《新英格兰医学杂志》临床试验随机化方法应用状况评价

Analysis of the application of randomization methods in clinical trials in NEJM

目的评价《新英格兰医学杂志》(NEJM)临床试验随机化方法的应用状况。方法计算机检索NEJM 2018年发表的随机对照试验(RCT),按盲态试验和非盲态试验两种情形,分析其临床试验设计要素特征和随机化方法应用状况,概括非盲态临床试验随机化方法应用及分配隐藏机制选择的特点。结果 2018年NEJM共发表151篇RCT,其中盲态试验75篇(49.67%)、非盲态试验76篇(50.33%)。未报告具体随机化方法的34篇(22.52%)、报告了具体随机化方法的117篇(77.48%)。报告了随机化方法的RCT中,分层区组随机化(72.65%)最多,其次为区组随机化(11.11%)、最小化(9.40%)、简单随机化(4.27%)等。盲态试验和非盲态试验之间报告随机化方法的比例及其采用不同随机化方法的比例均无明显差别(P>0.05)。在76篇非盲态RCT中,38篇(50.00%)报告了随机分配隐藏方法,其中37篇采用中央随机法(97.37%),1篇采用信封法(2.63%)。结论目前在NEJM发表的RCT仍存在随机化方法选择有待优化和随机化报告透明性不够的问题。

Objective To analyze the current status of the application of randomization methods in randomized controlled trials(RCTs) which have been published in New England Journal of Medicine(NEJM). Methods RCTs published by NEJM in 2018 were searched and collected. The characteristics of clinical trial design elements and the application status of randomization methods were comprehensively analyzed to distinguish blind trial and non-blind trial,and characteristics of application of randomization methods and selection of allocation concealment mechanisms of nonblind trials were summarized. Results A total of 151 RCTs were published in NEJM in 2018, in which blinded trials and non-blinded trials accounted for 75(49.67%) and 76(50.33%), respectively. 34(22.52%) RCTs did not report specific randomization methods, and the remaining 117(77.48%) reported. Among the latter, stratified block randomization accounted for the main body(72.65%), followed by block randomization(11.11%), minimization method(9.40%), simple randomization method(4.27%) and the others. There was no significant difference in the proportion of reporting or using randomization methods between blind and non-blind trials(P>0.05). In 76 non-blind trials, 38(50.00%) clearly reported the concealment method of random allocation, among which 37 used the central randomization(97.37%) and 1 used envelope method(2.63%). Conclusions The current RCTs published in NEJM still have problems in the selection of randomization methods to be optimized and the transparency of randomization reporting to be improved.