QL19
The Association Between Digitally Assessed Patient-Reported Outcomes and In-Clinic Assessments in the FLOODLIGHT Study in Multiple Sclerosis
Patient-reported outcomes (PROs) provide insight on treatment benefit from the patient’s perspective. A diverse range of PROs, typically administered as self-reported questionnaires, are used in clinical trials of multiple sclerosis (MS). Sensor-based, high-yield active and passive monitoring may be more sensitive than periodic in-clinic assessments for tracking changes in MS disease status and symptom severity.
Objectives:
To determine whether remote smartphone/smartwatch-based assessments in patients with MS are sensitive to changes in PROs compared with in-clinic, conventionally assessed MS outcomes.
Methods:
Patients (n=80) diagnosed with MS (McDonald 2010 criteria, 18–55 years of age, with an Expanded Disability Status Scale [EDSS] score of 0–5.5) and healthy controls (n=40) will be enrolled from two MS centers. For 24 weeks, participants will be given a preconfigured smartphone and smartwatch that prompt the user to perform the FLOODLIGHT test battery, comprising a combination of “active tests” (daily hand motor function, gait and static balance tests; weekly cognitive tests; and PROs) and “passive monitoring” (ongoing collection of metrics on gait and mobility). PROs will include the following smartphone-based assessments: Mood Scale question, a single question administered daily to assess patients’ perceived overall state, and Multiple Sclerosis Impact Scale-29 (version 2), a 29-item questionnaire administered biweekly to evaluate the physical and psychological impact of MS from the patient’s perspective. A wide range of in-clinic reference tests (including EDSS, 9-hole peg test, timed 25-foot walk test, Patient Health Questionnaire [PHQ-9] and Fatigue Scale for Motor and Cognitive Functions) will be performed at enrollment and Weeks 12 and 24. The primary endpoint will assess participants’ adherence by evaluating the number of tests conducted vs the total number of expected tests.
Results:
Data on enrollment status and the FLOODLIGHT test battery components will be presented, including the association between self-administered PROs and in-clinic reference tests.
Conclusions:
This study will evaluate the association between self-administered PRO data captured remotely using smartphone-based assessments and in-clinic, conventional measures in patients with MS and will help determine the feasibility of adopting digital technology for enhanced monitoring of the impact of MS on patients’ quality of life.