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)
Abstract Background 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’ health-related quality of life (HRQoL). To adequately capture patient persp...
Saved in:
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SpringerOpen
2025-07-01
|
| Series: | Journal of Patient-Reported Outcomes |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41687-025-00903-3 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849332717667221504 |
|---|---|
| author | Pietro Lampertico Aishwarya Chohan Hannah Elwick Nicola Williamson Rowena Jones Alon Yehoshua Caroline Burk Marvin Rock Robert Gish Nancy Reau Heiner Wedemeyer Maria Buti |
| author_facet | Pietro Lampertico Aishwarya Chohan Hannah Elwick Nicola Williamson Rowena Jones Alon Yehoshua Caroline Burk Marvin Rock Robert Gish Nancy Reau Heiner Wedemeyer Maria Buti |
| author_sort | Pietro Lampertico |
| collection | DOAJ |
| description | Abstract Background 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’ 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. Methods 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. Results The sample included participants with a range of liver fibrosis stages, including 11 with compensated (n = 9) and decompensated (n = 2) 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’ 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. Conclusion 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. |
| format | Article |
| id | doaj-art-dbdb475b15a344e0a39dfe03dc041c62 |
| institution | Kabale University |
| issn | 2509-8020 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Journal of Patient-Reported Outcomes |
| spelling | doaj-art-dbdb475b15a344e0a39dfe03dc041c622025-08-20T03:46:07ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202025-07-019111610.1186/s41687-025-00903-3Exploring 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)Pietro Lampertico0Aishwarya Chohan1Hannah Elwick2Nicola Williamson3Rowena Jones4Alon Yehoshua5Caroline Burk6Marvin Rock7Robert Gish8Nancy Reau9Heiner Wedemeyer10Maria Buti11Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale MaggiorePoliclinicoPatient-Centered Outcomes, Adelphi Values Ltd.Patient-Centered Outcomes, Adelphi Values Ltd.Patient-Centered Outcomes, Adelphi Values Ltd.Patient-Centered Outcomes, Adelphi Values Ltd.Gilead SciencesGilead SciencesGilead SciencesHepatitis B FoundationDepartment of Internal Medicine, Division of Digestive Diseases and Nutrition, Rush Medical CollegeDepartment of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical SchoolLiver Unit, Hospital Universitario Valle Hebron and Ciber-ehd del Instituto Carlos IIIAbstract Background 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’ 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. Methods 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. Results The sample included participants with a range of liver fibrosis stages, including 11 with compensated (n = 9) and decompensated (n = 2) 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’ 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. Conclusion 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.https://doi.org/10.1186/s41687-025-00903-3Cognitive debriefing (CD)Concept elicitation (CE)Content validityFatigue severity scale (FSS)Health-related quality of life (HRQoL)Hepatitis D virus (HDV) |
| spellingShingle | Pietro Lampertico Aishwarya Chohan Hannah Elwick Nicola Williamson Rowena Jones Alon Yehoshua Caroline Burk Marvin Rock Robert Gish Nancy Reau Heiner Wedemeyer Maria Buti 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) Journal of Patient-Reported Outcomes Cognitive debriefing (CD) Concept elicitation (CE) Content validity Fatigue severity scale (FSS) Health-related quality of life (HRQoL) Hepatitis D virus (HDV) |
| 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Cognitive debriefing (CD) Concept elicitation (CE) Content validity Fatigue severity scale (FSS) Health-related quality of life (HRQoL) Hepatitis D virus (HDV) |
| url | https://doi.org/10.1186/s41687-025-00903-3 |
| work_keys_str_mv | AT pietrolampertico exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT aishwaryachohan exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT hannahelwick exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT nicolawilliamson exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT rowenajones exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT alonyehoshua exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT carolineburk exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT marvinrock exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT robertgish exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT nancyreau exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT heinerwedemeyer exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss AT mariabuti exploringthepatientexperienceofchronichepatitisdchdandassessmentofcontentvalidityofthehepatitisqualityoflifequestionnaireandhqlqv2andthefatigueseverityscalefss |