Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors
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ClinicalTrials.gov Identifier: NCT03751878 |
Recruitment Status :
Completed
First Posted : November 23, 2018
Last Update Posted : May 21, 2019
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Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | November 21, 2018 | ||||||||||||||||||
First Posted Date ICMJE | November 23, 2018 | ||||||||||||||||||
Last Update Posted Date | May 21, 2019 | ||||||||||||||||||
Actual Study Start Date ICMJE | December 7, 2018 | ||||||||||||||||||
Actual Primary Completion Date | April 13, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Overall completeness of reporting [ Time Frame: Following manuscript revision (usually 2-3 months) ] Proportion of adequately reported CONSORT items in the first revised manuscript
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Original Primary Outcome Measures ICMJE |
Completeness of reporting [ Time Frame: Following manuscript revision (usually 2-3 months) ] Proportion of adequately reported CONSORT items
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Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors | ||||||||||||||||||
Official Title ICMJE | Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial | ||||||||||||||||||
Brief Summary | 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. | ||||||||||||||||||
Detailed Description | 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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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
24 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Actual Study Completion Date ICMJE | April 13, 2019 | ||||||||||||||||||
Actual Primary Completion Date | April 13, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | 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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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | United Kingdom | ||||||||||||||||||
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Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03751878 | ||||||||||||||||||
Other Study ID Numbers ICMJE | EC 02 | ||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | David Blanco, Universitat Politècnica de Catalunya | ||||||||||||||||||
Original Responsible Party | David Blanco, Universitat Politècnica de Catalunya, MMathStat | ||||||||||||||||||
Current Study Sponsor ICMJE | Universitat Politècnica de Catalunya | ||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Universitat Politècnica de Catalunya | ||||||||||||||||||
Verification Date | May 2019 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |