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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 (SF-36) @ BL, 12 mos Angina Status. Life Years.
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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 (SF-36) @ 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
Quality Adjusted Life Year • Measure of patient utility • Measured on a scale of 0-1.0 • Can be assessed directly or derived, SG vs SF-36
1.0 Quality Adjusted Life Years QALY = 0.5+0.25 = 0.75 Quality of Life 0.5 0 0.5 1.0 Quantity of Life
QALYs • Derived from SF-36 @ BL, 1 yr • SS-6D utility scoring • Adjusted for age after trial
SF-6D • Physical functioning • Role limitations • Social functioning • Pain • Mental health • Vitality
SF-6D Utility Scoring U = 1.000 + ∑Score – 0.070 Brazier et al. J Health Econ 2002;21:271-92.
QoL - Angina • CCS @ BL, 6, 12, 18, & 24 mos • SAQ @ 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 • Timefrom usual activities
CEA • Societal perspective • In-trial and lifetime horizons • Discounting @ 3% • Sensitivity analysis
c II I ? Not Cost-Effective e III ? IV Cost-Effective Black. Med Decis Making 1990. 10(3): 212-4.
c K II IB IA e IIIA IIIB IV Black. Med Decis Making 1990. 10(3): 212-4.
Uncertainty • Sensitivity analysis • Scatterplot of ICE • CE Acceptability curves
Sensitivity Analysis • LE • QALE • Costs • In-trial • Beyond-trial
Weintraub, W. S. et al. Circ CardiovascQual Outcomes 2008;1:12-20
Bootstrap Method • Sample n CTA subjects, compute C*CT, E*CT • Sample m SPE subjects, compute C*SP, E*SP • Plot ICE: (C*CT – C*SP, E*CT - E*SP) • Repeat steps 1-3 N times * mean