title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Veterans Administration Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA. bspiegel@mednet.ucla.edu
authors.forename: Brennan M R
authors.initials: BM
authors.lastname: Spiegel
authors.forename: Roger
authors.initials: R
authors.lastname: Bolus
authors.forename: Steven
authors.initials: S
authors.lastname: Han
authors.forename: Myron
authors.initials: M
authors.lastname: Tong
authors.forename: Eric
authors.initials: E
authors.lastname: Esrailian
authors.forename: Jennifer
authors.initials: J
authors.lastname: Talley
authors.forename: Tram
authors.initials: T
authors.lastname: Tran
authors.forename: Jason
authors.initials: J
authors.lastname: Smith
authors.forename: Hetal A
authors.initials: HA
authors.lastname: Karsan
authors.forename: Francisco
authors.initials: F
authors.lastname: Durazo
authors.forename: Bruce
authors.initials: B
authors.lastname: Bacon
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
authors.forename: Zobair
authors.initials: Z
authors.lastname: Younossi
authors.forename: Siew
authors.initials: S
authors.lastname: Hwa-Ong
authors.forename: Fasiha
authors.initials: F
authors.lastname: Kanwal
mesh_terms: D000328:Adult; D000368:Aged; D005006:Ethnicity; D005260:Female; D006304:Health Status; D006306:Health Surveys; D019694:Hepatitis B, Chronic / Q000453:epidemiology / Q000503:physiopathology* / Q000523:psychology; D006801:Humans; D007182:Income; D008297:Male; D017533:Marital Status; D008603:Mental Health; D008875:Middle Aged; D015995:Prevalence; D011581:Psychological Tests; D011788:Quality of Life; D015203:Reproducibility of Results; D014481:United States / Q000453:epidemiology