Impact of a Short Form of the SPIRIT Checklist for Peer Reviewers to Improve the Reporting of Protocols for Randomised Controlled Trials Published in Biomedical Journals: a Randomised Controlled Trial (SPIRIT-PR)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oxford
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Completeness of reporting
Study Overview
Brief Summary
Transparent and accurate reporting is key, so that readers can adequately interpreting the results of a study. The aim of this project is to evaluate whether reminding peer reviewers of the most important SPIRIT reporting items (including a short explanation of those items) will result in higher adherence to SPIRIT guidelines in published protocols for RCTS. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the SPIRIT checklist including the ten most important and poorly reported SPIRIT items ; or (ii) no checklist. The aim is to find an intervention which improves the reporting, making it easier for readers to adequately interpret the presented articles.
Detailed Description
The full protocol is available on Open Science Framework where the study was prospectively registered: https://osf.io/z2hm9
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Authors will be blinded to the intervention allocation. Editors will not be informed about the randomisation. To avoid potential bias, peer reviewers and authors will not be informed of the study hypothesis, design and intervention. All submitting authors and invited reviewers are routinely told that BMJ has a research programme and their article/review may be included in this research.
Outcomes will be assessed in duplicate by blinded outcome assessors
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •for journals:
- •It was planned from the beginning that this study will only be conducted at the BMJ Open as it publishes numerous protocols. Hence, no inclusion criteria for the journal were specified.
- •Inclusion criteria for manuscripts:
- •All submitted manuscripts sent out for external review that described protocols for RCTs.
Exclusion Criteria
- •l for manuscripts:
- •We excluded (i) Manuscripts which were clearly labelled as a pilot or feasibility study (ii) Studies randomizing animals or cells (iii) Separate publications of data analysis plans
- •Included peer-reviewers:
- •Peer reviewers that were invited following usual journal practice
Arms & Interventions
SPIRIT checklist plus usual practice
After accepting to review an article, peer reviewers will receive the automated, journal specific standard email with general information as per each journal's usual practice (e.g. where to access the manuscript, date when the peer review report is due). In addition, peer-reviewers who received a manuscript which was randomised to the experimental arm will receive an additional email including a short version of the SPIRIT checklist together with a short explanation of those items.
Intervention: SPIRIT checklist plus usual practice (Other)
Usual practice
After accepting to review an article, peer reviewers will receive the automated, journal specific standard email with general information as per each journal's usual practice.
Intervention: Usual practice (Other)
Outcomes
Primary Outcomes
Completeness of reporting
Time Frame: Through study completion, an average of 1 year
The primary outcome of this study will be the difference of the mean proportion of adequately reported items of the 10 most important and poorly reported SPIRIT items between the two intervention arms.
Secondary Outcomes
- Completeness of reporting(Through study completion, an average of 1 year)
- Time from assigning an academic editor until the first decision (as communicated to the author after the first round of peer-review).(Through study completion, an average of 4 months; will be assessed from routinely collected data)
- Proportion of articles directly rejected after the first round of peer-review(Through study completion, an average of 4 months; will be assessed from routinely collected data)
- Proportion of articles published(Through study completion, an average of 9 months; will be assessed from routinely collected data)