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Abstract Introduction Liver cirrhosis (LC) has a significant impact in quality of life, and it is frequently linked to loss of a job, mood fluctuations, anxiety, low self-esteem, and despair. Recent LC treatment primarily focuses on clinical manifestations rather than the patient’s quality of life. By analyzing quality of life, one can learn about the disease’s emotional, physical, and lifestyle effects. Objectives To find the relationship between quality of life with the severity of liver cirrhosis. Methods The research was conducted as an observational study with cross-sectional data being collected. The study’s participants were recruited from Saiful Anwar Hospital’s outpatient and inpatient clinics. The individuals completed a chronic liver disease questionnaire to assess their quality of life, and the Child-Pugh score was used to determine the severity of their liver disease. The data was analyzed using Kruskal-Wallis and the rank Spearman test, with a significance level of 0.05. Result There were 54 individuals, with an average age of 53.71 years and a male-to-female ratio of 74%. The results showed that there was a significant difference between the Child-Pugh A, Child-Pugh B, and Child-Pugh C groups in all aspects of the chronic liver disease questionnaire (p = 0.000). The rank Spearman test revealed a substantial link between quality of life and liver cirrhosis severity (r: −0.817). Conclusion The severity of LC is associated with the quality of life of the patients.

Introduction: Liver cirrhosis (LC) has a significant impact in quality of life, and it is frequently linked to loss of a job, mood fluctuations, anxiety, low self-esteem, and despair. Recent LC treatment primarily focuses on clinical manifestations rather than the patient's quality of life. By analyzing quality of life, one can learn about the disease's emotional, physical, and lifestyle effects. Objectives: To find the relationship between quality of life with the severity of liver cirrhosis. Methods: The research was conducted as an observational study with cross-sectional data being collected. The study's participants were recruited from Saiful Anwar Hospital's outpatient and inpatient clinics. The individuals completed a chronic liver disease questionnaire to assess their quality of life, and the Child-Pugh score was used to determine the severity of their liver disease. The data was analyzed using Kruskal-Wallis and the rank Spearman test, with a significance level of 0.05. Result: There were 54 individuals, with an average age of 53.71 years and a male-to-female ratio of 74%. The results showed that there was a significant difference between the Child-Pugh A, Child-Pugh B, and Child-Pugh C groups in all aspects of the chronic liver disease questionnaire (p = 0.000). The rank Spearman test revealed a substantial link between quality of life and liver cirrhosis severity (r: −0.817). Conclusion: The severity of LC is associated with the quality of life of the patients. [ABSTRACT FROM AUTHOR]

Purpose: The Chronic Liver Disease Questionnaire (CLDQ)-Nonalcoholic Fatty Liver Disease (NAFLD) is a disease-specific instrument to assess the health-related quality of life (HRQL) of patients with NAFLD. In order to provide further evidence for the cross-cultural utility of this instrument in the Chinese population, we translated the CLDQ-NAFLD into Chinese and examined its reliability and validity. Methods: Patients with NAFLD in 90 hospitals across China were enrolled in this multicenter cross-sectional survey. Eligible patients completed the Chinese version of CLDQ-NAFLD at enrollment to assess HRQL. Internal consistency of the questionnaire was assessed using Cronbach's alpha coefficient and split-half reliability. Convergent and discriminant validity were assessed using Spearman correlation coefficient. Factor analysis was used to test the construct validity. Results: Between March and August 2019, 5181 patients with a mean age of 43.8 ± 13.3 years were enrolled. All domains exhibited good internal consistency, with Cronbach's alpha and split-half reliability greater than 0.70. The scaling success rate of all domains was 100% for convergent validity and 99.4% (179/180) for discriminant validity. The inter-scale correlations indicated a significant correlation between all CLDQ-NAFLD domains (r = 0.608 to 0.832, all p < 0.001). Factor analysis of 36 items extracted 6 factors, which explained 69.14% of the total variance. Conclusion: The Chinese version of CLDQ-NAFLD is a reliable and valid instrument for assessing the HRQL of Chinese patients with NAFLD. [ABSTRACT FROM AUTHOR]

الملخص: أهداف البحث: مرض الكبد الدهني غير الكحولي هو مصدر قلق كبير في الصحة العامة، ولكن تأثيره على نوعية الحياة لم يتم التحقيق فيه بشكل كاف. تقيم هذه الدراسة تأثير العلاج القياسي لمرض الكبد الدهني غير الكحولي على نوعية حياة المرضى المصابين. طرق البحث: أجريت هذه الدراسة المستقبلية على المرضى الذين يعانون من مرض الكبد الدهني غير الكحولي، المراجعين لعيادة أمراض الجهاز الهضمي في مستشفى سينا طهران. خضع جميع المرضى لبروتوكول علاج قياسي. وتم تقييم المعالم الديموغرافية والمادية والبيوكيميائية، ودرجة الدهون في مرض الكبد الدهني غير الكحولي، ونوعية درجات الحياة من خلال استبانة منظمة الصحة العالمية بشأن جودة الحياة واستبانة أمراض الكبد المزمنة عند خط الأساس، بعد ثلاثة وستة أشهر من العلاج. تم تصنيف المرضى إلى مجموعتين; فقدان الوزن (>٥٪) وفقدان الوزن غير كبير (5%) and non-significant weight loss (

Background and Aims: Although patients with chronic liver disease (CLD) usually show few symptoms, they exhibit decreased health‐related QOL (HRQOL) with occurrence complications including hepatocellular carcinoma (HCC). Health‐related QOL is an important indicator in the management of CLD. The Chronic Liver Disease Questionnaire (CLDQ) was established as a tool for assessment of HRQOL. In this study, we evaluate its usefulness for the management of daily clinical practice. Methods: Patients (N = 190, median age 70 years old) treated between 2016 and 2019 were registered and prospectively followed‐up with annual CLDQ. Associations of liver function and development of factors for admission or death were evaluated. Results: Of the 190 patients registered, median age 70 years old, 140 were Child‐A, 121 were Fib‐4 index >2.67 and showed 80 HCC. All 6 domains including Systemic Symptoms (SS) were negatively correlated with Child‐Pugh score more than with albumin‐bilirubin score and Fib‐4 index. A hundred four admission events and 49 deaths were found during observation period, and median event‐free survival was 34.3 months. Treatment for HCC was the most frequent cause of admission, and 37 liver‐related deaths were found. Systemic Symptoms score 2 years after registration was decreased in both HCC‐ and non‐HCC cohort. Systemic Symptoms decreased and SS < 4 might be predictive for event occurrence. Conclusions: CLDQ is useful to assess HRQOL in patients with CLD and is well correlated with liver function especially Child‐Pugh. Chronic Liver Disease Questionnaire might be useful to predict the prognosis of CLD and can be a tool of management in clinical practice. [ABSTRACT FROM AUTHOR]

Abstract Background Health Related Quality of Life (HRQL) is a multi-dimensional construct that can comprehensively evaluate the patient’s health status, including physical, emotional, mental and social well-being. In this study, we aimed to evaluate the impact of non-alcoholic fatty liver disease (NAFLD) on HRQL in a Chinese population. Methods In this national multicenter cross-sectional survey, patients with NAFLD were enrolled. Chronic Liver Disease Questionnaire (CLDQ)-NAFLD was used to qualify HRQL. Univariate and multivariate analysis were used to identify independent risk factors of HRQL. Results A total of 5181 patients with NAFLD from 90 centers were enrolled in this study (mean age, 43.8 ± 13.3 years; male, 65.8%). The overall CLDQ score was 5.66 ± 0.89. Multivariate logistic regression analysis showed that body mass index (BMI: HR, 1.642; 95% CI, 1.330–2.026), alanine transaminase (ALT: HR, 1.006; 95% CI, 1.001–1.011), triglyceride (HR, 1.184; 95% CI, 1.074–1.305), disease severity (HR, 3.203; 95% CI, 1.418–7.232) and cardiovascular disease (HR, 4.305; 95% CI, 2.074–8.939) were independent risk factors for overall CLDQ score. In the logistic analyses of individual domain, BMI and triglyceride were independent risk factors of all domains. ALT, disease severity, diabetes, depression and cardiovascular disease were influencing factors for the CLDQ score of several domains. Conclusions This national multicenter cross-sectional survey in China indicated that the HRQL in patients with NAFLD was impaired. HRQL was found to be significantly associated with sociodemographic and clinical factors. Attention should be paid to the optimally managing care of patients with NAFLD to improve their HRQL.

Background: Liver cirrhosis remains the major cause of liver-related morbidity and mortality around the world. Cirrhosis also negatively affects health-related quality of life. Quality of life evaluation in cirrhosis treatment is often overlooked, despite its importance compared to traditional outcome. One of the specific tools to measure quality of life in cirrhosis patient is the Chronic Liver Disease Questionnaire (CLDQ). Although this tool has been widely used in many countries, no studies have been conducted on its validity and reliability in the Indonesian language. This study aimed to assess the validity and reliability of the Indonesian version of CLDQ using appropriate methods. Methods: This is a cross-sectional study conducted at Hepatobiliary outpatient clinic in Dr. Cipto Mangunkusumo National General Hospital (RSCM), from April-May 2021. The CLDQ was first translated into the Indonesian language and subsequent pretest was performed on 10 people, resulting in the final Indonesian version of the CLDQ. The final version was later tested in the main study with larger number of subjects (52 people). Validity was assessed using construct and external validity tests, while reliability was tested using internal consistency and test-retest methods. Results: The Indonesian version of CLDQ had a good construct validity (r 0.613-0.917), moderate external validity (54.1%), strong correlations between CLDQ and SF-36, good internal consistency (Cronbach-Alpha ≥ 0.7), and good test-retest reliability (ICC > 0.7). Conclusion: The Indonesian version of CLDQ is valid and reliable in measuring the quality of life of liver cirrhosis patients in Indonesia.

Background & Aims: Health-related quality of life (HRQoL) determined by patient-reported outcomes (PROs) is impaired in chronic hepatitis B (CHB) and C patients, but there are no data regarding patients with chronic hepatitis D (CHD). The aim of this study was to assess PRO scores in untreated patients with CHD and compare them with those obtained for patients with CHB. Methods: Patients with CHD completed 3 PRO instruments (Chronic Liver Disease Questionnaire [CLDQ], Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-F], and Work Productivity and Activity Impairment [WPAI]), and the results were compared with those of patients mono-infected with CHB. Results: In total, 125 patients were included: 43 with CHD and 82 with CHB. Overall, baseline PROs showed differences between both groups. Several assessments, such as the worry score from CLDQ (p = 0.0118), functional well-being from FACIT-F (p = 0.0281), and activity impairment from WPAI (p = 0.0029) showed a significant trend to worse scores in patients with CHD than with CHB. In addition, the linear regression model supports the finding that having CHD as opposed to having CHB was a predictor of a higher worry score (CLDQ) and a higher activity impairment (WPAI). Conclusions: In this first assessment in CHD, PROs recorded in patients with CHD showed a significant impairment in some domains of HRQoL questionnaires in comparison with those with CHB. Studies in larger cohorts with lengthier follow-up are needed to fully assess patient-reported quality of life over the course of CHD. Lay summary: Chronic hepatitis D (CHD) is a viral disease that causes rapid evolution to liver cirrhosis, amongst other severe complications, when compared to patients with chronic hepatitis B (CHB). Health-related quality of life in chronic hepatitis C and CHB has been reported widely, but no studies have been performed on patient-reported outcomes in patients with CHD. Results showed that CHD patients reported worse outcomes in psychological domains such as worry and emotional well-being, as well as in physical domains such as abdominal symptoms, physical well-being, and activity impairment in comparison with patients with CHB.

Background: Health Related Quality of Life (HRQL) is a multi-dimensional construct that can comprehensively evaluate the patient's health status, including physical, emotional, mental and social well-being. In this study, we aimed to evaluate the impact of non-alcoholic fatty liver disease (NAFLD) on HRQL in a Chinese population.Methods: In this national multicenter cross-sectional survey, patients with NAFLD were enrolled. Chronic Liver Disease Questionnaire (CLDQ)-NAFLD was used to qualify HRQL. Univariate and multivariate analysis were used to identify independent risk factors of HRQL.Results: A total of 5181 patients with NAFLD from 90 centers were enrolled in this study (mean age, 43.8 ± 13.3 years; male, 65.8%). The overall CLDQ score was 5.66 ± 0.89. Multivariate logistic regression analysis showed that body mass index (BMI: HR, 1.642; 95% CI, 1.330-2.026), alanine transaminase (ALT: HR, 1.006; 95% CI, 1.001-1.011), triglyceride (HR, 1.184; 95% CI, 1.074-1.305), disease severity (HR, 3.203; 95% CI, 1.418-7.232) and cardiovascular disease (HR, 4.305; 95% CI, 2.074-8.939) were independent risk factors for overall CLDQ score. In the logistic analyses of individual domain, BMI and triglyceride were independent risk factors of all domains. ALT, disease severity, diabetes, depression and cardiovascular disease were influencing factors for the CLDQ score of several domains.Conclusions: This national multicenter cross-sectional survey in China indicated that the HRQL in patients with NAFLD was impaired. HRQL was found to be significantly associated with sociodemographic and clinical factors. Attention should be paid to the optimally managing care of patients with NAFLD to improve their HRQL. [ABSTRACT FROM AUTHOR]

Non‐alcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide and one of the leading causes of hepatocellular carcinoma and liver transplantation. Moreover, patients with NAFLD frequently complain of non‐specific symptoms including fatigue, abdominal discomfort, as well as anxiety, and NAFLD is reported to affect patient‐reported outcomes (PROs). Thus, for clarifying the total burden of NAFLD, it is crucial to assess all associated outcomes, including not only clinical and economic outcomes but also PROs. PROs are thought to reflect what is happening in one's daily life and is an important way patients and health‐care professionals communicate. There are various instruments for the assessment of PROs. Recently, a NAFLD/non‐alcoholic steatohepatitis (NASH)‐specific instrument called "Chronic Liver Disease Questionnaire (CLDQ)‐NAFLD/NASH" has been developed. CLDQ‐NAFLD/NASH comprises six domains: (i) abdominal symptoms, (ii) activity/energy, (iii) emotional health, (iv) fatigue, (v) systemic symptoms, and (vi) worry. CLDQ‐NAFLD/NASH has demonstrated excellent internal consistency, face validity, content validity, and test–retest reliability. It has been sufficiently validated in two international phase 3 clinical trials. In this review, we summarize features of various instruments for assessing PROs by focusing on CLDQ‐NAFLD/NASH. We also examine the validity of CLDQ‐NAFLD/NASH in Japanese patients and alterations in CLDQ‐NAFLD/NASH score in Japanese patients with significant hepatic fibrosis. Moreover, we discuss the utility of CLDQ‐NAFLD/NASH in phase 3 clinical trials and in a real‐world clinical setting. [ABSTRACT FROM AUTHOR]

Objecive Patients with autoimmune hepatitis (AIH) reportedly have an impaired quality of life (QOL), mainly due to depression, even during remission. In addition, hypozincaemia has been demonstrated in patients with chronic liver disease, including AIH, and is known to be related to depression. Corticosteroids are known to cause mental instability. We therefore investigated the longitudinal association between zinc supplementation and changes in the mental status among AIH patients treated with corticosteroids. Materials This study enrolled 26 patients with serological remission of AIH routinely treated at our facility after excluding 15 patients who either discontinued polaprezinc (150 mg/day) within 24 months or interrupted treatment. Two questionnaires, the Chronic Liver Disease Questionnaire (CLDQ) and SF-36, were adopted to evaluate the QOL before and after zinc supplementation. Results Serum zinc levels were significantly elevated after zinc supplementation (p<0.0001). The CLDQ worry subscale significantly improved after zinc supplementation (p=0.017), but none of the SF-36 subscales was affected. Multivariate analyses demonstrated that daily prednisolone dosing was inversely related to both the CLDQ worry domain score (p=0.036) and the SF-36 mental health component (p=0.031). There was a significant negative correlation between the changes in the daily steroid dose and the CLDQ worry domain scores before and after zinc supplementation (p=0.006). No serious adverse events occurred during the observation period. Conclusion Zinc supplementation safely and efficiently improved mental impairment, possibly caused by continuous treatment with corticosteroids, in patients with AIH.

ABSTRACT Due to the severity of chronic hepatitis C, there are multiple factors that can negatively affect the quality of life of infected patients. The aim of this study was to evaluate changes in the health-related quality of life (HRQoL) in patients under second-generation direct-acting antiviral (DAA) (interferon-free) therapies and to assess treatment effectiveness. This was an observational study conducted in Curitiba (Brazil) using two instruments (a generic and a specific) for measuring the quality of life in patients with chronic hepatitis C, the Short Form-36 (SF-36) and the Chronic Liver Disease Questionnaire (CLDQ) for liver disease evaluation. The study included patients receiving any interferon-free therapy for hepatitis C treatment during 2016 and 2017. Data were collected before, during, and after treatment regarding the two questionnaires, effectiveness and safety. Fifty-six patients fulfilled all eligibility criteria and were included for analysis. Sustained virological response was obtained in 88% of the patients. They were mainly genotype 1, cirrhotic and treated with sofosbuvir combined with daclatasvir or sofosbuvir with simeprevir. Improvement in the quality of life was observed for several domains in both questionnaires (p < 0.05) in the comparison before and after treatment. Patients receiving sofosbuvir with daclatasvir had significantly lower scores compared to the group receiving sofosbuvir with simeprevir. Second-generation DAA therapies were effective and have considerably increased the HRQoL of patients with chronic hepatitis C virus.

Due to the severity of chronic hepatitis C, there are multiple factors that can negatively affect the quality of life of infected patients. The aim of this study was to evaluate changes in the health-related quality of life (HRQoL) in patients under second-generation direct-acting antiviral (DAA) (interferon-free) therapies and to assess treatment effectiveness. This was an observational study conducted in Curitiba (Brazil) using two instruments (a generic and a specific) for measuring the quality of life in patients with chronic hepatitis C, the Short Form-36 (SF-36) and the Chronic Liver Disease Questionnaire (CLDQ) for liver disease evaluation. The study included patients receiving any interferon-free therapy for hepatitis C treatment during 2016 and 2017. Data were collected before, during, and after treatment regarding the two questionnaires, effectiveness and safety. Fifty-six patients fulfilled all eligibility criteria and were included for analysis. Sustained virological response was obtained in 88% of the patients. They were mainly genotype 1, cirrhotic and treated with sofosbuvir combined with daclatasvir or sofosbuvir with simeprevir. Improvement in the quality of life was observed for several domains in both questionnaires (p < 0.05) in the comparison before and after treatment. Patients receiving sofosbuvir with daclatasvir had significantly lower scores compared to the group receiving sofosbuvir with simeprevir. Second-generation DAA therapies were effective and have considerably increased the HRQoL of patients with chronic hepatitis C virus. [ABSTRACT FROM AUTHOR]

Introduction. Hyponatremia is associated with high mortality and predicts hepatic encephalopathy but its effect on health-related quality of life remains to be established.Material and methods. In this study we prospectively analyzed the relationship between hyponatremia, clinical features and quality of life in a cohort of 116 patients with cirrhosis. Chronic Liver Disease Questionnaire and Medical Outcomes Study 36-Item Short Form Health Survey were performed to assess quality of life. Evaluation of hepatic encephalopathy included West-Haven criteria, Psychometric Hepatic Encephalopathy Score and Critical Flicker Frequency analysis. Severity of liver disease was assessed with Child-Pugh score and MELD. Univariate and multivariate analysis were implemented to evaluate the influence of analyzed factors on quality of life.Results. Multivariate analysis has identified serum natremia, Psychometric Hepatic Encephalopathy Score, Critical Flicker Frequency and severity of liver disease measured with MELD and Child-Pugh score as independent factors affecting quality of life in patients with cirrhosis. West Heaven criteria failed to show the relationship with quality of life in analyzed subjects. Serum kalemia showed correlation with neither quality of life, hepatic encephalopathy nor severity of the disease.Conclusion. In patients with cirrhosis serum natremia along with severity of liver disease and hepatic encephalopathy exerts a significant effect on patients’ quality of life.

Purpose: The chronic liver disease questionnaire (CLDQ) is a frequently used liver-specific quality of life instrument, but it does not provide information on preference-adjusted health status, which is essential for cost-utility analysis. We aimed to develop a mapping function deriving utilities from the CLDQ in primary sclerosing cholangitis (PSC).Methods: Short form-6D (SF-6D) utilities were calculated from SF-36 data collected in a recent prospective study in which unselected patients with PSC also completed the CLDQ. Ordinary least squares (OLS), generalized linear, median, and kernel regression analyses were employed to devise a mapping function predicting utilities. This was validated in three random subsamples of the cohort and in a separate sample of PSC patients following liver transplantation. Adjusted R (2) and root-mean-square error (RMSE) as well as Pearson's r coefficients and mean absolute errors between predicted and observed values were used to determine model performance.Results: Decompensated liver disease and fatigue, systemic symptoms, and emotional distress, assessed with the CLDQ, were related to worse SF-6D utilities. The final OLS prediction model explained 66.3 % of the variance in the derivation sample. Predicted and observed utilities were strongly correlated (r = 0.807, p < 0.001), but the mean absolute error (0.0604) and adjusted RMSE (10.6 %) were of intermediate size. Similar model characteristics were observed after employment of generalized linear and median regression models and at validation.Conclusions: A model has been constructed, showing good validity predicting SF-6D utilities from CLDQ scores at the group level in PSC. Further testing is required to externally validate the model. [ABSTRACT FROM AUTHOR]

Objective Few studies have evaluated health-related quality of life (HRQoL) of patients with chronic hepatitis B (CHB) in mainland China. We aimed at characterizing the impact of CHB on HRQoL in mainland Chinese and finding out factors associated with HRQoL. Methods 460 CHB patients (323 with CHB only, 54 with compensated cirrhosis and 83 with decompensated cirrhosis) and 460 pair-matched healthy controls were recruited in Xi'an city. They answered a structured questionnaire including the Short Form 36 version 2 (SF-36v2), the Chronic Liver Disease Questionnaire (CLDQ) (only for patients), and questions on sociodemographic and clinical characteristics. A blood sample was collected from each of patients for liver function tests. SF-36v2 scores were compared between patients and controls overall and by groups by paired-samples t-test, and CLDQ scores and paired differences of SF-36v2 scores were compared among three patient groups by one-way ANOVA or Kruskal-Wallis test. Multi-variable linear regression analyses were performed to identify determinants of HRQoL in patients. Results Patients, overall and by groups had significantly lower SF-36v2 scores than controls on all summaries and domains, with differences higher than the suggested minimally important difference values. Both the SF-36v2 and the CLDQ showed that HRQoL of patients with cirrhosis further deteriorated, but compensated and decompensated cirrhosis patients had similar total HRQoL impairments. The gradually increasing impairment with disease progression was confirmed only on physical components. Impaired liver function and currently taken anti-viral treatment were associated with lower HRQoL. Education attainment and annual per capita household income had a positive effect on HRQoL. Conclusions Mainland Chinese CHB patients suffered significant HRQoL impairment on all health dimensions, and the impairment reached a high level on mental health at initial stage of illness and increased gradually on physical health with disease progression. Attention should be paid to the reduction of patients' treatment cost burden and the provision of early health education accompanied with proper treatments. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: Patients with cirrhosis often experience muscle cramps with varying severity. We investigated the factors associated with the prevalence and morbidity associated with muscle cramps. Methods: A total of 150 adult patients with cirrhosis were enrolled consecutively. Cramp questionnaire with visual analogue scale for pain, Chronic Liver Disease Questionnaire (CLDQ), and blood for measurement of 25-(OH) vitamin D levels were obtained after informed consent. Results: A total of 101 patients (67%) reported muscle cramps in the preceding 3 months. Patients with cramps had significantly lower serum albumin (3.1±0.6 g/dL vs 3.3±0.7 g/dL, P =.04) and CLDQ scores (107±37 vs 137±34, P <.0001) compared with those without cramps. The median composite symptom score, defined as product of frequency and severity of cramps, in the study cohort was 12 with a range of 0.3 to 200. There were no clinical or biochemical predictors for occurrence of any cramps or severe cramps (composite symptom score>12). Muscle cramps (P <.001) and hepatic encephalopathy (P=.009) were associated independently with decreased CLDQ scores. Vitamin D deficiency was seen in 66% of the study cohort, but the serum 25-(OH) vitamin D levels were not significantly different between patients with and without cramps (18.0±8.9 ng/mL vs 19.6±9.5 ng/mL, P=.49). Conclusions: Muscle cramps are associated with significantly diminished quality of life in patients with cirrhosis. More research is needed to better understand their mechanism to develop effective treatment. [Copyright &y& Elsevier]

Background: In December 2019, the coronavirus disease-2019 (COVID-19) emerged and rapidly spread worldwide, becoming a global health threat and having a tremendous impact on the quality of life (QOL) of individuals., Aim: To evaluate the awareness of patients with chronic liver disease (CLD) regarding the COVID-19 emergency and how it impacted on their QOL., Methods: Patients with an established diagnosis of CLD (cirrhosis, autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis) who had been evaluated at our Outpatient Liver Disease Clinic during the 6-mo period preceding the start of Italian lockdown (March 8, 2020) were enrolled. Participants were asked to complete a two-part questionnaire, administered by telephone according to governmental restrictions: The first section assessed patients' basic knowledge regarding COVID-19, and the second evaluated the impact of the COVID-19 emergency on their QOL. We used the Italian version of the CLD questionnaire (CLDQ-I). With the aim of evaluating possible changes in the QOL items addressed, the questionnaire was administered to patients at the time of telephone contact with the specific request to recall their QOL perceptions during two different time points. In detail, patients were asked to recall these perceptions first during time 0 (t0), a period comprising the 2 wk preceding the date of ministerial lockdown decree (from February 23 to March 7, 2020); then, in the course of the same phone call, they were asked to recall the same items as experienced throughout time 1 (t1), the second predetermined time frame encompassing the 2 wk (from April 6 to April 19) preceding our telephone contact and questionnaire administration. All data are expressed as number (%), and continuous variables are reported as the median (interquartile range). The data were compared using the Wilcoxon paired non-parametric test., Results: A total of 111 patients were enrolled, of whom 81 completed the questionnaire. Forty-nine had liver cirrhosis, and all of them had compensated disease; 32 patients had autoimmune liver disease. The majority (93.8%) of patients were aware of COVID-19 transmission modalities and on how to recognize the most common alarm symptoms (93.8%). Five of 32 (15.6%) patients with autoimmune liver disease reported having had the need to receive more information about the way to manage their liver disease therapy during lockdown and nine (28.2%) thought about modifying their therapy without consulting their liver disease specialist. About the impact on QOL, all CLDQ-I total scores were significantly worsened during time t1 as compared to time t0., Conclusion: The COVID-19 epidemic has had a significant impact on the QOL of our population of patients, despite a good knowledge of preventive measure and means of virus transmission., Competing Interests: Conflict-of-interest statement: There are no conflicts of interest to report., (©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Liver cirrhosis remains the major cause of liver-related morbidity and mortality around the world. Cirrhosis also negatively affects health-related quality of life. Quality of life evaluation in cirrhosis treatment is often overlooked, despite its importance compared to traditional outcome. One of the specific tools to measure quality of life in cirrhosis patient is the Chronic Liver Disease Questionnaire (CLDQ). Although this tool has been widely used in many countries, no studies have been conducted on its validity and reliability in the Indonesian language. This study aimed to assess the validity and reliability of the Indonesian version of CLDQ using appropriate methods., Methods: This is a cross-sectional study conducted at Hepatobiliary outpatient clinic in Dr. Cipto Mangunkusumo National General Hospital (RSCM), from April-May 2021. The CLDQ was first translated into the Indonesian language and subsequent pretest was performed on 10 people, resulting in the final Indonesian version of the CLDQ. The final version was later tested in the main study with larger number of subjects (52 people). Validity was assessed using construct and external validity tests, while reliability was tested using internal consistency and test-retest methods., Results: The Indonesian version of CLDQ had a good construct validity (r 0.613-0.917), moderate external validity (54.1%), strong correlations between CLDQ and SF-36, good internal consistency (Cronbach-Alpha ≥ 0.7), and good test-retest reliability (ICC > 0.7)., Conclusion: The Indonesian version of CLDQ is valid and reliable in measuring the quality of life of liver cirrhosis patients in Indonesia.

Background & Aims: Health-related quality of life (HRQoL) determined by patient-reported outcomes (PROs) is impaired in chronic hepatitis B (CHB) and C patients, but there are no data regarding patients with chronic hepatitis D (CHD). The aim of this study was to assess PRO scores in untreated patients with CHD and compare them with those obtained for patients with CHB., Methods: Patients with CHD completed 3 PRO instruments (Chronic Liver Disease Questionnaire [CLDQ], Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], and Work Productivity and Activity Impairment [WPAI]), and the results were compared with those of patients mono-infected with CHB., Results: In total, 125 patients were included: 43 with CHD and 82 with CHB. Overall, baseline PROs showed differences between both groups. Several assessments, such as the worry score from CLDQ ( p  = 0.0118), functional well-being from FACIT-F ( p  = 0.0281), and activity impairment from WPAI ( p  = 0.0029) showed a significant trend to worse scores in patients with CHD than with CHB. In addition, the linear regression model supports the finding that having CHD as opposed to having CHB was a predictor of a higher worry score (CLDQ) and a higher activity impairment (WPAI)., Conclusions: In this first assessment in CHD, PROs recorded in patients with CHD showed a significant impairment in some domains of HRQoL questionnaires in comparison with those with CHB. Studies in larger cohorts with lengthier follow-up are needed to fully assess patient-reported quality of life over the course of CHD., Lay Summary: Chronic hepatitis D (CHD) is a viral disease that causes rapid evolution to liver cirrhosis, amongst other severe complications, when compared to patients with chronic hepatitis B (CHB). Health-related quality of life in chronic hepatitis C and CHB has been reported widely, but no studies have been performed on patient-reported outcomes in patients with CHD. Results showed that CHD patients reported worse outcomes in psychological domains such as worry and emotional well-being, as well as in physical domains such as abdominal symptoms, physical well-being, and activity impairment in comparison with patients with CHB., Competing Interests: MB and RE have served as a speaker and advisory board member for Gilead, Roche, and Arbutus. MRB has served as a speaker for AbbVie and Gilead. ZY has received research funds from Intercept, 10.13039/100004334Merck, 10.13039/100002491BMS, and 10.13039/100004340Siemens, and has served as consultant for Gilead, Terns, Viking, Intercept, Merck, Abbvie, Novartis, BMS, Shionogi, and Siemens. Please refer to the accompanying ICMJE disclosure forms for further details., (© 2021 The Authors.)

Recently, a clinical study using a Chronic Liver Disease Questionnaire (CLDQ) showed that ledipasvir/sofosbuvir (LDV/SOF)-treated patients' QOL was more favorable than that of IFN/ribavirin (RBV)-treated patients. However, no study has reported QOL assessment in clinical practice. In this study, we compared the QOL between patients treated with LDV/SOF and those treated with simeprevir (SMV)/peginterferon (Peg-IFN)/RBV to provide QOL information in clinical practice. The subjects were 169 patients with type I chronic hepatitis C or compensated cirrhosis C (Child-Pugh Grade A) who were treated with SMV/Peg-IFN/RBV or LDV/SOF in Hitachi General Hospital. The QOL was assessed ≥2 weeks after the start of administration using the Japanese version of the CLDQ (Kida et al., 2008 version). The total CLDQ score in the LDV/SOF group was significantly higher than in the SMV/Peg-IFN/RBV group (6.59 vs. 6.38, respectively, p=0.007). In particular, the scores for 4 domains (abdominal symptoms, systemic symptoms, activity, and emotional function) in the former were significantly higher than in the latter (p<0.05). Furthermore, the rates of patients scoring 7 (no symptom) on 8 items in the former were significantly higher than in the latter (p<0.05). In clinical practice, LDV/SOF-treated patients' QOL was more favorable than that of those receiving conventional treatment with IFN and RBV. This study may make it possible for health care professionals to provide clinical QOL information on LDV/SOF therapy to patients. Furthermore, QOL information may promote decision-making for treatment, leading to effective treatment.

Aims: Interferon-free direct-acting antiviral agent (DAA) regimens for chronic hepatitis C virus (HCV) patients have improved their health-related quality of life (HRQOL). Currently, there are no published data assessing the impact of DAAs regimens without sofosbuvir on HRQOL. The aim of this study was to investigate the improvement of HRQOL in Japanese HCV patients treated with a protease inhibitor and a nonstructural protein 5A inhibitor., Methods and Results: A total of 123 Japanese genotype 1b HCV patients receiving daclatasvir (DCV) and asunaprevir (ASV) for 24 weeks were enrolled. HRQOL was assessed using the Japanese version of the Chronic Liver Disease Questionnaire (CLDQ) at baseline; weeks 4, 12, and 24; and post-24 weeks. Changes in CLDQ scores were calculated by subtracting the CLDQ score at each time point from the baseline value. Improvement in the mean change of the Japanese version of the CLDQ score became statistically significant as early as week 4 after the initiation of treatment (+9.3%; P  < 0.0001) and was sustained during and after DCV/ASV treatment. The changes of CLDQ at posttreatment week 24 in patients with sustained virological responses (SVR) were significantly higher than those in patients without SVR (0.4% and -4.1%, respectively; P  < 0.05)., Conclusions: This study of DCV/ASV treatment for Japanese HCV patients in a clinical setting demonstrated that HRQOL can improve as early as at the initiation of treatment and can continue during and after treatment, regardless of the classes of DAAs regimens and race. Moreover, SVR are needed to continue HRQOL improvement.

A letter to the editor is presented on the validity of the Swedish version of chronic liver disease questionnaire (CLDQ).

Aim: To verify how malnutrition is related to health-related quality of life (HRQL) impairment in patients with cirrhosis., Methods: Data was retrospectively abstracted from medical records and obtained by direct interview. We included patients with cirrhosis from any etiology, evaluated at the Liver Clinic from Gastroenterology Department in a tertiary healthcare center, from June 2014 to June 2016. Child-Pugh score, data about complications, and demographic, clinical and anthropometric characteristics of patients were obtained. Nutritional status was evaluated by the Subjective Global Assessment (SGA). HRQL was evaluated through the Chronic Liver Disease Questionnaire. Patients were requested to assess their global HRQL with the following code: 0 = impairment of HRQL, when it was compared with other healthy subjects; 1 = good HRQL, if it was similar to the quality of life of other healthy subjects. To compare the primary outcome between malnourished and well-nourished groups, the χ 2 test, Fisher's exact test or Student's t -test were used, based on the variable type. Associations between predictor variables and deterioration of HRQL were determined by calculating the hazard ratio and 95% confidence interval using Cox proportional hazards regression., Results: A total of 127 patients with cirrhosis were included, and the mean age was 54.1 ± 12.3 years-old. According to Child-Pugh scoring, 25 (19.7%) were classified as A (compensated), 76 (59.8%) as B, and 26 (20.5%) as C (B/C = decompensated). According to SGA, 58 (45.7%) patients were classified as well-nourished. Sixty-nine patients identified HRQL as good, and 76 patients (59.8%) perceived impairment of their HRQL. Multivariate analysis to determine associations between predictor variables and self-perception of an impairment of HRQL found strong association with malnutrition ( P < 0.0001). The most important impaired characteristics in malnourished patients were: Presence of body pain, dyspnea on exertion with daily activities, decreased appetite, generalized weakness, trouble lifting or carrying heavy objects, and decreased level of energy ( P < 0.0001)., Conclusion: Malnutrition is a key factor related to impairment of HRQL in patients with cirrhosis., Competing Interests: Conflict-of-interest statement: The authors involved in this manuscript [Gabriela Rojas-Loureiro, Alfredo Servín-Caamaño, Elizabeth Pérez-Reyes, Luis Servín-Abad, Fátima Higuera-de la Tijera] have no conflicting commercial, personal, political, intellectual or religious interests.

Aim: To evaluate psychometrics of the Chinese (mainland) chronic liver disease questionnaire (CLDQ) in patients with chronic hepatitis B (CHB)., Methods: A cross-sectional sample of 460 Chinese patients with CHB was selected from the Outpatient Department of the Eighth Hospital of Xi'an, including CHB (CHB without cirrhosis) (n = 323) and CHB-related cirrhosis (n = 137). The psychometrics includes reliability, validity and sensitivity. Internal consistency reliability was measured using Cronbach's α. Convergent and discriminant validity was evaluated by item-scale correlation. Factorial validity was explored by principal component analysis with varimax rotation. Sensitivity was assessed using Cohen's effect size (ES), and independent sample t test between CHB and CHB-related cirrhosis groups and between alanine aminotransferase (ALT) normal and abnormal groups after stratifying the disease (CHB and CHB-related cirrhosis)., Results: Internal consistency reliability of the CLDQ was 0.83 (range: 0.65-0.90). Most of the hypothesized item-scale correlations were 0.40 or over, and all of such hypothesized correlations were higher than the alternative ones, indicating satisfactory convergent and discriminant validity. Six factors were extracted after varimax rotation from the 29 items of CLDQ. The eligible Cohen's ES with statistically significant independent sample t test was found in the overall CLDQ and abdominal, systematic, activity scales (CHB vs CHB-related cirrhosis), and in the overall CLDQ and abdominal scale in the stratification of patients with CHB (ALT normal vs abnormal)., Conclusion: The CLDQ has acceptable reliability, validity and sensitivity in Chinese (mainland) patients with CHB.