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
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
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02739737 -
Testing for the Presence of Authorship Bias in Peer Review
|
N/A |