title: Validation of the relevant outcome scale for Alzheimer's disease: a novel multidomain assessment for daily medical practice.
abstract: BACKGROUND
  The Relevant Outcome Scale for Alzheimer's Disease (ROSA) is a new observer rating instrument recently developed for routine medical practice. The validity and reliability of ROSA as well as sensitivity to changes due to intervention were examined in an open-label, single-arm, multicenter clinical study in patients with Alzheimer's disease (AD).
  
  
  METHODS
  The study enrolled 471 patients with a diagnosis of AD consistent with the criteria of the National Institute of Neurological and Communicative Disease and Stroke/Alzheimer's Disease and Related Disorders Association or with the Diagnostic and Statistical Manual Disorders criteria for dementia of Alzheimer's type. Following assessments of the ROSA and other standard assessments (Alzheimer's Disease Assessment Scale - cognitive subscale, Severe Impairment Battery, Neuropsychiatric Inventory, and Disability Assessment for Dementia), patients were treated with memantine for 12 weeks. Factor analysis of the baseline ROSA total scores was performed based on the principal components method using the varimax orthogonal rotational procedure. The psychometric analyses of the ROSA included internal consistency, test-retest reliability, inter-rater reliability, construct validity, and responsiveness to changes over time.
  
  
  RESULTS
  All items showed adequate factor loadings and were retained in the final ROSA as Factor 1 (all items related to cognition, communication, function, quality of life and caregiver burden) and Factor 2 (all behavior items). The ROSA demonstrated high internal consistency (Cronbach's α = 0.93), test-retest reliability (intraclass correlation coefficient = 0.93), and inter-rater reliability (intraclass correlation coefficient = 0.91). The correlation coefficients between the ROSA and each of the validated scales ranged between 0.4 and 0.7, confirming the ROSA construct validity. Nonsubstantial floor and ceiling effects were found in middle and late disease stages, whereas a small ceiling effect was observed in the early stage. The ROSA responsiveness to change was high (responsiveness index ≥0.8) for all severity stages.
  
  
  CONCLUSIONS
  The ROSA is a valid and reliable instrument to aid medical practitioners in sensitively assessing AD-relevant symptoms over time in their clinical practice.
authors.affiliation: Old Age Psychiatry and Cognitive Neuropsychiatry, University Hospital Carl Gustav Carus, University of Technology, Fetscherstraße 74, Dresden 01307, Germany. vjera.holthoff@uniklinikum-dresden.de.
authors.forename: Vjera A
authors.initials: VA
authors.lastname: Holthoff
authors.forename: Steven
authors.initials: S
authors.lastname: Ferris
authors.forename: Ralf
authors.initials: R
authors.lastname: Ihl
authors.forename: Philippe
authors.initials: P
authors.lastname: Robert
authors.forename: Bengt
authors.initials: B
authors.lastname: Winblad
authors.forename: Serge
authors.initials: S
authors.lastname: Gauthier
authors.forename: Kati
authors.initials: K
authors.lastname: Sternberg
authors.forename: Frank
authors.initials: F
authors.lastname: Tennigkeit