Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension

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.

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.

Conditions