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.
研究概览
详细说明
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
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients at participating locations.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：OTHER
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Construct Validity
大体时间：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. |
Up to 21 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Internal consistency
大体时间：Up to 21 days
|
Internal consistency reflects how closely items on the IPOS-Liver are related, or measure the same underlying construct. |
Up to 21 days
|
|
Inter-rater reliability
大体时间：Up to 21 days
|
Inter-rater reliability is the degree of agreement between different raters using the IPOS-Liver. |
Up to 21 days
|
|
Content and face validity
大体时间：Up to 21 days
|
The extent to which items reflect the construct being measured. |
Up to 21 days
|
|
Floor and ceiling effects
大体时间：Up to 21 days
|
The percentage of participants (staff or patients) who have either maximum or minimum IPOS-Liver scores will be calculated. |
Up to 21 days
|
合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 372666
- 26/EE/0195 (其他标识符：REC reference)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
IPD 共享时间框架
From completion of the study (2028-2029) for 5 years.
IPD 共享访问标准
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.
IPD 共享支持信息类型
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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