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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 the University of Oxford, who was instrumental in the development of the original CONSORT statement in 1996 and its updates in 2001 and 2010. However, numerous studies have shown that the quality of reporting for these trials is often not optimal, with key details missing or unclear. The CONSORT 2025 statement accounts for recent methodological advancements and feedback from end users and aims to improve research by establishing a minimum set of reporting requirements.
At the same time as CONSORT 2025, the team also updated SPIRIT 2025 statement, which is related to complete and transparent reporting of trial protocols and is due to be published later this month. Updating the SPIRIT and CONSORT statements together was an opportunity to further align reporting in both checklists and to provide users with consistent guidance in the reporting of trial design, conduct and analysis, from trial protocol to final publication.
‘Improving the transparency and completeness of trial reporting is crucial for advancing medical knowledge and ensuring that research findings can be appropriately used to inform clinical practice and health policy,’ said Sally. ‘The CONSORT 2025 guidelines will help trial authors, journal editors, and peer reviewers ensure that trial reports meet the highest standards of clarity and detail and reassure patients that healthcare decisions are based on robust research.’
The 2025 update of CONSORT and SPIRIT was funded by the Better Methods Better Research (BMBR) programme, a partnership between the Medical Research Council (MRC) and The National Institute for Health and Care Research (NIHR).