Donna M Evon1, Hsing-Hua S Lin2, Mandana Khalili3, Robert J Fontana4, Colina Yim5, Abdus S Wahed2, Michael W Fried1, Jay H Hoofnagle6. 1. Department of Medicine, University of North Carolina, Chapel Hill, NC, USA. 2. Departments of Epidemiology and Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA. 3. Department of Medicine, University of California, San Francisco, CA, USA. 4. Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA. 5. Toronto Centre for Liver Disease, University of Toronto, Toronto, Canada. 6. Liver Disease Research Branch, NIDDK, NIH, Bethesda, MD, USA.
Abstract
BACKGROUND: Patient-reported outcomes (PROs) such as health-related quality of life (HRQoL) and symptoms associated with chronic hepatitis B viral (HBV) infection have not been well-described in North American cohorts. AIMS: To evaluate several PROs and associations with HBV disease activity markers. METHODS: Cross-sectional analysis including 876 adults who completed PRO measures during the Hepatitis B Research Network Adult Cohort Study. Participants on HBV treatment were excluded. Outcomes included: HRQoL using the SF-36 mental component summary and physical component summary scores; symptom burden using a 10-item Total Symptom Checklist and fatigue using an instrument from the Patient-Reported Outcomes Measurement Information System®. Covariates included laboratory markers of disease severity, virological status, comorbidities and medications. RESULTS: Median age was 42 (range: 19-79), 51% were female, 73% Asian, 19% HBeAg (+), 2% had AST-platelet ratio index (APRI) ≥1.5 and 74% without comorbidities. Mean mental component summary T-score = 52, physical component summary T-score = 54 and PROMIS Fatigue T-score = 47. On a scale from 0 (none) to 40 (extreme), the mean Symptom Checklist score = 3 and 25% reported no symptoms. The most frequent symptoms were fatigue (60%), irritability (32%) and itching (32%). Most symptoms were 'a little bit' bothersome. In multivariable regressions, APRI ≥1.50 and more comorbidities were associated with worse patient-reported outcomes; virological markers were not. Adding the Total Symptom Checklist score to original regression models increased explanation of variation in the mental component summary score from 4% to 44% and the Physical Component Summary Score from 17% to 34%. CONCLUSIONS: Untreated North American HBV patients with mild liver disease report favourable health-related quality of life and minimal symptoms. HBV does not impact health-related quality of life unless advanced liver disease or comorbidities are present. High symptom burden explains substantial variation in health-related quality of life. (CT.gov identifier: NCT01263587).
BACKGROUND:Patient-reported outcomes (PROs) such as health-related quality of life (HRQoL) and symptoms associated with chronic hepatitis B viral (HBV) infection have not been well-described in North American cohorts. AIMS: To evaluate several PROs and associations with HBV disease activity markers. METHODS: Cross-sectional analysis including 876 adults who completed PRO measures during the Hepatitis B Research Network Adult Cohort Study. Participants on HBV treatment were excluded. Outcomes included: HRQoL using the SF-36 mental component summary and physical component summary scores; symptom burden using a 10-item Total Symptom Checklist and fatigue using an instrument from the Patient-Reported Outcomes Measurement Information System®. Covariates included laboratory markers of disease severity, virological status, comorbidities and medications. RESULTS: Median age was 42 (range: 19-79), 51% were female, 73% Asian, 19% HBeAg (+), 2% had AST-platelet ratio index (APRI) ≥1.5 and 74% without comorbidities. Mean mental component summary T-score = 52, physical component summary T-score = 54 and PROMIS Fatigue T-score = 47. On a scale from 0 (none) to 40 (extreme), the mean Symptom Checklist score = 3 and 25% reported no symptoms. The most frequent symptoms were fatigue (60%), irritability (32%) and itching (32%). Most symptoms were 'a little bit' bothersome. In multivariable regressions, APRI ≥1.50 and more comorbidities were associated with worse patient-reported outcomes; virological markers were not. Adding the Total Symptom Checklist score to original regression models increased explanation of variation in the mental component summary score from 4% to 44% and the Physical Component Summary Score from 17% to 34%. CONCLUSIONS: Untreated North American HBV patients with mild liver disease report favourable health-related quality of life and minimal symptoms. HBV does not impact health-related quality of life unless advanced liver disease or comorbidities are present. High symptom burden explains substantial variation in health-related quality of life. (CT.gov identifier: NCT01263587).
Authors: David Cella; William Riley; Arthur Stone; Nan Rothrock; Bryce Reeve; Susan Yount; Dagmar Amtmann; Rita Bode; Daniel Buysse; Seung Choi; Karon Cook; Robert Devellis; Darren DeWalt; James F Fries; Richard Gershon; Elizabeth A Hahn; Jin-Shei Lai; Paul Pilkonis; Dennis Revicki; Matthias Rose; Kevin Weinfurt; Ron Hays Journal: J Clin Epidemiol Date: 2010-08-04 Impact factor: 6.437
Authors: A M Di Bisceglie; M Lombardero; J Teckman; L Roberts; H L A Janssen; S H Belle; J H Hoofnagle Journal: J Viral Hepat Date: 2016-12-05 Impact factor: 3.728
Authors: Marc G Ghany; Robert Perrillo; Ruosha Li; Steven H Belle; Harry L A Janssen; Norah A Terrault; Margaret C Shuhart; Daryl T-Y Lau; W Ray Kim; Michael W Fried; Richard K Sterling; Adrian M Di Bisceglie; Steven-Huy B Han; Lilia Milkova Ganova-Raeva; Kyong-Mi Chang; Anna Suk-Fong Lok Journal: Clin Gastroenterol Hepatol Date: 2014-07-08 Impact factor: 11.382
Authors: Elegance T P Lam; Cindy L K Lam; C L Lai; M F Yuen; Daniel Y T Fong; Thomas M K So Journal: Health Qual Life Outcomes Date: 2009-06-05 Impact factor: 3.186
Authors: Donna M Evon; Hsing-Hua S Lin; Robert J Fontana; Mandana Khalili; Colina Yim; Abdus S Wahed; Jay H Hoofnagle Journal: GastroHep Date: 2021-05-05