Article first published online: 27 JUN 2007
Copyright © 2007 American Association for the Study of Liver Diseases
Volume 46, Issue 1, pages 113–121, July 2007
How to Cite
Spiegel, B. M. R., Bolus, R., Han, S., Tong, M., Esrailian, E., Talley, J., Tran, T., Smith, J., Karsan, H. A., Durazo, F., Bacon, B., Martin, P., Younossi, Z., Hwa-Ong, S. and Kanwal, F. (2007), Development and validation of a disease-targeted quality of life instrument in chronic hepatitis B: The hepatitis B quality of life instrument, version 1.0. Hepatology, 46: 113–121. doi: 10.1002/hep.21692
This research was previously published in abstract form at Digestive Disease Week 2006.
Potential conflict of interest: Nothing to report.
- Issue published online: 27 JUN 2007
- Article first published online: 27 JUN 2007
- Manuscript Accepted: 24 JAN 2007
- Manuscript Received: 11 SEP 2006
- Veterans Administration Health Services Research & Development Research Career Development Award. Grant Number: RCD 03-179-2
- NIH Training Grant. Grant Number: T32 DK07180-30
- CURE Digestive Diseases Research Center (NIH Grant). Grant Number: 2P30 DK 041301-17
- Novartis Pharma AG, Basel
Despite the increasing realization that health-related quality of life (HRQOL) is an important outcome in chronic HBV infection, there are no validated, disease-targeted instruments currently available. We sought to develop and validate the first disease-targeted HRQOL instrument in noncirrhotic HBV: the Hepatitis B Quality of Life instrument, version 1.0 (HBQOL v1.0). We established content validity for the HBQOL v1.0 by conducting a systematic literature review, an expert focus group, and cognitive interviews with HBV patients. We administered the resultant questionnaire to 138 HBV patients. We used factor analysis to test hypotheses regarding HRQOL domains and measured construct validity by comparing HBQOL v1.0 scores across several anchors, including viral response to treatment, SF-36 scores, and global health. Finally, we measured test–retest and internal consistency reliability. Content validation revealed that HBV affects multiple aspects of psychological, social, and physical health. The resultant questionnaire summarized this HRQOL impact with 31 items across six subscales: psychological well-being, anticipation anxiety, vitality, disease stigma, vulnerability, and transmissibility. Internal consistency and test–retest reliability were excellent. The HBQOL v1.0 discriminated between viral responders versus nonresponders and correlated highly with SF-36 scores and global health. Conclusion: Patients with chronic HBV infection attribute a wide range of negative psychological, social, and physical symptoms to their condition, even in the absence of cirrhosis or cancer. The HBQOL v1.0 is a valid and reliable measure that captures this HRQOL decrement. This instrument may be useful in everyday clinical practice and in future clinical trials. (HEPATOLOGY 2007;46:113–121.)