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Web-based Tool to Improve the Assessment of Reporting (COBPeer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119376
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
University of Oxford
University of Ottawa
University of California, Los Angeles
Information provided by (Responsible Party):
Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris

Brief Summary:

The peer review process is a cornerstone of biomedical research publication. Despite being essential, the assessment of the completeness of the reporting and the identification of switched outcomes are not appropriately performed. Furthermore, these tasks do not suppose a high level of expertise and could be performed by junior researchers.

To assess the completeness of reporting and identified switched outcome(s), junior peer reviewers could use a simple online tool (COBPeer) based on the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist and Elaboration and Explanation publication for reporting parallel-group RCTs. The tool would feature bullet points eliciting the meaning of each checklist item. The aim of this study that will compare the accuracy of junior peer reviewers using the tool to that of usual peer reviewers when evaluating the completeness of reporting and switched of primary outcome(s) in reports of RCTs


Condition or disease Intervention/treatment Phase
Peer Review Other: COBPEER Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Evaluation of an Online Tool (COBPeer) Dedicated to Junior Peer Reviewers for Assessing the Reporting of Randomized Controlled Trial Reports
Actual Study Start Date : December 10, 2017
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : January 20, 2018

Arm Intervention/treatment
No Intervention: USUAL PEER REVIEWER
Two researchers will read all the peer-review reports and editors' comments for the first round. The researchers will determine whether the peer-reviewers and/or editors raised some concern on the completeness of reporting of the 10 CONSORT items considered and identified a switch primary outcome(s) between the manuscript and the register. The assessment of all peer-review reports and editors' comments for each manuscript will be combined (i.e., the item will be rated as incompletely reported if at least one peer reviewer rated it as such). The 2 researchers will be blinded to the gold standard assessment.
Experimental: COBPeer
Junior peer reviewers will be invited to participate in an online training course on peer review (COBPeer).
Other: COBPEER
At the end of the online training, they can participate in the study and so peer review 1 manuscript randomly selected from our sample with our tool (COBPeer).

No Intervention: GOLD STANDARD
Pairs of systematic reviewers will independently extract data from eligible reports. Reviewers involved in the data extraction will have expertise in the conduct of systematic reviews and will assess the completeness of reporting from the systematic reviewer perspective. They will not have access to the tool to avoid being influenced by the tool. The systematic reviewers will also systematically compare the primary outcome(s) reported in the manuscript and the primary outcome(s) reported in the registry and will document any discrepancies.



Primary Outcome Measures :
  1. the mean number of items accurately classified per manuscript [ Time Frame: through study completion, an average of 6 month ]
    Each item will be classified as"adequately reported" (yes/no)


Secondary Outcome Measures :
  1. the mean number of items accurately classified per manuscript for the 10 CONSORT items [ Time Frame: through study completion, an average of 6 month ]
    Each item will be classified as"adequately reported" (yes/no)

  2. the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify switch in primary outcome(s). [ Time Frame: through study completion, an average of 6 month ]
    test for pair proportion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • master students,
  • PhD students,
  • residents involved in clinical research during their study,
  • clinicians who have never reviewed a manuscript

Exclusion Criteria:

  • none

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): NCT03119376


Locations
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France
Hotel Dieu, 1, place du parvis de notre dame
Paris, France, 75004
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
University of Oxford
University of Ottawa
University of California, Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Isabelle BOUTRON, Professor, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03119376    
Other Study ID Numbers: AC001
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris:
peer review
online tool
Randomized Controlled Trial