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

2. Outline Health outcomes Economic outcomes CEA

3. Health Outcomes MACE/ Revacularization Life years (Vital Status) QALYs (SF-36) @ BL, 12 mos Angina Status

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

5. Measure of patient utility Measured on a scale of 0-1.0 Can be assessed directly or derived, SG vs SF-36 Quality Adjusted Life Year

6. Standard Gamble

7. Quality Adjusted Life Years 00.51.0 0.5 1.0 Quantity of Life Quality of Life QALY = 0.5+0.25 = 0.75

8. QALYs

9. Derived from SF-36 @ BL, 1 yr SS-6D utility scoring Adjusted for age after trial

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

11. SF-6D Utility Scoring Physical Functioning TermScore PF1-0.000 PF2-0.053 PF3-0.011 PF4-0.040 PF5-0.054 PF6-0.111 U = 1.000 + ∑Score – 0.070 Brazier et al. J Health Econ 2002;21:271-92.

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

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

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

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

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

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

18. CEA Societal perspective In-trial and lifetime horizons Discounting @ 3% Sensitivity analysis

19. Base Case StrategyCostQALYs  Cost  QALYs ICER SPECTNA CCTA

20. c e III ? Cost-Effective III ? Not Cost-Effective IV Black. Med Decis Making 1990. 10(3): 212-4.

21. c e IIIB IV IIIA IA IIIB K Black. Med Decis Making 1990. 10(3): 212-4.

22. Uncertainty Sensitivity analysis Scatterplot of ICE CE Acceptability curves

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

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

25. 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

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