Strober Lauren, DeLuca John, Benedict Ralph Hb, Jacobs Adam, Cohen Jeffrey A, Chiaravalloti Nancy, Hudson Lynn D, Rudick Richard A, LaRocca Nicholas G
Kessler Foundation, East Hanover, NJ, USA.
Kessler Foundation, West Orange, NJ, USA.
Mult Scler. 2019 Nov;25(13):1781-1790. doi: 10.1177/1352458518808204. Epub 2018 Oct 18.
The need for more robust outcomes in multiple sclerosis (MS) clinical trials has been a main priority of the field for decades. Dissatisfaction with existing measures has led to several consensus meetings and initiatives over the past few decades in hopes of defining and gaining acceptance of measures that are valid, reliable, sensitive to change and progression, and most importantly, relevant to those living with MS. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) was formed for this purpose.
The objective of this paper is to describe the results of the MSOAC plan to obtain qualification for a cognitive performance measure that meets these requirements.
Using data from 14 MS disease-modifying registration trials, we completed a comprehensive examination of the psychometric qualities of the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT) with the goal of compiling evidence to support the utilization of one of these measures in future clinical trials.
Consistent with the published literature, the SDMT proved superior to the PASAT. The SDMT should be considered the measure of choice for MS trials in assessing cognitive processing speed.
几十年来，在多发性硬化症（MS）临床试验中获得更可靠结果的需求一直是该领域的主要优先事项。对现有测量方法的不满导致在过去几十年里召开了几次共识会议并开展了多项倡议，以期确定并使那些有效、可靠、对变化和进展敏感且最重要的是与MS患者相关的测量方法得到认可。多发性硬化症结果评估联盟（MSOAC）就是为此目的而成立的。
本文的目的是描述MSOAC为使一项符合这些要求的认知表现测量方法获得资质认证所制定计划的结果。
利用来自14项MS疾病修饰登记试验的数据，我们对符号数字模式测验（SDMT）和听觉连续加法测验（PASAT）的心理测量学特性进行了全面检查，目的是汇编证据以支持在未来临床试验中使用这些测量方法之一。
与已发表的文献一致，SDMT被证明优于PASAT。在评估MS试验中的认知处理速度时，SDMT应被视为首选测量方法。
