Abstract Background The current state of chronic obstructive pulmonary disease (COPD) management in clinical practice is unsatisfactory. The objective of the Quality Improvement Program (QIP) study is to address key gaps in management of patients with high-risk through a targeted quality improvement programme in a healthcare system or practice. Methods A interventional, cluster-randomized, pragmatic clinical study was conducted in China from 2023 to 2025. A total of 41 hospitals were selected. Among them, 40 eligible hospitals were randomized into the intervention group with implementation of COPD Quality Standard (QS) bundle or control group at the ratio of 1:1. The leading site were assigned to the intervention group without following the randomization procedure. Patients diagnosed with COPD (post-FEV1/FVC 0.7) who had FEV1%pred ≥ 25%, COPD Assessment Test (CAT) ≥ 10 and exacerbation history were recruited. Eligible patients were recruited in both groups and followed up every 12 weeks for 48 weeks. Efficacy was analysed in the full analysis set (FAS), defined as all subjects in randomized hospitals with at least one post-baseline efficacy measurement. Sensitivity analysis were conducted among all enrolled subjects who had at least one post-baseline efficacy data assessment. A mixed-effects model for repeated measures was fitted to the change in FEV₁ and CAT score from baseline, and a generalized linear mixed model (GLMM) was used to analyse moderate-to-severe COPD exacerbations. Centre level (grade 2/3), geographic region (East/West/South/North/Central), exacerbation history, baseline CAT score and baseline trough FEV₁ were included as covariates. Results Among 1,055 enrolled patients, 485 patients in the QS group and 504 in the control group were included in FAS. The change from baseline in trough FEV1 in QS group was significantly greater than in control group over 36 weeks (Least Squares LS mean of differences, 60 mL, p=0.042), but not over 48 week (LS mean of differences, 45 mL, p=0.124) (Figure 1). The change from baseline in CAT in QS group was greater than in control group over 48 weeks (LS mean of differences, -3.61, p0.001). The implementation of QS was associated with a significantly lower annualized rate of moderate or severe exacerbations (0.53 vs. 0.86, RR 0.59, 95% CI 0.50,0.70, p0.0001). Sensitivity analyses yielded consistent results. Conclusion Systematic implementation of a COPD QS bundle profoundly reduces moderate-to-severe exacerbations by 41% while sustainably improving symptoms. Widespread adoption of this practice-level strategy can effectively bridge evidence-to-practice gaps and substantially improve outcomes for high-risk COPD patients in China. This abstract is funded by: AstraZeneca China
Wang et al. (Fri,) studied this question.