CONSORT 2025 statement: updated guideline for reporting randomised trials

作者：An‐Wen Chan, Sunita Vohra, Philippe Ravaud, Frank W. Rockhold, David L. Schriger, Sarah E Lamb, David Moher, Dean A Fergusson, Nita Bhandari, Lehana Thabane, Andrew Farmer, Jesse A Berlin, Marion K Campbell, R. Tunn, Diana Elbourne, Asbjørn Hróbjartsson, Sophie Staniszewska, Kenneth F. Schulz, Nancy J. Butcher, Steff Lewis, Rachel L Knowles, John P. A. Ioannidis, Robert M Golub, Brennan C Kahan, Steven N. Goodman, Sally Hopewell, Elizabeth Loder, Martin Offringa, Isabelle Boutron, Professor Gary S. Collins, Runcie C.W. Chidebe, David Torgerson, R. Taylor, Rakesh Aggarwal, Nandi Siegfried, Dawn P. Richards, Tammy Hoffmann, Ian R. White, Michael Berkwits · 发表于：UNC Libraries · 年份：2026 · DOI：10.17615/as2m-4x82 · 研究领域：Meta-analysis and systematic reviews、Health Policy Implementation Science、Ethics in Clinical Research

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 (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. 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 (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 item...