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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAH Patients | Patients diagnosed with pulmonary arterial hypertension participating in a prospective observational study and completing quality of life questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Assessment | Other | Participants complete quality of life questionnaires and clinical data are collected. No therapeutic intervention is applied. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychometric properties of the PAH-QoL scale | 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. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with clinical parameters | Association between quality of life scores and clinical indicators, including WHO functional class and 6-minute walk distance. | Up to 3 months |
| Responsiveness of the PAH-QoL scale |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed with pulmonary arterial hypertension receiving routine clinical care in tertiary hospitals in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Luo | Contact | 13581777615 | luoqin2009@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35998707 | Background | 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. | |
| 27301413 |
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Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. De-identified data may be available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Ability of the scale to detect changes in patient condition over time.
| Baseline to 3 months |
| 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. |
| 37897461 | Background | 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. |