Evaluation of Functionally Meaningful Measures for Clinical Trials of Cognition Enhancement in Schizophrenia
Evaluation of Functionally Meaningful Measures for Clinical Trials of Cognition Enhancement in Schizophrenia
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DOI：
10.1176/appi.ajp.2010.10030414
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发表时间：
2011-04-01
影响因子：
17.7
通讯作者：
Marder, Stephen R.
中科院分区：
文献类型：
--
作者：
Green, Michael F.;Schooler, Nina R.;Marder, Stephen R.
目的：由于精神分裂症精神病症状的减轻并不能导致适当的社区功能，因此努力已转移到其他领域，如认知障碍。美国食品和药物管理局要求用于精神分裂症认知增强的药物在临床试验中表现出两种不同的结果测量：公认的认知表现电池和功能上有意义的主要测量。作者检验了功能上有意义的测量方法的信度、效度和实用性。方法：在这项四点验证性研究中，对精神分裂症患者在基线（N= 166）和4周后（N= 144）进行基于绩效的（独立生活量表、精神分裂症适应行为测试[TABS]和UCSD基于绩效的技能评估[UPSA]）和基于访谈的（认知评估访谈和临床认知总体印象量表）候选主要测量。此外，还评估了认知表现、社区功能和临床症状。评估了基于绩效的措施的完整形式和简短形式。结果：所有测量方法均被患者耐受良好，具有足够的重测信度，并且作为重复测量显示出良好的效用。测量与认知表现的相关性有所不同，基于表现的测量比基于访谈的测量具有更强的相关性。这些措施都没有显著的下限或上限效应或缺失数据。结论：在全形式措施中，UPSA被认为具有最强的综合性能。在短表格中，tab和UPSA似乎具有最强的特征。使用简短形式节省了时间，但代价是重测信度较低，与认知表现的相关性较弱。
Objective: 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.Method: 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.Results: 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.Conclusions: 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.