BackgroundRandomized 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.MethodsThe 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.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.

中文翻译：

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使用队列和常规收集的健康数据为 RCT 开发 CONSORT 扩展的协议

背景随机对照试验 (RCT) 通常复杂且执行起来成本高昂。只有不到三分之一的人实现了计划的招聘目标，后续工作可能需要大量劳动，而且许多人在现实世界中的普遍性有限。已经提出使用队列和常规收集的健康数据（包括登记册、电子健康记录和管理数据库）进行的 RCT 设计，以应对这些挑战，并正在迅速采用。然而，这些设计是相对较新的创新，已发表的 RCT 报告通常不会以标准化方式描述其方法的重要方面。我们的目标是通过使用队列和常规收集的健康数据的随机对照试验的共识驱动报告指南扩展统一报告试验标准 (CONSORT) 声明。方法 此 CONSORT 扩展的开发将包括五个阶段。第一阶段（已完成）包括项目启动，包括筹款、研究团队的建立和概念框架的开发。在第 2 阶段，将进行系统审查以确定 (1) 描述使用队列和常规收集的健康数据进行 RCT 的方法或报告注意事项的出版物，或 (2) 作为协议或报告此类 RCT 结果的出版物。将根据加强流行病学观察研究报告 (STROBE) 和使用观察性常规收集的健康进行的研究报告，生成一份可能修改 CONSORT 检查清单项目和报告指南可能新项目的初始“长清单”数据（RECORD）报表。将根据系统审查的结果确定其他可能的修改和新项目。第 3 阶段将包括三轮 Delphi 练习，方法和内容专家将评估“长列表”并生成关键项目的“短列表”。在第 4 阶段，这些项目将作为面对面共识会议的基础，以最终确定要包含在报告指南和清单中的一组核心项目。第 5 阶段将涉及起草清单和详细说明文件，以及指南的传播和实施。讨论此 CONSORT 扩展的开发将有助于更透明地报告使用队列和常规收集的健康数据进行的随机对照试验。第 3 阶段将包括三轮 Delphi 练习，方法和内容专家将评估“长列表”并生成关键项目的“短列表”。在第 4 阶段，这些项目将作为面对面共识会议的基础，以最终确定要包含在报告指南和清单中的一组核心项目。第 5 阶段将涉及起草清单和详细说明文件，以及指南的传播和实施。讨论此 CONSORT 扩展的开发将有助于更透明地报告使用队列和常规收集的健康数据进行的随机对照试验。第 3 阶段将包括三轮 Delphi 练习，方法和内容专家将评估“长列表”并生成关键项目的“短列表”。在第 4 阶段，这些项目将作为面对面共识会议的基础，以最终确定要包含在报告指南和清单中的一组核心项目。第 5 阶段将涉及起草清单和详细说明文件，以及指南的传播和实施。讨论此 CONSORT 扩展的开发将有助于更透明地报告使用队列和常规收集的健康数据进行的随机对照试验。这些项目将作为面对面共识会议的基础，以最终确定一组核心项目，并将其纳入报告指南和清单。第 5 阶段将涉及起草清单和详细说明文件，以及指南的传播和实施。讨论此 CONSORT 扩展的开发将有助于更透明地报告使用队列和常规收集的健康数据进行的随机对照试验。这些项目将作为面对面共识会议的基础，以最终确定一组核心项目，并将其纳入报告指南和清单。第 5 阶段将涉及起草清单和详细说明文件，以及指南的传播和实施。讨论此 CONSORT 扩展的开发将有助于更透明地报告使用队列和常规收集的健康数据进行的随机对照试验。