Top

Quality of Life Research

Gepubliceerd in:

01-04-2014

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

Auteurs: Roger T. Anderson, Robert W. Baran, Pennifer Erickson, Dennis A. Revicki, Birgitta Dietz, Katherine Gooch

Gepubliceerd in: Quality of Life Research | Uitgave 3/2014

Abstract

Purpose

To describe the psychometric properties and identify the minimally important difference (MID) of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument. Chronic HCV infection and associated treatments negatively affect PROs of function and well-being.

Methods

In a phase 2 trial, HCV-infected patients received direct-acting antivirals (DAAs) for 12 weeks with peg-interferon/ribavirin (peg-IFN/RBV) for 48 weeks, or placebo plus peg-IFN/RBV. The HCV-PRO total score, SF-36 PCS and MCS scores, EQ-5D-3L, and EQ VAS were measured at baseline, week 8, end of DAA treatment (EODT), end of peg-IFN/RBV treatment (EOT), and posttreatment week 24 (SVR₂₄). Convergent validity of the HCV-PRO was assessed by Pearson’s correlation coefficients. Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores (none vs. some) and presence/absence of depression or fatigue adverse events. MID was identified through effect size (ES) and receiver-operating characteristic (ROC) curve analyses (HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds).

Results

In 74 patients (22 % female; 81 % White; 51 % ≥50 years), correlations (0.64–0.96) between HCV-PRO total scores, SF-36 PCS/MCS scores, and EQ VAS scores at all time points supported convergent validity. HCV-PRO total scores were reduced to 10–30 points in patients impaired by depression, pain, or fatigue symptoms. Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time (EODT −0.76; EOT −0.93). ES and ROC curve analyses indicated an MID of −10 points.

Conclusion

The HCV-PRO was valid and responsive in the population studied. An MID of −10 points represented a threshold of clinical significance for the HCV-PRO.

vorige artikel Preliminary reliability and validity of Persian version of the Family Dermatology Life Quality Index (FDLQI)

volgende artikel Qualitative development of the ‘Questionnaire on Pain caused by Spasticity (QPS),’ a pediatric patient‐reported outcome for spasticity‐related pain in cerebral palsy

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/.

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.PubMed

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.PubMedCrossRef

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.PubMedCrossRef

Younossi, Z., Kallman, J., & Kincaid, J. (2007). The effects of HCV infection and management on health-related quality of life. Hepatology, 45, 806–816.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMed

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.PubMedCrossRef

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.PubMedCrossRef

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.CrossRef

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.PubMed

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.PubMedCrossRef

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.PubMedCrossRef

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.CrossRef

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.CrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

Titel: 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
Auteurs: Roger T. Anderson
Robert W. Baran
Pennifer Erickson
Dennis A. Revicki
Birgitta Dietz
Katherine Gooch
Publicatiedatum: 01-04-2014
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 3/2014
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-013-0519-1

Bohn Stafleu van Loghum

Deel dit onderdeel of sectie (kopieer de link)

Abstract

Purpose

Methods

Results

Conclusion

Log in om toegang te krijgen

Andere artikelen Uitgave 3/2014

Qualitative development of the ‘Questionnaire on Pain caused by Spasticity (QPS),’ a pediatric patient‐reported outcome for spasticity‐related pain in cerebral palsy

Validation of the Rhinoplasty Outcomes Evaluation (ROE) questionnaire adapted to Brazilian Portuguese

Assessing the performance of the EQ-VAS in the NHS PROMs programme

Development and validation of the functional assessment of chronic illness therapy treatment satisfaction (FACIT TS) measures

Validity, reliability and discriminative capacity of an electronic quality of life instrument (Pelican) for childhood asthma in the Netherlands

The Spanish version of the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is valid for use in the general population