Table 4 Validity of the FSS
From: Validation of the Fatigue Severity Scale in chronic hepatitis C
FSS scores | Actual score at time of clinical outcome | Change from baseline to clinical event | ||||
|---|---|---|---|---|---|---|
Treatment-naïve | Treatment-experienced | Treatment-naïve | P value | Treatment-experienced | P value | |
(PILLAR) | (ASPIRE) | (PILLAR) | (ASPIRE) | |||
Mean (SD) | Mean (SD) | Mean CFB (SD) | Mean CFB (SD) | |||
SVR24 | ||||||
Yes | 2.7 (1.59) | 3.0 (1.63) | -0.6 (1.41) | -0.4 (1.42) | ||
No | 3.5 (1.83) | 3.6 (1.80) | 0.3 (1.28) | *** | 0.4 (1.50) | *** |
Hemoglobin (EOT)a | ||||||
Normal | 4.3 (1.76) | 4.3 (1.77) | 0.8 (1.54) | (comparator) | 1.0 (1.56) | (comparator) |
Mild anemia | 4.3 (1.67) | 4.2 (1.73) | 1.2 (1.67) | n.s. | 0.9 (1.53) | n.s. |
Moderate/severe anemia | 4.7 (1.55) | 4.5 (1.73) | 1.5 (1.56) | * | 1.1 (1.62) | n.s. |
Anemia AE | ||||||
Case | 4.5 (1.79) | 4.8 (1.70) | 1.2 (1.76) | 1.1 (1.72) | ||
Control | 4.2 (1.73) | 4.4 (1.74) | 1.0 (1.38) | n.s. | 1.0 (1.38) | n.s. |
Fatigue AE | ||||||
Case | 4.4 (1.58) | 4.5 (1.59) | 1.1 (1.45) | 0.9 (1.35) | ||
Control | 3.8 (1.67) | 3.5 (1.67) | 0.5 (1.49) | * | 0.4 (1.26) | *** |
EQ-5D “Usual Activities” | ||||||
“No problems” | 3.3 (1.31) | 3.4 (1.51) | 0.6 (1.29) | (comparator) | 0.6 (1.38) | (comparator) |
“Some problems” | 5.2 (1.23) | 5.4 (1.19) | 1.6 (1.64) | *** | 1.5 (1.45) | *** |
“Cannot perform”b | 6.5 (0.48) | 6.5 (1.15) | 2.2 (1.97) | ** | 1.4 (1.69) | * |