Abstract
Importance: Mediation analyses of randomized trials and observational studies can generate evidence about the mechanisms by which interventions and exposures may influence health outcomes. Publications of mediation analyses are increasing, but the quality of their reporting is suboptimal. Objective: To develop international, consensus-based guidance for the reporting of mediation analyses of randomized trials and observational studies (A Guideline for Reporting Mediation Analyses; AGReMA). Design, Setting, and Participants: The AGReMA statement was developed using the Enhancing Quality and Transparency of Health Research (EQUATOR) methodological framework for developing reporting guidelines. The guideline development process included (1) an overview of systematic reviews to assess the need for a reporting guideline; (2) review of systematic reviews of relevant evidence on reporting mediation analyses; (3) conducting a Delphi survey with panel members that included methodologists, statisticians, clinical trialists, epidemiologists, psychologists, applied clinical researchers, clinicians, implementation scientists, evidence synthesis experts, representatives from the EQUATOR Network, and journal editors (n = 19; June-November 2019); (4) having a consensus meeting (n = 15; April 28-29, 2020); and (5) conducting a 4-week external review and pilot test that included methodologists and potential users of AGReMA (n = 21; November 2020). Results: A previously reported overview of 54 systematic reviews of mediation studies demonstrated the need for a reporting guideline. Thirty-three potential reporting items were identified from 3 systematic reviews of mediation studies. Over 3 rounds, the Delphi panelists ranked the importance of these items, provided 60 qualitative comments for item refinement and prioritization, and suggested new items for consideration. All items were reviewed during a 2-day consensus meeting and participants agreed on a 25-item AGReMA statement for studies in which mediation analyses are the primary focus and a 9-item short-form AGReMA statement for studies in which mediation analyses are a secondary focus. These checklists were externally reviewed and pilot tested by 21 expert methodologists and potential users, which led to minor adjustments and consolidation of the checklists. Conclusions and Relevance: The AGReMA statement provides recommendations for reporting primary and secondary mediation analyses of randomized trials and observational studies. Improved reporting of studies that use mediation analyses could facilitate peer review and help produce publications that are complete, accurate, transparent, and reproducible..
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1045-1056 |
| Number of pages | 12 |
| Journal | JAMA - Journal of the American Medical Association |
| Volume | 326 |
| Issue number | 11 |
| DOIs | |
| State | Published - Sep 21 2021 |
Funding
being a member of boards for the Health Technology Assessment (additional capacity funding board, end of life care and add-on studies board, prioritization group board, and trauma board). Dr VanderWeele reported receiving personal fees from Statistical Horizons. Dr Localio reported receiving grants from the Annals of Internal Medicine. Dr Guallar reported receiving personal fees from the American College of Physicians (Annals of Internal Medicine). Dr Kamper reported receiving grants from the National Health and Medical Research Council of Australia Fellowship. No other disclosures were reported. Explanation | Information about study funding and support is important for helping readers identify potential conflicts of interest or possible influence. Authors should identify and declare all sources of study funding and support. Authors should report the name of the persons or entities supported, the name of the funder, and the grant or award number if available. Authors should explicitly outline the roles and responsibilities of the funder/ sponsor in the study design, conduct, data analysis and interpretation, manuscript writing, and dissemination of results and should describe whether the funder/sponsor had input into the final decision regarding any of these aspects. If the funder/sponsor was not involved or had no influence, authors should specifically report this.
ASJC Scopus subject areas
- General Medicine