2012 OPEN FORUM Abstracts
USE OF ROUTINE SCREENING TOOLS FOR EARLY IDENTIFICATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE IN PRIMARY CARE PRACTICES: A RANDOMIZED CLUSTER DESIGN CLINICAL TRIAL.
Barbara Yawn1, Heather Paden2, Ahmar Iqbal3, Stephen Koval2; 1Department of Research, Olmsted Medical Center, Rochester, MN; 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT; 3Pfizer Inc, New York, NY
Background: COPD is the third cause of death in the US. COPD prevalence is largely underestimated, as many individuals only seek medical help at the latter stages of disease, when symptoms are intolerable. Although primary care physicians are in a key position to identify symptoms early, make a diagnosis, and instigate treatment, it is estimated that 5685% of subjects are undiagnosed. The COPD-Population screener (COPD-PS), a validated five-item screening tool, identifies at-risk subjects. Also, use of hand-held spirometric devices, such as the copd-6, is advocated for case-finding in subjects with airway obstruction. The SEARCH trial was designed to determine if routine screening could bridge the gap between diagnosed and undiagnosed COPD cases in real-life primary care settings. Method: This prospective, cluster-randomized, controlled trial included 168 primary care sites in nine US regions. Sites were randomized to three arms that evaluated the effectiveness of the COPD-PS alone (Arm 2) or in combination with the copd-6 (Arm 1) vs usual care (Arm 3). Sites were blinded to the other arms and did not receive extra training on COPD diagnosis. Subjects, aged =40 years, attending a scheduled visit were consecutively recruited. Subjects completed the COPD-PS (Arms 1 and 2 only) and those with scores =5 performed the copd-6 (Arm 1 only). The screening results were given to the primary care physicians. The primary endpoint was a new diagnosis of COPD by the primary care physicians within 8 weeks of the initial visit, as documented in the subjects medical records. Results: 8770 subjects with no prior diagnosis of COPD: 2871 (Arm 1); 2999 (Arm 2); and 2900 (Arm 3) were included in the study. 119 subjects had a new COPD diagnosis within 8 weeks of initial visit: 52 (Arm 1); 45 (Arm 2); and 22 (Arm 3). Comorbidities were more frequent in subjects with vs without a prior COPD diagnosis. Rates of new COPD diagnosis within 8 weeks of initial visit were statistically significantly higher in both Arms 1 and 2 vs Arm 3 (Figure). Combined use of the COPD-PS and copd-6 resulted in the highest rates of new COPD diagnoses vs usual care. Conclusions: This is the first prospective study demonstrating the effectiveness of screening tools that increased COPD diagnosis in a real-life setting using a randomized control approach. The two intervention arms were effective in increasing the rate of diagnosed COPD cases compared with usual care, which may aid earlier diagnosis. Sponsored Research - Boehringer Ingelheim Pharmaceuticals, Inc. Pfizer Inc