Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors

May 18, 2019 updated by: David Blanco, Universitat Politècnica de Catalunya

Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial

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.

Study Overview

Detailed Description

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.

In recent years, different stakeholders have acted to boost the completeness of reporting of the published randomised trials, and therefore their transparency and reproducibility. In a recently completed scoping review, the investigators identified and classified 31 interventions to improve adherence to reporting guidelines. This review revealed that it is primarily journals that have taken most efforts to improve the completeness of reporting of randomised trials - although most of their actions have been shown not to have the desired effect.

One of the most popular strategies used by journals to improve adherence to CONSORT requires authors to submit a populated checklist together with their manuscript indicating page numbers corresponding to each item. However, journals usually lack further actions throughout the editorial process to ensure that the corresponding information to each item is reported in the randomised trial manuscript. This has been hypothesized to be one of the reasons why this editorial strategy has not achieved optimal results.

In an effort to take full advantage of requiring the submission of populated checklists, 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.

Study Type

Interventional

Enrollment (Actual)

24

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • Protocols of randomised trials
  • Secondary trial analysis studies

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript. Feedback is provided to authors.
  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.
Other: Control arm
Standard peer review process.
Manuscripts will undergo the usual peer review process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall completeness of reporting
Time Frame: Following manuscript revision (usually 2-3 months)
Proportion of adequately reported CONSORT items in the first revised manuscript
Following manuscript revision (usually 2-3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of reporting for each item
Time Frame: Following manuscript revision (usually 2-3 months)
Proportion of manuscripts where each CONSORT item is adequately reported
Following manuscript revision (usually 2-3 months)
Time to perform the evaluation
Time Frame: Following the evaluation of reporting inconsistencies (1 week)
Time to perform the evaluation of reporting inconsistencies by the lead investigator (DB)
Following the evaluation of reporting inconsistencies (1 week)

Collaborators and Investigators

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

Investigators

  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 7, 2018

Primary Completion (Actual)

April 13, 2019

Study Completion (Actual)

April 13, 2019

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 18, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

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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