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Do we have to Include HCI Issues in Clinical Trials of Medical Devices? – A Discussion

    • Copenhagen University Hospital
    • University of Copenhagen

    Research output: Conference Article in Proceeding or Book/Report chapterArticle in proceedingsResearchpeer-review

    Abstract

    Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues.
    Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to the use of digital devices in treatments the protocols from the field of medicine is adopted. The question is whether or not this evidence based approach is useful when dealing with digital devices and whether the understanding of the efficiency of a treatment can be obtained without also looking at usability and lifestyle issues.
    Based on a case study of epilepsy, a literature study of protocols for investigating treatments using digital medical devices, the set-up of studies, the design of a current protocol for clinical trials, and finally preliminary results, we discuss if clinical trials have to include usability studies to determine if a treatment is effective.
    Original languageEnglish
    Title of host publicationOzCHI '17, Proceedings of the 29th Australian Conference on Computer-Human Interaction : November 28-December 1, 2017, Brisbane, QLD, Australia
    Number of pages4
    Place of PublicationBrisbane
    PublisherAssociation for Computing Machinery
    Publication date28 Nov 2017
    Pages352-355
    ISBN (Electronic)978-1-4503-5379-3
    DOIs
    Publication statusPublished - 28 Nov 2017
    EventOZCHI17: Human-Nature - Brisbane, Brisbane, QLD, , Australia
    Duration: 28 Nov 20171 Dec 2017
    Conference number: 29
    http://www.ozchi.org/2017/

    Conference

    ConferenceOZCHI17
    Number29
    Location Brisbane
    Country/TerritoryAustralia
    City Brisbane, QLD,
    Period28/11/201701/12/2017
    Internet address

    Keywords

    • Medical devise
    • Evidence-based medicine
    • Clinical Trial
    • usability
    • Lifestyle issues

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