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IPOS-Liver Validation Study

Advanced Chronic Liver Disease · Palliative Care · Patient Reported Outcome Measurements

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Accepted
Participants
71 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Live in England
  • Have capacity to give written informed consent to participate in the study, as judged by the clinical team
  • The patient is able to communicate and understand English adequately to complete the IPOS-Liver and provide informed consent (NHS translation services and reading of research documents will be used to support participation for those with limited English or literacy when feasible)
  • Have a diagnosis of ACLD from any underlying aetiology, with at least one of the following clinical scores:
  • Child-Pugh B9
  • UKELD 49
  • BCLC stage C
  • Is expected to be reviewed on two occasions within 5 days as an inpatient, or is being cared for as an outpatient.

Exclusion Criteria:

  • Patients without capacity to consent as judged by the clinical team
  • Patients currently too symptomatic or distressed to participate, as judged by the clinical team
  • Patients unable to understand written and verbal communication in English

Staff members caring for patients will also become participants in the study.

Staff-participant inclusion criteria are:

  • Be a healthcare professional involved with the care of a participant enrolled in the study
  • Have authorised access to the participant's medical notes
  • Give consent to be involved in the study

Study population

Patients at participating locations.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Construct Validity

Time frame: Up to 21 days

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.

Secondary measures

Internal consistency

Time frame: Up to 21 days

Internal consistency reflects how closely items on the IPOS-Liver are related, or measure the same underlying construct.

Inter-rater reliability

Time frame: Up to 21 days

Inter-rater reliability is the degree of agreement between different raters using the IPOS-Liver.

Content and face validity

Time frame: Up to 21 days

The extent to which items reflect the construct being measured.

Floor and ceiling effects

Time frame: Up to 21 days

The percentage of participants (staff or patients) who have either maximum or minimum IPOS-Liver scores will be calculated.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (0)

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No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor
University of Hull
Study start
Nov 5, 2026 Estimated
Primary completion
Apr 1, 2028 Estimated
Study completion
Apr 1, 2028 Estimated
First posted
Nov 10, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

A Longitudinal Observational Psychometric Validation Study of the Integrated Palliative Care Outcome Scale-Liver (IPOS-Liver) in Advanced Chronic Liver Disease.

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026