title: Use of health-related quality of life measures to predict health utility in postmenopausal osteoporotic women: results from the Multiple Outcomes of Raloxifene Evaluation study.
abstract: BACKGROUND
  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.
  
  
  METHODS
  Baseline 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.
  
  
  RESULTS
  Several 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.
  
  
  CONCLUSIONS
  Both 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.
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA. rburge@lilly.com.
authors.forename: Russel
authors.initials: R
authors.lastname: Burge
authors.forename: Wei
authors.initials: W
authors.lastname: Shen
authors.forename: April N
authors.initials: AN
authors.lastname: Naegeli
authors.forename: Jahangir
authors.initials: J
authors.lastname: Alam
authors.forename: Stuart
authors.initials: S
authors.lastname: Silverman
authors.forename: Deborah T
authors.initials: DT
authors.lastname: Gold
authors.forename: Tsehua
authors.initials: T
authors.lastname: Shih
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D002574:Cervical Vertebrae / Q000503:physiopathology; D005062:European Union; D005260:Female; D005544:Forecasting; D050723:Fractures, Bone / Q000150:complications; D006304:Health Status; D006801:Humans; D008875:Middle Aged; D009520:New Zealand; D009656:North America; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D017060:Patient Satisfaction; D011788:Quality of Life; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
chemical_list: D050071:Bone Density Conservation Agents; D020849:Raloxifene Hydrochloride