Development of A Guideline for Reporting Mediation Analyses (AGReMA)

Abstract

Background: There are a growing number of studies using mediation analysis to understand the mechanisms of health interventions and exposures. Recent work has shown that the reporting of these studies is heterogenous and incomplete. This problem stifles clinical application, reproducibility, and evidence synthesis. This paper describes the processes and methods that will be used to develop a guideline for reporting studies of mediation analyses (AGReMA). Methods/design: AGReMA will be developed over five overlapping stages. Stage one will comprise a systematic review to examine relevant evidence on the quality of reporting in published studies that use mediation analysis. In the second stage we will consult a group of methodologists and applied researchers by using a Delphi process to identify items that should be considered for inclusion in AGReMA. The third stage will involve a consensus meeting to consolidate and prioritise key items to be included in AGReMA. The fourth stage will involve the production of AGReMA and an accompanying explanation and elaboration document. In the final stage we will disseminate the AGReMA statement via journals, conferences, and professional meetings across multiple disciplines. Discussion: The development and implementation of AGReMA will improve the standardization, transparency, and completeness in the reporting of studies that use mediation analysis to understand the mechanisms of health interventions and exposures.

A Guideline for Reporting Mediation Analyses of Randomized Trials and Observational Studies

“…Additional details can be found in the protocol. 9 The University of New South Wales human research ethics advisory panel provided ethical approval (HC16599). All participants provided electronic informed consent prior to commencing the first Delphi round.…”

“…This section provides a summary of the methods (a flow diagram of the checklist development process appears in eFigure 1 in the Supplement). Additional details can be found in the protocol . The University of New South Wales human research ethics advisory panel provided ethical approval (HC16599).…”

Mediators of outcome in adolescent psychotherapy and their implications for theories and mechanisms of change: a systematic review

“…Yet, at least in the broad sense of having a group larger than 40 participants, fortunately almost 74% of the reviewed studies appeared sufficiently large for investigating mediation (cp., [28]). However, 64.7% of the studies did violate the temporal criterion, which has been noted as a concern before [21,67,68]. Perhaps the most alarming finding of this comprehensive review was the exceedingly large number of measures used to assess mediators; indeed, each mediator measure was only seldom employed in more than one or two studies.…”

An introduction to mediation analyses of randomized controlled trials

“…Advances in methods have made it possible to apply mediation analyses to more complex settings such as failure-time outcomes, multi-level or clustered RCTs, multiple mediator models, and time-varying interventions and mediators [1] . To ensure adequate reporting and appraisal of mediation analyses, reporting guidelines [5] and risk of bias assessment tools are being developed. Where possible, trialist should plan mediation analyses in advance to ensure mediators and possible mediator-outcome confounders are measured.…”