Objective: To describe the implementation of a quality improvement (QI) patient registry for deep brain stimulation (DBS) in Parkinson’s disease (PD).

Background: QI projects are a form of health effectiveness research focused on measuring and monitoring outcomes in order to secure positive change. Participating sites share performance on these quality measures and engage in active discussion. Continuous data collection relating to clearly defined quality measures for patients undergoing DBS for PD has not been previously performed.

Method: A multidisciplinary registry planning committee identified core data elements for inclusion in a multi‐site registry called RAD‐PD after review of existing resources. Relevant data elements were selected to minimize site burden and maximize use of patient reported outcomes (PROs). A central IRB granted an exemption determination. The CranialCloud is a web-based interface used as the data entry portal and repository for RAD-PD, which was deployed to all participating sites. A patient “report card” of individual progress with DBS was created in OUR‐DBS, a dedicated patient portal for the registry. A patient storyboard (based on outcome measures) and benchmarks (based on data elements and the registry visit schedule) are dashboarded to sites.  Quarterly QI meetings are used to review opportunities and strategies for improvement in DBS procedures and outcomes.

Results: RAD-PD launched in October 2018. 10 sites were activated in the first year of the project following a structured site activation process and the first patient was enrolled in March 2019. Issues surrounding data sharing and HIPAA compatibility were the main concerns before site approval for use of the data repository. Site-specific IRB-related concerns were another matter of discussion prior to site activation. Enrolled subjects are asked to sign informed consent for participation and data sharing, with specific strategies required for recruitment and retention.

Conclusion: RAD‐PD site activation (10 new sites in year 2) and patient enrollment actively continue, with the potential for close to 500 subjects enrolled in the first 2 years of the project.  QI projects pose a unique but navigable regulatory challenge especially when informed consent and data sharing are anticipated. The QI framework allows a unique forum for discussion of best practices and practice challenges, and will empower participating sites to implement and monitor changes in therapeutic delivery that will improve patient outcomes from DBS in PD.

« Back to 2019 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/strategies-for-implementation-of-a-quality-improvement-registry-for-dbs-in-parkinsons-disease/