A revised set of guidelines aimed at improving transparency and clarity in the reporting of randomised controlled trials (RCTs) has been published today. The CONSORT 2025 (Consolidated Standards of Reporting Trials) statement outlines a minimum set of essential items that should be included when reporting the results of RCTs.
Originally introduced in 1996 and updated in 2001 and 2010, the CONSORT guidelines have become the international gold standard for trial reporting. Widely endorsed by journals and institutions around the world, the CONSORT 2025 statement has been published simultaneously in leading medical journals including The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine.
Researchers, clinicians, journal editors, and other stakeholders are encouraged to adopt the updated recommendations to better communicate trial methods and findings—ultimately serving the needs of patients, healthcare providers, policymakers, and the broader scientific community.
The CONSORT 2025 statement introduces new checklist items, updates existing ones to improve clarity, and restructures the checklist to reflect open science principles. The goal is to enhance the reliability and validity of trial findings.
Among the key updates are four newly added checklist items:
- Patient and public involvement: Reporting on how patients and/or the public were involved in trial design, conduct, and dissemination.
- Data sharing: Information on where and how to access de-identified participant data, statistical code, and related materials.
- Harms: A detailed description of how harms—unintended effects of interventions—were defined and assessed.
- Intervention delivery: Clear reporting of how the intervention and comparator were administered, along with any associated care.
The CONSORT 2025 statement is accompanied by an expanded 30-item checklist, published in The BMJ, offering guidance on what to include for each reporting item. This is designed to be used alongside an explanatory document that provides context, supporting evidence, and examples of good reporting practice.
Well-conducted and transparently reported randomised trials are widely recognised as the most reliable form of evidence for evaluating healthcare interventions. Despite progress, studies continue to show that the quality of trial reporting often remains suboptimal, with missing or unclear information undermining research usefulness.
The CONSORT 2025 update reflects recent methodological developments and incorporates feedback from users, with the aim of raising the overall quality of trial reporting through a clearly defined minimum standard.
Improving the transparency and completeness of trial reporting is essential for advancing medical knowledge and informing clinical practice and health policy. The CONSORT 2025 guidelines will support authors, editors, and peer reviewers in ensuring that trial reports meet the highest standards—ultimately building trust that healthcare decisions are grounded in rigorous, well-reported evidence.
Source: University of Oxford
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