Orgogozo J M, Capildeo R, Anagnostou C N, Juge O, Péré J J, Dartigues J F, Steiner T J, Yotis A, Rose F C
Presse Med. 1983 Dec 29;12(48):3039-44.
Among the main methodological problems raised by clinical trials in cerebral vascular accidents, one of the most serious is the lack of well-established and widely accepted criteria to evaluate the course of the disease. On the basis of published scores and of several trials carried on by us in three different centres during the last few years, we have developed a neurological score devised to reflect, as accurately as possible, deficits due to infarctions in the Sylvian territory, yet rapid and simple enough to provide an objective and reproducible rating. We report here the results of a prospective study concerning the inter-rater variations of the score from one centre to the other (inter-centre study) and within each centre (intra-centre study). These results have led us to withdraw three items with insufficient response rate and poor agreement, viz, "mental confusion", "visual field" and "sensory disorders". With the remaining 10 items the mean agreement between individual items varied from 85% to 90% and the global score agreement exceeded 90%. A study comparing our score with the Barthel index showed close correlation up to the autonomy threshold (Barthel index = 60) and divergent results beyond that point. The good agreement observed between inter-rater variations suggests that the score is reliable but does not inform on its sensitivity. In view of their relative independence, the neurological and the functional score should be regarded as complementary and should be used together as criteria of clinical assessment.
在脑血管意外临床试验所引发的主要方法学问题中,最严重的问题之一是缺乏完善且被广泛接受的评估疾病进程的标准。基于已发表的评分以及我们在过去几年于三个不同中心进行的多项试验,我们制定了一种神经学评分,旨在尽可能准确地反映大脑外侧裂区域梗死所致的功能缺损,同时又要足够快速和简单,以提供客观且可重复的评级。我们在此报告一项前瞻性研究的结果,该研究涉及该评分在不同中心之间(中心间研究)以及每个中心内部(中心内研究)的评分者间差异。这些结果促使我们剔除了三项应答率不足且一致性较差的项目,即“精神错乱”、“视野”和“感觉障碍”。对于其余10项,各个项目之间的平均一致性在85%至90%之间,整体评分一致性超过90%。一项将我们的评分与巴氏指数进行比较的研究表明,在自主阈值(巴氏指数 = 60)之前两者密切相关,而在此之后结果则有所不同。评分者间差异方面观察到的良好一致性表明该评分是可靠的,但并未表明其敏感性。鉴于神经学评分和功能评分相对独立,应将它们视为互补的,并应一起用作临床评估的标准。