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The conduct and reporting of mediation analysis in recently published randomized controlled trials: results from a

Tat-Thang Vo1, Cecilia Superchi2, Isabelle Boutron3

  • 1Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Krijgslaan 281-S9, 9000, Ghent, Belgium; Université de Paris, CRESS, INSERM, INRA, F-75004, Paris, France.

Journal of Clinical Epidemiology
|October 9, 2019
PubMed
Abstract

Insights

Recent randomized controlled trials (RCTs) often use traditional mediation analyses (MAs) but lack methodological rigor. Improved guidelines are needed for planning, conducting, and reporting MAs in research.

Area of Science:

  • Methodology in Clinical Trials
  • Statistical Analysis in Health Research

Background:

  • Mediation analyses (MAs) are increasingly used in randomized controlled trials (RCTs) to understand intervention effects.
  • Methodological consistency and reporting quality in MAs require evaluation.

Purpose of the Study:

  • To assess the methodological characteristics of MAs in recent RCTs.
  • To provide recommendations for improving the planning, conduct, and reporting of MAs.

Main Methods:

  • Systematic review of RCTs and secondary analyses reporting MAs.
  • Searched MEDLINE from January 2017 to December 2018.
  • Data extracted from 98 eligible studies by two independent reviewers.

Main Results:

  • Nearly all MAs (96%) used traditional approaches.
  • Most studies lacked sample size calculations (96%) and assessment of treatment-by-mediator interactions (96%).
  • Simultaneous measurement of mediators and outcomes occurred in 53% of studies; confounder adjustment was inconsistent.

Conclusions:

  • Mediation analyses in RCTs show considerable heterogeneity in conduct and reporting.
  • A consensus-based guideline is recommended to enhance the quality of future MAs.
Keywords:
Counterfactual-based mediation approachesMediation analysisRandomized controlled trialReportingSystematic reviewTraditional mediation approaches

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