Leveraging linked registry and electronic health records to examine long-term patient outcomes after peripheral vascular intervention"

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Leveraging linked registry and electronic health records to examine long-term patient outcomes after peripheral vascular intervention Project Summary/Abstract Peripheral arterial disease (PAD) affects over 200 million people worldwide. Peripheral vascular interventions (PVI) are the most common procedures that are performed to manage PAD. Existing randomized controlled trials (RCTs) and observational studies of patient outcomes after PVIs all had limited follow-up lengths due to difficulties in long-term data collections. In addition, heterogeneity of treatment effect (HTE) for stent placement vs. percutaneous transluminal angioplasty (PTA) alone has not been well understood with the current approach of effect modifier assessment. Real-world data (RWD), particularly registries linked with electronic health data (EHR), are useful for studying long-term outcomes after vascular procedures. However, methods for working with multiple data sources and analyzing unstructured text data are still evolving. The proposed research aims to address current evidence gaps in long-term patient outcomes after PVI procedures. This will be facilitated by innovatively apply and refine data linkage, natural language processing (NLP), and effect modifier assessment methods. Specifically, this project will link registry and EHR data to 1) examine long-term major adverse limb events after stent placement vs. PTA alone as well as assess heterogeneity of treatment effect by patient characteristics; 2) develop an NLP pipeline with machine learning methods to analyze unstructured text data and examine long-term efficacy endpoints after stent placement vs. PTA alone, and; 3) establish feasibility and updating requirements for the deployment of the NLP tool for long-term PVI outcome assessment to other institutions. To support the research activities and the transition toward independence, the candidate will undertake the following career development activities during the award period: 1) gaining an in- depth understanding of NLP and machine learning methods; 2) refining data science expertise to integrate EHR into medical device epidemiologic research; 3) strengthening knowledge in current and novel vascular disease treatment; 4) developing and improving skills in grant writing and academic leadership; 5) training in responsible conduct of research. The candidate will be mentored by a team of experts with complementary strengths in surgical and device outcomes research, natural language processing and machine learning, and vascular disease and surgery. The proposed career development and research activities will develop the candidate's skillset and expertise and lead to an R01 level application. The candidate's long-term goal is to become an independent researcher focusing on the development and application of advanced multidisciplinary methods in the evaluation of surgical and device outcomes in the vascular disease area, supporting clinical, patient, and regulatory decision-making.