Clinical trial NCT03751878: Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors
Official title: Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peer Review, Publishing
Completeness of Reporting
Keywords: Reporting guidelines
CONSORT
Adherence
Completeness of reporting
Quality of reporting
Peer review
Lead sponsor: Universitat Politècnica de Catalunya
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: The BMJ
First posted: 2018-11-23
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomised trials are considered the gold standard in medical research. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of reporting of randomised trials. Without transparent reporting, readers cannot judge the reliability and validity of trial findings, and therefore these findings cannot inform clinical practice. Different stakeholders, including biomedical journals, have taken different actions to try to improve author adherence to CONSORT. The most popular action among biomedical journals is to instruct authors to submit a completed RG checklist with page numbers indicating where the CONSORT items are addressed when they submit their manuscript. However, this measure alone has been proven not to be effective. In this study, the investigators intend to evaluate in a real editorial context whether assessing during peer review the consistency between the submitted CONSORT checklist and the information reported in the manuscripts of randomised trials, as well as to provide feedback to authors on the inconsistencies found, improves the completeness of reporting of published trials.

Detailed description: Randomised trials are considered the gold standard in medical research. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of reporting of randomised trials. Without transparent reporting, readers cannot judge the reliability and validity of trial findings, and therefore these findings cannot inform clinical practice.

In recent years, different stakeholders have acted to boost the completeness of reporting of the published randomised trials, and therefore their transparency and reproducibility. In a recently completed scoping review, the investigators identified and classified 31 interventions to improve adherence to reporting guidelines. This review revealed that it is primarily journals that have taken most efforts to improve the completeness of reporting of randomised trials - although most of their actions have been shown not to have the desired effect.

One of the most popular strategies used by journals to improve adherence to CONSORT requires authors to submit a populated checklist together with their manuscript indicating page numbers corresponding to each item. However, journals usually lack further actions throughout the editorial process to ensure that the corresponding information to each item is reported in the randomised trial manuscript. This has been hypothesized to be one of the reasons why this editorial strategy has not achieved optimal results.

In an effort to take full advantage of requiring the submission of populated checklists, the investigators intend to evaluate in a real editorial context whether assessing during peer review the consistency between the submitted CONSORT checklist and the information reported in the manuscripts of randomised trials, as well as to provide feedback to authors on the inconsistencies found, improves the completeness of reporting of published trials.

Eligibility criteria: Inclusion Criteria:

Manuscripts will be eligible if:

* They have been submitted to BMJ Open,
* They are original research submissions reporting the results of a randomised trial, and
* They have passed the first editorial filters and have been subsequently sent out for peer review.
* Authors of these manuscripts have provided a completed CONSORT checklist.

According to the official CONSORT extensions, the investigators will also consider other study designs (cluster, non-inferiority and equivalence, pragmatic, N-of-1 trials, Pilot and feasibility, and within person trials), and different intervention types (Herbal, non-pharmacologic, acupuncture and Chinese herbal medicine formulas) in all areas of clinical specialty.

Exclusion Criteria:

* Protocols of randomised trials
* Secondary trial analysis studies

Primary outcomes:
measure: Overall completeness of reporting
timeFrame: Following manuscript revision (usually 2-3 months)
Secondary outcomes:
measure: Completeness of reporting for each item
timeFrame: Following manuscript revision (usually 2-3 months)
measure: Time to perform the evaluation
timeFrame: Following the evaluation of reporting inconsistencies (1 week)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: BMJ Open
Study officials:
affiliation: The BMJ, London
name: Sara Schroter
role: STUDY_CHAIR
affiliation: The BMJ, London
name: Adrian Aldcroft
role: STUDY_CHAIR
affiliation: Ottawa Hospital Research Institute, Ottawa
name: David Moher
role: STUDY_CHAIR
affiliation: Paris Descartes University, Paris
name: Isabelle Boutron
role: STUDY_CHAIR
affiliation: University of Liverpool, Liverpool
name: Jamie J Kirkham
role: STUDY_CHAIR
affiliation: Universitat Politècnica de Catalunya, Barcelona
name: Erik Cobo
role: STUDY_CHAIR
References:
citation: Blanco D, Schroter S, Aldcroft A, Moher D, Boutron I, Kirkham JJ, Cobo E. Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial. BMJ Open. 2020 May 18;10(5):e036799. doi: 10.1136/bmjopen-2020-036799.