title: Health-Related Quality-of-Life Outcomes in Patients Treated with Push-Pull OROS Hydromorphone versus Extended-Release Oxycodone for Chronic Hip or Knee Osteoarthritis Pain: A Randomized, Open-Label, Parallel-Group, Multicenter Study.
abstract: BACKGROUND
  Chronic osteoarthritis (OA) pain impacts health-related quality of life (HR-QOL).
  
  
  OBJECTIVE
  The primary aim of this study was to evaluate and compare HR-QOL outcomes following treatment with once-daily push-pull Osmotic controlled-Release Oral delivery System (OROS) hydromorphone versus twice-daily extended-release (ER) oxycodone for moderate to severe chronic knee or hip OA pain.
  
  
  METHODS
  This was a 6-week, randomized, open-label, parallel-group, multicenter study of 124 patients with OA whose pre-trial treatment included NSAIDs or other non-steroidal, non-opioid analgesics. The HR-QOL of patients was assessed using the Medical Outcomes Study (MOS) Sleep Scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™). Within- and between-group changes from baseline to 6 weeks were evaluated using ANOVA.
  
  
  RESULTS
  At baseline, trial patients had significantly worse MOS Sleep Scale (multivariate ANOVA [MANOVA] F = 11.0, p < 0.001) and WOMAC™ scores (MANOVA F = 55.7, p < 0.001) than chronic disease benchmarks. Both treatment groups showed significant improvements on the sleep disturbance scale (p < 0.01), with additional improvements observed with OROS hydromorphone on the sleep quantity (p = 0.046), sleep snoring (p = 0.044), awaken short of breath or with a headache (p = 0.024), 6-item sleep problems index I (p < 0.001), and 9-item sleep problems index II (p < 0.001) scales. Significant treatment differences in favor of OROS hydromorphone over ER oxycodone were also observed on the awaken short of breath or with a headache (p = 0.014) scale and sleep problems index I (p = 0.045). Both treatment groups showed comparable large effect size (>0.8 SD unit) improvements on the WOMAC™ scale (measuring functionality outcomes such as pain, stiffness, physical function etc).
  
  
  CONCLUSIONS
  Both OROS hydromorphone and ER oxycodone improved sleep and function, with greater sleep benefits being observed in patients treated with OROS hydromorphone.
authors.affiliation: 1 Abt Bio-Pharma Solutions, Incorporated, Lexington, Massachusetts, USA 2 QualityMetric Incorporated, Lincoln, Rhode Island, USA 3 Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey, USA 4 Janssen Pharmaceutica, Beerse, Belgium 5 Patient Value Solutions, Huldenberg, Belgium.
authors.forename: Kavita
authors.initials: K
authors.lastname: Gajria
authors.forename: Mark
authors.initials: M
authors.lastname: Kosinski
authors.forename: Jeff
authors.initials: J
authors.lastname: Schein
authors.forename: Shane
authors.initials: S
authors.lastname: Kavanagh
authors.forename: Dominique
authors.initials: D
authors.lastname: Dubois