Hopin Lee1,2, Aidan G Cashin3,4, Sarah E Lamb1,5, Sally Hopewell1, Stijn Vansteelandt6,7, Tyler J VanderWeele8, David P MacKinnon9, Gemma Mansell10, Gary S Collins1,11, Robert M Golub12,13, James H McAuley4,14, A Russell Localio15,16, Ludo van Amelsvoort17,18, Eliseo Guallar19,20, Judith Rijnhart21, Kimberley Goldsmith22, Amanda J Fairchild23, Cara C Lewis24, Steven J Kamper25,26, Christopher M Williams2, Nicholas Henschke27. 1. Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England. 2. School of Medicine and Public Health, University of Newcastle, Callaghan, Australia. 3. Prince of Wales Clinical School, Faculty of Medicine, University of New South Wales, Sydney, Australia. 4. Neuroscience Research Australia, Sydney. 5. College of Medicine and Health, University of Exeter Medical School, Exeter, England. 6. Department of Applied Mathematics, Computer Science, and Statistics, Ghent University, Ghent, Belgium. 7. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, England. 8. Departments of Epidemiology and Biostatistics, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts. 9. Department of Psychology, Arizona State University, Phoenix. 10. College of Health and Life Sciences, Aston University, Birmingham, England. 11. NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, England. 12. JAMA Editorial Office, Chicago, Illinois. 13. Division of General Internal Medicine and Geriatrics, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 14. School of Health Sciences, Faculty of Medicine, University of New South Wales, Sydney, Australia. 15. Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia. 16. Associate Editor, Annals of Internal Medicine. 17. Faculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, the Netherlands. 18. Assoicate Editor, Journal of Clinical Epidemiology. 19. Welch Center for Prevention, Epidemiology, and Clinical Research, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland. 20. Deputy Editor, Annals of Internal Medicine. 21. Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, Amsterdam, the Netherlands. 22. Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, England. 23. Department of Psychology, University of South Carolina, Columbia. 24. Kaiser Permanente Washington Health Research Institute, Seattle. 25. School of Health Sciences, University of Sydney, Sydney, Australia. 26. Nepean Blue Mountains Local Health District, Kingswood, Australia. 27. School of Public Health, University of Sydney, Sydney, Australia.
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.
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.
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