Department of Psychiatry, Semel Institute for Neuroscience and HumanBehavior, Geffen School of Medicine, University of California, Los Angeles, 300 Medical Plaza, Room 2243, Los Angeles, CA 90095, USA.
Schizophr Bull. 2013 May;39(3):583-91. doi: 10.1093/schbul/sbs001. Epub 2012 Feb 10.
To obtain Food and Drug Administration approval for the treatment of cognitive impairments associated with schizophrenia, a drug will need to demonstrate benefits beyond those that may be documented on objective cognitive tests. Interview-based measures of cognition such as the Cognitive Assessment Interview (CAI) are candidate coprimary outcome measures.
Psychiatrically stable schizophrenia outpatients (n=150) were studied using the CAI to obtain information about cognitive functioning from both the patient and an informant. Patients also received objective assessments of neurocognition, functional capacity, functional outcome, and symptoms, at baseline and 1 month later.
The CAI had good internal consistency (Cronbach's alpha=.92) and good test-retest reliability (r=.83). The CAI was moderately correlated with objective neurocognitive test scores (r's=-.39 to -.41) and moderately correlated with social functioning (r=-.38), work functioning (r=-.48), and overall functional outcome (r=-.49). The correlations of CAI scores with external validity indicators did not differ significantly by source of information (patient alone ratings were valid). Overall functional outcome correlated more strongly with patient CAI scores (r=-.50) than with objective neurocognitive test scores (r=.29) or functional capacity (r=.29).
Field testing of the CAI produced reliable ratings of cognitive functioning that were correlated with functional outcome. Patient ratings alone yielded scores with reliability and validity values appropriate for use in clinical trials. The CAI appears to provide useful complementary information and possesses practical advantages for rating cognitive functioning including an interview-based method of administration, brief assessment time (15 min for the patient assessment), little or no practice effects, and ease of scoring.
为了获得食品和药物管理局（FDA）批准治疗与精神分裂症相关的认知障碍，一种药物需要证明其益处不仅体现在客观认知测试上。基于访谈的认知测量，如认知评估访谈（CAI），是候选的共同主要结局测量。
对稳定的精神分裂症门诊患者（n=150）进行研究，使用 CAI 从患者和知情者那里获取认知功能的信息。患者还在基线和 1 个月后接受神经认知、功能能力、功能结果和症状的客观评估。
CAI 具有良好的内部一致性（Cronbach's alpha=.92）和良好的重测信度（r=.83）。CAI 与客观神经认知测试分数中度相关（r's=-.39 至-.41），与社会功能（r=-.38）、工作功能（r=-.48）和总体功能结果（r=-.49）中度相关。CAI 分数与外部有效性指标的相关性不因信息来源而异（患者单独评分有效）。总体功能结果与患者 CAI 评分的相关性更强（r=-.50），而与客观神经认知测试评分（r=.29）或功能能力（r=.29）的相关性较弱。
CAI 的现场测试产生了可靠的认知功能评分，与功能结果相关。患者单独评分具有可靠性和有效性，适用于临床试验。CAI 似乎提供了有用的补充信息，具有实用优势，包括基于访谈的管理方法、简短的评估时间（患者评估 15 分钟）、很少或没有练习效应以及易于评分。
