Chronic Liver Disease Questionnaire Scores Research Articles

Safety and Effectiveness of Liv.52 DS in Patients With Varied Hepatic Disorders: An Open-Label, Multi-centre, Phase IV Study.

Background The hepatoprotective function of polyherbal formulation Liv.52 in chronic liver diseases is well recognized in published literature. The objective of this open-label, phase IV study was to further strengthen and validate its safety and effectiveness using a large patient pool in a real-world scenario and provide scientific data on symptomatic improvement and supportive treatment in liver function with improvement in quality of life. Methods Adult patients of either sex with one or more clinical symptoms like fatigue, nausea, anorexia, abdominal pain or discomfort, muscle cramps, jaundice, or any other signs and symptoms with a history suggestive of mild-to-moderate hepatic disorders like alcoholic liver disease (ALD), non-alcoholic fatty liver disease (NAFLD), drug-induced hepatotoxicity, or hepatitis were treated with two Liv.52 DS tablets (oral) twice daily for 12 weeks. Results Out of the 1000 enrolled patients, 962 (96%) completed the study with the following subgroups ALD: 375 (38.9%), NAFLD: 379 (39.3%), drug-induced hepatotoxicity: 78 (8.1%), hepatitis: 130 (13.5%). The mean age of enrolled patients was 37.7 years, and the majority of them, 785 (78.5%) were men. The common adverse events observed (with >1.5% incidence) in the study were abdominal pain: 26 (2.6%) and headache: 17 (1.7%). Liv.52 showed statistically significant improvement (P<0.0001) in various clinical signs and symptoms in the majority of patients namely, fatigue: 357/723 (49%), anorexia: 485/620 (78.2%), jaundice: 48/52 (92%). Majority of the patients showed significant improvements from baseline to end of 12 weeks in the liver function test parameters namely, aspartate aminotransferase: 633/840 (75.36%), alanine aminotransferase: 592/729 (81.21%), serum bilirubin: 244/347 (70.32%), alkaline phosphatase: 279/355 (78.59%) with P<0.0001 for all parameters. Statistically significant improvement (P<0.005) was also seen in all the components of the chronic liver disease questionnaire (CLDQ) scores from baseline to 12 weeks. Conclusions The study demonstrated that Liv.52 was hepatoprotective and well tolerated in the study population after treatment for 12 weeks. Significant improvements were seen in clinical signs and symptoms, laboratory parameters of liver function, and CLDQ scores from baseline to 12 weeks. No significant or new safety signals emerged from this study.

Continuous home terlipressin infusion increases handgrip strength and reduces ascites-A prospective randomized crossover study.

Observational studies suggest a beneficial effect of continuous terlipressin infusion (CTI) on ascites and sarcopenia in decompensated cirrhosis with portal hypertension. This single-center, prospective, cross-over study randomized 30 patients with cirrhosis, ascites, and sarcopenia to commence on 12 weeks of home CTI or 12 weeks of observation prior to cross-over. The co-primary outcomes were change in handgrip strength and paracentesis volume. Secondary outcomes included quality of life, sarcopenia measures, renal function, safety, and hospitalization. The median age of participants was 62 years (IQR: 57-64), the median Model for End-Stage Liver Disease-Sodium was 16 (12.3-20.8), and 22 (73%) were male. Handgrip strength increased by a mean adjusted difference (MAD) of 3.09 kg (95% CI: 1.11-5.08 kg) between CTI and observation ( p =0.006); an 11.8% increase from baseline. The total volume of ascites drained decreased by a MAD of 11.39L (2.99-19.85, p =0.01), with 1.75 fewer episodes of paracentesis (0.925-2.59, p <0.001) on CTI. Serum creatinine decreased, urinary sodium excretion increased, and quality of life was significantly higher on CTI (all p <0.001), with an increase in Chronic Liver Disease Questionnaire score of 0.41 points (0.23-0.59). There were 7 minor line-related complications but no cardiac events or pulmonary edema. This novel study demonstrates a significant increase in handgrip strength, reduction in paracentesis volume, and improved quality of life in patients with decompensated cirrhosis treated with continuous terlipressin infusion. These findings provide a strong rationale for the use of ambulatory CTI in appropriately selected patients with cirrhosis.

Frailty Predicting Health-Related Quality of Life Trajectories in Individuals with Sarcopenia in Liver Cirrhosis: Finding from BCAAS Study.

The association between frailty and health-related quality of life (HRQoL) among Asian patients with liver cirrhosis and sarcopenia remains largely unexplored. To address this knowledge gap, we conducted a cross-sectional study involving individuals aged 32 to 69 years, all diagnosed with liver cirrhosis. The chronic liver disease questionnaire (CLDQ) was used to assess HR-QoL, the CLDQ score was used as an outcome to measure the factors related to HR-QoL, and the liver frailty index (LFI) was used to assess the frailty status. The association between the frailty status and the CLDQ summary scales was investigated using the correlation coefficient and multiple regression analyses. A total of 138 patients in the frail (n = 62) and non-frail (n = 76) groups with (alcohol: 97; viral: 24; autoimmune: 17; and cryptogenic: 12) were included in the study. Age, CTP score, and model for end-stage liver disease (MELD) sodium were significantly higher in the frail group. In the CLDQ domains, there was a significant difference between the frail and non-frail groups (p value = 0.001). In health-related quality-of-life summary measures, there was a strong negative correlation between frailty and the scores for activities, emotional function, and fatigue (p value = 0.001). When comparing frail to non-frail patients, these characteristics demonstrated significantly increased odds as indicated by their adjusted odds ratios: OR 3.339 (p value = 0.013), OR 3.998 (p value = 0.006), and OR 4.626 (p value = 0.002), respectively.

Psychometric Properties of the Chronic Liver Disease Questionnaire in Patients with Chronic Liver Disease

Purpose: Chronic liver disease (CLD) is a major public health problem worldwide and it leads to increase in morbidity and mortality. This study aimed to evaluate the psychometric properties of Chronic Liver Disease Questionnaire (CLDQ) in Turkish patients with Chronic liver disease (CLD).&#x0D; Material and Methods: The study was conducted in the methodological research design. Using a convenience sampling method 235 patients with CLD in a university hospital, located in southern Turkey. The instrument’s psychometric properties were examined to determine factor analysis, criterion-related validity, internal consistency, interrater reliability.&#x0D; Results: The patients average age was 55.48±12.02 years. Viral hepatitis was the most common etiology of CLD (53.6%). The total sample had a mean CLDQ score of 4.73±1.12. &#x0D; The factor analysis revealed that the scale consists of six sub-dimensions. No item was removed from the original scale. Cronbach's alpha coefficient was found as 0.95. &#x0D; Conclusion: Valid and reliable measurement tools are needed to evaluate health related quality of life (HRQoL) in patients with liver disease. Chronic Liver Disease Questionnaire is a valid and reliable measurement instrument.

Simple bedside tests of muscle strength and function correlate with computed tomography-skeletal muscle index for assessment of sarcopenia in cirrhosis.

Sarcopenia assessment can be done by skeletal muscle index (SMI) or bedside tests such as handgrip strength (HGS) and gait speed (GS). This study evaluated the correlations of HGS and GS with SMI, health-related quality of life (HRQOL) and cognition and assessed them as predictors of mortality. As many as 116outpatients with cirrhosis were included in this prospective cohort study. Assessment for sarcopenia was done by SMI, HGS and GS. HRQOL was assessed using the chronic liver disease questionnaire (CLDQ) and fatigue severity scale (FSS). Cognition was assessed by mini-mental state examination (MMSE). Correlations of HGS and GS with SMI, HRQOL and cognition were analyzed. Area under the curve (AUCs) were calculated to compare them as predictors of mortality. Alcoholic liver disease (47.4%) was thecommonest etiology of cirrhosis followed by hepatitis C (12.9%). Sarcopenia was diagnosed in 64 (55.2%) patients. A strong correlation was seen between SMI and HGS (ρ = 0.78) and GS (ρ = 0.65). AUCs of GS (0.91 (95% confidence interval [CI], 0.85-0.96) was maximum, followed by HGS (95% CI, 0.86 [0.78-0.93] and SMI [95% CI, 0.8 0.71-0.88]) in predicting mortality (p > 0.05). CLDQ (3.2 vs. 5.6, p < 0.01) and MMSE scores (24.3 vs. 26.3, p < 0.01) were lower, whereas FSS score (5.7 vs. 3.1, p < 0.01) was higher in patients with sarcopenia. CLDQ (ρ = 0.83) and MMSE (ρ = 0.73) showed thestrongest correlation with HGS, whereas FSScorrelated well (ρ = 0.77) with GS. Bedside tests of muscle strength and function, including HGS and GS, correlate strongly with SMI for sarcopenia assessment and prediction of mortality in patients with cirrhosis.

Longitudinal increase in albumin-bilirubin score is associated with non-malignancy-related mortality and quality of life in patients with liver cirrhosis.

Due to the developments in the treatment for hepatitis, it is possible to prevent the progression of liver fibrosis and improve patients’ prognosis even if it has already led to liver cirrhosis (LC). Consequently, a two-step study was conducted. To begin with, a retrospective study was conducted to identify the potential predictors of non-malignancy-related mortality from LC. Then, we prospectively analyzed the validity of these parameters as well as their association with patients’ quality of life. In the retrospective study, 89 cases were included, and the multivariate Cox regression analysis indicated that age (P = 0.012), model for end-stage liver disease (MELD) score (P = 0.012), and annual rate of change of the albumin–bilirubin (ALBI) score (P < 0.001) were significantly associated with LC prognosis. In the prospective study, 70 patients were included, and the patients were divided into cirrhosis progression and non-progression groups. The univariate logistic regression analysis indicated the serum procollagen type III N-terminal peptide level (P = 0.040) and MELD score (P = 0.010) were significantly associated with the annual rate of change of the ALBI score. Furthermore, the mean Chronic Liver Disease Questionnaire score worsened from 5.3 to 4.9 in the cirrhosis progression group (P = 0.034). In conclusion, a longitudinal increase in the ALBI score is closely associated with non-malignancy-related mortality and quality of life.

Bedside Tests of Muscle Function are Non-inferior to Skeletal Muscle Index in Predicting Outcomes in Patients with Cirrhosis and Correlate Better with Health-related Quality of Life and Cognitive Function

Presenting Author: Dr. Surender Singh Background: Sarcopenia is an independent predictor of poor outcomes in patients with cirrhosis. Assessment of sarcopenia can be done either by Computer Tomography based skeletal muscle index (SMI) or bedside tests like Handgrip strength or Gait speed. Aims: To compare Handgrip strength and Gait-speed with SMI in predicting mortality and their correlation with Health-related quality of life (HRQOL) and cognitive function in cirrhosis. Methods: 116 outpatients with cirrhosis were included in this prospective cohort study. Assessment for sarcopenia was done by SMI, Handgrip strength and Gait speed and Receiver operative curves (ROC) curves were plotted to compare them as predictors of mortality. HRQOL was assessed using the chronic liver disease questionnaire (CLDQ) and fatigue severity scale (FSS). Cognitive function was assessed by mini-mental state examination (MMSE). Correlations of SMI with Handgrip strength, Gait speed, HRQOL, and cognitive function were analyzed. Results: 100(86.2%) males and 16(13.8%) females with a mean age of 50.2(48.4-51.9, 95%CI) years were included. The most common cause of cirrhosis was alcoholic liver disease (47.4%) followed by hepatitis C (12.9%). Sarcopenia was diagnosed in 64(55.2%) patients using SMI. The AUCs of Gait speed, Handgrip strength, and SMI in predicting mortality were 0.91(0.85- 0.96), 0.86(0.78-0.93), and 0.8(0.71-0.88) respectively (P >0.05). The CLDQ and MMSE scores were significantly lower in the sarcopenic group, whereas the FSS score was higher suggestive of poor HRQOL and cognitive function in comparison to the Not sarcopenic group. Significant correlation was seen between SMI and Handgrip strength (r=0.75) and Gait-speed (r=0.63), (P<0.01). CLDQ(r=0.86) and FSS(r=0.77) showed strongest correlation with Handgrip strength and MMSE with Gait-speed (r=0.71), (P<0.01). Conclusion: The Handgrip strength and Gait-speed are non-inferior to SMI as an independent predictor of mortality, and correlate better with HRQOL and cognitive function, and could replace SMI for assessment of sarcopenia.

Assessment of Sleep among Patients with Chronic Liver Disease: Association with Quality of Life.

The present study aims to assess the sleep characteristics and health-related quality of life (HRQOL) among patients with chronic liver diseases (CLDs), as well as the relationship between them. We conducted a prospective cross-sectional study, over a period of eight months, on patients with CLDs. Sleep was assessed by subjective tools (self-reported validated questionnaires), semi-objective methods (actigraphy), and HRQOL by using the 36-Item Short Form Survey (SF-36) and Chronic Liver Disease Questionnaire (CLDQ). The results indicated that 48.21% of patients with CLDs had a mean Pittsburgh Sleep Quality Index (PSQI) score higher than five, suggestive of poor sleep; 39.29% of patients had a mean Epworth Sleepiness Scale (ESS) score ≥11, indicative of daytime sleepiness. Actigraphy monitoring showed that patients with cirrhosis had significantly more delayed bedtime hours and get-up hours, more awakenings, and more reduced sleep efficacy when compared to pre-cirrhotics. The CLDQ and SF-36 questionnaire scores were significantly lower in cirrhotics compared to pre-cirrhotics within each domain. Moreover, we identified significant correlations between the variables from each questionnaire, referring to HRQOL and sleep parameters. In conclusion, sleep disturbances are commonly encountered among patients with CLDs and are associated with impaired HRQOL. This is the first study in Romania that assesses sleep by actigraphy in a cohort of patients with different stages of CLD.

Health-Related Quality of Life and Its Influencing Factors in Patients with Hepatitis B: A Cross-Sectional Assessment in Southeastern China.

Health-related quality of life (HRQoL) is an important aspect in the management of patients with hepatitis B (HB), which remains a serious health problem in China. There have been relatively few HRQoL studies involving Chinese patients with HB. The aim of this study was to analyze HRQoL in patients diagnosed with HB living in Zhejiang Province, China. A cross-sectional sample of 98 patients with chronic HB (CHB), 56 patients with advanced HB that have developed cirrhosis, and 48 healthy controls (HCs), all from Zhejiang Province, was used in this study. HRQoL was assessed using Short-Form 36 (SF-36) version 2, European quality of life questionnaire-5 dimensions (EQ-5D), and chronic liver disease questionnaire (CLDQ). Intergroup score differences were detected with U tests. Factors with a significant effect on HRQoL were identified with Spearman correlational analyses. Patients with HB (both groups) had lower SF-36 scores than HCs (p < 0.01), with the exception of general health subscores. Patients with HB cirrhosis had the lowest scores in the EQ-5D visual analog scale (VAS) component. Furthermore, patients with HB cirrhosis had lower (p < 0.01) CLDQ scores than patients with CHB. In our HB patient cohort, disease stage and income level were the factors most associated with HRQoL variables; age, education level, and marital status were, each, also significantly associated with some HRQoL variables in patients with HB in our study (p < 0.05 or p < 0.01). HRQoL is diminished in patients with HB in southeastern China. Disease stage and income emerged as key determinants of HRQoL scores. Augmenting social and medical supports for patients with HB, especially those with a socioeconomic status and an advanced disease stage, may help to enhance HRQoL.

Health-related quality of life in Chinese population with non-alcoholic fatty liver disease: a national multicenter survey

BackgroundHealth 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.MethodsIn 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.ResultsA 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.ConclusionsThis 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.

Efficacy and Safety of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycholic Acid Combination in Chronic Hepatitis Related to Metabolic Syndrome Components.

Steatohepatitis related to metabolic syndrome is a chronic liver disease prevalent in patients not only with non-alcoholic steatohepatitis but also with alcoholic liver disease and chronic viral hepatitis. On the other hand, there is limited data on the effects of hepatotonic agents in these patients. Therefore, this study evaluated the efficacy of a combined hepatotonic agent in this population. Thirty-three adults with chronic hepatitis and one or more components of metabolic syndrome were assigned randomly to receive biphenyl dimethyl dicarboxylate/ursodeoxycholic acid or a placebo for 24 weeks. The primary outcome was the normalization of ALT (≤40 U/L). The secondary outcomes were the change in controlled attenuation parameter, transient elastography, and Chronic Liver Disease Questionnaire score. The 33 patients were assigned randomly to two groups. Eight (50%) of 16 patients who received the intervention drug showed the normalization of ALT, whereas only one (6%) of 17 patients in the placebo group did so. In contrast, the change in controlled attenuation, transient elastography, and Chronic Liver Disease Questionnaire were similar in the two groups. ALT was changed significantly during the four assessment periods, and this change was affected by the group. The interaction between the group and time was also significant. AST was changed significantly during the same period. This change was not affected by the group. Biphenyl dimethyl dicarboxylate/ursodeoxycholic acid combination reduced ALT in chronic liver disease related to metabolic syndrome. On the other hand, there is no evidence that this leads to improved hepatic steatosis and fibrosis within 6 months.

A Multicenter Pilot Randomized Clinical Trial of a Home-Based Exercise Program for Patients With Cirrhosis: The Strength Training Intervention (STRIVE).

We developed the strength training intervention (STRIVE), a home-based exercise program targeting physical function in patients with cirrhosis. In this pilot study, we aimed to evaluate the safety and efficacy of STRIVE. Eligible were adult patients with cirrhosis at 3 sites. Patients were randomized 2:1-12 weeks of STRIVE, a 30-minute strength training video plus a health coach or standard of care (SOC). Physical function and quality of life were assessed using the Liver Frailty Index (LFI) and Chronic Liver Disease Questionnaire (CLDQ), respectively. Fifty-eight and 25 were randomized to STRIVE and SOC arms, respectively: 43% women, median age was 61 years, MELDNa, Model for End-Stage Liver Disease Sodium was 14, and 54% were Child-Pugh B/C. Baseline characteristics were similar in the STRIVE vs SOC arms except for rates of hepatic encephalopathy (19 vs 36%). LFI @ 12 weeks was available in 43 STRIVE and 20 SOC participants. After 12 weeks, the median LFI improved from 3.8 to 3.6 (ΔLFI -0.1) in the STRIVE arm and 3.7 to 3.6 (ΔLFI -0.1) in the SOC arm (P = 0.65 for ΔLFI difference). CLDQ scores improved from 4.6 to 5.2 in STRIVE participants (ΔCLDQ 0.38) and did not change in SOC participants (4.2-4.2; ΔCLDQ -0.03) (P = 0.09 for ΔCLDQ difference). One patient died (SOC arm) of bleeding. Only 14% of STRIVE participants adhered to the strength training video for 10-12 weeks. No adverse events were reported by STRIVE participants. STRIVE, a home-based structured exercise program for patients with cirrhosis, was safely administered at 3 sites, but adherence was low. Although all participants showed minimal improvement in the LFI, STRIVE was associated with a substantial improvement in quality of life.

Impact of newer direct-acting antiviral drugs based on quality-adjusted life years: A prospective pharmacoeconomic study in hepatitis C patients.

Context:The Indian government is dispensing newer direct-acting antiviral (DAA) drugs, which may have impact on hepatitis C virus (HCV) patients’ quality of life (QoL).Aims:To evaluate different DAA regimens and impact on QoL in terms of quality-adjusted life year (QALY) in HCV patients and to measure cost-effectiveness.Methods:This prospective, observational study was carried out on patients who were diagnosed with HCV. Recruited patients were followed up until 12–24 weeks. Patients were recruited following the selection criteria. Along with demographic and drug details, the regimens used were analyzed and evaluated for cost minimization, cost-effectiveness, and cost–utility analysis. For health quality check, the Chronic Liver Disease questionnaire (CLDQ) was used which was also used for QALY assessment. Data were entered into MS Excel 2016. Difference in between the regimens for total cost was done using unpaired t-test and ANOVA test using SPSS 25.0. Overall cost-effectiveness, cost minimization, cost utility and cost of illness analysis was also calculated. P < 0.05 was considered statistically significant.Results:A total of 31 patients were enrolled. A total of five drugs, namely, sofosbuvir, daclatasvir, ribavirin, velpatasvir, and ledipasvir were widely used. Sofosbuvir was most common (46.25%)component of drug combination in our study. A total of five types of regimen were used according to the genotype of patients. With 44,260.13 ± 15,884.92 INR of the total drug cost, 70.97% of patients spent around 30,000–40,000 INR for the whole pharmacotherapy. The total indirect cost was 2768.39 ± 3916.13 INR with the total direct cost of 48,660.90 ± 15,356.39 INR. The total cost including direct as well as indirect cost spent during 6-month therapy by 61.29% of patients was 40,000–50,000 INR. Based on the CLDQ score, QoL was 64.1 ± 25. Regimen 2 (sofosbuvir + velpatasavir) stood out with the lowest cost. Regimen 5 (ribavirin [200 mg] + sofosbuvir [400 mg] + velpatasvir [100 mg]) was found to be the most cost-effective. Considering 1 life year with good health after treatment, QALY was 0.31.Conclusions:Ribavirin (200 mg) + sofosbuvir (400 mg) + velpatasvir (100 mg) was found to be the cost-effective and cost-saving regimen among DAAs.

Factors associated with a reduction in the quality of life of patients with chronic hepatitis C treated by ledipasvir/sofosbuvir therapy

ObjectiveWe investigated factors associated with a reduction in the quality of life and their OR of patients with chronic hepatitis C who underwent ledipasvir/sofosbuvir therapy.MethodsThe subjects were 141 outpatients who...

Health-Related Quality of Life among Patients with Hepatitis C Virus Infection: A Cross-Sectional Study in Jianping County of Liaoning Province, China.

Background Patients with chronic liver disease (CLD) have extrahepatic manifestations and impaired health-related quality of life (HRQOL), and hepatitis C virus (HCV) infection is a leading cause of CLD, cirrhosis, and hepatocellular carcinoma (HCC). This study is aimed at assessing HRQOL in patients with HCV infection in the rural areas and identifying factors associated with impairment of HRQOL. Methods A cross-sectional study was conducted in a county of Liaoning Province in northeast China. HRQOL of patients with HCV infection was assessed using the chronic liver disease questionnaire (CLDQ) and EuroQol-5 dimensions (EQ-5D). Data were transformed to score comparisons of six major CLDQ domains, EQ index, and visual analog scale (VAS). Results A total of 397 (93.4%) subjects, including 67 healthy subjects (HSs), 314 patients with chronic hepatitis C (CHC), and 16 patients with liver cirrhosis (LC) completed the study. The overall quartile CLDQ scores for HSs, patients with CHC, and patients with LC were 6.4 (6.0, 6.7), 5.8 (4.6, 6.4), and 4.1 (3.0, 6.0), respectively. The quartile scores of EQ index for the three groups were 1.0 (1.0, 1.0), 1.0 (0.8, 1.0), and 0.9 (0.6, 1.0), respectively. The median scores of EQ VAS for the three groups were 85.0, 60.0, and 60.0, respectively. Female sex, patients with family history of hepatitis, other comorbid chronic diseases, drinking, and disease duration ≥ 10 years were associated with significant improvement in overall CLDQ scores, and family history of hepatitis and other comorbid chronic diseases were considered predictive factors for EQ index and VAS, respectively. Conclusions Compared with HSs, HCV infection had a greater negative impact on HRQOL in patients with CHC and LC. The significant factors associated with HRQOL include female sex, patients with a family history of hepatitis, other comorbid chronic diseases, drinking, and disease duration ≥ 10 years. Patients with HCV infection in the rural areas should be paid careful attention regarding their HRQOL with proper health education and disease management.

QOL Assessment in Chronic Hepatitis C Patients Receiving Ledipasvir/ Sofosbuvir or Simeprevir/Peginterferon/Ribavirin in Clinical Practice

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.

Liver Dysfunction may be Associated with QOL in Adults with CF

Background: More individuals with cystic fibrosis (CF) are living into their adulthood due to significant advances in medical care. The adult CF clinic at Indiana University cares for one of the largest adult populations with CF. Liver disease is common in children and adults with CF. However, the characteristics and consequences of CF liver disease (CFLD) in adults are not well understood. In this ongoing, IRB approved study, we systematically characterized the liver manifestations and their health related quality of life in adults with well characterized CF.&#x0D; Methods: Individual patient demographics and clinical data were collected for study participants. Participants completed two quality of life study questionnaires: Chronic Liver Disease Questionnaire (CLDQ) and Revised Cystic Fibrosis Questionnaire (CFQ-R). 10mL of blood was collected for future research. Finally, participants underwent a bedside transient elastography via FibroScan®.&#x0D; Results: There were 50 patients, with a mean age of 30.9 years, enrolled in the study. Pancreatic insufficiency was the most common co-morbidity, as it affected 90% of patients. The mean AST was 23.55 units/L, mean ALT was 25.20 units/L, and mean alkaline phosphatase level was 117.73 units/L. From the FibroScan®, the median liver stiffness measurement (LSM) was 4.65 kPa and the mean controlled attenuation parameter (CAP) was 219.52 dB/M. The mean CLDQ score was 5.343.&#x0D; Conclusion: This ongoing study reveals that increased alkaline phosphatase and CAP scores are associated with a poor QOL. More data is needed to further understand the pathophysiology behind CFLD. Use of noninvasive imaging, noninvasive markers, and the CLDQ may aid in early identification of adult CFLD.&#x0D; &#x0D;

1012 Impact of Treatment With Direct Anti Viral Agents on Health Related Quality of Life Using Chronic Liver Disease Questionnaire in Chronic Hepatitis C Patients

INTRODUCTION: Health related quality of life (HRQOL) is important for the physical and psychosocial wellbeing of patients with chronic illnesses. The Chronic Liver Disease Questionnaire (CLDQ) is validated to assess HRQOL. We aim to determine the effect on HRQOL and associated predictive factors in patients treated with direct antiviral agent for Hepatitis C. METHODS: Patients receiving sofosbuvir, daclatasvir and ribavirin combination for 12 weeks for Hepatitis C eradication were enrolled. CLDQ consisted of 29 questions assessed on a seven point Likert scale, consisting of 6 domains; Abdomen symptoms, Fatigue, Systemic symptoms, Activity, Emotional function and Worry. Higher score was indicative of minimum symptoms. RESULTS: In 168 patients, majority were females (53 %) with mean age of 45.6 ± 10.8 yrs. Most of study population were uneducated (47 %) and had a low socioeconomic status (60.1%). End of treatment response was achieved in all participants. Mean CLDQ score before and after HCV treatment was 3.8 ± 1.0 and 5.2 ± 1.7, respectively (P = 0.00). Median Child score before and after treatment was 10 and 9, respectively. (P = 0.00) Similarly, MELD score improved from 13 to 10 after treatment. (P = 0.00) Statistical significant improvement in all domain of CLDQ score was also observed after treatment. (P = 0.00) On multiple regression analysis pretreatment systemic and activity score showed statistical significant association with post treatment CLDQ score. CONCLUSION: We report positive impact of HRQOL in hepatitis C patients treated with direct antiviral agents. Pre-treatment Systemic and Activity scores are statistically significant predictors of improvements in HRQOL.

Health-related Quality of Life in Nonalcoholic Fatty Liver Disease Associates With Hepatic Inflammation

Chronic liver disease has negative effects on health-related quality of life (HRQL). We analyzed data from the European non-alcoholic fatty liver disease (NAFLD) registry to assess the effects of NAFLD on HRQL. We collected data from 304 patients (mean age, 52.3 ± 12.9 years) with histologically defined NAFLD enrolled prospectively into the European NAFLD Registry in Germany, the United Kingdom, and Spain. The chronic liver disease questionnaire (CLDQ) was completed within 6 months of liver biopsy collection. The mean CLDQ overall score was 5.0 ± 1.2, with the lowest score in the category fatigue (4.3 ± 1.6) and the highest scores for activity (5.4 ± 1.4). Women had significantly lower CLDQ scores than men (4.6 ± 1.3 vs 5.3 ± 1.1; P < .001). We found negative correlations between CLDQ scores and presence of obesity (P < .001), type 2 diabetes (P < .001), and dyslipidaemia (P < .01). There was a negative correlation between level of aspartate aminotransferase, but not alanine aminotransferase, and HRQL. Higher histological score of steatosis (1 vs 3) resulted in lower mean CLDQ score (5.3 ± 1.1 vs 4.5 ± 1.4; P < .01); higher level of lobular inflammation (0 vs 3) also resulted in lower mean CLDQ score (5.3 ± 1.2 vs 3.9 ± 1.8; P <. 001). In contrast, advanced fibrosis (F3-4) compared to early or intermediate fibrosis (F0-2) had no significant effect on mean CLDQ score (4.9 ± 1.2 vs 5.1 ± 1.3; P = .072). In multivariate analysis, patients sex, age, presence of type 2 diabetes, and inflammation were independently associated with low HRQL. In an analysis of data from the European NAFLD registry, we observed a substantial burden of symptoms in patients. In addition to age, sex, and the presence of diabetes, detection of lobular inflammation in biopsies correlated with lower HRQL.

Health-related quality of life in patients with autoimmune hepatitis: A questionnaire survey.

AimHealth-related quality of life is impaired in patients with autoimmune hepatitis, but the association between health-related quality of life and patients’ backgrounds remains unknown. We assessed health-related quality of life in patients with autoimmune hepatitis and identified factors associated with its impairment.MethodsWe assessed health-related quality of life in patients with autoimmune hepatitis, patients with chronic hepatitis C, and healthy subjects using the Japanese version of the Chronic Liver Disease Questionnaire and the 36-Item Short Form Survey. We compared health-related quality of life in patients with autoimmune hepatitis with that of patients with chronic hepatitis C and healthy subjects.ResultsA total of 265 patients with autoimmune hepatitis, 88 patients with chronic hepatitis C, and 97 healthy subjects were enrolled; most patients were women. The median ages of patients were 65, 66, and 57 years, respectively. Of these patients with autoimmune hepatitis, 10.6% and 57.0% had cirrhosis and comorbid diseases, respectively. The overall Chronic Liver Disease Questionnaire scores (5.5 vs. 6.2, P < 0.001) and physical (48.1 vs. 54.2, P < 0.001) and mental (51.8 vs. 55.0, P = 0.004) component summaries of 36-Item Short Form Survey were significantly lower in patients with autoimmune hepatitis than in healthy subjects, and similar to scores in patients with chronic hepatitis C. Having cirrhosis, comorbid diseases, and treatment for autoimmune hepatitis were associated with impaired health-related quality of life among patients with autoimmune hepatitis. In particular, prednisolone use was associated with lower scores on the worry domain of the Chronic Liver Disease Questionnaire.ConclusionsPatients with autoimmune hepatitis showed impairment in health-related quality of life, which was associated with not only disease progression, but also comorbid diseases and treatment. Ways to improve health-related quality of life should be considered in patients with AIH when disease outcome is not favorable and when using prednisolone.