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.
調査の概要
状態
状態
条件
条件
詳細な説明
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
研究の種類
研究の種類
入学 (推定)
入学
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients at participating locations.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：OTHER
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Construct Validity
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Internal consistency
時間枠：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
時間枠：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
時間枠：Up to 21 days
|
The extent to which items reflect the construct being measured. |
Up to 21 days
|
|
Floor and ceiling effects
時間枠：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
|
協力者と研究者
協力者
協力者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 372666
- 26/EE/0195 (その他の識別子：REC reference)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
From completion of the study (2028-2029) for 5 years.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。