CONSORT 2025 statement: Updated guideline for reporting randomised trials.
| Title: | CONSORT 2025 statement: Updated guideline for reporting randomised trials. |
|---|---|
| Authors: | Hopewell S; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.; Chan AW; Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.; Collins GS; United Kingdom EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.; Hróbjartsson A; Department of Clinical Research, Centre for Evidence-Based Medicine Odense and Cochrane Denmark, University of Southern Denmark, Odense, Denmark.; Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.; Moher D; Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.; Schulz KF; Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.; Tunn R; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.; Aggarwal R; Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.; Berkwits M; Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.; Berlin JA; Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, New Jersey, United States of America.; JAMA Network Open, Chicago, Illinois, United States of America.; Bhandari N; Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.; Butcher NJ; Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.; Campbell MK; Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom.; Chidebe RCW; Project PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.; Department of Sociology and Gerontology, Miami University, Oxford, Ohio, United States of America.; Elbourne D; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.; Farmer A; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.; Fergusson DA; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.; Golub RM; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America.; Goodman SN; Department of Epidemiology and Population Health, Stanford University, Palo Alto, California, United States of America.; Hoffmann TC; Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, Queensland, Australia.; Ioannidis JPA; Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, United States of America.; Kahan BC; MRC Clinical Trials Unit at University College London, London, United Kingdom.; Knowles RL; University College London, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.; Lamb SE; NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom.; Lewis S; Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, United Kingdom.; Loder E; The BMJ, BMA House, London, United Kingdom.; Harvard Medical School, Boston, Massachusetts, United States of America.; Offringa M; Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.; Ravaud P; Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.; Richards DP; Clinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada.; Rockhold FW; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, United States of America.; Schriger DL; Department of Emergency Medicine, University of California, Los Angeles, California, United States of America.; Siegried NL; South African Medical Research Council, Cape Town, South Africa.; Staniszewska S; Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, United Kingdom.; Taylor RS; MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.; Thabane L; Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.; St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.; Torgerson D; York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.; Vohra S; Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.; White IR; MRC Clinical Trials Unit at University College London, London, United Kingdom.; Boutron I; Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.; Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France. |
| Source: | PLoS medicine [PLoS Med] 2025 Apr 14; Vol. 22 (4), pp. e1004587. Date of Electronic Publication: 2025 Apr 14 (Print Publication: 2025). |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 101231360 Publication Model: eCollection Cited Medium: Internet ISSN: 1549-1676 (Electronic) Linking ISSN: 15491277 NLM ISO Abbreviation: PLoS Med Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: San Francisco, CA : Public Library of Science, [2004]- |
| MeSH Terms: | Randomized Controlled Trials as Topic*/standards ; Guidelines as Topic*/standards ; Research Report*/standards ; Publishing*/standards ; Research Design*/standards; Checklist/standards ; Humans ; Delphi Technique |
| Abstract: | Background: Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users.; Methods: We conducted a scoping review of the literature and developed 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, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). 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 two-day online expert consensus meeting of 30 invited international experts.; Results: We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item.; Conclusions: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.; (Copyright: © 2025 Hopewell et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.) |
| Competing Interests: | I have read the journal’s policy and the authors of this manuscript have the following competing interests: support from MRC-NIHR for the submitted work. SH, IB, A-WC, AH, KFS, and DM are members of the SPIRIT-CONSORT executive group. SH, IB, A-WC, AH, KFS, GSC, DM, MKC, NJB, MO, RST, and SV are involved in the development, update, implementation, and dissemination of several reporting guidelines. GSC is the director of the UK EQUATOR Centre, a statistical editor for The BMJ and NIHR Senior Investigator, DM is the director of the Canadian EQUATOR Centre, and member of The BMJ’s regional advisory board for North America, IB is deputy director and PR is director of the French EQUATOR Centre, TCH is director of the Australasian EQUATOR Centre, JPAI is director of the US EQUATOR Centre. RA is president of the World Association of Medical Editors. MKC is chair of the MRC-NIHR: Better Methods Better Research funding panel. RCWC is executive director of Project PINK-BLUE, which receives funding from Roche-Product. AF is director of the UK National Institute for Health and Care Research Health Technology Assessment Programme. DPR is a full time employee of Five02 Laboratories, which under contract to Clinical Trials Ontario provides services related to patient and public engagement; and is the volunteer vice president of the Canadian Arthritis Patient Alliance, which receives funding through independent grants from pharmaceutical companies. IRW was supported by the MRC Programmes MCUU00004/07 and MCUU00004/09. DLS is JAMA associate editor and receives editing stipends from JAMA and Annals of Emergency Medicine.Provenance and peer review: Not commissioned; externally peer reviewed. |
| Comments: | Comment in: PLoS Med. 2025 Apr 28;22(4):e1004588. doi: 10.1371/journal.pmed.1004588.. (PMID: 40294530) |
| References: | BMC Med. 2015 Sep 15;13:221. (PMID: 26370288); Med J Aust. 2006 Sep 4;185(5):263-7. (PMID: 16948622); Ann Intern Med. 2017 Jul 4;167(1):40-47. (PMID: 28630973); Ann Intern Med. 2012 Sep 18;157(6):429-38. (PMID: 22945832); Ann Intern Med. 2001 Apr 17;134(8):663-94. (PMID: 11304107); JAMA. 2012 Dec 26;308(24):2594-604. (PMID: 23268518); PLoS Med. 2008 Jan 22;5(1):e20. (PMID: 18215107); JAMA. 2019 Apr 23;321(16):1610-1620. (PMID: 31012939); JAMA. 2001 Apr 18;285(15):1987-91. (PMID: 11308435); Syst Rev. 2012 Nov 29;1:60. (PMID: 23194585); J Clin Epidemiol. 2019 Sep;113:168-175. (PMID: 31153976); JAMA. 2022 Dec 13;328(22):2252-2264. (PMID: 36511921); J Clin Epidemiol. 2023 Mar;155:48-63. (PMID: 36669708); Trials. 2020 Jun 17;21(1):528. (PMID: 32546273); Lancet. 2014 Jan 18;383(9913):267-76. (PMID: 24411647); BMJ. 2017 Jun 30;357:j2835. (PMID: 28667088); PLoS One. 2012;7(4):e35621. (PMID: 22558178); J Clin Epidemiol. 2024 May;169:111309. (PMID: 38428538); Sci Transl Med. 2016 Jun 1;8(341):341ps12. (PMID: 27252173); Syst Rev. 2021 Mar 29;10(1):89. (PMID: 33781348); BMJ. 2016 Oct 24;355:i5239. (PMID: 27777223); Ann Intern Med. 2009 Aug 18;151(4):JC2-2, JC2-3. (PMID: 19687477); BMJ. 2024 Jul 9;386:e078524. (PMID: 38981645); BMJ. 2023 Oct 20;383:e076387. (PMID: 37863501); BMJ. 2014 Mar 07;348:g1687. (PMID: 24609605); BMJ. 2015 May 14;350:h1738. (PMID: 25976398); JAMA. 2023 Dec 5;330(21):2106-2114. (PMID: 38051324); BMJ. 2010 Mar 23;340:c869. (PMID: 20332511); BMJ. 2012 Sep 04;345:e5661. (PMID: 22951546); PLoS Med. 2010 Feb 16;7(2):e1000217. (PMID: 20169112); BMJ. 2017 Nov 23;359:j5085. (PMID: 29170161); BMJ. 2025 Apr 14;389:e081124. (PMID: 40228832); BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884); Nat Med. 2022 Sep;28(9):1740-1743. (PMID: 36109642); JAMA. 1996 Aug 28;276(8):637-9. (PMID: 8773637); JAMA. 2001 Apr 18;285(15):1992-5. (PMID: 11308436); BMC Med. 2019 Nov 19;17(1):205. (PMID: 31744489); BMJ. 1996 Sep 7;313(7057):570-1. (PMID: 8806240); Ann Intern Med. 2013 Feb 5;158(3):200-7. (PMID: 23295957); JAMA. 2013 Feb 27;309(8):814-22. (PMID: 23443445); BMJ. 2019 Jul 31;366:l4378. (PMID: 31366597); BMJ. 2017 Jun 8;357:j2490. (PMID: 28596181); Ann Intern Med. 2010 Jun 1;152(11):726-32. (PMID: 20335313); Trials. 2018 Jul 31;19(1):407. (PMID: 30060754); J Clin Epidemiol. 2023 Jun;158:149-165. (PMID: 37100738); BMJ. 2008 Nov 11;337:a2390. (PMID: 19001484) |
| Entry Date(s): | Date Created: 20250414 Date Completed: 20250414 Latest Revision: 20250428 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC11996237 |
| DOI: | 10.1371/journal.pmed.1004587 |
| PMID: | 40228477 |
| Database: | MEDLINE |
Journal Article