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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
Sponsor:
Collaborators:
University of Liverpool
The BMJ
Information provided by (Responsible Party):
David Blanco, Universitat Politècnica de Catalunya

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.

Condition or disease Intervention/treatment Phase
Peer Review, Publishing Completeness of Reporting Behavioral: Evaluation of reporting inconsistencies Behavioral: Standard Peer Review. Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

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.
Behavioral: Evaluation of reporting inconsistencies
  1. 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.
  2. 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.
  3. This editor will include the report in the letter to authors alongside the standard peer review reports.

Control arm
Standard peer review process.
Behavioral: Standard Peer Review.
Manuscripts will undergo the usual peer review process.




Primary Outcome Measures :
  1. Overall completeness of reporting [ Time Frame: Following manuscript revision (usually 2-3 months) ]
    Proportion of adequately reported CONSORT items in the first revised manuscript


Secondary Outcome Measures :
  1. 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

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
BMJ Open
London, United Kingdom, WC1H 9JR
Sponsors and Collaborators
Universitat Politècnica de Catalunya
University of Liverpool
The BMJ
Investigators
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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
  Study Documents (Full-Text)

Documents provided by David Blanco, Universitat Politècnica de Catalunya:

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Responsible Party: David Blanco, Principal Investigator, Universitat Politècnica de Catalunya
ClinicalTrials.gov Identifier: NCT03751878     History of Changes
Other Study ID Numbers: EC 02
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Blanco, Universitat Politècnica de Catalunya:
Reporting guidelines
CONSORT
Adherence
Completeness of reporting
Quality of reporting
Peer review