Havranek E, Simon T, L'italien G, Smitten A, Hauber AB, Chen R, Lapuerta P. The relationship between health perception and utility in heart failure patients in a clinical trial: results from the OVERTURE study. Circulation. 2002 Oct 15;106(16):E111.

INTRODUCTION: Current consensus holds that the measure of effectiveness in cost-effectiveness analyses in health care should be incremental years of life gained adjusted for quality of life with a measure known as a utility. Utilities for patients in a clinical trial are likely to differ from those in the general population, but eliciting utilities from all subjects in a large-scale randomized trial would be prohibitively cumbersome. We therefore sought a relationship to estimate utilities for all subjects from results obtained in a subset of patients.

METHODS: We studied 153 patients who comprised a subset of the 5770 patients enrolled in OVERTURE, a randomized clinical trial of the vasopeptidase inhibitor omapatrilat for the treatment of heart failure. Survey instruments (a time trade-off questionnaire, a visual analog scale score of overall health perception, and the Duke Activity Status Index) were administered to patients by telephone interviews. The completed visual analog scale was returned by mail.

RESULTS: Using non-linear regression, we established a significant (p0.0001) relationship between visual analog scale score and utility described by the power function u 1-(1-v)q, where q 2.17 (95% CI 1.76 to 2.58). There was a significant positive correlation (r 0.17, p0.04) between the DASI and utility, and a significant negative correlation (r -0.26, p0.001) between utility and NYHA functional class.

CONCLUSIONS: There is a significant relationship between the relatively easily obtainable health perception score by visual analog scale with the more complex utility by time trade-off for a subset of patients in this randomized clinical trial. This relationship appears to differ from previously published results in patients not in a trial. Utility measurement within clinical trials may be necessary for examining the cost-effectiveness of new treatments for heart failure.

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