Patients Reported Outcomes, Pulmonary Arterial Hypertension (PAH), Quality of Life
Conditions
Brief summary
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
Participants complete quality of life questionnaires and clinical data are collected. No therapeutic intervention is applied.
Sponsors
Chinese Pulmonary Vascular Disease Research Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychometric properties of the PAH-QoL scale | Up to 3 months | Evaluation of the psychometric properties of the PAH-specific quality of life scale, including internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient), and construct validity assessed by factor analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation with clinical parameters | Up to 3 months | Association between quality of life scores and clinical indicators, including WHO functional class and 6-minute walk distance. |
| Responsiveness of the PAH-QoL scale | Baseline to 3 months | Ability of the scale to detect changes in patient condition over time. |
Contacts
CONTACTQin Luo
Outcome results
None listed