This study synthesizes clinician and patient priorities—highlighting tremor, rigidity, bradykinesia, global motor function, hand/mobility difficulties, depression, and fatigue—to inform the design of a smartphone/wearable digital endpoint (PD-FIDI).

By defining clinically and patient-relevant, remotely measurable outcomes, the paper supports development of validated digital endpoints that can improve trial sensitivity and outcome measurement for Parkinson's therapeutics, though it does not address disease mechanisms or interventions directly.

BACKGROUND: Novel clinical outcome measures that accurately track Parkinson's disease (PD) progression are required to enhance patient care by improving physician decision-making and optimizing clinical trial design. The Parkinson's Disease Functional Impacts Digital Instrument (PD-FIDI) is a smartphone-app and wrist-worn wearable-based digital endpoint instrument designed to remotely measure PD functional impacts, including severity, progression, and functional changes. OBJECTIVES: Evaluate clinician- and patient-perspectives on the most relevant and meaningful aspects of PD to incorporate into the PD-FIDI. METHODS: An advisory panel of eight clinical experts guided a literature review of qualitative studies reporting patient perspectives on the everyday impacts of PD. Clinician perspectives were acquired from the same expert panel. The perspectives of people with PD were gathered through an online survey (n = 189 people with idiopathic PD; n = 13 people with PD and GBA1 mutation). Clinician- and patient-perspectives were summarized through a meaningfulness classification scheme which scaled (low, medium, or high) the reported PD functional impacts. RESULTS: Clinicians and patients considered a subset of motor (tremor, rigidity/stiffness, bradykinesia, global motor function, and hand and mobility difficulties) and non-motor (depression and fatigue) PD aspects to be most bothersome and meaningful if improved. CONCLUSIONS: PD aspects identified as highly meaningful were incorporated into the PD-FIDI's design where technically viable, operationally feasible, and safe. Results support the evaluation of the PD-FIDI in an ongoing clinical study which will determine the instruments' analytical and clinical validity and usability.