An updated set of guidelines aimed at enhancing transparency and clarity in reporting randomized controlled trials has been recently released. The CONSORT (Consolidated Standards of Reporting Trials) 2025 statement outlines a minimum set of essential items that should be included when presenting the results of randomized trials.
Initially published in 1996, the CONSORT guidelines have undergone revisions in 2001 and 2010. They have become widely recognized as the gold standard for reporting randomized trials and are endorsed by numerous journals and organizations globally. The updated CONSORT guidelines are simultaneously being published in prestigious journals such as the BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine.
Researchers, clinicians, journal editors, and other stakeholders are encouraged to embrace these updated recommendations to effectively communicate their trial methods and findings to benefit patients, clinicians, policymakers, and the scientific community at large.
The international team of researchers leading the update of the guidelines, including Sally Hopewell, Professor of Clinical Trials and Evidence Synthesis at the Oxford Clinical Trials Unit within NDORMS, University of Oxford, emphasized the significance of the CONSORT 2025 statement. The new checklist items focus on open science principles, with the goal of enhancing the reliability and validity of trial findings.
Key additions to the guidelines include aspects such as patient and public involvement in the trial design, sharing of data, definition and assessment of harms, and details related to intervention delivery. The CONSORT 2025 statement is complemented by an expanded 30-item checklist published in the BMJ, offering additional insights into critical elements to incorporate for each reporting item.
Well-designed and properly executed randomized trials are essential for providing reliable evidence on the benefits of healthcare interventions. However, studies have shown that the quality of reporting for these trials can be suboptimal, with crucial details often missing or unclear. The CONSORT 2025 statement aims to address these shortcomings by establishing a minimum set of reporting requirements based on recent methodological advancements and user feedback.
In addition to CONSORT 2025, the team also updated the SPIRIT 2025 statement, which focuses on transparent reporting of trial protocols. The alignment of reporting in both checklists ensures consistent guidance from trial protocol to final publication, promoting transparency and completeness in trial reporting.
Enhancing the transparency and completeness of trial reporting is crucial for advancing medical knowledge and informing clinical practice and health policy. The CONSORT 2025 guidelines provide authors, journal editors, and peer reviewers with a framework to meet the highest standards of clarity and detail in trial reports, ultimately bolstering the credibility of research findings and supporting evidence-based healthcare decisions.
