Journal article : Comment
Improving the completeness and transparency of protocols and reports of randomized trials: SPIRIT 2025 and CONSORT 2025
- Abstract:
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Objectives
To update SPIRIT 2013 and CONSORT 2010 reporting guidelines.
Methods
For SPIRIT 2025, a comprehensive review process incorporating scoping reviews, expert consultations, and a Delphi survey led to a revised checklist. CONSORT 2025 underwent a similar update, addressing methodological advancements and user feedback gathered through scoping reviews, expert consultations, and a Delphi survey.
Results
Key changes include the addition of two new items, revisions to five, and the deletion or merging of five, alongside a new Open Science section. Emphasis on harm assessment, intervention description, and patient/public involvement has also been strengthened. The SPIRIT 2025 statement provides a 34-item checklist, a schedule diagram, and an expanded checklist with explanations. Similarly, seven new items were added, three revised, and one deleted, with content integrated from existing CONSORT extensions. A new Open Science section was also incorporated. The CONSORT 2025 statement offers a 30-item checklist, a flow diagram, and a detailed explanatory checklist.
Conclusion
Both updated statements and explanatory articles aim to enhance transparency and completeness in trial protocols and reporting. Widespread adoption by investigators, funders, ethics committees, journals, and regulators should improve the quality and usability of research, ultimately benefiting patients and others.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
Actions
Access Document
- Files:
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-
(Preview, Accepted manuscript, pdf, 63.0KB, Terms of use)
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- Publisher copy:
- 10.1016/j.jclinepi.2025.111792
Authors
- Publisher:
- Elsevier
- Journal:
- Journal of Clinical Epidemiology More from this journal
- Volume:
- 182
- Article number:
- 111792
- Place of publication:
- United States
- Publication date:
- 2025-04-17
- Acceptance date:
- 2025-04-11
- DOI:
- EISSN:
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1878-5921
- ISSN:
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0895-4356
- Pmid:
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40252855
- Language:
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English
- Keywords:
- Subtype:
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Comment
- Pubs id:
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2119622
- Local pid:
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pubs:2119622
- Deposit date:
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2025-07-28
- ARK identifier:
Terms of use
- Copyright holder:
- Elsevier Inc
- Copyright date:
- 2025
- Rights statement:
- © 2025 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
- Notes:
- The author accepted manuscript (AAM) of this paper has been made available under the University of Oxford's Open Access Publications Policy, and a CC BY public copyright licence has been applied.
- Licence:
- CC Attribution (CC BY)
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