Curry Joe I, Reeves Barnaby, Stringer Mark D
BAPS Multicentre Research Office, British Association of Paediatric Surgeons and Health Services Research Unit, London School of Hygiene and Tropical Medicine, London, England.
J Pediatr Surg. 2003 Apr;38(4):556-9. doi: 10.1053/jpsu.2003.50121.
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?
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.
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.
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.
背景/目的：随机对照试验（RCT）被公认为评估临床干预效果的金标准，但在小儿外科领域却鲜有报道。在过去5年提交给英国小儿外科医师协会（BAPS）年会的随机对照试验是否设计合理且规模足够大，能够得出有效的结果？
与一位资深卫生服务研究人员合作，对1996年至2000年间BAPS年会接受的摘要进行审查。对所有可识别的临床随机对照试验的设计质量、方法、统计分析和结论以及样本量的充足性进行评估。
在760篇被接受的摘要中，只有9项临床干预随机对照试验（占1%）。只有4项试验在研究开始时明确规定了相关的主要终点，且没有一项记录了随机化方法。只有一篇摘要提到了对干预措施或结果测量的盲法。样本量甚至不足以检测出较大的临床差异。迄今为止，这些随机对照试验中只有一项发表在英文同行评审期刊上。
对于随机对照试验的开展存在明确的指导原则，但在BAPS年会上展示的小儿外科随机对照试验摘要中，很少有符合这些标准的记录。样本量不足。小儿外科的随机对照试验难以实施，但该专业将受益于精心设计、认真开展的多中心临床随机对照试验，以推动循证医学实践。
