Evidence map›Paper›PMID 34546296›Full record

ArticleJAMA2021

A Guideline for Reporting Mediation Analyses of Randomized Trials and Observational Studies: The AGReMA Statement.

Hopin Lee, Aidan G Cashin, Sarah E Lamb, Sally Hopewell, Stijn Vansteelandt, Tyler J VanderWeele, David P MacKinnon, Gemma Mansell, Gary S Collins, Robert M Golub and 12 more

Abstract readConsensus Statement
In one paragraph

Article in JAMA, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 293 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
293citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

293 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. Associations Between the Built Environment and Adult Obesity and the Mediating Role of Physical Activity: A Systematic Review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2025
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233 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Hopin LeeCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.
Aidan G CashinPrince of Wales Clinical School, Faculty of Medicine, University of New South Wales, Sydney, Australia.
Sarah E LambCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.
Sally HopewellCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.
Stijn VansteelandtDepartment of Applied Mathematics, Computer Science, and Statistics, Ghent University, Ghent, Belgium.
Tyler J VanderWeeleDepartments of Epidemiology and Biostatistics, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.
David P MacKinnonDepartment of Psychology, Arizona State University, Phoenix.
Gemma MansellCollege of Health and Life Sciences, Aston University, Birmingham, England.
Gary S CollinsCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.
Robert M GolubJAMA Editorial Office, Chicago, Illinois.
James H McAuleyNeuroscience Research Australia, Sydney.
AGReMA group
A Russell LocalioDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Ludo van AmelsvoortFaculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, the Netherlands.
Eliseo GuallarWelch Center for Prevention, Epidemiology, and Clinical Research, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.
Judith RijnhartDepartment of Epidemiology and Data Science, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, Amsterdam, the Netherlands.
Kimberley GoldsmithInstitute of Psychiatry, Psychology, and Neuroscience, King's College London, London, England.
Amanda J FairchildDepartment of Psychology, University of South Carolina, Columbia.
Cara C LewisKaiser Permanente Washington Health Research Institute, Seattle.
Steven J KamperSchool of Health Sciences, University of Sydney, Sydney, Australia.
Christopher M WilliamsSchool of Medicine and Public Health, University of Newcastle, Callaghan, Australia.
Nicholas HenschkeSchool of Public Health, University of Sydney, Sydney, Australia.

Funding

Estimating Mediation Effects in Prevention StudiesR37DA009757 · NIDA · ARIZONA STATE UNIVERSITY-TEMPE CAMPUS · PI MACKINNON, DAVID P · 2015 to 2024
$3.5M
Theory and methods for mediation and interactionR01CA222147 · NCI · HARVARD SCHOOL OF PUBLIC HEALTH · PI TCHETGEN TCHETGEN, ERIC JOEL, VANDERWEELE, TYLER · 2018 to 2022
$2.1M
Cancer Research UK 27294NCI NIH HHS R01 CA222147NIDA NIH HHS R37 DA009757
6 · The paper itself

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.

Indexed as

Guidelines as TopicMediation AnalysisObservational Studies as TopicRandomized Controlled Trials as TopicChecklistDelphi TechniqueHumansPeer ReviewSystematic Reviews as Topic

Identifiers

PMID34546296
PMCPMC8974292

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.