NCT05820971

A Short CONSORT Checklist for Peer Reviewers to Improve the Reporting of Randomised Controlled Trials Published

Impact of a Short Form of the CONSORT Checklist for Peer Reviewers to Improve the Reporting of Randomised Controlled Trials Published in Biomedical Journals: a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Transparent and accurate reporting is key, so that readers can adequately interpreting the results of a study. Despite improvement with implementation of the CONSORT Statement (CONsolidated Standards for Reporting Trials), there remain major reporting deficiencies in published randomized controlled trials (RCT). The aim of this project is to evaluate whether reminding peer reviewers of the most important CONSORT items (including a short explanation of those items) will result in higher adherence to CONSORT guidelines in published RCTs. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the CONSORT checklist including the ten most important and poorly reported CONSORT items as defined by a group of experts of the CONSORT Statement (C-short); 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 results.

Detailed description

The CONSORT Statement (CONsolidated Standards for Reporting Trials), is perhaps the most important reporting guideline designed to help improve the transparency and quality of reporting of randomized controlled trials. Despite some improvement in reporting following the implementation of the CONSORT Statement, there still remain major reporting deficiencies in published RCTs. The investigators are conducting a multicentre randomized controlled trial to evaluate whether reminding peer reviewers of the most important CONSORT items (including a short explanation of those items) will result in higher adherence to CONSORT guidelines in published RCTs. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the CONSORT checklist including the ten most important and poorly reported CONSORT items as defined by a group of experts of the CONSORT Statement (C-short plus usual practice); or (ii) no checklist (usual practice). 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 CONSORT items between the two intervention arms. The Full protocol is available on Open Science Framework where the study was prospectively registered (https://osf.io/c4hn8)

Conditions

• Adequate Reporting in Randomized Controlled Trials

Interventions

Type	Name	Description
OTHER	C-short plus usual practice	Peer reviewer will be reminded of the following 10 CONSORT items (including a short description): * Outcomes (6a) * Sample size (7a) * Sequence generation (8a) * Allocation concealment (9) * Blinding (11a) * Outcomes and estimation (17a/b) * Harms (19) * Registration (23) * Protocol (24) * Funding (25)

Timeline

• Start date: 2019-06-15
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2023-04-20
• Last updated: 2023-04-24

Locations

2 sites across 2 countries: United States, United Kingdom