DA2 The Role of Patient Registries in Disease Management and Outcomes Research

Abstract

There is growing enthusiasm for the use of health-care claims databases representing thousands or even millions of covered lives to assess the potential value of medical interventions, including pharmaceuticals and disease management programs. However, evaluations of the effectiveness and safety of such interventions conducted in this manner may be confounded by clinical or patient differences between treatment groups that are not captured in readily-available databases. Patient registries designed to meet specific research objectives can provide a more robust source of data for outcomes research and disease management by linking administrative databases, medical records, patient questionnaires, death certificates, etc. The result is comprehensive longitudinal information on diagnosis, treatment, course of illness, outcomes, quality of life, and costs of the diseases of interest. By seeking the informed consent of participants the registry can also obviate growing public concerns about the research use of confidential health-care data. Workshop participants will receive a detailed overview of the registry concept and implementation, emphasizing its research value as well as its potential role in support of new product development and marketing and in the development and testing of disease management programs. Case studies of successful registries in the fields of reproductive health, cardiovascular disease, and asthma will be used to illustrate general principles and methods. Persons who have responsibility for planning or conducting outcomes research or disease management programs in the pharmaceutical industry, hospitals, or managed care will benefit from attending this workshop.