CONSORT 2025声明：随机试验报告指南更新版

doi:10.3969/j.issn.1673-5765.2025.05.009

摘要/Abstract

摘要： 背景设计良好且执行得当的随机试验被认为是评估医疗干预措施效益最可靠的证据。然而，目前此类试验的报告质量并不理想。CONSORT声明于1996年首次发布，并提供了1份随机试验报告应包含的必备条目清单，旨在提高随机试验报告质量。该声明于2001年和2010年进行了两次更新。本文介绍最新的CONSORT 2025声明，旨在反映近期的方法学进展及终端用户的意见反馈。
方法我们对相关文献进行了范围综述，并制定了包括CONSORT相关实证和理论证据的专用数据库，用于生成可能需要修订的清单条目列表。该列表整合了现有CONSORT扩展（不良事件、结局、非药物治疗）主要作者提供的建议、其他相关报告指南[如干预措施描述与复制模板（template for intervention description and replication，TIDieR）]及其他来源（如个人交流）的建议。清单的潜在修订内容通过由317名国际参与者组成的大型在线德尔菲调查（共3轮）进行评估，随后由30名国际专家参与的线上专家共识会议进行进一步的讨论。
结果本次更新对CONSORT清单进行了实质性修订：新增7个条目、修订3个条目、删除1个条目，并整合了若干重要的CONSORT扩展条目。同时，我们对清单结构进行了调整，新增了“开放科学”板块。最终形成的CONSORT 2025声明包含1份含30个条目的随机试验报告信息清单，以及1个用于记录试验参与者的流程图。为了便于推广应用，本次更新还开发了CONSORT 2025声明随机试验报告信息清单的扩展版本，详细列出了每个条目的关键要素。
结论作者、编辑、审稿人及其他潜在用户应在撰写和评估RCT稿件时参考CONSORT 2025声明，以确保试验报告内容清晰、透明。

关键词: 随机试验; 临床研究; 报告; 指南

Abstract: Background Well-designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users.
Methods We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (harms, outcomes, non-pharmacological treatment), other related reporting guidelines [template for intervention description and replication (TIDieR)], and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts.
Results We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate the implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item.
Conclusions Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.

Key words: Randomized trial; Clinical research; Report; Guideline

中图分类号:

译者：李辉, 谢雪微. CONSORT 2025声明：随机试验报告指南更新版[J]. 中国卒中杂志, 2025, 20(5): 620-629.

Translator: LI Hui, XIE Xuewei. CONSORT 2025 Statement: Updated Guideline for Reporting Randomised Trials[J]. Chinese Journal of Stroke, 2025, 20(5): 620-629.

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