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Mediators and moderators of treatment effects in randomized clinical trials
Helena Chmura Kraemer1, G Terence Wilson, Christopher G Fairburn
1Department of Psychiatry and Behavioral Sciences, Stanford University, Calif 94305, USA.
Abstract:
Randomized clinical trials (RCTs) not only are the gold standard for evaluating the efficacy and effectiveness of psychiatric treatments but also can be valuable in revealing moderators and mediators of therapeutic change. Conceptually, moderators identify on whom and under what circumstances treatments have different effects. Mediators identify why and how treatments have effects. We describe an analytic framework to identify and distinguish between moderators and mediators in RCTs when outcomes are measured dimensionally. Rapid progress in identifying the most effective treatments and understanding on whom treatments work and do not work and why treatments work or do not work depends on efforts to identify moderators and mediators of treatment outcome. We recommend that RCTs routinely include and report such analyses.
Insights
Randomized clinical trials (RCTs) can reveal why and for whom psychiatric treatments work. Analyzing moderators and mediators in RCTs enhances understanding of therapeutic change and treatment effectiveness.
Area of Science:
- Psychiatry and Behavioral Sciences
- Clinical Research Methodology
Background:
- Randomized clinical trials (RCTs) are crucial for assessing psychiatric treatment efficacy and effectiveness.
- Understanding moderators (who and when treatments work) and mediators (why and how treatments work) is vital for advancing psychiatric care.
Purpose of the Study:
- To present an analytic framework for identifying and distinguishing moderators and mediators within RCTs.
- To emphasize the importance of analyzing moderators and mediators for progress in psychiatric treatment research.
Main Methods:
- The study proposes a conceptual framework for analyzing moderators and mediators in RCTs.
- The framework is applicable when treatment outcomes are measured dimensionally.
Main Results:
- Moderators explain differential treatment effects across individuals and circumstances.
- Mediators elucidate the mechanisms through which treatments exert their effects.
- Distinguishing moderators and mediators provides a comprehensive understanding of treatment outcomes.
Conclusions:
- Identifying moderators and mediators in RCTs is essential for rapid progress in psychiatric treatment research.
- Routine inclusion and reporting of moderator and mediator analyses in RCTs are recommended.
- This approach will deepen the understanding of treatment effectiveness and individual patient responses.