symptoms and functioning at baseline. For most patients, symptom scores improved during treatment which is consistent with the reduction in HCV-related symptoms reported in the trials. Reliability was acceptable (Cronbach's α ≥ 0.7, test-retest ICC ≥ 0.7) for most scores except the HCV-SIQv4 Gastrointestinal and Integumentary domain scores. Convergent validity was observed between PRO scores and concurrent measures of the same concept. Greater symptom severity and worse impact scores were associated with liver cirrhosis, depression, severe fatigue, and health limitations. Patients who achieved SVR12 had better outcomes on all PRO instruments. HCV-SIQv4 symptom and domain scores were responsive to improvements and worsening in health state (effect sizes ≥ 0.5). Thresholds for change in scores indicating a clinically important improvement (or worsening) were: 8 (8) for HCV-SIQv4 Overall Body System Score; 1 (1) for FSS; 3 (6) for CES-D; and 8 (worsening not studied) for EQ-5D-5L VAS. ConClusions: The FSS, CES-D, EQ-5D-5L, and HCV-SIQv4 are reliable, valid, and responsive measures of HCV treatment outcomes suitable for patients regardless of liver disease stage.
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