Qualitative Study: Nonalcoholic Steatohepatitis

• Research type

  Research Study

• Full title

  Qualitative study of symptoms and impact of Non-alcoholic steatohepatitis (NASH) and cirrhosis

• IRAS ID

  242844

• Contact name

  Quentin Anstee

• Contact email

  quentin.anstee@ncl.ac.uk

• Sponsor organisation

  The Newcastle upon Tyne Hospitals NHS Foundation Trust

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  In the first part of this qualitative study we aim to conduct interviews with Nonalcoholic Steatohepatitis (NASH) patients with fibrosis stage F4 (cirrhosis) about the burden of disease on different areas of their lives. The data will be analysed and our findings will be cross-referenced against an existing patient reported outcome measure (The NASH-CHECK instrument which has been developed for patients with fibrosis stages F1-F3) to help us understand what changes/additions are necessary for the questionnaire to be suitable for use with the F4 patient population.

  Any changes we may need to make will be tested to make sure that the questionnaire is usable so in the second part of the study we would like to recruit patients who have been diagnosed with NASH F4 to complete the revised questionnaire and provide us with detailed feedback.

  Lay summary of study results: This study focused on people in the UK living with a liver condition called metabolic dysfunction-associated steatohepatitis (MASH). MASH is caused by fat and inflammation in the liver and can progress to a more serious stage known as compensated cirrhosis, where the liver is scarred but still functions.
  Researchers wanted to find out if an existing questionnaire—called NASH-CHECK—was suitable for use with people at this more advanced stage. This questionnaire was originally designed to help people with earlier stages of the disease describe their symptoms and how MASH affects their quality of life.
  To test its suitability, the study team interviewed 24 people with compensated cirrhotic MASH from the UK. Participants described symptoms such as fatigue, abdominal discomfort, sleep difficulties, and feelings of worry or low mood—all of which were already included in the NASH-CHECK questionnaire. These UK findings were combined with results from a parallel group of patients in another country to strengthen the overall conclusions. Across the full sample, the questionnaire was confirmed to be relevant, clear, and easy to complete.
  The study found that NASH-CHECK is appropriate for use with people who have compensated cirrhotic MASH, meaning it can now support research and care for those with more advanced liver disease.
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: This study was never registered on a publicly accessible register, as it is not considered a clinical trial by the HRA, and so was not required to be registered.
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Published journal article - https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Flink.springer.com%252Farticle%252F10.1186%252Fs41687-025-00881-6%2FNBTI%2FsuO_AQ%2FAQ%2Fd12062ba-e83e-4f1f-b5ee-cc803b7e272f%2F1%2FGLuFGAu3Bx&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7C30af35f25de443d6380f08ddca9c7495%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638889495522515910%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=VaaI1RLClLme%2FXF9dp2vDzeva6f5CcN9GF6TPtWOpFM%3D&reserved=0

  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.sciencedirect.com%252Fscience%252Farticle%252Fpii%252FS2589555920300331%2FNBTI%2FsuO_AQ%2FAQ%2Fd12062ba-e83e-4f1f-b5ee-cc803b7e272f%2F2%2FiEq7HGhP9i&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7C30af35f25de443d6380f08ddca9c7495%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638889495522544026%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=CwhaAMdJGhxtOI1roZlXd9Ovub3iMqPUnkyZ7a80b%2Fs%3D&reserved=0
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: No
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected:
  If no, explain why they haven't: Feedback of the overall results of the study was not included in the protocol, ethics or consent procedure.
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: Due to the detailed, qualitative nature of the data there were concerns about data sharing through a repository (there is wide debate in the research community regarding sharing of qualitative data). Consequently people were not asked to consent to the sharing of their data.
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: No tissue was collected as part of this study.
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• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  18/LO/1594

• Date of REC Opinion

  11 Sep 2018

• REC opinion

  Favourable Opinion