Rudick R, Antel J, Confavreux C, Cutter G, Ellison G, Fischer J, Lublin F, Miller A, Petkau J, Rao S, Reingold S, Syndulko K, Thompson A, Wallenberg J, Weinshenker B, Willoughby E
Mellen Center, Cleveland Clinic Foundation, OH, USA.
Ann Neurol. 1996 Sep;40(3):469-79. doi: 10.1002/ana.410400321.
This article represents initial deliberation of an international task force appointed by the US National Multiple Sclerosis Society to develop recommendations for optimal clinical assessment tools for multiple sclerosis clinical trials. Presented within this article are the key issues identified by the task force during its initial year of deliberation. These include the precise purpose for a clinical assessment tool, the clinical dimensions to be measured in a multidimensional outcome measure, desirable attributes of an optimal clinical outcome measure, the complexities of multidimensional outcome measures, the relative merits of categorical clinical ratings and quantitative functional assessments, and a number of other important design issues that relate to the use of a multidimensional outcome measure. An action plan for analysis of existing data is summarized, as are the plans for more detailed recommendations from the task force.
本文介绍了美国国家多发性硬化症协会任命的一个国际特别工作组的初步审议情况，该工作组旨在为多发性硬化症临床试验制定最佳临床评估工具的建议。本文介绍了特别工作组在审议的第一年确定的关键问题。这些问题包括临床评估工具的确切用途、多维结果测量中要测量的临床维度、最佳临床结果测量的理想属性、多维结果测量的复杂性、分类临床评级和定量功能评估的相对优点，以及与使用多维结果测量相关的许多其他重要设计问题。总结了现有数据分析的行动计划，以及特别工作组提出更详细建议的计划。
