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

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.

Trial registration number: NCT03751878.

Keywords: medical education & training; medical journalism; statistics & research methods.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Schema of the study design. RCT, randomised controlled trial.

Figure 2

CONSORT flow diagram. CONSORT, Consolidated Standards of Reporting Trials; RCT, randomised controlled trial.

Figure 3

Evolution of the scores for all manuscripts that passed the first round of peer review (n=18).

Figure 4

Proportion of manuscripts (n=18) where each CONSORT item is adequately reported. CONSORT items: 6a: ‘Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed’; 8a: ‘Method used to generate the random allocation sequence’; 9: ‘Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned’; 11a: ‘If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how’); 11b: ‘If relevant, description of the similarity of interventions’; 13a: ‘For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome’; 13b: ‘For each group, losses and exclusions after randomisation, together with reasons’; 17a: ‘For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)’). CONSORT, Consolidated Standards of Reporting Trials; Cont, control group; Int, intervention group.