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).

中文翻译：

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北美一个患有慢性乙型肝炎病毒的队列中患者报告的结局：一项横断面分析。

背景技术在北美人群中，尚未对患者报告的结局（PRO）（例如与健康相关的生活质量（HRQoL）和与慢性乙型肝炎病毒（HBV）感染相关的症状）进行描述。目的评估几种​​PRO以及与HBV疾病活动标记的关联。方法横断面分析包括876名在乙型肝炎研究网络成人队列研究期间完成PRO措施的成年人。参加乙肝病毒治疗的参与者被排除在外。结果包括：使用SF-36精神成分摘要和身体成分摘要评分的HRQoL；使用10项总症状核对表减轻症状负担，并使用“患者报告的结果测量信息系统”®中的仪器减轻疲劳。协变量包括疾病严重程度，病毒学状况，合并症和药物的实验室指标。结果中位年龄为42岁（范围：19-79岁），女性为51％，亚洲人为73％，HBeAg（+）为19％，AST-血小板比率指数（APRI）≥1.5的患者为2％，无合并症的患者为74％。平均心理成分摘要T分数= 52，身体成分摘要T分数= 54，PROMIS疲劳T分数=47。在从0（无）到40（极端）的等级上，平均症状清单得分= 3和25 ％报告​​无症状。最常见的症状是疲劳（60％），烦躁（32％）和瘙痒（32％）。大多数症状“有点”令人不安。在多变量回归中，APRI≥1.50和更多合并症与较差的患者报告的结局有关。病毒学标记没有。将总症状检查表评分添加到原始回归模型中，可以将对心理成分摘要评分的变化的解释从4％增加到44％，将身体成分摘要评分的变化从17％增加到34％。结论未经治疗的北美HBV轻度肝病患者报告了与健康相关的良好生活质量和极少的症状。除非存在晚期肝病或合并症，否则HBV不会影响与健康相关的生活质量。高症状负担可以解释与健康相关的生活质量的显着差异。（CT.gov标识符：NCT01263587）。除非存在晚期肝病或合并症，否则HBV不会影响与健康相关的生活质量。高症状负担可以解释与健康相关的生活质量的显着差异。（CT.gov标识符：NCT01263587）。除非存在晚期肝病或合并症，否则HBV不会影响与健康相关的生活质量。高症状负担可以解释与健康相关的生活质量的显着差异。（CT.gov标识符：NCT01263587）。