A Short SPIRIT Checklist for Peer Reviewers to Improve the Reporting Quality in Published Articles (SPIRIT-PR)

Study Overview
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Brief Summary
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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
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The full protocol is available on Open Science Framework where the study was prospectively registered: https://osf.io/z2hm9

Official Title
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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)

Conditions
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Adequate Reporting in Published Study Protocols of Randomized Controlled Trials

Intervention / Treatment
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* Other: SPIRIT checklist plus usual practice
* Other: Usual practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPIRIT checklist plus usual practice<br>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. | Other: SPIRIT checklist plus usual practice<br>* Peer reviewer will be reminded of the following 10 CONSORT items (including a short description): Outcomes (12) Sample size (14) Recruitment (15) Allocation implementation (16 c) Blinding (17 a) Data collection methods (18 a) Data collection methods - retention (18 b) Statistical methods (20 a) Population analysed (20 c) Access to data (29)<br>|
| Other: Usual practice<br>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. | Other: Usual practice<br>* Peer review as it is usual practice at the journal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completeness of reporting | 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. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completeness of reporting | Mean proportion of adequate reporting of the 10 most important and poorly reported SPIRIT items, considering each sub-item as a separate item. | Through study completion, an average of 1 year | 
| Completeness of reporting | Mean proportion for each of the 10 most important and poorly reported SPIRIT items separately (including also separate analysis of sub-items). | 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 |