Publisher: Wiley Blackwell Country of Publication: England NLM ID: 101543738 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1759-2887 (Electronic) Linking ISSN: 17592879 NLM ISO Abbreviation: Res Synth Methods Subsets: MEDLINE

Publication: : Chichester : Wiley Blackwell
Original Publication: Malden, MA : John Wiley & Sons, 2010-

Meta-Analysis as Topic* ; Randomized Controlled Trials as Topic* ; Research Design*; Bayes Theorem ; Carbamazepine/therapeutic use ; Data Interpretation, Statistical ; Humans ; Proportional Hazards Models ; Seizures/drug therapy ; Software ; Time Factors ; Valproic Acid/therapeutic use

Many randomized trials evaluate an intervention effect on time-to-event outcomes. Individual participant data (IPD) from such trials can be obtained and combined in a so-called IPD meta-analysis (IPD-MA), to summarize the overall intervention effect. We performed a narrative literature review to provide an overview of methods for conducting an IPD-MA of randomized intervention studies with a time-to-event outcome. We focused on identifying good methodological practice for modeling frailty of trial participants across trials, modeling heterogeneity of intervention effects, choosing appropriate association measures, dealing with (trial differences in) censoring and follow-up times, and addressing time-varying intervention effects and effect modification (interactions).We discuss how to achieve this using parametric and semi-parametric methods, and describe how to implement these in a one-stage or two-stage IPD-MA framework. We recommend exploring heterogeneity of the effect(s) through interaction and non-linear effects. Random effects should be applied to account for residual heterogeneity of the intervention effect. We provide further recommendations, many of which specific to IPD-MA of time-to-event data from randomized trials examining an intervention effect.We illustrate several key methods in a real IPD-MA, where IPD of 1225 participants from 5 randomized clinical trials were combined to compare the effects of Carbamazepine and Valproate on the incidence of epileptic seizures.
(© 2019 The Authors. Research Synthesis Methods published by John Wiley & Sons Ltd.)

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825746 European Union, European Commission, Directorate-General for Research and Innovation, Horizon 2020 Framework Programme; 91617050 ZonMW, Netherlands Organization for Health Research and Development; 91810615 ZonMW, Netherlands Organization for Health Research and Development

Keywords: heterogeneity; individual participant data; intervention; meta-analysis; time-to-event

33CM23913M (Carbamazepine)
614OI1Z5WI (Valproic Acid)

Date Created: 20191124 Date Completed: 20201223 Latest Revision: 20210110

20221216

PMC7079159

10.1002/jrsm.1384

31759339