NEW APPROACHES FOR GRAPHING PROBABILISTIC PATIENT-RELEVANT HEALTH OUTCOMES- THE CASE OF RENAL DENERVATION FOR RESISTANT HYPERTENSION
Author(s)
Geisler BP1, Cohen JT2, Neumann PJ2, Pietzsch JB11Wing Tech Inc., Menlo Park, CA, USA, 2Tufts Medical Center, Boston, MA, USA
Presentation Documents
OBJECTIVES: Probabilistic sensitivity analysis (PSA) repeatedly runs a simulation model with randomly selected inputs to characterize the plausible distributions of projected outcomes. In cost-effectiveness analysis, PSA results are conventionally displayed as incremental cost-effectiveness scatter plots or cost-effectiveness acceptability curves. We explored patient-relevant health outcomes other than QALYs and investigated approaches for displaying probabilistically generated values, using the case of catheter-based renal denervation (RDN) for resistant hypertension. METHODS: A Markov model with 54 input distributions simulated the impact of RDN on stroke, myocardial infarction (MI), coronary heart disease (CHD), heart failure (HF), end-stage renal disease (ESRD), cardiovascular (CV) and all-cause death based on the Symplicity HTN-2 RCT and the literature. We report medians and 95% credible intervals (95% CI), defined as containing 95% of all simulation results, of 10-year relative risk reductions. One-sample t-tests and ANOVA were used to compare posterior distributions. Additional analyses evaluated alternative time horizons, with values ranging from one year to lifetime. RESULTS: Relative risk reductions over ten years (95% CI) were: stroke 31.4% (23.1; 36.0%), MI 30.0% (8.9; 38.1%), CHD 22.2% (9.0; 29.4%), HF 13.9% (11.0; 21.7%), ESRD 30.7% (28.8; 34.5%), CV death 30.3% (12.6; 35.7%), and all-cause death 14.4% (4.1; 20.1%). All clinical outcomes were significantly different from 0% and between each other (p<0.0001). Distribution dotplots, cumulative hazard curves, and survival curves with 95% credibility intervals were developed as graphic representations of probabilistic results. CONCLUSIONS: While model-based projections suggest that catheter-based renal denervation leads to clinically and statistically significant event reductions across clinical outcomes, considerable differences exist between the distributions of individual reductions. Graphic, probabilistic representation of patient-relevant endpoints may facilitate a deeper understanding of uncertainty associated with the long-term clinical effectiveness of new therapies. In addition to informing clinicians and payers, the proposed conceptual approach could also contribute to patient education and shared decision making.
Conference/Value in Health Info
2012-06, ISPOR 2012, Washington, D.C., USA
Value in Health, Vol. 15, No. 4 (June 2012)
Code
PMD57
Topic
Methodological & Statistical Research
Topic Subcategory
Confounding, Selection Bias Correction, Causal Inference
Disease
Cardiovascular Disorders