Table 4 Patient-related outcome measures
Questionnaire | Initial visit | 24-week visit | Results from other published studies in patients with MS | |
|---|---|---|---|---|
FAMS (scale: 0–176) Total score (without regard to additional concerns) | N = 129 | N = 97 | ||
Mean (SD) | 135.5 (29.2) | 134.6 (33.7) | 120.3 (33.2) | N = 137 [19] |
120.3 (30.7) | N = 344 [20] | |||
107.5 (32.9) | N = 377 [15] | |||
110.4 (31.7) | N = 463–472 [21] | |||
Median (range) | 145.2 (58–171) | 146 (56–176) | ---- | |
HADS – anxiety (scale: 0–21) | N = 131 | N = 94 | ||
Mean (SD) | 5.3 (4.1) | 5.4 (4.3) | 8.03 (4.2) | N = 4516 [23] |
Median (range) | 5 (0–18) | 5 (0–19) | ---- | |
Cut-off ≥8, % | 26.5 | 26.6 | ---- | |
HADS – depression (scale: 0–21) | N = 131 | N = 94 | ---- | |
Mean (SD) | 3.7 (3.7) | 4.1 (4.1) | 7.37 (4.2) | N = 4516 [23] |
7.0 (2.9) | N = 269 [24] | |||
Median (range) | 2 (0–15) | 3 (0–16) | ---- | |
Cut-off ≥8, % | 16.7 | 19.2 | ---- | |
CES-D (scale: 0–60) | N = 131 | N = 95 | ||
Mean (SD) | 12.8 (9.6) | 13.0 (11.6) | 18.5 (10.1) | N = 51 [22] |
20 (12.1) | N = 463–472 [21] | |||
Median (range) | 10 (0–40) | 9 (0–43) | ---- | |
< 16, % | 65.7 | 65.3 | ---- | |
16–21, % | 16.8 | 12.6 | ---- | |
> 21, % | 17.6 | 22.1 | ---- | |
FSMC (scale: 20–100) | ---- | |||
Cognitive | N = 66 | N = 95 | ---- | |
Mean (SD) | 23.0 (11.0) | 22.2 (10.8) | ---- | |
Median (range) | 21.5 (10–50) | 18 (10–50) | ---- | |
Motor | N = 131 | N = 98 | ---- | |
Mean (SD) | 23.6 (11.1) | 24.1 (11.8) | ---- | |
Median (range) | 22.9 (10–49) | 20.5 (10–50) | ---- | |
Total | N = 66 | N = 95 | ||
Mean (SD) | 47.3 (21.9) | 46.1 (21.9) | 65.2 (17.5) | N = 51 [22] |
Median (range) | 47.5 (20–98) | 39 (20–100) | ---- | |
SDMT Total (scale: 0–110) | N = 116 | N = 75 | ||
Mean (SD) | 47.9 (12.6) | 51.5 (14.4) | 49.06 (10.01) | N = 51 [22] |
51 (13.0) | N = 159 [26] | |||
47.66 (14.71) | N = 100 [25] | |||
55.3 (12.17) | N = 22 [27] | |||
Median (range) | 49 (16–76) | 51 (15–95) | ---- | |