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.

中文翻译：

---

报告随机试验和观察研究中介分析的指南：AGReMA 声明。


重要性 随机试验和观察性研究的中介分析可以生成有关干预措施和暴露可能影响健康结果的机制的证据。中介分析的出版物正在增加，但其报告的质量并不理想。目的 为报告随机试验和观察性研究的中介分析制定基于共识的国际指南（中介分析报告指南；AGReMA）。设计、设置和参与者 AGReMA 声明是使用提高健康研究质量和透明度 (EQUATOR) 方法框架来制定报告指南。指南制定过​​程包括 (1) 系统评价概述，以评估报告指南的必要性； (2) 对报告调解分析的相关证据进行系统审查； (3) 与小组成员进行德尔菲调查，小组成员包括方法学家、统计学家、临床试验专家、流行病学家、心理学家、应用临床研究人员、临床医生、实施科学家、证据综合专家、EQUATOR 网络代表和期刊编辑（n = 19； 2019 年 6 月至 11 月）； (4) 召开共识会议（n=15；2020年4月28-29日）； (5) 进行为期 4 周的外部审查和试点测试，其中包括 AGReMA 的方法学家和潜在用户（n = 21；2020 年 11 月）。结果 先前报告的 54 项调解研究系统评价的概述表明需要制定报告指南。从调解研究的 3 项系统回顾中确定了 33 个潜在的报告项目。 在 3 轮中，德尔福小组成员对这些项目的重要性进行了排名，为项目细化和优先顺序提供了 60 条定性评论，并建议了新的项目供考虑。所有项目均在为期 2 天的共识会议期间进行了审查，参与者就以中介分析为主要焦点的研究制定了 25 项 AGReMA 声明，并就以中介分析为次要的研究制定了 9 项简短的 AGReMA 声明重点。这些清单由 21 名专家方法学家和潜在用户进行了外部审查和试点测试，从而对清单进行了细微调整和整合。结论和相关性 AGReMA 声明为报告随机试验和观察性研究的主要和次要中介分析提供了建议。改进使用中介分析的研究报告可以促进同行评审，并有助于产生完整、准确、透明和可重复的出版物。