{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,8]],"date-time":"2025-07-08T04:06:59Z","timestamp":1751947619092,"version":"3.41.2"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,7,7]],"date-time":"2025-07-07T00:00:00Z","timestamp":1751846400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,7,7]],"date-time":"2025-07-07T00:00:00Z","timestamp":1751846400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","award":["Gilead Sciences"],"award-info":[{"award-number":["Gilead Sciences"]}],"id":[{"id":"10.13039\/100005564","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>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Chronic hepatitis D (CHD) is the most severe form of viral hepatitis, which results in accelerated progression to cirrhosis and poor prognosis compared with other hepatitis infections, impacting patients\u2019 health-related quality of life (HRQoL). To adequately capture patient perspectives of new hepatitis D virus (HDV) treatments in clinical trials, patient-reported outcome (PRO) measures that are valid and assess key concepts relevant to the patient are needed. This study aimed to explore the patient experience of CHD and evaluate the content validity of the Hepatitis Quality of Life Questionnaire (HQLQv2) and the Fatigue Severity Scale (FSS) for use in an HDV population.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>Combined qualitative concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted with 39 patients in Germany, Italy, Spain, and the US with a clinician-confirmed diagnosis of CHD. Participants described their experience of CHD, informing the development of a conceptual model, and then completed the HQLQv2 and FSS using a think-aloud technique to assess understanding, relevance, and comprehensiveness of items, instructions, response scales, and recall periods. Interviews were conducted in the principal language of each country; official translations of the instruments were used, and all patient-facing study documents and the interview guide were translated by certified translators.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>The sample included participants with a range of liver fibrosis stages, including 11 with compensated (<jats:italic>n<\/jats:italic>\u2009=\u20099) and decompensated (<jats:italic>n<\/jats:italic>\u2009=\u20092) cirrhosis. Fatigue, loss of appetite, nausea, joint pain, and pain over the liver were the most frequently reported signs\/symptoms. Fatigue was most commonly mentioned and was described as a severe and particularly burdensome symptom, that impacted several aspects of patients\u2019 daily lives. Participants reported that CHD impacted their emotional wellbeing (low mood, anxiety), physical functioning (difficulty walking), social functioning (attending social events), activities of daily living (household chores), and work. Participants demonstrated a good understanding of the HQLQv2 and FSS items, instructions, response scales and recall periods, and the concepts assessed were considered relevant to CHD by most participants.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>Findings contribute to the understanding of the patient experience of CHD and support content validity of the HQLQv2 and FSS as outcome assessments for use in an HDV population.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s41687-025-00903-3","type":"journal-article","created":{"date-parts":[[2025,7,7]],"date-time":"2025-07-07T11:23:36Z","timestamp":1751887416000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Exploring the patient experience of chronic hepatitis D (CHD) and assessment of content validity of the Hepatitis Quality of Life Questionnaire and (HQLQv2) and the Fatigue Severity Scale (FSS)"],"prefix":"10.1186","volume":"9","author":[{"given":"Pietro","family":"Lampertico","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aishwarya","family":"Chohan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hannah","family":"Elwick","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicola","family":"Williamson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rowena","family":"Jones","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alon","family":"Yehoshua","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Burk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marvin","family":"Rock","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Gish","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nancy","family":"Reau","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heiner","family":"Wedemeyer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Buti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,7,7]]},"reference":[{"issue":"3","key":"903_CR1","doi-asserted-by":"publisher","first-page":"523","DOI":"10.1016\/j.jhep.2020.04.008","volume":"73","author":"AJ Stockdale","year":"2020","unstructured":"Stockdale AJ, Kreuels B, Henrion MYR, Giorgi E, Kyomuhangi I, de Martel C et al (2020) The global prevalence of hepatitis D virus infection: systematic review and meta-analysis. 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The study was performed in accordance with the Declaration of Helsinki 1964 and its later amendments and in line with guidelines related to Good Clinical Practice. All data resulting from the study were handled in accordance Health Insurance Portability and Accountability (HIPAA) legislation and the General Data Protection Regulation (GDPR) for the security and privacy of health data.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All participants provided informed consent indicating their data will be used for medical research purposes and the study results may be published.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Pietro Lampertico is a paid speaker and\/or advisor for Roche Pharma\/Diagnostics, Gilead Sciences,GSK, AbbVie, Janssen, MYR, Eiger, Antios, Aligos, VIR, Grifols, Altona, and Roboscreen. Aishwarya Chohan and Rowena Jones are employees of Adelphi Values Ltd, a health outcomes agency, who were paid by the study sponsor (Gilead Sciences Inc.) to conduct the research described in this manuscript and to write this manuscript. Hannah Elwick was an employee of Adelphi Values Ltd at the time of research and is now employed by the University of Nottingham. Nicola Williamson was an employee of Adelphi Values Ltd at the time of research and is now employed by UCB. Caroline Burk and Marvin Rock are employees of Gilead Sciences Inc, the study sponsor. Alon Yehoshua was an employee of Gilead Sciences Inc at the time of research. Robert Gish is a paid consultant and\/or advisor toAbbott, AbbVie, Altimunne, Antios, Arrowhead, Dynavax, Eiger, Eisai, Enyo, Genentech, Genlantis, Gerson Lehrman Group, Gilead Sciences, Helios, HepaTX, HepQuant, Intercept, Janssen, Merck, Pfizer, Topography Health, Venatorx and Prodigy, holds grants from Gilead, and holds stock options in Eiger, Genlantis, HepQuant AngioCrine, HepaTx. Nancy Reau is a paid consultant for Gilead, VIR,AbbVie, Abbott, and Salix and holds grants with Eiger, AbbVie, Gilead, and Salix. Heiner Wedemeyer is a paid consultant and\/or speaker for Aligos, Altimmune, Biotest, BMS, BTG, Dicerna, Enanta, Gilead,Janssen, Merck\/MSD, Roche and VIR, holds grants from Biotest, Gilead, Merck\/MSD, Roche and isinvolved in clinical trials for Altimmune, BMS, Gilead, Janssen, Merck\/MSD, Novartis and VIR. Maria Buti is a paid consultant for Gilead.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing of interest"}}],"article-number":"84"}}