Abstract
BackgroundThe aim of this study is to examine the associations between health utility (HU), health-related quality of life (HRQoL), and patient characteristics in postmenopausal osteoporotic (PMO) women.MethodsBaseline data from a subsample of 1,245 participants of the Multiple Outcomes of Raloxifene Evaluation study, a randomized, placebo-controlled, multinational clinical trial to evaluate the safety and efficacy of raloxifene, were analyzed. The study cohort included 694 participants from non-European Union (non-EU) countries and 551 participants from EU countries. All participants with complete baseline HU and HRQoL assessments were included in the following analyses: 1) HU (HUI or EQ-5D) and HRQoL (QualEFFO or OPAQ and NHP) associations; 2) HU variability explained by HRQoL domains; and 3) the percentage of HU variability explained by statistically significant (p < 0.05) HRQoL domains, after adjusting for baseline characteristics.ResultsSeveral domains were significantly associated with HU scores. HU variance was well explained (41% to 61%) by 4 to 6 (p < 0.05) significant HRQoL domains. After controlling for baseline characteristics, 48% to 64% of the HU variance was well explained by 5 to 7 significant (p < 0.05) HRQoL domains. Additional trend analyses detected statistically significant decreases in HRQoL and HU scores with an increased number of vertebral and non-vertebral fractures.ConclusionsBoth disease-targeted and generic HRQoL domains were well correlated with HU. A large percentage (48% to 64%) of the HU variance was explained by HRQoL, after adjusting for baseline characteristics. Both disease-targeted and generic HRQoL measures were significant predictors of HU. HRQoL and HU scores decreased with increased vertebral and non-vertebral fractures.
Highlights
The aim of this study is to examine the associations between health utility (HU), health-related quality of life (HRQoL), and patient characteristics in postmenopausal osteoporotic (PMO) women
Previous research has reported that lumbar vertebral fractures, in particular, are associated with a reduced HRQoL, as measured by the Osteoporosis Assessment Questionnaire (OPAQ) [9,15,16]; the European HUI Health Utility NHP Nottingham Health Profile (Index) (Union) (EU) Foundation of Osteoporosis Quality-of-Life Assessment (QualEFFO) [7,16]; and, to a lesser degree, the Nottingham Health Non-EU Non-European Union (Profile) (NHP) and EQ-5D [11]
Other statistically significant differences included a higher percentage of smokers and alcohol users, more years of education, and more with self-reported, preexisting medical conditions among the non-EU cohort compared to the EU cohort
Summary
The aim of this study is to examine the associations between health utility (HU), health-related quality of life (HRQoL), and patient characteristics in postmenopausal osteoporotic (PMO) women. Osteoporosis is a major public health threat, affecting an estimated 200 million postmenopausal osteoporotic (PMO) women worldwide [1,2]. Vertebral fractures in PMO women can result in acute and chronic back pain, declines. Previous research has reported that lumbar vertebral fractures, in particular, are associated with a reduced HRQoL, as measured by the Osteoporosis Assessment Questionnaire (OPAQ) [9,15,16]; the European Union (EU) Foundation of Osteoporosis Quality-of-Life Assessment (QualEFFO) [7,16]; and, to a lesser degree, the Nottingham Health Profile (NHP) and EQ-5D [11]. HU values provide preference-based measures of utility that are used to derive quality-adjusted life years (QALYs), which are standardized outcome measures applicable to any therapeutic area, used in cost-utility analyses (incremental costs divided by incremental QALYs) in economic evaluations of competing healthcare interventions [18]
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