Knopman D S, Knapp M J, Gracon S I, Davis C S
Department of Neurology, University of Minnesota Hospitals, Minneapolis 55455.
Neurology. 1994 Dec;44(12):2315-21. doi: 10.1212/wnl.44.12.2315.
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.
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。