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

Peer Review Clinical Trial

Official title:

Evaluation of an Online Tool (COBPeer) Dedicated to Junior Peer Reviewers for Assessing the Reporting of Randomized Controlled Trial Reports

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119376
• Other study ID #: AC001
• Status: Completed
• Phase: N/A
• Start date: December 10, 2017
• Est. completion date: January 20, 2018

Study information

• Verified date: September 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

BACKGROUND: Context Inadequate reporting is a frequent cause of waste of research. To overcome this issue, the CONSORT statement, an evidence-based, minimum set of recommendations for reporting RCTs was developed in 1996. These guidelines have since been updated in 2001 and more recently in 2010. Many journals endorse the CONSORT statement. Some journals provide recommendations to authors to follow the CONSORT guidelines and some editors enforce the use of the CONSORT guidelines by requesting authors to submit a checklist in either the submission or acceptance stage. Nevertheless, inadequate reporting remains.

HYPOTHESE: To assess the completeness of reporting, junior peer reviewers could use a simple online tool based on the CONSORT 2010 checklist and Elaboration and Explanation publication for reporting parallel-group RCT

OBJECTIVE: 1) Develop an online tool and training module dedicated to junior peer reviewers for a) assessing the completeness of reporting of key items and b) identifying switched primary outcome(s) in reports of RCTs. 2) Compare the performance of junior peer reviewers using this tool with the usual peer-review process in identifying inadequate reporting and switched primary outcome(s) in reports of RCTs.

STUDY DESIGN: randomized ratio 1:1 controlled trial with two parallel arms. Participants will be invited to participate by invitation.

ELIGIBILITY: eligible participants are juniors peer reviewers. Junior peer reviewers are defined as early stage researchers: master students, PhD students, residents involved in clinical research during their study, and clinicians who have never reviewed a manuscript

INTERVENTION: the peer-review tool will be based on 10 items of the CONSORT Statement. This tool reminds the peer reviewer of the CONSORT item which must be reported by explicating it with a series of questions. The training module will explain each item to be evaluated with examples followed by a series of exercises from published randomized trial extracts.

MANUSCRIPT SELECTION: sample of randomized controlled trials published by Annals of Emergency Medicine, British Medical Journal, British Medical Journal Open and BioMed Central series medical.

EVALUATION BY THE JUNIOR PEER REVIEWERS: the junior peer reviewer who has accepted to participate and who has passed the training with success, will have to evaluate 1 article of the selected randomized sample.

EVALUATION OF THE USUAL PEER REVIEWERS: the evaluation by the usual peer-reviewers will be obtained by an analysis of the comments of the peer-reviewers which are available on line or obtained from the publisher.

GOLD STANDARD: peers of researchers who are experts in conducting systematic reviews will evaluate each article independently from other evaluations. Disagreements will be resolved by consensus.

PRIMARY OUTCOME: the mean number of items accurately classified per manuscript

SECONDARY OUTCOMES: the mean number of items accurately classified per manuscript for the 10 CONSORT items; the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify switch in primary outcome(s).

SAMPLE SIZE: 120 manuscripts and 120 peer reviewers juniors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 20, 2018
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• master students,

• PhD students,

• residents involved in clinical research during their study,

• clinicians who have never reviewed a manuscript

Exclusion Criteria:

Related Conditions & MeSH terms

• Peer Review

Intervention

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).

Locations

Country	Name	City	State
France	Hotel Dieu, 1, place du parvis de notre dame	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	University of California, Los Angeles, University of Ottawa, University of Oxford

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the mean number of items accurately classified per manuscript	Each item will be classified as"adequately reported" (yes/no)	through study completion, an average of 6 month
Secondary	the mean number of items accurately classified per manuscript for the 10 CONSORT items	Each item will be classified as"adequately reported" (yes/no)	through study completion, an average of 6 month
Secondary	the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify switch in primary outcome(s).	test for pair proportion	through study completion, an average of 6 month