Advertisement

Quality of Life Research

, Volume 9, Issue 5, pp 499–508 | Cite as

Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C

  • L. Kleinman
  • M.W. Zodet
  • Z. Hakim
  • J. Aledort
  • C. Barker
  • K. Chan
  • L. Krupp
  • D. Revicki
Article

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.

Chronic hepatitis C Clinical trials Fatigue severity scale Item response theory Reliability Validity 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    WHO Consultation. Global surveillance and control of hepatitis C: Report of a WHO consultation organized in collaboration with the viral hepatitis prevention board, Antwerp, Belgium. J Viral Hepat 1999; 6: 35–47.CrossRefGoogle Scholar
  2. 2.
    Alter MJ. Epidemiology of hepatitis C. Hepatology 1997; 26 (Suppl 1): 62S–65S.PubMedCrossRefGoogle Scholar
  3. 3.
    Carithers RL, Sugano D, Bayliss M. Health assessment for chronic HCV infection: Results of quality of life. Dig Dis Sci 1996; 41: 75S–80S.PubMedCrossRefGoogle Scholar
  4. 4.
    Davis GL, Balart MD, SchiffER, et al. Assessing health-related quality of life in chronic hepatitis C using the sickness impact profile. Clin Ther 1994; 16: 334–343.PubMedGoogle Scholar
  5. 5.
    Ware JE, Bungay K, Bandek B, Bayliss M. Assessment of the health-related quality of life (HRQL) of patients with chronic hepatitis C (CHC) [Abstract]. Gastroenterology 1994; 106: A393.Google Scholar
  6. 6.
    Foster GR, Goldin RD, Thomas HC. Chronic hepatitis C infection causes a significant reduction in quality of life in the absence of cirrhosis. Hepatology 1998; 27: 209–212.PubMedCrossRefGoogle Scholar
  7. 7.
    Bonkovsky HL, Woolley JM, the Consensus Interferon Study Group. Reduction of health-related quality of life in HCV and improvement with interferon therapy. Hepatology 1999; 29: 264–270.PubMedCrossRefGoogle Scholar
  8. 8.
    Neary MP, Cort S, Bayliss MS, Ware JE. Sustained virologic response is associated with improved health-related quality of life in relapsed chronic Hepatitis C patients. Semin Liver Dis 1999; 19 (Suppl 1): 77–85.PubMedGoogle Scholar
  9. 9.
    Ware JE, Bayliss MS, Mannocchia M, Davis GL, the International Hepatitis Interventional Therapy Group. Health-related quality of life in chronic hepatitis C: Impact of disease and treatment response. Hepatology 1999; 30: 550–555.PubMedCrossRefGoogle Scholar
  10. 10.
    Barkhuizen A, Rosen HR, Wolf S, Flora K, Benner K, Bennett RM. Musculoskeletal pain and fatigue are associated with chronic hepatitis C: A report of 239 hepatology clinic patients. Am J Gastroenterol 1999; 94: 1355–1360.PubMedGoogle Scholar
  11. 11.
    Kenny-Walsh E. Clinical outcomes after hepatitisCinfection from contaminated anti-D immune globulin. Irish hepatology research group. N Engl J Med 1999; 340: 1228–1233.PubMedCrossRefGoogle Scholar
  12. 12.
    Dusheiko B. Side effects of a interferon in chronic hepatitis C. Hepatology 1997; 26 (Suppl 1): 112S–121S.PubMedCrossRefGoogle Scholar
  13. 13.
    Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989; 27 (Suppl): S217–S232.PubMedGoogle Scholar
  14. 14.
    Nelles S, Abbey S, Stewart DE, Margulies M, Wanless IR, Heathcote EJ. Fatigue assessment in patients with hepatitis C [Abstract]. Gastroenterology 1996; 110(4): A1276.Google Scholar
  15. 15.
    Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The Fatigue Severity Scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989; 46: 1121–1123.PubMedGoogle Scholar
  16. 16.
    Grey-Amante P, Wild D, Hakim Z, et al. The cross-cultural adaptation of the fatigue severity scale. Poster Presentation, Annual Drug Information Association Quality of Life Meeting, Hilton Head, SC. April 2–4, 2000.Google Scholar
  17. 17.
    Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center, 1993.Google Scholar
  18. 18.
    Hunt SM. Cross-cultural issues in the use of quality of life measures in randomized controlled trials. In: Staquet MJ, Hays RD, Fayers PM (eds) Quality of Life Assessment in Clinical Trials, Oxford: Oxford University Press, 1998: 51–68.Google Scholar
  19. 19.
    Ware JE, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scores: A User's Manual. Boston: The Health Institute, New England Medical Center, 1994.Google Scholar
  20. 20.
    Streiner DL, Norman, GR. Health Measurement Scales: A Practical Guide to Their Development and Use, 2nd ed. New York: Oxford University Press, 1995.Google Scholar
  21. 21.
    Cella DF, Loyd SR, Wright BD. Cross-cultural instrument equating: Current research and future directions. Pages 707–716 in Spilker B. Quality of Life and Pharmacoeconomics in Clinical Trials, Second Edition. Philadelphia, PA: Lippincott-Raven Publishers, 1996.Google Scholar
  22. 22.
    Hambleton RK, Swaminathan H, Rogers HJ. Fundamentals of Item Response Theory. Newbury Park, CA: Sage Publications, 1991.Google Scholar
  23. 23.
    Samejima F. Estimation of latent trait ability using a response pattern of graded scores. Psychometrika Monograph Supplement 1969; 17: No. 17.Google Scholar
  24. 24.
    Mauraki E, Block RD. PARSCALE: IRT-based Tested Scoring and Item Analysis for Graded Open-ended Exercises and Performance Tasks. Chicago, IL: Scientific Software International, 1996.Google Scholar
  25. 25.
    Nunally JC, Bernstein IH. Psychometric Theory, 3rd ed. New York: McGraw-Hill, 1994.Google Scholar
  26. 26.
    Hays RD, Anderson RT, Revicki D. Assessing reliability and validity of measurement in clinical trials. In: Staquet MJ, Hays RD, Fayers PM (eds) Quality of Life Assessment in Clinical Trials: Methods and Practice, Oxford: Oxford University Press, 1998: 169–182.Google Scholar

Copyright information

© Kluwer Academic Publishers 2000

Authors and Affiliations

  • L. Kleinman
    • 1
  • M.W. Zodet
    • 1
  • Z. Hakim
    • 2
  • J. Aledort
    • 3
  • C. Barker
    • 2
  • K. Chan
    • 1
  • L. Krupp
    • 4
  • D. Revicki
    • 1
  1. 1.Center for Health Outcomes ResearchMEDTAP® International, Inc.BethesdaUSA
  2. 2.Hoffman-La Roche, Inc.Palo AltoUSA
  3. 3.Hoffman-La Roche, Inc.NutleyUSA
  4. 4.Department of NeurologyState University of New York at StonybrookStonybrookUSA

Personalised recommendations