Validation of the Fatigue Severity Scale in chronic hepatitis C

Health and Quality of Life Outcomes

Jane Scott³  Jeffrey Bubb¹  Monika Peeters⁶  Karin Cerri⁴  Leen Gilles⁶  Min Fu⁵  Kathleen Rosa² 

[1] Wu Consulting, Inc, Radnor, PA, USA;University of North Carolina at Wilmington, Wilmington, NC, USA;Janssen Global Services, Global Commercial Strategic Organization, Manchester, UK;Janssen Global Services, Global Commercial Strategy Organization, Beerse, Belgium;Janssen Research and Development, Radnor, PA, USA;Janssen Research and Development, Beerse, Belgium

关键词: Fatigue;    Health status;    Fatigue Severity Scale;    Psychometric validation;    Chronic hepatits C;   

Others  :  834708
DOI  :  10.1186/1477-7525-12-90

 received in 2013-09-19, accepted in 2014-06-06,  发布年份 2014

【 摘 要 】

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-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 (<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 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 < 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.

【 授权许可】

   
2014 Rosa et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Malaguarnera M, Vacante M, Bertino G, Neri S, Malaguarnera M, Gargante MP, Motta M, Lupo L, Chisari G, Bruno CM, Pennisi G, Bella R: The supplementation of acetyl-L-carnitine decreases fatigue and increases quality of life in patients with hepatitis C treated with pegylated interferon-alpha 2b plus ribavirin. J Interferon Cytokine Res 2011, 31:653-659.
• [2]Sarkar S, Jiang Z, Evon DM, Wahed AS, Hoofnagle JH: Fatigue before, during and after antiviral therapy of chronic hepatitis C: results from the Virahep-C study. J Hepatol 2012, 57:946-952.
• [3]Neri S, Pistone G, Saraceno B, Pennisi G, Luca S, Malaguarnera M: L-carnitine decreases severity and type of fatigue induced by interferon-alpha in the treatment of patients with hepatitis C. Neuropsychobiology 2003, 47:94-97.
• [4]Casey LC, Lee WM: Hepatitis C therapy update. Curr Opin Gastroenterol 2012, 28:188-192.
• [5]Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S: Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011, 364:2405-2416.
• [6]Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M: Telaprevir for retreatment of HCV infection. N Engl J Med 2011, 364:2417-2428.
• [7]Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP: Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011, 364:1195-1206.
• [8]Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R: Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011, 364:1207-1217.
• [9]Marcellin P, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Serfaty L, De BK, Van HR, Luo D, Picchio G, Beumont M: Telaprevir is effective given every 8 or 12 hours with ribavirin and peginterferon alfa-2a or -2b to patients with chronic hepatitis C. Gastroenterology 2011, 140:459-468.
• [10]Lawitz F, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, Corregidor A, DeJesus E, Pearlman B, Rabinovitz M, Gitlin N, Lim JK, Pockros PJ, Scott JD, Fevery B, Lambrecht T, Ouwerkerk-Mahadevan S, Callewaert K, Symonds WT, Picchio G, Lindsay KL, Beumont M, Jacobson IM: Simeprevir plus sofosbuvir with/without ribavirin for treating chronic HCV genotype 1 infection in prior null-responders to peginterferon/ribavirin and treatment-naïve patients (COSMOS: a randomised study). Lancet 2014. in press
• [11]Zeuzem S, Berg T, Gane E, Ferenci P, Foster GR, Fried MW, Hézode C, Hirschfield GM, Jacobson I, Nikitin I, Pockros P, Poordad F, Lenz O, Peeters M, Sekar V, De Smedt G, Beumont-Mauviel M: Simeprevir (TMC435) in treatment-experienced HCV genotype 1 patients; the Phase IIb, randomized: controlled ASPIRE trial. Gastroenterology 2014, 146:430-441.
• [12]Fried MW, Buti M, Dore GJ, Flisiak R, Ferenci P, Jacobson I, Marcellin P, Manns M, Nikitin I, Poordad F, Sherman M, Zeuzem S, Scott J, Gilles L, Lenz O, Peeters M, Sekar V, De SG, Beumont-Mauviel M: Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology 2013, 58:1918-1929.
• [13]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.
• [14]Lerdal A, Wahl A, Rustoen T, Hanestad BR, Moum T: Fatigue in the general population: a translation and test of the psychometric properties of the Norwegian version of the fatigue severity scale. Scand J Public Health 2005, 33:123-130.
• [15]Valko PO, Bassetti CL, Bloch KE, Held U, Baumann CR: Validation of the fatigue severity scale in a Swiss cohort. Sleep 2008, 31:1601-1607.
• [16]Kleinman L, Zodet MW, Hakim Z, Aledort J, Barker C, Chan K, Krupp L, Revicki D: Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C. Qual Life Res 2000, 9:499-508.
• [17]Bernstein D, Kleinman L, Barker CM, Revicki DA, Green J: Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients. Hepatology 2002, 35:704-708.
• [18]Kleinman L, Mannix S, Yuan Y, Kummer S, L'Italien G, Revicki D: Review of patient-reported outcome measures in chronic hepatitis C. Health Qual Life Outcomes 2012, 10:92.
• [19]Rabin R, de Charro F: EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001, 33:337-343.
• [20]Versteegh MM, Rowen D, Brazier JE, Stolk EA: Mapping onto Eq-5 D for patients in poor health. Health Qual Life Outcomes 2010, 8:141.
• [21]Cronbach L: Coefficient alpha and the internal structure of tests. Psychometrika 1951, 16:297-334.
• [22]Nunnally J, Bernstein I: The assessment of reliability. In Psychometric Theory. New York, NY, USA: McGraw Hill; 1994:248-292.
• [23]Shrout PE, Fleiss JL: Intraclass correlations: uses in assessing rater reliability. Psychol Bull 1979, 86(2):420-428.
• [24]Litwin M: How to measure survey reliability and validity. In The Survey Kit. Thousand Oaks, CA, USA: Sage Publications; 1995.
• [25]U.S. Department of Health and Human Services: Guidance for Industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. [http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091977.pdf webcite]
• [26]Norman GR, Sloan JA, Wyrwich KW: Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003, 41:582-592.
• [27]What are the signs and symptoms of anemia? http://www.nhlbi.nih.gov/health/health-topics/topics/anemia/signs.html webcite
• [28]Bunn HF: Approach to the anemias. In Goldman's Cecil Textbook of Medicine. 24th edition. Edited by Goldman L, Schafer AI. Philadelphia, PA, USA: Elsevier Saunders; 2012:1031-1039.
• [29]Senzolo M, Schiff S, D'Aloiso CM, Crivellin C, Cholongitas E, Burra P, Montagnese S: Neuropsychological alterations in hepatitis C infection: the role of inflammation. World J Gastroenterol 2011, 17:3369-3374.
• [30]Marquis P, Chassany O, Abetz L: A comprehensive strategy for the interpretation of quality-of-life data based on existing methods. Value Health 2004, 7:93-104.
• [31]De La Loge C, Trudeau E, Marquis P, Revicki DA, Rentz AM, Stanghellini V, Talley NJ, Kahrilas P, Tack J, Dubois D: Responsiveness and interpretation of a quality of life questionnaire specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol 2004, 2:778-786.
• [32]Center for Drug Evaluation and Research: Guidance for industry patient-reported outcome measures: use in medicinal project development to support labeling claims. [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf webcite]
• [33]Scott J, Gilles L, Peeters M, Cerri K, Beumont-Mauviel M: Simeprevir reduces time with peginterferon/ribavirin-induced symptoms and quality-of-life impairments: 72-week results from three phase III studies. J Hepatol 2014, 60:S450-S451.