Abstract
BACKGROUND: Vesnarinone Trial (VesT) was a three-armed, placebo-controlled, randomized clinical trial designed to study the effects of 30 mg or 60 mg/day vesnarinone. Certain contradictory results involving patient health-related quality-of-life (HRQOL) and overall survival (OS) have made a definitive and unified conclusion difficult. METHODS: To reconcile these findings, we have focused on the HRQOL-adjusted OS, commonly known as quality-adjusted life years (QALYs). Currently, analyses of QALYs incorporate a single HRQOL subscale. However, the VesT HRQOL instrument had two subscales: physical (PHYS) and emotional (EMOT). We have developed new ways to visualize and compare EMOT- and PHYS-adjusted OS. RESULTS: In each VesT arm, there was an increased probability of superior EMOT-adjusted OS, compared to PHYS-adjusted OS. The magnitude of these findings was comparable across trial arms. Despite inferior survival and superior EMOT and PHYS scores, the 60-mg/day arm presents similar EMOT- and PHYS-adjusted OS compared to the placebo arm. CONCLUSIONS: We have provided a fresh perspective on the complex interactions between multiple HRQOL dimensions and OS. These novel methods address the burgeoning need for robust information on the interplay between OS and HRQOL from a patient, clinical care and public policy perspective.