Department of Surgery, The University of Melbourne, St. Vincent's Hospital Melbourne, Victoria, Australia.
College of Human and Social Futures, the Newcastle Business School, University of Newcastle, Newcastle, Australia.
Ann Surg. 2021 Jun 1;273(6):1102-1107. doi: 10.1097/SLA.0000000000004719.
To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods.
Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns.
Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias.
Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%.
Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors.
PROSPERO (CRD42019133296).
通过系统评价方法确定的试验设计方面的预期和实际情况之间的差异，探讨安慰剂手术对照试验是否能达到其预期目的。
由于对不必要的手术和低价值医疗保健的社会成本的关注，对安慰剂手术对照试验的兴趣日益增加。随着关于在手术中使用安慰剂对照的合理性问题得到解决，人们现在开始关注更实际的问题。
从 2020 年 5 月开始，在六个数据库中进行了搜索（MEDLINE、Embase、Emcare、APA PsycInfo、CINAHL、Cochrane Library）。纳入了有发表方案的安慰剂手术对照试验。三名作者从方案中提取“预期”设计方面，从主要结果论文中提取“实际”设计方面。每个试验都呈现了预期设计方面和实际设计方面之间的绝对和相对差异。试验根据是否达到目标样本量（“完成”）和及时完成进行分组。两组作者评估了偏倚风险。
在有数据分析的 24 项试验中，有 3 项完成并在目标时间范围内得出结论；10 项完成并在目标时间范围外得出结论；4 项完成但没有明确的目标时间框架；2 项未完成但在目标框架内得出结论；5 项未完成且在目标时间范围外得出结论。达到招募目标的试验低估了试验持续时间 88%，低估了招募地点数量 87%。
试验设计者需要在未来的安慰剂手术对照试验中考虑额外的时间和地点。一个强有力的预期和实际试验设计报告框架对试验设计者从他们的前辈中学习至关重要。
PROSPERO（CRD42019133296）。
