The American Heart Association's Recommendations for Expanding the Applications of Existing and Future Clinical Registries A Policy Statement From the American Heart Association

Clinical registries play an important role in measuring healthcare delivery and supporting quality improvement for individuals with cardiovascular disease and stroke. Well-designed clinical registry programs provide important mechanisms to monitor patterns of care, evaluate healthcare effectiveness and safety, and improve clinical outcomes. The use of clinical registries is likely to grow given the increasing focus on measuring and improving healthcare delivery and patient outcomes by stakeholders in both the private and public sectors. The American Heart Association (AHA) has a longstanding commitment to promoting the innovative and effective use of clinical registries. The importance of clinical registries was highlighted recently in an AHA Scientific Statement on “Essential Features of a Surveillance System to Support the Prevention and Management of Heart Disease and Stroke” in the United States.1 This policy statement expands on the previous scientific statement by providing recommendations to policy makers and the healthcare community for expansion of the applications of existing and future clinical registries. The term “clinical registry” is defined here as an observational database of a clinical condition, procedure, therapy, or population in which there are often no registry-mandated approaches to therapy and relatively few inclusion or exclusion criteria. The focus of clinical registries is to capture data that reflect “real-world” clinical practice in large patient populations. The data from clinical registries do not replace the need for traditional randomized controlled trials. Rather, registries and trials are complementary approaches, each with unique advantages and imperfections.2 Such clinical registries do not solely contain claims or administrative data yet may be linked to such data sources. There are at least 3 classifications of clinical registries based on the patient population, including procedure/therapy/encounter-based, disease-based, and population-based registries. Registries also can be classified from a functional perspective, such as whether the registry is used to conduct clinical research, …