Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: Validity, responsiveness, and identification of the minimally important difference in a phase 2 clinical trial

Quality of Life Research

Volumn 23, Issue 3, 2014, Pages 877-886

  Anderson, Roger T ^a,e   Baran, Robert W ^b   Erickson, Pennifer ^a,c   Revicki, Dennis A ^d   Dietz, Birgitta ^b   Gooch, Katherine ^b  

^a PENN STATE MILTON S HERSHEY MEDICAL CENTER   (United States)

^b ABBVIE INC   (United States)

^c OLGA   (United States)

^d UNITED BIOSOURCE CORPORATION   (United States)

^e PENN STATE COLLEGE OF MEDICINE   (United States)

Author keywords

Health status; Psychometric methods; Quality of life; Questionnaires

Indexed keywords

ANTIVIRUS AGENT; INTERFERON; PLACEBO; RIBAVIRIN;

ADOLESCENT; ADULT; AGED; ANXIETY; ARTICLE; CLASSIFICATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DRUG COMBINATION; DRUG EFFECT; FEMALE; HEALTH STATUS INDICATOR; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; MALE; MIDDLE AGED; MULTICENTER STUDY; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PSYCHOLOGICAL ASPECT; PSYCHOMETRY; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; SEVERITY OF ILLNESS INDEX; STANDARD; STATISTICAL ANALYSIS; TREATMENT OUTCOME; VALIDATION STUDY; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; ANXIETY; DATA INTERPRETATION, STATISTICAL; DEPRESSION; DRUG THERAPY, COMBINATION; FEMALE; HEALTH STATUS INDICATORS; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON TYPE I; MALE; MIDDLE AGED; PATIENT OUTCOME ASSESSMENT; PLACEBOS; PSYCHOMETRICS; QUALITY OF LIFE; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; RIBAVIRIN; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84897040631     PISSN: 09629343     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11136-013-0519-1     Document Type: Article

References (26)

1. World Health Organization. (2012). Hepatitis C. Fact Sheet N°164. Geneva, Switzerland: World Health Organization. Accessed September 17, 2012, from http://www.who.int/mediacentre/factsheets/fs164/en/.
2. Smith, B. D.; Morgan, R. L.; Beckett, G. A.; Centers for Disease Control and Prevention, et al. (2012). Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep, 61(RR-4), 1-36.
3. Davis, G. L.; Alter, M. J.; El-Serag, H.; Poynard, T.; & Jennings, L. W. (2010). Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology, 138, 513-521.
4. Ware, J. E, Jr, Bayliss, M. S.; Mannocchia, M.; & Davis, G. L. (1999). Health-related quality of life in chronic hepatitis C: Impact of disease and treatment response. The interventional therapy group. Hepatology, 30, 550-555.
5. Younossi, Z.; Kallman, J.; & Kincaid, J. (2007). The effects of HCV infection and management on health-related quality of life. Hepatology, 45, 806-816.
6. Hsu, P. C.; Federico, C. A.; Krajden, M.; et al. (2012). Health utilities and psychometric quality of life in patients with early- and late-stage hepatitis C virus infection. Journal of Gastroenterology and Hepatology, 27, 149-157.
7. DiBonaventura, M. D.; Wagner, J. S.; Yuan, Y.; L'Italien, G.; Langley, P.; & Ray Kim, W. (2010). Humanistic and economic impacts of hepatitis C infection in the United States. Journal of Medical Economics, 13, 709-718.
8. Ghany, M. G.; Strader, D. B.; Thomas, D. L.; & Seeff, L. B. (2009). Diagnosis, management, and treatment of hepatitis C: An update. Hepatology, 49, 1335-1374.
9. Thein, H. H.; Krahn, M.; Kaldor, J. M.; & Dore, G. J. (2005). Estimation of utilities for chronic hepatitis C from SF-36 scores. American Journal of Gastroenterology, 100, 643-651.
10. Bergmann, J. F.; Vrolijk, J. M.; van der Schaar, P.; et al. (2007). Gamma-glutamyltransferase and rapid virological response as predictors of successful treatment with experimental or standard peginterferon-alpha-2b in chronic hepatitis C non-responders. Liver International, 27, 1217-1225.
11. Hassanein, T.; Cooksley, G.; Sulkowski, M.; et al. (2004). The impact of peginterferon alfa-2a plus RBV combination therapy on health-related quality of life in chronic hepatitis C. Journal of Hepatology, 40, 675-681.
12. Bernstein, D.; Kleinman, L.; Barker, C.; Revicki, D. A.; & Green, J. (2002). Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients. Hepatology, 35, 704-708.
13. Younossi, Z. M.; Aggarwal, J.; Martin, M.; et al. (2012). Health-related quality-of-life among genotype 1 treatment-naïve chronic hepatitis C patients receiving telaprevir combination treatment: Post-hoc analyses of data from the ADVANCE trial. Journal of Hepatology, 56(Suppl 2), S462-S463.
14. Younossi, Z. M.; Aggarwal, J.; Martin, M.; et al. (2012). Health-related quality-of-life among genotype 1 treatment-naïve chronic hepatitis C patients receiving telaprevir combination treatment: Post-hoc analyses of data from the ADVANCE trial. Gastroenterology, 142(Suppl 5), S-955. [Abstract Sa1048].
15. Gralnek, I. M.; Hays, R. D.; Kilbourne, A.; et al. (2000). Development and evaluation of the liver disease quality of life instrument in persons with advanced, chronic liver disease-the LDQOL 1.0. American Journal of Gastroenterology, 95, 3552-3565.
16. Bayliss, M. S.; Gandek, B.; Bungay, K. M.; Sugano, D.; Hsu, M. A.; & Ware, J. E, Jr. (1998). A questionnaire to assess the generic and disease-specific health outcomes of patients with chronic hepatitis C. Quality of Life Research, 7, 39-55.
17. Anderson R. T.; Baran R. W.; Dietz B.; Kallwitz E.; Erickson P.; Revicki D. A. (2013). Development and psychometric evaluation of the hepatitis C virus-patient reported outcomes (HCV-PRO) instrument. Qual Life Res, in review.
18. Food and Drug Administration. (2009). Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 74, 65132-65133.
19. Revicki, D. A.; Hays, R.; Cella, D.; & Sloan, J. (2008). Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Journal of Clinical Epidemiology, 61, 102-109.
20. Gaultier, I.; Cohen, D. E.; Bhathena, A.; et al. (2011). The effect of IL28B polymorphism on virologic response to treatment with pegylated interferon alpha-2a and RBV (SOC) added to ABT-450/ritonavir (ABT-450/r), ABT-333, or ABT-072. Journal of Hepatology, 54(Suppl 1), S523.
21. Ware, J. E, Jr, Kosinski, M.; Bjorner, J. B.; Turner-Bowker, D. M.; Gandek, B.; & Maruish, M. E. (2007). User's manual for the SF-36v2 health survey (2nd ed.). Lincoln, RI: QualityMetric Incorporated.
22. The EuroQol Group. (1990). EuroQol-a new facility for the measurement of health-related quality of life. Health Policy, 16, 199-208.
23. Nunnally, J. C.; & Bernstein, I. H. (1994). Psychometric theory (3rd ed.). New York, NY: McGraw-Hill Inc.
24. Strand, V.; Boers, M.; Idzerda, L.; et al. (2011). It's good to feel better but it's better to feel good and even better to feel good as soon as possible for as long as possible. Response criteria and the importance of change at OMERACT 10. Journal of Rheumatology, 38, 1720-1727.
25. Spiegel, B. M. R.; Younossi, Z. M.; Hays, R. D.; Revicki, D.; Robbins, S.; & Kanwal, F. (2005). Impact of hepatitis C on health related quality of life: A systematic review and quantitative assessment. Hepatology, 41, 790-800.
26. Coteur, G.; Feagan, B.; Kleininger, D. L.; & Kosinski, M. (2009). Evaluation of the meaningfulness of health related quality of life improvements as assessed by the SF-36 and EQ-5D VAS in patients with active Crohn's disease. Alimentary Pharmacology and Therapeutics, 29, 1032-1041.