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Background: The recent approval of several fixed-dose combination long-acting β2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) products has increased the use of dual bronchodilators in the treatment of chronic obstructive pulmonary disease (COPD). Understanding the comparative safety of this combination is important for informing treatment decisions. Objective: To compare the risk of cardiovascular and cerebrovascular (CCV) events associated with LABA/LAMA compared with a combination of LABA and inhaled corticosteroid (ICS). Methods: This was a retrospective, observational cohort study using health insurance claims data to identify COPD patients initiating LABA/LAMA or LABA/ICS. CCV outcomes included hospitalizations with a primary diagnosis for acute coronary syndrome, heart failure, cardiac dysrhythmia, stroke, or transient ischemic attack. Patients were followed until they experienced an event, discontinued treatment, initiated medication from the opposite cohort, or lost enrollment. Patients were matched 1:4 on propensity scores, and time to event was compared using Cox proportional hazards models. Results: After matching, there were 3842 patients in the LABA/LAMA cohort and 15 225 in the LABA/ICS cohort. Cardiovascular events in the LABA/LAMA cohort were lower than in the LABA/ICS: hazard ratio (HR) = 0.794; 95% CI = 0.623-0.997. No significant difference in the risk of cerebrovascular events (HR = 1.166; 95% CI = 0.653-1.959) was observed. Conclusions: Despite concerns about the CCV effects of LAMA and LABA monotherapy, the LABA/LAMA combination had similar or lower risk of these events in comparison to LABA/ICS. Further studies are recommended to confirm these findings.

Introduction Several dual bronchodilator fixed-dose inhaler medications were recently approved for the treatment of chronic obstructive pulmonary disease (COPD). These products combine a long-acting β2-agonist (LABA) and long-acting muscarinic antagonist (LAMA). In clinical trials, the separate mechanisms of the bronchodilators resulted in improved lung function. COPD treatment guidelines currently recommend combination LABA/LAMA as alternative therapy to combination LABA/inhaled corticosteroid (ICS). Evidence is limited on the comparative effectiveness of LABA/LAMA and LABA/ICS in COPD. The objective of this study was to compare real-world COPD exacerbation rates among patients treated with LABA/LAMA with those treated with LABA/ICS. Methods This was a retrospective observational study of COPD patients in the United States treated with LABA/LAMA or LABA/ICS combination. Insurance claims from January 1, 2004, through December 31, 2014, were used as the data source. Patients were required to have greater than one prescription filled for the combination medications, and they were followed from 30 days after drug initiation. Individuals were censored if they discontinued a study medication, initiated medication from the opposite cohort (LAMA or ICS), lost enrollment eligibility, or at the study period end. Exacerbation rates were compared using Poisson regression. Results There were 5384 patients in the LABA/LAMA cohort and 473,388 patients in the LABA/ICS cohort. The LABA/LAMA cohort was older, had more comorbidities, and more severe COPD. Unadjusted annual exacerbation rates were 2.87 events per person-year (standard deviation [SD] 5.14) in the LABA/LAMA cohort and 1.68 (SD 9.82) in the LABA/ICS cohort. The adjusted incidence rate ratio was 0.98 (95% confidence interval 0.95–1.01) for LABA/LAMA compared with LABA/ICS. Conclusions The LABA/LAMA combination had similar effectiveness to LABA/ICS as measured by exacerbation rates in COPD patients. As a result, characteristics other than effectiveness, such as symptom control, cost, patient preferences, and adverse events, may be important in selecting between the two regimens.

Background Studies indicate that not all physicians in clinical practice use spirometry routinely in the diagnosis of COPD. Understanding the patterns of spirometry use across geographic regions in patients with newly diagnosed COPD may help to identify the factors associated with the use of spirometry and to improve the quality of COPD care. The objective of this study was to characterize the regional variation in spirometry use for patients with newly diagnosed COPD using the Healthcare Effectiveness Data and Information Set (HEDIS) 2006 spirometry performance measure. Methods We identified patients within the Veteran Health Administration who were > 42 years of age who had received a new diagnosis of COPD between July 2003 and June 2004. The date of the COPD diagnosis was the index date. Spirometry use from 760 days prior to the index date to 180 days after the index date was identified. The Veterans Integrated Service Networks (VISNs) was used as the geographic unit for comparison. Results Of the 93,724 patients included in the study, 36.7% underwent spirometry during the study period. Using the largest VISN as the referent, there was more than a threefold difference in the adjusted odds ratios (AORs) for spirometry use between the regions with the lowest use (AOR, 0.52; 95% confidence interval [CI], 0.48 to 0.57) and the highest use (AOR, 1.61; 95% CI, 1.46 to 1.78). Conclusions Overall, the use of spirometry in patients with newly diagnosed COPD was low using the new HEDIS spirometry measure with a significant regional variation comprising a more than threefold difference between the regions with the lowest and highest rates of spirometry use.

Global Initiative on Chronic Obstructive Lung Disease (GOLD) guidelines recently removed stage 0, a group with symptoms but without airways obstruction, from their severity staging. However, in practice this group may still be diagnosed and medically managed. The aim of this study was to characterize healthcare utilization patterns of chronic obstructive pulmonary disease (COPD) patients by disease severity, focusing on the possible unique attributes of patients who would have been classified as GOLD stage 0. This is a prospective cohort pilot study performed at the Hines Veterans Administration Hospital. One hundred twenty patients with a diagnosis of COPD were enrolled. The participants completed quality-of-life questionnaires and a pulmonary function test. Healthcare utilization data were obtained 1 year prior and 2 years after the enrollment date. Three disease severity groups were defined based on GOLD criteria for comparison [GOLD stage 1-2 (GS 1-2), GOLD stage 3-4 (GS 3-4), and formerly GOLD stage 0 ("at risk")]. The "at risk" group had an average of 14.4 (SD = 30.5) outpatient visits/year and 0.3 (SD = 0.8) hospitalizations/year, which were higher than the other groups, but this was not statistically significant. Respiratory medications were used by 6 (26%), 30 (59%), and 40 (91%) patients from "at risk" to GS 3-4, respectively. Patients in the "at risk" group had a decrement in health status, significant utilization of healthcare services, and were often receiving medications not consistent with guidelines.

Spirometry is necessary to diagnose and assess severity of COPD, but is used infrequently. Therapy with inhaled medications can improve COPD outcomes, but are not without risks. The use of spirometry may help mitigate the therapy risks if treatment is appropriate based on spirometry results. Before determining benefits of spirometry use, it is important to examine use of medications and the use of spirometry. Our objective was to characterize the association between the use of spirometry and respiratory medications in newly diagnosed COPD. This is a retrospective, longitudinal study using data from the Department of Veterans Affairs. We identified patients with a new diagnosis of COPD (index date). Spirometry use was measured two years before to six months after the index date. Respiratory medications were measured within one year following the index date. The association between spirometry and medication use was evaluated using logistic regressions and stratified by quintiles of the propensity scores for the probability of having had spirometry performed. A total of 81,162 patients were included and 30.8% had a spirometry performed. Patients with spirometry were more likely to have been dispensed an inhaled corticosteroid (AOR = 1.22 (95% CI, 1.11-1.36) to 1.61 (1.45-1.79)), long-acting beta-agonists (AOR = 1.41(1.25-1.58) to 1.63(1.45-1.83)), and ipratropium bromide (AOR = 1.25(1.16-1.35) to 1.64 (1.49-1.81)) across quintiles. Patients with spirometry were more likely to have medications added. The use of spirometry around a new diagnosis of COPD was associated with higher likelihood of using and adding respiratory medications after diagnosis.

Exacerbations are important disease events for patients with chronic obstructive pulmonary disease (COPD) as they are relatively frequent, result in significant resource use and can indicate worsening disease. Little is known about variation in COPD exacerbation rates across a health system in various geographic regions.To compare COPD exacerbation rates by regional service networks called Veterans Integrated Service Network (VISN) in the Veterans Health Administration (VA) system.Retrospective, observational study.Patients with a COPD diagnosis from October 1999 to September 2000 with follow-up to September 2002.Acute exacerbations of COPD during the baseline and follow-up periods.A total of 198,981 patients were identified. Average exacerbation rate at baseline was 0.503 events per person per year. In the follow-up period, there were 187,686 exacerbations experienced by 87,494 persons (44.0% of cohort). During follow-up, the average adjusted exacerbation rate was 0.589 per person per year and varied from 0.335 (95% CI, 0.328-0.342) in VISN 1 to 0.749 (95% CI, 0.735-0.0.763) in VISN 9. Using the median rate of exacerbation during the baseline period as the referent, 9 VISNs had lower adjusted rate ratios and 12 VISNs had higher adjusted rate ratios in the follow-up period.Geographic variation in the VA VISN system supports evidence that the medical care system including provider factors, and less so patient factors, affect COPD exacerbations. Understanding the reasons underlying this variation in COPD exacerbation rates may lead to improvements in future care and outcomes.

Approximately 20% of patients hospitalized for COPD exacerbations in the United States will be readmitted within 30 days. The Centers for Medicare and Medicaid Services has recently proposed to revise the Hospital Readmissions Reduction Program to financially penalize hospitals with high all-cause 30-day rehospitalization rates after a hospitalization for COPD exacerbation on or after October 1, 2014.To report the results of a systematic review of randomized clinical trials evaluating interventions to reduce the rehospitalizations after COPD exacerbations.Multiple electronic databases were systematically searched to identify relevant studies published between January 1966 and June 2013. Titles, abstracts, and, subsequently, full-text articles were assessed for eligibility. Each study was appraised using predefined criteria.Among 913 titles and abstracts screened, 5 studies (1,393 participants) met eligibility criteria. All studies had a primary outcome of rehospitalization at 6 or 12 months. No study examined 30-day rehospitalization as the primary outcome. Each study tested a different set of interventions. Two studies (one conducted in Canada and one conducted in Spain and Belgium) showed a decrease in all-cause rehospitalization over 12 months in the intervention group versus comparator group (mean number of hospitalizations per patient, 1.0 vs. 1.8; P = 0.01; percent hospitalized, 45 vs. 67%; P = 0.028; respectively). The only study conducted in the United States found a greater than twofold higher risk of mortality in the intervention group (17 vs. 7%, P = 0.003) but no significant difference in rehospitalizations. It was unclear which set of interventions was effective or harmful.The evidence base is inadequate to recommend specific interventions to reduce rehospitalizations in this population and does not justify penalizing hospitals for high 30-day rehospitalization rates after COPD exacerbations.

Guidelines that recommend spirometry to confirm airflow obstruction among patients with suspected COPD are not routinely followed. We conducted a qualitative study to identify attitudes and barriers of primary care physicians to performing spirometry for patients with possible COPD. We conducted four focus groups, each with three primary care physicians (PCPs) who practice in an urban, academic medical center. In general, PCPs believed that spirometry was not necessary to confirm the diagnosis of COPD. Compared to other co-morbid conditions, in a patient with a diagnosis of COPD without self-reported symptoms, COPD was not a priority during a clinic visit. This was in part due to the belief that there was lack of evidence that medication used in COPD lead to improved outcomes and that there was no point of care measure for COPD compared to other co-morbid conditions such as diabetes mellitus or hypertension. Health system barriers specific to spirometry use was not identified. In conclusion, in our sample of PCPs, there was skepticism that spirometry is warranted to diagnose and manage COPD. Availability of spirometry was not a perceived barrier. Our results explain, in part, why previous interventions to improve access to spirometry and diagnosis of COPD in primary care settings have been difficult to conduct and/or have had marginal success. Our findings strongly suggest that a first step toward increasing the use of spirometry among primary care physicians is to have them believe in its utility in the diagnosis of COPD.

Background Objective measurement of airflow obstruction by spirometry is an essential part of the diagnosis of asthma or COPD. During exacerbations, the feasibility and utility of spirometry to confirm the diagnosis of asthma or chronic obstructive pulmonary disease (COPD) are unclear. Addressing these gaps in knowledge may help define the need for confirmatory testing in clinical care and quality improvement efforts. This study was designed to determine the feasibility of spirometry and to determine its utility to confirm the diagnosis in patients hospitalized with a physician diagnosis of asthma or COPD exacerbation. Methods Multi-center study of four academic healthcare institutions. Spirometry was performed in 113 adults admitted to general medicine wards with a physician diagnosis of asthma or COPD exacerbation. Two board-certified pulmonologists evaluated the spirometry tracings to determine the proportion of patients able to produce adequate quality spirometry data. Findings were interpreted to evaluate the utility of spirometry to confirm the presence of obstructive lung disease, according to the 2005 European Respiratory Society/American Thoracic Society recommendations. Results There was an almost perfect agreement for acceptability (κ = 0.92) and reproducibility (κ =0.93) of spirometry tracings. Three-quarters (73%) of the tests were interpreted by both pulmonologists as being of adequate quality. Of these adequate quality tests, 22% did not present objective evidence of obstructive lung disease. Obese patients (BMI ≥30 kg/m2) were more likely to produce spirometry tracings with no evidence of obstructive lung disease, compared to non-obese patients (33% vs. 8%, p = 0.007). Conclusions Adequate quality spirometry can be obtained in most hospitalized adults with a physician diagnosis of asthma or COPD exacerbation. Confirmatory spirometry could be a useful tool to help reduce overdiagnosis of obstructive lung disease, especially among obese patients.

Background To better understand how medications have been used and the complexity of regimens used to treat patients, we characterized patterns of medication use and the degree to which patients used different classes of medications in combination and over time in a cohort of newly diagnosed chronic obstructive pulmonary disease (COPD) patients. Objective The objectives of this study were to characterize patterns of medication use, including the degree to which patients used different classes of medications in combination and over time within a cohort of newly diagnosed COPD patients and to identify the proportion of patients who had gaps in filling their prescriptions. Methods We identified a cohort of patients from the Veterans Affairs health care system with newly diagnosed COPD between 1999 and 2003. Using prescription fill information, we quantified the prevalence and incidence of exposure to short-acting β-agonists (SABAs), long-acting β-agonists (LABAs), short-acting anticholinergics (eg, ipratropium [IPRA]), and inhaled corticosteroids (ICSs) over 1 year. We additionally characterized the sequencing of medication addition and discontinuation and gaps between prescription fills. The prevalence of multiple respiratory medication use was summarized at 90, 180, and 365 days of follow-up. Results Of 133,737 patients with newly diagnosed COPD, the majority (80.0%) used a SABA, followed by 40.0% using IPRA, 33.2% using an ICS and 16.0% using a LABA during the 1-year follow-up. Medication changes were frequent, with 57.7% of patients having a medication addition and 48.6% discontinuing medication. The sequence of medication changes varied greatly across patients. Multiple respiratory medication use was common, with 29% of patients dispensed 3 to 4 medication classes in 1 year. Conclusions Many COPD patients who are started on medication management undergo changes in prescribed pharmacotherapy and are taking multiple medications. Despite clinical practice guidelines, there is an ad hoc nature of COPD medication management, and such heterogeneity challenges the ability to estimate relationships between drug exposure and outcomes using real-world data.

It is unclear if primary care physicians are following guidelines or using other patient characteristics and factors to determine when to perform spirometry in patients at risk for COPD. It is also unclear to what degree a diagnosis of COPD is accurately reflected by spirometry results.To examine characteristics associated with use of spirometry in primary care for patients with increased risk for COPD and to determine the accuracy of COPD diagnosis in patients with spirometry.Retrospective cohort study.A cohort that met the following criteria was identified: ≥35 years of age; ≥ 2 primary care visits in internal medicine clinic in 2007; at least one respiratory or smoking cessation medication, or diagnosis of COPD or shortness of breath or dyspnea in 2007.Medical records of all primary care physician visits prior to the time of inclusion in 2007 were reviewed. Data on patient demographics, co-morbidities, respiratory medication use, presence of symptoms, history of tobacco use, and pulmonary function tests were extracted.A total 1052 patients were identified. Dyspnea on exertion (Adjusted odds ratio (AOR) 1.52 [95% CI 1.06-2.18]) and chronic cough (AOR 1.71 [1.07-2.72]) were the only chronic symptoms associated with use of spirometry. Current (AOR 1.54 [0.99-2.40]) or past smoking (AOR 1.09 [0.72-1.65]) status were not associated with use of spirometry. Of the 159 patients with a diagnosis of COPD, 93 (58.5%) met GOLD criteria and 81(50.9%) met lower limit of normal (LLN) criteria for COPD.Clinicians use spirometry more often among patients with symptoms suggestive of COPD but not more often among patients with current or past tobacco use. For patients who had a spirometry and a diagnosis of COPD, primary care physicians were accurate in their diagnosis only half of the time.

Background Administrative data is often used to identify patients with chronic obstructive pulmonary disease (COPD), yet the validity of this approach is unclear. We sought to develop a predictive model utilizing administrative data to accurately identify patients with COPD. Methods Sequential logistic regression models were constructed using 9573 patients with postbronchodilator spirometry at two Veterans Affairs medical centers (2003-2007). COPD was defined as: 1) FEV1/FVC Results 4564 of 9573 patients (47.7%) had an FEV1/FVC < 0.70. The presence of ≥1 outpatient COPD visit had a sensitivity of 76% and specificity of 67%; the AUC was 0.75 (95% CI 0.74-0.76). Adding the use of albuterol MDI increased the AUC of this model to 0.76 (95% CI 0.75-0.77) while the addition of ipratropium bromide MDI increased the AUC to 0.77 (95% CI 0.76-0.78). The best performing model included: ≥6 albuterol MDI, ≥3 ipratropium MDI, ≥1 outpatient ICD-9 code, ≥1 inpatient ICD-9 code, and age, achieving an AUC of 0.79 (95% CI 0.78-0.80). Conclusion Commonly used definitions of COPD in observational studies misclassify the majority of patients as having COPD. Using multiple diagnostic codes in combination with pharmacy data improves the ability to accurately identify patients with COPD.

Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible. In a patient presenting with respiratory symptoms and risk factors, the recommendation is to perform spirometry to determine the presence of airflow obstruction. However, only about a third of patients with a diagnosis of COPD have spirometry along with their diagnosis, although studies have shown that history and physical examination alone are neither sensitive nor specific for diagnosing COPD. Thus, in current practice, many health care providers continue to diagnose and manage COPD without an accurate diagnosis and assessment of severity based on spirometry. This can contribute to inconsistent care and outcomes, as evidenced by findings of variation in spirometry use and acute exacerbation rates of COPD across geographic regions. As there is increasing evidence that pharmacotherapy for COPD has associated risks, including poor cardiovascular outcomes and pneumonia, it is pertinent to obtain an accurate diagnosis to determine appropriate risk–benefit ratios. Previous studies have shown that spirometry has an impact on COPD management; however, there seem to be barriers to the use of spirometry at the patient, provider, and health system level. Innovative quality improvement approaches, such as the application of the various components of the Chronic Care Model, could improve spirometry use in COPD. Only with accurate diagnosis can appropriate management and evidence-based treatment strategies be applied in practice. Therefore, it is important that we continue efforts to increase the use of spirometry in the diagnosis of COPD.

Background The Patient Reported Outcomes Measurement Information System 43-item short form (PROMIS-43) and the five-level EQ-5D (EQ-5D-5L) are recently developed measures of health-related quality of life (HRQL) that have potentially broad application in evaluating treatments and capturing burden of respiratory-related diseases. The aims of this study were: (1) to examine their psychometric properties in patients with chronic obstructive pulmonary disease (COPD), and (2) to identify dimensions of HRQL that differ and do not differ by lung function. Methods We conducted a multi-center, cross-sectional study (“COPD Outcomes-based Network for Clinical Effectiveness & Research Translation” [CONCERT]). We analyzed patients who met spirometric criteria for COPD, and completed EQ-5D-5L and PROMIS questionnaires. Disease severity was graded based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Pulmonary function test, PROMIS-43, EQ-5D (index score and EQ-Visual Analog Scale [EQ-VAS]), six minute walk test (6MWT), and three dyspnea scales (mMRC, Borg, FACIT-Dyspnea) were administered. Validity and reliability of EQ-5D-5L and PROMIS-43 were examined, and differences in HRQL by GOLD grade were assessed. Results Data from 670 patients with COPD were analyzed (mean age 68.5 years; 58% male). More severe COPD was associated with more problems with mobility, self-care and usual activities (all p-values

Summary Introduction The use of inhaled corticosteroids (ICS) in COPD may be associated with an increased risk of pneumonia. Little is known of this risk in newly diagnosed COPD patients. The objective of this study was to determine if the use of ICS among newly diagnosed COPD patients is associated with an increased risk of pneumonia hospitalizations. Methods Using data from the Department of Veterans Affairs and Centers for Medicare and Medicaid Services, a nested case–control study was performed. We identified patients 65 years of age or older with a new diagnosis of COPD from 1998 to 2002. A total of 145,586 patients were identified. Cases were defined based on hospitalization for pneumonia and exposure was prior use of ICS. Up to 10 controls were matched for each case based on age, sex, month and year of the case. The association between ICS use and pneumonia was evaluated with conditional logistic regression controlling for age, comorbidities, medication classes associated with the risk of pneumonia, and markers of COPD severity. Results There were 13,995 cases of pneumonia. The cohort was predominantly male with an average age of 75.1 (SD = 5.4) years. The rate of pneumonia was 6.4 per 100 person-years. After adjustment for covariates, patients with current use of ICS were 1.38 (95% CI, 1.31–1.45) times more likely to have a hospitalization for pneumonia than those without current use of ICS. Conclusions The use of ICS among patients with newly diagnosed COPD is associated with an increased risk of hospitalization for pneumonia.