The CONSORT 2025 statement, an updated guideline for reporting randomised trials is being simultaneously published in The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine.
An updated set of guidelines to improve transparency and clarity in the reporting of randomised controlled trials have been published today. The CONSORT (Consolidated Standards of Reporting Trials) 2025 statement provides a minimum set of essential items that should be included when reporting the results of randomised trials.
First published in 1996, the CONSORT guidelines saw additional updates in 2001 and 2010. Becoming the gold standard for reporting randomised trials, CONSORT is endorsed by numerous journals and organisations worldwide and is being published simultaneously today in The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine.
Researchers, clinicians, journal editors, and other stakeholders are encouraged to adopt these updated recommendations to help communicate their trial methods and findings in a way that best serves the interests of patients, clinicians, policymakers, and the broader scientific community.
Leading the international team of researchers updating the guidelines, Sally Hopewell, Professor of Clinical Trials and Evidence Synthesis, based at the Oxford Clinical Trials Unit within NDORMS, University of Oxford said: ‘The CONSORT 2025 statement includes new checklist items, revisions to existing items to enhance reporting, and a restructuring of the checklist to focus on open science principles, with the aim of improving the reliability and validity of trial findings.’
Among the updates are the addition of four new key checklist items:
- Patient and public involvement – how patients and/or the public were involved in the design, conduct, and reporting of the trial.
- Sharing of data – where and how the individual de-identified participant data, statistical and other materials can be accessed.
- Harms – how harms i.e. the unwanted effects of an intervention, were defined and assessed.
- Intervention delivery – including how the intervention and comparator (such as, another intervention, usual care or use of a placebo) were actually administered, and details of the associated care received during the trial.
The CONSORT 2025 statement is accompanied by an expanded 30-item checklist published in The BMJ, that provides additional details on the critical elements to include for each reporting item. It is intended to be used alongside a detailed explanation and elaboration document that provides the rationale, evidence, and examples of good reporting for each checklist item.
Well designed and properly executed randomised trials are widely considered to provide the most reliable evidence on the benefits of healthcare interventions. This was recognised by Professor Doug Altman, Centre for Statistics in Medicine, NDORMS, at t