Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension
Development and Validation of a Chinese Patient-Reported Outcome Measure for Quality of Life in Pulmonary Arterial Hypertension Patients
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Qin Luo
- Telefonnummer: 13581777615
- E-post: luoqin2009@163.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
PAH Patients
Patients diagnosed with pulmonary arterial hypertension participating in a prospective observational study and completing quality of life questionnaires.
|
Participants complete quality of life questionnaires and clinical data are collected.
No therapeutic intervention is applied.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Psychometric properties of the PAH-QoL scale
Tidsram: 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.
|
Up to 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Correlation with clinical parameters
Tidsram: Up to 3 months
|
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
Tidsram: Baseline to 3 months
|
Ability of the scale to detect changes in patient condition over time.
|
Baseline to 3 months
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- China PAH-QoL Study
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