EVIDENCE-BASED OPERATIONS IN PEDIATRIC-SURGERY

It has been assumed that only 10% of medical interventions are support ed by solid scientific evidence. The aim of this study was to determin e the type of research evidence supporting operations in a tertiary re ferral paediatric surgical unit. All patients admitted over a 4-week p eriod to two surgical firms were enrolled in the study. All major oper ations carried out on each patient since birth were evaluated. Patient s for whom a diagnosis was not reached were excluded. A bibliographic database (MEDLINE) was used to search for the articles published betwe en January 1986 and December 1995 on the analysed operations. The type of evidence supporting the operations was classified as follows: I = evidence from randomised controlled trials (RCTs); II=self-evident int ervention (obvious effectiveness not requiring RCTs); III = evidence f rom prospective and/or comparative studies; IV = evidence from follow- up studies and/or retrospective case series; and V=intervention withou t substantial evidence for or against results of randomised trials. Se venty operations (32 individual types) were performed on 49 patients ( 1-5 operations/patient); 18 (26%) were supported by RCTs (type of evid ence I). Two patients (3%) received a self-evident intervention (type II); 48 operations (68%) were based on non-randomised prospective or r etrospective studies (type III = 13%; type IV = 55%). Two patients (3% ) received an operation not supported by or against convincing scienti fic evidence (type V). A significant proportion of operations in paedi atric surgery is supported by RCTs. However, the vast majority of thes e trials were conducted on adult patients. Sixty-eight per cent of the operations were based on prospective followup studies or retrospectiv e case series, which may not represent solid scientific evidence. More RCTs are needed in paediatric surgery.