Preliminary Results from Real-World Data Collection in RAD-PD
Recommended Citation
Jimenez-Shahed J, Berg A, York M, Kirk J, Siddiqui M, Schwalb J, McInerney J. Preliminary Results from Real-World Data Collection in RAD-PD. Movement Disorders 2022; 37:S10-S11.
Document Type
Conference Proceeding
Publication Date
6-1-2022
Publication Title
Movement Disorders
Abstract
Background: Deep brain stimulation (DBS) is wellestablished to improve Parkinson's disease (PD) motor symptoms. However, disparities in outcomes exist with limited evidence relating to their determinants. Disparities in non-motor outcomes are not well characterized yet may impact the quality of life and satisfaction. Real-world data (RWD) captured in a patient registry can be used to establish real-world evidence (RWE) related to best practices, adverse events, and outcomes disparities that will fill knowledge gaps related to DBS that cannot be accomplished through randomized trials. Objective: To describe real-world data aggregation in a multi-center registry of patients with PD undergoing DBS. Methods: 20 participating sites are prospectively collecting data elements representing clinical data and patient-reported outcomes. An electronic data repository facilitates data review for completeness and subject retention. Results: To date, 138 complete datasets related to baseline pre-operative evaluations, 76 corresponding surgery datasets, and 20 6-month follow-ups have been captured. Baseline disease, psychosocial characteristics, and surgical techniques vary substantially. At 6-months, the majority of patients improved on the MDS-UPDRS 3 with reduced levodopa equivalent dosing, though some worsened (10%) and/or increased medications (11%). The severity of gait freezing (n=5), generally improved. MoCA remained stable at the group level but worsened by 20% at 6-months. Mean scores on BDI, GAD-7, QUIP-RS, and NMSS improved overall but individually worsened by 15%, 5%, 30%, and 5% (respectively). The majority experienced improved MDS-UPDRS 2 but unchanged instrumental activities of daily living. Quality of life indicators improved overall but scores at 6-months declined in some [NQoL-ability (30%), PDQ-39 (11%), and EQ- 5D VAS (18%)]. Conclusions: These early results confirm the feasibility of RWD collection related to PD patients receiving DBS, and disparities in motor and nonmotor outcomes. The analysis will better define the natural history of PD after DBS and yield RWE that will drive improvements in DBS outcomes.
Volume
37
First Page
S10
Last Page
S11
