exp cohort analysis/ 13 exp longitudinal studies/ 14 exp follow-up studies/ 15 prospective stud$.tw. 16 cohort stud$.tw. 17 longitudinal stud$.tw. 18 (follow-up stud$ or followup stud$).tw. 19 panel stud$.tw. 20 or/11-19 21 10 and 20 22 animal/ or nonhuman/ 23 human/ 24 22 not (22 and 23) 25 21 not 24
46
CINAHL search strategy 1 exp wound infection/ 2 exp surgical wound infection/ 3 (postoperative wound infection$ or post operative wound infection$).tw. 4 surgical wound infection$.tw. 5 wound infect$.tw. 6 (wound infect$) adj10 surgery.tw. 7 surgical site infection$.tw. 8 (nosocomial infection$) adj10 surg$.tw. 9 or/1-8 10 exp prospective studies/ 11 prospective stud$.tw. 12 cohort stud$.tw. 13 longitudinal stud$.tw. 14 (follow-up stud$ or followup stud$).tw. 15 panel stud$.tw. 16 or/10-15 17 9 and 16 Cochrane Library search strategy 1 wound-infection explode all trees (MeSH) 2 surgical-wound-infection explode all trees (MeSH) 3 postoperative wound infection* or post operative wound infection* 4 surgical wound infection* 5 wound infect* 6 (wound infect*) near surgery 7 surgical site infection* 8 (nosocomial infection*) near surg* 9 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8) 10 prospective-studies explode all trees (MeSH) 11 cohort-studies explode all trees (MeSH) 12 longitudinal-studies explode all trees (MeSH) 13 follow-up-studies explode all trees (MeSH) 14 prospective study or prospective studies 15 cohort study or cohort studies 16 longitudinal study or longitudinal studies 17 follow-up study or follow-up studies or followup study or followup studies 18 panel study or panel studies 19 (#10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18) 20 (#9 and #19)
47
Search strategy no. 2. Surgical wound infection: measurement and validation
studies
Medline search strategy 1 exp surgical wound infection/ 2 exp wound infec tion/ 3 (postoperative wound infection$ or post operative wound infection$).tw. 4 surgical wound infection$.tw. 5 wound infect$.tw. 6 (wound infect$) adj10 surgery.tw. 7 surgical site infection$.tw. 8 (nosocomial infection$) adj10 surg$.tw. 9 or/1-8 10 exp reproducibility of results/ 11 exp "Sensitivity and Specificity"/ 12 exp predictive value of tests/ 13 exp diagnostic errors/ 14 validity.tw. 15 reliability.tw. 16 sensitivity.tw. 17 specificity.tw. 18 reproducibility.tw. 19 test retest.tw. 20 measurement.tw. 21 grading system$.tw. 22 scoring system$.tw. 23 definition.tw. 24 or/10-23 25 9 and 24 26 wound scoring.tw. 27 wound grading.tw. 28 wound classification.tw. 29 or/26-28 30 25 or 29 31 animal/ not (animal/ and human/) 32 30 not 31
48
EMBASE search strategy 1 exp surgical infection/ exp wound infection/ exp surgical wound/ (postoperative wound infection$ or post operative wound infection$).tw. surgical wound infection$.tw. wound infect$.tw. (wound infect$) adj10 surgery.tw. surgical site infection$.tw. (nosocomial infection$) adj10 surg$.tw. or/1-9 exp reproducibility/ exp diagnostic accuracy/ exp measurement/ exp reliability/ exp observer variation/ exp accuracy/ validity.tw. reliability.tw. sensitivity.tw. 20. specificity.tw. 21. reproducibility.tw. 22. test retest.tw. 23. measurement.tw. 24. grading system$.tw. 25. scoring system$.tw. 26. definition.tw. 27. or/11-26 28. 10 and 27 29. wound scoring.tw. 30. wound grading.tw. 31. wound classification.tw. 32. or/29-31 33. 28 or 32 34. animal/ or nonhuman/ 35. human/ 36. 34 not (34 and 35) 37. 33 not 36
49
CINAHL search strategy 1 exp wound infection/ 2 exp surgical wound infection/ 3 (postoperative wound infection$ or post operative wound infection$).tw. 4 surgical wound infection$.tw. 5 wound infect$.tw. 6 (wound infect$) adj10 surgery.tw. 7 surgical site infection$.tw. 8 (nosocomial infection$) adj10 surg$.tw. 9 or/1-8 10 exp reproducibility of results/ 11 exp reliability and validity/ 12 exp test-retest reliability/ 13 exp clinical assessment tools/ 14 exp diagnostic errors/ 15 validity.tw. 16 reliability.tw. 17 sensitivity.tw. 18 specificity.tw. 19 reproducibility.tw. 20 test retest.tw. 21 measurement.tw. 22 grading system$.tw. 23 scoring system$.tw. 24 definition.tw. 25 or/10-24 26 9 and 25 27 wound scoring.tw. 28 wound grading.tw. 29 wound classification.tw. 30 or/27-29 31 26 or 30
50
Cochrane Library search strategy 1 wound-infection explode all trees (MeSH) 2 surgical-wound-infection explode all trees (MeSH) 3 postoperative wound infection* or post operative wound infection* 4 surgical wound infection* 5 wound infect* 6 (wound infect*) near surgery 7 surgical site infection* 8 (nosocomial infection*) near surg* 9 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8) 10 reproducibility of results explode all trees (MeSH) 11 diagnostic errors explode all trees (MeSH) 12 predictive value of tests explode all trees (MeSH) 13 sensitivity and specificity explode all trees (MeSH) 14 validity 15 reliability 16 sensitivity 17 specificity 18 reproducibility 19 test retest 20 measurement 21 grading system* 22 scoring system* 23 definition 24 (#10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22
or #23) 25 (#9 and #24) 26 (wound classification) 27 (wound scoring) 28 (wound grading) 29 (#26 or #27 or #28) 30 #25 or #29
51
Search Strategy no. 3. Surgical wound infection: surveillance and monitoring
studies
Medline search strategy 1 exp surgical wound infection/ 2 exp wound infection/ 3 (postoperative wound infection$ or post operative wound infection$).tw. 4 surgical wound infection$.tw. 5 wound infect$.tw. 6 (wound infect$) adj10 surgery.tw. 7 surgical site infection$.tw. 8 (nosocomial infection$) adj10 surg$.tw. 9 or/1-8 10 exp population surveillance/ 11 exp sentinel surveillance/ 12 exp data collection/ 13 exp registries/ 14 exp medic al records/ 15 exp nursing records/ 16 aftercare/ 17 exp patient discharge/ 18 exp outpatients/ 19 exp ambulatory surgical procedures/ 20 surveillance.tw. 21 monitoring.tw. 22 patient discharge.tw. 23 hospital discharge.tw. 24 ambulatory surgery.tw. 25 or/10-24 26 9 and 25 27 animal/ not (animal/ and human/) 28 26 not 27
52
EMBASE search strategy 1 exp surgical infection/ 2 exp wound infection/ 3 exp surgical wound/ 4 (postoperative wound infection$ or post operative wound infection$).tw. 5 surgical wound infection$.tw. 6 wound infect$.tw. 7 (wound infect$) adj10 surgery.tw. 8 surgical site infection$.tw. 9 (nosocomial infection$) adj10 surg$.tw. 10 or/1-9 11 exp hospital discharge/ 12 exp ambulatory surgery/ 13 exp health survey/ 14 exp registries/ 15 exp medical record/ 16 exp outpatient/ 17 ambulatory surgery.tw. 18 hospital discharge.tw. 19 patient discharge.tw. 20 surveillance.tw. 21 monitoring.tw. 22 or/11-21 23 10 and 22 24 animal/ or nonhuman/ 25 human/ 26 24 not (24 and 25) 27 23 not 26
53
CINAHL search strategy 1 exp surgical wound infection/ 2 exp wound infection/ 3 (postoperative wound infection$ or post operative wound infection$).tw. 4 surgical wound infection$.tw. 5 wound infect$.tw. 6 (wound infect$) adj10 surgery.tw. 7 surgical site infection$.tw. 8 (nosocomial infection$) adj10 surg$.tw. 9 or/1-8 10 exp disease surveillance/ 11 exp data collection/ 12 exp registries, disease/ 13 exp medical records/ 14 exp patient discharge/ 15 exp outpatients/ 16 exp ambulatory surgery/ 17 after care/ 18 surveillance.tw. 19 monitoring.tw. 20 patient discharge.tw. 21 hospital discharge.tw. 22 ambulatory surgery.tw. 23 or/10-22 24 9 and 23
54
Cochrane Library search strategy 1 wound-infection explode all trees (MeSH) 2 surgical-wound-infection explode all trees (MeSH) 3 postoperative wound infection* or post operative wound infection* 4 surgical wound infection* 5 wound infect* 6 (wound infect*) near surgery 7 surgical site infection* 8 (nosocomial infection*) near surg* 9 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8) 10 population-surveillance explode all trees (MeSH) 11 patient-discharge explode all trees (MeSH) 12 ambulatory-surgical-procedures explode all trees (MeSH) 13 sentinel-surveillance explode all trees (MeSH) 14 data-collection explode all trees (MeSH) 15 registries explode all trees (MeSH) 16 medical-records explode all trees (MeSH) 17 nursing-records explode all trees (MeSH) 18 aftercare explode all trees (MeSH) 19 outpatients explode all trees (MeSH) 20 surveillance 21 monitoring 22 patient discharge 23 hospital discharge 24 ambulatory surgery 25 (#10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22
or #23 or #24) 26 (#9 and #25)
55
Appendix B Critical Appraisal of Included non-comparative PDS studies Table B1 Descriptive characteristics of the study First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Amiel (1999) Israel 1033/1098 (94% to telephone survey, 87.6% attended the 7 day outpatient clinic follow-up)
Intermittent To evaluate the cosmetic outcomes and complications of the application of N-Butyl-2-cyanocrylate for the approximation of elective surgical incisions in a paediatric population.
Hospital Paediatrics HAB (Histoacryl Blue, N-Butyl-2-cyanoacrylate) tissue adhesive: Orchidopexy, inguinal hernia, umbilical hernia or hydrocele repair.
Andreasen (2002)
Denmark 180 operations (100%)
Intermittent To gain experience with continuous electronic registration of data regarding postoperative wound infection following heart surgery.
Hospital Cardiac All heart operations
56
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Arbman (2000) Sweden 80 patients (%followed up varied depending on the time point but ranged from 84% and 97%)
Intermittent The aim of this study was to compare closed (Ferguson) haemorrhoidectomy to open (Milligan-Morgan) haemorrhoidectomy regarding postoperative conditions, complications and long term results
Hospital Gastrointestinal Closed and open haemorrhoidectomy
Astagneau (2001)
France 38973 Intermittent To determine whether SSI is associated with severe or fatal outcome in surgical patients and what is its role, independent of other survival predictors.
Private and public hospitals
Various Various
Avato (2002) USA 1271/1324 (96%) Intermittent To assess the influence of post discharge infection surveillance on risk-adjusted SSI rates for CABG procedures
Tertiary care referral hospital
Cardiac CABG procedures that included both chest and leg incisions
57
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Beaujean (2002) Netherlands 515/576 (89%) Intermittent To compare the efficacy of two surveillance methods in the diagnosis of SSIs. CS (using complication surveillance criteria). NIS using CDC criteria.
Hospital General, trauma & vascular (emergency admissions included/outpatients excluded)
Various
Bhatia (2003) India 615 patients (% response not reported)
Intermittent To report postoperative wound infection in CABG surgery patients
Hospital Cardiac CABG
Bitzer (2000) Germany 502 patients(73% at 3 months)
Intermittent To determine the success of surgery for inguinal hernia from the patients perspective.
NS NS Inguinal hernia repair
Cadwallader (2001)
Australia 510 procedures (100%)
Intermittent Two compare two different methods of surgical site infections following orthopaedic surgery
Hospital Orthopaedics Hemi-arthoplasty or internal fixation of fractured neck of femur.
Callaghan (1999) USA 24 patients (50% follow up at final follow-up time not stated)
Intermittent To assess whether one stage revision surgery for infection after total hip arthroplasty in selected patients predictably eradicates the infection
NS Orthopaedics One-stage revision surgery of the infected hip.
58
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Canonico (2001) Italy 18 patients Intermittent To describe the preliminary results of a special method of wound closure in varicose vein surgery
NS NS Varicose vein surgery
Dagan (1999) Canada 455 patients (% followed up not reported)
Intermittent To evaluate whether changes have occurred at our centre in the rate of nosocomial infections and in the infectious organisms consequent to changes in policy and procedure as of 1987.
Hospital Cardiac surgery Cardiopulmonary bypass/no bypass
De Boer (2001) The Netherlands Number followed up post discharge not reported
NS To assess the relative importance of risk factors for surgical site infections following total hip and knee prosthesis in the Netherlands
Hospitals Orthopaedics Total hip and knee prostheses.
Delgado-Rodriguez (2001)
Spain 1444/1477 (97.8%) followed up
Intermittent To study postoperative infections in hospital and after discharge and to identify the risk factors for such infections
Hospital General surgery Various
59
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Derzie (2000) USA 331 patients NS To compare to two different wound closure techniques in gastric surgery for morbid obesity to see which is associated with lower rates of acute wound complications.
NS Gastric Gastric Bariatric operations
Eriksen (2003) Tanzania 396 operations on 388 patients (64% follow up)
Intermittent To identify the incidence of SSI and associated risk factors.
Hospital General surgery (orthopaedic, urological and gynaecological operations were not included)
Various
Ferraz (2001) Brazil 50 patients (100% follow up)
Intermittent To analyse the late clinical follow-up of patients operated on for Chagas megaseophogus with the Thal-Hatafuku procedure.
Hospital NS Thal-Hatafuku procedure.
Fields (1999) USA 50 surgeons (83-88% response to survey questionnaires)
Intermittent To evaluate a PDS system using surgeon questionnaires
Hospital General Various
Fowler(2003) USA 5500 patients (15.5% patients)
Intermittent To evaluate the utility of blood cultures in identifying patients with mediastinitis.
Hospital Cardiac CABG
60
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Friedman (2001) USA 555 TKA (total knee arthroplasty)
Intermittent To evaluate whether the additional use of electronic chart review is an effective and efficient means of identifying SSI
Hospital Orthopaedic TKA (Total knee arthroplasty)
Gerbitz (2000) Switzerland 106 patients Intermittent Retrospective
Unclear Hospital NS Hernia operations
Goldsborough (1999)
USA 547 patients (no response rate reported)
Unclear To determine the prevalence of postoperative leg wound complications after CABG at our institution and to determine factors that place patients at higher risk for these complications.
Hospital Cardiac CABG alone or in combination with another cardiac procedure.
Habib (2002) Saudi Arabia 754 caesarean sections
Intermittent To measure the rate of wound infection after caesarean section and to assess risk factors
Hospital Obstetrics Caesarean section
Heah (2000) UK 25 NS To evaluate the role of laparoscopic suture rectopexy without resection as a safe and effective treatment for full- thickness rectal prolapse.
Hospital Colorectal surgery Laparoscopic suture rectopexy
61
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Henderson (2001)
Australia 158/207 (76%) Intermittent To establish whether patient information during hospitalisation is sufficient to enable patient self-care upon discharge
Hospital General surgery Abdominal/colorectal
Henriksen (2003) Denmark 1090/1946 (56%) Intermittent To assess the incidence and severity of short term complications after breast augmentation
Private/public clinics of plastic surgery
Plastic surgery Breast augmentation
Higgins (1999) USA 450 patients Intermittent To test the hypothesis that prophylactic antibiotic treatment in elective laparoscopic cholecystectomy does not lower the already low infection rate associated with this procedure
Hospital NS Laparoscopic cholecystectomy
Hui (1999) USA 621/1412 (44%) Intermittent Prospective analysis of mechanisms of PGB (perforation of gallbladder) and postoperative infectious complications
Hospital NS Laparoscopic cholecystectomy
62
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Jamali (2001) Pakistan 252 patients Intermittent To compare the effect of theatre condition on postoperative infection rate.
Hospitals NS Clean surgery only
Jonkers (2003) Netherlands 1885 (100% patient response) 91% response from family physician
Intermittent To study the prevalence of sternal wound and donor site infections during hospitalisation and at 30/90 days post operatively
Hospital Cardiac Various
Kent (2001) Australia 1257/1291 (98.7% followed up)
Intermittent To examine the impact of effective post-discharge SSI follow up on the overall SSI rate
Hospital General surgery Joint replacement Gall bladder surgery Abdominal/gynaecological surgery
Killian (2001) USA 765 caesarean sections (30% response rate from physician survey)
Intermittent To identify risk factors associated with SSIs following caesarean sections
Hospital Obstetrics & Gynaecology Caesarean section
Krupova (2001) NS 117 patients (% followed up not reported)
NS NS Hospital Neurosurgery Various
Kumar (2001) UK 20 patients (100% follow up)
Intermittent To review the safety, practicality and cost-effectiveness of day surgery anterior cruciate ligament reconstruction
NS (presume hospital)
Orthopaedics Anterior cruciate ligament reconstruction
63
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Letrelliart (2001) France 2199/7540 (29%) Intermittent To study both surgical and nonsurgical nosocomial infections (NIs) seen by primary-care physicians (general practitioners [GPs]) in France.
General practice NS NS
Mahatharadol (2001)
Thailand 102 (100% follow up)
Intermittent To assess postoperative complications in patients receiving antibiotic prophylaxis in elective laparoscopic cholecystectomy
Hospital NS Elective laparoscopic cholecystectomy
Mahomed (2003) Canada/USA 75,051 patients Population-based study
Continuous To characterise rates and immediate postoperative outcomes of primary and revision total hip replacement
Medicare population
Orthopaedics Primary & revision total hip replacement
Marroni (2003) Italy 668 patients NS NS Hospital Various Vascular surgery Amputation Other cardiovascular surgery
McCowan (1999) Scotland 62 Intermittent Pilot study to establish means of assessing post discharge SSI
Hospital NS NS
Melling (2001) UK 421patients (% response unclear)
Intermittent within an RCT
To asssess whether warming patients before short duration, clean surgery would reduce infection rates.
Hospital Various Elective hernia repair, varicose vein surgery or breast surgery.
64
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Nelzen (2000) Sweden 149 operations on 138 patients
Intermittent To establish morbidity, patient satisfaction and long term results of SEPS
Hospital Vascular surgery Subfascial endoscopic perforator surgery (SEPS)
Noy (2002) Australia 247/277 (89%) Intermittent To evaluate a multi-method approach to PDS SSI
Hospital Obstetrics/Gynaecology Caesarean section
Oliveira (2002) Brazil 398/504 patients (79%)
Intermittent To determine the incidence of surgical wound infections in surgical patients and to compare the frequency of surgical wound infection diagnosed in hospital
Hospital Digestive tract surgery Not further specified.
Paajanen (2003) Finland 317/964 using Lichtenstein procedure
Intermittent To determine the effect of surgeon’s training level on long term results of groin hernia repair
Hospital NS Groin hernia repair using Lichtenstein technique
Perencevich (2003)
USA 89/4571 procedures (1.9% had SSI)
Intermittent To assess clinical outcome and resource utilisation in an 8 week postoperative period associated with PD SSI
Hospital Non-obstretric in or outpatient procedures not further specified.
Various
Pernice (2001) Italy 56 (100% follow up)
Intermittent To assess long term outcome of circular staple haemorrhoidectomy
Medical unit NS Circular staple haemorrhoidectomy
65
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Platt (2002) USA 149/536 (34%) that had sufficient documentation that could be retrieved.
Intermittent To determine if infection indicators were sufficiently consistent across health plans to allow comparison of hospital risks for infection after CABG
Hospitals Cardiac CABG
Porras-Hernandez (2003)
Mexico 428/530 (80.7% follow up)
Intermittent To quantify SSI rates and identify risk factors in a tertiary care paediatric hospital
Hospital General surgery, cardiovascular and neurosurgical
Various
Powell (2002) South Africa 731/912 (80.15%) patients
Intermittent To determine if cost effectiveness is sustained, whether there are hidden complications and whether there is a need for routine follow-up.
Hospital day unit Day case procedures confined to the inguinoscrotal region
Inguinal herniotomy, orchidopexy and circumcision.
Rammelt (2003) Germany 169/314 (54% follow up)
Intermittent Critical results of the medium- term results of open reduction and internal fixation (ORIF) of displaced intra-articular calcaneus fractures with a standardized protocol in a greater patient cohort.
Hospital NS Open reduction and internal fixation (ORIF) of displaced intra-articular calcaneus fractures
66
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Reid (2002) New Zealand 1904/1934 (98.5% follow up)
Intermittent To determine incidence of and risk factors for infections following clean surgery
Hospital General surgery Various
Reilly (2002) Scotland 2202 patients Intermittent To evaluate the effectiveness of a gold standard surveillance methodology for SSI
Hospital General surgery Clean, elective operations
Ridderstolpe (2001)
Sweden 3008/3026 (99%) Continuous from January 1996-September 1999
To detect the incidence of (and risk factors for) sternal wound infections, post discharge
Hospital Cardiac Various, including CABG and valve surgery
Rishi (2001) Libya 1295 Intermittent NS Hospital Various Various Rovera (2003) Italy 346 NS To compare the
incidence and types of infections occurring after 2 different VATS (Video-assisted thorascopic surgery) procedures
Centre for Thoracic Surgery (University of Insurbia, Varese, Italy)
Thoracic surgery Lung wedge resection. Biopsy of pleura/mediastinal mass.
Saeed (2001) UK 127/150 Intermittent To assess patient-based outcomes following radial artery harvesting for CABG
NS Cardiac Radial artery harvesting for CABG
Schneeberger (2002)
The Netherlands 89 operations (% followed up not stated)
Intermittent NS Hospital Orthopaedic NS
67
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical Specialty Procedure
Sewonou (2002)
France 5, 183 patients Intermittent To estimate the incidence of surgical-site infections in ambulatory surgery and to identify risk factors based on the surveillance network INCISO in 1999-2000.
Hospital Various Orthopaedic, gynaecologic/obstetrics, head and neck, skin and soft tissue surgery accounted for 83% of ambulatory procedures.
Sjol (2002) Denmark 855/1034 (82.7%) patients
Intermittent To assess the impact of surgical caps and masks on infection rates during cardiac catheterisation
Hospital Cardiac Cardiac catheterisation
Sorensen (2003)
Denmark 57/60 (95%) patients
Intermittent To test the hypothesis that short-term pre-operative cessation of smoking in colorectal surgery decreases the incidence of postoperative tissue and wound complications
Hospital Colorectal Open colonic or rectal operative procedure with formation of an enteric anatomises.
Stockley (2001) UK 667 patients (92.7% up)
Intermittent NS Hospital Various Total abdominal hysterectomy, inguinal hernia repair, large bowel surgery, vascular surgery.
68
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting
Surgical specialty Procedure
Taylor (2004) Scotland 3046 (93.3%) of eligible population 2665 (87.5%) complete follow-up data available.
Intermittent To determine the incidence of, and risk factors for, SSI after hernia repair
32 Scottish hospitals
NS Hernia repair
Tegnell (2002) Sweden 200 175/200 (87.5%) complete follow-up data available
Intermittent Describing the early development of wound infections after cardiac surgery to identify markers for upcoming infections
University Hospital
Cardiac CABG, valve surgery, or combined procedures.
Thibon (2002) France 3705 Of those 1525 (41.2%) had follow-up for greater than 30 days
Intermittent To take into account the proportion of patients lost to follow-up when calculating surgical-site infection rates.
27 surgical units within 11 institutions
Various Various inpatient procedures (oupatient procedures were not included in this study)
Vilar-Compte (2001)
Mexico 1556 surgeries. 1350 followed up at 30 days (87%)
Intermittent To evaluate the ambulatory surgical site infection rate and risk factors associated with SSI.
Tertiary-care cancer hospital
Ambulatory outpatient surgeries (80% clean surgeries)
Various
69
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Vrijland (2000) Netherlands 136/171 (80%) included in analysis + 6 patients lost to follow up, therefore n=130 (76%)
Intermittent To determine whether enterocutaneous fistulas occurred after repair of incisional hernias with polypropylene mesh
NS NS Incisional hernia repair
Whitney (2001) USA 24 patients (% response unclear)
Intermittent To explore clinical healing outcomes and complications in the two study groups.
NS NS Inguinal hernia repair
Yerdel (2001) Turkey 280 Intermittent (within an RCT)
To assess the value of a single-dose, intravenous, prophylactic ampicillin and sulbactum in the prevention of wound infections during open prosthetic inguinal hernia repair by a double blind, prospective randomised trial.
NS NS Inguinal hernia repair
Yokoe (2001) USA 100 patients (random sample)
Intermittent To identify postpartum infections and describe the epidemiology of these infections
Hospital Obstetrics & Gynaecology Caesarean/vaginal delivery
70
Table B1 Descriptive characteristics of the study (Continued) First author (year)
Location Sample size (% response)
Type of surveillance (continuous or intermittent)
Study aim Practice setting Surgical specialty Procedure
Zhu (2001) Hong Kong 180 patients Intermittent (within an RCT)
To compare the rates of postoperative infectious complications of neurosurgery with prophylactic ceftriaxone and ampicillin/sulbactum, a less expensive antibiotic.
Hospital Neurosurgery Craniotomies, burr holes, cerebral cyst shuntings, transphenodial surgeries, cranioplasties and laminectomies for intradural pathology.
NS-not stated
71
Table B2 Methods and definitions of post discharge surveillance First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Amiel (1999) Outpatient clinic visit and telephone survey
7 days and then at least 6 months postoperatively. Patients or physicians could also request additional follow-up if required but this was not recorded
NS NS NS NS
Andreasen (2002)
A registration chart given to the patient upon discharge to be returned upon contact with primary health care workers. Outpatient/telephone follow up
30 days postoperative Postoperative wound infection was defined as infection in skin and subcutaneous tissue. Postoperative deep wound infection was defined as infection in skin and subcutaneous tissue.
NS Yes. Authors own. Authors own includes clean, potentially contaminated, certainly contaminated and severely contaminated
Arbman (2000) Follow up was done by visit or telephone. Staff involved not reported
3 weeks, 6 weeks and after at least a year.
NS NS NS NS
Astagneau (2001)
Standardised form completed by hospital staff
30 days postoperative CDC (1992) NS NNIS risk index Altemeier classification (Altemeier et al 1992)
Avato (2002) Data collection checklist to record any infection since patient discharge and for use at outpatient visit. Microbiological reports reviewed periodically and at 30 days post operative
Periodically and 30 days post operative over a period of 27 months
CDC NNIS CDC NNIS risk index NS
72
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Beaujean (2002)
NIS study arm did not do PDS. PDS in “CS” Study arm only: Outpatient visit at least 30 days post discharge. Telephone and postal questionnaires also used.
30 days post discharge System developed by Association of Surgeons of the Netherlands that is not specific to surgical wound infection.
NS NS NS
Bhatia (2003) Outpatient visits 2 months post operatively
CDC NNIS (modified) NS NS NS
Bitzer(2000) Postal questionnaire Average of 3 and 14 months post operatively
NS NS NS NS
Cadwallader (2001)
Routine patient data and forms for surgeons to fill in when patients had a SSI that was detected during an outpatient visit
NS CDC (1992) NS NS CDC
Callaghan (1999)
NS NS although patients were followed up for an average of 9.1 years
NS NS NS NS
Canonico (2001)
Direction observation by healthcare worker
7 days postoperatively NS NS NS NS
Dagan (1999) Not specified 2 months post discharge
CDC (1988) NS Authors own based on the therapeutic intervention scoring system
NS
De Boer (2001)
Not specified, although reported to be according to a standardised protocol.
Follow up until 1 year after the operation
CDC Altmeier (1984) NNIS CDC
73
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used
Wound classification system
Delgado-Rodriguez (2001)
Review of emergency department forms and telephone questionnaire
30 days post discharge CDC NS SENIC/NNIS risk index
Clean, clean- contaminated, contaminated, dirty
Derzie (2000) NS 30 days post discharge CDC (1992) NS NS CDC Eriksen (2003)
Review of patient files at 30 days post operation. Outpatient clinic.
30 days post operation CDC (1999) NS NNIS CDC
Ferraz (2001) Outpatient follow-up Time period post operative not stated
NS NS NS NS
Fields (1999) Questionnaire mailed to surgeons 30 days postoperative. Responses returned by mail or communicated by telephone
At least 30 days post operative
NS NS NS Clean, clean-contaminated
Fowler (2003) Blood culture drawn Within 90 days of CABG
Mediastinitis was defined according to CDC definition
NS NS NS
Friedman (2001)
Traditional surveillance methods: microbiology reports & follow up of readmissions. Additionally, electronic chart review from clinic visits.
Electronic chart review at 2 weeks, 6 weeks 6 months, and 1 year
NNIS ASA score NNIS risk index Clean, clean-contaminated, contaminated, dirty
Gerbitz (2000)
Patient questionnaire. 3 months post operative.
NS NS NS NS
74
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Goldsborough (1999)
The nurse case managers were notified by the patient or by other health care providers (home health nurse or primary physician) of any wound complications.
Up to 30 days postoperatively, exact time unclear.
NS NS NS NS
Habib (2002) Inspection of wound at outpatient postnatal clinic
5-10 days post discharge
NS Part ASEPSIS (Unclear) NS NS
Heah (2000) Outpatient appointments or where necessary by telephone review
Unclear NS NS NS NS
Henderson (2001)
Telephone interview 1-2 weeks post discharge
NS NS NS NS
Henrikson (2003)
Standardised follow up sheets completed by surgeons
At each follow up visit, planned consultation or extra visit due to complications (No uniform time period)
NS NS NS NS
Higgins (1999) Examination 7 to 10 days after the procedure and were followed up for 30 days.
At 7,10 and 30 days post operation
Authors own NS ASA and the Culver (1991) wound infection risk classification
Infected wounds were classified as superficial surgical site, deep surgical site and distant.
Hui (1999) Mailed patient questionnaire & telephone interviews
6-86 months post operative. (Average 49 months)
NS NS NS NS
Jamali (2001) Direct observation of wound by health care provider.
48 hours, 4 days and at 4 weeks postoperatively
A wound with a positive culture was defined as infected.
NS NS NS
75
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Jonkers (2003)
Observation of wound by medical attendant and patient questionnaire administered at 2-6 week outpatient visit. At 90 days, fa mily physician asked to fill in questionnaire
2-6 weeks; 90 days CDC (1992) NS NS NS
Kent (2001) Surgeon questionnaire and three follow up telephone calls. Medical records consulted where necessary
Questionnaire 3-4 weeks post discharge. Telephone calls 1 month post survey
CDC (1992) NS NNIS NS
Killian (2001) Hospital readmission data and physician questionnaire, following NNIS system
30 days post operative CDC/NNIS NS NS NS
Krupova (2001)
NS NS NS NS NS NS
Kumar (2001) Physiotherapist home visits and an in clinic visit
Post-operative visits occurred on days 1,3 and 6 post surgery. Clinic visits were conducted at 2 and 6 weeks post operatively.
NS NS NS NS
76
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Letrilliart (2001)
Data collected (via teleinformatics) from GP regarding (amongst other items) patient consultations for post discharge infection
Within 30 days of discharge CDC (1988) NS NS NS
Mahatharadol (2001)
Data collected at outpatient clinic or by telephone contact
30 days post operative Authors own Unclear NS Authors own (Superficial or deep)
Mahomed (2003)
Data collected from Medicare claims submitted by hospitals, physicians and outpatient facilities
90 days postoperative ICD-9-CM/CPT codes
NS NS Only deep wound infections were captured by this study
Marroni (2003)
NS 30 days post operative and 1 year post operative if there was an implant
CDC (1999) NS CDC NNIS CDC
McCowan (1999)
Post-card patient questionnaire, telephone interviews, clinic review
NS NS NS NS NS
77
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Melling (2001) Outpatient clinic visit or visit to patients home and patient diary
At 2 and 6 weeks postoperatively Authors own ASEPSIS NS NS
Nelzen (2000) Outpatient review at 7-10 days post operative/surgeon review at 3-4 months/patient postal questionnaire to assess long-term complications
7-10 days; 3-4 months Long term (exact time period not stated)
NS NS NS NS
Noy (2002) Patient postal questionnaire/telephone follow up/physician consultation/pathological report/chart review
30 days post operative CDC (1999) NS NS NS
Oliviera (2002)
Outpatient clinic visits Within 30 days post operatively. CDC (1999) NS NNIS Unclear- possibly CDC
Paajanen (2003)
Patient postal questionnaire & clinical examination
Mean 3 years (range 1-6) NS NS NS NS
Perencevich (2003)
Automated medical record screening, pharmacy records, hospital readmission/emergency room claims patient postal questionnaire/telephone follow up/administrative databases
30 days or 8 weeks postoperative for questions regarding resource use.
CDC NNIS (1991) NS NS NS
78
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Pernice (2001)
Outpatient visit and telephone follow up
Outpatient visits at 1,2,4 weeks; telephone follow up 5-120 months (mean 33)
NS NS NS NS
Platt (2002) Review of medical records that contained indicator codes suggestive of postoperative SSI
Unclear, although utilised patient records that contained information on outpatient claims up to 30 days post operative
CDC (1992) NS NS NS
Porras-Hernandez (2003)
Outpatient clinic visits and full chart review at 30 days post operative. Also 6 month chart review where implant in place
30 days/6 months post operative CDC (1992) NS NNIS Altmeier et al (1984) and CDC (1992) (Note these two methods were not compared in this study).
Powell (2002) Outpatient clinic visit 2 weeks post surgery. NS Southampton wound assessment scale
ASA Southampton wound assessment scale
Rammelt (2003)
NS NS NS NS NS NS
Reid (2002) Telephone interview with patient. Clarification with GP or surgeon review of wound where required
30 days post discharge ACHC (1995) NS NS NS
Reilly (2002) Patients reviewed prospectively at home or at special wound surveillance clinics
30 days post operative As those used by the Second UK NPS 1992
Southampton wound assessment scale
Risk analysis conducted but no index mentioned
NS
79
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Ridderstolpe (2001)
Review of operating room logs to classify surgical revisions (CDC criteria). Patient telephone follow up, plus questionnaire. Further data collected at surgeon consultation + physician questionnaire
Telephone follow up at 2 weeks postoperative; questionnaire at 6 weeks. Data from surgeon consultation 2/6 months
CDC (1999) NS NS CDC
Rishi (2001) Visit to outpatient clinic within 28 of operation.
Within 28 days of operation, unclear that all patients were observed at the same time period post discharge
NS NS NS National Research Council classification of clean, clean contaminated, contaminated and dirty.
Risnes (2001) Wound inspection. 3 days and 6 weeks postoperatively A score of 4 or more on the Authors wound scoring system
Authors own NS NS
Rovera (2003)
NS 30 days post operatively CDC (1999) NS NS NS
Saeed (2001) Telephone survey of patients
Median time post surgery 8 months Range 0.2-15 months
Defined by author as clinical infection requiring antibiotic treatment.
NS NS NS
Schneeberger (2002)
Outpatient clinic visit. One year period postoperatively although exact dates that patients visited the outpatient clinic were not stated
CDC (1992) NS NNIS CDC
Sewonou (2002)
Outpatient clinic visit and assessment of readmission data from hospital records
30 days post operative CDC NS NNIS CDC
80
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Sjol (2002) Patient questionnaire About two months post operatively NS NS NS NS Sorensen (2003)
Outpatient clinic visit 30 days post operative NS NS NS NS
Stockley (2001)
Telephone contact of patients at home Subgroup nurse visit at home Patients also given a questionnaire to be given to health professional if a visit was made
25-35 days post operative, subgroup at 10 days Time visited at home not stated. Survey tio be returned after patient in contact with health provider.
NINSS NS NS NS
Taylor (2004) Telephone contact 10,20,30 days after surgery CDC (1992) Unclear Unclear NS Tegnell (2002)
Telephone contact or contact via mail and records of patients from healthcare visits 3 months post-operatively
3-4 months after surgery NS ASEPSIS (1986) NS NS
Thibon (2002) Examination of patient records
30 days post operative CDC (1992) NS NS NS
Vilar-Compte (2001)
Full review of microbiology reports and medical records
30 days post operatively CDC (1992) NS NS National Academy of Sciences/ National Research Council wound classification
81
Table B2 Methods and definitions of post discharge surveillance (Continued) First author (year)
Surveillance Method Time period when surveillance carried out
Definition of surgical wound infection given
Wound scoring system been used (reference)
SSI risk index used Wound classification system
Vrijland (2000)
Review of medical records from outpatient visits or questionnaire sent to GP
NS Authors own NS NS A mild wound infection was defined as redness surrounding the laparotomy wound. A moderate wound produced pus and a severe infection was defined as a non-healing defect of the wound extending into the subcutaneous tissue.
Whitney (2001)
Examination of patient records and a follow-up phone call.
30 days post discharge. ASEPSIS Method used by Wilson et al (1986) ASEPSIS
NS NS
Yerdel (2001) Follow up visits to the surgeon
At suture removal 7-9 days post operatively and then 4-6 weeks, 6 months, and then at 1 year
CDC (1992) NS NS CDC (1992)
Yokoe (2001) Automated Health Maintenance Organisation data, pharmacy dispensing data, administrative claims & full text ambulatory medical records. Patient questionnaire
30 days postpartum 6 weeks post discharge
CDC (1992) NS NS NS
Zhu (2001) NS 6 weeks post operatively CDC (1992) NS NS Unclear NS-not stated
82
Table B3 Personnel involved and intrinsic features of post discharge surveillance First author (year)
Staff and method of data collection
Training given to staff
Patient education given
Linkage of data Validation of data Feedback to users Others
Amiel (1999) Data was collected at outpatient clinic visit and telephone surveys. Staff involved not reported.
NS Yes, but related to preventative steps of wound infection not surveillance.
NS NS NS
Andreasen (2002)
Doctor recorded the occurrence of PWI in medical records. Secretarial staff were also employed to retrieve records outside of county.
NS NS NS NS NS
Arbman (2000) NS NS NS NS NS NS Astagneau (2001)
Nursing staff, anaesthetists and surgeons completed a standardised form for each patient. Data was then entered into an EPI-INFO based programme
NS NS NS Before analysis all data was checked for missing or incorrect values using a logical EPI-INFO software programme
NS
Avato (2002) Operating room nurse/surgeon/nurse practitioner/infection control practitioner
Training on form completion given by infection control practitioners
NS Medical chart, microbiological data, prescription of antibiotics and data from post surgical visit
Medical charts reviewed by ICP
NS Some economic analysis p365
Beaujean (2002)
NS NS NS NS NS NS
Bhatia (2003) Outpatient clinic staff NS NS NS NS NS Bitzer (2000) Patient self report, no staff
required NS NS NS NS NS
83
Table B3 Personnel involved and intrinsic features of post discharge surveillance (Continued) First author (year)
Staff and method of data collection
Training given to staff
Patient education given
Linkage of data Validation of data Feedback to users Others
Cadawallader (2001)
Surgeons and ward staff Collected data on infections occuring at outpatient clinic visits and if patients were readmitted with suspected SSIs.
NS NS NS NS NS Although a comparative study post-discharge methods not compared
Callaghan (1999)
NS NS NS NS NS NS
Canonico (2001)
NS NS NS NS NS NS
Dagan (1999) Infectious disease nurse NS NS NS NS NS De Boer (2001)
NS NS NS NS Checks of data were performed
NS
Delgado-Rodriguez (2001)
Review of all emergency department forms and telephone interview with patient. Staff not stated
NS NS In-hospital SSI data NS NS
Derzie (2000) NS NS NS NS NS NS Eriksen (2003) Hospital staff (not further
specified) data was collected from patient records
NS NS Patient files were marked so that medical personnel at other wards could notify the investigator if a patient included in the study was admitted into a different section of the hospital
NS NS
Ferraz (2001) Outpatient clinic Staff (exact staff not reported)
NS NS NS NS NS
84
Table B3 Personnel involved and intrinsic features of post discharge surveillance (Continued) First author (year)
Staff and method of data collection
Training given to staff
Patient education given
Linkage of data Validation of data Feedback to users Others
Fields (1999) Clerical staff, Infection Control staff
Surgeons given CDC guidelines
NS NS NS NS Resource analysis conducted
Fowler (1999) Infection control practioners, clinical staff
NS NS Archived records of blood cultures and the database containing operative data for patients undergoing cardiac surgery
NS NS
Friedman (2001)
Researchers reviewed the electronic chart
NS NS NS NS NS
Goldsborough (1999)
Patients or healthcare providers (home health nurse or primary physician) notified nurse case manager of any wound infections.
NS NS NS NS NS
Habib (2002) Obstetrician NS NS NS NS NS Heah (2000) NS NS NS NS NS NS Henderson (2001)
Clinical nurse consultant/researchers/ Patient self report
NS Yes, this is the intervention
Unclear NS NS
Henrikson (2003)
Surgeon completed standardised forms
NS NS NS NS NS
Higgins (1999) Attending surgeon NS NS NS NS NS Hui (1999) PDS staff not stated. Patient
self report NS NS NS NS NS
Jamali (2001) Data was collected from patients at time of evaluation. Staff involved in this process were not reported
NS NS Cultures taken from wounds
NS NS
Jonkers (2003) Medical attendants, family physician, patient self report
NS NS Outpatient/family physician data
NS NS
85
Table B3 Personnel involved and intrinsic features of post discharge surveillance (Continued) First author (year)
Staff and method of data collection
Training given to staff
Patient education given
Linkage of data Validation of data Feedback to users Others
Kent (2001) Nurses, anaesthetic, surgical staff, practice secretaries
Yes: definitions, guidelines, training handouts etc
NS Inpatient/outpatient SSI rates
NS Risk adjusted SSIrates were fed back to induvidual surgeons
Krupova (2001)
NS NS NS NS NS NS
Kumar (2001) Physiotherapists and day clinic staff
NS NS NS NS NS, although clinic staff did perform the post-operative assessment.
Cost analysis for day patient vs. inpatient
Killian (2001) Physicians. Patient records were checked.
NS NS NS NS NS
Letrilliart (2001)
GPs. Patient notes were checked.
Standard protocol used – refs 19, 20
NS NS GP/hospital physician telephone interviews
NS
Mahatharadol (2001)
NS NS NS NS NS NS
Mahomed (2003)
NS NS NS NS NS NS
Marroni (2003) NS NS NS NS NS NS McCowan (1999)
NS NS NS Authors refer to “triangulation of methods” p.71 suggests data was cross-validated
NS NS
Melling (2001) Single trained observer and from patient diary.
NS NS NS NS NS
Nelzen (2000) Trained nurses, surgeon NS NS NS NS NS
86
Table B3 Personnel involved and intrinsic features of post discharge surveillance (Continued) First author (year)
Staff and method of data collection
Training given to staff
Patient education given
Linkage of data Validation of data Feedback to users Others
Noy (2002) NS NS NS Yes, via multi-method approach
NS SSI rates provided on monthly basis to surgeons
Economic analysis carried out. Examples of postal & telephone questionnaire tools given
Oliveira (2002) Data was collected from patient records collected from attendance at outpatient clinics. Staff involved not specified.
NS NS NS Checked regularly for completeness. Not specified by whom
NS
Paajanen (2003)
NS NS NS NS NS NS Questionnaire details given
Perencevich (2003)
Review of records judged to indicate a post discharge SSI by initial screening.
NS NS NNIS criteria with initial screening results for SSI p.196
NS NS Economic analysis of SSI (not PDS system)
Pernice (2001) NS NS NS NS NS NS Platt (2002) Health maintainence
organisations databases were searched for indicator codes. These were then confirmed as infected or not by a trained abstractor using the CDC classification of SSI
NS NS Unclear NS NS
Porra-Hernandez (2003)
Data retrieved from medical records. Staff involved not mentioned.
NS NS NS NS NS
Powell (2002) Surgeon NS Yes NS NS Surgeon that performed the operation performed the post discharge follow-up
87
Table B3 Personnel involved and intrinsic features of post discharge surveillance (Continued) First author (year)
Staff and method of data collection
Training given to staff
Patient education given
Linkage of data Validation of data Feedback to users Others
Rammelt (2003)
NS NS NS NS NS NS
Reid (2002) Research nurse, medical/surgical staff
NS NS NS NS Monthly feedback to surgeons on number of clean wounds and number of infections
Discussion on wound definition systems p.342
Reilly (2002) Wound surveillance nurse collected data from case notes and daily visits were made to the patients.
Intervention part of a wider programme of change for evidence-based surgical practice
NS NS NS Feedback given to surgeons and nurses participating in the study
Ridderstolpe (2001)
Surgeons notes were reviewed. Both a physician and patient questionnaire were undertaken.
NS NS NS NS NS
Rishi (2001) Staff member not stated although data collected at the time of patient attendance at an outpatient clinic
NS NS NS NS NS
Risnes (2001) NS NS NS NS NS NS Rovera (2003) Unclear NS NS NS NS NS Saeed (2001) Patients were interviewed by
telephone. Staff undertaking the survey not reported.
NS NS NS NS NS
Schneeberger (2002)
Data was collected from patient record data collected at outpatient clinic visit. Exact staff involved not stated.
Yes. Training on ASEPSIS principles given twice yearly.
NS NS Performed by another national body.
Surgeons and assisting personnel were informed of the results of SSI’s
88
Table B3 Personnel involved and intrinsic features of post discharge surveillance (Continued) First author (year)
Staff and method of data collection
Training given to staff
Patient education given
Linkage of data Validation of data Feedback to users Others
Sewonou (2002)
Surgical staff completed standardised forms for each patient which described SSI occurrence
* * * * *
Sjol (2002) Patient reported symptoms of infection as reported in patient questionnaire
* * * * *
Sorensen (2003)
Staff member not stated although data collected at the time of patient attendance at an outpatient clinic
NS NS NS NS NS
Stockley (2001)
Infection control audit nurse gave patient information pack whilst in hospital and gave form to be completed if treatment was required by health professional
NS Yes NS NS NS Methods changed over time in this study as such rates observed may have been affected by changes in methods.
Taylor (2004) G.P.s and other healthcare workers not defined
NS NS NS NS NS
Tegnell (2002) G.P.s and nursing staff NS - but yes on scoring system
NS NS NS NS
Thibon (2002) NS NS NS NS 5% of randomly selected files were verified compared to original patient files
NS
Whitney (2001)
Patient records from visits to hospital or community clinics made within 30 days of surgery
NS NS NS Interater reliability of ASEPSIS scoring between the three members of the research team.
NS
89
Table B3 Personnel involved and intrinsic features of post discharge surveillance (Continued) First author (year)
Staff and method of data collection
Training given to staff
Patient education given
Linkage of data Validation of data Feedback to users Others
Villar-Compte (2001)
Data was obtained from microbiology reports and medical records
NS NS NS NS NS
Vrijland (2000) NS NS NS NS NS NS Yerdel (2001) Patient records from follow
up visits NS NS NS NS Yes
Yokoe (2001) NS NS NS NS NS NS Zhu (2001) Unclear NS NS NS NS NS NS-not stated
90
Appendix C Example of audit sent to Infection Control lead within Trusts
Department of Health Sciences
Research Section, First Floor, Area 2 Seebohm Rowntree Building Heslington York YO10 5DD
Telephone (01904) 321362 Fax (01904) 321382
www.york.ac.uk/healthsciences
MONITORING OF SURGICAL WOUNDS FOR INFECTION, POST HOSPITAL DISCHARGE. (Please complete and return this questionnaire even if you are not monitoring surgical wounds for infection, post hospital discharge) SECTION 1 – Contact Details To be completed by the person responsible for infection control (or, where appropriate, the person responsible for monitoring of surgical wounds, post hospital discharge). If this has been sent to you incorrectly, please pass this form to the appropriate person within your Trust, or return it to Emily Petherick by fax: 01904 321382 with new contact details. Name: Position: Tel: Fax: Email: Name of Hospital Trust: NHS Region: SECTION 2 – Monitoring of surgical wound infection, post hospital discharge 1. Does your Trust currently monitor surgical patients for wound infection after discharge from hospital?
91
Yes � No � If you have answered no to question 1, please return this questionnaire by fax to Emily Petherick: 01904 321382 by Friday 14 th May 2004. We thank you for your co-operation. If you have answered yes, please complete questions 2 and 3. 2. Which patients (or types of surgery) are currently included in the monitoring system? ………………………………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… 3. What methods are currently used in the monitoring system? (please tick all that apply): Routine clinic follow up � Patient telephone survey � Patient postal survey � Surgeon survey � Direct observation by health practitioner � Other (Please specify) � .. ………………………………………………………………………………. ………………………………………………………………………………… ………………………………………………………………………………….. …………………………………………………………………………………. Thank you for your co-operation with this survey. Please indicate whether you would be willing to be contacted again in the future. Yes � No �
92
Appendix D Telephone interview 1st contact Telephone interview schedule to survey responders carrying out PDS: 1st contact Date: Contact name: Position: Name of Trust: Introduction & confirm their details correct/that they are responsible for monitoring PDS etc. …Thank you for responding so promptly to our recent survey regarding PD monitoring of SSI. Very interested to learn that you are currently carrying out a system of surveillance at your Trust. Indeed, yours was selected as one of the more interesting ones and we’d like to talk to you about it in more detail. You’ve already indicated that you might be willing to talk to us further. Are you still happy to do this?
Y / N (Recap: purpose of this is audit is to understand more clearly what systems are already in place and whether these might be evaluated/replicated elsewhere - NOT to review performance of your Trust in any way). If yes, would like to arrange a convenient time for a telephone interview (5-30 minutes of your time, depending on how much to talk about). Briefly go through proposed topics & send copy of schedule in advance. email/fax details: For ease of data processing, we’d like to be able to record the interview – would you be happy for us to do this? (for use only as transcription aid, but see also below on dissemination plan) Y / N ….Because our aim is to identify what is happening in different parts of the country, it would be useful to us to have your agreement to the identification of your Trust when writing our results (It is not an anonymous report - Trusts (not individuals) will be identified in a report to the National Co-ordinating Centre for Research Methodology at University of Birmingham – no paper publications, but the NCCRM may put the report on the web and will certainly be sent out for peer review. (NB However, in certain circumstances eg, failure of PDS, might be able to accommodate some anonymity). Are you willing to agree to this? Y / N
93
Appendix E Telephone interview 2nd contact Telephone interview schedule to survey responders carrying out PDS SSI (Post Discharge Surveillance of Surgical Site Infection) 2nd contact – interview Date: Start time: Finish time: Contact name: Position: Name of Trust: From survey response, confirm/ascertain the following, as appropriate: What is the practice setting? (distinguish between setting where surveillance initiated and setting where patients observed) What population is followed up? All or sample? Ascertain details of: On what basis does the Trust select the sample (where applicable): What surgical speciality is included in the PDS system? What surgical procedure is included in the PDS system? What is the risk status of patients followed up? Confirm what method of PDS & expand:
For how long are patients followed up?
How frequently are they seen? Does this vary?
Where are they seen? Does this vary?
94
Who sees the patients to assess their wound? (NB. As part of the surveillance
programme - not relevant if not seen as part of surveillance)
What training, if any, is given to staff on PDS?
Who has overall responsibility for PDS?
IF patients are self assessing – has the Trust compared patient assessment with
professional assessment. IF NOT, does the Trust collect data on false positives, ie, those
patients who think they have a wound infection, but professionals think have not.
Is patient information given as part of the surveillance programme (in relation to
reporting wound infection or the whole programme)?
How is surgical wound infection defined? (eg, CDC guidelines – what aspect is used: classification/diagnostic/risk index etc) (What scoring system, if any, is used? (eg, ASA, ASEPSIS..) What classification system, if any, is used? (eg, clean, contaminated, dirty…does this refer to the wound or the operation?) What is the Trust’s view on the practicality of method(s) currently used? Has the Trust tried any other methods/compared/discarded? Expand. Has there been any evaluation of the PDS system? (what measures eg, increased identification of SSI)
Have you ever calculated the cost of this surveillance system to your Trust? What resource use, eg, staff time/grade etc Is the surveillance system linked with any wider local or national audit? Do you give the data to anyone? (eg, feedback to surgeons) + any other specific issues about survey response….. Would it be OK for me to call you again for clarification on any of these points?
95
APPENDIX F Individual components of wound definition systems not previously described in Bruce et al (2001). First author (year) Purulent discharge without
culture Culture mandatory Other mandatory criteria, used alone or in combination
Andreasen (2002) Yes - Superficial: Purulent discharge without culture OR surgical wound revision with positive culture from evacuated material or bacteria isolated from subcutaneous collection in primarily closed wounds. Deep: Purulent discharge without culture OR wound rupture or wound revision with findings of infection involving fascia and muscle (culture must be positive) and/or finding of subfascial abscess on puncture, surgical revision or reoperation.
Higgins (1999) Superficial SSI:Yes above the fascia Deep SSI:Yes deep to the fascia or near the gallbladder fascia.
- Superficial: Purulent discharge without culture OR erythema.
Jamali (2001) - Yes NS Mahathardol (2001) Superficial SSI: Yes above the
fascial layer Deep SSI: Yes at or beneath the fascial layer
_ Superficial: Purulent discharge without culture OR erythema
Melling (2001) Yes ? Purulent discharge without culture OR a painful erythema that lasted for 5 days and was treated with antibiotics within 6 weeks of surgery.
The Australian Council on Healthcare Standards (1995), published in Reid (2002)
Yes - Purulent discharge without culture OR evidence of inflammation around the wound, OR if they were deemed to be infected by surgical staff.
Rishi (2001) ? ? Each wound was given a score from 0 to 7 with zero representing the optimal, physiologic postoperative wound appearance. Wound infection was defined as a score of 4 or more that meant postoperative wound conditions with pus combined with other signs and symptoms such as erythema, oedema, or increased pain.
Vrijland (2000) ? ? A mild wound infection was defined as redness surrounding the laparotomy wound. A moderate wound produced pus and a severe infection was defined as a non-healing defect of the wound extending into the subcutaneous tissue.
?-Unclear SSI-Surgical site infection
96
Appendix G Excluded Studies
Duplicated reporting of post-discharge surveillance (In some of these studies
further follow-up had taken place in more recent studies)
Creedy, D. K. and D. L. Noy (2001). Postdischarge surveillance after cesarean section.
Birth 28(4): 264-9.
Golliot, F., P. Astagneau, et al. (1999). [Surveillance of surgical-site infections: results of
the INCISO 1998 Network]. Annales de Chirurgie 53(9): 890-7.
Leaper, D. J. and A. G. Melling (2001). Antibiotic prophylaxis in clean surgery: clean
non-implant wounds. Journal of Chemotherapy(1): 96-101.
Reilly, J. S. (1999). The effect of surveillance on surgical wound infection rates. Journal of
Tissue Viability 9(2): 57-60.
Reilly, J. S., D. Baird, et al. (2001). The importance of definitions and methods in surgical
wound infection audit. Journal of Hospital Infection 47(1): 64-66.
Reilly, J., S. Twaddle, et al. (2001). An economic analysis of surgical wound infection.
Journal of Hospital Infection 49(4): 245-9.
Reilly, J., J. McIntosh, et al. (2002). Changing surgical practice through feedback of
performance data. Journal of Advanced Nursing 38(6): 607-14.
Taylor, E. W., K. Duffy, et al. (2003). Telephone call contact for post-discharge
surveillance of surgical site infections. A pilot, methodological study. Journal of
Hospital Infection 55(1): 8-13.
Vilar-Compte, D., et al., [Surveillance of surgical wound infections. 18-month experience in the
Instituto Nacional de Cancerologia]. Salud Publica de Mexico, 1999. 41(1): p. S44-50.
Editorial
Hall, J. C. (1999). Monitoring wound infection after surgery: the quest for useful
information at a reasonable cost.[comment]. Australian & New Zealand Journal
97
of Surgery 69(2): 84.
Mitchell, D. H. (2001). Post-discharge surgical wound surveillance. ANZ Journal of
Surgery 71(10).
Spearing, N. and D. Olesen (2001). Editorial comment. Surveillance: the next step in the
process. Australian Infection Control 6(2): 40-1.
Study already included in Bruce et al (2001)
Sands, K., G. Vineyard, et al. (1999). Efficient identification of postdischarge surgical site
infections: use of automated pharmacy dispensing information, administrative
data, and medical record information. Journal of Infectious Diseases 179(2): 434-
41.
Weiss, I. C., C. L. Statz, et al. (1999). Six years of surgical wound infection surveillance at
a tertiary care center: Review of the microbiologic and epidemiological aspects of
20 007 wounds. Archives of Surgery 134(10): 1041-1048.
Letter
Kennon, J., P. Russo, et al. (2001). A comparison of two methods for identifying surgical
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Narrative review
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Anon (2001). Survey program monitors surgical site infections. Same-Day Surgery
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25(11): 131-2.
Anon (2001). The top five. Capitalize on the advantages of semiautomated data
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Gaynes, R. P. (2000). Surgical-site infections and the NNIS SSI Risk Index: room for
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Heeg, P. (2003). Surveillance of Postoperative Wound Infections. [German]. Aktuelle
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Post discharge surveillance not undertaken as part of study or unclear that
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Anon(2001). Surveillance of nosocomial infections and registration of bacterial isolates
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100
Farinas-Alvarez, C., M. C. Farinas, et al. (2000). Analysis of risk factors for nosocomial
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Geel, C. W. and A. S. Flemister, Jr. (2001). Standardized treatment of intra-articular
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Gerberding, J., R. Gaynes, et al. (1999). National Nosocomial Infections Surveillance
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Hebden, J. (2000). Use of ICD-9-CM coding as a case-finding method for sternal wound
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Murphy, C. L. and M. L. McLaws (2000). Erratum: Methodologies used in surveillance of
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Murphy, G. J., R. Pararajasingam, et al. (2001). Methicillin-resistant Staphylococcus
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Przybylski, G. J. and A. D. Sharan (2001). Single-stage autogenous bone grafting and
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101
osteomyelitis. Journal of Neurosurgery 94(1 Suppl): 1-7.
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Study did not separate results for infections that occurred and were detected in the post
discharge period
McGreevy, J. M., P. P. Goodney, et al. (2003). A prospective study comparing the
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Systematic review not limited to post discharge surgical site infection surveillance
(checked for references no new studies located)
Wallace, W. C., M. E. Cinat, et al. (2000). New epidemiology for postoperative
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102
Study unable to be translated (Sufficient information was available to deduce that
this was not a study comparing methods of post-discharge surveillance
van Dalen, T., et al., [Frequency of postoperative wound infections: an unsuita ble parameter for
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Studies unable to be located within time frame of review
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103
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