Economic methods in the century trial--a comprehensive lifestyle modification study for managing coronary artery disease.

While most studies assess the cost-effectiveness of treating acute coronary conditions, the Century Health Study for Cardiovascular Medicine (Century Trial) focuses on ameliorating coronary artery disease (CAD) through a comprehensive lifestyle modification program. This 1,300-patient phase III randomized study uses positron emission tomography for risk stratification, complemented with comprehensive educational and motivational therapy for patients with preclinical or established CAD. The Century Trial is in its second year of a five-year follow-up protocol, and it is one of the first to combine imaging technology and lifestyle modification as a way to improve patient behavior and health. In this article, we present the economic study design used in the Century Trial and provide considerable methodological detail to serve as reference for other researchers. We describe the cost and effect estimation methods as well as our analysis and uncertainty modeling plans. The study will incorporate quality-adjusted life years and use a societal perspective to measure both in-trial and lifetime costs through incremental cost-effectiveness ratios. The approach we follow should provide further evidence on the cost-effectiveness of comprehensive lifestyle modification programs in regressing coronary artery disease.