Benedict Ralph Hb, DeLuca John, Phillips Glenn, LaRocca Nicholas, Hudson Lynn D, Rudick Richard
Department of Neurology and Buffalo General Medical Center, University at Buffalo, Buffalo, NY, USA.
Kessler Foundation, West Orange, NJ, USA; Rutgers New Jersey Medical School, Newark, NJ, USA.
Mult Scler. 2017 Apr;23(5):721-733. doi: 10.1177/1352458517690821. Epub 2017 Feb 16.
Cognitive and motor performance measures are commonly employed in multiple sclerosis (MS) research, particularly when the purpose is to determine the efficacy of treatment. The increasing focus of new therapies on slowing progression or reversing neurological disability makes the utilization of sensitive, reproducible, and valid measures essential. Processing speed is a basic elemental cognitive function that likely influences downstream processes such as memory. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. Among the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step for these neuroperformance metrics is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are deemed clinically meaningful. This topical review provides an overview of research on one particular cognitive measure, the Symbol Digit Modalities Test (SDMT), recognized as being particularly sensitive to slowed processing of information that is commonly seen in MS. The research in MS clearly supports the reliability and validity of this test and recently has supported a responder definition of SDMT change approximating 4 points or 10% in magnitude.
认知和运动表现测量在多发性硬化症(MS)研究中普遍使用,尤其是在旨在确定治疗效果时。新疗法越来越关注减缓疾病进展或逆转神经功能障碍,这使得使用敏感、可重复且有效的测量方法至关重要。处理速度是一种基本的认知功能,可能会影响诸如记忆等下游过程。多发性硬化症结果评估联盟(MSOAC)包括来自倡导组织、美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)、美国国立神经疾病和中风研究所(NINDS)、学术机构、行业合作伙伴以及MS患者的代表。MSOAC的目标之一是让监管机构认可并鉴定那些高度可靠、有效、实用、具有成本效益且对MS患者有意义的性能结果。这些神经性能指标的关键一步是阐明临床相关基准、明确界定的残疾程度以及被认为具有临床意义的变化梯度。本专题综述概述了关于一种特定认知测量方法——符号数字模态测验(SDMT)的研究,该测验被认为对MS中常见的信息处理速度减慢特别敏感。MS领域的研究明确支持了该测试的可靠性和有效性,并且最近还支持了一个关于SDMT变化的反应者定义,变化幅度约为4分或10%。