IPOS-Liver Validation Study
A Longitudinal Observational Psychometric Validation Study of the Integrated Palliative Care Outcome Scale-Liver (IPOS-Liver) in Advanced Chronic Liver Disease.
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.
Visão geral do estudo
Status
Status
Condições
Condições
Descrição detalhada
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
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients at participating locations.
Descrição
Inclusion Criteria:
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Live in England
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Have capacity to give written informed consent to participate in the study, as judged by the clinical team
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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)
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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
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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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: OTHER
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Construct Validity
Prazo: Up to 21 days
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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. |
Up to 21 days
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Internal consistency
Prazo: Up to 21 days
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Internal consistency reflects how closely items on the IPOS-Liver are related, or measure the same underlying construct. |
Up to 21 days
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Inter-rater reliability
Prazo: Up to 21 days
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Inter-rater reliability is the degree of agreement between different raters using the IPOS-Liver. |
Up to 21 days
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Content and face validity
Prazo: Up to 21 days
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The extent to which items reflect the construct being measured. |
Up to 21 days
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Floor and ceiling effects
Prazo: Up to 21 days
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The percentage of participants (staff or patients) who have either maximum or minimum IPOS-Liver scores will be calculated. |
Up to 21 days
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- 372666
- 26/EE/0195 (Outro identificador: REC reference)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
From completion of the study (2028-2029) for 5 years.
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- ANALYTIC_CODE
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