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

Jacob O. Day; Stephen Smith; Alastair J. Noyce; Jane Alty; Alison Jeffery; Rebecca Chapman; Camille Carroll

doi:10.3233/jpd-223162

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

Jacob O. Day^*, Stephen Smith, Alastair J. Noyce, Jane Alty, Alison Jeffery, Rebecca Chapman, Camille Carroll

^*Corresponding author for this work

Peninsula Medical School

Research output: Contribution to journal › Article › peer-review

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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 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.

Original language	English
Pages (from-to)	1-5
Number of pages	0
Journal	Journal of Parkinson's Disease
Volume	0
Issue number	0
Early online date	20 Apr 2022
DOIs	https://doi.org/10.3233/jpd-223162
Publication status	Published - 20 Apr 2022

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JPD223162 Challenges

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AU - Jeffery, Alison

AU - Chapman, Rebecca

AU - Carroll, Camille

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AB - 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.

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

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