A conceptual model for chronic hepatitis B and content validity of the Hepatitis B Quality of Life (HBQOL) instrument

• Main Authors: Jane Abbott (Author), Natalie V. J. Aldhouse (Author), Helen Kitchen (Author), Hannah C. Pegram (Author), Fiona Brown (Author), Malcolm Macartney (Author), Angelina Villasis-Keever (Author), Urbano Sbarigia (Author), Tetsuro Ito (Author), Eric K. H. Chan (Author), Patrick T. Kennedy (Author)
• Format: Book
• Published: SpringerOpen, 2024-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 10.1186/s41687-023-00675-8; 2509-8020
• Keywords: Chronic hepatitis B; Clinical outcome assessment; Health-related quality of life; Patient-reported outcome; Quality of life; Public aspects of medicine; RA1-1270
• Source: Journal of Patient-Reported Outcomes, Vol 8, Iss 1, Pp 1-14 (2024)

Abstract Background There is increased emphasis on incorporating patient perspectives and patient-relevant endpoints in drug development. We developed a conceptual model of the impact of chronic hepatitis B (CHB) on patients' lives and evaluated the content validity of the Hepatitis B Quality of Life (HBQOL) instrument, a patient-reported outcome tool for use in clinical studies, as a patient-relevant endpoint to measure health-related quality of life in patients with CHB. Methods A literature review of qualitative studies of patient experience with CHB and concept elicitation telephone interviews with patients with CHB in the United Kingdom were used to develop a conceptual model of the experience and impact of living with CHB. The content validity of the HBQOL was evaluated using cognitive debriefing techniques. Results The qualitative literature review (N = 43 publications) showed that patients with CHB experience emotional/psychological impacts. During concept elicitation interviews (N = 24), fatigue was the most commonly reported symptom, and most participants were worried/anxious about virus transmission and disease progression/death. A conceptual model of patients' experiences with CHB was developed. The conceptual relevance and comprehensibility of the HBQOL were supported, though limitations, including the lack of a self-stigma item and recall period, were noted for future improvement. Conclusions The conceptual model shows that patients with CHB experience emotional/psychological impacts that affect their lifestyles, relationships, and work/schooling. The cognitive debriefing interviews support the content validity of the HBQOL as a conceptually relevant patient-reported outcome measure of health-related quality of life.