Clinical trial NCT05820971: A Short CONSORT Checklist for Peer Reviewers to Improve the Reporting of Randomised Controlled Trials Published
Official title: Impact of a Short Form of the CONSORT Checklist for Peer Reviewers to Improve the Reporting of Randomised Controlled Trials Published in Biomedical Journals: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adequate Reporting in Randomized Controlled Trials
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Transparent and accurate reporting is key, so that readers can adequately interpreting the results of a study. Despite improvement with implementation of the CONSORT Statement (CONsolidated Standards for Reporting Trials), there remain major reporting deficiencies in published randomized controlled trials (RCT). The aim of this project is to evaluate whether reminding peer reviewers of the most important CONSORT items (including a short explanation of those items) will result in higher adherence to CONSORT guidelines in published RCTs. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the CONSORT checklist including the ten most important and poorly reported CONSORT items as defined by a group of experts of the CONSORT Statement (C-short); or (ii) no checklist. The aim is to find an intervention which improves the reporting, making it easier for readers to adequately interpret the presented results.

Detailed description: The CONSORT Statement (CONsolidated Standards for Reporting Trials), is perhaps the most important reporting guideline designed to help improve the transparency and quality of reporting of randomized controlled trials. Despite some improvement in reporting following the implementation of the CONSORT Statement, there still remain major reporting deficiencies in published RCTs. The investigators are conducting a multicentre randomized controlled trial to evaluate whether reminding peer reviewers of the most important CONSORT items (including a short explanation of those items) will result in higher adherence to CONSORT guidelines in published RCTs. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the CONSORT checklist including the ten most important and poorly reported CONSORT items as defined by a group of experts of the CONSORT Statement (C-short plus usual practice); or (ii) no checklist (usual practice). The primary outcome of this study will be the difference of the mean proportion of adequately reported items of the 10 most important and poorly reported CONSORT items between the two intervention arms.

The Full protocol is available on Open Science Framework where the study was prospectively registered (https://osf.io/c4hn8)

Eligibility criteria: Inclusion Criteria:

* Included journals must:
* Endorse the CONSORT Statement (e.g. assessed via journals Instruction to Authors);
* Publish primary results of at least five RCTs in 2017 (identified in a brief PubMed search as publishing RCTs in 2017)

Included Manuscript must:

-Report primary results of an RCTs for which the journal decides to send out for external peer review (since the 10 chosen CONSORT checklist items are applicable to different study designs, the investigators will include all RCTs regardless of study design \[e.g. parallel group trial, cluster trial, superiority trial, non-inferiority trial\]).

Exclusion Criteria:

* Articles presenting clearly secondary trial results.
* Articles presenting clearly additional time points and not the time point where the primary result was measured.
* Economic analyses
* Any other analyses derived from an RCT dataset not including the study's main results -- -RCTs which are clearly labelled as a pilot or feasibility study
* RCTs randomising animals or cells instead of individuals

Included peer-reviewers:

-Peer reviewers that were invited following usual journal practice

Primary outcomes:
measure: Completeness of reporting
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Completeness of reporting
timeFrame: Through study completion, an average of 1 year
measure: Completeness of reporting
timeFrame: Through study completion, an average of 1 year
measure: Time from assigning an academic editor until the first decision (as communicated to the author after the first round of peer-review).
timeFrame: Through study completion, an average of 4 months; will be assessed from routinely collected data
measure: Proportion of articles directly rejected after the first round of peer-review
timeFrame: Through study completion, an average of 4 months; will be assessed from routinely collected data
measure: Proportion of articles published
timeFrame: Through study completion, an average of 9 months; will be assessed from routinely collected data
Other outcomes:
measure: Peer reviewer comments for any reference to CONSORT and trial reporting
timeFrame: Assessed from available peer-reviewer responses; on average 3 months after randomisation
Locations:
city: San Francisco
country: United States
facility: Public Library of Science (PLOS)
state: California
city: London
country: United Kingdom
facility: The BMJ Publishing Group
Study officials:
affiliation: Centre for Statistics in Medicine, Oxford University
name: Sally Hopewell, Ass. Prof
role: STUDY_CHAIR
References: