Potvin A R, Tourtellotte W W, Syndulko K, Potvin J
Crit Rev Bioeng. 1981;6(3):177-224.
Traditionally, neurologists have emphasized qualitative techniques for assessing results of clinical trials. However, in recent years qualitative evaluations have been increasingly augmented by quantitative tests for measuring neurologic functions pertaining to mental state, strength, steadiness, reactions, speed, coordination, sensation, fatigue, gait, station, and simulated activities of daily living. Quantitative tests have long been used by psychologists for evaluating asymptomatic function, assessing human information processing, and predicting proficiency in skilled tasks; however, their methodology has never been directly assessed for validity in a clinical environment. In this report, relevant contributions from the literature on asymptomatic human performance and that on clinical quantitative neurologic function are reviewed and assessed. While emphasis is focused on tests appropriate for evaluating clinical neurologic trials, evaluations of tests for reproducibility, reliability, validity, and examiner training procedures, and for effects of motivation, learning, handedness, age, and sex are also reported and interpreted. Examples of statistical strategies for data analysis, scoring systems, data reduction methods, and data display concepts are presented. Although investigative work still remains to be done, it appears that carefully selected and evaluated tests of sensory and motor function should be an essential factor for evaluating clinical trials in an objective manner.
传统上,神经科医生一直强调采用定性技术来评估临床试验结果。然而,近年来,定性评估越来越多地通过定量测试得到补充,这些测试用于测量与精神状态、力量、稳定性、反应、速度、协调性、感觉、疲劳、步态、姿势以及模拟日常生活活动相关的神经功能。长期以来,心理学家一直使用定量测试来评估无症状功能、评估人类信息处理能力以及预测熟练任务中的表现;然而,其方法在临床环境中的有效性从未得到直接评估。在本报告中,对无症状人类表现的文献以及临床定量神经功能的文献中的相关贡献进行了综述和评估。虽然重点放在适合评估临床神经学试验的测试上,但也报告并解释了对测试的可重复性、可靠性、有效性、检查者培训程序以及动机、学习、用手习惯、年龄和性别的影响的评估。还介绍了数据分析的统计策略、评分系统、数据简化方法和数据显示概念的示例。尽管仍有待开展调查工作,但似乎精心挑选和评估的感觉和运动功能测试应该是以客观方式评估临床试验的一个重要因素。