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 44106, USA.
Ann Neurol. 1997 Sep;42(3):379-82. doi: 10.1002/ana.410420318.
This article provides recommendations from the National Multiple Sclerosis Society's Clinical Outcomes Assessment Task Force. The Task Force was appointed in 1994 and charged with recommendending improved approaches for clinical outcomes assessment in future controlled clinical trials. The recommendations herein follow extensive deliberation and data analysis during 2.5 years. General principles and desirable measurement attributes were used to assess alternative measurement techniques and clinical scales. On the basis of the analysis of existing multiple sclerosis (MS) data sets, a new measurement approach is proposed. The approach is based on quantitative functional composites that consist of simple quantitative measures from the major clinical dimensions of MS combined into a single score. Quantitative functional composites are likely to provide improved precision and sensitivity in future MS clinical trials. Studies necessary to further refine quantitative functional composites as useful MS clinical trial outcomes are delineated.
本文提供了美国国家多发性硬化症协会临床结局评估特别工作组的建议。该特别工作组于1994年被任命，负责为未来的对照临床试验推荐改进的临床结局评估方法。本文中的建议是经过2.5年的广泛审议和数据分析得出的。使用一般原则和理想的测量属性来评估替代测量技术和临床量表。在对现有多发性硬化症（MS）数据集进行分析的基础上，提出了一种新的测量方法。该方法基于定量功能综合指标，该指标由MS主要临床维度的简单定量测量值组合成一个单一分数。定量功能综合指标可能会在未来的MS临床试验中提供更高的精度和灵敏度。文中还描述了进一步完善定量功能综合指标以使其成为有用的MS临床试验结局所需的研究。
