statistical analysis of individual participant data meta-analyses a comparison of methods and recommendations for practice统计分析的个体参与者数据荟萃分析比较的方法和实践的建议.pdf

Statistical Analysis of Individual Participant Data Meta- Analyses: A Comparison of Methods and Recommendations for Practice 1 2 3 4 1 Gavin B. Stewart *, Douglas G. Altman , Lisa M. Askie , Lelia Duley , Mark C. Simmonds , Lesley A. Stewart1 1 Centre for Reviews and Dissemination, University of York, York, United Kingdom, 2 Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom, 3 NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia, 4 Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, United Kingdom Abstract Background: Individual participant data (IPD) meta-analyses that obtain ‘‘raw’’ data from studies rather than summary data typically adopt a ‘‘two-stage’’ approach to analysis whereby IPD within trials generate summary measures, which are combined using standard meta-analytical methods. Recently, a range of ‘‘one-stage’’ approaches which combine all individual participant data in a single meta-analysis have been suggested as providing a more powerful and flexible approach. However, they are more complex to implement and require statistical support. This study uses a dataset to compare ‘‘two-stage’’ and ‘‘one-stage’’ models of varying complexity, to ascertain whether results obtained from the approaches differ in a clinically meaningful way. Methods and Findings: We included data from 24 randomised controlled trials, evaluating antiplatelet agents, for the prevention of pre-eclampsia in pregnancy. We performed two-stage and one-stage IPD meta-analyses to estimate overall treatment effect and to explore potential treatment interactions whereby particular type