CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

Sally Hopewell*, An Wen Chan, Gary S. Collins, Asbjorn Hróbjartsson, David Moher, Kenneth F. Schulz, Ruth Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A. Berlin, Nita Bhandari, Nancy J. Butcher, Marion K. Campbell, Runcie C.W. Chidebe, Diana Elbourne, Andrew Farmer, Dean A. Fergusson, Robert M. Golub, Steven N. Goodman, Tammy C. HoffmannJohn P.A. Ioannidis, Brennan C. Kahan, Rachel L. Knowles, Sarah E. Lamb, Steff Lewis, Elizabeth Loder, Martin Offringa, Philippe Ravaud, Dawn P. Richards, Frank W. Rockhold, David L. Schriger, Nandi L. Siegfried, Sophie Staniszewska, Rod S. Taylor, Lehana Thabane, David Torgerson, Sunita Vohra, Ian R. White, Isabelle Boutron

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

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.

Original languageEnglish
Article number081124
JournalBMJ
Volume389
Number of pages61
ISSN0959-8146
DOIs
Publication statusPublished - 14. Apr 2025

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