Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial

Conditions
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Peer Review, Publishing, Completeness of Reporting

Intervention / Treatment
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* Behavioral: Evaluation of reporting inconsistencies
* Behavioral: Standard Peer Review.


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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<br>* The completed CONSORT checklist submitted by authors of manuscripts randomised to the intervention group will be assessed by the lead investigator (DB) as to whether it is consistent with the information that was actually reported in the manuscript. This evaluation will be focused on 8 core CONSORT items. DB will produce a standardised report containing precise requests for authors in order to improve the completeness of reporting of the items where reporting inconsistencies were found. This report will consist of a brief introduction followed by a point by point description of the inconsistencies found together with precise requests related to the information missing and examples extracted from CONSORT. DB will upload this report to the submission on the managing system of the journal (Scholar One) to make it accessible to the handling editor of the manuscript. This editor will include the report in the letter to authors alongside the standard peer review reports.<br>|
| Other: Control arm<br>Standard peer review process. | Behavioral: Standard Peer Review.<br>* Manuscripts will undergo the usual peer review process.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | Time to perform the evaluation of reporting inconsistencies by the lead investigator (DB) | Following the evaluation of reporting inconsistencies (1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reporting guidelines, CONSORT, Adherence, Completeness of reporting, Quality of reporting, Peer review