PMA18: THE AVANDIA WORLDWIDE AWARENESS REGISTRY (AWARE®): AN INTERNET-BASED PROGRAM FOR EVALUATION OF CLINICAL, HUMANISTIC AND ECONOMIC OUTCOMES OF PATIENTS WITH TYPE 2 DIABETES

Abstract

AWARe® is an Internet-based database designed to capture clinical and humanistic outcomes from diabetes practice settings around the world. The main goal of AWARe® is to better understand how patients with type 2 diabetes respond to different treatments in a naturalistic environment. OBJECTIVE: To describe an innovative method of collecting clinical, humanistic and economic outcomes of patients with type 2 diabetes in a “real world” practice setting. METHODS: The data collection methods involve the electronic linkage of clinical information and humanistic outcomes of patients with type 2 diabetes. Patients at least 18 years of age who are maintained on oral antidiabetic therapy are eligible to participate in AWARe®. As providers enter patients' clinical information into the patient's electronic medical record, the data elements of interest are automatically transmitted to a secure Internet site (Pharmacon EB-HealthTM) where the data are stored and continuously updated. Data collected in AWARe® include: demographic information, prescription use, HbA1c, fasting plasma glucose, total cholesterol, triglycerides, LDL, HDL, blood pressure, liver function tests, the SF-36, and the Diabetes and Treatment Satisfaction Questionnaire (DTSQ). Every six months, participants use hand-held devices to complete the electronic versions of the SF-36 and the DTSQ. The results from these surveys are instantaneously transmitted via wireless technology to EB-HealthTM. CONCLUSION: AWARe® permits immediate retrieval of clinical and humanistic information from an Internet-based registry. Information on the patient's clinical progress may be continuously transmitted to EB-HealthTM, allowing researchers, clinicians and administrators to perform “real time” analyses of the clinical effectiveness of antidiabetic therapy, as well as to determine its impact on patients' quality of life and satisfaction with treatment. As AWARe® is expanded to sites around the US and throughout the world, it will provide valuable information on the impact of the different treatments for type 2 diabetes on patients' clinical, humanistic and economic outcomes.