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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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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container_issue 1
container_start_page 90
container_title Health and quality of life outcomes
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creator Rosa, Kathleen
Fu, Min
Gilles, Leen
Cerri, Karin
Peeters, Monika
Bubb, Jeffrey
Scott, Jane
description 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 (
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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 (&lt;0.5 g/dL hemoglobin [Hb] change between Weeks 12/24). Correlation with the EQ-5D visual analog scale (VAS) and "Usual Activity" domain score was used to assess concurrent validity. Clinical validity was evaluated using a case-control method to link spontaneously reported fatigue and anemia adverse events (AEs) during the study to FSS scores. FSS total scores demonstrated good reliability (Cronbach's α: 0.95, 0.96; ICC: 0.74, 0.86 for PILLAR and ASPIRE, respectively) and concurrent validity (correlation with EQ-5D VAS: -0.63, -0.66) with a monotonic relationship between the EQ-5D "Usual Activities" item response and FSS. Clinical validity was confirmed by a significant difference between cases and controls for fatigue AEs (p &lt; 0.05); however, anemia defined by AE or Hb abnormalities was only weakly related to FSS score. Analyses indicate that a change of 0.33-0.82 in mean FSS scores represents a meaningful improvement in fatigue, and a one-point change is a conservative indicator of an important change in individual FSS scores. 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This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.</rights><rights>Copyright © 2014 Rosa et al.; licensee BioMed Central Ltd. 2014 Rosa et al.; licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b684t-c999f533a4df0854ce035813dca542857a502dfe1587fe56586516d06112606f3</citedby><cites>FETCH-LOGICAL-b684t-c999f533a4df0854ce035813dca542857a502dfe1587fe56586516d06112606f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4094687/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/1544702885?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24915781$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rosa, Kathleen</creatorcontrib><creatorcontrib>Fu, Min</creatorcontrib><creatorcontrib>Gilles, Leen</creatorcontrib><creatorcontrib>Cerri, Karin</creatorcontrib><creatorcontrib>Peeters, Monika</creatorcontrib><creatorcontrib>Bubb, Jeffrey</creatorcontrib><creatorcontrib>Scott, Jane</creatorcontrib><title>Validation of the Fatigue Severity Scale in chronic hepatitis C</title><title>Health and quality of life outcomes</title><addtitle>Health Qual Life Outcomes</addtitle><description>Fatigue is a common symptom of chronic hepatitis C virus (cHCV) infection and a common side effect of interferon-based treatment for cHCV. 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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 (&lt;0.5 g/dL hemoglobin [Hb] change between Weeks 12/24). Correlation with the EQ-5D visual analog scale (VAS) and "Usual Activity" domain score was used to assess concurrent validity. Clinical validity was evaluated using a case-control method to link spontaneously reported fatigue and anemia adverse events (AEs) during the study to FSS scores. FSS total scores demonstrated good reliability (Cronbach's α: 0.95, 0.96; ICC: 0.74, 0.86 for PILLAR and ASPIRE, respectively) and concurrent validity (correlation with EQ-5D VAS: -0.63, -0.66) with a monotonic relationship between the EQ-5D "Usual Activities" item response and FSS. Clinical validity was confirmed by a significant difference between cases and controls for fatigue AEs (p &lt; 0.05); however, anemia defined by AE or Hb abnormalities was only weakly related to FSS score. Analyses indicate that a change of 0.33-0.82 in mean FSS scores represents a meaningful improvement in fatigue, and a one-point change is a conservative indicator of an important change in individual FSS scores. A difference of ≥0.7 in mean FSS scores can be considered a clinically important difference within groups over time or between groups. A one-point change or less in individual FSS scores indicates a clinically relevant change in fatigue.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>24915781</pmid><doi>10.1186/1477-7525-12-90</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record>
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source Open Access: PubMed Central; ProQuest - Publicly Available Content Database
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
title Validation of the Fatigue Severity Scale in chronic hepatitis C
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