Journal
BMC MEDICAL RESEARCH METHODOLOGY
Volume 18, Issue -, Pages -Publisher
BMC
DOI: 10.1186/s12874-018-0578-7
Keywords
Mediation; Indirect effect; Counterfactuals; Reporting; Mediation analysis; Survival; Time-to-event; Methodology
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Funding
- CIHR Fellowship Award [FRN 146714]
- Philipson Scholar program at the University of Toronto
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BackgroundMediation analysis tests whether the relationship between two variables is explained by a third intermediate variable. We sought to describe the usage and reporting of mediation analysis with time-to-event outcomes in published healthcare research.MethodsA systematic search of Medline, Embase, and Web of Science was executed in December 2016 to identify applications of mediation analysis to healthcare research involving a clinically relevant time-to-event outcome. We summarized usage over time and reporting of important methodological characteristics.ResultsWe included 149 primary studies, published from 1997 to 2016. Most studies were published after 2011 (n=110, 74%), and the annual number of studies nearly doubled in the last year (from n=21 to n=40). A traditional approach (causal steps or change in coefficient) was most commonly taken (n=87, 58%), and the majority of studies (n=114, 77%) used a Cox Proportional Hazards regression for the outcome. Few studies (n=52, 35%) mentioned any of the assumptions or limitations fundamental to a causal interpretation of mediation analysis.ConclusionThere is increasing use of mediation analysis with time-to-event outcomes. Current usage is limited by reliance on traditional methods and the Cox Proportional Hazards model, as well as low rates of reporting of underlying assumptions. There is a need for formal criteria to aid authors, reviewers, and readers reporting or appraising such studies.
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