Validation of Fox Insight Cohort via Virtual Research Visits (4749)

Objective: To describe the results of a remote cross-sectional study examining the validity of self-reported Parkinson’s disease (PD) diagnosis among Fox Insight participants.

Background: Participation in traditional clinical research studies is restricted by disability and geographical location. New research methods are needed to reach a broader population; the Michael J. Fox Foundation for Parkinson’s Research has implemented Fox Insight, a large-scale prospective online clinical research study. Currently, over 40,000 participants have enrolled and the study may offer valuable insights into the natural history of PD; however, self-reported disease state has not yet been validated in this cohort.

Design/Methods: Over approximately eight months, we enrolled 213 Fox Insight participants and completed visits with 203 individuals (165 with self-reported PD and 38 without). Enrollment was stratified by self-reported disease state and disease duration. Participants completed standard patient- and clinician-reported outcome measures over two virtual visits conducted using web-based videoconferencing software. The most likely diagnosis was determined based on expert clinical assessment.

Results: Agreement between self-reported and clinician-determined PD diagnosis was very good (kappa=0.85, 95% CI 0.76–0.94). Disagreement occurred in 10/203 cases. Of the eight cases with self-reported PD, four had an alternative cause of parkinsonism and four did not have parkinsonism. Of the two cases without self-reported PD, both had a clinician-determined diagnosis of PD. The clinician-determined PD cohort (n=159) was 61% male, 95% Caucasian, and had a mean (SD) age of 66.7 (8.9), MDS-UPDRS motor score 23.1 (12.1), Montreal Cognitive Assessment score 25.3 (3.6), and modified Schwab & England 85.2 (12.7). Over 95% were satisfied with the study and were willing to participate in future research studies with virtual visits.

Conclusions: Self-reported PD diagnosis in Fox Insight is accurate. Virtual visits can expand the clinical characterization of participants in online clinical research studies and interest in participating in studies with virtual visits is high.

Disclosure: Dr. Schneider has received research support from Biohaven Pharma, Acadia Pharmaceuticals, Pfizer Pharmaceuticals. Dr. Myers has nothing to disclose. Dr. Daeschler has nothing to disclose. Dr. Tarolli has nothing to disclose. Dr. Adams has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with VisualDx. Dr. Adams has received research support from Biogen.Dr. Barbano has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with VisualDx, Oscine Corporation, Ipsen, Merz, Revance, Allergan. Dr. Barbano has received personal compensation in an editorial capacity for AAN. Dr. Barbano holds stock and/or stock options in VisualDx. Dr. Barbano has received research support from Vaccinex, Revance. Dr. Riley has nothing to disclose. Dr. Amondikar has nothing to disclose. Dr. Auinger has nothing to disclose. Dr. Gil Diaz has nothing to disclose. Dr. Dorsey has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Roche; Sanofi; Clintrex; Olson Research Group, Inc.; Denali Therapetuics; Biogen; Abbvie; DeciBio; Prilenia. He has ownerships interests with Blackfynn and Grand Rounds. Dr. Dorsey has received personal compensation in an editorial capacity for Karger. Dr. Dorsey has received research support from Biogen; Pfizer; Biosensics; Abbvie.Dr. Marras has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Grey Matter Technologies LLC, Acorda Therapeutics, EMD Serono. Dr. Marras has received research support from Acorda Therapeutics.Dr. Tanner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Voyager Therapeutics, Intec Pharma, Neurocrine Biosciences, Adamas Therapeutics, Grey Matter, CNS Ratings, Acorda, Amneal. Dr. Tanner has received research support from BioElectron, Roche/Genentech, Biogen Idec , Gateway LLC.