A Short CONSORT Checklist for Peer Reviewers to Improve the Reporting of Randomised Controlled Trials Published (CONSORT-PR)

April 20, 2023 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • The BMJ Publishing Group
  • United States
    • California
      • San Francisco, California, United States, 94111
        • Public Library of Science (PLOS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C-short plus usual practice
After accepting to review an article, peer reviewers will receive the automated, journal specific standard email with general information as per each journal's usual practice (e.g. where to access the manuscript, date when the peer review report is due). In addition, peer-reviewers who received a manuscript which was randomised to C-short will receive an additional email including a short version of the CONSORT checklist together with a short explanation of those items.
Other: C-short plus usual practice

Peer reviewer will be reminded of the following 10 CONSORT items (including a short description):

  • Outcomes (6a)
  • Sample size (7a)
  • Sequence generation (8a)
  • Allocation concealment (9)
  • Blinding (11a)
  • Outcomes and estimation (17a/b)
  • Harms (19)
  • Registration (23)
  • Protocol (24)
  • Funding (25)
No Intervention: Usual practice
After accepting to review an article, peer reviewers will receive the automated, journal specific standard email with general information as per each journal's usual practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of reporting
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of reporting
Time Frame: Through study completion, an average of 1 year
Mean proportion of adequate reporting of the 10 most important and poorly reported CONSORT items, considering each sub-item (see also "Assessment of outcomes") as a separate item.
Through study completion, an average of 1 year
Completeness of reporting
Time Frame: Through study completion, an average of 1 year
Mean proportion for each of the 10 most important and poorly reported CONSORT items separately (including also separate analysis of sub-items).
Through study completion, an average of 1 year
Time from assigning an academic editor until the first decision (as communicated to the author after the first round of peer-review).
Time Frame: Through study completion, an average of 4 months; will be assessed from routinely collected data
Through study completion, an average of 4 months; will be assessed from routinely collected data
Proportion of articles directly rejected after the first round of peer-review
Time Frame: Through study completion, an average of 4 months; will be assessed from routinely collected data
Through study completion, an average of 4 months; will be assessed from routinely collected data
Proportion of articles published
Time Frame: Through study completion, an average of 9 months; will be assessed from routinely collected data
Through study completion, an average of 9 months; will be assessed from routinely collected data

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peer reviewer comments for any reference to CONSORT and trial reporting
Time Frame: Assessed from available peer-reviewer responses; on average 3 months after randomisation
For journals where peer reviewer comments are subsequently published alongside the published article, the investigators will examine the peer reviewer comments for any reference to CONSORT and trial reporting.
Assessed from available peer-reviewer responses; on average 3 months after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Study Chair: Sally Hopewell, Ass. Prof, Centre for Statistics in Medicine, Oxford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CONSORT-PR 2019
  • R62779/RE001 (Other Identifier: MEDICAL SCIENCES INTERDIVISIONAL RESEARCH ETHICS COMMITTEE, University of Oxford)
  • P300PB_177933 (Other Grant/Funding Number: Swiss National Science Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators plan to publish the anonymised data set together with the main publication.

IPD Sharing Time Frame

The investigators plan to submit the study protocol to a peer reviewed journal in 2019.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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