Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial
Author
Blanco de Tena Davila, David
Schroter, Sara
Aldcroft, Adrian
Moher, David
Boutron, Isabelle
Kirkham, Jamie J.
Cobo, Erik
Publication date
2020ISSN
2044-6055
Abstract
Objective To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials. Design Randomised controlled trial (RCT). Setting BMJ Open’s quality improvement programme. Participants 24 manuscripts describing RCTs. Interventions 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. Outcomes 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. Results 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. Conclusions 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.
Document Type
Article
Document version
Published version
Language
English
Subject (CDU)
61 - Medical sciences
Keywords
Integritat
Assaigs
Millora de la qualitat
Normes consolidades d’assaigs d’informes
Integridad
Ensayos
Mejora de la calidad
Mejora de la calidad
Integrity
Essays
Quality improvement
Consolidated reporting standards
Pages
10
Publisher
BMJ Publishing Group
Collection
10;
Is part of
BMJ Open
Citation
Blanco, David; Schroter, Sara; Aldcroft, Adrian [et al.]. Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial. BMJ Open, 2020, 10(5), e036799. Disponible en: <https://bmjopen.bmj.com/content/10/5/e036799>. Fecha de acceso: 15 sep. 2021. DOI: 10.1136/bmjopen-2020-036799
This item appears in the following Collection(s)
- Ciències de la Salut [745]
Rights
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