A comprehensive update to the CONSORT (Consolidated Standards of Reporting Trials) statement provides researchers with enhanced guidelines for reporting randomized trials. The CONSORT 2025 statement—which updates the original publication in 1996 and revisions in 2001 and 2010—was developed through rigorous international consensus. The authors of the update aimed to improve transparency and completeness in trial reporting, and "to account for recent methodological advancements and feedback from end users."
Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care interventions. However, there is overwhelming evidence that the quality of reporting of trial results is not optimal. The updated CONSORT 2025 statement, published in JAMA, addresses this issue by providing a minimum set of items to be included in a report of a randomized trial.
The development process for the update involved a scoping review of the literature and a project-specific database of empirical and theoretical evidence related to CONSORT to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (harms, outcomes, nonpharmacological treatment), other related reporting guidelines (Template for Intervention Description and Replication), and recommendations from other sources.
The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a 2-day online expert consensus meeting of 30 invited international experts.
Key Modifications
The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomized trial, as well as a diagram for documenting the flow of participants through the trial. Substantive changes include:
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The addition of seven new checklist items, including data sharing, financial and other conflicts of interest of manuscript authors, patient and public involvement, eligibility criteria for sites and individuals delivering interventions, assessment of harms, definition of who is included in each analysis, and intervention delivery details.
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The revision of three items related to trial protocol and statistical analysis plan accessibility, reporting of important post-commencement changes, and specifying the number of participants included in analyses.
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The deletion of one item on generalizability of trial findings (now incorporated under trial limitations).
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The integration of several items from key CONSORT extensions.
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Restructuring of the CONSORT checklist, with a new section on open science, which includes items that are conceptually linked such as trial registration, protocol, and statistical analysis plan access; sharing of deidentified participant-level data; and funding and conflicts of interest
Douglas G. Altman, PhD, who was instrumental in the development of CONSORT, is quoted in the document: "Readers should not have to infer what was probably done; they should be told explicitly."
Implementation and Further Resources
To facilitate implementation, the developers of the update have created an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. A joint SPIRIT-CONSORT website (consort-spirit.org) has been established to provide more information about the CONSORT and SPIRIT statements, including additional resources and training materials aimed at researchers, research trainees, journal editors, and peer reviewers. The website also includes resources for patients and the public that explain the importance of clear and transparent reporting of randomized trials and their importance in the delivery of evidence-based health care.
The CONSORT 2025 statement supersedes the CONSORT 2010 statement, which should no longer be used. Journal editors and publishers should update their instructions to authors to refer to CONSORT 2025. Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent.
CONSORT 2025 represents a living guideline that will continue to be periodically updated to reflect new evidence and emerging perspectives. Such an approach is important to ensure the guidance remains relevant to end users, including authors, patients and the public, journal editors, and peer reviewers.
The statement was simultaneously published in The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine.
All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/conflicts-of-interest/.