Kwakkenbos Linda, Juszczak Edmund, Hemkens Lars G, Sampson Margaret, Fröbert Ole, Relton Clare, Gale Chris, Zwarenstein Merrick, Langan Sinéad M, Moher David, Boutron Isabelle, Ravaud Philippe, Campbell Marion K, Mc Cord Kimberly A, van Staa Tjeerd P, Thabane Lehana, Uher Rudolf, Verkooijen Helena M, Benchimol Eric I, Erlinge David, Sauvé Maureen, Torgerson David, Thombs Brett D
1Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands.
2NPEU Clinical Trials Unit, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Res Integr Peer Rev. 2018 Oct 29;3:9. doi: 10.1186/s41073-018-0053-3. eCollection 2018.
Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.
The development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial "long list" of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the "long list" and generate a "short list" of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.
Development of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.
随机对照试验（RCT）的实施往往复杂且成本高昂。不到三分之一的试验能实现计划招募目标，随访工作可能耗费大量人力，而且许多试验在现实世界中的普遍适用性有限。为应对这些挑战，已有人提出利用队列及常规收集的健康数据（包括登记处数据、电子健康记录和行政数据库）开展RCT的设计方案，且这些方案正迅速得到采用。然而，这些设计相对较新，已发表的RCT报告往往未以标准化方式描述其方法的重要方面。我们的目标是扩展《报告试验的统一标准》（CONSORT）声明，制定一份基于共识的使用队列及常规收集的健康数据的RCT报告指南。
这份CONSORT扩展版的制定将包括五个阶段。第一阶段（已完成）包括项目启动，涵盖筹集资金、组建研究团队以及构建概念框架。在第二阶段，将进行系统综述，以识别以下两类出版物：（1）描述使用队列及常规收集的健康数据开展RCT的方法或报告考量因素的；（2）此类RCT的方案或报告结果的。将基于《加强流行病学观察性研究报告规范》（STROBE）和《使用常规收集的健康数据进行观察性研究的报告规范》（RECORD）声明，生成一份对CONSORT清单项目可能的修改以及报告指南可能的新项目的初始“长清单”。根据系统综述的结果，还将确定其他可能的修改和新项目。第三阶段将由方法学和内容专家进行三轮德尔菲法练习，以评估“长清单”并生成关键项目的“短清单”。在第四阶段，这些项目将作为面对面共识会议的基础，以敲定纳入报告指南和清单的核心项目集。第五阶段将涉及起草清单和详细解释文件，以及指南的传播与实施。
这份CONSORT扩展版的制定将有助于更透明地报告使用队列及常规收集的健康数据开展的RCT。
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