RWE Project
REAL WORLD EVIDENCE PROJECTS
Additional funding from the FDA PDC program supports the RWE Demonstration project of SWPDC
Effects of Aorto-Pulmonary Shunts on Post-Surgical Outcomes
The current SWPDC RWE demonstration project aims to analyze historical cardiac intensive care unit data from a large group of pediatric patients with congenital heart disease (CHD) who have undergone aorto-pulmonary (AP) shunt placement. AP shunts are used to improve pulmonary blood flow in various CHD cases, but they carry a risk of thrombosis, which can lead to sudden cardiac arrest if pulmonary blood flow is interrupted. The project’s objectives are to evaluate AP shunt performance, identify predictors of shunt occlusion in neonates with CHD, and create a predictive model for adverse events.
Leaders of the project: Ashish Ankola, MD, R. Brandon Hunter, MD, Balakrishna Haridas, Ph.D, Achu Byju, MS
Continuous Glucose Monitors (CGM) for Diabetes Management.
The previous RWE project was in collaboration with an NSF-funded Engineering Research Center (PATHS-UP at Texas A&M). PATHS-UP is focused on remote monitoring for diabetes and cardiovascular disease in urban and rural underserved populations to develop, test, and validate the use of an EHR-based data network to support evidence generation for medical devices across the total product life cycle.
The SWPDC RWE demonstration project involved the extraction of longitudinal data for all pediatric diabetes patients across the health system, many of whom are utilizing continuous glucose monitors (CGM) for diabetes management.
This project is aligned with the strategic plans and goals of the National Evaluation System for The Health Technology Coordinating Center (NESTcc) of the public-private partnership, Medical Device Innovation Consortium (MDIC), as the systematic process deployed to validate and test the pathways for evidence generation is expected to produce a scalable model to inform an industry-wide roadmap toward the use of EHR-based data networks for the responsible access and use of practice data, in both the pre-market and post-market spaces.
Leaders of the Project: Daniel Joseph DeSalvo, M.D., Saurabh Biswas, Ph.D