DGI Clinical Inc., Halifax, Nova Scotia, Canada.
Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
Alzheimers Dement. 2021 May;17(5):856-865. doi: 10.1002/alz.12242. Epub 2021 Apr 29.
The Clinician's Interview-Based Impression of Change Plus caregiver input (CIBIC-Plus) has been widely used in dementia drug trials to evaluate cognition, behavior, and function. New trials of symptomatic drugs forecast renewed interest in this measure.
To test its clinical meaningfulness, we examined how CIBIC-Plus performed in two cholinesterase inhibitor trials compared to goal attainment scaling Scale (GAS) scores, a patient-reported outcome measure.
Net goal attainment was seen for all but one GAS domains in subjects who improved on the CIBIC-Plus. Subjects who improved initially on CIBIC-Plus scores were likely to remain improved across all other outcomes for each trial's duration, except for Disability Assessment for Dementia scores.
The initial response to treatment, as assessed by CIBIC-Plus, remained stable for most outcome measures. Even small CIBIC-Plus improvement changes are associated with clinically meaningful change as assessed by GAS. Other tests detect decline better than improvement.
基于临床医生访谈的变化印象加照料者输入(CIBIC-Plus)已广泛用于痴呆症药物试验,以评估认知、行为和功能。针对症状性药物的新试验预示着人们对该措施重新产生兴趣。
为了检验其临床意义,我们比较了 CIBIC-Plus 与目标实现量表(GAS)评分在两项胆碱酯酶抑制剂试验中的表现,GAS 评分是一种患者报告的结果测量。
在 CIBIC-Plus 评分改善的患者中,除了一个 GAS 领域外,所有领域的净目标都实现了。在 CIBIC-Plus 评分最初改善的患者中,除了痴呆残疾评估评分外,他们在每个试验的持续时间内都有可能在所有其他结果上保持改善。
治疗开始时的反应,如 CIBIC-Plus 评估,在大多数结果测量中保持稳定。即使 CIBIC-Plus 略有改善变化,也与 GAS 评估的临床有意义变化相关。其他测试更能检测到下降而不是改善。