Clinical trial NCT05820984: A Short SPIRIT Checklist for Peer Reviewers to Improve the Reporting Quality in Published Articles (SPIRIT-PR)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adequate Reporting in Published Study Protocols of Randomized Controlled Trials
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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 criterial 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

Primary outcomes:
measure: Completeness of reporting
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Completeness of reporting
timeFrame: Through study completion, an average of 1 year
measure: Completeness of reporting
timeFrame: Through study completion, an average of 1 year
measure: Time from assigning an academic editor until the first decision (as communicated to the author after the first round of peer-review).
timeFrame: Through study completion, an average of 4 months; will be assessed from routinely collected data
measure: Proportion of articles directly rejected after the first round of peer-review
timeFrame: Through study completion, an average of 4 months; will be assessed from routinely collected data
measure: Proportion of articles published
timeFrame: Through study completion, an average of 9 months; will be assessed from routinely collected data
Other outcomes:
measure: Peer reviewer comments for any reference to SPIRIT and trial reporting
timeFrame: Assessed from available peer-reviewer responses; on average 3 months after randomisation
Locations:
city: London
country: United Kingdom
facility: The BMJ Publishing Group
Study officials:
References: