Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C |
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Authors: | L Kleinman MW Zodet Z Hakim J Aledort C Barker K Chan L Krupp D Revicki |
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Institution: | 1. Center for Health Outcomes Research, MEDTAP? International, Inc., Bethesda, MD, USA 2. Hoffman-La Roche, Inc., Palo Alto, CA, USA 3. Hoffman-La Roche, Inc., Nutley, NJ, USA 4. Department of Neurology, State University of New York at Stonybrook, Stonybrook, NY, USA
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Abstract: | Evidence exists demonstrating that infection with hepatitis C virus impairs health-related quality of life, but less is known
about the effect of fatigue, a common symptom, on everyday life. The psychometric properties of the fatigue severity scale
(FSS) were explored to determine suitability as an outcome measure in clinical trials. The FSS includes nine items developed
to measure disabling fatigue and a visual analog scale (VAS) to measure overall fatigue. Using baseline data from three clinical
trials (n = 1225) involving chronic hepatitis C patients, scaling and psychometric characteristics of the FSS were assessed.
The SF-36 was also used in the trials. Item response theory analysis demonstrated that the FSS items can be placed along a
single homogenous domain, fatigue. Internal consistency reliability was 0.94. Test–retest reliability was 0.82 for the total
score and 0.80 for the VAS. The total score and the VAS were significantly correlated with the SF-36 vitality subscale (r = −0.76 and r = −0.76 respectively). Correlations with other SF-36 subscales were moderate (r = −0.46 to r = −0.67, all p < 0.0001). In summary, the FSS possesses good psychometric properties.
This revised version was published online in June 2006 with corrections to the Cover Date. |
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Keywords: | Chronic hepatitis C Clinical trials Fatigue severity scale Item response theory Reliability Validity |
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