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

• Sponsor: Universitat Politècnica de Catalunya
• Collaborators: University of Liverpool; The BMJ
• Information provided by (Responsible Party): David Blanco, Universitat Politècnica de Catalunya

Tracking Information

• First Submitted Date: November 21, 2018
• First Posted Date: November 22, 2018
• Last Update Posted Date: May 21, 2019
• Actual Study Start Date: December 7, 2018
• Actual Primary Completion Date: April 13, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 30, 2019)

Overall completeness of reporting [ Time Frame: Following manuscript revision (usually 2-3 months) ]

Proportion of adequately reported CONSORT items in the first revised manuscript

Original Primary Outcome Measures (submitted: November 21, 2018)

Completeness of reporting [ Time Frame: Following manuscript revision (usually 2-3 months) ]

Proportion of adequately reported CONSORT items

• Change History: Complete list of historical versions of study NCT03751878 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: April 30, 2019)

• 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
• 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)

Original Secondary Outcome Measures (submitted: November 21, 2018)

• Percentage of manuscript compliance with the checklist [ Time Frame: Following the evaluation of reporting inconsistencies (1 week) ]
  Percentage of compliance between the checklist and the manuscript for the trials in the intervention arm
• 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).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors
• Official Title: Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Peer Review, Publishing
• Completeness of Reporting

Intervention

• Behavioral: Evaluation of reporting inconsistencies
  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.
• Behavioral: Standard Peer Review.
  Manuscripts will undergo the usual peer review process.

Study Arms

• Experimental: Intervention arm
  Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript. Feedback is provided to authors.
  Intervention: Behavioral: Evaluation of reporting inconsistencies
• Control arm
  Standard peer review process.
  Intervention: Behavioral: Standard Peer Review.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 21, 2018): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 13, 2019
• Actual Primary Completion Date: April 13, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03751878
• Other Study ID Numbers: EC 02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• 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.

• Responsible Party: David Blanco, Universitat Politècnica de Catalunya
• Study Sponsor: Universitat Politècnica de Catalunya

Collaborators

• University of Liverpool
• The BMJ

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

• PRS Account: Universitat Politècnica de Catalunya
• Verification Date: May 2019