Validity Study for Clinical Use of Hand-Held Spirometer in Patients with Chronic Obstructive Pulmonary Disease

A spirometer is a medical device frequently used clinically for the diagnosis and prediction of lung disease. This study aimed to investigate the clinical usefulness of a hand-held spirometer (The Spirokit), compared with conventional spirometry in patients with chronic obstructive pulmonary disease (COPD). This study was conducted from February 2022 to October 2022. Measurements from 80 patients with COPD (male: 53, female: 27) were obtained using The Spirokit and PC-based pulmonary function test equipment, and the resulting values were compared and analyzed. For the concurrent validity comparison of The Spirokit, the intra-class correlation (ICC 2, 1), coefficients of variation (CV_ME), 95% limits of agreement (95% LOA), and Cohen's Kappa Index were analyzed. The Spirokit showed high agreement (ICC: 0.929-0.989; 95% LOA: -0.525 to 2.559; and CV_ME: 0.05-0.08) with the PC-based pulmonary function tester. Using the Cohen's kappa coefficients, the device showed high sensitivity, specificity, and accuracy scores of Pa: 0.90, Pc: 0.52, and K: 0.79, respectively, indicating considerable agreement. The Spirokit, a portable pulmonary function test device, is a piece of equipment with high validity and portability, with high potential for replacing PC-based pulmonary function test equipment.