Abstract
BackgroundHepatitis C virus (HCV) infection and its treatments are associated with significant symptoms, side effects and impact on patients functioning. The Hepatitis C Symptom and Impact Questionnaire version 4 (HCV-SIQv4) was developed according to FDA Patient Reported Outcomes (PRO) Guidance, for evaluating chronic HCV infection and its treatment.ObjectivesThis study evaluated the psychometric properties and clinically important change (CIC) thresholds of the measure.MethodsPRO data were pooled from three Phase IIb and III trials evaluating interferon-free simeprevir-containing regimens for treatment of chronic HCV infection. Scale range adequacy, reliability, validity, responsiveness and CIC thresholds were assessed incorporating knowledge of the appropriate measurement model.ResultsData from 437 patients were analyzed. Stage of liver disease was associated with symptom severity and functioning at baseline. Reliability was acceptable (test-retest ICC ≥0.7) for most scores except the Gastrointestinal and Integumentary domains. Convergent validity was observed between HCV-SIQv4 scores and concurrent measures of conceptual similarity. 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 than those failing to. HCV-SIQv4 symptom and domain scores were responsive to changes in health state (effect sizes ≥0.5). Exploratory thresholds for change in scores indicating a clinically important improvement and worsening were HCV-SIQv4 Overall Body System Score (BSS), 8 and 8; Constitutional BSS, 10 and 10; Gastrointestinal BSS, 5 and 5; Psychiatric BSS, 8 and 8; Neurocognitive BSS, 8 and 8; and Integumentary BSS, 5 and 5.ConclusionsThe HCV-SIQv4 offers reliable, responsive assessments within HCV clinical development. CIC thresholds are now available to aid score interpretation.
Highlights
Hepatitis C virus (HCV) infection and its treatments are associated with significant symptoms, side effects and impact on patients functioning
Floor effects were observed for the Overall BSS (OBSS), Overall Body System Score without Injection Site (OBSS-IS), Total Symptom Score (TSS) and TSS-ISS at Follow-up Week 24 only (22.5% for all scores) and for all individual Body System Scores at all time points
This study, conducted in line with regulatory and professional guidance, provides evidence to support the psychometric strength of the HCV-SIQv4 and provides further information on its utility in a chronic HCV population
Summary
Hepatitis C virus (HCV) infection and its treatments are associated with significant symptoms, side effects and impact on patients functioning. The Hepatitis C Symptom and Impact Questionnaire version 4 (HCV-SIQv4) was developed according to FDA Patient Reported Outcomes (PRO) Guidance, for evaluating chronic HCV infection and its treatment. PROs administered within clinical studies must undergo psychometric validation, a cumulative process in which empirical evidence is accumulated to support the meaningfulness and appropriateness of their score inferences for the population of interest.[17,18,19] Regulatory and professional bodies have published guidance and recommendations on the development, validation and use of PRO measures, including evidence for reliability, validity and ability to detect change.[20,21,22] It is paramount to define the level of change observed on PRO scores considered clinically important, to aid interpretation of treatment benefit.[23,24]
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