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 22, 2018
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peer Review, Publishing Completeness of Reporting||Behavioral: Evaluation of reporting inconsistencies Behavioral: Standard Peer Review.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial|
|Actual Study Start Date :||December 7, 2018|
|Actual Primary Completion Date :||April 13, 2019|
|Actual Study Completion Date :||April 13, 2019|
Experimental: Intervention arm
Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript. Feedback is provided to authors.
Behavioral: Evaluation of reporting inconsistencies
Standard peer review process.
Behavioral: Standard Peer Review.
Manuscripts will undergo the usual peer review process.
- Overall completeness of reporting [ Time Frame: Following manuscript revision (usually 2-3 months) ]Proportion of adequately reported CONSORT items in the first revised manuscript
- Completeness of reporting for each item [ Time Frame: Following manuscript revision (usually 2-3 months) ]Proportion of manuscripts where each CONSORT item is adequately reported
- Time to perform the evaluation [ Time Frame: Following the evaluation of reporting inconsistencies (1 week) ]Time to perform the evaluation of reporting inconsistencies by the lead investigator (DB)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751878
|London, United Kingdom, WC1H 9JR|
|Study Chair:||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|