NCT03751878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2019

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

November 21, 2018

Last Update Submit

May 18, 2019

Conditions

Peer Review, PublishingCompleteness of Reporting

Keywords

Reporting guidelinesCONSORTAdherenceCompleteness of reportingQuality of reportingPeer review

Outcome Measures

Primary Outcomes (1)

  • Overall completeness of reporting

    Proportion of adequately reported CONSORT items in the first revised manuscript

    Following manuscript revision (usually 2-3 months)

Secondary Outcomes (2)

  • Completeness of reporting for each item

    Following manuscript revision (usually 2-3 months)

  • Time to perform the evaluation

    Following the evaluation of reporting inconsistencies (1 week)

Study Arms (2)

Intervention arm

EXPERIMENTAL

Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript. Feedback is provided to authors.

Behavioral: Evaluation of reporting inconsistencies

Control arm

OTHER

Standard peer review process.

Behavioral: Standard Peer Review.

Interventions

Evaluation of reporting inconsistenciesBEHAVIORAL

1. The completed CONSORT checklist submitted by authors of manuscripts randomised to the intervention group will be assessed by the lead investigator (DB) as to whether it is consistent with the information that was actually reported in the manuscript. This evaluation will be focused on 8 core CONSORT items. 2. DB will produce a standardised report containing precise requests for authors in order to improve the completeness of reporting of the items where reporting inconsistencies were found. This report will consist of a brief introduction followed by a point by point description of the inconsistencies found together with precise requests related to the information missing and examples extracted from CONSORT. DB will upload this report to the submission on the managing system of the journal (Scholar One) to make it accessible to the handling editor of the manuscript. 3. This editor will include the report in the letter to authors alongside the standard peer review reports.

Intervention arm
Standard Peer Review.BEHAVIORAL

Manuscripts will undergo the usual peer review process.

Control arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Protocols of randomised trials
  • Secondary trial analysis studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMJ Open

London, WC1H 9JR, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32430454DERIVED

Study Officials

  • Sara Schroter

    The BMJ, London

    STUDY CHAIR

  • Adrian Aldcroft

    The BMJ, London

    STUDY CHAIR

  • David Moher

    Ottawa Hospital Research Institute, Ottawa

    STUDY CHAIR

  • Isabelle Boutron

    Paris Descartes University, Paris

    STUDY CHAIR

  • Jamie J Kirkham

    University of Liverpool, Liverpool

    STUDY CHAIR

  • Erik Cobo

    Universitat Politècnica de Catalunya, Barcelona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 23, 2018

Study Start

December 7, 2018

Primary Completion

April 13, 2019

Study Completion

April 13, 2019

Last Updated

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

The content of the interventional peer review reports will appear as part of the review history of the manuscripts. However, in order to protect confidentiality, no dataset including individual manuscript data or outcome data identifying the performance of individual participants will be released. When the study is finished, DB will assign a study number to each paper and store that code with the manuscript ID, password protect it, and store it (File 1) in the BMJ Google Drive folder for the study. In this file, we will also include all identifying variables (Submission date, Trial registration number, Title, Latest editorial decision, applicable CONSORT extensions). For the file containing the peer review reports and the study outcomes (File 2), DB will strip all identifying variables other than the study code and store that file separate from File 1. DB will stick all study files in one folder, compress this folder using WinZip, password protect it, and store it in the same folder.

Locations

GB(1)