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 OX3 7LD, UK.
Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.
BMJ. 2025 Apr 14;389:e081124. doi: 10.1136/bmj-2024-081124.
Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims 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 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.
只有当随机试验的设计、实施、分析和结果得到完整且准确的报告时，才有可能对其质量进行批判性评估。如果不透明地报告方法和结果，读者将无法充分评估试验结果的可靠性和有效性。CONSORT（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，并于2001年和2010年进行了更新。CONSORT包括一份随机试验报告中应包含的基本项目清单，以及一个用于记录试验参与者流程的图表。CONSORT声明已更新（CONSORT 2025），以反映最近的方法学进展和终端用户的反馈，确保其仍然适用。在此，我们展示更新后的CONSORT解释与详述文件，该文件已进行了广泛修订，描述了每个CONSORT 2025清单项目的基本原理和科学背景，并提供了良好报告的已发表示例。目的是加强CONSORT 2025的使用、理解和传播，并为作者提供如何改进其试验报告并确保试验报告完整且透明的指导。
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