Randomized controlled trials in pediatric surgery: could we do better?
OBJECTIVE
Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?


METHODS
Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.


RESULTS
From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.


CONCLUSIONS
Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
Curry
Joe I
JI
BAPS Multicentre Research Office, British Association of Paediatric Surgeons and Health Services Research Unit, London School of Hygiene and Tropical Medicine, London, England.
Reeves
Barnaby
B
Stringer
Mark D
MD
D015706:Bibliometrics; D002648:Child; D002675:Child, Preschool; D003226:Congresses as Topic / Q000706:statistics & numerical data; D019983:Guideline Adherence / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D010372:Pediatrics; D017410:Practice Guidelines as Topic; D011643:Publishing; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D012107:Research Design; D018401:Sample Size; D013514:Surgical Procedures, Operative; D006113:United Kingdom