Objective: This study aims to validate Real-world evidence (RWE) using claims-based algorithms to identify adverse events (AEs) among patients implanted with a Deep Brain Stimulation (DBS) system.

Background: DBS is an advanced therapeutic option for movement disorders such as Parkinson’s Disease (PD), and Essential Tremor (ET). While DBS is effective, it is crucial to identify and understand potential AEs to optimize patient outcomes. RWE, which incorporates clinical practice data such as electronic health records and insurance claims, offers a comprehensive understanding of safety and effectiveness.

Method: De novo DBS U.S. implants (implanted 1/2020–12/2023) were identified in three linked data sources: Medicare Fee-for-Service (FFS) claims, Abbott device registration and physician-adjudicated post-market clinical data. Outcomes included the following device and procedure-related AEs: malfunction, infection, dislodgement, erosion, pain, allergy, paresthesia, hemorrhage/hematoma, edema, hemiparesis, deep vein thrombosis (DVT), stroke, and cognitive impairment. The AEs were identified in claims using ICD-10 diagnosis codes. Agreement in AEs observed between the claims and clinical data were evaluated using the Cohen’s Kappa statistic, testing the null hypothesis that Kappa=0.

Results: There were 35 patients who linked between claims and Abbott data and were included in this analysis. Mean ± SD age was 71.8±3.4 and 51.4% were female. DBS indications noted in clinical data were 51.4% Disabling Tremor and 48.6% PD, with nearly all indications correctly identified in the claims data. Cohen’s Kappa coefficient for the AE analysis was 0.61 (p<0.0001), indicating substantial agreement between claims and clinical data in identifying AEs. Majority of patients did not have an AE in either data source (> 69%). All AEs observed in the clinical data were correctly identified in claims data and included malfunction, DVT, and cognitive impairment. Additional AEs were identified in claims that were not in the clinical data; it is possible these were not device-related or considered to be AEs in the clinical study.

Conclusion: These results suggest that claims data could be a valid source for identifying AEs in patients with a DBS implant. The findings underscore the importance of using multiple data sources, including real-world evidence, for comprehensive and timely AE identification, particularly at the population level.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/validating-real-world-evidence-for-identifying-adverse-events-related-to-a-deep-brain-stimulation-implant/