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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.

SUBMITTER: Blanco D

PROVIDER: S-EPMC7239541 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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

Blanco David D Schroter Sara S Aldcroft Adrian A Moher David D Boutron Isabelle I Kirkham Jamie J JJ Cobo Erik E

BMJ open 20200518 5

<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 ...[more]

PMID: 32430454

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Project description:The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications.We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision.A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n?=?166; control n?=?158), of which 197 were reports of randomised trials (n?=?94; n?=?103). Over a third (39%; n?=?127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n?=?43; n?=?50), pragmatic (n?=?20; n?=?16) and cluster (n?=?10; n?=?9). In a quarter of manuscripts, authors either wrongly selected an extension or failed to select the right extension when registering their manuscript on the WebCONSORT study site. Overall, there was no important difference in the overall mean score between WebCONSORT (mean score 0.51) and control (0.47) in the proportion of CONSORT and CONSORT extension items reported pertaining to a given study (mean difference, 0.04; 95% CI -0.02 to 0.10).This study failed to show a beneficial effect of a customised web-based CONSORT checklist to help authors prepare more complete trial reports. However, the exclusion of a large number of inappropriately registered manuscripts meant we had less precision than anticipated to detect a difference. Better education is needed, earlier in the publication process, for both authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions.ClinicalTrials.gov: NCT01891448 [registered 24 May 2013].

Project description:ImportanceNumerous studies have shown that adherence to reporting guidelines is suboptimal.ObjectiveTo evaluate whether asking peer reviewers to check if specific reporting guideline items were adequately reported would improve adherence to reporting guidelines in published articles.Design, setting, and participantsTwo parallel-group, superiority randomized trials were performed using manuscripts submitted to 7 biomedical journals (5 from the BMJ Publishing Group and 2 from the Public Library of Science) as the unit of randomization, with peer reviewers allocated to the intervention or control group.InterventionsThe first trial (CONSORT-PR) focused on manuscripts that presented randomized clinical trial (RCT) results and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline, and the second trial (SPIRIT-PR) focused on manuscripts that presented RCT protocols and reported following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. The CONSORT-PR trial included manuscripts that described RCT primary results (submitted July 2019 to July 2021). The SPIRIT-PR trial included manuscripts that contained RCT protocols (submitted June 2020 to May 2021). Manuscripts in both trials were randomized (1:1) to the intervention or control group; the control group received usual journal practice. In the intervention group of both trials, peer reviewers received an email from the journal that asked them to check whether the 10 most important and poorly reported CONSORT (for CONSORT-PR) or SPIRIT (for SPIRIT-PR) items were adequately reported in the manuscript. Peer reviewers and authors were not informed of the purpose of the study, and outcome assessors were blinded.Main outcomes and measuresThe difference in the mean proportion of adequately reported 10 CONSORT or SPIRIT items between the intervention and control groups in published articles.ResultsIn the CONSORT-PR trial, 510 manuscripts were randomized. Of those, 243 were published (122 in the intervention group and 121 in the control group). A mean proportion of 69.3% (95% CI, 66.0%-72.7%) of the 10 CONSORT items were adequately reported in the intervention group and 66.6% (95% CI, 62.5%-70.7%) in the control group (mean difference, 2.7%; 95% CI, -2.6% to 8.0%). In the SPIRIT-PR trial, of the 244 randomized manuscripts, 178 were published (90 in the intervention group and 88 in the control group). A mean proportion of 46.1% (95% CI, 41.8%-50.4%) of the 10 SPIRIT items were adequately reported in the intervention group and 45.6% (95% CI, 41.7% to 49.4%) in the control group (mean difference, 0.5%; 95% CI, -5.2% to 6.3%).Conclusions and relevanceThese 2 randomized trials found that it was not useful to implement the tested intervention to increase reporting completeness in published articles. Other interventions should be assessed and considered in the future.Trial registrationClinicalTrials.gov Identifiers: NCT05820971 (CONSORT-PR) and NCT05820984 (SPIRIT-PR).

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

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

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