Hopewell Sally, Chan An-Wen, Collins Gary S, Hróbjartsson Asbjørn, Moher David, Schulz Kenneth F, Tunn Ruth, Aggarwal Rakesh, Berkwits Michael, Berlin Jesse A, Bhandari Nita, Butcher Nancy J, Campbell Marion K, Chidebe Runcie C W, Elbourne Diana, Farmer Andrew, Fergusson Dean A, Golub Robert M, Goodman Steven N, Hoffmann Tammy C, Ioannidis John P A, Kahan Brennan C, Knowles Rachel L, Lamb Sarah E, Lewis Steff, Loder Elizabeth, Offringa Martin, Ravaud Philippe, Richards Dawn P, Rockhold Frank W, Schriger David L, Siegfried Nandi L, Staniszewska Sophie, Taylor Rod S, Thabane Lehana, Torgerson David, Vohra Sunita, White Ian R, Boutron Isabelle
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford UK.
Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.
Lancet. 2025 Apr 14. doi: 10.1016/S0140-6736(25)00672-5.
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 (Consolidated Standards of Reporting Trials) 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. 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 (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. 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 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. 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.
设计良好且执行得当的随机试验被认为是关于医疗保健干预措施益处的最可靠证据。然而，有大量证据表明报告质量并不理想。CONSORT（随机对照试验报告统一标准）声明旨在提高报告质量，并提供了随机试验报告中应包含的最少项目集。CONSORT于1996年首次发布，随后在2001年和2010年进行了更新。在此，我们展示更新后的CONSORT 2025声明，其目的是考虑到近期的方法学进展以及最终用户的反馈。我们对文献进行了范围综述，并开发了一个与CONSORT相关的实证和理论证据的特定项目数据库，以生成清单的潜在更改列表。该列表通过现有CONSORT扩展（危害、结局、非药物治疗）的主要作者提供的建议、其他相关报告指南（TIDieR）以及其他来源的建议（例如个人交流）得到了充实。在一项涉及317名参与者的大型国际在线三轮德尔菲调查中对清单的潜在更改列表进行了评估，并在一次由30名受邀国际专家参加的为期两天的在线专家共识会议上进行了讨论。我们对CONSORT清单进行了实质性更改。我们新增了七个清单项目，修订了三个项目，删除了一个项目，并整合了关键CONSORT扩展中的几个项目。我们还对CONSORT清单进行了重新架构，新增了一个关于开放科学的部分。CONSORT 2025声明由一份30项的基本项目清单组成，这些项目在报告随机试验结果时应包含在内，以及一个用于记录参与者在试验中的流程的图表。为便于CONSORT 2025的实施，我们还开发了CONSORT 2025清单的扩展版本，其中包含引出每个项目关键要素的要点。作者、编辑、审稿人和其他潜在用户在撰写和评估随机试验稿件时应使用CONSORT 2025，以确保试验报告清晰透明。
