Abstract
BackgroundThe number of steps taken per day (steps/day) provides a reliable and valid outcome of free-living walking behavior in persons with multiple sclerosis (MS).ObjectiveThis study examined the clinical meaningfulness of steps/day using the minimal clinically important difference (MCID) value across stages representing the developing impact of MS.MethodsThis study was a secondary analysis of de-identified data from 15 investigations totaling 786 persons with MS and 157 healthy controls. All participants provided demographic information and wore an accelerometer or pedometer during the waking hours of a 7-day period. Those with MS further provided real-life, health, and clinical information and completed the Multiple Sclerosis Walking Scale-12 (MSWS-12) and Patient Determined Disease Steps (PDDS) scale. MCID estimates were based on regression analyses and analysis of variance for between group differences.ResultsThe mean MCID from self-report scales that capture subtle changes in ambulation (1-point change in PDSS scores and 10-point change in MSWS-12 scores) was 779 steps/day (14% of mean score for MS sample); the mean MCID for clinical/health outcomes (MS type, duration, weight status) was 1,455 steps/day (26% of mean score for MS sample); real-life anchors (unemployment, divorce, assistive device use) resulted in a mean MCID of 2,580 steps/day (45% of mean score for MS sample); and the MCID for the cumulative impact of MS (MS vs. control) was 2,747 steps/day (48% of mean score for MS sample).ConclusionThe change in motion sensor output of ∼800 steps/day appears to represent a lower-bound estimate of clinically meaningful change in free-living walking behavior in interventions of MS.
Highlights
There has been an ongoing debate regarding outcome measures in clinical research involving persons with multiple sclerosis (MS) [1], with increasing interest in approaches for objectively monitoring patients under real-world conditions [2]
The change in motion sensor output of,800 steps/day appears to represent a lower-bound estimate of clinically meaningful change in free-living walking behavior in interventions of MS
We examined steps/day across 1-point incremental increases in Patient Determined Disease Steps (PDDS) scores and this is consistent with 1-point changes in Expanded Disability Status Scale (EDSS) considered as reflecting worsening MS disability
Summary
There has been an ongoing debate regarding outcome measures in clinical research involving persons with multiple sclerosis (MS) [1], with increasing interest in approaches for objectively monitoring patients under real-world conditions [2] This interest has highlighted the potential for the objective monitoring of freeliving walking behavior using motion sensors such as accelerometers and pedometers in clinical research involving persons with neurologic diseases [3] including MS [2]. Such devices are worn around the waist or ankle during the waking hours of the day and over a representative sampling period (e.g., seven days). The number of steps taken per day (steps/day) provides a reliable and valid outcome of free-living walking behavior in persons with multiple sclerosis (MS)
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