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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

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.

Condition or disease Intervention/treatment Phase
Randomized Controlled Trial Other: WebCONSORT tool Other: Modified WebCONSORT tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Impact of an Intervention Using a Web-based Tool to Improve the Reporting of Randomized Controlled Trials
Actual Study Start Date : March 25, 2013
Actual Primary Completion Date : September 22, 2015
Actual Study Completion Date : September 22, 2015

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Rejection rate [ Time Frame: Following manuscript revision at 3 months ]
    The rejection rate of articles by journal.

  2. Compliance rate [ Time Frame: Following manuscript revision at 3 months ]
    The compliance rate of the authors with submitting a checklist to the journal.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891448


Locations
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France
Université Paris Descartes
Paris, France
United Kingdom
University of Oxford
Oxford, United Kingdom
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
University of Oxford
Investigators
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Principal Investigator: Philippe Ravaud, PhD Université Paris Descartes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01891448     History of Changes
Other Study ID Numbers: RAV008
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018