Economies, health-related quality of life, and cost-effectiveness methods for the TACTICS (treat angina with Aggrastat (R) [tirofiban] and determine cost of therapy with invasive or conservative strategy)-TIMI 18 trial

Concern over escalating health care costs has led to increasing focus on ec onomics and assessment of outcome measures for expensive forms of therapy. This is being investigated in the Treat Angina With Aggrastat(R) [tirofiban ] and Determine Cost of Therapy with Invasive or Conservative Strategy (TAC TICS)-TIMI 18 trial, a randomized trial comparing outcome of patients with unstable angina or non-Q-wave myocardial infarction treated with tirofiban and then randomized to an invasive versus a conservative strategy. Hospital and professional costs initially and over 6 months, including outpatient c osts, will be assessed. Hospital costs wilt be determined for patients in t he United States from the UB92 formulation of the hospital bill, with costs derived from charges using departmental cost to charge ratios. Professiona l costs will be determined by accounting for professional services and then converted to resource units using the Resource Based Relative Value Scale and then to costs using the Medicare conversion factor. Follow-up resource consumption, including medications, testing and office visits, wilt be care fully measured with a Patient Economic Form, and converted to costs from th e Medicare fee schedule. Health-related quality of life will be assessed wi th a specific instrument, the Seattle Angina Questionnaire, and a general i nstrument, the Health Utilities Index at baseline, 1, and 6 months. The Hea lth Utilities Index will also be used to construct a utitity. By knowing ut ility and survival, quality-adjusted life years will be determined. These m easures will permit the performance of a cost-effectiveness analysis, with the cost-effectiveness of the invasive strategy defined and the difference in cost between the invasive and conservative strategies divided by the dif ference in quality-adjusted life years. The economic and health-related qua lity of life aspects of TACTICS-TIMI 18 are an integral part of the study d esign and will provide a comprehensive understanding of the impact of invas ive versus conservative management strategies on a broad range of outcomes after hospitalization for unstable angina or non-Q-wave myocardial infarcti on. (C)1999 by Excerpta Medica, Inc.