Dataset Information

Health-related quality of life in liver cirrhosis patients using SF-36 and CLDQ questionnaires.

ABSTRACT: Aim of the study:To determine the factors that are likely to influence the domains of health-related quality of life (HRQOL) using SF-36 and CLDQ questionnaires in patients with liver cirrhosis. Material and methods:Patients with liver cirrhosis were compared with age- and gender-matched healthy controls for physical and mental components of the SF-36 score. Effects of age, co-morbidity, namely diabetes, severity of liver disease and complications of liver cirrhosis on HRQOL using self-administered or by direct interview SF-36 and CLDQ questionnaires were studied. Statistical analysis: chi square test, ANOVA, Kruskal-Wallis test and stepwise linear regression analysis. A p value of < 0.05 was considered significant. Results:Regarding SF-36 score, except for bodily pain, 149 patients had significantly low individual and composite domain scores (p value < 0.0001) compared to age/gender-matched controls. Patients below 45 years, the majority of whom belonged to Child-Turcotte-Pugh (CTP) class C with a high Model of End-Stage Liver Disease (MELD) and higher rates of complication had low SF-36 for bodily pain (KW p < 0.005) and those above 55 years for physical function (p < 0.05). Both the physical components had a major impact on mental composite score (MCS) (KW p < 0.05). The overall CLDQ score was also low in patients below 45 years old (p < 0.05). Diabetes with or without other co-morbid conditions had no effect on SF-36 or CLDQ scores, while non-diabetic co-morbid conditions did on physical domains (physical function, bodily pain and role physical) and the physical component score of SF-36 (KW p < 0.01 to < 0.0001). In linear regression, MELD had a direct and significant association with overall PCS, MCS and CLDQ. Conclusions:Age below 45 years, higher MELD and CTP score with the presence of ascites and hepatic encephalopathy affect the overall CLDQ scores.

SUBMITTER: Janani K

PROVIDER: S-EPMC6311749 | biostudies-other | 2018 Dec

REPOSITORIES: biostudies-other

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Health-related quality of life in liver cirrhosis patients using SF-36 and CLDQ questionnaires.

Janani K K Jain Mayank M Vargese Joy J Srinivasan Vijaya V Harika Kavya K Michael Tom T Venkataraman Jayanthi J

Clinical and experimental hepatology 20181203 4

<h4>Aim of the study</h4>To determine the factors that are likely to influence the domains of health-related quality of life (HRQOL) using SF-36 and CLDQ questionnaires in patients with liver cirrhosis.<h4>Material and methods</h4>Patients with liver cirrhosis were compared with age- and gender-matched healthy controls for physical and mental components of the SF-36 score. Effects of age, co-morbidity, namely diabetes, severity of liver disease and complications of liver cirrhosis on HRQOL using ...[more]

PMID: 30603670

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Project description:Health-Related Quality of Life (HRQoL) measures are becoming increasingly used in clinical trials as primary outcome measures. Investigators are now asking statisticians for advice on how to analyse studies that have used HRQoL outcomes.HRQoL outcomes, like the SF-36, are usually measured on an ordinal scale. However, most investigators assume that there exists an underlying continuous latent variable that measures HRQoL, and that the actual measured outcomes (the ordered categories), reflect contiguous intervals along this continuum. The ordinal scaling of HRQoL measures means they tend to generate data that have discrete, bounded and skewed distributions. Thus, standard methods of analysis such as the t-test and linear regression that assume Normality and constant variance may not be appropriate. For this reason, conventional statistical advice would suggest that non-parametric methods be used to analyse HRQoL data. The bootstrap is one such computer intensive non-parametric method for analysing data. We used the bootstrap for hypothesis testing and the estimation of standard errors and confidence intervals for parameters, in four datasets (which illustrate the different aspects of study design). We then compared and contrasted the bootstrap with standard methods of analysing HRQoL outcomes. The standard methods included t-tests, linear regression, summary measures and General Linear Models.Overall, in the datasets we studied, using the SF-36 outcome, bootstrap methods produce results similar to conventional statistical methods. This is likely because the t-test and linear regression are robust to the violations of assumptions that HRQoL data are likely to cause (i.e. non-Normality). While particular to our datasets, these findings are likely to generalise to other HRQoL outcomes, which have discrete, bounded and skewed distributions. Future research with other HRQoL outcome measures, interventions and populations, is required to confirm this conclusion.

Project description:Background & Aims:Non-alcoholic steatohepatitis (NASH) is known to have a negative impact on patients' health-related quality of life (HRQoL), even before progression to cirrhosis has occurred. The burden of NASH-related cirrhosis from the patient perspective remains poorly understood. Herein, we aimed to identify the burden of disease and HRQoL impairment among patients with NASH-related compensated cirrhosis. Methods:This targeted literature review sought first to identify the humanistic burden of disease from the perspective of patients with diagnosed NASH-cirrhosis and, secondly, to identify generic or disease-specific patient-reported outcome measures (PROMs) used to assess the impact of NASH-cirrhosis. Searches were conducted in bibliographical databases, grey or unpublished literature, liver disease websites, support group websites and online blogs. A quality assessment of specific PROMs was conducted. Results:Patients with NASH-cirrhosis are reported to suffer from lower HRQoL than patients with non-cirrhotic NASH and the general population with respect to physical health/functioning, emotional health and worry, and mental health. Thirteen PROMs were identified, of which 4 were liver-disease specific: CLDQ, CLDQ-NAFLD, LDQoL and LDSI. The most commonly used measures do not comply with current industry or regulatory standards for PROMs and/or are not validated for use in a cirrhotic NASH population. Conclusions:Patients with NASH-cirrhosis have lower HRQoL and poorer physical health than patients with non-cirrhotic NASH. However, the literature lacked detail of the everyday impact on patients' lives. Currently, a number of PROMs are available to measure the impact of the disease in patients with chronic liver conditions. The lack of studies that include qualitative insights in this population mandates further exploration and research. Lay summary:It is not well understood how having non-alcoholic fatty liver disease (NAFLD)-related cirrhosis affects a person's everyday wellbeing and quality of life. Some research has been done with patients who have early stages of liver disease but not people with cirrhosis. We found that patients with NAFLD-related cirrhosis tended to have poorer health than patients without cirrhosis. But there was not very much information from patients themselves and there were no tools or questionnaires just for this group of patients.

Dataset Information

Health-related quality of life in liver cirrhosis patients using SF-36 and CLDQ questionnaires.

Publications

Health-related quality of life in liver cirrhosis patients using SF-36 and CLDQ questionnaires.

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