Health-Related Quality of Life in Chronic Hepatitis B Patients Xiaoyan Guo

Background Chronic hepatitis B infects approximately 400 million people worldwide and causes 1 million deaths annually of liver disease.1 Clinically, people with chronic hepatitis infection are at high risk of liver damage, with approximately 15% to 40% of infected patients eventually developing cirrhosis, liver failure, or hepatocellular carcinoma during the course of hepatitis B virus (HBV) infection.2 HBV is the leading worldwide cause of liver disease, liver death, and liver morbidity.

Background however,those of chronic HBV infection are less clear. Little is known about symptoms in patients with chronic hepatitis B and even less about its impact on the health-related quality of life (HRQoL) of such patients; consequently, it is a field that is poorly studied despite this being the most prevalent form of chronic viral hepatitis worldwide. HRQoL is a multifactorial construct that describes individuals’ perceptions of their physical, psychological, and social functioning.

purpose we sought to examine HRQoL in HBV patients, stratified by disease severity, compared with normal controls and hypertensive patients, using the Short Form 36 Health Survey (SF-36) and the EQ-5D self-report questionnaire.

Patients and Methods Results Discussion

Patients and Methods  Subjects and Study Design  Instruments  Data Analysis

Subjects and Study Design Post-liver transplants Asympotomatic carriers Chronic Hepatitis B Hepatocellular carcinoma Decompensated cirrhosis Compensated cirrhosis groups Patients were stratified by the following clinical groups:

Subjects and Study Design From July 2003 to November 2006, all patients attending clinics for their respective conditions were approached to partic -cipate in the study. The study protocol was approved by the Institutional Review Board. After informed consent, HBV patients attending the University Digestive Centre and hypertension patients from the Hypertension Clinic filled in the Short Form 36 Health Survey (SF-36) and the EQ-5D self-report questionnaire (EQ5D) before or after their clinic appointment.

Instruments  SF-36  EQ5D  Data Analysis

Instruments SF-36 The SF-36 is a commonly used profile-based HR -QoL instrument validated in various disease populations. It consists of 8 multi-item domains that evaluate various aspects of physical and psychological functioning and well-being, with higher scores indicating better health. In addition,the 8 domains are aggregated into 2 summary measures: physical component summary (PCS) and mental component summary (MCS) scales.

Instruments EQ5D. The EQ-5D self-reported questionnaire is a generic preference-based HRQoL instrument. The 5 dimensions of the self-classifier are mobility, selfcare,usual activities, pain/ discomfort, and anxiety/depression, with 3 levels of severity.

Instruments Two generic HRQoL instruments were used in the study because each of the 2 instruments has its advantages and the information collected may complement each other.

Data Analysis All SF-36 and EQ5D scales scores were tested for their normal distributions. One-way analysis of variance and post-hoc tests or Kruskal-Wallis test were performed to test for statistically significant differences in all SF-36 scales scores, EQ5D utility, and VAS scores among different categories of patients and the other comparison groups. Comparisons were

Data Analysis in the first instance against HBV patients with normal controls as the reference, then with disease controls as the reference, and lastly comparing differences within HBV patients with asymptomatic carriers as the reference.

Data Analysis Multiple linear regression analyses were performed using normal controls, hypertension patients, asymptomatic carrier patients, and chronic hepatitis B patients respectively, as a reference, adjusting for the influences of sociodemographic factors such as age, sex, ethnicity, and education level.

Results  Subjects’ Characteristics  HRQoL Scores  SF-36 and EQ5D Scores

Subjects’ Characteristics a total of 432 HBV (156 asymptomatic carrier, 142 chronic hepatitis B, 66 compensated cirrhosis, 24 decompensated cirrhosis,22 hepatocellular carcinoma and 22 post –livertransp lants) patients, 93 hypertension patients, and 108 normal controls participated in the study.

Subjects’ Characteristics There are differences in age, sex, ethnicity, and education level between normal controls, hepatitis B patients, and hyperte -nsive patients. These differences may affect the interpretation of results and hence were corrected using multivariate analysis.

Univariate Analysis  (1)HRQoL Scores.  Comparison Between HBV Patients and Normal Controls  Comparison of HBV Patients Against Disease Controls  Comparison Against Different Groups of HBV Patients  (2) EQ5D Scores  Comparison Between HBV Patients and Normal Controls  Comparison of HBV Patients Against Disease Controls.  Comparison Against Different Groups of HBV Patients.  EQ5D Self-Classifier

HRQoL Scores Comparison Between HBV Patients and Normal Controls (Reference). Compared with normal controls in the PCS scale, patients who had decompensated cirrhosis, hepatocellular carcinoma, and were post–liver transplantation scored lower, whereas in the mental component summary (MCS) scale a similar pattern was seen, except that chronic hepatitis B but not post –liver transplantation patients had lower scores.

HRQoL Scores In the PCS scale, compared with hypertension patients, asymptomatic carrier patients scored significantly better.Chronic hepatitis B and compensated cirrhosis were similar to hyperten -sion patients,and decompensated cirrhosis,hepatocellular carcinoma, and post–liver transplantation patients were signifi -cantly worse. In the MCS scale, only chronic hepatitis B and hepatocellular carcinoma patients showed significantly lower MCS scores than those of hypertension patients. Comparison of HBV Patients Against Disease Controls (Reference).

HRQoL Scores In the PCS scale (Table 2), chronic hepatitis B and compensated cirrhosis were similar to asymptomatic carriers, whereas decompensated cirrhosis, hepatocellular carcinoma, and post–liver transplantation patients were significantly lower, with hepatocellular carcinoma patients demonstrating the lowest score. In the MCS scale, chronic hepatitis B, decompensated cirrhosis,and hepatocellular carcinoma patients showed significantly lower MCS scores than those of asymptomatic carriers. Comparison Against Different Groups of HBV Patients (Asymptomatic Carriers as the Reference).

HRQoL Scores  (2) EQ5D Scores  Comparison Between HBV Patients and Normal Controls  Comparison of HBV Patients Against Disease Controls.  Comparison Against Different Groups of HBV Patients.

HRQoL Scores EQ5D Self-Classifier. The domain that was perceived to be to be most affected by patients was the anxiety/ depression scale (Table 3) based on the finding of the lowest percentages of patients that reported “no anxiety/ depression.” The MCS scale of SF-36 and the anxiety/depression scale of the EQ5D examine overall mental health and showed similar results-asymptomatic carrier patients were very similar to normal controls.The groups with the highest proportions of anxiety/depression were

HRQoL Scores hepatocellular carcinoma (50%), followed by post–liver transplantation patients (36.3%), decompensated cirrhosis (30.4%), chronic hepatitis B (27.8%), and compensated cirrhosis (23.0%).There was no difference between asymptomatic carriers, chronic hepatitis B and compensated cirrhosis patients, and normal controls in most of the EQ5D self-classifier scales; however, there were significant differences compared with decompensated cirrhosis,hepatocellular carcinoma, and post –liver transplantation patients.

Multivariate Analysis

SF-36 and EQ5D Scores Comparison Between HBV Patients and Normal Controls (Reference).The general trends observed in this analysis showed that asymptomatic carrier patients had a similar SF-36 score to normal controls,but with disease progression to chronic hepatitis B and compensated cirrhosis, more dimensions became affected such that decompensated cirrhosis and hepatocellular carcinoma patients had significantly lower SF-36 scores in all scales (Table 4). Interestingly, the dimension affected in all patients

SF-36 and EQ5D Scores including asymptomatic carrier patients was the general health scale, and the next most affected were the Mental Health (MH) and MCS scales, both reflecting the mental dimension. In the EQ5D self-classifier, there was generally increasing differences with progression of liver disease, whereas the VAS scores generally were lower in most patient groups except asymptomatic carriers.

SF-36 and EQ5D Scores Comparison of HBV Patients Against Disease Controls (Reference). In Table 4, we note that hypertension patients compared with normal controls had significantly lower SF-36 scores in general health, MH, MCS, role physical, EQ5D self -classifier, and VAS. Consequently, this results in asymptomatic carrier patients having significantly higher scores in most SF-36 scales compared with hypertension patients, and little difference compared with chronic hepatitis B and compensated cirrhosis,

SF-36 and EQ5D Scores but progression to decompensated cirrhosis and hepatocellular carcinoma results in significantly lower scores (data not shown). The EQ5D self classifier and VAS scores generally showed no significant differences.

Comparison Against Different Groups of HBV Patients With Asymptomatic Carriers as the Reference. When compared with asymptomatic carriers (Table 5), chronic hepatitis B patients scored significantly worse,whereas compensated cirrhosis patients appeared to fare better in most scales of SF-36 (Table 5). However, when we performed multivariate analysis with chronic hepatitis B as the reference, there was no statistical difference between any of the SF-36 or EQ5D dimensions compared with compensated cirrhosis.

already seen in comparisons with normal controls and hypertension as reference groups. A similar pattern was seen in EQ5D self-classifier, but all patient groups except post –liver transplantation patients had significantly lower VAS scores. With progression to decompensated cirrhosis and hepatocellular carcinoma, there is a universal worsening of scores, a pattern

Discussion

The finding that deterioration in HRQoL was associated with progression of liver disease was not surprising,but the early changes were in dimensions of general and mental health, rather than physical symptoms. An important implication of this is that patients unaware of the stage of their hepatitis B liver disease who are asymptomatic may thus have little or no deterioration in HRQoL. This becomes important when it impacts patient followup.

Discussion An implication of this is that patients without advanced disease who need therapy are likely to be asymptomatic; thus, initiation of treatment will require careful explanation, and compliance with continued medication may be affected by absence of altered HRQoL and absence of symptoms.

Discussion In a follow-up study, the results showed that only 32% of patients interviewed realized that early liver cancer was not symptomatic.36 In the effort to manage chronic hepatitis B better and prevent end-stage liver disease through regular screening and expedient and appropriate therapy, detailed explanation is needed that symptoms in well-compensated

Discussion liver disease becomes advanced. Such counseling, relating disease progression to symptoms, is central if we are to change these patients’beliefs on illness. chronic hepatitis B are absent and only deteriorate once

conclusion we have shown that the HRQoL status in asymptomatic is similar to that of normal controls and better than that of hypertensive patients, but deteriorates with disease progression. The initial stage of deterioration affects mainly the mental dimension,whereas in the advanced stage,almost all components are affected. These findings confirm clinical impressions that chronic hepatitis B is largely asymptomatic and HRQoL is affected with disease progression.

conclusion Consequently, the impetus for patients to return for follow -up rests largely on patient education:that the disease can lead to complications,that the complications are serious, and that treatment can reduce such complications, key aspects of the health belief model.

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