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Evaluation of multiple sclerosis disability outcome measures using pooled clinical trial data

Neurology® Nov 28, 2019

Goldman MD, LaRocca NG, Rudick RA, et al. - Standardized data of 12,776 people was recruited from control and treatment arms of 14 clinical trials in order to report analyses of a pooled database by the Multiple Sclerosis Outcome Assessments Consortium to assess four proposed components of a multidimensional test battery. Outstanding test-retest reliability was noted in the performance measures along with expected variations between subgroups based on disease duration and Expanded Disability Status Scale score (EDSS) level. In identifying the time to 3-month, progression rates affirmed worsening were lower for Timed 25-Foot Walk and 9-Hole Peg Test, in comparison with EDSS, while progression rates for Low Contrast Letter Acuity and Symbol Digit Modalities Test were comparable to EDSS. When the four measures were investigated as a multidimensional measure rather than as individual measures, an improvement on any of the one performance measure was more sensitive vs the EDSS. Worsening on the performance measures investigated individually or as a multidimensional test battery was related to clinically significant Short Form–36 Physical Component Summary score worsening, establishing the clinical significance of indicated performance test score worsening. Thus, the use of the four proposed performance measures, individually or combined into a multidimensional test battery as study outcome measures was supported.
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