Real-world characterization and differentiation of the Global Initiative for Chronic Obstructive Lung Disease strategy classification

Abstract

David B Price,1 Christine L Baker,2 Kelly H Zou,3 Victoria S Higgins,4 James T Bailey,4 James S Pike4 1University of Aberdeen, Division of Applied Health Sciences, Aberdeen, UK; 2Pfizer Inc, Outcomes and Evidence, Global Health and Value, New York, USA; 3Pfizer Inc, Statistical Center for Outcomes, Real-World and Aggregate Data, Global Innovative Pharma Business, New York, USA; 4Adelphi Real World, Macclesfield, UK Background: This study aimed to characterize and differentiate the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy 2011 cut points through the modified Medical Research Council dyspnea scale (mMRC) and chronic obstructive pulmonary disease (COPD) assessment test (CAT). Methods: Analysis of COPD patient data from the 2012 Adelphi Respiratory Disease Specific Program was conducted in Europe and US. Matched data from physicians and patients included CAT and mMRC scores. Receiver operating characteristic curves and kappa analysis determined a cut point for CAT and mMRC alignment and thus defined patient movement (“movers”) within GOLD groups A–D, depending on the tool used. Logistic regression analysis, with a number of physician- and patient-reported covariates, characterized those movers. Results: Comparing GOLD-defined high-symptom patients using mMRC and CAT cut points (≥2 and ≥10, respectively), there were 890 (53.65%) movers; 887 of them (99.66%) moved from less symptomatic GOLD groups A and C (using mMRC) to more symptomatic groups B and D (using CAT). For receiver operating characteristic (area under the curve: 0.82, P<0.001) and kappa (maximized: 0.45) recommended CAT cut points of ≥24 and ≥26, movers reduced to 429 and 403 patients, respectively. Logistic regression analysis showed variables significantly associated with movers were related to impact on normal life, age, cough, and sleep (all P<0.05). Within movers, direction of movement was significantly associated with the same variables (all P<0.05). Conclusion: Use of current mMRC or CAT cut points leads to inconsistencies for COPD assessment classification. It is recommended that cut points are aligned and both tools administered simultaneously for optimal patient care and to allow for closer management of movers. Our research may suggest an opportunity to investigate a combined score approach to patient management based on the worst result of mMRC and CAT. The reduced number of remaining movers may then identify patients who have greater impact of disease and may require a more personalized treatment plan. Keywords: GOLD classification, mMRC, CAT, cut points, kappa analysis, receiver operating curves