TY - JOUR
T1 - Identifying an important change estimate for the Multiple Sclerosis Walking Scale-12 (MSWS-12v1) for interpreting clinical trial results
AU - Mehta, Lahar
AU - McNeill, Manjit
AU - Hobart, Jeremy
AU - Wyrwich, Kathleen W.
AU - Poon, Jiat Ling
AU - Auguste, Priscilla
AU - Zhong, John
AU - Elkins, Jacob
PY - 2015/9/1
Y1 - 2015/9/1
N2 - 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.
AB - 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.
U2 - 10.1177/2055217315596993
DO - 10.1177/2055217315596993
M3 - Article
SN - 2055-2173
VL - 1
JO - Multiple Sclerosis Journal - Experimental, Translational and Clinical
JF - Multiple Sclerosis Journal - Experimental, Translational and Clinical
IS - 0
ER -