Point of care microspirometry to facilitate the COPD diagnostic process in primary care: a clustered randomised trial

We studied if pre-bronchodilator FEV₁/FEV₆ determinations with microspirometers by GPs improve the diagnostic process for COPD in a 6-8 month clustered randomised controlled trial in Dutch general practices ( http://www.trialregister.nl : NTR4041). GPs allocated to microspirometry (MI) used COPD-6^® microspirometers in patients ≥50 years old with a smoking history and respiratory complaints that could indicate undiagnosed COPD and ask to refer patients for full spirometry if MI was positive (FEV₁/FEV₆ <0.73). Introduction of the COPD-6^® was postponed in the usual care (UC) group. GPs of both study arms were asked to list all patients that fulfilled study criteria and at the end of the study we screened the electronic medical record system for number of patients that fulfilled study criteria and visited their GP within the study period. Main end point was a documented diagnostic conclusion of COPD within 3 months after the patient's visit. We used multilevel logistic regression with correction for relevant covariates. Next, we described the process of care. 21 practices (88 GPs) participated and 416 possible undiagnosed COPD patient visited these practices in the study period. 78 (of 192 visiting) subjects were listed by MI GPs and diagnostic conclusions were documented in 77%, compared to 61 listed (of 224 visiting) subjects and 44% with documented diagnostic conclusions by UC GPs (Odds Ratio: OR: 4.3, 95%CI: 1.6-11.5). Microspirometry improved the diagnostic process for possible underlying COPD in patients who consulted their GP with respiratory symptoms, but the majority of possible undiagnosed COPD patients remained unrecognised by GPs.