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

NCT ID: NCT05820971

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2022-06-30

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)

Conditions

Adequate Reporting in Randomized Controlled Trials

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

C-short plus usual practice

Intervention Type: 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)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally Hopewell, Ass. Prof

Role: STUDY_CHAIR

Centre for Statistics in Medicine, Oxford University

Locations

Public Library of Science (PLOS)

San Francisco, California, United States

The BMJ Publishing Group

London, , United Kingdom

Countries

United States; United Kingdom

References

Speich B, Mann E, Schonenberger CM, Mellor K, Griessbach AN, Dhiman P, Gandhi P, Lohner S, Agarwal A, Odutayo A, Puebla I, Clark A, Chan AW, Schlussel MM, Ravaud P, Moher D, Briel M, Boutron I, Schroter S, Hopewell S. Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials. JAMA Netw Open. 2023 Jun 1;6(6):e2317651. doi: 10.1001/jamanetworkopen.2023.17651.

Reference Type: DERIVED

PMID: 37294569 (View on PubMed)

Other Identifiers

R62779/RE001

Identifier Type: OTHER

Identifier Source: secondary_id

P300PB_177933

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CONSORT-PR 2019

Identifier Type: -

Identifier Source: org_study_id