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Patient-reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross-sectional analysis.


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).

SUBMITTER: Evon DM 

PROVIDER: S-EPMC6989387 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Patient-reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross-sectional analysis.

Evon Donna M DM   Lin Hsing-Hua S HS   Khalili Mandana M   Fontana Robert J RJ   Yim Colina C   Wahed Abdus S AS   Fried Michael W MW   Hoofnagle Jay H JH  

Alimentary pharmacology & therapeutics 20200114 4


<h4>Background</h4>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.<h4>Aims</h4>To evaluate several PROs and associations with HBV disease activity markers.<h4>Methods</h4>Cross-sectional analysis including 876 adults who completed PRO measures during the Hepatitis B Research Network Adult Cohort Study. Participants on HBV treatment were ex  ...[more]

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