CONSORT 2025 Statement:updated guideline for reporting randomized trials
Hopewell S., Chan AW., Collins GS., Hróbjartsson A., Moher D., Schulz KF., Tunn R., Aggarwal R., Berkwits M., Berlin JA., Bhandari N., Butcher NJ., Campbell MK., Chidebe RCW., Elbourne D., Farmer A., Fergusson DA., Golub RM., Goodman SN., Hoffmann TC., Ioannidis JPA., Kahan BC., Knowles RL., Lamb SE., Lewis S., Loder E., Offringa M., Ravaud P., Richards DP., Rockhold FW., Schriger DL., Siegfried NL., Staniszewska S., Taylor RS., Thabane L., Torgerson D., Vohra S., White IR., Boutron I.
Background Well-designed and well-conducted randomized controlled trials (RCTs) are considered the most reliable evidence regarding the benefits of healthcare interventions. However, there is overwhelming evidence that reporting quality is suboptimal. CONSORT The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve reporting quality and specifies the minimum items that should be included in reports of randomized controlled trials (RCTs). CONSORT was first published in 1996 and subsequently revised in 2001 and 2010. Here, we present the revised CONSORT 2025 statement, which takes into account recent methodological advances and feedback from end users.Methods We conducted a scoping review of the literature to build a project-specific database of empirical and theoretical evidence relevant to CONSORT and to develop a list of potential checklist modifications. This list was based on existing CONSORT extensions (harms, outcomes, non-pharmacological treatments), other relevant reporting guidelines (TIDieR), and other relevant guidelines.The checklist was enriched with recommendations provided by the lead author, as well as recommendations from other sources (e.g., personal communication). The list of potential changes to the checklist was evaluated in a large-scale, international, online, three-round Delphi survey involving 317 participants and further discussed in a two-day online expert consensus meeting with 30 international experts. ResultsWe made significant changes to the CONSORT checklist, adding seven new checklist items, modifying three items, deleting one item, and integrating several items from the main CONSORT extension. We also restructured the CONSORT checklist to include a new section on open science. The CONSORT 2025 statement provides a 30-item checklist of essential items to include when reporting the results of an RCT, as well as a diagram for documenting participant flow through the trial.To facilitate the implementation of CONSORT 2025, we have also developedConclusion Authors, editors, reviewers, and other potential users should use CONSORT 2025 when preparing and evaluating RCT manuscripts to ensure clear and transparent reporting. an expanded CONSORT 2025 checklist that lists key elements of each item.