{
    "abstract": "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.\nWe 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 (eg, 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.\nWe 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.\nAuthors, 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.",
    "authors": [
        {
            "affiliation": "Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford OX3 7LD, UK.",
            "firstname": "Sally",
            "initials": "S",
            "lastname": "Hopewell"
        },
        {
            "affiliation": "Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.",
            "firstname": "An-Wen",
            "initials": "AW",
            "lastname": "Chan"
        },
        {
            "affiliation": "UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.",
            "firstname": "Gary S",
            "initials": "GS",
            "lastname": "Collins"
        },
        {
            "affiliation": "Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.\nOpen Patient data Explorative Network, Odense University Hospital, Odense, Denmark.",
            "firstname": "Asbj\u00f8rn",
            "initials": "A",
            "lastname": "Hr\u00f3bjartsson"
        },
        {
            "affiliation": "Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.",
            "firstname": "David",
            "initials": "D",
            "lastname": "Moher"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.",
            "firstname": "Kenneth F",
            "initials": "KF",
            "lastname": "Schulz"
        },
        {
            "affiliation": "Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford OX3 7LD, UK.",
            "firstname": "Ruth",
            "initials": "R",
            "lastname": "Tunn"
        },
        {
            "affiliation": "Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.",
            "firstname": "Rakesh",
            "initials": "R",
            "lastname": "Aggarwal"
        },
        {
            "affiliation": "Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.",
            "firstname": "Michael",
            "initials": "M",
            "lastname": "Berkwits"
        },
        {
            "affiliation": "Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.\nJAMA Network Open, Chicago, IL, USA.",
            "firstname": "Jesse A",
            "initials": "JA",
            "lastname": "Berlin"
        },
        {
            "affiliation": "Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.",
            "firstname": "Nita",
            "initials": "N",
            "lastname": "Bhandari"
        },
        {
            "affiliation": "Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.\nDepartment of Psychiatry, University of Toronto, Toronto, ON, Canada.",
            "firstname": "Nancy J",
            "initials": "NJ",
            "lastname": "Butcher"
        },
        {
            "affiliation": "Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.",
            "firstname": "Marion K",
            "initials": "MK",
            "lastname": "Campbell"
        },
        {
            "affiliation": "Project PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.\nDepartment of Sociology and Gerontology, Miami University, OH, USA.",
            "firstname": "Runcie C W",
            "initials": "RCW",
            "lastname": "Chidebe"
        },
        {
            "affiliation": "Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.",
            "firstname": "Diana",
            "initials": "D",
            "lastname": "Elbourne"
        },
        {
            "affiliation": "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.",
            "firstname": "Andrew",
            "initials": "A",
            "lastname": "Farmer"
        },
        {
            "affiliation": "Ottawa Hospital Research Institute, Ottawa, ON, Canada.",
            "firstname": "Dean A",
            "initials": "DA",
            "lastname": "Fergusson"
        },
        {
            "affiliation": "Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.",
            "firstname": "Robert M",
            "initials": "RM",
            "lastname": "Golub"
        },
        {
            "affiliation": "Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.",
            "firstname": "Steven N",
            "initials": "SN",
            "lastname": "Goodman"
        },
        {
            "affiliation": "Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, QLD, Australia.",
            "firstname": "Tammy C",
            "initials": "TC",
            "lastname": "Hoffmann"
        },
        {
            "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, CA, USA.",
            "firstname": "John P A",
            "initials": "JPA",
            "lastname": "Ioannidis"
        },
        {
            "affiliation": "MRC Clinical Trials Unit at University College London, London, UK.",
            "firstname": "Brennan C",
            "initials": "BC",
            "lastname": "Kahan"
        },
        {
            "affiliation": "University College London, UCL Great Ormond Street Institute of Child Health, London, UK.",
            "firstname": "Rachel L",
            "initials": "RL",
            "lastname": "Knowles"
        },
        {
            "affiliation": "NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.",
            "firstname": "Sarah E",
            "initials": "SE",
            "lastname": "Lamb"
        },
        {
            "affiliation": "Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.",
            "firstname": "Steff",
            "initials": "S",
            "lastname": "Lewis"
        },
        {
            "affiliation": "The BMJ, BMA House, London, UK.\nHarvard Medical School, Boston, MA, USA.",
            "firstname": "Elizabeth",
            "initials": "E",
            "lastname": "Loder"
        },
        {
            "affiliation": "Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.",
            "firstname": "Martin",
            "initials": "M",
            "lastname": "Offringa"
        },
        {
            "affiliation": "Universit\u00e9 Paris Cit\u00e9, Inserm, INRAE, Centre de Recherche Epid\u00e9miologie et Statistiques, Universit\u00e9 Paris Cit\u00e9, Paris, France.",
            "firstname": "Philippe",
            "initials": "P",
            "lastname": "Ravaud"
        },
        {
            "affiliation": "Clinical Trials Ontario, MaRS Centre, Toronto, ON, Canada.",
            "firstname": "Dawn P",
            "initials": "DP",
            "lastname": "Richards"
        },
        {
            "affiliation": "Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.",
            "firstname": "Frank W",
            "initials": "FW",
            "lastname": "Rockhold"
        },
        {
            "affiliation": "Department of Emergency Medicine, University of California, Los Angeles, CA, USA.",
            "firstname": "David L",
            "initials": "DL",
            "lastname": "Schriger"
        },
        {
            "affiliation": "South African Medical Research Council, Cape Town, South Africa.",
            "firstname": "Nandi L",
            "initials": "NL",
            "lastname": "Siegfried"
        },
        {
            "affiliation": "Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.",
            "firstname": "Sophie",
            "initials": "S",
            "lastname": "Staniszewska"
        },
        {
            "affiliation": "MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.",
            "firstname": "Rod S",
            "initials": "RS",
            "lastname": "Taylor"
        },
        {
            "affiliation": "Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.\nSt Joseph's Healthcare Hamilton, Hamilton, ON, Canada.",
            "firstname": "Lehana",
            "initials": "L",
            "lastname": "Thabane"
        },
        {
            "affiliation": "York Trials Unit, Department of Health Sciences, University of York, York, UK.",
            "firstname": "David",
            "initials": "D",
            "lastname": "Torgerson"
        },
        {
            "affiliation": "Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.",
            "firstname": "Sunita",
            "initials": "S",
            "lastname": "Vohra"
        },
        {
            "affiliation": "MRC Clinical Trials Unit at University College London, London, UK.",
            "firstname": "Ian R",
            "initials": "IR",
            "lastname": "White"
        },
        {
            "affiliation": "Universit\u00e9 Paris Cit\u00e9 and Universit\u00e9 Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.\nCentre d'Epid\u00e9miologie Clinique, H\u00f4pital H\u00f4tel Dieu, AP-HP, Paris, France.",
            "firstname": "Isabelle",
            "initials": "I",
            "lastname": "Boutron"
        }
    ],
    "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.",
    "copyrights": "\u00a9 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.",
    "doi": "10.1136/bmj-2024-081123\n10.1136/bmj.313.7057.570\n10.1186/2046-4053-1-60\n10.1016/S0140-6736(13)62228-X\n10.7326/0003-4819-157-6-201209180-00537\n10.1001/jama.1996.03540080059030\n10.1001/jama.285.15.1987\n10.7326/0003-4819-134-8-200104170-00012\n10.7326/0003-4819-152-11-201006010-00232\n10.1136/bmj.c869\n10.7326/0003-4819-158-3-201302050-00583\n10.1136/bmj.e7586\n10.5694/j.1326-5377.2006.tb00557.x\n10.1136/bmj.j2490\n10.1001/jama.285.15.1992\n10.7326/0003-4819-151-4-200908180-02002\n10.1038/s41591-022-01989-8\n10.1136/bmj-2024-081477\n10.1371/journal.pmed.1000217\n10.17605/OSF.IO/6HJYG\n10.1016/j.jclinepi.2024.111309\n10.1016/j.jclinepi.2023.01.003\n10.1002/cesm.12057\n10.1016/j.jclinepi.2023.04.005\n10.1001/jama.2022.21022\n10.1016/j.jclinepi.2019.05.030\n10.7326/M17-0046\n10.1136/bmj.g1687\n10.1136/bmj-2024-081124\n10.1186/s12916-015-0460-y\n10.1186/s12916-019-1436-0\n10.1186/s13643-021-01626-4\n10.1186/s13063-020-04334-x\n10.1136/bmj.e5661\n10.1136/bmj.l4378\n10.1136/bmj-2023-076387\n10.1001/jama.2023.19793\n10.1001/jama.2012.87802\n10.1136/bmj.a2390\n10.1001/jama.2019.3087\n10.1136/bmj.h1738\n10.1136/bmj.i5239\n10.1136/bmj.j2835\n10.1001/jama.2013.879\n10.1136/bmj-2023-078524\n10.1186/s13063-018-2733-1\n10.1371/journal.pmed.0050020\n10.1136/bmj.j5085\n10.1371/journal.pone.0035621\n10.1126/scitranslmed.aaf5027",
    "journal": "BMJ (Clinical research ed.)",
    "keywords": [],
    "methods": null,
    "publication_date": "2025-04-15",
    "pubmed_id": "40228833\n8806240\n23194585\n24411647\n22945832\n8773637\n11308435\n11304107\n20335313\n20332511\n23295957\n23303884\n16948622\n28596181\n11308436\n19687477\n36109642\n20169112\n38428538\n36669708\n37100738\n36511921\n31153976\n28630973\n24609605\n26370288\n31744489\n33781348\n32546273\n22951546\n31366597\n37863501\n38051324\n23268518\n19001484\n31012939\n25976398\n27777223\n28667088\n23443445\n38981645\n30060754\n18215107\n29170161\n22558178\n27252173",
    "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.",
    "title": "CONSORT 2025 statement: updated guideline for reporting randomised trials.",
    "xml": "<Element 'PubmedArticle' at 0x788505972610>"
}