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Completed

NCT Number: NCT05820971

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The BMJ Publishing Group, London, United Kingdom

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C-short plus usual practice

Other

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

  4. 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

  5. Proportion of articles published

    Time frame: Through study completion, an average of 9 months; will be assessed from routinely collected data

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Acronym: CONSORT-PR

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2023
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.