Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimer's Disease Cooperative Study.

Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimer's Disease Cooperative Study.
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DOI:
10.1097/00002093-199700112-00004
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发表时间:
1997
影响因子:
2.1
通讯作者:
L. Schneider;J. Olin;R. Doody;C. M. Clark;J. Morris;B. Reisberg;F. Schmitt;M. Grundman;R. G. Thomas;S. Ferris
L. Schneider;J. Olin;R. Doody;C. M. Clark;J. Morris;B. Reisberg;F. Schmitt;M. Grundman;R. G. Thomas;S. Ferris
中科院分区:
医学4区
文献类型:
--
作者:
L. Schneider;J. Olin;R. Doody;C. M. Clark;J. Morris;B. Reisberg;F. Schmitt;M. Grundman;R. G. Thomas;S. Ferris

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本文报告了阿尔茨海默病合作研究 - 临床总体印象变化 (ADCS-CGIC) 的发展和心理测量特性。目前,临床试验中使用了一些未经验证的CGIC量表,评级方法也多种多样。 ADCS-CGIC 是根据对 ADCS 临床医生的调查并调整现有仪器而设计的。它包括有组织但非结构化的格式,临床医生可以用它来解决临床相关的变化。该仪器的可靠性和有效性在一项针对阿尔茨海默病 (AD) 和健康受试者的为期 12 个月的前瞻性试验中进行了评估。它在 1 个月和 2 个月时表现出良好的短期可靠性,分别有 90% 和 94% 的 AD 受试者被评为完全没有变化或只有最小程度的变化。 ADCS-CGIC 的表面有效性通过未经处理得到证明。 AD 受试者在 6 个月(56% 被评定为恶化)和 12 个月(81% 被评定为恶化)时均被评定为随时间恶化,而只有 2% 的对照受试者表现出轻微恶化。作为预测有效性的衡量标准,12 个月时的 ADCS-CGIC 评级与四种严重程度的变化显着相关。与其他指标一样,评级变化对痴呆症的严重程度很敏感。中度受损的受试者比其他受试者表现出更严重的恶化。知情者访谈后,ADCS-CGIC 给出了更严重恶化的评级,无论首先访谈的是知情者还是受试者。 ADCS-CGIC 是用于临床试验的有效且可靠的仪器。
This article reports the development and psychometric properties of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC). At present, a number of unvalidated CGIC scales are used in clinical trials, with various methods for making ratings. The ADCS-CGIC was designed on the basis of a survey of ADCS clinicians and by adapting existing instruments. It includes an organized but unstructured format, with which a clinician can address clinically relevant change. The instrument's reliability and validity were assessed in a prospective trial of Alzheimer's disease (AD) and healthy subjects over a 12-month period. It showed good short-term reliability at 1 and 2 months, with 90 and 94% of AD subjects, respectively, rated as having changed not at all or only minimally. The ADCS-CGIC's face validity was demonstrated by untreated. AD subjects rated as having worsened over time at both 6 months (56% rated as having worsened) and 12 months (81% rated as having worsened), whereas only 2% of control subjects showed minimal worsening. As a measure of predictive validity, ADCS-CGIC ratings at 12 months were significantly associated with change on four severity scales. As with other measures, change ratings were sensitive to dementia severity. Moderately impaired subjects showed greater worsening than other subjects. ADCS-CGIC ratings of greater worsening were made after the informant interview, regardless of whether informants or subjects were interviewed first. The ADCS-CGIC is a valid and reliable instrument for use in clinical trials.