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Challenges of Incorporating Digital Health Technology Outcomes in a Clinical Trial: Experiences from PD STAT

Lookup NU author(s): Professor Camille CarrollORCiD

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Abstract

© 2022 - The authors. Published by IOS Press.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 Parkinson's 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.

Publication metadata

Author(s): Day JO, Smith S, Noyce AJ, Alty J, Jeffery A, Chapman R, Carroll C

Publication type: Article

Publication status: Published

Journal: Journal of Parkinson's Disease

Year: 2022

Volume: 12

Issue: 5

Pages: 1605-1609

Online publication date: 08/07/2022

Acceptance date: 01/04/2022

Date deposited: 31/01/2024

ISSN (print): 1877-7171

ISSN (electronic): 1877-718X

Publisher: IOS Press BV

URL: https://doi.org/10.3233/JPD-223162

DOI: 10.3233/JPD-223162

PubMed id: 35466954

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