Category: Technology
Objective: To understand from the patient perspective the relevance and comprehensiveness of the performance outcome (PerfO) measures administered via digital health technologies (DHTs) in the WATCH-PD study, a 12-month multi-center observational study in individuals with early, untreated Parkinson’s disease (PD).
Background: Critical Path for Parkinson’s (CPP) Consortium is one of many precompetitive public private partnerships led by Critical Path Institute, funded by industry and nonprofit organizations. CPP’s Digital Drug Development (3DT) initiative launched in 2019 as a dedicated effort aiming to advance regulatory maturity of DHTs for PD clinical trials and has been actively involved with WATCH-PD. To support the use of DHTs for clinical trial endpoint(s), the content validity of PerfO measures (WATCH-PD physical and cognitive tasks) administered via DHTs needs to be established.
Method: A subgroup of CPP 3DT members including academics, industry, and people living with PD designed this qualitative study with advice from the FDA. Purposive sampling was used to recruit a subset of participants with PD (n=40) who completed WATCH-PD for virtual interviews. The first part of the interview guide included an open-ended discussion of experienced symptoms and their impacts on daily life. The second part was dedicated to cognitive interviewing to demonstrate understanding of the WATCH-PD tasks, relevance of tasks to symptoms and daily life, and perceived importance of task completion to measure symptom progression.
Results: Mock interviews were conducted with study team members living with PD. Revisions were made to the interview guide for further probing on symptoms and clarity of cognitive interviewing questions based on their feedback.
Conclusion: The role of DHT in PerfO measure administration is evolving, and it is critical that there remains a focus on demonstrating that digitally-derived endpoints are fit-for-purpose and relevant to patients in their daily life. The content validity evidence generated from this qualitative study is an essential component. Our unique approach through a precompetitive consortium ensures involvement of all relevant stakeholders including the voice of the patient.
To cite this abstract in AMA style:
R. Speck, J. Mammen, P. Yang, S. Jensen-Roberts, M. Kostrzebski, R. Dorsey, M. Müller, J. Cosman, J. Hellsten, J. Crawford, G. Stebbins, J. Cedarbaum, T. Simuni, T. Dam, K. Ward Barowicz, D. Stephenson, J. Adams. A precompetitive consortium approach to designing a qualitative study to generate content validity evidence to support the use of digital health technologies among people with early Parkinson’s disease [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/a-precompetitive-consortium-approach-to-designing-a-qualitative-study-to-generate-content-validity-evidence-to-support-the-use-of-digital-health-technologies-among-people-with-early-parkinson/. Accessed July 4, 2025.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/a-precompetitive-consortium-approach-to-designing-a-qualitative-study-to-generate-content-validity-evidence-to-support-the-use-of-digital-health-technologies-among-people-with-early-parkinson/