<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03751878</url>
  </required_header>
  <id_info>
    <org_study_id>EC 02</org_study_id>
    <nct_id>NCT03751878</nct_id>
  </id_info>
  <brief_title>Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors</brief_title>
  <official_title>Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitat Politècnica de Catalunya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The BMJ</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitat Politècnica de Catalunya</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomised trials are considered the gold standard in medical research. The CONSORT&#xD;
      (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of&#xD;
      reporting of randomised trials. Without transparent reporting, readers cannot judge the&#xD;
      reliability and validity of trial findings, and therefore these findings cannot inform&#xD;
      clinical practice. Different stakeholders, including biomedical journals, have taken&#xD;
      different actions to try to improve author adherence to CONSORT. The most popular action&#xD;
      among biomedical journals is to instruct authors to submit a completed RG checklist with page&#xD;
      numbers indicating where the CONSORT items are addressed when they submit their manuscript.&#xD;
      However, this measure alone has been proven not to be effective. In this study, the&#xD;
      investigators intend to evaluate in a real editorial context whether assessing during peer&#xD;
      review the consistency between the submitted CONSORT checklist and the information reported&#xD;
      in the manuscripts of randomised trials, as well as to provide feedback to authors on the&#xD;
      inconsistencies found, improves the completeness of reporting of published trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomised trials are considered the gold standard in medical research. The CONSORT&#xD;
      (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of&#xD;
      reporting of randomised trials. Without transparent reporting, readers cannot judge the&#xD;
      reliability and validity of trial findings, and therefore these findings cannot inform&#xD;
      clinical practice.&#xD;
&#xD;
      In recent years, different stakeholders have acted to boost the completeness of reporting of&#xD;
      the published randomised trials, and therefore their transparency and reproducibility. In a&#xD;
      recently completed scoping review, the investigators identified and classified 31&#xD;
      interventions to improve adherence to reporting guidelines. This review revealed that it is&#xD;
      primarily journals that have taken most efforts to improve the completeness of reporting of&#xD;
      randomised trials - although most of their actions have been shown not to have the desired&#xD;
      effect.&#xD;
&#xD;
      One of the most popular strategies used by journals to improve adherence to CONSORT requires&#xD;
      authors to submit a populated checklist together with their manuscript indicating page&#xD;
      numbers corresponding to each item. However, journals usually lack further actions throughout&#xD;
      the editorial process to ensure that the corresponding information to each item is reported&#xD;
      in the randomised trial manuscript. This has been hypothesized to be one of the reasons why&#xD;
      this editorial strategy has not achieved optimal results.&#xD;
&#xD;
      In an effort to take full advantage of requiring the submission of populated checklists, the&#xD;
      investigators intend to evaluate in a real editorial context whether assessing during peer&#xD;
      review the consistency between the submitted CONSORT checklist and the information reported&#xD;
      in the manuscripts of randomised trials, as well as to provide feedback to authors on the&#xD;
      inconsistencies found, improves the completeness of reporting of published trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">April 13, 2019</completion_date>
  <primary_completion_date type="Actual">April 13, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall completeness of reporting</measure>
    <time_frame>Following manuscript revision (usually 2-3 months)</time_frame>
    <description>Proportion of adequately reported CONSORT items in the first revised manuscript</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Completeness of reporting for each item</measure>
    <time_frame>Following manuscript revision (usually 2-3 months)</time_frame>
    <description>Proportion of manuscripts where each CONSORT item is adequately reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to perform the evaluation</measure>
    <time_frame>Following the evaluation of reporting inconsistencies (1 week)</time_frame>
    <description>Time to perform the evaluation of reporting inconsistencies by the lead investigator (DB)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Peer Review, Publishing</condition>
  <condition>Completeness of Reporting</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript. Feedback is provided to authors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard peer review process.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Evaluation of reporting inconsistencies</intervention_name>
    <description>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.&#xD;
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.&#xD;
This editor will include the report in the letter to authors alongside the standard peer review reports.</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Peer Review.</intervention_name>
    <description>Manuscripts will undergo the usual peer review process.</description>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Manuscripts will be eligible if:&#xD;
&#xD;
          -  They have been submitted to BMJ Open,&#xD;
&#xD;
          -  They are original research submissions reporting the results of a randomised trial,&#xD;
             and&#xD;
&#xD;
          -  They have passed the first editorial filters and have been subsequently sent out for&#xD;
             peer review.&#xD;
&#xD;
          -  Authors of these manuscripts have provided a completed CONSORT checklist.&#xD;
&#xD;
        According to the official CONSORT extensions, the investigators will also consider other&#xD;
        study designs (cluster, non-inferiority and equivalence, pragmatic, N-of-1 trials, Pilot&#xD;
        and feasibility, and within person trials), and different intervention types (Herbal,&#xD;
        non-pharmacologic, acupuncture and Chinese herbal medicine formulas) in all areas of&#xD;
        clinical specialty.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Protocols of randomised trials&#xD;
&#xD;
          -  Secondary trial analysis studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara Schroter</last_name>
    <role>Study Chair</role>
    <affiliation>The BMJ, London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adrian Aldcroft</last_name>
    <role>Study Chair</role>
    <affiliation>The BMJ, London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Moher</last_name>
    <role>Study Chair</role>
    <affiliation>Ottawa Hospital Research Institute, Ottawa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isabelle Boutron</last_name>
    <role>Study Chair</role>
    <affiliation>Paris Descartes University, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jamie J Kirkham</last_name>
    <role>Study Chair</role>
    <affiliation>University of Liverpool, Liverpool</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Erik Cobo</last_name>
    <role>Study Chair</role>
    <affiliation>Universitat Politècnica de Catalunya, Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BMJ Open</name>
      <address>
        <city>London</city>
        <zip>WC1H 9JR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>May 18, 2019</last_update_submitted>
  <last_update_submitted_qc>May 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitat Politècnica de Catalunya</investigator_affiliation>
    <investigator_full_name>David Blanco</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Reporting guidelines</keyword>
  <keyword>CONSORT</keyword>
  <keyword>Adherence</keyword>
  <keyword>Completeness of reporting</keyword>
  <keyword>Quality of reporting</keyword>
  <keyword>Peer review</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03751878/Prot_SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>May 31, 2022</submitted>
    <returned>March 15, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03751878
org study id: EC 02
nct id: NCT03751878
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Overall completeness of reporting
time frame: Following manuscript revision (usually 2-3 months)
description: Proportion of adequately reported CONSORT items in the first revised manuscript
measure: Completeness of reporting for each item
time frame: Following manuscript revision (usually 2-3 months)
description: Proportion of manuscripts where each CONSORT item is adequately reported
measure: Time to perform the evaluation
time frame: Following the evaluation of reporting inconsistencies (1 week)
description: Time to perform the evaluation of reporting inconsistencies by the lead investigator (DB)
arm group label: Intervention arm
arm group type: Experimental
description: Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript. Feedback is provided to authors.
arm group label: Control arm
arm group type: Other
description: Standard peer review process.
intervention type: Behavioral
intervention name: Evaluation of reporting inconsistencies
description: 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.
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.
This editor will include the report in the letter to authors alongside the standard peer review reports.
arm group label: Intervention arm
intervention type: Behavioral
intervention name: Standard Peer Review.
description: Manuscripts will undergo the usual peer review process.
arm group label: Control arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sara Schroter
role: Study Chair
affiliation: The BMJ, London
last name: Adrian Aldcroft
role: Study Chair
affiliation: The BMJ, London
last name: David Moher
role: Study Chair
affiliation: Ottawa Hospital Research Institute, Ottawa
last name: Isabelle Boutron
role: Study Chair
affiliation: Paris Descartes University, Paris
last name: Jamie J Kirkham
role: Study Chair
affiliation: University of Liverpool, Liverpool
last name: Erik Cobo
role: Study Chair
affiliation: Universitat Politècnica de Catalunya, Barcelona
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Universitat Politècnica de Catalunya
investigator full name: David Blanco
investigator title: Principal Investigator
sharing ipd: No
ipd 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.
provided document: 
submitted: May 31, 2022
returned: March 15, 2023