An observational study in Advanced Chronic Liver Disease, Palliative Care and Patient Reported Outcome Measurements, sponsored by University of Hull. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Hull · Observational
People with advanced liver disease often experience complex physical symptoms, emotional concerns, and practical difficulties, especially as their illness progresses. Currently, there are no questionnaires designed specifically to capture these needs and experiences. A purposely designed questionnaire could help healthcare professionals better understand patients' needs and improve the care they receive. The questionnaire must be tested to make sure that it is reliable, accurate and acceptable to patients. This process is known as validation.
This study is testing a new questionnaire called the Integrated Palliative care Outcome Scale- Liver (IPOS-Liver). It asks about symptoms and concerns experienced by people living with advanced liver disease.
The study will take place in two NHS hospitals in England. 71 NHS patients with advanced chronic liver disease will take part, together with healthcare professionals involved in their care. Patients and healthcare professionals will be asked to complete the IPOS-Liver questionnaire alongside other established questionnaires. These will be completed at two time points a few days apart. The results will be statistically analysed to see whether the new questionnaire gives consistent and useful results. A small number of patients will additionally be invited to take part in a 30-minute interview about their experience of completing the IPOS-Liver. Adult NHS patients in England will be invited to take part after the clinician caring for them identifies that they are eligible for the study.
This multi location, longitudinal, observational mixed methods study will evaluate the psychometric properties of the Integrated Palliative Care Outcome Scale-Liver (IPOS Liver). The IPOS Liver is a newly developed patient reported outcome measure within the IPOS family, designed to capture symptoms, concerns, and unmet palliative care needs specific to people with advanced chronic liver disease (ACLD). Existing outcome measures do not fully reflect the unique palliative symptoms experienced by this population.
The IPOS Liver was developed in collaboration with a patient and public involvement and engagement (PPIE) group and an expert panel comprising hepatology and palliative care clinicians. This study will assess the measure's psychometric properties in 71 adults with ACLD receiving care in hospitals, hospices, or outpatient settings across England using a consecutive eligibility sampling strategy.
Validity and reliability will be examined through correlations between IPOS Liver scores and established clinical outcome measures, assessment of change in IPOS Liver scores over two time points, and evaluation of whether IPOS-Liver score changes correspond with clinical change. In addition, the views and experiences of using the IPOS Liver will be explored through qualitative interviews with a purposively sampled subgroup of patients and healthcare professionals to further support content validity.
The study will be conducted in two locations in England and will be supported by clinicians affiliated with the British Association for the Study of the Liver (BASL) Palliative Hepatology Specialist Interest Group. Ethical safeguards including on-going capacity assessments to ensure decision-specific consent and the right to withdraw with full data deletion, will protect vulnerable participants. Findings from this 18 month study will determine whether the IPOS Liver is a reliable and valid outcome measure suitable for use in clinical practice and research involving people with ACLD
154 studies on the registry are indexed under End Stage Liver Disease; 30 are open to participants now.
This study's planned enrollment of 71 is below the median of 200 across 55 observational studies indexed under End Stage Liver Disease.
Browse End Stage Liver Disease studies →University of Hull is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients at participating locations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have a diagnosis of ACLD from any underlying aetiology, with at least one of the following clinical scores:
Exclusion Criteria:
Staff members caring for patients will also become participants in the study.
Staff-participant inclusion criteria are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Construct Validity
Construct validity establishes the theoretical relationship between variables on the new IPOS-Liver and those on established measures of the same construct and scores between sub-groups of participants (DeVellis \& Thorpe, 2022). This will be established by exploring convergent and divergent validity as well as known group comparisons.
Time frame: Up to 21 days
Internal consistency
Internal consistency reflects how closely items on the IPOS-Liver are related, or measure the same underlying construct.
Time frame: Up to 21 days
Inter-rater reliability
Inter-rater reliability is the degree of agreement between different raters using the IPOS-Liver.
Time frame: Up to 21 days
Content and face validity
The extent to which items reflect the construct being measured.
Time frame: Up to 21 days
Floor and ceiling effects
The percentage of participants (staff or patients) who have either maximum or minimum IPOS-Liver scores will be calculated.
Time frame: Up to 21 days
No study locations are listed for this record.
Plan to share: Yes — Participants will be informed that only anonymised data may be shared with other researchers (i.e. the data set will be shared, but the consent forms linking the name and study identification number will not be shared), this will be facilitated through depositing the data in the University of Hull's Repository.
Supporting information: Analytic code
Time frame: From completion of the study (2028-2029) for 5 years.
Access criteria: Ethically-approved academic and medical research projects in the UK and European Union that have an adequacy decision in place, equivalent data security measures and valid data sharing contracts (in accordance with UK GDPR) will be able to access the fully-anonymised data set.
Start is estimated for Nov 2026; primary completion for Apr 2028, 16 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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