Adin-Cristian Andrei1, Kathleen L Grady. 1. Bluhm Carrdiovascular Institute, Northwestern University, 676 N St Clair St., Suite 1700, Chicago, IL, USA, aandrei@nmh.org.
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.
RCT Entities:
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.
Authors: Annika Ahlström; Minna Tallgren; Seija Peltonen; Pirjo Räsänen; Ville Pettilä Journal: Intensive Care Med Date: 2005-07-28 Impact factor: 17.440
Authors: J N Cohn; S O Goldstein; B H Greenberg; B H Lorell; R C Bourge; B E Jaski; S O Gottlieb; F McGrew; D L DeMets; B G White Journal: N Engl J Med Date: 1998-12-17 Impact factor: 91.245