Establishing a cardiology registry: navigating quality and regulatory challenges with a focus on congenital heart disease

Abstract

Registries have become pivotal in medical research, offering a robust foundation for understanding disease incidence, treatment patterns, and patient outcomes across diverse populations. By aggregating real-world data (RWD), registries provide invaluable insights into real-world evidence (RWE), shaping clinical guidelines, healthcare policies, and regulatory decisions. Their widespread acceptance underscores their scientific validity and their role in driving evidence-based medicine, ultimately improving healthcare outcomes. In cardiology, particularly within the specialized field of congenital heart disease (CHD), national and international registries have emerged as indispensable tools. They enable the systematic collection of data on patient demographics, disease progression, therapeutic interventions, and long-term outcomes. These datasets support a range of purposes, including observational studies, quality improvement initiatives, and regulatory assessments of medical devices or pharmaceuticals. Establishing a high-quality registry requires meticulous planning and adherence to established guidelines. Professional organizations, such as the European Society of Cardiology (ESC) and the American Heart Association (AHA), offer detailed guidance documents for setting up and managing registries. Additionally, various checklists and frameworks exist to evaluate and ensure registry quality, aiding researchers in optimizing data reliability and utility. With advancements in digital health, the potential of electronic health records (EHRs) to complement or replace traditional registries is increasingly explored. EHRs offer a dynamic, real-time data collection mechanism, reducing redundancy and operational costs while maintaining data accuracy. However, considerations around interoperability, data privacy, and standardization remain critical in leveraging EHRs for registry purposes.

Keywords: Review; cardiology; congenital heart disease (CHD); observational study; registry.