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.
Trial registration number NCT03751878.
- medical journalism
- statistics & research methods
- medical education & training
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JJK and EC are joint senior authors.
Twitter @david_blanco91, @dmoher
Collaborators José Antonio González and Jordi Cortés (Universitat Politècnica de Catalunya).
Contributors DB: conceptualisation, methodology, software, formal analysis, investigation, writing (original draft preparation). SS, AA: conceptualisation, methodology, resources, writing (review and editing). DM, IB: conceptualisation, methodology, writing (review and editing). JJK, EC: conceptualisation, methodology, outcome evaluation, writing (review and editing), supervision.
Funding This study is part of the ESR 14 research project from the Methods in Research on Research (MiRoR) project (http://miror-ejd.eu/), which has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement no 676 207. DM is supported through a University Research Chair (University of Ottawa). The sponsor and the funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.
Competing interests AA is Editor in Chief of BMJ Open. AA was involved in the design of the study and writing the manuscript but not in data collection or data analysis. AA was not involved in the decision-making on this manuscript; the handling editor for the manuscript was instructed to raise any queries to the Deputy Editor, and AA was blinded to the editorial notes and discussion of the manuscript. The editorial team were instructed not to treat this manuscript any differently and that they should reject it if the reviewers felt it was not methodologically robust. SS is Senior Researcher at The BMJ. DM is Director of the Canadian EQUATOR Centre. IB is Deputy Director of the French EQUATOR Centre. DM, IB and EC are members of the CONSORT steering group.
Patient consent for publication Not required.
Ethics approval We obtained ethics approval from the Research Committee of the Governing Council of the Universitat Politècnica de Catalunya (UPC) (ref: EC 02, 13 September 2018). We did not seek consent from authors as this was part of a quality improvement programme at BMJ Open. However, all authors of the submitted manuscripts are routinely informed that BMJ has a research programme and that they can opt out if they wish.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. The content of the intervention reports reflecting reporting inconsistencies will appear as part of the peer review history of the manuscripts included in the study. However, in order to protect confidentiality, we are not releasing any data set including individual manuscript data or outcome data identifying the performance of individual participants.
Author note This RCT is the third part of DB’s PhD project, the first part of which was a scoping review to identify and classify interventions to improve adherence to RGs8 and the second part was a survey to explore biomedical editors’ opinion on various editorial interventions to improve adherence to RGs.18
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