LIU Yaqi 1,2 , LIU Man 1,2 , LIU Yuxiu 1,2,3 , CHEN Wensong 1,2 , YUAN Yangdan 2,3
  • 1. Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, P.R.China;
  • 2. Department of Critical Care Medicine, General Hospital of Eastern Theater Command, Nanjing 210002, P.R.China;
  • 3. Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou 510515, P.R.China;
LIU Yuxiu, Email: liu_yuxiu@163.com
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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 non-blind 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.

Citation: LIU Yaqi, LIU Man, LIU Yuxiu, CHEN Wensong, YUAN Yangdan. Analysis of the application of randomization methods in clinical trials in NEJM. Chinese Journal of Evidence-Based Medicine, 2021, 21(3): 303-307. doi: 10.7507/1672-2531.202010080 Copy

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