文献类型：期刊文献

英文题名：Justification and reporting of subgroup analyses were lacking or inadequate in randomized controlled trials

作者：Fan, Jingchun[1,2];Song, Fujian[2];Bachmann, Max O.[2]

第一作者：Fan, Jingchun;樊景春

通信作者：Song, FJ[1]

机构：[1]Gansu Univ Chinese Med, Epidemiol & Evidence Based Med, Sch Publ Hlth, Lanzhou, Gansu, Peoples R China;[2]Univ East Anglia, Publ Hlth & Hlth Serv Res, Norwich Med Sch, Norwich, Norfolk, England

第一机构：甘肃中医药大学公共卫生学院

通信机构：[1]corresponding author), Univ East Anglia, Norwich Med Sch, Fac Med & Hlth Sci, Norwich NR4 7TJ, Norfolk, England.

年份：2019

卷号：108

起止页码：17

外文期刊名：JOURNAL OF CLINICAL EPIDEMIOLOGY

收录：;Scopus(收录号：2-s2.0-85059341633);WOS:【SCI-EXPANDED(收录号:WOS:000462953100004)】；

基金：J.F., as a visiting scholar to the University of East Anglia, was supported by funding from China Scholarship Council (No. 201608625033), P. R. China. No other external funding received for this study.

语种：英文

外文关键词：Subgroup analysis; Subgroup effect; Prespecification; Clinical trial; Study protocol; Study reporting

摘要：Objectives: The aim of the article was to assess the appropriateness and rationales of subgroup analyses planned in protocols of randomized controlled trials and reported in subsequent corresponding trial publications. Study Design and Setting: We searched PubMed to identify trial protocols published in journals during 2006-2017. From a total of 3,774 initially identified records, we included a random sample of 479 protocols and identified 280 trial publications corresponding to the included protocols. Results: Subgroup analyses were specified in 19% of the protocols and reported in 21% of the trial publications. Of the 94 protocols with planned subgroup analyses, 32% mentioned testing for interaction, and only three considered statistical power. Subgroup analyses were not prespecified in 56% of the 59 trial publications with subgroup analyses. Subgroup analyses were stated as prespecified in nine trial publications, without support evidence from the corresponding protocols. Subgroup analyses were often reported insufficiently for assessing the consistency of subgroup effects across studies. Justifications for subgroup analyses were provided in only four trial protocols and seven trial publications. Conclusion: Inappropriate specification and reporting of subgroup analyses remain problematic in protocols and reports of randomized controlled trials. Justifications or rationales for subgroup analyses were only rarely provided in trial protocols and reports. (C) 2018 The Authors. Published by Elsevier Inc.