|
Variable
|
Within Study Groups
|
Between Study Groups at Last Visit
|
|---|
|
MMCD
|
SD
|
Correlation
|
MMCD
|
SD Group A
|
SD Group B
|
|---|
|
Power is ≥0.85 for the primary outcome
|
|
FSS-9
|
1.2–2.0
|
1.1–1.4
|
0.6
|
0.7 [35]
|
0.9
|
1.1
|
|
Power is ≥0.90 for secondary outcomes
|
|
MSQOL-54
| | | | | | |
|
PHC
|
11.5
|
16.0
|
0.6
|
17.0
|
17.0
|
19.0
|
|
MHC
|
12.0
|
17.0
|
0.5
|
18.0
|
18.0
|
19.0
|
|
6 min walk test
|
35
|
50.0
|
0.5
|
45.0
|
45.0
|
50.0
|
|
Timed 25 ft walk
|
2.9
|
4.0
|
0.5
|
4.0
|
4.0
|
4.3
|
|
9 hole peg test
|
5.5
|
8.0
|
0.5
|
8.0
|
8.1
|
8.3
|
|
PASATa
|
4.2
|
6.0
|
0.5
|
5.8
|
6.0
|
6.3
|
- Abbreviations: FSS Fatigue Severity Scale, MSQOL-54 Multiple Sclerosis Quality of Life 54, PHC MSQOL-54 physical health composite score, MHC MSQOL-54 mentalhealth composite score, PASAT Paced Auditory Serial Addition Test, MMCD Minimun Mean Clinical Difference
- aPower and sample size calculations based on PASAT. Per NMSS, SDMT-O replaces the PASAT measure in this study
