NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction–associated steatohepatitis and compensated cirrhosis
Abstract Background NASH-CHECK is a patient-reported outcome measure (PROM) that assesses symptoms and broader health-related quality of life (HRQOL) impacts of metabolic dysfunction–associated steatohepatitis (MASH), previously called non-alcoholic steatohepatitis (NASH). The measure was initially...
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| Format: | Article |
| Language: | English |
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SpringerOpen
2025-07-01
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| Series: | Journal of Patient-Reported Outcomes |
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| Online Access: | https://doi.org/10.1186/s41687-025-00881-6 |
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| author | Lynda C. Doward Matthew Breckons Maria-Magdalena Balp James Twiss Luke Vale Lorraine McSweeney Clifford A. Brass Quentin M. Anstee Arun J. Sanyal |
| author_facet | Lynda C. Doward Matthew Breckons Maria-Magdalena Balp James Twiss Luke Vale Lorraine McSweeney Clifford A. Brass Quentin M. Anstee Arun J. Sanyal |
| author_sort | Lynda C. Doward |
| collection | DOAJ |
| description | Abstract Background NASH-CHECK is a patient-reported outcome measure (PROM) that assesses symptoms and broader health-related quality of life (HRQOL) impacts of metabolic dysfunction–associated steatohepatitis (MASH), previously called non-alcoholic steatohepatitis (NASH). The measure was initially developed and validated for patients with non-cirrhotic MASH. This study describes an evaluation of the suitability of NASH-CHECK for patients with compensated cirrhotic MASH. Methodology Concept elicitation (CE) interviews were conducted with patients with clinically confirmed compensated cirrhotic MASH in the United States (US) and United Kingdom (UK) to determine the symptom burden and broader HRQOL impact of MASH. Symptoms and broader HRQOL impacts identified during analysis of the CE data were compared with the key concepts included in NASH-CHECK; any symptoms reported in the CE interviews but not reflected in NASH-CHECK were reviewed for relevance by clinical experts. The content validity of NASH-CHECK was evaluated further via cognitive debriefing (CD) interviews conducted with patients with compensated cirrhotic MASH in the US and UK. Results CE interviews were conducted with 33 patients with compensated cirrhotic MASH (US = 9, UK = 24; 60.6% female; mean age, 64.3 years). Key symptoms described were similar to those reported by patients with non-cirrhotic MASH identified during the development of NASH-CHECK; these included abdominal pain, abdominal bloating, itch, fatigue, sleeping difficulties, and cognitive symptoms. Other key HRQOL impacts included activity limitations and emotional, social, relationship, and work impacts. All key symptom and broader HRQOL impacts reported by patients with compensated cirrhotic MASH are currently included in NASH-CHECK, and no additional symptoms or HRQOL impacts reported during the CE interviews were deemed relevant for inclusion. CD interviews were conducted with 17 patients with compensated cirrhotic MASH (US = 8, UK = 9; 47.1% female; mean age, 62.8 years). Patient feedback on NASH-CHECK content confirmed that the concepts captured by the items were considered important, relevant, and comprehensive for addressing the impact of compensated cirrhotic MASH. Conclusions The results support the content validity of NASH-CHECK for patients with compensated cirrhotic MASH, demonstrating that NASH-CHECK is a suitable PROM for use in clinical trials, studies, and practice for this patient population. |
| format | Article |
| id | doaj-art-6c7b6fedf5ab44feb0e817bfc56afa05 |
| 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-6c7b6fedf5ab44feb0e817bfc56afa052025-08-20T04:01:36ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202025-07-019111910.1186/s41687-025-00881-6NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction–associated steatohepatitis and compensated cirrhosisLynda C. Doward0Matthew Breckons1Maria-Magdalena Balp2James Twiss3Luke Vale4Lorraine McSweeney5Clifford A. Brass6Quentin M. Anstee7Arun J. Sanyal8RTI Health SolutionsPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle UniversityNovartis Pharma AGRTI Health SolutionsPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle UniversityPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle UniversityNovartis Pharmaceutical CorporationTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle UniversityStravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University School of MedicineAbstract Background NASH-CHECK is a patient-reported outcome measure (PROM) that assesses symptoms and broader health-related quality of life (HRQOL) impacts of metabolic dysfunction–associated steatohepatitis (MASH), previously called non-alcoholic steatohepatitis (NASH). The measure was initially developed and validated for patients with non-cirrhotic MASH. This study describes an evaluation of the suitability of NASH-CHECK for patients with compensated cirrhotic MASH. Methodology Concept elicitation (CE) interviews were conducted with patients with clinically confirmed compensated cirrhotic MASH in the United States (US) and United Kingdom (UK) to determine the symptom burden and broader HRQOL impact of MASH. Symptoms and broader HRQOL impacts identified during analysis of the CE data were compared with the key concepts included in NASH-CHECK; any symptoms reported in the CE interviews but not reflected in NASH-CHECK were reviewed for relevance by clinical experts. The content validity of NASH-CHECK was evaluated further via cognitive debriefing (CD) interviews conducted with patients with compensated cirrhotic MASH in the US and UK. Results CE interviews were conducted with 33 patients with compensated cirrhotic MASH (US = 9, UK = 24; 60.6% female; mean age, 64.3 years). Key symptoms described were similar to those reported by patients with non-cirrhotic MASH identified during the development of NASH-CHECK; these included abdominal pain, abdominal bloating, itch, fatigue, sleeping difficulties, and cognitive symptoms. Other key HRQOL impacts included activity limitations and emotional, social, relationship, and work impacts. All key symptom and broader HRQOL impacts reported by patients with compensated cirrhotic MASH are currently included in NASH-CHECK, and no additional symptoms or HRQOL impacts reported during the CE interviews were deemed relevant for inclusion. CD interviews were conducted with 17 patients with compensated cirrhotic MASH (US = 8, UK = 9; 47.1% female; mean age, 62.8 years). Patient feedback on NASH-CHECK content confirmed that the concepts captured by the items were considered important, relevant, and comprehensive for addressing the impact of compensated cirrhotic MASH. Conclusions The results support the content validity of NASH-CHECK for patients with compensated cirrhotic MASH, demonstrating that NASH-CHECK is a suitable PROM for use in clinical trials, studies, and practice for this patient population.https://doi.org/10.1186/s41687-025-00881-6Metabolic dysfunction–associated steatohepatitisBurdenHealth-related quality of lifePatient-reported outcomesPsychosocial impactNAFLD |
| spellingShingle | Lynda C. Doward Matthew Breckons Maria-Magdalena Balp James Twiss Luke Vale Lorraine McSweeney Clifford A. Brass Quentin M. Anstee Arun J. Sanyal NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction–associated steatohepatitis and compensated cirrhosis Journal of Patient-Reported Outcomes Metabolic dysfunction–associated steatohepatitis Burden Health-related quality of life Patient-reported outcomes Psychosocial impact NAFLD |
| title | NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction–associated steatohepatitis and compensated cirrhosis |
| title_full | NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction–associated steatohepatitis and compensated cirrhosis |
| title_fullStr | NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction–associated steatohepatitis and compensated cirrhosis |
| title_full_unstemmed | NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction–associated steatohepatitis and compensated cirrhosis |
| title_short | NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction–associated steatohepatitis and compensated cirrhosis |
| title_sort | nash check patient reported outcome instrument evaluation of content and face validity for patients with metabolic dysfunction associated steatohepatitis and compensated cirrhosis |
| topic | Metabolic dysfunction–associated steatohepatitis Burden Health-related quality of life Patient-reported outcomes Psychosocial impact NAFLD |
| url | https://doi.org/10.1186/s41687-025-00881-6 |
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