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关于临床试验中神经精神科问卷的管理与评分的评论

Comment on administration and scoring of the Neuropsychiatric Inventory in clinical trials.

作者信息

Connor Donald J, Sabbagh Marwan N, Cummings Jeffery L

机构信息

Cleo Roberts Center for Clinical Research, Sun Health Research Institute, Sun City, AZ, USA.

出版信息

Alzheimers Dement. 2008 Nov;4(6):390-4. doi: 10.1016/j.jalz.2008.09.002.

DOI:10.1016/j.jalz.2008.09.002
PMID:19012863
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2645415/
Abstract

BACKGROUND

The Neuropsychiatric Inventory (NPI) is commonly used in dementia trials to quantify and qualitate changes in psychiatric symptoms.

METHODS

A questionnaire was administered to clinical trial raters to assess whether they were being trained to administer and score the NPI differently between clinical trial protocols.

RESULTS

Responses to the survey indicated that there are differences between clinical trials protocols in how the instrument is administered and scored.

DISCUSSION

Clarification of administration and scoring rules are provided, including the behavioral sampling period, whether premorbid characteristics are considered, and what behaviors are considered in rating frequency, severity, and caregiver distress.

摘要

背景

神经精神科问卷(NPI)常用于痴呆症试验,以量化和定性精神症状的变化。

方法

向临床试验评分者发放一份问卷,以评估他们是否接受培训,从而在不同的临床试验方案中对NPI进行不同的管理和评分。

结果

调查回复表明,不同临床试验方案在该工具的管理和评分方式上存在差异。

讨论

提供了管理和评分规则的说明,包括行为抽样期、是否考虑病前特征,以及在评定频率、严重程度和照料者痛苦时考虑哪些行为。

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