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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) *
  1. AE adverse event, CFB change from baseline, EOT end of treatment, EQ-5D European Quality of Life 5 dimension questionnaire, FSS, Fatigue Severity Scale, n.s. not significant, SD standard deviation, SVR24 sustained virologic response rate 24 weeks post treatment.
  2. *p < 0.05; **p < 0.01; ***p < 0.001.
  3. aClinical groups were defined as normal: >12 g/dL (female), >13.5 g/dL (male); mild (Grade 1) 11–12 g/dL (female), 12.5–13.5 g/dL (male); moderate (Grade 2) 9.5–10.9 g/dL (female), 10.5–12.4 g/dL (male); severe/life-threatening (Grade 3/4) <9.5 g/dL (female), <10.5 g/dL (male).
  4. bThe “cannot perform” group included low numbers of patients: PILLAR, n = 8; ASPIRE, n = 16.