NCT03119376

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

December 10, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

April 3, 2017

Last Update Submit

September 10, 2018

Conditions

Keywords

peer reviewonline toolRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • the mean number of items accurately classified per manuscript for the 10 CONSORT items

    through study completion, an average of 6 month

  • 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 month

Study Arms (3)

USUAL PEER REVIEWER

NO INTERVENTION

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.

COBPeer

EXPERIMENTAL

Junior peer reviewers will be invited to participate in an online training course on peer review (COBPeer).

Other: COBPEER

GOLD STANDARD

NO INTERVENTION

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.

Interventions

COBPEEROTHER

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).

COBPeer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu, 1, place du parvis de notre dame

Paris, 75004, France

Location

Related Publications (2)

  • Chauvin A, Ravaud P, Moher D, Schriger D, Hopewell S, Shanahan D, Alam S, Baron G, Regnaux JP, Crequit P, Martinez V, Riveros C, Le Cleach L, Recchioni A, Altman DG, Boutron I. Accuracy in detecting inadequate research reporting by early career peer reviewers using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process: a cross-sectional diagnostic study. BMC Med. 2019 Nov 19;17(1):205. doi: 10.1186/s12916-019-1436-0.

  • Chauvin A, Moher D, Altman D, Schriger DL, Alam S, Hopewell S, Shanahan DR, Recchioni A, Ravaud P, Boutron I. A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials. BMJ Open. 2017 Sep 15;7(9):e017462. doi: 10.1136/bmjopen-2017-017462.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 18, 2017

Study Start

December 10, 2017

Primary Completion

January 20, 2018

Study Completion

January 20, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations