Evidence map›Paper›PMID 40228833›Full record

ArticleBMJ (Clinical research ed.)2025

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

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

Article in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 13 registered trials, which are not on this map. Cited by 907 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
907citing 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.

NCT07125456 nanot yet recruitingnot on this map

The Effect of Simulation-Based Learning Experiences on Nursing Students' Knowledge, Skills and Self-Efficacy Levels in Teaching Postmortem Care

TypeinterventionalSponsorIstanbul University - CerrahpasaRan2025 to 2027Enrolled68ConditionsPostmortem CareArmsPostmortem Care Teaching Simulation
NCT07137611 nacompletednot on this map

Effect of Exercise Intensity on Neurochemical and Cognitive Function: The Role of Lactate and BDNF

TypeinterventionalSponsorAksaray University Training and Research HospitalRan2025 to 2025Enrolled12ConditionsExercise Training, BDNF, Cognitive Functions, Lactate Blood IncreaseArmsLow Exercise, Moderate-Intensity Exercise, HIIT Exercise
NCT07367412 narecruitingnot on this mapstarted 2026, after this paper: background citation

Effect of Zinc Supplementation on Occurrence of Infections in Older Medical Patients (ZOOM) - a Cluster Randomized Controlled Trial (ZOOM OUT).

TypeinterventionalSponsorHerlev HospitalRan2026 to 2028Enrolled8,000ConditionsOlder Adults (65 Years and Older), Medical Patients in the Emergency DepartmentArmsZinc (zinc sulphate)
NCT07375823 nacompletednot on this map

Effects of Electrical Muscle Stimulation Applied Concurrently With Active Movement and Exercise Therapy in Cervical Radiculopathy: A Randomized Trial

TypeinterventionalSponsorEuropean University of LefkeRan2025 to 2026Enrolled50ConditionsCervical Radiculopathy, Cervical Radicular Pain, Neck Pain, NumbnessArmsExercise Therapy, Superimposition of electrical muscle stimulation on active movement
NCT07434921 naenrolling by invitationnot on this mapstarted 2026, after this paper: background citation

Testing an mtm theory-based intervention on reducing drowsy driving behavior, "stay awake, stay alive, ©" among college students: an educational randomized controlled trial

TypeinterventionalSponsorUniversity of Nevada, Las VegasRan2026 to 2026Enrolled72ConditionsDrowsiness, Sleep Deprivation, FatigueArmsMTM Theory based intervention, Standard AAA Knowledge based
NCT07495371 completednot on this map

Effects Of Passive Static Stretching On Hip Range Of Motion In Patients With Joint Pathologies And Healthy Individuals: A Pilot Study

TypeobservationalSponsorOmicron beta researchRan2025 to 2025Enrolled12ConditionsHip Joint Disorders, Recovery After Total Hip Arthroplasty, Healthy Individuals
NCT07517549 narecruitingnot on this mapstarted 2026, after this paper: background citation

The Effect Of Sexual Counseling Based On the Extended Plissit Model On Sexual Function, Marital Adjustment, Sexual Quality Of Life, Depression, Anxiety, And Stress During Pregnancy And Postpartum

TypeinterventionalSponsorOrdu UniversityRan2026 to 2026Enrolled70ConditionsSexuality, Depression, Pregnancy RelatedArmssexuality health education group
NCT07518199 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

The Effect of an Artificial Intelligence-Supported Virtual Reality Simulation on Nursing Students' Holistic Care Skills

TypeinterventionalSponsorGazi UniversityRan2026 to 2026Enrolled80ConditionsNursing Students, Decision-Making, Diagnostic ReasoningArmsAI-VRS, Control
NCT07624682 naenrolling by invitationnot on this mapstarted 2026, after this paper: background citation

AI Clinical Reasoning Training Agent on Medical Students' Clinical Reasoning Skills and Case-based Learning Experience: A Cluster Randomized Controlled Trial

TypeinterventionalSponsorPeking Union Medical College HospitalRan2026 to 2026Enrolled88ConditionsMedical Education, Clinical Reasoning, AI AgentArmsAI agent, Study materials
NCT07666399 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Evaluating Artificial Intelligence for Language Translation of Health-related Knowledge Mobilization Resources: A Randomized Controlled Trial and Qualitative Study

TypeinterventionalSponsorUniversity of AlbertaRan2026 to 2027Enrolled576ConditionsCommunication ResearchArmsKM Resource - English, KM Resource - Professionally Translated, KM Resouce - AI
NCT07688031 phase4completednot on this map

Efficacy and Safety of Topical Lidocaine 23%/Tetracaine 7% Ointment Versus Placebo for Post-Hemorrhoidectomy Pain: A Double-Blind Randomized Controlled Trial

TypeinterventionalSponsorPontificia Universidad Catolica de ChileRan2023 to 2026Enrolled74ConditionsPain Management, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree, Hemorrhoids Second DegreeArmsLidocaine 23% / Tetracaine 7% topical ointment (compounded), Placebo ointment
NCT07695220 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy and Safety of an Early Intensive Blood Pressure-Lowering Strategy Using Remifentanil and Dexmedetomidine in Patients With Spontaneous Intracerebral Hemorrhage: A Multicenter, Prospective, Superiority, Randomized Controlled Trial

TypeinterventionalSponsorThe Third Affiliated Hospital of Southern Medical UniversityRan2026 to 2028Enrolled1,116ConditionsIntracerebral HemorrhageArmsRemifentanil and Dexmedetomidine, Guideline standard care
NCT07755839 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

CanCOG® - Cognitive Rehabilitation in Cancer: A Protocol for a Multicenter Pilot Randomized Controlled Trial With Non-central Nervous System Cancer Survivors

TypeinterventionalSponsorAveiro UniversityRan2026 to 2028Enrolled60ConditionsCancer-related Cognitive Impairment, Cancer-related Cognitive Dysfunction, Cancer-related Cognitive Difficulties, Depression and Anxiety SymptomsArmsCanCOG® - Cogntive Rehabilitation in Cancer
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Renal failure · 2026
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  15. Effects of Using High-Frequency TENS During an Exercise Therapy Program in Knee Osteoarthritis: A Randomized Sham-Controlled Trial.Physiotherapy research international : the journal for researchers and clinicians in physical therapy · 2026
    Trial
  16. Comfort and Usability of Digital Versus Conventional Custom-Fit Mouthguards: A Randomized Clinical Trial.Dental traumatology : official publication of International Association for Dental Traumatology · 2026
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  17. Effects of Photobiomodulation Therapy in Lateral Luxation of Anterior Permanent Teeth: A Randomized, Double-Blind Clinical Trial.Dental traumatology : official publication of International Association for Dental Traumatology · 2026
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  19. Effect of Global Postural Re-Education in Individuals With Text Neck Syndrome: A Randomized Controlled Trial.Physiotherapy research international : the journal for researchers and clinicians in physical therapy · 2026
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  20. Trial

847 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 OX3 7LD, UK.ORCID 0000-0002-6881-6984
An-Wen ChanDepartment of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.ORCID 0000-0002-4498-3382
Gary S CollinsUK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.ORCID 0000-0002-2772-2316
Asbjørn HróbjartssonCentre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-2451-5012
David MoherCentre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID 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.ORCID 0000-0003-2596-7616
Ruth TunnOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford OX3 7LD, UK.ORCID 0000-0003-1187-1808
Rakesh AggarwalJawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.ORCID 0000-0001-9689-494X
Michael BerkwitsOffice of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID 0000-0001-5962-2857
Jesse A BerlinDepartment of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.ORCID 0000-0002-9810-745X
Nita BhandariCentre for Health Research and Development, Society for Applied Studies, New Delhi, India.ORCID 0000-0003-0349-087X
Nancy J ButcherChild Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.ORCID 0000-0002-5152-0108
Marion K CampbellAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.ORCID 0000-0001-5386-4097
Runcie C W ChidebeProject PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.ORCID 0000-0002-6025-776X
Diana ElbourneDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0003-3044-4545
Andrew FarmerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-6170-4402
Dean A FergussonOttawa Hospital Research Institute, Ottawa, ON, Canada.ORCID 0000-0002-3389-2485
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.ORCID 0000-0002-3872-5723
Tammy C HoffmannInstitute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, QLD, Australia.ORCID 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 0000-0003-3118-6859
Brennan C KahanMRC Clinical Trials Unit at University College London, London, UK.ORCID 0000-0001-9957-0844
Rachel L KnowlesUniversity College London, UCL Great Ormond Street Institute of Child Health, London, UK.ORCID 0000-0002-5490-7682
Sarah E LambNIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.ORCID 0000-0003-4349-7195
Steff LewisEdinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.ORCID 0000-0003-1210-2314
Elizabeth LoderThe BMJ, BMA House, London, UK.ORCID 0000-0003-1501-2947
Martin OffringaChild Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.ORCID 0000-0002-4402-5299
Philippe RavaudUniversité Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.ORCID 0000-0001-8264-9206
Dawn P RichardsClinical Trials Ontario, MaRS Centre, Toronto, ON, Canada.ORCID 0000-0003-1151-0826
Frank W RockholdDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.ORCID 0000-0003-3732-4765
David L SchrigerDepartment of Emergency Medicine, University of California, Los Angeles, CA, USA.ORCID 0000-0003-0242-1127
Nandi L SiegfriedSouth African Medical Research Council, Cape Town, South Africa.ORCID 0000-0002-4081-1698
Sophie StaniszewskaWarwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.ORCID 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, UK.ORCID 0000-0002-3043-6011
Lehana ThabaneDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.ORCID 0000-0003-0355-9734
David TorgersonYork Trials Unit, Department of Health Sciences, University of York, York, UK.ORCID 0000-0002-1667-4275
Sunita VohraFaculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.ORCID 0000-0002-6210-7933
Ian R WhiteMRC Clinical Trials Unit at University College London, London, UK.ORCID 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 0000-0002-5263-6241

Funding

MRC-NIHR National Institutes of Health Research MR/W020483/1
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 (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.

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.

conclusionAuthors, 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

PMID40228833
PMCPMC11995449

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

and 7 more above

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.