A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010
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OBJECTIVES: To identify, summarize, and analyse comments on the core reporting guidelines for protocols of randomized trials (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] 2013) and for completed trials (Consolidated Standards of Reporting Trials [CONSORT] 2010), with special emphasis on suggestions for guideline modifications. METHODS: We included documents written in English and published after 2010 that explicitly commented on SPIRIT 2013 or CONSORT 2010. We searched four bibliographic databases (Embase and MEDLINE to June 2022; Web of Science and Google Scholar to April 2022) and other sources (e.g., the EQUATOR Network website, the BMC Blog Network, and the BMJ rapid response section). Two authors independently assessed documents for eligibility and extracted data on basic characteristics and the wording of the main comments. We categorized comments as 'suggestion for modification to the wording of an existing guideline item,' 'suggestion for a new item,' or 'reflections on challenges or strengths.' We provided a summary and examples of the proposed suggestions and categorized comments into those that were directly linked to empirical investigations, were continuations of previous methodological discussions, or reflected new methodological developments. RESULTS: We assessed full text of 2,320 potentially eligible documents and included 93 documents with 114 comments. In total, 37 comments suggested modifications to existing guideline items. The participant flow section of CONSORT 2010 received the most comments (eight comments made different suggestions, e.g., one comment suggested to add numbers on nonrandomized screened participants). There were 46 comments suggesting new items. Multiple suggestions were related to trial interventions (eight comments made different suggestions, e.g., one comment suggested to add content on cointerventions), blinding (six comments suggested to add content on risk of unblinding), statistical methods (five comments made different suggestions, e.g., one comment suggested to add content on blinding of statisticians), and participant flow (seven comments made different suggestions, e.g., three comments suggested to add content on missing data). Half (53%) of the suggestions were directly linked to empirical investigations. Six (7%) suggestions were continuations of previous methodological discussions and five (6%) suggestions reflected new methodological developments related to conflicts of interest and funding, data sharing, and patient and public involvement. CONCLUSION: The issues raised provide context to authors, peer reviewers, editors, and readers of trials using SPIRIT 2013 and CONSORT 2010 and inform the planned updates of the core guidelines.
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A scoping review of the literature was conducted to identify published comments suggesting modifications and additions or reflecting on strengths and challenges of CONSORT 2010.
“we first conducted a scoping review of the literature to identify published comments suggesting modifications and additions or reflecting on strengths and challenges of CONSORT 2010, the findings of which have been published separately [22].”
From CONSORT 2025 statement: Updated guideline for reporting randomised trials (2025) · cites this paper as [22]
The SPIRIT 2025 update included a scoping review of published comments suggesting changes to SPIRIT 2013 and CONSORT 2010.
“conducted a scoping review of published comments suggesting changes to SPIRIT 2013 and CONSORT 2010,18”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [18]
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- Authors
- Nejstgaard, C. H., Boutron, I., Chan, A.-W., Chow, R., Hopewell, S., Masalkhi, M., Moher, D., Schulz, K. F., Shlobin, N. A., Østengaard, L., & Hróbjartsson, A.
- Affiliations
- University of Southern Denmark (DK)
- Inserm (FR)
- University of Toronto (CA)
- University of Ottawa (CA)
- University of Oxford (GB)
- University College Dublin (IE)
- University of North Carolina at Chapel Hill (US)
- Northwestern University (US)
- Corresponding author
- Nejstgaard, Camilla H.
- ORCID
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2023-03
- Volume
- 155
- Pages
- 48-63
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W4317214279
- Cited by
- 21
- References
- 35
- Citations by year
- 2026: 1 · 2025: 17 · 2024: 3
- FWCI
- 1.48
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Clinical Epidemiology (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion, cc-by)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by)
- UNC Libraries
- Funders
- Medical Research Council (MR/W020483/1)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- CONSORT 2010, reporting guidelines, trial protocol reporting, trial reporting, participant flow, blinding, missing data, conflicts of interest, funding disclosure, data sharing, patient and public involvement, peer review, peer reviewers
- MeSH terms
- Humans, Reference Standards, Research Design, Writing
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