{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T21:52:58Z","timestamp":1783547578034,"version":"3.55.0"},"reference-count":33,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,3,4]],"date-time":"2024-03-04T00:00:00Z","timestamp":1709510400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,3,4]],"date-time":"2024-03-04T00:00:00Z","timestamp":1709510400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceuticals","doi-asserted-by":"publisher","award":["Janssen Pharmaceuticals"],"award-info":[{"award-number":["Janssen Pharmaceuticals"]}],"id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Patient Rep Outcomes"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>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\u2019 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The qualitative literature review (N\u2009=\u200943 publications) showed that patients with CHB experience emotional\/psychological impacts. During concept elicitation interviews (N\u2009=\u200924), 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\u2019 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41687-023-00675-8","type":"journal-article","created":{"date-parts":[[2024,3,4]],"date-time":"2024-03-04T10:03:09Z","timestamp":1709546589000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A conceptual model for chronic hepatitis B and content validity of the Hepatitis B Quality of Life (HBQOL) instrument"],"prefix":"10.1186","volume":"8","author":[{"given":"Jane","family":"Abbott","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalie V. 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NVJA and HK are employees and stockholders of Clarivate, a health economics and outcomes research consultancy that consults for various pharmaceutical companies, including Janssen Global Services, LLC, which funded the conduct of this study. HCP and FB were employees of Clarivate at the time this study was conducted, and HCP holds stock in Clarivate. MM, AV-K, US, TI, and EKHC are employees of Janssen Pharmaceuticals and Johnson & Johnson stockholders. PTK has received payment for participation in speakers bureaus and consultancy for Janssen, Gilead Sciences, Aligos, MedImmune, and GlaxoSmithKline, and has received grant support from Gilead Sciences.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"29"}}