Evidence map›Paper›PMID 40294953›Full record

ArticleBMJ (Clinical research ed.)2025

SPIRIT 2025 statement: updated guideline for protocols of randomised trials.

An-Wen Chan, Isabelle Boutron, Sally Hopewell, David Moher, Kenneth F Schulz, Gary S Collins, Ruth Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A Berlin and 29 more

3 registry-linked trialsAbstract readConsensus StatementScoping Review
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 3 registered trials, which are not on this map. Cited by 363 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
363citing papers in PubMed, 2 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.

NCT07145060 nanot yet recruitingnot on this map

A Randomized Controlled Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome

TypeinterventionalSponsorChina-Japan Friendship HospitalRan2025 to 2028Enrolled105ConditionsPrimary Sjögren's Syndrome (pSS)ArmsYiqi Yangyin Formula, Yiqi Yangyin Formula placebo
NCT07512401 completednot on this map

Safety of Reduced Methotrexate Lab Monitoring: a Population-based, Target Trial Emulation Study

TypeobservationalSponsorMayo ClinicRan2012 to 2025Enrolled2,414ConditionsRheumatic DiseasesArmsStandard methotrexate lab monitoring, Reduced methotrexate lab monitoring
NCT07661836 naactive not recruitingnot on this mapstarted 2026, after this paper: background citation

Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in Adults With Scleroderma

TypeinterventionalSponsorUniversidad de ZaragozaRan2026 to 2026Enrolled24ConditionsScleroderma, Scleroderma (Limited and Diffuse), Systemic Sclerosis (SSc)ArmsPersonalized Online Occupational Therapy Intervention, Usual Care
3 · Its place in the literature

Who cites it

363 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors.

An-Wen ChanDepartment of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, M5S 1B2, Canada anwen.chan@utoronto.ca.ORCID 0000-0002-4498-3382
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
Sally HopewellOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.ORCID 0000-0002-6881-6984
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
Gary S CollinsUK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.ORCID 0000-0002-2772-2316
Ruth TunnOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, 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 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, 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 R ElbourneDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0003-3044-4545
Andrew J 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 J 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
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

Funding

MRC-NIHR National Institutes of Health Research MR/W020483/1
6 · The paper itself

Abstract

importanceThe protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users.

objectiveTo systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial.

designWe completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting.

findingsOverall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

Indexed as

Clinical Trial Protocols as TopicRandomized Controlled Trials as TopicResearch DesignChecklistDelphi TechniqueHumans

Identifiers

PMID40294953
PMCPMC12035670

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.