Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial
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 ap...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/5/e036799.full |
| _version_ | 1819226609034461184 |
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| author | Sara Schroter David Moher David Blanco Isabelle Boutron Jamie J Kirkham Erik Cobo Adrian Aldcroft |
| author_facet | Sara Schroter David Moher David Blanco Isabelle Boutron Jamie J Kirkham Erik Cobo Adrian Aldcroft |
| author_sort | Sara Schroter |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-23T10:28:12Z |
| format | Article |
| id | doaj.art-689066b3587f4bde8c2e5c99bca15c8a |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-12-23T10:28:12Z |
| publishDate | 2020-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-689066b3587f4bde8c2e5c99bca15c8a2022-12-21T17:50:31ZengBMJ Publishing GroupBMJ Open2044-60552020-05-0110510.1136/bmjopen-2020-036799Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trialSara SchroterDavid MoherDavid BlancoIsabelle BoutronJamie J KirkhamErik CoboAdrian AldcroftObjective 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.https://bmjopen.bmj.com/content/10/5/e036799.full |
| spellingShingle | Sara Schroter David Moher David Blanco Isabelle Boutron Jamie J Kirkham Erik Cobo Adrian Aldcroft Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial BMJ Open |
| title | Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial |
| title_full | Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial |
| title_fullStr | Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial |
| title_full_unstemmed | Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial |
| title_short | Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial |
| title_sort | effect of an editorial intervention to improve the completeness of reporting of randomised trials a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/5/e036799.full |
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