Development and Validation of a Healthcare Utilization-Based Algorithm to Identify Acute Exacerbations of Chronic Obstructive Pulmonary Disease.

Introduction: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are important events that may precipitate other adverse outcomes. Accurate AECOPD event identification in electronic administrative data is essential for improving population health surveillance and practice management. Objective: Develop codified algorithms to identify moderate and severe AECOPD in two US healthcare systems using administrative data and electronic medical records, and validate their performance by calculating positive predictive value (PPV) and negative predictive value (NPV). Methods: Data from two large regional integrated health systems were used. Eligible patients were identified using International Classification of Diseases (Ninth Edition) COPD diagnosis codes. Two algorithms were developed: one to identify potential moderate AECOPD by selecting outpatient/emergency visits associated with AECOPD-related codes and antibiotic/systemic steroid prescriptions; the other to identify potential severe AECOPD by selecting inpatient visits associated with corresponding codes. Algorithms were validated via patient chart review, adjudicated by a pulmonologist. To estimate PPV, 300 potential moderate AECOPD and 250 potential severe AECOPD events underwent review. To estimate NPV, 200 patients without any AECOPD identified by the algorithms (100 patients each without moderate or severe AECOPD) during the two years following the index date underwent review to identify AECOPD missed by the algorithm (false negatives). Results: The PPVs (95% confidence interval [CI]) for both moderate and severe AECOPD were high: 293/298 (98.3% [96.1-99.5]) and 216/225 (96.0% [92.5-98.2]), respectively. NPV was lower for moderate AECOPD (75.0% [65.3-83.1]) than for severe AECOPD (95.0% [88.7-98.4]). Results were consistent across both healthcare systems. Conclusion: This study developed healthcare utilization-based algorithms to identify moderate and severe AECOPD in two separate healthcare systems. PPV for both algorithms was high; NPV was lower for the moderate algorithm. Replication and consistency of results across two healthcare systems support the external validity of these findings.

A retrospective study to assess clinical characteristics and time to initiation of open-triple therapy among patients with chronic obstructive pulmonary disease, newly established on long-acting mono- or combination therapy.

INTRODUCTION: An incremental approach using open-triple therapy may improve outcomes in patients with chronic obstructive pulmonary disease (COPD). However, there is little sufficient, real-world evidence available identifying time to open-triple initiation. METHODS: This retrospective study of patients with COPD, newly initiated on long-acting muscarinic antagonist (LAMA) monotherapy or inhaled corticosteroid/long-acting ß2-agonist (ICS/LABA) combination therapy, assessed baseline demographics, clinical characteristics, and exacerbations during 12 months prior to first LAMA or ICS/LABA use. Time to initiation of open-triple therapy was assessed for 12 months post-index date. Post hoc analyses were performed to assess the subsets of patients with pulmonary-function test (PFT) information and patients with and without comorbid asthma. RESULTS: Demographics and clinical characteristics were similar between cohorts in the pre-specified and post hoc analyses. In total, 283 (19.3%) and 160 (10.9%) patients had moderate and severe exacerbations at baseline, respectively, in the LAMA cohort, compared with 482 (21.3%) and 289 (12.8%) patients in the ICS/LABA cohort. Significantly more patients initiated open-triple therapy in the LAMA cohort compared with the ICS/LABA cohort (226 [15.4%] versus 174 [7.7%]; P<0.001); results were similar in the post hoc analyses. Mean (standard deviation) time to open-triple therapy was 79.8 (89.0) days in the LAMA cohort and 122.9 (105.4) days in the ICS/LABA cohort (P<0.001). This trend was also observed in the post hoc analyses, though the difference between cohorts was nonsignificant in the subset of patients with PFT information. DISCUSSION: In this population, patients with COPD are more likely to initiate open-triple therapy following LAMA therapy, compared with ICS/LABA therapy. Further research is required to identify factors associated with the need for treatment augmentation among patients with COPD.

Survival among COPD patients using fluticasone/salmeterol in combination versus other inhaled steroids and bronchodilators alone.

Recent retrospective studies have suggested that use of inhaled corticosteroids (ICS) may improve survival in chronic obstructive pulmonary disease (COPD), particularly when combined with a long-acting beta-agonist (LABA). However, the study methodologies have been questioned, and no study has examined the survival effect of the newer combination ICS/LABA inhalers. The goal of this project was to further examine the relationship between ICS treatment, with or without LABA, and survival in COPD. COPD patients were identified from the administrative databases of four different integrated health care delivery systems. All patients who were diagnosed with COPD between September 1, 2000 and August 31, 2001 and who had at least 3 months treatment with either a combined fluticasone/salmeterol inhaler (FSI, N=866), any ICS used with a LABA (ICS/LABA, N=525), ICS alone (N=742), LABA alone (N=531), or a short-acting bronchodilator alone (SABD, N=1832), were included. Analyses were conducted using three different analysis approaches that adjust for various biases that may affect the results. In the basic Cox proportional hazards models, use of FSI, ICS/LABA, ICS alone, and LABA alone had significant survival benefits as compared to SABD, after adjustment for differences in age, gender, comorbidities, asthma status, and disease severity (HRs 0.61 [0.45-0.83], 0.59 [0.46-0.77], 0.76 [0.61-0.95], 0.75 [0.57-0.98], respectively). Propensity score matching to reduce the clinical differences between the treatment groups versus the SABD reference group found very similar results. Nested case-control analyses, which are based on survival status instead of treatment, continued to show a significant survival benefit for FSI, ICS/LABA, and ICS alone. Treatment with FSI or another ICS with or without LABA is associated with improved survival in COPD. The treatment benefit is reproducible and is robust to application of a number of different analysis techniques designed to adjust for differences in confounding variables and for bias by indication.