title: Analyzing Health-Related Quality of Life in the EVOLVE Trial: The Joint Impact of Treatment and Clinical Events.
abstract: The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) clinical trial evaluated the effects of cinacalcet on clinical events in patients with secondary hyperparathyroidism (sHPT) who were on hemodialysis. Health-related quality of life (HRQoL) was assessed by a generic, preference-based health outcome measure (EQ-5D) at scheduled visits and after a study event. Here, we report the HRQoL analysis from EVOLVE.
  
  
  
  We assessed changes in HRQoL from baseline to scheduled visits, and estimated the acute (3 mo) and chronic (beyond 3 mo) effects of sHPT-related events on HRQoL using generalized estimating equation analysis controlling for baseline HRQoL and randomized assignment.
  
  
  
  Data on HRQoL were available for 3547 of 3883 subjects, with 1650 events in the placebo and 1502 in the cinacalcet arm. At the study end, no difference in change from baseline HRQoL was observed in the direct comparison of EQ-5D by treatment arms. The regression analysis showed significant effects of events on HRQoL and a modest positive effect of cinacalcet. Estimated quality-adjusted life-year gains were of similar magnitude based on the observed data or the predictions from the model, with only a small gain in precision from the predicted analysis.
  
  
  
  By contrast with a conventional comparison, a regression analysis demonstrated large decrements in HRQoL after events and a modest improvement in HRQoL with cinacalcet. As randomized controlled trials are rarely powered to detect differences in HRQoL, a prespecified regression analysis may be acceptable to improve precision of the effects and understand their origin.
authors.affiliation: Health Economics & Health Technology Assessment, University of Glasgow, UK (AHB)
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Briggs
authors.affiliation: Memorial University, St. John's, Newfoundland, Canada (PSP)
authors.forename: Patrick S
authors.initials: PS
authors.lastname: Parfrey
authors.affiliation: IMS Health, Basel, Switzerland (NK)
authors.forename: Nasreen
authors.initials: N
authors.lastname: Khan
authors.affiliation: Amgen Inc., Thousand Oaks, CA (ST, BD, YK, VB)
authors.forename: Spring
authors.initials: S
authors.lastname: Tseng
authors.affiliation: Amgen Inc., Thousand Oaks, CA (ST, BD, YK, VB)
authors.forename: Bastian
authors.initials: B
authors.lastname: Dehmel
authors.affiliation: Amgen Inc., Thousand Oaks, CA (ST, BD, YK, VB)
authors.forename: Yumi
authors.initials: Y
authors.lastname: Kubo
authors.affiliation: Stanford University School of Medicine, Palo Alto, CA (GMC)
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.affiliation: Amgen Inc., Thousand Oaks, CA (ST, BD, YK, VB)
authors.forename: Vasily
authors.initials: V
authors.lastname: Belozeroff
mesh_terms: D000328:Adult; D000368:Aged; D057966:Calcimimetic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D000069449:Cinacalcet / Q000008:administration & dosage / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012044:Regression Analysis; D006435:Renal Dialysis; D012107:Research Design
chemical_list: D057966:Calcimimetic Agents; D000069449:Cinacalcet
keywords: cinacalcet; quality of life; randomized clinical trial