Evidence map›Paper›PMID 40229553›Full record

ReviewNature medicine2025

CONSORT 2025 statement: updated guideline for reporting randomized 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 and 29 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 148 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

148 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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88 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors.

Sally HopewellOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK. sally.hopewell@csm.ox.ac.uk.ORCID http://orcid.org/0000-0002-6881-6984
An-Wen ChanDepartment of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
Gary S CollinsUK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-2772-2316
Asbjørn HróbjartssonCentre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
David MoherCentre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID http://orcid.org/0000-0003-2434-4206
Kenneth F SchulzDepartment of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Ruth TunnOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
Rakesh AggarwalJawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.ORCID http://orcid.org/0000-0001-9689-494X
Michael BerkwitsOffice of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Jesse A BerlinDepartment of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.
Nita BhandariCentre for Health Research and Development, Society for Applied Studies, New Delhi, India.
Nancy J ButcherChild Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Marion K CampbellAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
Runcie C W ChidebeProject PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.
Diana ElbourneDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Andrew FarmerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-6170-4402
Dean A FergussonOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Robert M GolubDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Steven N GoodmanDepartment of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.
Tammy C HoffmannInstitute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland, Australia.ORCID http://orcid.org/0000-0001-5210-8548
John P A IoannidisDepartments 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.ORCID http://orcid.org/0000-0003-3118-6859
Brennan C KahanMRC Clinical Trials Unit at University College London, London, UK.
Rachel L KnowlesUniversity College London, UCL Great Ormond Street Institute of Child Health, London, UK.ORCID http://orcid.org/0000-0002-5490-7682
Sarah E LambNIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
Steff LewisEdinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.
Elizabeth LoderThe BMJ, BMA House, London, UK.
Martin OffringaChild Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-4402-5299
Philippe RavaudUniversité Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.
Dawn P RichardsClinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada.
Frank W RockholdDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.ORCID http://orcid.org/0000-0003-3732-4765
David L SchrigerDepartment of Emergency Medicine, University of California, Los Angeles, CA, USA.
Nandi L SiegfriedSouth African Medical Research Council, Cape Town, South Africa.
Sophie StaniszewskaWarwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.
Rod S TaylorMRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0002-3043-6011
Lehana ThabaneDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
David TorgersonYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Sunita VohraFaculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Ian R WhiteMRC Clinical Trials Unit at University College London, London, UK.
Isabelle BoutronUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.ORCID http://orcid.org/0000-0002-5263-6241

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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.

Indexed as

Guidelines as TopicRandomized Controlled Trials as TopicResearch DesignResearch ReportChecklistDelphi TechniqueHumansPublishing

Identifiers

PMID40229553

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.