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Methodologic Issues regarding Outcome Measures for Clinical Drug Trials of Psychiatric Complications in Dementia
Journal of Geriatric Psychiatry and Neurology ( IF 2.6 ) Pub Date : 2020-09-15 , DOI: 10.1177/089198879500801s01
Linda Teri 1 , Rebecca G. Logsdon 1
Affiliation  

Selecting outcome measures that are both psychometrically sound and sensitive to change is a very important aspect of clinical outcome research. A variety of measures have been introduced in recent years to assess behavioral complications in dementia, but few have been adequately tested in clinical trials. This article provides a discussion of factors to consider in selecting measures, including psychometrics, item content, assessment source, and sensitivity to change. A review of behavioral and psychiatric measures for dementia patients is provided, including measures of general behavioral disturbance, and measures specifically developed for agitation and depression. Each measure's psychometric characteristics, prior use with demented patients, and strengths and weaknesses with regard to treatment outcome research is summarized. The importance of linking measures to the investigators’ hypotheses is discussed, along with recommendations for evaluating and selecting outcome measures depending on the needs of the specific investigation. (J Geriatr Psychiatry Neurol 1995; 8(suppl 1):S8–S17).



中文翻译:

关于痴呆症精神病并发症临床药物试验结果指标的方法学问题

选择心理上合理且对变化敏感的结局指标是临床结局研究的一个非常重要的方面。近年来,已采取了多种措施来评估痴呆症的行为并发症,但很少有在临床试验中经过充分测试的。本文讨论了在选择度量时要考虑的因素,包括心理测验,项目内容,评估来源以及对变化的敏感性。本文对痴呆症患者的行为和精神病学措施进行了综述,其中包括一般性行为障碍的措施,以及专为激动和抑郁而开发的措施。总结了每种测量的心理测量特征,对痴呆患者的先前使用以及治疗结果研究的优缺点。讨论了将度量与调查员的假设联系起来的重要性,以及根据特定调查的需求评估和选择结果度量的建议。(精神科神经病学杂志1995; 8(补编1):S8–S17)。

更新日期:2020-09-15
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