title: Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed.
abstract: OBJECTIVE
  To evaluate the performance (in terms of responsiveness to change, associations with other criterion standards, and indicators of Alzheimer's disease [AD] severity) of a quality-of-life measure (Quality of Life in Alzheimer's Disease [QOL-AD]) and a health utility measure (Health Utilities Index Mark 3 [HUI-3]) from two recently completed clinical trials of a new drug for AD.
  
  
  METHODS
  Change from baseline scores was calculated, and treatment effects were analyzed using mixed models for repeated measures. Three separate models were then estimated to examine the association between the quality-of-life/utility end points and the clinical and other health outcome end points measured during the trials, including cognition, function, behavior, and dependence.
  
  
  RESULTS
  The performance of the two measures differed. Subject-assessed QOL-AD was found to be weakly associated with clinical measures of cognition, and with caregiver reports of function, behavior, and dependence, and showed little movement over time and did not appear to differ by baseline AD severity. Proxy-assessed QOL-AD scores were consistently lower than subject-assessed scores, and the level of decline in QOL-AD was greater using proxy-assessed QOL-AD. Proxy-assessed HUI-3 scores were more strongly associated with clinical measures of cognition, function, behavior, and dependence than the subject- and proxy-assessed QOL-AD scores. Larger proportionate changes over 78 weeks were observed with HUI-3 scores and greater separation in HUI-3 scores by baseline severity.
  
  
  CONCLUSIONS
  Subject-assessed QOL-AD is less likely than proxy-assessed QOL-AD to respond to changes in clinical measures used to track progression in clinical trials of subjects with mild to moderate AD. Proxy-assessed HUI-3 assessments were more in line with other outcome assessments and could therefore be better outcome measures to evaluate clinical progression in mild to moderate AD.
authors: Janssen Alzheimer Immunotherapy Research & Development, LLC, San Francisco, CA, USA.
authors: Loretto
authors: L
authors: Lacey
authors: Pfizer, Inc., Collegville, PA, USA. Electronic address: joel.bobula@pfizer.com.
authors: Joel
authors: J
authors: Bobula
authors: Pfizer, Inc., Collegville, PA, USA.
authors: Katja
authors: K
authors: Rüdell
authors: Pfizer, Inc., Collegville, PA, USA.
authors: Jose
authors: J
authors: Alvir
authors: Janssen Alzheimer Immunotherapy Research & Development, LLC, San Francisco, CA, USA.
authors: Chris
authors: C
authors: Leibman
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D017028:Caregivers / Q000523:psychology; D003071:Cognition / Q000187:drug effects; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D018697:Nootropic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018697:Nootropic Agents; C545458:bapineuzumab
keywords: Alzheimer’s disease; Health Utility Index (HUI); Quality of Life in Alzheimer’s Disease (QOL-AD); patient-reported outcomes