CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

doi:10.1136/bmj-2024-081124

. 2025 Apr 14:389:e081124.

doi: 10.1136/bmj-2024-081124.

CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

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

5}, David Moher⁶, Kenneth F Schulz⁷, Ruth Tunn¹, Rakesh Aggarwal⁸, Michael Berkwits⁹, Jesse A Berlin^{10

11}, Nita Bhandari¹², Nancy J Butcher^{13

14}, Marion K Campbell¹⁵, Runcie C W Chidebe^{16

17}, Diana Elbourne¹⁸, Andrew Farmer¹⁹, Dean A Fergusson²⁰, Robert M Golub²¹, Steven N Goodman²², Tammy C Hoffmann²³, John P A Ioannidis²⁴, Brennan C Kahan²⁵, Rachel L Knowles²⁶, Sarah E Lamb²⁷, Steff Lewis²⁸, Elizabeth Loder^{29

30}, Martin Offringa¹³, Philippe Ravaud³¹, Dawn P Richards³², Frank W Rockhold³³, David L Schriger³⁴, Nandi L Siegfried³⁵, Sophie Staniszewska³⁶, Rod S Taylor³⁷, Lehana Thabane^{38

39}, David Torgerson⁴⁰, Sunita Vohra⁴¹, Ian R White²⁵, Isabelle Boutron^{42

43}

Affiliations

¹ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford OX3 7LD, UK.
² Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, 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, ON, Canada.
⁷ Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
⁹ Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
¹⁰ Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.
¹¹ JAMA Network Open, Chicago, IL, USA.
¹² Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.
¹³ Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.
¹⁴ Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
¹⁵ Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
¹⁶ Project PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.
¹⁷ Department of Sociology and Gerontology, Miami University, OH, USA.
¹⁸ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
¹⁹ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
²⁰ Ottawa Hospital Research Institute, Ottawa, ON, Canada.
²¹ Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
²² Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.
²³ Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, QLD, Australia.
²⁴ 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.
²⁵ MRC Clinical Trials Unit at University College London, London, UK.
²⁶ University College London, UCL Great Ormond Street Institute of Child Health, London, UK.
²⁷ NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
²⁸ Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.
²⁹ The BMJ, BMA House, London, UK.
³⁰ Harvard Medical School, Boston, MA, USA.
³¹ Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.
³² Clinical Trials Ontario, MaRS Centre, Toronto, ON, Canada.
³³ Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
³⁴ Department of Emergency Medicine, University of California, Los Angeles, CA, USA.
³⁵ South African Medical Research Council, Cape Town, South Africa.
³⁶ Warwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, UK.
³⁷ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
³⁸ Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.
³⁹ St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
⁴⁰ York Trials Unit, Department of Health Sciences, University of York, York, UK.
⁴¹ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
⁴² Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.
⁴³ Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France.

PMID: 40228832
PMCID: PMC11995452
DOI: 10.1136/bmj-2024-081124

CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

Sally Hopewell et al. BMJ. 2025.

. 2025 Apr 14:389:e081124.

doi: 10.1136/bmj-2024-081124.

Authors

Affiliations

¹ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford OX3 7LD, UK.
² Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, 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, ON, Canada.
⁷ Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
⁹ Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
¹⁰ Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.
¹¹ JAMA Network Open, Chicago, IL, USA.
¹² Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.
¹³ Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.
¹⁴ Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
¹⁵ Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
¹⁶ Project PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.
¹⁷ Department of Sociology and Gerontology, Miami University, OH, USA.
¹⁸ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
¹⁹ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
²⁰ Ottawa Hospital Research Institute, Ottawa, ON, Canada.
²¹ Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
²² Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.
²³ Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, QLD, Australia.
²⁴ 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.
²⁵ MRC Clinical Trials Unit at University College London, London, UK.
²⁶ University College London, UCL Great Ormond Street Institute of Child Health, London, UK.
²⁷ NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
²⁸ Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.
²⁹ The BMJ, BMA House, London, UK.
³⁰ Harvard Medical School, Boston, MA, USA.
³¹ Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.
³² Clinical Trials Ontario, MaRS Centre, Toronto, ON, Canada.
³³ Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
³⁴ Department of Emergency Medicine, University of California, Los Angeles, CA, USA.
³⁵ South African Medical Research Council, Cape Town, South Africa.
³⁶ Warwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, UK.
³⁷ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
³⁸ Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.
³⁹ St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
⁴⁰ York Trials Unit, Department of Health Sciences, University of York, York, UK.
⁴¹ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
⁴² Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.
⁴³ Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France.

PMID: 40228832
PMCID: PMC11995452
DOI: 10.1136/bmj-2024-081124

Abstract

Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims 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 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.

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Conflict of interest statement

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. 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.

Figures

**Fig 1**
CONSORT 2025 flow diagram. Flow diagram of participant progress through the phases of a two group, parallel randomised trial (ie, enrolment, intervention allocation, follow-up, and data analysis). CONSORT=Consolidated Standards of Reporting Trials

**Fig 2**
Flow diagram of a multicentre trial of total (TKR) versus partial (PKR) knee replacement

**Fig 3**
Flow diagram of a multicentre trial of glucocorticoid intradiscal injection in patients with chronic low back pain. ESR=erythrocyte sedimentation rate; GC IDI=glucocorticoid intradiscal injection; MRI=magnetic resonance imaging

See this image and copyright information in PMC

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[1] Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996;313:570-1. 10.1136/bmj.313.7057.570 - DOI - PMC - PubMed

[2] Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996;313:570-1. 10.1136/bmj.313.7057.570 - DOI - PMC - PubMed

[3] Glasziou P, Altman DG, Bossuyt P, et al. . Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014;383:267-76. 10.1016/S0140-6736(13)62228-X - DOI - PubMed

[4] Glasziou P, Altman DG, Bossuyt P, et al. . Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014;383:267-76. 10.1016/S0140-6736(13)62228-X - DOI - PubMed

[5] Turner L, Shamseer L, Altman DG, 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:MR000030. 10.1002/14651858.MR000030.pub2 - DOI - PMC - PubMed

[6] Turner L, Shamseer L, Altman DG, 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:MR000030. 10.1002/14651858.MR000030.pub2 - DOI - PMC - PubMed

[7] Savović J, Jones HE, Altman DG, et al. . Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med 2012;157:429-38. 10.7326/0003-4819-157-6-201209180-00537 - DOI - PubMed

[8] Savović J, Jones HE, Altman DG, et al. . Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med 2012;157:429-38. 10.7326/0003-4819-157-6-201209180-00537 - DOI - PubMed

[9] Goldacre B, Drysdale H, Powell-Smith A, et al. The COMPare Trials Project. https://www.compare-trials.org/ 2016.

[10] Goldacre B, Drysdale H, Powell-Smith A, et al. The COMPare Trials Project. https://www.compare-trials.org/ 2016.

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CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

Affiliations

CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

Authors

Affiliations

Abstract

Conflict of interest statement

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