Study Rationale: RAD-PD is a quality improvement patient registry project that will address clinical questions about deep brain stimulation (DBS) therapy that cannot be practically answered via the methodology of traditional clinical trials. It will allow investigators to identify adverse effects of DBS therapy, assess the economics and disparities related to DBS, and yield recommendations for practice improvement across a spectrum of clinical care environments that will enhance therapy outcomes for people with Parkinson’s disease (PD).
Hypothesis: By collecting purpose-driven data systematically and feeding actionable information back to care providers (via benchmarking and dashboarding), we hypothesize that clinics participating in this registry project will be able to identify the best practices surrounding DBS therapy — including subject selection, surgical approaches and post-operative management — and thereby enhance therapeutic outcomes.
Study Design: Credentialed investigators and site staff from the Parkinson Study Group network at 20 sites are recruiting participants and collecting clinical data and patient reported outcomes in a web-based electronic data portal. To date, over 300 subjects have been enrolled, with complete baseline datasets on over 170 subjects and complete surgery data on over 110 subjects. Follow-up data collection will continue at 6-month, 12-month, and 2-year follow-up visits. Continuous data collection relating to various aspects of DBS for PD ensures that longitudinal outcomes can be assessed. Participants (i.e., clinical sites) will share performance on quality measures and engage in active discussion.
Impact on Diagnosis/Treatment of Parkinson’s Disease: The quality improvement design of this patient registry will generate large datasets that can provide insights into treatment patterns and outcomes for DBS. By collecting purpose-driven data systematically and feeding actionable information back to care providers, participation will help clinicians identify ways to improve DBS treatment processes and patient outcomes.
Next Steps for Development: The baseline dataset reveals broad heterogeneity in practices for patient selection and surgical implantation. Analysis of outcomes data will therefore apply to a wide spectrum of clinical care environments and can be generalized to varied populations and treating practitioners.