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为一项多中心临床试验培训考官进行定量神经学检查。

Training examiners to administer a quantitative neurological examination for a multicenter clinical trial.

作者信息

Henderson W G, Tourtellotte W W, Potvin A R

出版信息

Arch Phys Med Rehabil. 1975 Jul;56(7):289-95.

PMID:167673
Abstract

A battery of quantitative neurological tests was used in a multicenter clinical trial to compare ACTH with placebo for the treatment of patients with multiple sclerosis in acute exacerbation. Since the battery of tests was administered in ten centers by physical therapists, it was critical that the examiners were well trained and remained so. Results of experiments showed that physical therapists could be successfully trained to administer the tests in a uniform fashion and remained trained for three years, the duration of the clinical trial. The fact that physical therapists are not taught tell-tale side effects of a treatment, and hence do not perceive these as do the physician examiners, introduces another level of objectivity into neurological clinical trials.

摘要

在一项多中心临床试验中,使用了一系列定量神经学测试,以比较促肾上腺皮质激素(ACTH)与安慰剂治疗急性加重期多发性硬化症患者的效果。由于这些测试是由物理治疗师在十个中心进行的,因此确保检查人员接受良好培训并保持这种状态至关重要。实验结果表明,物理治疗师能够成功接受培训,以统一的方式进行测试,并且在为期三年的临床试验期间一直保持培训状态。物理治疗师没有学习过某种治疗的明显副作用,因此不像医生检查人员那样能够察觉到这些副作用,这一事实为神经学临床试验引入了另一个客观层面。

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