TY - JOUR
T1 - Responsiveness and clinically meaningful improvement, according to disability level, of five walking measures after rehabilitation in multiple sclerosis
T2 - A European multicenter study
AU - Baert, Ilse
AU - Freeman, Jennifer
AU - Smedal, Tori
AU - Dalgas, Ulrik
AU - Romberg, Anders
AU - Kalron, Alon
AU - Conyers, Helen
AU - Elorriaga, Iratxe
AU - Gebara, Benoit
AU - Gumse, Johanna
AU - Heric, Adnan
AU - Jensen, Ellen
AU - Jones, Kari
AU - Knuts, Kathy
AU - Maertens De Noordhout, Benoît
AU - Martic, Andrej
AU - Normann, Britt
AU - Eijnde, Bert O.
AU - Rasova, Kamila
AU - Santoyo Medina, Carmen
AU - Truyens, Veronik
AU - Wens, Inez
AU - Feys, Peter
N1 - Funding Information:
Coordination of this study was partially funded via a unrestricted educational grant from Novartis Pharma AG to the European RIMS network which is acknowledged for facilitating inter-European consultation and testing. The staff of each participating site is thanked for their cooperation. Thanks to Dr H. Thijs (CENSTAT, Hasselt University) and B. Bibby (Department of Biostatistics, Aarhus University) for statistical advice. We gratefully thank all the participating persons with multiple sclerosis, and acknowledge the contribution of Domien Gijbels in study preparation.
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was partially funded via a unrestricted educational grant from Novartis Pharma AG to RIMS.
PY - 2014/9
Y1 - 2014/9
N2 - Background. Evaluation of treatment effects on walking requires appropriate and responsive outcome measures. Objectives. To determine responsiveness of 5 walking measures and provide reference values for clinically meaningful improvements, according to disability level, in persons with multiple sclerosis (pwMS). Methods. Walking tests were measured pre- and postrehabilitation in 290 pwMS from 17 European centers. Combined anchor- and distribution-based methods determined responsiveness of objective short and long walking capacity tests (Timed 25-Foot Walk [T25FW] and 2- and 6-Minute Walk Tests [2MWT and 6MWT] and of the patient-reported Multiple Sclerosis Walking Scale-12 [MSWS-12]). A global rating of change scale, from patients' and therapists' perspective, was used as external criteria to determine the area under the receiver operating characteristic curve (AUC), minimally important change (MIC), and smallest real change (SRC). Patients were stratified into disability subgroups (Expanded Disability Status Scale score ≤4 [n = 98], >4 [n = 186]). Results. MSWS-12, 2MWT, and 6MWT were more responsive (AUC 0.64-0.73) than T25FW (0.50-0.63), especially in moderate to severely disabled pwMS. Clinically meaningful changes (MICs) from patient and therapist perspective were -10.4 and -11.4 for MSWS-12 (P <.01), 9.6 m and 6.8 m for 2MWT (P <.05), and 21.6 m (P <.05) and 9.1 m (P =.3) for 6MWT. In subgroups, MIC was significant from patient perspective for 2MWT (10.8 m) and from therapist perspective for MSWS-12 (-10.7) in mildly disabled pwMS. In moderate to severely disabled pwMS, MIC was significant for MSWS-12 (-14.1 and -11.9). Conclusions. Long walking tests and patient-reported MSWS-12 were more appropriate than short walking tests in detecting clinically meaningful improvement after physical rehabilitation, particularly the MSWS-12 for moderate to severely disabled pwMS.
AB - Background. Evaluation of treatment effects on walking requires appropriate and responsive outcome measures. Objectives. To determine responsiveness of 5 walking measures and provide reference values for clinically meaningful improvements, according to disability level, in persons with multiple sclerosis (pwMS). Methods. Walking tests were measured pre- and postrehabilitation in 290 pwMS from 17 European centers. Combined anchor- and distribution-based methods determined responsiveness of objective short and long walking capacity tests (Timed 25-Foot Walk [T25FW] and 2- and 6-Minute Walk Tests [2MWT and 6MWT] and of the patient-reported Multiple Sclerosis Walking Scale-12 [MSWS-12]). A global rating of change scale, from patients' and therapists' perspective, was used as external criteria to determine the area under the receiver operating characteristic curve (AUC), minimally important change (MIC), and smallest real change (SRC). Patients were stratified into disability subgroups (Expanded Disability Status Scale score ≤4 [n = 98], >4 [n = 186]). Results. MSWS-12, 2MWT, and 6MWT were more responsive (AUC 0.64-0.73) than T25FW (0.50-0.63), especially in moderate to severely disabled pwMS. Clinically meaningful changes (MICs) from patient and therapist perspective were -10.4 and -11.4 for MSWS-12 (P <.01), 9.6 m and 6.8 m for 2MWT (P <.05), and 21.6 m (P <.05) and 9.1 m (P =.3) for 6MWT. In subgroups, MIC was significant from patient perspective for 2MWT (10.8 m) and from therapist perspective for MSWS-12 (-10.7) in mildly disabled pwMS. In moderate to severely disabled pwMS, MIC was significant for MSWS-12 (-14.1 and -11.9). Conclusions. Long walking tests and patient-reported MSWS-12 were more appropriate than short walking tests in detecting clinically meaningful improvement after physical rehabilitation, particularly the MSWS-12 for moderate to severely disabled pwMS.
KW - clinically meaningful improvement
KW - multiple sclerosis rehabilitation
KW - responsiveness
KW - walking measures
UR - http://www.scopus.com/inward/record.url?scp=84906261642&partnerID=8YFLogxK
U2 - 10.1177/1545968314521010
DO - 10.1177/1545968314521010
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AN - SCOPUS:84906261642
SN - 1545-9683
VL - 28
SP - 621
EP - 631
JO - Neurorehabilitation and Neural Repair
JF - Neurorehabilitation and Neural Repair
IS - 7
ER -