Validity and reliability of the Italian version of the Chronic Liver Disease Questionnaire (CLDQ-I) for the assessment of health-related quality of life

doi:10.1016/j.dld.2005.02.014

Digestive and Liver Disease

Volume 37, Issue 11, November 2005, Pages 850-860

https://doi.org/10.1016/j.dld.2005.02.014 Get rights and content

Abstract

Background.

The Chronic Liver Disease Questionnaire is a specific health-related quality of life assessment designed for patients with liver diseases.

Aim.

The aim of this paper is to report on the validity, reliability and sensitivity to change of the Italian version (Chronic Liver Disease Questionnaire-I) in subjects with HCV infection.

Subjects.

The Chronic Liver Disease Questionnaire-I was administered to 350 subjects with HCV infection together with the World Health Organization Quality of Life Assessment, abbreviated version, a generic quality of life assessment.

Methods.

The instrument was translated from English, backtranslated and reviewed in focus groups in the framework of a large multicentre study. Exploratory factor analysis identified five factors accounting for 65% of the variance of Chronic Liver Disease Questionnaire-I items and only partially overlapping with those found in the original version.

Results.

The Chronic Liver Disease Questionnaire-I proved to discriminate between subjects with and without comorbid diseases at baseline (t-test = 3.59, p < 0.001). Test–retest reliability was moderate (ICC = 0.60). The Chronic Liver Disease Questionnaire-I was sensitive to change in patients who deteriorated after one month of treatment. Change in the overall Chronic Liver Disease Questionnaire-I score in deteriorated patients was correlated with changes in World Health Organization Quality of Life Assessment, abbreviated version scores in the physical, psychological and environment, but not in the social area.

Conclusions.

The Italian version of Chronic Liver Disease Questionnaire is a valid and reliable instrument to be used in cross-sectional and longitudinal studies.

Introduction

In the last decades, quality of life (QOL) has become an increasingly important outcome measure in clinical research. Whilst a variety of generic QOL measures have been developed, there is a need of specific instruments endowed with sufficient sensitivity to document clinically significant changes over time, even if these changes are small [1]. Converging evidence from studies conducted all over the world indicates that chronic liver disease is associated with significant impairment in quality of life [2], [3], [4].

The Chronic Liver Disease Questionnaire (CLDQ) is a specific health-related quality of life assessment designed for patients with liver disease. It was developed by Younossi et al. [5] and proved to have good test–retest reliability and validity [5], [6], [7].

Aim of this paper is to report on the development of the Italian version of the CLDQ and on the validation procedures carried out within the framework of the multicentre trial ‘Quality of life in HCV-infected patients in antiviral treatment’, promoted and funded by the Italian National Institute of Health.

Section snippets

Patient selection

Study subjects enrolled at 14 academic centres located at eight Italian towns (Rome, Milan, Naples, Florence, Padua, Cagliari, L’Aquila, Palermo) were from consecutive patients presenting for treatment and included chronic hepatitis C patients who were either naive to prior interferon treatment or retreated, with compensated liver disease, stable haematological parameters, compensated thyroid function, stable cardiovascular and renal function.

All subjects entering the protocol provided written

Results

At baseline, 350 subjects filled out the CLDQ-I questionnaire. Three questionnaires were omitted from the analyses because there were more than 20% missing items.

The 347 subjects included were 222 males and 125 females with a mean age of 44.5 years (S.D. = 11.4, range 20–69). One hundred and eighty-three of them were assigned to treatment with interferon, 164 to interferon in combination with ribavirine. The mean and standard deviation of the CLDQ-I items at baseline are provided in Table 1.

Discussion

This paper reports on the development and validation of the Italian version of the CLDQ in a large sample of patients with HCV infection participating in a multicentre trial. We provided evidence of the validity of the instrument to discriminate HCV-infected subjects with and without comorbid physical illnesses. Moreover, we have shown its sensitivity to detect changes occurring over the first month of treatment, which is an issue not yet widely examined [3]. Results also indicated that the

Acknowledgments

This study was funded by the Italian Institute of Health in the framework of the project “Assessment of quality of life and disabilities in psychiatric and medical illnesses”.

The collaborating group also includes the following investigators: Benedetti Marta, Sbaragli Serena: Department of Critical Care, University of Florence, Italy; Boccato Silvia: Department of Clinical and Experimental Medicine, University of Padua, Italy; Ambu Silvia: Clinic of Infectious Diseases Careggi, Florence, Italy;

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Liver, Pancreas and Biliary TractValidity and reliability of the Italian version of the Chronic Liver Disease Questionnaire (CLDQ-I) for the assessment of health-related quality of life