Abstract
IntroductionThe 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).MethodsThe 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.ResultsAll 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.ConclusionsThe ROSA is a valid and reliable instrument to aid medical practitioners in sensitively assessing AD-relevant symptoms over time in their clinical practice.
Highlights
The Relevant Outcome Scale for Alzheimer’s Disease (ROSA) is a new observer rating instrument recently developed for routine medical practice
Only results obtained from the full analysis set (FAS) analysis will be presented because, besides validity and reliability of the ROSA, the FAS analysis provides an estimate of the ROSA responsiveness; that is, the ability of the scale to detect changes over time due to a treatment, which is an essential psychometric property of all evaluative instruments
The Mini-Mental State Estimation (MMSE) total score distribution across the Alzheimer’s disease (AD) severity groups showed a decrease in the mean MMSE score from the early (23.3 ± 4.2) to the late (12.5 ± 5.5) disease stages
Summary
The Relevant Outcome Scale for Alzheimer’s Disease (ROSA) is a new observer rating instrument recently developed for routine medical practice. The Relevant Outcome Scale for Alzheimer’s Disease (ROSA) is a novel observer rating instrument recently developed for daily clinical practice to allow physicians and other medical practitioners with expertise in the requirements were determined for an ideal practical scale: easy and quick administration; high reliability and validity for AD; multidomain assessment of cognition, activities of daily living, behavior, communication, quality of life, and caregiver burden; relevance for all AD severity stages; suitability for long-term monitoring disease progression; and high sensitivity to treatment effects [1].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
