title: Clinical evaluation of global change in Alzheimer's disease: identifying consensus.
abstract: It is important that clinicians who rate global change as part of Alzheimer's disease (AD) clinical drug trials agree on a relevant set of behaviors and information to be considered in formulating their rating. Yet, consensus among raters has been difficult to establish, and inter-rater reliability of clinical global impression of change (CGIC) ratings has been low. In preparation for the development of a new CGIC scale to be used in AD clinical trials, the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), we surveyed clinicians at sites comprising the National Institute on Aging-sponsored ADCS participating centers to identify whether or not consensus regarding CGICs exists. Overall, respondents reported that a CGIC should include an assessment of the patient's function and mental status, a care giver interview, and a standardized set of questions, and it should take approximately 20 minutes per interview. Depending on a patient's level of impairment, raters consider different areas of behavior in formulating a CGIC rating. These findings demonstrate the considerable consensus regarding the CGIC rating process, and were integrated into the design of the ADCS-CGIC, currently in use.
authors.affiliation: University of Southern California School of Medicine, Los Angeles, USA.
authors.forename: J T
authors.initials: JT
authors.lastname: Olin
authors.forename: L S
authors.initials: LS
authors.lastname: Schneider
authors.forename: R S
authors.initials: RS
authors.lastname: Doody
authors.forename: C M
authors.initials: CM
authors.lastname: Clark
authors.forename: S H
authors.initials: SH
authors.lastname: Ferris
authors.forename: J C
authors.initials: JC
authors.lastname: Morris
authors.forename: B
authors.initials: B
authors.lastname: Reisberg
authors.forename: F A
authors.initials: FA
authors.lastname: Schmitt
mesh_terms: D000544:Alzheimer Disease / Q000523:psychology*; D003657:Decision Making; D006801:Humans; D011569:Psychiatric Status Rating Scales; D011795:Surveys and Questionnaires