This paper is only available as a PDF. To read, Please Download here.
Abstract
Objective
To identify, summarise, and analyse comments on the core reporting guidelines for protocols of randomised trials (SPIRIT 2013) and for completed 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 categorised 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 2320 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 non-randomised 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 co-interventions), 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.
Keywords
Article info
Publication history
Accepted:
January 12,
2023
Received:
November 11,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 The Author(s). Published by Elsevier Inc.
User license
Creative Commons Attribution (CC BY 4.0) | How you can reuse 
Elsevier's open access license policy
Creative Commons Attribution (CC BY 4.0)
Permitted
- Read, print & download
- Redistribute or republish the final article
- Text & data mine
- Translate the article
- Reuse portions or extracts from the article in other works
- Sell or re-use for commercial purposes
Elsevier's open access license policy
