Evidence map›Paper›PMID 40228477›Full record

ArticlePLoS medicine2025

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 and 29 more

3 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in PLoS medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 55 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 1 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.

NCT07149506 phase3enrolling by invitationnot on this map

Efficacy of Oral or Topical Catechins vs. Placebo as an Adjuvant for the Prevention and Management of Radiation Dermatitis in Oncology Patients: a Randomized Trial

TypeinterventionalSponsorCARLOS FRANCISCO SAAVEDRA GARCIARan2025 to 2027Enrolled162ConditionsRadiation Dermatitis Acute, Radiation Dermatitis, Fibrosis, SkinArmsEpicatechin, Epigallocatechin Gallate (EGCG), Microcrystalline Cellulose NF (placebo), Saline (0.9% NaCl)
NCT07149987 nacompletednot on this map

Assessing the Role of 3D-Printed Surgical Guides in Enhancing Dental Implant Placement Precision and Patient Outcomes

TypeinterventionalSponsorUniversity of MosulRan2025 to 2025Enrolled30ConditionsDental Implant, Dental Implant Failure, Peri Implantitis, Cone Beam Computed TomographyArmsAll implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area
NCT07503418 nacompletednot on this map

Enhancing Nursing Students' Empathy and Learning in Parkinson's Disease Through High-Fidelity Simulation and Blended Learning: A Randomised Controlled Trial

TypeinterventionalSponsorUniversity of CadizRan2025 to 2025Enrolled84ConditionsParkinson Disease (PD)ArmsBlended-learning capsules, High-Fidelity Physical Simulation, Simulated Home Environment
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

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, United Kingdom.ORCID https://orcid.org/0000-0002-6881-6984
An-Wen ChanDepartment of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-4498-3382
Gary S CollinsUnited Kingdom EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-2772-2316
Asbjørn HróbjartssonDepartment of Clinical Research, Centre for Evidence-Based Medicine Odense and Cochrane Denmark, University of Southern Denmark, Odense, Denmark.ORCID https://orcid.org/0000-0002-2451-5012
David MoherCentre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID https://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, North Carolina, United States of America.ORCID https://orcid.org/0000-0003-2596-7616
Ruth TunnOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0003-1187-1808
Rakesh AggarwalJawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.ORCID https://orcid.org/0000-0001-9689-494X
Michael BerkwitsOffice of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.ORCID https://orcid.org/0009-0005-1316-5861
Jesse A BerlinDepartment of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, New Jersey, United States of America.ORCID https://orcid.org/0000-0002-9810-745X
Nita BhandariCentre for Health Research and Development, Society for Applied Studies, New Delhi, India.ORCID https://orcid.org/0000-0003-0349-087X
Nancy J ButcherChild Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-5152-0108
Marion K CampbellAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom.ORCID https://orcid.org/0000-0001-5386-4097
Runcie C W ChidebeProject PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.ORCID https://orcid.org/0000-0002-6025-776X
Diana ElbourneDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.ORCID https://orcid.org/0000-0003-3044-4545
Andrew FarmerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-6170-4402
Dean A FergussonOttawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID https://orcid.org/0000-0002-3389-2485
Robert M GolubDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America.ORCID https://orcid.org/0009-0000-3270-0632
Steven N GoodmanDepartment of Epidemiology and Population Health, Stanford University, Palo Alto, California, United States of America.
Tammy C HoffmannInstitute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, Queensland, Australia.ORCID https://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, California, United States of America.ORCID https://orcid.org/0000-0003-3118-6859
Brennan C KahanMRC Clinical Trials Unit at University College London, London, United Kingdom.
Rachel L KnowlesUniversity College London, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.ORCID https://orcid.org/0000-0002-5490-7682
Sarah E LambNIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom.ORCID https://orcid.org/0000-0003-4349-7195
Steff LewisEdinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, United Kingdom.
Elizabeth LoderThe BMJ, BMA House, London, United Kingdom.
Martin OffringaChild Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.ORCID https://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.ORCID https://orcid.org/0000-0003-1151-0826
Frank W RockholdDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, United States of America.ORCID https://orcid.org/0000-0003-3732-4765
David L SchrigerDepartment of Emergency Medicine, University of California, Los Angeles, California, United States of America.
Nandi L SiegriedSouth African Medical Research Council, Cape Town, South Africa.ORCID https://orcid.org/0000-0002-4081-1698
Sophie StaniszewskaWarwick Applied Health, Warwick Medical School, University of Warwick, Coventry, United Kingdom.ORCID https://orcid.org/0000-0002-7723-9074
Rod S TaylorMRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.ORCID https://orcid.org/0000-0002-3043-6011
Lehana ThabaneDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0003-0355-9734
David TorgersonYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.ORCID https://orcid.org/0000-0002-1667-4275
Sunita VohraFaculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.ORCID https://orcid.org/0000-0002-6210-7933
Ian R WhiteMRC Clinical Trials Unit at University College London, London, United Kingdom.ORCID https://orcid.org/0000-0002-6718-7661
Isabelle BoutronUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.ORCID https://orcid.org/0000-0002-5263-6241

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWell 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.

methodsWe 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 (e.g., 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.

resultsWe 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.

conclusionsAuthors, 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.

Indexed as

Guidelines as TopicPublishingRandomized Controlled Trials as TopicResearch DesignResearch ReportChecklistDelphi TechniqueHumans

Identifiers

PMID40228477
PMCPMC11996237

What OpenQuestion holds

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Registered trials

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.