Epub: Hobart et al.Timed 25-Foot Walk: Direct evidence that improving 20% or greater is clinically meaningful in MS. Neurology. 2013 Mar 27.
OBJECTIVE: In this study, the investigators’ used data from clinical trials of dalfampridine (fampridine outside the United States) to re-examine the clinical meaningfulness of Timed 25-Foot Walk (T25FW) changes.
METHODS: Pooled data were analyzed from 2 phase III randomized placebo-controlled clinical trials of dalfampridine in multiple sclerosis (MS) (n = 533). Walking speed (T25FW) and MSer-reported walking ability (MS Walking Scale-12 [MSWS-12]) were measured, concurrently, multiple times before and during treatment. They examined T25FW speed variability within and between visits, correlations of T25FW speed with MSWS-12 score, and changes in MSWS-12 (mean scores, effect sizes) associated with percent T25FW changes.
RESULTS: T25FW speed variability was small (within- and between-visit averages = 7.2%-8.7% and 14.4%-16.3%). Correlations between T25FW and MSWS-12 values were low (-0.20 to -0.30), but relatively stronger between their change values (-0.33 to -0.41). Speed improvements of >20%, and possibly 15%, were associated with clinically meaningful changes in self-reported walking ability using MSWS-12 change score and effect size criteria.
CONCLUSIONS: This study builds on existing research and provides direct evidence that improvements in T25FW speed of ≥20% are meaningful to MSers. The dalfampridine data enabled examinations previously not possible, including spontaneous and induced speed changes, speed change anchored to change in self-reported walking ability, and a profile of speed changes. Results support the T25FW as a clinically meaningful outcome measure for MS clinical trials.
Becker et al. Promising New Approaches to Assess Cognitive Functioning in People with Multiple Sclerosis. Int J MS Care. 2012 Summer;14(2):71-76.
Background: Cognitive impairment has a major impact on the lives of MSers. Yet, it is often under-diagnosed, and more effective assessment methods are needed. In particular, brief measures that focus on cognitive functioning in daily life situations, are sensitive to modest change over time, and do not require a highly skilled assessor merit exploration.
“These studies indicate that MS-related outcome measures are now a mini-industry in themselves. It is important to keep in mind that although they may be clinically meaningful MSers need to feel that when doing these outcomes they relate to them; for example some cognitive tests are so disconnected to day-to-day functioning that MSers hate doing them and think that they are irrelevant.”