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Table 5 Responsiveness of the FSS score

From: Validation of the Fatigue Severity Scale in chronic hepatitis C

FSS scores Treatment-naïve Treatment-experienced
(PILLAR) (ASPIRE)
  Mean CFB (SD) P value Mean CFB (SD) P value
Hemoglobin     
Baseline to Week 24a     
 Worsened 1.3 (1.61)   1.0 (1.47)  
 Not worsened 0.8 (1.48) n.s. 0.8 (1.51) n.s.
EOT to 24-wk FUb     
 Improved -1.6 (1.73)   -1.3 (1.55)  
 Unimproved -1.1 (1.38) ** -1.0 (1.52) n.s.
EQ-5D VAS     
Baseline to Week 24     
 Worsened 1.6 (1.61)   1.5 (1.47)  
 Not worsened 0.5 (1.33) *** 0.5 (1.33) ***
EOT to 24-wk FU     
 Improved -2.1 (1.62)   -1.6 (1.65)  
 Unimproved -0.8 (1.37) *** -0.7 (1.23) ***
EQ-5D “Usual Activities”     
Baseline to Week 24     
 “No problems” to “some problems” 1.90 (1.51)   1.72 (1.44)  
 Not worsened 0.52 (1.35) *** 0.57 (1.34) ***
EOT to 24-wk FU     
 “Some problems” to “no problems” -2.27 (1.68)   -2.05 (1.53)  
 Unimproved -0.98 (1.30) *** -0.80 (1.35) ***
  1. CFB change from baseline, EOS end of study, EOT end of treatment, EQ-5D VAS, European Quality of Life 5 dimension questionnaire visual analog scale, FSS Fatigue Severity Scale, FU follow-up, n.s. not significant, SD standard deviation.
  2. **p < 0.01; ***p < 0.001.
  3. a“Worsened” was defined, using data from baseline and Week 24, as those patients with at least a Grade 1 change in anemia based on hemoglobin levels.
  4. b“Improved” was defined, using data from EOT and EOT + 24 weeks (EOS, 72 weeks), as at least a Grade 1 improvement in anemia based on hemoglobin levels.