Last fall, the NeuroPoint Alliance (NPA) joined together with the Parkinson’s Study Group (PSG), Neurotargeting, and the Michael J Fox Foundation (MJFF) to launch the Registry for the Advancement of Deep Brain Stimulation in Parkinson’s Disease (RAD-PD). This is the latest registry project of the NPA, which currently maintains the Quality Outcomes Database and Stereotactic Radiosurgery registries.
The launch of RAD-PD represents a unique partnership between neurologists and neurosurgeons with support from MJFF. The registry enrolled its first patients in March, just prior to Parkinson’s Disease Awareness month in April. The goal of RAD-PD is to create the largest cohort of comprehensively characterized patients with Parkinson’s disease (PD) who have contemplated or undergone deep brain stimulation (DBS) surgery and longitudinally follow them for five years or more.
While DBS is considered the standard of care for advanced PD, knowledge gaps still persist for the use of this therapy, despite the implantation of over 100,000 patients worldwide. This project aims to answer many questions, including the incidence and risk factors for adverse events as well as the role of health economics and disparities all in an effort to elucidate best practices. Some of the issues that will be addressed include patient selection methods, therapeutic decision-making, understanding patient outcomes, stimulation response, treatment practices, evidence-based patient management strategies and cost-effective treatment and management practices. Extensive use of patient reported outcomes, surgical risk analysis, post-operative implantation imaging and analysis of stimulation parameters will allow for the most comprehensive analysis of the multifactorial nature of stimulation treatment.
A total of 20 centers will look to enroll most, if not all, of their PD patients with a goal of at least 500 patients entered over the first two years. Data entry will be facilitated by CranialCloud software provided by Neurotargeting. This data platform has been designed around the workflow of a DBS patient work up and should ideally streamline the process, rather than add additional work. Further, many of the patient-reported outcomes will be automated, giving patients the opportunity to report online. Patients will also be provided with a progress “report card” that will incentivize them to complete their reports.
As is common in registry projects, individual sites will own and maintain their own data, while de-identified data will be uploaded to the registry for compilation and analysis. This is a quality improvement project and actionable quality improvement metrics will be provided back to the sites in the form of treatment benchmarks and treatment dashboard reporting. Individual sites will be able to run queries on their own data and access to the entire de-identified data set can be requested from the Data Use and Access Committee of the Registry’s Steering Committee.
Given the complexity of the DBS work-up and treatment details it is virtually impossible and certainly cost and time prohibitive to use randomized clinical trials to answer the clinical questions that have been raised. This real life biopsy of clinical practice in the field is a much more efficient way to gather data that, in turn, is more likely to produce actionable results. The potential for this registry project is extensive and several investigators have already proposed potential analyses of the data.
While the initial sites have been chosen, there is potential for additional sites to be involved in RAD-PD in the future. For more information about RAD-PD, visit www.rad-pd.org.
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