Although HRQoL of CHB patients has been evaluated in several counties and regions [7–11], the current study from mainland China where has a high HBV prevalence and the largest CHB population in the world may provide important evidence for expanding the knowledge about the impact of CHB on health of people. The pair-matched healthy controls and the exclusion of patients with any other chronic diseases are distinguishing features of the current study, which can better control the influence of confounding factors and accurately characterize the impact of CHB. A generic instrument provides a global assessment and allows for comparisons with other health conditions, while a disease-specific instrument addresses some important HRQoL domains specifically associated with this disease. Both used together may also verify each other’s findings.
Our study found that CHB patients had significantly lower SF-36v2 scores than healthy controls on all summaries and domains regardless of whether with or without cirrhosis. These HRQoL impairments were clinically significant according to the suggested MID values . The similar results were reported by the study from Hong Kong in which the Chinese (Hong Kong) SF-36v2 was used and local general population norms were taken as controls . In this previous study, however, MCS scores in most patient subgroups were similar to that in local general population. The SF-36v2 MCS measures global mental health: a low score indicates frequent psychological distress and social and role disability due to emotional problems . It is inferred that compared with the CHB patients living in Hong Kong where has the similar HBV prevalence but markedly higher socioeconomic status and healthcare level, our CHB patients suffer more serious emotional problems and so more frequent psychological distress and more substantial social and role disability. Although the previous studies from other countries and regions reported impaired HRQoL in CHB patients with or without cirrhosis [7–11], almost all showed the impairment on some but not all dimensions [7–9, 11].
Our results from both the SF-36v2 and the CLDQ showed that HRQoL of CHB patients significantly deteriorated with development of cirrhosis, and that the impairment on physical components had a gradually increasing trend with disease progression. These findings were consistent with those in the Hong Kong and the Singapore studies [7, 8]. Our study did not find any significant differences in HRQoL impairment between compensated and decompensated cirrhosis patients. Small sample sizes in both groups might be an explication. More possibly, however, it suggested similar impairment between the two types of patients. The serious complications of ascites, variceal bleeding or hepatic encephalopathy may be relieved after successful treatment, and the patients classified as with decompensated cirrhosis according to their complication histories may have similar or moderately poorer physical health status than those with compensated cirrhosis in their daily life. In addition, adaptation and positive coping behaviors may lead to a positive response shift in patients’ psychological perceptions .
As expected, the SF-6D values also indicated significant health impairment in CHB patients regardless of whether with or without cirrhosis. The Hong Kong study reported the SF-6D values of 0.755, 0.745, 0.720 and 0.701 in CHB patients with uncomplicated disease, impaired liver function, hepatocellular carcinoma and cirrhosis, respectively, and 0.787 in local general population . Our healthy controls had the same level of preference for their health status as Hong Kong general population, but our CHB patients lower than the CHB patients living in Hong Kong. In the only study touching upon mainland Chinese preferences for CHB-related health states , with the standard gamble method the preference values elicited from uninfected individuals for CHB and compensated cirrhosis were between 0.7 and 0.8, similar to the Hong Kong’s results but higher than ours. However, the preference values elicited from uninfected individuals for decompensated cirrhosis and elicited from CHB patients for all CHB-related states were from 2.5 to 0.6, obviously lower than the Hong Kong’s and our results. The disparities may be caused by differences in participants and preference evaluation methods [12, 13]. In addition, another difference should be noted. In the Hong Kong and our studies, the patients selected from outpatients or past discharged patients reported their perceptions based on their own health status in daily life, when some serious or typical symptoms may be relieved. In the study with the standard gamble method , however, the respondents reported their perceptions based on the pre-set health state-specific indications. For example, decompensated cirrhosis is indicated as “sometimes I vomit blood and have to go to the hospital for a blood transfusion and to have a tube placed in my stomach through my nose”. This might induce respondents to give their response to typical symptoms presented only at the onset stage usually with needs of in-hospital treatment. CHB is a chronic disease and the vast majority patients will live with it till death . The onset of typical symptoms is only an episode in the long disease history, though it may repeat. Therefore, the Hong Kong’s and our results should be more suitable for use in the cost-effectiveness evaluation of interventions with long-term or lifelong impacts. There was no significant difference in SF-6D value impairment between compensated and decompensated cirrhosis patients in our study. Whether it means the difference of preference between the two states is negligible in relevant cost-effectiveness evaluations, further studies are needed.
The stepwise regression analyses further confirmed the association of HRQoL and stages of CHB: more advanced stages with lower physical health. TBIL level may be considered as an important biomarker associated with physical health of CHB patients. The Hong Kong study also reported the association of higher TBIL levels with lower SF-36v2 PCS scores . Currently taken anti-viral treatment was found having a negative relationship with HRQoL of CHB patients, especially on mental dimensions. This could be due to side effects of treatment or the selection of the patients who were more ill or anxious for treatment . Previous studies on patients with hepatitis C also found that anti-viral treatment reduced HRQoL initially , but an improvement was observed after successful treatment . Education attainment and annual per capita household income were positively related to HRQoL of CHB patients. The two factors were rarely addressed in the previous studies. This finding is particularly significant in mainland China, where most CHB cases occur in rural areas with low socioeconomic status and poor education and the treatment places a heavy economic burden on patients and their families , which may hinder patients taking regular treatment and increase patients’ worry . It suggests that reducing treatment cost burden and providing health education might play certain roles in improving HRQoL of CHB patients in mainland China.
There were two major limitations in our study. The study was implemented only in an area that limited the generalizability of the results for whole mainland China. The small sample sizes in compensated and decompensated cirrhosis patients limited the power of the related results for drawing more exact conclusions.