Patient-centered Development of a Composite Digital Endpoint of Mobility and Pain for Knee Osteoarthritis

This project aims to develop a novel composite digital endpoint tailored to integrate synchronous digital measures of pain and gait patterns in daily life. The project will employ a patient-centered approach within the Verification, Analytical Validation, Usability Validation, and Clinical Validation (V3+) framework. During the UG3 phase, the project will focus on technology selection and development, analytical validation (n = 60), and initial usability validation. The UH3 phase will involve clinical validation using data from an existing large-scale cohort study (the Multicenter Osteoarthritis Study, MOST; n ~ 2000) and a new placebo-controlled randomized clinical trial (n = 140) of intra-articular corticosteroid therapy in individuals with knee OA.