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Randomized controlled trials in pediatric surgery: could we do better?
Joe I Curry1, Barnaby Reeves, Mark D Stringer
1BAPS Multicentre Research Office, British Association of Paediatric Surgeons and Health Services Research Unit, London School of Hygiene and Tropical Medicine, London, England.
Insights
Pediatric surgery randomized controlled trials (RCTs) presented at the BAPS Congress had poor design and inadequate sample sizes. Improving RCT quality is crucial for advancing evidence-based pediatric surgical practice.
Area of Science:
- Pediatric Surgery
- Clinical Trials
- Evidence-Based Medicine
Background:
- Randomized controlled trials (RCTs) are the gold standard for evaluating clinical interventions.
- However, RCTs are infrequently reported in pediatric surgery literature.
- This study assesses the quality of RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress.
Purpose of the Study:
- To evaluate the design, methodology, statistical analysis, and sample size adequacy of pediatric surgical RCTs presented at BAPS over a five-year period.
- To determine if these RCTs were sufficiently robust to yield valid results.
Main Methods:
- A review of abstracts from the Annual BAPS Congress meetings between 1996 and 2000 was conducted.
- Identifiable clinical RCTs were assessed for design quality, methodology, statistical analysis, conclusions, and sample size adequacy.
- Collaboration with a senior health services researcher ensured a thorough evaluation.
Main Results:
- Only 9 (1%) of 760 accepted abstracts represented clinical RCTs.
- Few trials specified primary endpoints, documented randomization methods, or mentioned blinding.
- Sample sizes were insufficient to detect significant clinical differences, and only one RCT has been published.
Conclusions:
- Compliance with established RCT guidelines was notably poor in presented pediatric surgical RCT abstracts.
- Inadequate sample sizes were a common issue, limiting the validity of findings.
- The specialty would benefit from well-designed, multicenter RCTs to enhance evidence-based pediatric surgical practice.
Background/Purpose:
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.