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

Day, JO, Smith, S, Noyce, AJ, Alty, J ORCID: 0000-0002-5456-8676, Jeffery, A, Chapman, R and Carroll, C 2022 , 'Challenges of incorporating digital health technology outcomes in a clinical trial: experiences from PD STAT' , Journal of Parkinson's Disease, vol. 12, no. 5 , pp. 1605-1609 , doi: https://doi.org/10.3233/JPD-223162.

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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 Parkinsons 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 Type: Article
Authors/Creators:Day, JO and Smith, S and Noyce, AJ and Alty, J and Jeffery, A and Chapman, R and Carroll, C
Keywords: Parkinson's, digital technologies, clinical trials, phase 3, Parkinson's disease, digital outcomes, sensors, data management
Journal or Publication Title: Journal of Parkinson's Disease
Publisher: IOS Press
ISSN: 1877-7171
DOI / ID Number: https://doi.org/10.3233/JPD-223162
Copyright Information:

© 2022 The authors. Published by IOS Press.This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non Commercial 4.0 International (CC BY-NC 4.0) License, (https://creativecommons.org/licenses/by-nc/4.0/)

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