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  • A core outcome set for clinical trials in whiplash-associated disorders (WAD): a study protocol

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    Author(s)
    Maujean, Annick
    Carroll, Linda
    Curatolo, Michele
    Elliott, James
    Kasch, Helge
    Walton, David
    Sterling, Michele
    Griffith University Author(s)
    Sterling, Michele
    Year published
    2018
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    Abstract
    Background: Whiplash-associated disorders (WAD) as a consequence of a motor vehicle crash are a costly health burden in Western societies. Up to 50% of injured people do not fully recover. There have been numerous clinical trials and cohort studies conducted for WAD with many varied outcome measures used, making data pooling difficult and hindering meta-analysis. These issues could be addressed through the development of a core outcome set (COS) that should be included in all clinical trials for WAD. The purpose of this project is to develop and disseminate a COS for clinical trials in WAD. Methods/design: An international ...
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    Background: Whiplash-associated disorders (WAD) as a consequence of a motor vehicle crash are a costly health burden in Western societies. Up to 50% of injured people do not fully recover. There have been numerous clinical trials and cohort studies conducted for WAD with many varied outcome measures used, making data pooling difficult and hindering meta-analysis. These issues could be addressed through the development of a core outcome set (COS) that should be included in all clinical trials for WAD. The purpose of this project is to develop and disseminate a COS for clinical trials in WAD. Methods/design: An international Steering Committee was formed to initiate and support the development of this COS. The project will comprise five phases: (1) a comprehensive review of core outcome domains used in clinical trials in WAD, (2) an international Delphi survey including individuals with WAD, health care providers, clinical researchers and insurance personnel to define the core outcome domains, (3) a meeting of relevant stakeholders to reach consensus regarding the final core outcome domains, (4) identification and evaluation of instruments used to measure the final core outcome domains, and (5) a consensus meeting to agree on the core outcome measurement instruments to be used. Discussion: The aim of this proposal is to complete a five-stage process to develop a COS for all clinical trials in WAD. An implementation strategy will also be proposed.
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    Journal Title
    TRIALS
    Volume
    19
    DOI
    https://doi.org/10.1186/s13063-018-3019-3
    Copyright Statement
    © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
    Subject
    Cardiorespiratory Medicine and Haematology
    Clinical Sciences
    Publication URI
    http://hdl.handle.net/10072/383057
    Collection
    • Journal articles

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