Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial

Blanco, David, Schroter, Sara, Aldcroft, Adrian, Moher, David, Boutron, Isabelle, Kirkham, Jamie J ORCID: 0000-0003-2579-9325 and Cobo, Erik (2020) Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial. BMJ OPEN, 10 (5). e036799-.

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Official URL: http://dx.doi.org/10.1136/bmjopen-2020-036799

Abstract

<h4>Objective</h4>To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.<h4>Design</h4>Randomised controlled trial (RCT).<h4>Setting</h4><i>BMJ Open</i>'s quality improvement programme.<h4>Participants</h4>24 manuscripts describing RCTs.<h4>Interventions</h4>We used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.<h4>Outcomes</h4>The primary outcome is the number of adequately reported items (0-8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.<h4>Results</h4>Manuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.<h4>Conclusions</h4>We demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.<h4>Trial registration number</h4>NCT03751878.

Item Type:	Article
Uncontrolled Keywords:	Humans, Consensus, Peer Review, Checklist, Research Report, Quality Improvement
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Population Health
Depositing User:	Symplectic Admin
Date Deposited:	23 Jul 2021 10:09
Last Modified:	18 Jan 2023 21:35
DOI:	10.1136/bmjopen-2020-036799
Open Access URL:	http://doi.org/10.1136/bmjopen-2020-036799
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3131040