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Challenges of incorporating digital health technology outcomes in a clinical trial: experiences from PD STAT

Citation

Day, JO and Smith, S and Noyce, AJ and Alty, J and Jeffery, A and Chapman, R and Carroll, C, Challenges of incorporating digital health technology outcomes in a clinical trial: experiences from PD STAT, Journal of Parkinson's Disease pp. 1-5. ISSN 1877-7171 (In Press) [Refereed Article]


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DOI: doi:10.3233/JPD-223162

Abstract

Digital health technologies (DHTs) have great potential for use as clinical trial outcomes; however, practical issues need to be addressed in order to maximise their benefit. We describe our experience of incorporating two DHTs as secondary/exploratory outcome measures in PD STAT, a randomised clinical trial of simvastatin in people with Parkinsonís disease. We found much higher rates of missing data in the DHTs than the traditional outcome measures, in particular due to technical and software difficulties. We discuss methods to address these obstacles in terms of protocol design, workforce training and data management.

Item Details

Item Type:Refereed Article
Keywords:Parkinson's, digital technologies, clinical trials, phase 3, Parkinson's disease, digital outcomes, sensors, data management
Research Division:Biomedical and Clinical Sciences
Research Group:Clinical sciences
Research Field:Geriatrics and gerontology
Objective Division:Health
Objective Group:Evaluation of health and support services
Objective Field:Evaluation of health outcomes
UTAS Author:Alty, J (Associate Professor Jane Alty)
ID Code:149943
Year Published:In Press
Deposited By:Wicking Dementia Research and Education Centre
Deposited On:2022-05-02
Last Modified:2022-05-02
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