- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03751878
Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors
Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, WC1H 9JR
- BMJ Open
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Manuscripts will be eligible if:
- They have been submitted to BMJ Open,
- They are original research submissions reporting the results of a randomised trial, and
- They have passed the first editorial filters and have been subsequently sent out for peer review.
- Authors of these manuscripts have provided a completed CONSORT checklist.
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:
- Protocols of randomised trials
- Secondary trial analysis studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript.
Feedback is provided to authors.
|
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Other: Control arm
Standard peer review process.
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Manuscripts will undergo the usual peer review process.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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Following manuscript revision (usually 2-3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Following manuscript revision (usually 2-3 months)
|
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)
|
Following the evaluation of reporting inconsistencies (1 week)
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Collaborators and Investigators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EC 02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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