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| Name | Class |
|---|---|
| University of Liverpool | OTHER |
| The BMJ | OTHER |
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Randomised trials are considered the gold standard in medical research. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of reporting of randomised trials. Without transparent reporting, readers cannot judge the reliability and validity of trial findings, and therefore these findings cannot inform clinical practice. Different stakeholders, including biomedical journals, have taken different actions to try to improve author adherence to CONSORT. The most popular action among biomedical journals is to instruct authors to submit a completed RG checklist with page numbers indicating where the CONSORT items are addressed when they submit their manuscript. However, this measure alone has been proven not to be effective. In this study, the investigators intend to evaluate in a real editorial context whether assessing during peer review the consistency between the submitted CONSORT checklist and the information reported in the manuscripts of randomised trials, as well as to provide feedback to authors on the inconsistencies found, improves the completeness of reporting of published trials.
Randomised trials are considered the gold standard in medical research. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of reporting of randomised trials. Without transparent reporting, readers cannot judge the reliability and validity of trial findings, and therefore these findings cannot inform clinical practice.
In recent years, different stakeholders have acted to boost the completeness of reporting of the published randomised trials, and therefore their transparency and reproducibility. In a recently completed scoping review, the investigators identified and classified 31 interventions to improve adherence to reporting guidelines. This review revealed that it is primarily journals that have taken most efforts to improve the completeness of reporting of randomised trials - although most of their actions have been shown not to have the desired effect.
One of the most popular strategies used by journals to improve adherence to CONSORT requires authors to submit a populated checklist together with their manuscript indicating page numbers corresponding to each item. However, journals usually lack further actions throughout the editorial process to ensure that the corresponding information to each item is reported in the randomised trial manuscript. This has been hypothesized to be one of the reasons why this editorial strategy has not achieved optimal results.
In an effort to take full advantage of requiring the submission of populated checklists, the investigators intend to evaluate in a real editorial context whether assessing during peer review the consistency between the submitted CONSORT checklist and the information reported in the manuscripts of randomised trials, as well as to provide feedback to authors on the inconsistencies found, improves the completeness of reporting of published trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript. Feedback is provided to authors. |
|
| Control arm | Other | Standard peer review process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of reporting inconsistencies | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall completeness of reporting | Proportion of adequately reported CONSORT items in the first revised manuscript | Following manuscript revision (usually 2-3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of reporting for each item | Proportion of manuscripts where each CONSORT item is adequately reported | Following manuscript revision (usually 2-3 months) |
| Time to perform the evaluation |
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Inclusion Criteria:
Manuscripts will be eligible if:
According to the official CONSORT extensions, the investigators will also consider other study designs (cluster, non-inferiority and equivalence, pragmatic, N-of-1 trials, Pilot and feasibility, and within person trials), and different intervention types (Herbal, non-pharmacologic, acupuncture and Chinese herbal medicine formulas) in all areas of clinical specialty.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Schroter | The BMJ, London | Study Chair |
| Adrian Aldcroft | The BMJ, London | Study Chair |
| David Moher | Ottawa Hospital Research Institute, Ottawa | Study Chair |
| Isabelle Boutron | Paris Descartes University, Paris | Study Chair |
| Jamie J Kirkham | University of Liverpool, Liverpool | Study Chair |
| Erik Cobo | Universitat Politècnica de Catalunya, Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BMJ Open | London | WC1H 9JR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32430454 | Derived | Blanco D, Schroter S, Aldcroft A, Moher D, Boutron I, Kirkham JJ, Cobo E. Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial. BMJ Open. 2020 May 18;10(5):e036799. doi: 10.1136/bmjopen-2020-036799. |
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The content of the interventional peer review reports will appear as part of the review history of the manuscripts. However, in order to protect confidentiality, no dataset including individual manuscript data or outcome data identifying the performance of individual participants will be released. When the study is finished, DB will assign a study number to each paper and store that code with the manuscript ID, password protect it, and store it (File 1) in the BMJ Google Drive folder for the study. In this file, we will also include all identifying variables (Submission date, Trial registration number, Title, Latest editorial decision, applicable CONSORT extensions). For the file containing the peer review reports and the study outcomes (File 2), DB will strip all identifying variables other than the study code and store that file separate from File 1. DB will stick all study files in one folder, compress this folder using WinZip, password protect it, and store it in the same folder.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 31, 2022 | |
| Reset | Mar 15, 2023 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2019 | May 18, 2019 | Prot_SAP_003.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 31, 2022 | Mar 15, 2023 |
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| Standard Peer Review. | Behavioral | Manuscripts will undergo the usual peer review process. |
|
Time to perform the evaluation of reporting inconsistencies by the lead investigator (DB)
| Following the evaluation of reporting inconsistencies (1 week) |