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Identifying an important change estimate for the Multiple Sclerosis Walking Scale-12 (MSWS-12v1) for interpreting clinical trial results
- Source :
- Multiple sclerosis journal-experimental, translational and clinical
- Publication Year :
- 2015
- Publisher :
- SAGE Publications, 2015.
-
Abstract
- Background The 12-question Multiple Sclerosis Walking Scale (MSWS-12v1) is a widely-used patient-reported outcome (PRO) measure of walking ability in multiple sclerosis (MS). Objective To estimate the magnitude of an important change in MSWS-12v1 scores for the interpretation of meaningful subject-level improvements across a 6-month trial of MS patients with walking disability. Methods MOBILE was a 6-month exploratory study assessing fampridine’s effect on walking ability in 132 people with MS. Three PRO measures assessed walking ability: MSWS-12v1, EuroQol 5-Dimension-5 Level (EQ-5D-5L) mobility question, and a patient global impression of change (PGIC) in overall walking ability. Pre-specified anchor- and distribution-based analyses estimated the MSWS-12v1 change scores representing an important change for participants. Results were triangulated to propose a single best value indicating meaningful improvement. Results Using baseline to week 2 through week 24 change scores, anchor-based analyses demonstrated mean and median improvements of 5.2–6.6 (PGIC) and 9.7–13.4 (EQ-5D-5L mobility) points on the MSWS-12v1, indicating meaningful improvements. The distribution-based estimate was 6.8 points. Triangulation across the results suggested an 8-point reduction in MSWS-12v1 score represents an important subject-level change in these participants. Conclusion In similar MS clinical trials, an 8-point improvement on the MSWS-12v1 is a reasonable estimate of meaningful improvement in walking ability.
- Subjects :
- walking ability
medicine.medical_specialty
Multiple sclerosis
anchor-based analysis
Important change
MSWS-12
medicine.disease
responder definition
patient-reported outcome
multiple sclerosis
Outcome (game theory)
Clinical trial
Cellular and Molecular Neuroscience
Physical medicine and rehabilitation
Geography
distribution-based analysis
meaningful improvement
medicine
Physical therapy
Patient-reported outcome
Original Article
Neurology (clinical)
Walking scale
Subjects
Details
- Language :
- English
- ISSN :
- 20552173
- Volume :
- 1
- Database :
- OpenAIRE
- Journal :
- Multiple sclerosis journal - experimental, translational and clinical
- Accession number :
- edsair.doi.dedup.....88b5a7818ed2320aa55ac814f9d236cd