CONSORT 2025 statement: updated guideline for reporting randomized trials

Sally Hopewell¹, An-Wen Chan², Gary S Collins³, Asbjørn Hróbjartsson^{4

5}, David Moher⁶, Kenneth F Schulz⁷, Ruth Tunn⁸, Rakesh Aggarwal⁹, Michael Berkwits¹⁰, Jesse A Berlin^{11

12}, Nita Bhandari¹³, Nancy J Butcher^{14

15}, Marion K Campbell¹⁶, Runcie C W Chidebe^{17

18}, Diana Elbourne¹⁹, Andrew Farmer²⁰, Dean A Fergusson²¹, Robert M Golub²², Steven N Goodman²³, Tammy C Hoffmann²⁴, John P A Ioannidis²⁵, Brennan C Kahan²⁶, Rachel L Knowles²⁷, Sarah E Lamb²⁸, Steff Lewis²⁹, Elizabeth Loder^{30

31}, Martin Offringa¹⁴, Philippe Ravaud³², Dawn P Richards³³, Frank W Rockhold³⁴, David L Schriger³⁵, Nandi L Siegfried³⁶, Sophie Staniszewska³⁷, Rod S Taylor³⁸, Lehana Thabane^{39

40}, David Torgerson⁴¹, Sunita Vohra⁴², Ian R White²⁶, Isabelle Boutron^{43

44}

Affiliations

¹ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK. sally.hopewell@qiuluzeuv.cn.
² Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
³ UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
⁴ Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
⁵ Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
⁶ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁷ Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
⁹ Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
¹⁰ Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
¹¹ Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.
¹² JAMA Network Open, Chicago, IL, USA.
¹³ Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.
¹⁴ Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
¹⁵ Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
¹⁶ Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
¹⁷ Project PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.
¹⁸ Department of Sociology and Gerontology, Miami University, Oxford, OH, USA.
¹⁹ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
²⁰ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
²¹ Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
²² Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
²³ Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.
²⁴ Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland, Australia.
²⁵ 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, CA, USA.
²⁶ MRC Clinical Trials Unit at University College London, London, UK.
²⁷ University College London, UCL Great Ormond Street Institute of Child Health, London, UK.
²⁸ NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
²⁹ Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.
³⁰ The BMJ, BMA House, London, UK.
³¹ Harvard Medical School, Boston, MA, USA.
³² Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.
³³ Clinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada.
³⁴ Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
³⁵ Department of Emergency Medicine, University of California, Los Angeles, CA, USA.
³⁶ South African Medical Research Council, Cape Town, South Africa.
³⁷ Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.
³⁸ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
³⁹ Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
⁴⁰ St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
⁴¹ York Trials Unit, Department of Health Sciences, University of York, York, UK.
⁴² Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
⁴³ Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.
⁴⁴ Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France.

PMID: 40229553
DOI: "VSports最新版本" 10.1038/s41591-025-03635-5

Review

CONSORT 2025 statement: updated guideline for reporting randomized trials

Sally Hopewell et al. Nat Med. 2025 Jun.

. 2025 Jun;31(6):1776-1783.

doi: 10.1038/s41591-025-03635-5. Epub 2025 Apr 15.

Authors

Affiliations

¹ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK. sally.hopewell@qiuluzeuv.cn.
² Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
³ UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
⁴ Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
⁵ Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
⁶ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁷ Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
⁹ Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
¹⁰ Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
¹¹ Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.
¹² JAMA Network Open, Chicago, IL, USA.
¹³ Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.
¹⁴ Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
¹⁵ Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
¹⁶ Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
¹⁷ Project PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.
¹⁸ Department of Sociology and Gerontology, Miami University, Oxford, OH, USA.
¹⁹ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
²⁰ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
²¹ Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
²² Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
²³ Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.
²⁴ Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland, Australia.
²⁵ 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, CA, USA.
²⁶ MRC Clinical Trials Unit at University College London, London, UK.
²⁷ University College London, UCL Great Ormond Street Institute of Child Health, London, UK.
²⁸ NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
²⁹ Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.
³⁰ The BMJ, BMA House, London, UK.
³¹ Harvard Medical School, Boston, MA, USA.
³² Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.
³³ Clinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada.
³⁴ Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
³⁵ Department of Emergency Medicine, University of California, Los Angeles, CA, USA.
³⁶ South African Medical Research Council, Cape Town, South Africa.
³⁷ Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.
³⁸ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
³⁹ Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
⁴⁰ St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
⁴¹ York Trials Unit, Department of Health Sciences, University of York, York, UK.
⁴² Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
⁴³ Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.
⁴⁴ Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France.

PMID: 40229553
DOI: 10.1038/s41591-025-03635-5

Abstract

Well-designed and properly executed randomized 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 VSports手机版. 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 randomized 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. 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 (such as 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. 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 randomized 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. 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. .

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Conflict of interest statement

Ethical approval: Ethical approval was granted by the Central University Research Ethics Committee, University of Oxford ( R76421 /RE001). All Delphi participants provided informed consent to participate. Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www. icmje. org/conflicts-of-interest/ and declare: support from MRC-NIHR for the submitted work. S. H. , I. B. , A. -W. C. , A. H. , K. F V体育ios版. S. and D. M. are members of the SPIRIT-CONSORT executive group. S. H. , I. B. , A. -W. C. , A. H. , K. F. S. , G. S. C. , D. M. , M. K. C. , N. J. B. , M. O. , R. S. T. and S. V. are involved in the development, update, implementation, and dissemination of several reporting guidelines. G. S. C. is the director of the UK EQUATOR Centre, a statistical editor for the BMJ and NIHR senior investigator. D. M. is the director of the Canadian EQUATOR Centre, and member of the BMJ regional advisory board for North America. I. B. is deputy director and P. R. is director of the French EQUATOR Centre. T. C. H. is director of the Australasian EQUATOR Centre. J. P. A. I. is director of the US EQUATOR Centre. R. A. is president of the World Association of Medical Editors. M. K. C. is chair of the MRC-NIHR: Better Methods Better Research funding panel. R. C. W. C. is executive director of Project PINK-BLUE, which receives funding from Roche-Product. A. F. is director of the UK National Institute for Health and Care Research Health Technology Assessment Programme. D. P. R. 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. I. R. W. was supported by the MRC Programmes MCUU00004/07 and MCUU00004/09. D. L. S. is JAMA associate editor and receives editing stipends from JAMA and Annals of Emergency Medicine.

References (VSports在线直播)

1. Altman, D. G. Better reporting of randomised controlled trials: the CONSORT statement. Brit. Med. J. 313, 570–571 (1996). - PubMed (V体育安卓版) - PMC
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CONSORT 2025 statement: updated guideline for reporting randomized trials

Affiliations

CONSORT 2025 statement: updated guideline for reporting randomized trials

Authors

Affiliations

Abstract

Conflict of interest statement

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