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Web-based Tool to Improve Reporting of Randomized Controlled Trials (WebCONSORT)

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ClinicalTrials.gov Identifier: NCT01891448
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE May 24, 2013
First Posted Date  ICMJE July 3, 2013
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE March 25, 2013
Actual Primary Completion Date September 22, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2013)		 Completeness of reporting [ Time Frame: Following manuscript revision at 3 months ]
The proportion of most poorly reported CONSORT items (initial and extensions) reported in each article.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 28, 2013)
  • Rejection rate [ Time Frame: Following manuscript revision at 3 months ]
    The rejection rate of articles by journal.
  • Compliance rate [ Time Frame: Following manuscript revision at 3 months ]
    The compliance rate of the authors with submitting a checklist to the journal.
  • Feedback [ Time Frame: Following manuscript revision at 3 months ]
    Feedback from authors on the review process after the editor's decision, and feedback from journal editors.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Web-based Tool to Improve Reporting of Randomized Controlled Trials
Official Title  ICMJE Impact of an Intervention Using a Web-based Tool to Improve the Reporting of Randomized Controlled Trials
Brief Summary The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized trials. If trials are not well reported it is difficult for clinicians to use best evidence to inform clinical practice and patients may not get the best care. A number of different CONSORT extensions have been developed which specify additional information needed for more complex trials. The aim of this project is to evaluate whether using a simple web-based tool (WEBCONSORT) improves the reporting of clinical trials. The tool combines different CONSORT extensions and allows authors to obtain a checklist and flow diagram which is specific to their individual trial. In this study authors of participating journals are requested, at the manuscript revision stage, to use a web-based tool to improve the reporting of their randomized trial. Authors registering to use the tool are randomized to intervention or control. In the intervention group authors are directed to the WebCONSORT tool. In the control group, authors are directed to a different version of the WebCONSORT tool which includes the flow diagram part of the tool but not the main checklist or elements relating to CONSORT extensions. The aim is that this tool should lead to improvements in the reporting of randomized trials, making it easier for clinicians to read and interpret published findings.
Detailed Description The CONSORT (Consolidated Standards of Reporting Trials) Statement (www.consort-statement.org) is an evidence based guideline which aims to improve the reporting of randomized controlled trials. If trials are not well reported it is difficult for clinicians to use best evidence to inform clinical practice and patients may not get the best care. A number of different CONSORT extensions have been developed which specify additional information needed for more complex trials.We are conducting a multicentre randomized controlled trial to evaluate whether using a simple web-based tool (WebCONSORT) improves the completeness of reporting of clinical trials. To be eligible for inclusion in this study journals must publish reports of randomized trials and endorse the CONSORT Statement (e.g. refer to it on the journal website) but do not actively implement it (e.g. require authors to submit a completed CONSORT checklist at the time of manuscript submission. Participating journals ask authors to register their manuscript (at the revision stage of the manuscript) on the WebCONSORT website where he or she will be randomized into one of two groups (i.e. intervention and control). In the intervention group, authors will be directed to the WebCONSORT tool. The tool allows authors to combine different extensions relevant to their trial and generate a list of items and a flowchart specific to their trial design and the type of intervention tested. The checklist of items generated by the WebCONSORT tool should then be reported in the revised paper and the completed checklist and flow diagram submitted to the journal along with the revised manuscript.In the control group, authors will be directed to a different version of the WebCONSORT tool. This tool will include the flowchart part of the WEBCONSORT tool but not the main checklist or elements relating to CONSORT extensions. The primary outcome measure is the percentage of poorly reported methodological items in the submitted manuscript. Secondary outcomes include time spent on the WEBCONSORT website, rejection rate of studies, feedback from authors and compliance rate. It is anticipated that the web-based tool will lead to improvements in the reporting and transparency of trial findings, thus aiding their critical appraisal and interpretation by readers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Randomized Controlled Trial
Intervention  ICMJE
  • Other: WebCONSORT tool
    Authors are directed to the WebCONSORT tool. The tool allows authors to obtain a customized CONSORT checklist and flow diagram specific to their trial design (e.g., non-inferiority trial, pragmatic trial, cluster trial) and type of intervention (e.g., pharmacological or non pharmacological). The checklist items and flow diagram should then be reported in the manuscript and the completed checklist submitted to the journal along with the revision.
  • Other: Modified WebCONSORT tool
    Authors are directed to a different version of the WebCONSORT tool. This tool includes the flow diagram part of the tool but not the main checklist or elements relating to CONSORT extensions.
Study Arms  ICMJE
  • Experimental: WebCONSORT tool
    This WebCONSORT tool allows authors to combine different extensions relevant to their trial and generate a list of items and a flowchart specific to their trial design and the type of intervention tested.
    Intervention: Other: WebCONSORT tool
  • Modified WebCONSORT tool
    This tool will include the flowchart part of the WEBCONSORT tool but not the main checklist or elements relating to CONSORT extensions.
    Intervention: Other: Modified WebCONSORT tool
Publications * Hopewell S, Boutron I, Altman DG, Barbour G, Moher D, Montori V, Schriger D, Cook J, Gerry S, Omar O, Dutton P, Roberts C, Frangou E, Clifton L, Chiocchia V, Rombach I, Wartolowska K, Ravaud P. Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial. BMC Med. 2016 Nov 28;14(1):199. doi: 10.1186/s12916-016-0736-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2018)		 324
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2013)		 300
Actual Study Completion Date  ICMJE September 22, 2015
Actual Primary Completion Date September 22, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Journals which publish reports of randomized trials and endorse the CONSORT Statement (e.g. refer to it on the journal website) but do not actively implement it (e.g. require authors to submit a completed CONSORT checklist at the time of manuscript submission).

Exclusion Criteria:

  • Journals which endorse the CONSORT Statement (e.g. refer to it on the journal website) and actively implement it (e.g. require authors to submit a completed CONSORT checklist at the time of manuscript submission).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01891448
Other Study ID Numbers  ICMJE RAV008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Oxford
Investigators  ICMJE
Principal Investigator: Philippe Ravaud, PhD Université Paris Descartes
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP