Choi S C, Marmarou A, Bullock R, Nichols J S, Wei X, Pitts L H
Department of Biostatistics, Medical College of Virginia of Virginia Commonwealth University, Richmond 23298-0032, USA.
J Neurotrauma. 1998 Oct;15(10):771-6. doi: 10.1089/neu.1998.15.771.
The most commonly used primary end point in phase III clinical trials of severe head trauma is the Glasgow Outcome Scale (GOS), usually dichotomized to favorable (good) and unfavorable (poor) outcomes. The alternative endpoints include the Disability Rating Scale (DRS) with a 31-point scale. The purpose of this study was to compare DRS and GOS using the data collected from two completed clinical trials organized by the American Brain Injury Consortium and two pharmaceutical companies. The two outcome scales were examined and compared in terms of the correlation between the two scales, sensitivity, and p values between the differences between two arms of the trials. There was no indication that the DRS was more sensitive or advantageous relative to the dichotomized or four-category GOS. In addition, the highly significant correlation between the two outcome scales (r = 0.95; p < 0.0001) could not justify the DRS as an end point. The other problems with the DRS include the difficulty of determining the clinically meaningful difference in designing trials. The study suggested that the GOS is a better primary end point than DRS.
在重度颅脑创伤的III期临床试验中，最常用的主要终点是格拉斯哥预后量表（GOS），通常将其分为良好和不良预后两类。替代终点包括31分制的残疾评定量表（DRS）。本研究的目的是利用从美国脑损伤协会和两家制药公司组织的两项已完成的临床试验中收集的数据，比较DRS和GOS。从两个量表之间的相关性、敏感性以及试验两组之间差异的p值等方面对这两个预后量表进行了检验和比较。没有迹象表明DRS相对于二分法或四类GOS更敏感或更具优势。此外，两个预后量表之间的高度显著相关性（r = 0.95；p < 0.0001）并不能证明DRS可作为一个终点。DRS的其他问题包括在设计试验时难以确定具有临床意义的差异。该研究表明，GOS作为主要终点比DRS更好。
