PMID- 24915781
OWN - NLM
STAT- MEDLINE
DCOM- 20141208
LR  - 20240321
IS  - 1477-7525 (Electronic)
IS  - 1477-7525 (Linking)
VI  - 12
DP  - 2014 Jun 11
TI  - Validation of the Fatigue Severity Scale in chronic hepatitis C.
PG  - 90
LID - 10.1186/1477-7525-12-90 [doi]
AB  - BACKGROUND: 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. METHODS: The study used data from 
      two double-blind, randomized, placebo-controlled, Phase IIb trials evaluating the 
      efficacy and safety of simeprevir plus peginterferon-alpha/ribavirin in 
      treatment-naive (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 alpha at Week 24 
      (internal consistency reliability) and intraclass correlation (ICC) between FSS 
      at Weeks 12 and 24 in stable patients (<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. RESULTS: FSS 
      total scores demonstrated good reliability (Cronbach's alpha: 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 < 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. CONCLUSION: 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.
FAU - Rosa, Kathleen
AU  - Rosa K
FAU - Fu, Min
AU  - Fu M
FAU - Gilles, Leen
AU  - Gilles L
FAU - Cerri, Karin
AU  - Cerri K
FAU - Peeters, Monika
AU  - Peeters M
FAU - Bubb, Jeffrey
AU  - Bubb J
FAU - Scott, Jane
AU  - Scott J
AD  - Janssen Global Services, Global Commercial Strategic Organization, Manchester, 
      UK. jscott51@its.jnj.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20140611
PL  - England
TA  - Health Qual Life Outcomes
JT  - Health and quality of life outcomes
JID - 101153626
RN  - 0 (Heterocyclic Compounds, 3-Ring)
RN  - 0 (Sulfonamides)
RN  - 9WS5RD66HZ (Simeprevir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Fatigue/*classification/diagnosis
MH  - Female
MH  - Hepatitis C, Chronic/drug therapy/*physiopathology
MH  - Heterocyclic Compounds, 3-Ring/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Psychometrics/instrumentation
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Reproducibility of Results
MH  - Simeprevir
MH  - Sulfonamides/therapeutic use
MH  - Surveys and Questionnaires
PMC - PMC4094687
EDAT- 2014/06/12 06:00
MHDA- 2014/12/15 06:00
PMCR- 2014/06/11
CRDT- 2014/06/12 06:00
PHST- 2013/09/19 00:00 [received]
PHST- 2014/06/06 00:00 [accepted]
PHST- 2014/06/12 06:00 [entrez]
PHST- 2014/06/12 06:00 [pubmed]
PHST- 2014/12/15 06:00 [medline]
PHST- 2014/06/11 00:00 [pmc-release]
AID - 1477-7525-12-90 [pii]
AID - 10.1186/1477-7525-12-90 [doi]
PST - epublish
SO  - Health Qual Life Outcomes. 2014 Jun 11;12:90. doi: 10.1186/1477-7525-12-90.