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基于临床医生访谈的印象(CIBI):阿尔茨海默病中临床医生的整体变化评定量表

The Clinician Interview-Based Impression (CIBI): a clinician's global change rating scale in Alzheimer's disease.

作者信息

Knopman D S, Knapp M J, Gracon S I, Davis C S

机构信息

Department of Neurology, University of Minnesota Hospitals, Minneapolis 55455.

出版信息

Neurology. 1994 Dec;44(12):2315-21. doi: 10.1212/wnl.44.12.2315.

DOI:10.1212/wnl.44.12.2315
PMID:7991118
Abstract

Global assessments are Food and Drug Administration-required primary outcome measures in trials of putative antidementia drugs. Global ratings are intended to provide an index of clinical importance of change that cannot be obtained from quantitative assessment measures such as mental status examinations. We examined the performance of a global assessment of change instrument, the Clinician Interview-Based Impression (CIBI), in the placebo group of a 30-week, randomized, double-blind clinical trial of tacrine in patients with Alzheimer's disease. Initially there were 184 placebo patients, of whom 125 completed the 30-week study. Descriptive statistics, correlations with changes on other assessment instruments, and test-retest reliability were determined for the CIBI. At week 30, clinicians rated more than 40% of patients on the CIBI as unchanged. The CIBI ratings were weakly but significantly correlated, in the expected direction, with change scores on the quantitative cognitive assessments. The CIBI was modestly reliable on test-retest at weeks 22 and 24 but less reliable compared with other quantitative outcome measures. Modifications of the CIBI that might improve its reliability and acceptance include (1) no restrictions on the form of the bedside mental status assessment, (2) inclusion of caregiver input, and (3) better definition of ratings on the global scale. Global instruments, if properly constructed, can provide an index of clinically important change for the assessment of dementia patients.

摘要

在假定的抗痴呆药物试验中,整体评估是美国食品药品监督管理局要求的主要疗效指标。整体评分旨在提供一个变化的临床重要性指数,这是诸如精神状态检查等定量评估措施无法获得的。我们在一项为期30周的他克林治疗阿尔茨海默病患者的随机双盲临床试验的安慰剂组中,检验了一种整体变化评估工具——基于临床医生访谈的印象(CIBI)的性能。最初有184名安慰剂组患者,其中125名完成了为期30周的研究。我们确定了CIBI的描述性统计数据、与其他评估工具变化的相关性以及重测信度。在第30周时,临床医生根据CIBI将超过40%的患者评定为无变化。CIBI评分与定量认知评估的变化分数在预期方向上呈弱但显著的相关性。CIBI在第22周和第24周的重测中具有一定的可靠性,但与其他定量疗效指标相比可靠性较低。可能提高CIBI可靠性和可接受性的修改包括:(1)对床边精神状态评估的形式不设限制;(2)纳入护理人员的意见;(3)更好地定义整体量表上的评分。如果构建得当,整体评估工具可为痴呆患者的评估提供临床重要变化的指数。

相似文献

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The Clinician Interview-Based Impression (CIBI): a clinician's global change rating scale in Alzheimer's disease.基于临床医生访谈的印象(CIBI):阿尔茨海默病中临床医生的整体变化评定量表
Neurology. 1994 Dec;44(12):2315-21. doi: 10.1212/wnl.44.12.2315.
2
Linking the Clinical Dementia Rating Scale-Sum of Boxes, the Clinician's Interview-Based Impression Plus Caregiver Input, and the Clinical Global Impression Scale: Evidence based on Individual Participant Data from Five Randomized Clinical Trials of Donepezil.将临床痴呆评定量表-总箱、临床医生基于访谈的印象加照顾者输入与临床总体印象量表联系起来:基于多奈哌齐五项随机临床试验的个体参与者数据的证据。
J Alzheimers Dis. 2021;82(3):1075-1084. doi: 10.3233/JAD-201541.
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A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer's disease. The Tacrine Study Group.一项针对阿尔茨海默病患者的高剂量他克林的30周随机对照试验。他克林研究小组。
JAMA. 1994 Apr 6;271(13):985-91.
4
Apolipoprotein E genotype and gender influence response to tacrine therapy.载脂蛋白E基因型和性别影响对他克林治疗的反应。
Ann N Y Acad Sci. 1996 Dec 16;802:101-10. doi: 10.1111/j.1749-6632.1996.tb32603.x.
5
Effects of estrogen replacement therapy on response to tacrine in patients with Alzheimer's disease.雌激素替代疗法对阿尔茨海默病患者他克林反应的影响。
Neurology. 1996 Jun;46(6):1580-4. doi: 10.1212/wnl.46.6.1580.
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A controlled trial of tacrine in Alzheimer's disease. The Tacrine Study Group.他克林治疗阿尔茨海默病的对照试验。他克林研究小组。
JAMA. 1992 Nov 11;268(18):2523-9.
7
Clinical global impressions in Alzheimer's clinical trials.
Int Psychogeriatr. 1996 Summer;8(2):277-88; discussion 288-90. doi: 10.1017/s1041610296002645.
8
A double-blind, placebo-controlled multicenter study of tacrine for Alzheimer's disease. The Tacrine Collaborative Study Group.他克林治疗阿尔茨海默病的双盲、安慰剂对照多中心研究。他克林协作研究组。
N Engl J Med. 1992 Oct 29;327(18):1253-9. doi: 10.1056/NEJM199210293271801.
9
Treatment outcome of tacrine therapy depends on apolipoprotein genotype and gender of the subjects with Alzheimer's disease.他克林治疗的结果取决于阿尔茨海默病患者的载脂蛋白基因型和性别。
Neurology. 1998 Mar;50(3):669-77. doi: 10.1212/wnl.50.3.669.
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Metrifonate benefits cognitive, behavioral, and global function in patients with Alzheimer's disease.敌百虫对阿尔茨海默病患者的认知、行为及整体功能有益。
Neurology. 1998 May;50(5):1222-30. doi: 10.1212/wnl.50.5.1222.

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