Multicentre development and two-stage validation of a patient-reported outcome measure for chronic obstructive...

Existing patient-reported outcome measures (PROMs) for Chinese patients with chronic obstructive pulmonary disease (COPD) exacerbations have limited conceptual frameworks, uncertain post-COVID-19 validity, and poor clinical interpretability. We conducted a multicenter, two-stage study (pre-pandemic: n = 300; post-pandemic: n = 423) to develop and validate a comprehensive COPD-PROM. The conceptual framework was derived from literature review, expert consultation, and patient interviews. Reliability, validity, and sensitivity were examined, and the minimal clinically important difference (MCID) was established using anchor- and distribution-based methods. The final 52-item COPD-PROM included four domains-physiological, psychological, social, and therapeutic-with Cronbach's α > 0.7 across domains except social. Confirmatory factor analysis indicated acceptable model fit (pre-pandemic: CFI = 0.993, RMSEA = 0.014; post-pandemic: CFI = 0.934, RMSEA = 0.054). The COPD-PROM provides a reliable and interpretable measure of health-related quality of life in COPD, supporting patient-centred assessment and individualized management across healthcare settings.