Validation of the Fatigue Severity Scale in chronic hepatitis C

Fatigue is a common symptom of chronic hepatitis C virus (cHCV) infection and a common side effect of interferon-based treatment for cHCV. This study provides confirmatory evidence of the reliability and validity of the Fatigue Severity Scale (FSS) to document fatigue in cHCV research and identifies...

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Bibliographic Details
Published in:Health and quality of life outcomes 2014-06, Vol.12 (1), p.90-90, Article 90
Main Authors: Rosa, Kathleen, Fu, Min, Gilles, Leen, Cerri, Karin, Peeters, Monika, Bubb, Jeffrey, Scott, Jane
Format: Article
Language:English
Subjects:
Adult
Aged
Analysis
Care and treatment
Clinical trials
Double-Blind Method
Fatigue
Fatigue - classification
Fatigue - diagnosis
Female
Health aspects
Hepatitis
Hepatitis C
Hepatitis C virus
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - physiopathology
Heterocyclic Compounds, 3-Ring - therapeutic use
Humans
Infections
Male
Measurement
Middle Aged
Patients
Psychometrics - instrumentation
Quality of Life
Questionnaires
Randomized Controlled Trials as Topic
Reproducibility of Results
Simeprevir
Studies
Sulfonamides - therapeutic use
Surveys and Questionnaires
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Summary:Fatigue is a common symptom of chronic hepatitis C virus (cHCV) infection and a common side effect of interferon-based treatment for cHCV. This study provides confirmatory evidence of the reliability and validity of the Fatigue Severity Scale (FSS) to document fatigue in cHCV research and identifies values that indicate clinically important differences in FSS to aid in interpreting fatigue in cHCV clinical trials. The study used data from two double-blind, randomized, placebo-controlled, Phase IIb trials evaluating the efficacy and safety of simeprevir plus peginterferon-α/ribavirin in treatment-naïve (PILLAR, n = 386) and treatment-experienced patients (ASPIRE, n = 462) with cHCV infection. Patients completed the FSS and EuroQoL 5 dimension questionnaire (EQ-5D) at baseline and at regular intervals throughout both trials. Reliability was assessed using Cronbach's coefficient α at Week 24 (internal consistency reliability) and intraclass correlation (ICC) between FSS at Weeks 12 and 24 in stable patients (
ISSN:1477-7525
1477-7525
DOI:10.1186/1477-7525-12-90