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BMJ 2004;329:720 (25 September), doi:10.1136/bmj.38232.646227.DE (published 14 September 2004)
A P R Wilson, consultant microbiologist1, C Gibbons, research fellow2, B C Reeves, senior lecturer in epidemiology2, B Hodgson, registered general nurse1, M Liu, physicist3, D Plummer, head of medical physics3, Z H Krukowski, consultant surgeon4, J Bruce, research fellow in epidemiology5, J Wilson, SSI surveillance programme leader6, A Pearson, manager and consultant epidemiologist7
1 Department of Clinical Microbiology, University College London Hospitals, London WC1E 6DB, 2 Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, 3 Department of Medical Physics, University College London Hospitals, 4 Department of Surgery, Medical School, Aberdeen, 5 Department of Public Health, Medical School, Aberdeen, 6 Nosocomial Infection Surveillance Unit, HPA Central Public Health Laboratory, London, 7 Health VFM Audit, National Audit Office, London
Correspondence to: A P R Wilson peter.wilson{at}uclh.nhs.uk
Design Prospective observational study.
Setting London teaching hospital group receiving emergency cases as well as tertiary referrals.
Participants 4773 surgical patients staying in hospital at least two nights.
Main outcome measures Numbers of wound infections based on purulent discharge alone, on the Centers for Disease Control (CDC) definition of wound infection, on the nosocomial infection national surveillance scheme (NINSS) version of the CDC definition, and on the ASEPSIS scoring method.
Results 5804 surgical wounds were assessed during 5028 separate hospital admissions. The mean percentage of wounds classified as infected differed substantially with different definitions: 19.2% with the CDC definition (95% confidence interval 18.1% to 20.4%), 14.6% (13.6% to15.6%) with the NINSS version, 12.3% (11.4% to 13.2%) with pus alone, and 6.8% (6.1% to 7.5%) with an ASEPSIS score > 20. The agreement between definitions with respect to individual wounds was poor. Wounds with pus were automatically defined as infected with the CDC, NINSS, and pus alone definitions, but only 39% (283/714) of these had ASEPSIS scores > 20.
Conclusions Small changes made to the CDC definition or even in its interpretation, as with the NINSS version, caused major variation in estimated percentage of wound infection. Substantial numbers of wounds were differently classified across the grades of infection. A single definition used consistently can show changes in percentage wound infection over time at a single centre, but differences in interpretation prevent comparison between different centres.
There has been little or no critical evaluation of the definition of surgical site infection that is to be used for surveillance in England, namely the nosocomial infection national surveillance scheme (NINSS) version of the definition set out by the Centers for Disease Control (CDC) in 1992.5 Moreover, the version or interpretation of the definition used varies between hospitals and regions.6 7 Designers of a national surveillance system must judge the available definitions by their ability to identify infections that matter most to patients and to health services and by the practicability of collecting the required information.
We therefore compared agreement between four common definitions of surgical site infectionnamely (a) the CDC 1992 definition, (b) the NINSS modification of the CDC definition, (c) the presence of pus, and (d) the ASEPSIS scoring method8applied to the same series of surgical wounds. We also compared the percentage of infection based on the CDC definition and on the NINSS modification to investigate the potential effect of subjective CDC criteria and of variation between hospitals in data collection methods.
Definitions of surgical site infection
The 1992 CDC definition requires the observation of 16 wound or patient characteristics in order to classify infection and has two subjective criteria, namely a surgeon's diagnosis of infection and the culture of microorganisms from the wound.5 The US national nosocomial infections surveillance system (NNISS) recommends that the latter criterion should be based only on positive cultures of fluid and tissue rather than wound swabs,5
7 but this interpretation does not seem to be applied generally.7 The English NINSS method modified the CDC definition to exclude the need for a surgeon's diagnosis and required that pus cells be present to satisfy the criterion of micro-organisms cultured from the wound.6 Another definition of infection simply requires the presence of pus, even though some infections are missed.9 ASEPSIS is a quantitative scoring method that provides a numerical score related to the severity of wound infection using objective criteria based on wound appearance and the clinical consequences of the infection.7
8
For purposes of comparison, we classified ASEPSIS scores > 20 as infected. ASEPSIS scores of 10-20 ("disturbance of healing") are known to describe some infections, but most reflect wound breakdown due to other causes.10 Moderate to severe infections score > 30. The CDC definition also describes the severity of infection, classifying infections as "none," "superficial," or "deep or organ space" (termed "deep" in this article). Both definitions purport to describe the importance of an infection with respect to the patient's morbidity and the likely clinical consequences.
Data collection
Surveillance staff assessed patients every two or three days by direct observation, case note review, and questioning of nurses. We contacted patients by post or telephone one to two months after their operations to complete a questionnaire designed to ascertain late infections. Thus, we followed up patients either until their wounds had healed without infection or until an infection was detected. We therefore classified wounds as infected or not and recorded the proportion of wounds classified as infected at any time during follow up.
Statistical analysis
Counts and percentages presented are of wounds unless otherwise indicated. Confidence intervals for proportions of infection were adjusted for clustering on patient. We summarised agreement between the different definitions of infection using the
statistic and the proportional agreement of ASEPSIS and CDC respectively for positive (Ppos) and negative (Pneg) diagnoses of infection.11 Confidence intervals for the agreement statistics were adjusted for clustering on patient and calculated by bootstrap methods. The values shown are "bias-corrected."
The mean percentage of wound infection differed substantially with the different definitions; 19.2% (95% confidence interval 18.1% to 20.4%) with the CDC definition, 14.6% (13.6% to 15.6%) with the NINSS version, 12.3% (11.4% to 13.2%) with pus alone, and 6.8% (6.1% to 7.5%) with an ASEPSIS score > 20. The table shows the level of agreement between the ASEPSIS and CDC systems. When superficial infections (according to CDC category) were included, 13% (778) of all observed wounds received conflicting diagnoses, and 6% were classified as infected by both definitions. When superficial infections were excluded, the two definitions estimated about the same overall percentage infection (6.8% and 7.0% respectively), but there were almost twice as many conflicting infection diagnoses (n=371) as concordant ones (n=215).
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Wounds with pus were automatically diagnosed as infected by the CDC, NINSS, and pus alone definitions, but only 39% of these (283/714) had ASEPSIS scores > 20 (see figure). For these wounds, the CDC scale also consistently diagnosed greater infection severity than did ASEPSIS.
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In wounds without pus the relation of ASEPSIS and CDC scales was less consistent (figure). For example, 42% (177/421) of wounds classified only as "disturbance of healing" by ASEPSIS were classified as infected by the CDC definition. Conversely, four of the six wounds classified as "severe wound infections" by ASEPSIS were classified as superficial by the CDC definition.
Comparison of wound classification with the CDC definition and with the NINSS version also revealed discrepancies. For example, more than 30% of wounds defined as superficially infected with CDC were classified as not infected with NINSS (229/709). In the CDC "superficial infection" category 94% (222/237) of the observed discrepancy was attributable to the NINSS modification of the CDC criterion related to positive bacterial cultures. In the CDC "deep infection" category the discrepancy observed was due to the exclusion of infections based solely on a surgeon's diagnosis.
Potential limitations of this study
For the CDC definition, we often assumed the requirement for a surgeon's diagnosis of infection to be satisfied when a decision was made to start specific antibiotic treatment or to provide surgical treatment. In other studies, differences in results between CDC and other surveillance methods have been associated with lack of follow up, use of positive culture results, or clinical criteria.12 Although our study was conducted in a single group of hospitals, data came from multiple sites, many surgical specialties, and a large number of surgeons, so that most of the relevant sources of variation were represented.
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Comparison of the different definitions
Other health outcome measures have been psychometrically evaluated, but similar information is lacking for most definitions of wound infection.13 ASEPSIS in its original form was reported to be repeatable and related to outcome,10
14 but it has since been modified and reproducibility is currently being reassessed. Choosing an optimal definition is therefore extremely difficult.
The absence of a clear pattern to the type of wounds classified as infected by CDC but as not infected by NINSS supports the view that the CDC criteria responsible for the discrepancy are difficult to apply consistently. Small changes made to the CDC definition or even to its interpretation, as with the NINSS version, cause substantial variation in the apparent percentage of infected wounds. Although the CDC definition has been adopted in many countries to allow international comparison, this faith seems unwarranted.
Conclusions
Using wound infection rates as a performance indicator to compare centres or countries is premature. Without a means to interpret absolute rates, such comparisons will be compromised by discrepancies in the way that infections are defined. External agencies should not judge the quality of medical care on these measures.15 Comparative performance tables should be reported only once a scientifically based and agreed definition has been produced.
This is the abridged version of an article that was posted on bmj.com on 14 September 2004: http://bmj.com/cgi/doi/10.1136/bmj.38232.646227.DE We thank the members of the wound surveillance team (D Archibald, J Leach, and E O'Donnell).
Funding: Wound surveillance was supported by a start up grant from UCLH trustees for the first two years. Subsequently it has been funded directly by UCLH Trust. The analysis by CG reported in this paper has been funded by a grant from the National NHS R&D Research Methodology Programme. None of these funding sources have contributed to, or influenced the interpretation of, the analyses reported.
Competing interests: None declared.
Ethical approval: This was not deemed necessary as the surveillance was part of the hospital audit programme.
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