Abstract Background Simplified spirometry may identify spirometric chronic obstructive pulmonary disease (COPD) with high accuracy, but its use must be clinically validated in large-scale real-world community populations. We aim to evaluate the clinical performance of simplified spirometry for spirometric COPD screening in primary care settings. Methods We designed a prospective, multisite, observational, diagnostic accuracy study recruiting community-dwelling adults aged 20 years or older in China. Participants completed a COPD screening questionnaire followed by prebronchodilator simplified spirometry and postbronchodilator routine spirometry. Routine spirometry was defined as three maneuvers that meet the criteria for acceptability and reproducibility criteria according to the international technical standards. Simplified spirometry requires only the first acceptable maneuvers. Spirometric COPD was defined as a postbronchodilator FEV1/FVC 0.70. Sensitivity analysis was performed using FEV1/FVC LLN and clinical COPD as the diagnostic standard. Subgroup analyses were performed by age, sex, body mass index, smoking status, and presence of chronic respiratory symptoms. The primary outcome was the discriminative accuracy of prebronchodilator simplified spirometry in identifying spirometric COPD, measured by the area under the receiver operating characteristic curve (AUROC). Secondary outcomes included the area under the precision recall curve (AUPRC), sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and consistence and correlation between simplified and routine spirometry indicators. Findings Among 141,118 participants, 7,423 (5.3%) met the criteria for spirometric COPD, 1696 (1.2%) met the criteria for clinical COPD, 45.5% were men, and 69.9% were never-smokers (mean age 47.1 ± SD 13.3 years). Prebronchodilator simplified spirometry demonstrated high discriminative accuracy for identifying spirometric COPD (AUROC=0.987, 95% CI: 0.987-0.988; AUPRC=0.891, 95% CI: 0.883-0.898). Using prebronchodilator simplified spirometry FEV1/FVC0.70 as the positive screening criterion, accuracy was 96.4% (95% CI: 96.3%-96.5%), sensitivity was 93.0% (95% CI: 92.4%-93.6%), specificity was 96.6% (95% CI: 96.5%-96.7%), NPV was 99.6% (95% CI: 99.6%-99.7%), and PPV was 60.0% (95% CI: 59.2%-61.0%). Simplified and routine spirometry indicators were highly correlated and consistent. The results were maintained in sensitivity and subgroup analyses. Interpretations In primary care settings, prebronchodilator simplified spirometry demonstrated high accuracy for identifying spirometric COPD and clinical COPD. Further research is needed to evaluate whether implementation of simplified spirometry screening for COPD is associated with improved respiratory outcomes. This abstract is funded by: the Foundation of Guangzhou National Laboratory (SRPG22-016 and SRPG22-018)
Wu et al. (Fri,) studied this question.