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优化阿尔茨海默病协作研究认知功能评估量表工作表:对临床试验评分者认知的调查

Optimizing ADAS-Cog Worksheets: A Survey of Clinical Trial Rater s' Perceptions.

作者信息

Meyer Stephen M, Bertzos Kristina A, Perez Magdalena, Connor Donald J, Schafer Kimberly, Walter Sarah

机构信息

inVentiv Health. United States.

Consultants in Cognitive and Clinical Trials. United States.

出版信息

Curr Alzheimer Res. 2017;14(9):1008-1016. doi: 10.2174/1567205014666170417122744.

Abstract

BACKGROUND

The Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog) remains the most widely used test of longitudinal cognitive functioning in Alzheimer's disease (AD) clinical trials. Unlike most neuropsychological tests, the ADAS-Cog source documentation worksheets are not uniform across clinical trials, and vary by document layout, inclusion of administration and/or scoring instructions, and documentation of subtest scoring (e.g., recording correct versus incorrect scores), among other differences. Many ADAS-Cog test administrators (raters) participate in multiple AD trials and switching between different ADAS-Cog worksheets may increase the likelihood of administration and/or scoring mistakes that lessen the reliability of the instrument. An anonymous online survey sought raters' experiences with ADAS-Cog worksheets and their opinions on the design and content of the worksheets.

RESULTS

Results of the survey indicated preference for structure and standardization of the ADASCog worksheets, which has been considered in the development of a standard ADAS-Cog source document by the Alzheimer's Disease Cooperative Study (ADCS) Working Group.

摘要

背景

阿尔茨海默病评估量表认知分量表(ADAS-Cog)仍然是阿尔茨海默病(AD)临床试验中最广泛使用的纵向认知功能测试。与大多数神经心理学测试不同,ADAS-Cog原始资料工作表在不同临床试验中并不统一,在文档布局、是否包含施测和/或评分说明以及子测试评分记录(例如,记录正确与错误分数)等方面存在差异。许多ADAS-Cog测试管理员(评分者)参与多项AD试验,在不同的ADAS-Cog工作表之间切换可能会增加施测和/或评分错误的可能性,从而降低该工具的可靠性。一项匿名在线调查征求了评分者对ADAS-Cog工作表的体验以及他们对工作表设计和内容的看法。

结果

调查结果表明,评分者倾向于ADAS-Cog工作表的结构化和标准化,阿尔茨海默病协作研究(ADCS)工作组在制定标准ADAS-Cog原始文档时已考虑到这一点。

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