| Abstract|| |
Background and Objectives: Quality of life may be reduced in patients with chronic liver diseases. The purpose of this study was to assess the impact of chronic viral liver diseases on health-related quality of life (HRQOL) among Egyptian patients compared to an interventional group of patients undergoing interferon (IFN) therapy and a control group of noninfected individuals via HRQOL specific assessment instruments focusing on liver disease. Subject and Methods: Quality of life was investigated in 150 patients with chronic viral liver disease, 150 patients undergoing IFN based therapy, and 150 matched controls. The generic short form (SF)-12 questionnaire, the Iowa Fatigue Scale (IFS), the chronic liver disease (CLD) questionnaire, and the Hospital Anxiety and Depression Scale (HADS) were applied to measure the HRQOL. Results: A significant difference in the mean IFS score was found among the three groups. Higher mean scores were observed among cases compared to controls [32.4 ± 11.3 vs 20.7 ± 5.8, OR (95% CI); 11.3 (9.6–13.7), P < 0.0001] and to the IFN group [32.4 ± 11.3 vs 25.1 ± 7.3, OR (95% CI); 5.8 (2.9–6), P < 0.0001]. The mean score was relatively higher among the IFN group compared to the controls [32.4 + 11.3 vs 25.1 ± 7.3, OR (95% CI); 7.3 (5.1–9.5), P < 0.0001]. Categorical scores of IFS in terms of cognitive, fatigue, energy, and productivity subscale were significantly lower among cases compared to the control and IFN groups. Mental and physical numeric and categorical scores for the absence of disability, CLD scale, and HADS were significantly worse in patients compared to the controls. Conclusion: Our results confirm that the quality of life is reduced in the patients with chronic viral liver disease in comparison with the healthy persons. Antiviral therapy with pegylated IFN-α and ribavirin can significantly improve physical and functional aspects of HRQOL.
Keywords: Chronic hepatitis C virus (HCV) patients, Egypt, health-related quality of life (HRQOL)
|How to cite this article:|
Abd El-Wahab EW. Health-related quality of life among chronic HCV patients: Measuring disease and treatment response impacts. Ann Trop Med Public Health 2016;9:152-8
|How to cite this URL:|
Abd El-Wahab EW. Health-related quality of life among chronic HCV patients: Measuring disease and treatment response impacts. Ann Trop Med Public Health [serial online] 2016 [cited 2020 May 28];9:152-8. Available from: http://www.atmph.org/text.asp?2016/9/3/152/181656
| Introduction|| |
Chronic hepatitis C virus (HCV) infection is a major public health crisis with around 300 million people infected worldwide, and currently it is the most frequent cause of liver related morbidity and mortality., The disease is progressive and follows a protracted course., Egypt has been widely regarded as having an epidemic, with the highest recorded prevalence of HCV in the world, ranging from 6% to more than 40% among regions and demographic groups.
Health-related quality of life (HRQOL) refers to the hepatitis C burden is multiplied by its impact on physical, cognitive, psychosocial, and other determinants of HRQOL.,, HRQOL refers to the subjective assessment of patients regarding the physical, mental, and social dimensions of well-being., Chronic HCV patients report consistent and significant reduction in their quality of life even in absence of clinically significant liver disease or complications. In the last decade, there has been a significant improvement in the treatment of chronic HCV infections. The side effect produced by interferon (INF) based therapy are often so intense, that can force up to 30% of those undergoing therapy to interrupt the treatment temporarily or to reduce its dosage. The most common side effects include depression, anorexia, malaise, sleep alteration, musculoskeletal pain, and fatigue that greatly affect the patient's quality of life.,,
The patients on IFN therapy are always evaluated for viral clearance but the impaired HRQOL receives less attention. The description of the quality of life during a disease shows the importance of the individual in a social and health-related context. There is accordingly a need to incorporate parameters for assessing the quality of life to guide the decision-making process when choosing the best medical approach for the patient keeping the individual's well-being in mind, and for a better distribution of resources within the health-care system.,
HRQOL has been useful in quantifying the impact of chronic hepatitis C (CHC) on the patient's well-being and in monitoring a response to the treatment. In this view, we evaluated the impact of chronic viral hepatitis on the HRQOL of Egyptian patients compared it with the impact of the same on the HRQOL of an interventional group of patients undergoing IFN therapy and a control group of noninfected individuals using HRQOL specific assessment instruments focusing on liver disease. We also investigated possible relationships between HRQOL and demographic and laboratory parameters.
| Subject and Methods|| |
Study design, setting, and participants
A comparative cross-sectional study was conducted between September 2013 and December 2013 at two hepatology units of a health insurance and a public hospital in Alexandria, Egypt. A total of 450 subjects were enrolled in the study using simple random selection. The sample comprised 150 chronic HCV patients designated as cases, an intervention group of 150 chronic HCV patients undergoing IFN therapy, and 150 healthy controls attending the same setting and matched for age and sex. The criteria for inclusion were as follows: Age from 18 years to 60 years, both sex, HCV-RNA positive polymerase chain reaction (PCR), liver biopsy showing Ishak stage from 1 to 4, complete blood count (CBC) picture within normal ranges, HBV/HIV seronegative, and all eligible cases for treatment according to the international guidelines. We excluded from the study those with established diabetes mellitus (diagnosed according to the WHO criteria) or with previous history of gestational diabetes in females and all cases found ineligible for the treatment [age under 18 years or above 60 years; history of major depression or psychosis, malignancy, coronary artery disease, solid organ transplant, untreated thyroid disease, active substance abuse, Wilson's disease, hemochromatosis, α1-antitrypsin deficiency, hepatic decompensation, and autoimmune hepatitis or other autoimmune disease (such as systemic lupus erythematosus, rheumatoid arthritis, or auto immune hepatitis, uncontrolled seizures, uncontrolled diabetes, uncontrolled hypertension, current or planned pregnancy for 18 months following start of treatment, end stage renal disease or serum creatinine greater than 1.5 mg/mL, continued pattern of alcohol abuse >40 g/day in the last 6 months); WBC <3,000/cmm; hemoglobin <10 g/dL; platelet count <100,000/cmm; liver biopsy Ishak stage more than 4/6; retinopathy; concomitant Schistosoma mansoni, HIV, or HBV infection; and obese patients (BMI >35)].
Data collection tools
Personal sociodemographic data, special habits, comorbidities, liver function test [alanine aminotransferase (ALT), prothrombin time, serum albumen, and bilirubin], CBC, current mediations, and parameters of liver compensation were all determined at baseline. HRQOL was evaluated using the following four previously validated specific assessment instruments focusing on liver disease: (i) Short form (SF)-12 quality of life questionnaire: A widely used generic HRQOL tool developed by the medical outcome trust to reduce the time of administering the SF-36.,, This 12-item questionnaire summarizes two scales describing mental well-being (the mental component summary–MCS) and physical well-being (the physical component summary–PCS), which encompass eight scales of the SF-36 physical functionality, role-physical, bodily pain, general health, vitality (energy/fatigue), social function, mental health (emotional well-being), and role-emotion., Instead of five decimal places for the MCS and the PCS, we used a simpler numeric scoring method (rounded whole integer scoring system for each answer). Both scales were calculated as numeric and two categorical values (>50 = absence of disability; ≤50 = presence of disability). In general, lower scores on the MCS and the PCS indicated greater disability.
(ii) Chronic Liver Disease Questionnaire (CLDQ),: It includes 29 items on a 7 response point Likert scale (ranging from “1–all of the time” to “7–none of the time”), covering abdominal symptoms, systemic symptoms, fatigue, activity, emotional functions and worry, and reflecting the patient's status 2 weeks prior to testing. Means are computed for all subscales and for the overall score. Higher scores indicate minimum frequency of symptoms and therefore a better HRQOL. (iii) Hospital Anxiety and Depression Scale (HADS): It is a widely used reliable instrument for detecting states of anxiety and depression in clinical settings. Subscales are also valid measures of severity of the emotional disorder. Each scale is made up of seven items, which are summed to a score ranging from 0 to 21 categorized as follows: Normal (0–7), mild (8–10), moderate (11–14), severe (15–21). iv) Iowa Fatigue Scale (IFS): A standardized self-report instrument used to assess the severity of fatigue. It was derived by combining and condensing many existing scales and includes 11 items on a 5 response point Likert scale (ranging from “1–not at all” to “5–extremely”). A total score of 30–39 indicates substantial fatigue and score of 40 or more indicates severe fatigue. Subscales were investigated through specific items as follows: Cognitive = Q3 + Q5 + Q9+ (6 – Q11), fatigue = Q1 + Q6, energy = (6 – Q2) + (6 – Q7) + (6 – Q10), and productivity = (6 – Q4) + Q8.
We united our Arabic expressions of some mysterious questionnaire expressions (feel down hearted or blue) for more resolute and clear answers.
A structured predesigned face-to-face questionnaire form was used for data collection. Each patient was interviewed alone, in a separate room, and had been particularly asked retrospectively about items included in each of the four HRQOL questionnaires. Each testing block typically took between 30 min and 45 min.
Data were collected, revised, coded, and fed to statistical software Statistical Package for the Social Sciences (SPSS) for windows, version 16.0 (SPSS Inc., Chicago, IL, USA). All statistical analysis was done using two tailed tests and alpha error of 0.05. The means with standard deviation and percent were used to describe the scale and categorical data, respectively. Normal distributed parametric data were calculated using Student's t-test. Nonnormal data were compared by Mann–Whitney test or Kruskal–Wallis test. Nonparametric variables were calculated by Chi-square or Fisher's exact test. Significant variables were introduced into a univariate logistic regression model and further multivariate analysis was done. P < 0.05 and <0.01 were set as levels of significance for univariate and multivariate analysis, respectively. Results are presented with 95% confidence intervals (95% CI).
The study was approved by the institutional review board and the ethics committee of the High Institute of Public Health affiliated to Alexandria University, Egypt. The research complied with the international ethical research guidelines and principles of the Helsinki Declaration of 2013. All participants were invited to sign an informed written consent after explaining the aim and concerns of the study to them. Data sheets were coded to ensure anonymity and confidentiality of the patient's data.
| Results|| |
Characteristics of the enrolled patients and controls
The analysis of sociodemographic characteristics of the enrolled chronic HCV patients and their controls revealed significant statistical differences in mean ages and residence, of the cases group, INF group and control group. Full-time employment were less encountered between cases compared to the control group (39% vs 61%, respectively, OR (95% CI); 0.4 (0.3–0.65), P = 0.0002). The numbers of retired and unemployed patients were higher among the cases [11% vs 0%, respectively, OR (95% CI); 14.8 (1–25), P = 0.0002] compared to the control group [39% vs 61%, respectively, OR (95% CI); 0.4 (0.3–0.65), P = 0.0002). Regarding the marital status, the percentages of singles were significantly higher among cases (14.3% vs 85.7%, P = 0.016). There were more divorced patients in the IFN and control groups compared to the cases (88.8% vs 11.1%, P = 0.04 and 75% vs 25%, P = 0.046, respectively). No significant difference in individual habits, including smoking and substance abuse, was observed among cases and the IFN and control groups. Comorbidities in terms of hypertension and diabetes mellitus were more prevalent among cases compared to the IFN and control groups. Sequelae of advanced liver disease, such as splenomegaly, esophageal varices, ascites, and hepatic encephalopathy, were only seen in the cases [Table 1].
|Table 1: Sociodemographic characteristics and quality of life in patients with chronic viral liver diseases and controls|
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Quality of life in patients with chronic viral liver diseases and controls
There was a significant difference regarding the mean IFS score between the three groups. Higher mean scores were observed among cases compared to controls [32.4 ± 11.3 vs 20.7 ± 5.8, OR (95% CI); 11.3 (9.6–13.7), P < 0.0001] and to the IFN group [32.4 ± 11.3 vs 25.1 ± 7.3, OR (95% CI); 5.8 (2.9–6), P < 0.0001]. The mean score was relatively higher among the IFN group compared to the controls [32.4 + 11.3 vs 25.1 ± 7.3, OR (95% CI); 7.3 (5.1–9.5), P < 0.0001] [Table 1].
Categorical scores of IFS in terms of cognitive, fatigue, energy, and productivity subscales were significantly lower among the cases compared to the controls and IFN group. Likewise, results of the mental and physical numeric and categorical scores for the absence of disability, CLD scale, and HAS were significantly worse in the patients compared to the controls [Table 1]. We found no association between HRQOL score and age or gender. Rural residence, never married were significantly associated with lower Mental component score component of SF-12 (P = 0.001, 0.021 respectively).
| Discussion|| |
Chronic viral liver disease impairs the quality of life, especially its physical component., The treatment of chronic HCV infection may temporarily worsen HRQOL, and common adverse effects of currently available agents include fatigue, muscle aches, depression, and cognitive deficits. The impact of the diagnosis of hepatitis C, a potentially serious disease, and the presence of comorbidities, such as alcohol and drugs, may aggravate the process. Mood-related aspects of HRQOL may even be organically mediated by HCV colonization of brain microglia and activation of brain interleukins. However, HRQOL is also impaired through somatic symptoms, which may be specific to HCV pathophysiology. There are several reports demonstrating that the physical component is more diminished than the mental component of the quality of life in chronic liver disease with established liver cirrhosis. In the present study, mental numeric scores were more diminished in patients compared to those in the IFN and control groups ,, despite the absence of mental comorbidities and presence of other comorbid illness. This correlates with the presence of encephalopathy among one-fifth of the cases. There was a significant difference between the two groups regarding trend toward more comorbid health conditions. The presence of physical disability due complications, such as cirrhosis, ascites, esophageal varices, and splenomegaly, may aggravate depression severity. Moreover, higher mean of age among cases may aggravate the mental and physical conditions of these patients. Treatment of hepatitis C could worsen the depression and fatigue in chronic HCV patients due to the activation of brain cytokines, flu like symptoms caused by IFN, andanemia caused by ribavirin. Several trials showed improvements in HRQOL in the patients undergoing antiviral treatment independently of SVR, raising the hypothesis that viral suppression alone can achieve significant physiological changes., This agrees with the present findings where HRQOL was significantly better in the patients undergoing IFN therapy compared to the cases that are not on treatment.
| Conclusion|| |
Our results confirm that the quality of life is reduced in the patients with chronic viral liver disease compared to the healthy persons. Antiviral therapy with pegylated IFN-α and ribavirin can significantly improve physical and functional aspects of HRQOL.
Financial support and sponsorship
Conflicts of interest
All authors declares no conflicts of interest.
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Ekram W Abd El-Wahab
High Institute of Public Health, Alexandria University, 165 El Horreya Road, 21561, Alexandria, Egypt.
Source of Support: None, Conflict of Interest: None