Validity of the portable piko-6 spirometer used for screening obstructive airway diseases in community pharmacy practice

Background: Obstructive airway diseases (OADs) are among the leading causes of morbidity and mortality worldwide. Shortness of breath (SOB) is the main symptom associated with OADs. International guidelines from the Global Initiative for Chronic Lung Disease (GOLD) and the Global Initiative for Asthma (GINA) have recommended spirometry as an indispensable tool for the diagnosis of asthma and chronic obstructive pulmonary diseases (COPD), but spirometry is rarely used in family practice. Simple and reliable diagnostic tools are necessary for screening community patients with onset of OADs for timely management. Purpose: This thesis examined screening utility of the PiKo-6 forced expiratory volume in one second (pFEV₁) , in six second (pFEV₆), and the pRatio ( pFEV₁/pFEV₆) in SOB patients for OADs in community pharmacy settings. FEV₆ has recently been suggested an excellent surrogate for Forced Vital Capacity (FVC), which requires maximum exhalation of the lungs. Methods: Patients with SOB symptoms who were prescribed pulmonary inhalers, by their family physicians, were recruited via community pharmacies. Trained pharmacists collected two PiKo-6 tests to assess the repeatability of the PiKo-6 device. All patients performed laboratory spirometry ( FEV₁, FVC and FEV₁/FVC) to obtain physician diagnosis of their OADs. The results of the PiKo-6 spirometer and laboratory spirometer were compared. In addition, the PiKo-6 pRatio and laboratory FEV₁/FVC were assessed against physician diagnosed COPD. Results: Sixty three patients volunteered to perform the PiKo-6 spirometry. Of these, 52.4 % were men (age 53.9 ± 15.3 years; BMI 31.9 ± 7.40 kg/m2). Repeated testing with pFEV₁, pFEV6 and pRatio correlated significantly (within correlation, r = 0.835, p-Value≤ 0.05 ; 0.872, p- Value≤ 0.05; and 0.664, p-Value≤ 0.05). In addition, pFEV₁, pFEV6 and pRatio correlated significantly with FEV₁, FVC and FEV₁/FVC, respectively (between correlation = 0.630, p- Value≤ 0.05 ; 0.660, p-Value≤ 0.05 and 0.580, p-Value≤ 0.05). The cut-off value corresponding to the greatest sum of sensitivity and specificity of pRatio for physician-diagnosed COPD was <0.80, the sensitivity and specificity were 84 % and 50%, respectively. Conclusions The portable PiKo-6 correlates moderately well with the standard spirometry, when delivered by community pharmacists to patients with OADs. The PiKo-6 spirometer may play a role in screening patients suspected of having an OAD in community pharmacies that may benefit from early physician diagnosis and appropriate management.