Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire Assessment.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension (PAH), Quality of Life, Patients Reported Outcomes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Validation of a Chinese Patient-Reported Outcome Measure for Quality of Life in Pulmonary Arterial Hypertension Patients
Overview
This study aims to develop and validate a culturally appropriate, reliable, and clinically applicable patient-reported outcome (PRO) instrument to assess quality of life in patients with pulmonary arterial hypertension (PAH) in China. The study includes two phases: (1) scale development using literature review, Delphi expert consultation, and patient interviews; and (2) multicenter prospective observational validation to evaluate reliability, validity, and responsiveness. The final scale is expected to support clinical assessment, treatment monitoring, and health policy decision-making.
Detailed description
This is a multicenter, prospective observational study conducted in China to develop and validate a disease-specific quality of life scale for patients with pulmonary arterial hypertension (PAH).
The study consists of two main stages. The first stage involves item generation and selection based on literature review, expert consensus using the Delphi method, and patient interviews. The second stage includes multicenter validation to assess psychometric properties of the scale.
Participants will complete questionnaires at baseline, 1-2 weeks (for test-retest reliability), and 3 months (for responsiveness). Clinical data such as WHO functional class, 6-minute walk distance, and NT-proBNP will also be collected.
Psychometric evaluation includes internal consistency, construct validity, convergent and discriminant validity, and responsiveness. The study aims to establish a standardized, culturally adapted QoL assessment tool for Chinese PAH patients.
Interventions
- Other Questionnaire Assessment
Participants complete quality of life questionnaires and clinical data are collected. No therapeutic intervention is applied.
Primary outcome measures
- Psychometric properties of the PAH-QoL scale [Time frame: Up to 3 months]
Secondary outcome measures (2)
- Correlation with clinical parameters [Time frame: Up to 3 months]
- Responsiveness of the PAH-QoL scale [Time frame: Baseline to 3 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Diagnosed with pulmonary arterial hypertension
- Able to read and complete questionnaires
- Provided informed consent
Exclusion criteria
- Severe physical condition preventing participation
- History of psychiatric disorders or current use of psychiatric medication
- Pregnancy or lactation
- Any condition preventing completion of questionnaires
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Yarlas A, Mathai SC, Nathan SD, DuBrock HM, Morland K, Anderson N, Kosinski M, Lin X, Classi P. Considerations When Selecting Patient-Reported Outcome Measures for Assessment of Health-Related Quality of Life in Patients With Pulmonary Hypertension: A Narrative Review. Chest. 2022 Nov;162(5):1163-1175. doi: 10.1016/j.chest.2022.08.2206. Epub 2022 Aug 23. PMID 35998707
- McCollister D, Shaffer S, Badesch DB, Filusch A, Hunsche E, Schuler R, Wiklund I, Peacock A; IRB information for the 5 clinical sites. Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT(R)) questionnaire: a new patient-reported outcome instrument for PAH. Respir Res. 2016 Jun 14;17(1):72. doi: 10.1186/s12931-016-0388-6. PMID 27301413
- Rose SW, Highland KB, Kelkar AA. Clinical Utility of Patient-Reported Outcome Instruments in the Management of Pulmonary Hypertension: A Systematic Review. JACC Heart Fail. 2024 Feb;12(2):366-376. doi: 10.1016/j.jchf.2023.09.008. Epub 2023 Oct 25. PMID 37897461
Identifiers
NCT: NCT07570615 · China PAH-QoL Study