title: Using EQ-5D-3L and OAB-5D to assess changes in the health-related quality of life of men with lower urinary tract symptoms associated with benign prostatic hyperplasia.
abstract: To assess changes in the health status of men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) using the EQ-5D-3L and OAB-5D instruments and to evaluate the sensitivity of the instruments.
  
  
  
  Data were available from a large randomised phase III trial of men with moderate-to-severe storage and voiding LUTS/BPH (NEPTUNE). Men received a fixed-dose combination of solifenacin 6 mg plus oral controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS, 0.4 mg), TOCAS monotherapy or placebo and completed the EQ-5D-3L and OAB-5D at baseline and weeks 4, 8 and 12. Analysis of covariance was used to estimate changes in EQ-5D-3L Index, EQ-VAS and OAB-5D. Changes in dimension level were summarised using the Paretian Classification of Health Change (PCHC).
  
  
  
  Improved health-related quality of life from baseline was seen in all treatment arms on EQ-5D-3L and OAB-5D at week 12, although only OAB-5D showed statistically significant differences between active treatment and placebo, both on the index score and using the PCHC approach. Effect sizes in the active treatment groups were large (>0.8) on OAB-5D but small (≈0.2) on EQ-5D-3L. EQ-5D-3L showed a very high ceiling effect (45% of men reported full health at baseline) and a substantial proportion of these men reported improvements at week 12 in several dimensions of OAB-5D.
  
  
  
  A large ceiling effect on EQ-5D-3L substantially limited its sensitivity in this population. OAB-5D proved more sensitive to changes in health status and could be considered a complement to ED-5D-3L as a source of utilities for health economic modelling.
authors.affiliation: Astellas Pharma Europe B.V., Astellas Medical Affairs, Global, HEOR, Sylviusweg 62, 2300 AH, Leiden, The Netherlands. zalmai.hakimi@astellas.com.
authors.forename: Zalmai
authors.initials: Z
authors.lastname: Hakimi
authors.affiliation: Office of Health Economics, London, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Herdman
authors.affiliation: Data Management Centre, European Foundation for the Study of Chronic Liver Failure (EF-CLIF), Barcelona, Spain.
authors.forename: Marco
authors.initials: M
authors.lastname: Pavesi
authors.affiliation: Office of Health Economics, London, UK.
authors.forename: Nancy
authors.initials: N
authors.lastname: Devlin
authors.affiliation: Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR, Chertsey, UK.
authors.forename: Jameel
authors.initials: J
authors.lastname: Nazir
authors.affiliation: Office of Health Economics, London, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Hoyle
authors.affiliation: Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR, Chertsey, UK.
authors.forename: Isaac A O
authors.initials: IA
authors.lastname: Odeyemi
mesh_terms: D000368:Aged; D006304:Health Status; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000209:etiology / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology*
keywords: Health-related quality of life; LUTS/BPH; Solifenacin; Tamsulosin