RESCUE: Assessing Health and Economic Outcomes William C. Black, M.D. Dartmouth-Hitchcock Medical Center

Outline Health outcomes Economic outcomes CEA

Health Outcomes MACE/ Revacularization Life years (Vital Status) QALYs BL, 12 mos Angina Status

Life Years All observed deaths thru trial All projected deaths after trial Framingham survival estimates based on age, sex, and CV events

Measure of patient utility Measured on a scale of Can be assessed directly or derived, SG vs SF-36 Quality Adjusted Life Year

Standard Gamble

Quality Adjusted Life Years Quantity of Life Quality of Life QALY = = 0.75

QALYs

Derived from BL, 1 yr SS-6D utility scoring Adjusted for age after trial

SF-6D 1.Physical functioning 2.Role limitations 3.Social functioning 4.Pain 5.Mental health 6.Vitality

SF-6D Utility Scoring Physical Functioning TermScore PF PF PF PF PF PF U = ∑Score – Brazier et al. J Health Econ 2002;21:

QoL - Angina BL, 6, 12, 18, & 24 mos BL, 12 mos Not “preference” based

Economic Outcomes Direct cardiac* inpatient care outpatient care medications Indirect cardiac* time and travel

Economic Outcomes Based on 201x dollars Adjusted for timing w MC CPI Projected by age beyond trial

Hospitalization Costs Triggered by patient questionnaire DRGs and CPTs coded by MRA Medicare reimbursement Part A MEDPAR Part B Physician Fee Schedule

Outpatient Costs Triggered by patient questionnaire CPTs coded by MRA Medicare Physician Fee Schedule Red Book avg wholesale prices

Indirect Costs Triggered by patient questionnaire Travel and other expenses Time from usual activities

CEA Societal perspective In-trial and lifetime horizons 3% Sensitivity analysis

Base Case StrategyCostQALYs  Cost  QALYs ICER SPECTNA CCTA

c e III ? Cost-Effective III ? Not Cost-Effective IV Black. Med Decis Making (3):

c e IIIB IV IIIA IA IIIB K Black. Med Decis Making (3):

Uncertainty Sensitivity analysis Scatterplot of ICE CE Acceptability curves

Sensitivity Analysis  LE  QALE Costs In-trial Beyond-trial

Weintraub, W. S. et al. Circ Cardiovasc Qual Outcomes 2008;1:12-20

Bootstrap Method 1.Sample n CTA subjects, compute C* CT, E* CT 2.Sample m SPE subjects, compute C* SP, E* SP 3.Plot ICE: (C* CT – C* SP, E* CT - E* SP ) 4.Repeat steps 1-3 N times * mean

Fenwick et al. BMC Health Serv Res 2006;6:52.