Interpretation and Examples: Key Updates in CONSORT 2025
Abstract
Standardized clinical trial reporting is crucial for ensuring the scientific validity, reproducibility, and clinical translational value of reported results. The Consolidated Standards of Reporting Trials (CONSORT) statement, an internationally recognized guideline for randomized controlled trials (RCTs), has become an important reference standard for writing research papers in medicine since the 2010 version of CONSORT was published. With advancements in scientific research methodologies and the emergence of new forms of clinical trials, the CONSORT working group released an updated version in April 2025, published in journals such as The BMJ. Herein, we provide a systematic interpretation of the core revisions of CONSORT 2025, as well as a comparison with CONSORT 2010 to highlight the key differences. By providing practical, example-based recommendations, we aim to help domestic researchers apply the new guidelines efficiently, thereby improving the quality of clinical trial reports authored by domestic researchers.
Keywords: CONSORT 2025, Clinical trials, Reporting guidelines, Interpretation
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HARITON E, LOCASCIO J J. Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG, 2018, 125(13): 1716. doi: 10.1111/1471-0528.15199.
SAVOVIć J, JONES H E, ALTMAN D G, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med, 2012, 157(6): 429-38. doi: 10.7326/0003-4819-157-6-201209180-00537.
GLASZIOU P, ALTMAN D G, BOSSUYT P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet, 2014, 383(9913): 267-276. doi: 10.1016/S0140-6736(13)62228-X.
BEGG C, CHO M, EASTWOOD S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8): 637-639. doi: 10.1001/jama.1996.03540080059030.
MOHER D, SCHULZ K F, ALTMAN D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Jama, 2001, 285(15): 1987-1991. doi: 10.1001/jama.285.15.1987.
SCHULZ K F, ALTMAN D G, MOHER D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c332. doi: 10.1136/bmj.c332.
ALTMAN D G, SCHULZ K F, MOHER D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med, 2001, 134(8): 663-694. doi: 10.7326/0003-4819-134-8-200104170-00012.
MOHER D, HOPEWELL S, SCHULZ K F, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869. doi: 10.1136/bmj.c869.
NEJSTGAARD C H, BOUTRON I, CHAN A W, et al. A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010. J Clin Epidemiol, 2023, 155: 48-63. doi: 10.1016/j. jclinepi.2023.01.003.
ØSTENGAARD L, BARRIENTOS A, BOUTRON I, et al. Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010. Cochrane Evid Synth Methods, 2024, 2(5): e12057. doi: 10.1002/cesm.12057.
HOPEWELL S, CHAN A W, COLLINS G S, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081123. doi: 10.1136/bmj-2024-081123.
HOPEWELL S, CHAN A W, COLLINS G S, et al. CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081124. doi: 10.1136/bmj-2024-081124.
BONACA M P, CATARIG A M, HOULIND K, et al. Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial. Lancet, 2025, 405(10489): 1580-1593. doi: 10. 1016/S0140-6736(25)00509-4.
BONACA M P, CATARIG A M, HANSEN Y, et al. Design and baseline characteristics of the STRIDE trial: evaluating semaglutide in people with symptomatic peripheral artery disease and type 2 diabetes. Eur Heart J Cardiovasc Pharmacother, 2025, 10(8): 728-737. doi: 10.1093/ehjcvp/pvae071.
PASKINS Z, BROMLEY K, LEWIS M, et al. Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial. BMJ, 2022, 377: e068446. doi: 10.1136/bmj-2021-068446.
GILBODY S, LITTLEWOOD E, MCMILLAN D, et al. Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trial. Lancet Healthy Longev, 2024, 5(2): e97-e107. doi: 10. 1016/S2666-7568(23)00238-6.
SANTER M, MULLER I, BECQUE T, et al. Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials. BMJ, 2022, 379: e072007. doi: 10.1136/bmj-2022-072007.
VICTOR R G, LYNCH K, LI N, et al. A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops. N Engl J Med, 2018, 378(14): 1291-301. doi: 10.1056/NEJMoa1717250.
SANDBORN W J, VERMEIRE S, PEYRIN-BIROULET L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet, 2023, 401(10383): 1159-1171. doi: 10.1016/S0140-6736(23)00061-2.
WANG Y, ZHANG D, DU G, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet, 2020, 395(10236): 1569-1578. doi: 10.1016/S0140-6736(20) 31022-9.
TURNER L, SHAMSEER L, ALTMAN D G, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev, 2012, 11(11): Mr000030. doi: 10.1002/ 14651858.MR000030.pub2.
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