Semel Institute of Neuroscience and Human Behavior, UCLA, Los Angeles, USA.
Am J Psychiatry. 2011 Apr;168(4):400-7. doi: 10.1176/appi.ajp.2010.10030414. Epub 2011 Feb 1.
Because reduction of psychotic symptoms in schizophrenia does not result in adequate community functioning, efforts have shifted to other areas, such as cognitive impairment. The U.S. Food and Drug Administration requires that drugs for cognition enhancement in schizophrenia show improvement on two distinct outcome measures in clinical trials: an accepted cognitive performance battery and a functionally meaningful coprimary measure. The authors examined the reliability, validity, and practicality of functionally meaningful measures.
In this four-site validation study, schizophrenia patients were assessed at baseline (N=166) and 4 weeks later (N=144) on performance-based (Independent Living Scales, Test of Adaptive Behavior in Schizophrenia [TABS], and UCSD Performance-based Skills Assessment [UPSA]) and interview-based (Cognitive Assessment Interview and Clinical Global Impression Scale for Cognition) candidate coprimary measures. In addition, cognitive performance, community functioning, and clinical symptoms were assessed. Both full and short forms of the performance-based measures were evaluated.
All measures were well tolerated by patients, had adequate test-retest reliability, and showed good utility as a repeated measure. Measures differed in their correlation with cognitive performance, with performance-based measures having stronger correlations than interview-based measures. None of the measures had notable floor or ceiling effects or missing data.
Among the full-form measures, the UPSA was judged to have the strongest overall properties. Among the short forms, the TABS and UPSA appeared to have the strongest features. Use of the short forms saves time, but at the cost of lower test-retest reliability and weaker correlations with cognitive performance.
由于精神分裂症患者的精神病症状减轻并未导致其充分的社区功能恢复，因此研究重点已转移到其他领域，如认知障碍。美国食品和药物管理局要求用于改善精神分裂症认知功能的药物在临床试验中需要在两个不同的结果测量上显示出改善：一个公认的认知表现测试套件和一个具有功能意义的次要共同测量指标。作者研究了具有功能意义的测量指标的可靠性、有效性和实用性。
在这项四项地点验证研究中，精神分裂症患者在基线时（N=166）和 4 周后（N=144）进行了基于表现的（独立生活量表、精神分裂症适应行为测试[TABS]和圣地亚哥大学基于表现的技能评估[UPSA]）和基于访谈的（认知评估访谈和认知临床总体印象量表）候选次要共同测量评估。此外，还评估了认知表现、社区功能和临床症状。对基于表现的测量的完整和简短形式进行了评估。
所有的测量方法都能被患者很好地耐受，具有足够的测试-重测信度，并且作为重复测量具有良好的实用性。各项措施与认知表现的相关性不同，基于表现的措施与基于访谈的措施相比相关性更强。没有任何一项措施具有明显的地板或天花板效应或数据缺失。
在完整形式的措施中，UPSA 被认为具有最强的整体特性。在简短形式中，TABS 和 UPSA 似乎具有最强的特性。使用简短形式可以节省时间，但代价是测试-重测信度降低，与认知表现的相关性减弱。
