Developing a disease-specific tool for assessment of quality of life of patients with hepatitis C virus associated chronic liver disease

ABSTRACT

To develop an Egyptian disease-specific instrument to assess the health related quality of life [HRQoL] in patients with chronic hepatitis C [CRC], and to assess the HRQoL in CHC patients according to this instrument. Based on responses from 100 patients, 5 liver experts, and from reviewing previous studies and other disease-specific instruments, items affecting the HRQoL of CRC patients were selected. Responses from 100 patients were used for determining and maximizing the questionnaire's internal consistency reliability [ICR] and construct validity. Retained items were scaled and the final questionnaire was pretested in 20 patients. Using this instrument, the HRQoL was assessed in 126 subjects distributed into three equal groups, one healthy and two groups of patients having chronic liver disease [CLD] with and without hepatitis C antibodies [CLD HC+ve, CLD HC-ve respectively]. Sixty seven items were identified in the item selection process, and 33 were retained at the end of the process of maximizing ICR and construct validity. In pretesting, five items were combined into two, and three questions for assessing the general health perception [GHP] were added. Patients found the final 33 questionnaire clear and easy to complete in 15 minutes. The developed instrument proved gradients among CHC patients, CLD HC-ve controls and normal controls, and among patients with different grades of liver disease severity. Certain domains did better than others in discriminating among the three groups and in comparing different grades of disease severity. The specific questionnaire has acceptable reliability, good construct validity, and correlates with disease severity. Further researches were needed for investigating its usefulness in clinical practice and for supporting the findings of the major decrements in HRQoL domains