Items for consideration in a reporting guideline for mediation analyses: a Delphi study

Cashin, Aidan G; McAuley, James H.; Lamb, Sarah E; Hopewell, Sally; Kamper, Steven J.; Williams, Christopher M; Lee, Hopin

doi:10.1136/bmjebm-2020-111406

Cited by 7 publications

(5 citation statements)

References 31 publications

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“…The panel reached consensus on 34 reporting items for study design, analytic procedures, and effect estimates; 3 items were rated as “optional”; and 60 qualitative comments were provided for item refinement and prioritization . The detailed methods and results of the Delphi study have been reported …”

Section: Methodsmentioning

confidence: 99%

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

Lee

Cashin

Lamb

et al. 2021

JAMA

Self Cite

266

136

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and the AGReMA group 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 PARTICIPANTSThe 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). RESULTSA 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 RELEVANCEThe 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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Section: Methodsmentioning

confidence: 99%

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

Lee

Cashin

Lamb

et al. 2021

JAMA

Self Cite

266

136

View full text Add to dashboard Cite

show abstract

“…Risk of bias associated with study design was assessed using the Liverpool University Quality Assessment Tool relevant to the particular study design [ 27 ]. Given that there is no standard approach for quality assessment of mediation analyses, we added three criteria based on a previous mediation review and on qualitative work informing reporting guidelines for studies of mediation [ 15 , 28 ]. Aspects of study design relevant to mediation analysis included: consideration of exposure-mediator interaction in the analysis; a directed acyclic graph (DAG) [ 29 ] informing the mediation analysis; and consideration of causal assumptions underpinning the mediation analysis.…”

Section: Methodsmentioning

confidence: 99%

Mediators of socioeconomic inequalities in preterm birth: a systematic review

et al. 2022

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Background Rates of preterm birth are substantial with significant inequalities. Understanding the role of risk factors on the pathway from maternal socioeconomic status (SES) to preterm birth can help inform interventions and policy. This study therefore aimed to identify mediators of the relationship between maternal SES and preterm birth, assess the strength of evidence, and evaluate the quality of methods used to assess mediation. Methods Using Scopus, Medline OVID, “Medline In Process & Other Non-Indexed Citation”, PsycINFO, and Social Science Citation Index (via Web of Science), search terms combined variations on mediation, socioeconomic status, and preterm birth. Citation and advanced Google searches supplemented this. Inclusion criteria guided screening and selection of observational studies Jan-2000 to July-2020. The metric extracted was the proportion of socioeconomic inequality in preterm birth explained by each mediator (e.g. ‘proportion eliminated’). Included studies were narratively synthesised. Results Of 22 studies included, over one-half used cohort design. Most studies had potential measurement bias for mediators, and only two studies fully adjusted for key confounders. Eighteen studies found significant socioeconomic inequalities in preterm birth. Studies assessed six groups of potential mediators: maternal smoking; maternal mental health; maternal physical health (including body mass index (BMI)); maternal lifestyle (including alcohol consumption); healthcare; and working and environmental conditions. There was high confidence of smoking during pregnancy (most frequently examined mediator) and maternal physical health mediating inequalities in preterm birth. Significant residual inequalities frequently remained. Difference-of-coefficients between models was the most common mediation analysis approach, only six studies assessed exposure-mediator interaction, and only two considered causal assumptions. Conclusions The substantial socioeconomic inequalities in preterm birth are only partly explained by six groups of mediators that have been studied, particularly maternal smoking in pregnancy. There is, however, a large residual direct effect of SES evident in most studies. Despite the mediation analysis approaches used limiting our ability to make causal inference, these findings highlight potential ways of intervening to reduce such inequalities. A focus on modifiable socioeconomic determinants, such as reducing poverty and educational inequality, is probably necessary to address inequalities in preterm birth, alongside action on mediating pathways.

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“…The AGReMA statement was developed using the Enhancing Quality and Transparency of Health Research (EQUATOR) methodologic framework for developing reporting guidelines. 2 This included an overview of systematic reviews to assess the need for a guideline 3 ; systematic reviews of relevant evidence on reporting practices 4 ; a Delphi study 5 that rated the importance of proposed reporting items by panel members (methodologists, statisticians, clinical trialists, epidemiologists, psychologists, applied clinical researchers, clinicians, implementation scientists, evidence synthesis experts, representatives from the EQUATOR Network, and journal editors); an international consensus meeting; and a 4-week external review and pilot test among potential users of AGReMA. Full details on the process of the development of AGReMA are given elsewhere.…”

Section: To the Editormentioning

confidence: 99%