为使用队列和常规收集的健康数据的 RCT 制定 CONSORT 扩展协议。

IF 7.2 Q1 ETHICS
Research integrity and peer review Pub Date : 2018-10-29 eCollection Date: 2018-01-01 DOI:10.1186/s41073-018-0053-3
Linda Kwakkenbos, Edmund Juszczak, Lars G Hemkens, Margaret Sampson, Ole Fröbert, Clare Relton, Chris Gale, Merrick Zwarenstein, Sinéad M Langan, David Moher, Isabelle Boutron, Philippe Ravaud, Marion K Campbell, Kimberly A Mc Cord, Tjeerd P van Staa, Lehana Thabane, Rudolf Uher, Helena M Verkooijen, Eric I Benchimol, David Erlinge, Maureen Sauvé, David Torgerson, Brett D Thombs
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引用次数: 0

摘要

背景:随机对照试验(RCT)通常比较复杂,而且成本高昂。只有不到三分之一的试验能达到计划的招募目标,随访工作可能会耗费大量人力物力,而且许多试验在现实世界中的可推广性有限。为了应对这些挑战,人们提出了使用队列和常规收集的健康数据(包括登记册、电子健康记录和行政数据库)进行 RCT 的设计方案,并迅速得到采用。然而,这些设计都是相对较新的创新,已发表的 RCT 报告往往没有以标准化的方式描述其方法的重要方面。我们的目标是扩展《试验报告综合标准》(CONSORT)声明,为使用队列和常规收集的健康数据的 RCT 制定一个共识驱动的报告指南:方法:CONSORT 扩展声明的制定将分为五个阶段。第 1 阶段(已完成)包括项目启动,包括筹资、建立研究团队和制定概念框架。在第 2 阶段,将进行系统性综述,以确定以下出版物:(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) 属于此类 RCT 的方案或报告结果的出版物。将根据 "加强流行病学观察性研究的报告"(STROBE)和 "使用常规收集的观察性健康数据进行的研究的报告"(RECORD)声明,为报告指南编制一份 "长清单",列出可能对 CONSORT 核对表项目进行的修改和可能新增的项目。还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 阶段将由方法和内容专家进行三轮德尔菲练习,以评估 "长清单 "并生成关键项目的 "短清单"。在第 4 阶段,这些项目将作为当面共识会议的基础,以最终确定将纳入报告指南和核对表的一套核心项目。第 5 阶段将包括起草核对表和阐述-解释文件,以及指南的传播和实施:该 CONSORT 扩展版的开发将有助于对使用队列和常规收集的健康数据进行的 RCT 进行更透明的报告。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data.

Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data.

Background: 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.

Methods: 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.

Discussion: Development of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.

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