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CONSORT 2025 statement: Updated guideline for reporting randomised trials
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Sally Hopewell ,
Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Supervision, Writing – original draft, Writing – review & editing
* E-mail: sally.hopewell@csm.ox.ac.uk
Affiliation Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
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An-Wen Chan,
Roles Conceptualization, Investigation, Methodology, Supervision, Writing – original draft, Writing – review & editing
Affiliation Department of Medicine, Women’s College Research Institute, University of Toronto, Toronto, Ontario, Canada
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Gary S. Collins,
Roles Conceptualization, Funding acquisition, Investigation, Methodology, Supervision, Writing – original draft, Writing – review & editing
Affiliation United Kingdom EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
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Asbjørn Hróbjartsson,
Roles Conceptualization, Investigation, Methodology, Writing – original draft, Writing – review & editing
Affiliations 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
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David Moher,
Roles Conceptualization, Investigation, Methodology, Supervision, Writing – original draft, Writing – review & editing
Affiliation Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
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Kenneth F. Schulz,
Roles Conceptualization, Investigation, Methodology, Supervision, Writing – original draft, Writing – review & editing
Affiliation Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
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Ruth Tunn,
Roles Conceptualization, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing
Affiliation Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
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Rakesh Aggarwal,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
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Michael Berkwits,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
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Jesse A. Berlin,
Roles Writing – review & editing
Affiliations 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
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Nita Bhandari,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Centre for Health Research and Development, Society for Applied Studies, New Delhi, India
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Nancy J. Butcher,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliations Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
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Marion K. Campbell,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom
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Runcie C. W. Chidebe,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliations Project PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria, Department of Sociology and Gerontology, Miami University, Oxford, Ohio, United States of America
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Diana Elbourne,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
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Andrew Farmer,
Roles Writing – review & editing
Affiliation Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom
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Dean A. Fergusson,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
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Robert M. Golub,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America
⨯ - Steven N. Goodman,
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Tammy C. Hoffmann,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, Queensland, Australia
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John P. A. Ioannidis,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation 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
⨯ - Brennan C. Kahan,
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Rachel L. Knowles,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation University College London, UCL Great Ormond Street Institute of Child Health, London, United Kingdom
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Sarah E. Lamb,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom
⨯ - Steff Lewis,
- Elizabeth Loder,
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Martin Offringa,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
⨯ - Philippe Ravaud,
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Dawn P. Richards,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Clinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada
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Frank W. Rockhold,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, United States of America
⨯ - David L. Schriger,
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Nandi L. Siegried,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation South African Medical Research Council, Cape Town, South Africa
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Sophie Staniszewska,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, United Kingdom
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Rod S. Taylor,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom
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Lehana Thabane,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliations Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada, St Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada
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David Torgerson,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom
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Sunita Vohra,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada
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Ian R. White,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliation MRC Clinical Trials Unit at University College London, London, United Kingdom
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Isabelle Boutron
Roles Conceptualization, Investigation, Methodology, Supervision, Writing – original draft, Writing – review & editing
Affiliations 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
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https://orcid.org/0000-0002-6881-6984
CONSORT 2025 statement: Updated guideline for reporting randomised trials
- Sally Hopewell,
- An-Wen Chan,
- Gary S. Collins,
- Asbjørn Hróbjartsson,
- David Moher,
- Kenneth F. Schulz,
- Ruth Tunn,
- Rakesh Aggarwal,
- Michael Berkwits,
- Jesse A. Berlin
- Published: April 14, 2025
- https://doi.org/10.1371/journal.pmed.1004587