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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03119376
Enrollment
120
Registered
2017-04-18
Start date
2017-12-10
Completion date
2018-01-20
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peer Review

Keywords

peer review, online tool, Randomized Controlled Trial

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

Detailed 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.

Interventions

OTHERCOBPEER

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).

Sponsors

University of Oxford
CollaboratorOTHER
University of Ottawa
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
the mean number of items accurately classified per manuscriptthrough study completion, an average of 6 monthEach item will be classified asadequately reported (yes/no)

Secondary

MeasureTime frameDescription
the mean number of items accurately classified per manuscript for the 10 CONSORT itemsthrough study completion, an average of 6 monthEach item will be classified asadequately reported (yes/no)
the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify switch in primary outcome(s).through study completion, an average of 6 monthtest for pair proportion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026