SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.
| Title: | SPIRIT 2025 statement: Updated guideline for protocols of randomised trials. |
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| Authors: | Chan AW; Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.; Boutron I; Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.; Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France.; Hopewell S; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.; Moher D; Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.; Schulz KF; Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.; Collins GS; UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.; Tunn R; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.; Aggarwal R; Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.; Berkwits M; Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.; Berlin JA; Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, New Jersey, United States of America.; JAMA Network Open, Chicago, Illinois, United States of America.; Bhandari N; Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.; Butcher NJ; Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.; Campbell MK; Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom.; Chidebe RCW; Project PINK BLUE-Health & Psychological Trust Centre, Utako, Abuja, Nigeria.; Department of Sociology and Gerontology, Miami University, Ohio, United States of America.; Elbourne DR; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.; Farmer AJ; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.; Fergusson DA; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.; Golub RM; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America.; Goodman SN; Department of Epidemiology and Population Health, Stanford University, Palo Alto, California, United States of America.; Hoffmann TC; Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, Queensland, Australia.; Ioannidis JPA; 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, California, United States of America.; Kahan BC; MRC Clinical Trials Unit at University College London, London, United Kingdom.; Knowles RL; University College London, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.; Lamb SE; NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom.; Lewis S; Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, United Kingdom.; Loder E; The BMJ, BMA House, London, United Kingdom.; Harvard Medical School, Boston, Massachusetts, United States of America.; Offringa M; Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.; Ravaud P; Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.; Richards DP; Clinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada.; Rockhold FW; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, United States of America.; Schriger DL; Department of Emergency Medicine, University of California, Los Angeles, California, United States of America.; Siegfried NL; South African Medical Research Council, Cape Town, South Africa.; Staniszewska S; Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, United Kingdom.; Taylor RS; MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.; Thabane L; Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.; St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.; Torgerson DJ; York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.; Vohra S; Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.; White IR; MRC Clinical Trials Unit at University College London, London, United Kingdom.; Hróbjartsson A; Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark. |
| Source: | PLoS medicine [PLoS Med] 2025 Apr 28; Vol. 22 (4), pp. e1004589. Date of Electronic Publication: 2025 Apr 28 (Print Publication: 2025). |
| Publication Type: | Consensus Statement; Journal Article |
| Language: | English |
| Journal Info: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 101231360 Publication Model: eCollection Cited Medium: Internet ISSN: 1549-1676 (Electronic) Linking ISSN: 15491277 NLM ISO Abbreviation: PLoS Med Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: San Francisco, CA : Public Library of Science, [2004]- |
| MeSH Terms: | Randomized Controlled Trials as Topic*/standards ; Randomized Controlled Trials as Topic*/methods ; Research Design*/standards; Humans ; Checklist ; Consensus ; Delphi Technique |
| Abstract: | Importance: The 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.; Objective: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial.; Design: We 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.; Findings: Overall, 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.; (Copyright: © 2025 Chan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.) |
| Competing Interests: | I have read the journal's policy and the authors of this manuscript have the following competing interests: support from MRC-NIHR for the submitted work; SH, IB, A-WC, AH, KFS, and DM are members of the SPIRIT-CONSORT executive group. SH, IB, A-WC, AH, KFS, GSC, DM, MKC, NJB, MO, RST, and SV are involved in the development, update, implementation, and dissemination of several reporting guidelines. GSC is the director of the UK EQUATOR Centre and a statistical editor for The BMJ, DM is the director of the Canadian EQUATOR Centre, and member of The BMJ’s regional advisory board for North America, IB is deputy director and PR is director of the French EQUATOR Centre, TCH is director of the Australasian EQUATOR Centre, JPAI is director of the US EQUATOR Centre. RA is president of the World Association of Medical Editors. MKC is chair of the MRC-NIHR: Better Methods Better Research funding panel. RCWC is executive director of Project PINK-BLUE which receives funding from Roche-Product. AF is director of the UK National Institute for Health and Care Research Health Technology Assessment Programme. DPR is a full time employee of Five02 Laboratories, which under contract to Clinical Trials Ontario provides services related to patient and public engagement; and is the volunteer vice president of the Canadian Arthritis Patient Alliance, which receives funding through independent grants from pharmaceutical companies. DLS is JAMA Associate Editor and receives editing stipends from JAMA and Annals of Emergency Medicine. IRW was supported by the MRC Programmes MCUU00004/07 and MCUU00004/09. |
| Comments: | Comment in: PLoS Med. 2025 Apr 28;22(4):e1004588. doi: 10.1371/journal.pmed.1004588.. (PMID: 40294530) |
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| Entry Date(s): | Date Created: 20250428 Date Completed: 20250429 Latest Revision: 20260224 |
| Update Code: | 20260225 |
| PubMed Central ID: | PMC12037212 |
| DOI: | 10.1371/journal.pmed.1004589 |
| PMID: | 40294521 |
| Database: | MEDLINE |
Consensus Statement; Journal Article