A retrospective analysis to identify predictors of COPD-related rehospitalization.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is often associated with recurrent hospitalizations. This study aimed to identify factors related to COPD rehospitalization. METHODS: A national US claims database was used to identify patients, aged ≥40 years, hospitalized for COPD. Their first COPD-related hospital admission date in 2009 was set as the index date, with post-discharge COPD-related rehospitalization assessed for 180 days post-index date. Data were analyzed for: 1) all eligible patients in whom early COPD-related rehospitalization was evaluated (1-30 days post discharge; all-patient cohort) and 2) a patient subset not rehospitalized early in whom late COPD-related rehospitalization was evaluated (>30 days post discharge to 180 days post-index date; late cohort). Logistic regressions controlling for age and sex assessed potential COPD-related rehospitalization predictors. Variables from the 360-day pre-index period and index hospitalization were evaluated for each cohort, and 30-day post-discharge variables evaluated for the late cohort. RESULTS: Of 3612 patients with an index hospitalization, 4.8 % (174) had an early COPD-related rehospitalization, and of the remaining 3438 patients, 13.7 % (471) had a late COPD-related rehospitalization. Several pre-index variables were predictive of early COPD-related rehospitalization including: pneumonia; comorbidities; COPD-related drug therapies; and prior hospitalizations. In patients not rehospitalized early, the strongest predictor of late COPD-related rehospitalization was pre-index COPD-related hospitalization (OR = 3.64 [P < 0.001]). The strongest index hospitalization factors predictive of late COPD-related rehospitalization were use of steroids (any route: OR = 1.62 [P = 0.007]) and nebulizers (OR = 1.65 [P = 0.007]); neither predicted early COPD-related rehospitalization. Generally, factors predicting COPD-related rehospitalization were similar in both cohorts. CONCLUSIONS: Several pre-index variables were associated with COPD-related rehospitalization. A strong predictor of COPD-related rehospitalization was prior hospitalization during the pre-index period, particularly with a primary COPD diagnosis, whilst other predictive factors related to increased COPD severity; these may be useful indicators for COPD-related rehospitalization risk assessment. Some factors, e.g., recurrent pneumonia and exacerbations, may be modifiable.

The epidemiology and treatment of anal fissures in a population-based cohort.

BACKGROUND: Anal fissure (AF) is regarded as a common problem, but there are no published epidemiologic data, nor information on current treatment. The purpose of this study was to examine the incidence, associated comorbidities, and treatment of AF in a population-based cohort. METHODS: We conducted a retrospective analysis of all persons who were enrolled in one large regional managed care system and treated for AF during calendar years 2005-2011. All persons aged 6 years or older who had a clinic, hospitalization, or surgical procedure associated with AF were identified from utilization data. To identify comorbidities associated with AF, each case was matched by age and gender to 3 controls. RESULTS: There were 1,243 AF cases, including 721 (58%) females and 522 (42%) males; 150 (12%) of the cases occurred in children aged 6-17 years. The overall annual incidence was 0.11% (1.1 cases per 1000 person-years), but ranged widely by age [0.05% in patients 6-17 years to 0.18% in patients 25-34 years]. The incidence also varied by sex, and was significantly higher among females 12-24 years, and among males 55-64 years (P < 0.001). Comorbidities associated with AF included chronic constipation (prevalence 14.2% vs 3.6%), hypothyroidism (14.7% vs 10.4%), obesity (13.0% vs 7.7%), and solid tumors without metastasis (5.2% vs 3.7%) (P < 0.001 for all comparisons). A total of 448 were dispensed a topical prescription medication, 31 had botulinum toxin injection, and only 13 had lateral internal sphincterotomy. CONCLUSIONS: AF is a common clinical problem, and the incidence varies substantially by age and sex. Constipation, obesity, and hypothyroidism are associated comorbidities. Most patients are prescribed topical treatments, although it appears that many prescriptions are never filled. Surgical interventions for AF including botulinum toxin and lateral internal sphincterotomy are uncommon.

Disease Burden and Health-Related Quality of Life (HRQoL) of Chronic Obstructive Pulmonary Disease (COPD) in the US - Evidence from the Medical Expenditure Panel Survey (MEPS) from 2016-2019.

Purpose: Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with reduced life expectancy, increased morbidity, mortality, and cost. This study characterized the US COPD burden, including socioeconomic and health-related quality of life (HRQoL) outcomes. Study Design and Methods: In this retrospective, cross-sectional study using nationally representative estimates from Medical Expenditures Survey (MEPS) data (2016-2019), adults (≥18 years) living with and without COPD were identified. Adults living without COPD (control cohort) and with COPD were matched 5:1 on age, sex, geographic region, and entry year. Demographics, clinical characteristics, socioeconomic, and generic HRQoL measures were examined to include a race-stratified analysis of people living with COPD. Results: A total of 4,135 people living with COPD were identified; the matched dataset represented a weighted non-institutionalized population of 11.3 million with and 54.2 million people without COPD. Among people living with COPD, 66.3% had ≥1 COPD-related condition; 62.7% had ≥1 cardiovascular condition, compared to 33.5% and 50.5% without COPD. More people living with COPD were unemployed (56.2% vs 45.3%), unable to work due to illness/disability (30.1% vs 12.1%), had problems paying bills (16.1% vs 8.8%), reported poorer perceived health (fair/poor: 36.2% vs 14.4%), missed more working days due to illness/injury per year (median, 2.5 days vs 0.0 days), and had limitations in physical functioning (40.1% vs 19.4%) (all P<0.0001). In race-stratified analyses for people living with COPD, people self-reporting as Black had higher prevalence of cardiovascular-risk conditions, poorer socioeconomic and HRQoL outcomes, and higher healthcare expenses than White or Other races. Conclusion: Adults living with COPD had higher clinical disease burden, lower socioeconomic status, and reduced HRQoL than those without, with greater disparities among Black people living with COPD compared to White and other races. Understanding the characteristics of patients helps address care disparities and access challenges.

Development of a modified BODE index as a mortality risk measure among older adults with and without chronic obstructive pulmonary disease.

The BODE index was developed as a prognostic mortality risk tool for persons with chronic obstructive pulmonary disease (COPD). It incorporates 4 measures: body mass index, lung obstruction, dyspnea, and exercise capacity. The intent of this study was to examine how well a BODE-like index constructed using a simpler lung function measure, peak expiratory flow, in combination with physical functioning and symptom information more readily found in survey data (a quasi-BODE index), performs in identifying persons at higher risk of mortality and whether it may be extended as an assessment of mortality risk to persons without diagnosed COPD. Using US national survey data from the Health Retirement Study for 2006-2010, each unit increase in the quasi-BODE index score was associated with a multiplicative 50% increase in mortality risk (odds ratio = 1.50, 95% confidence interval: 1.41, 1.59). The quasi-BODE index is a multidimensional health status instrument based on the BODE index, which is a good predictor of mortality. The quasi-BODE index was compiled using simple measures of physical and respiratory function. It is a potentially useful prognostic instrument for older adult populations with or without COPD, including those with severe physical limitations, particularly when combined with demographic factors and comorbid conditions.

National and Local Direct Medical Cost Burden of COPD in the United States From 2016 to 2019 and Projections Through 2029.

BACKGROUND: Despite the significant burden posed by COPD to health care systems, there is a lack of up-to-date information quantifying the general COPD burden, costs, and long-term projections to various stakeholders in the United States. RESEARCH QUESTION: What are the updated state-specific and nationwide estimates of the COPD disease burden and direct costs in 2019, along with projections of COPD-attributable medical costs through 2029? STUDY DESIGN AND METHODS: A cross-sectional, retrospective study design using the 2016 to 2019 Medical Expenditure Panel Survey, 2019 American Community Survey, and 2019 Behavioral Risk Factor Surveillance System data was applied to generate COPD-attributable expenditure estimates. Cost projections for the years 2020 to 2029 were based on 2017 national population projections reported by the US Census Bureau, and all costs were adjusted to 2019 US dollars. RESULTS: In total, 4,135 people living with COPD were included; a higher proportion had other concurrent conditions such as cardiovascular-related conditions compared with people without COPD (n = 86,021). Overall, in 2019, COPD-attributable medical costs after adjusting for demographic characteristics and 19 concurrent conditions (including COPD-related and non-COPD-related conditions) were estimated at $31.3 billion, with state-specific cost estimates reporting wide variation, from $44.8 million in Alaska to $3.1 billion in Florida. Nationwide COPD-attributable medical costs borne by payer type were as follows: private insurance, $11.4 billion; Medicare, $10.8 billion; and Medicaid, $3.0 billion. Projections of national medical costs attributable to COPD are reported to increase to $60.5 billion in 2029. INTERPRETATION: Understanding the current disease and economic burden of COPD in the United States, along with the projected costs attributable to COPD in the next decade, will highlight unmet needs and gaps in care that help inform health care decision-makers in planning future actions to alleviate this disease burden.

Limited lung function: impact of reduced peak expiratory flow on health status, health-care utilization, and expected survival in older adults.

The authors examined whether peak expiratory flow (PEF) is a valid measure of health status in older adults. Survey and test data from the 2006 and 2008 cycles of the Health and Retirement Study, a longitudinal study of US adults over age 50 years (with biennial surveys initiated in 1992), were used to develop predicted PEF regression models and to examine relations between low PEF values and other clinical factors. Low PEF (<80% of predicted value) was prevalent among persons with chronic conditions, including frequent pain, obstructive lung disease, heart disease, diabetes, and psychological distress. Persons with higher physical disability scores had substantially higher adjusted odds of having low PEF, on par with those for conditions known to be associated with poor health (cancer, heart disease, and stroke). In a multivariate regression model for difficulty with mobility, PEF remained an independent factor (odds ratio (OR) = 1.69, 95% confidence interval (CI): 1.53, 1.86). Persons with low PEF in 2006 were more likely to be hospitalized (OR = 1.26, 95% CI: 1.10, 1.43) within the subsequent 2 years and to estimate their chances of surviving for 10 or more years at less than 50% (OR = 1.69, 95% CI: 1.24, 2.30). PEF is a valid measure of health status in older persons, and low PEF is an independent predictor of hospitalization and poor subjective mortality assessment.

Frailty Among Older Individuals with and without COPD: A Cohort Study of Prevalence and Association with Adverse Outcomes.

Rationale: Frailty prevalence estimates among individuals with COPD have varied widely, and few studies have investigated relationships between frailty and adverse outcomes in a COPD population. Objectives: Describe frailty prevalence among individuals with and without COPD and examine associations between frailty and mortality and other adverse outcomes in the next two years. Methods: This was an observational cohort study using Health and Retirement Study data (2006-2018) of community living individuals ages 50-64 and ≥65 with and without COPD (non-COPD). Frailty (Fried phenotype [5 items], and a modified Frailty Index-Comprehensive Geriatric Assessment [Enhanced FI-CGA] [37 items], and debility (modified BODE Index [4 items]) were assessed. Two-year post-assessment outcomes (mortality, ≥1 inpatient stay, home health and skilled nursing facility (SNF) use) were reviewed in a population matched 3:1 (non-COPD: COPD) on age, sex, race, and year using univariate and multivariate logistic regression (adjusted for morbidities). Area-under-the-curve (AUC) was used to evaluate regressions. Results: The study included 18,979 survey observations for age 50-64, and 24,162 age ≥65; 7.8% and 12.0% respectively reporting a diagnosis of COPD. Fried phenotype frailty prevalence for age ≥65 was 23.1% (COPD) and 9.4% (non-COPD), and for the Enhanced FI-CGA, 45.9% (COPD) and 22.4% (non-COPD). Two-year mortality for COPD was more than double non-COPD for age 50-64 (95% CI: 3.8-5.9% vs 0.7-1.3%) and age ≥65 (95% CI: 11.9-14.3% vs 5.6-6.6%). Inpatient utilization, home health care use, or at least temporary SNF placement were also more frequent for COPD. Measures were predictive of adverse outcomes. In adjusted models, the Fried phenotype and modified BODE score performed similarly, and both performed better than the Enhanced FI-CGA index. AUC values were higher for morality regressions. Conclusion: Frailty prevalence among individuals with COPD in this national survey is substantially greater than without COPD, even at pre-retirement (50-64 years). These measures identify patients with increased risk of poor outcomes.

Identifying and characterizing COPD patients in US managed care. A retrospective, cross-sectional analysis of administrative claims data.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death among US adults and is projected to be the third by 2020. In anticipation of the increasing burden imposed on healthcare systems and payers by patients with COPD, a means of identifying COPD patients who incur higher healthcare utilization and costs is needed. METHODS: This retrospective, cross-sectional analysis of US managed care administrative claims data describes a practical way to identify COPD patients. We analyze 7.79 million members for potential inclusion in the COPD cohort, who were continuously eligible during a 1-year study period. A younger commercial population (7.7 million) is compared with an older Medicare population (0.115 million). We outline a novel approach to stratifying COPD patients using "complexity" of illness, based on occurrence of claims for given comorbid conditions. Additionally, a unique algorithm was developed to identify and stratify COPD exacerbations using claims data. RESULTS: A total of 42,565 commercial (median age 56 years; 51.4% female) and 8507 Medicare patients (median 75 years; 53.1% female) were identified as having COPD. Important differences were observed in comorbidities between the younger commercial versus the older Medicare population. Stratifying by complexity, 45.0%, 33.6%, and 21.4% of commercial patients and 36.6%, 35.8%, and 27.6% of older patients were low, moderate, and high, respectively. A higher proportion of patients with high complexity disease experienced multiple (≥2) exacerbations (61.7% commercial; 49.0% Medicare) than patients with moderate- (56.9%; 41.6%), or low-complexity disease (33.4%; 20.5%). Utilization of healthcare services also increased with an increase in complexity. CONCLUSION: In patients with COPD identified from Medicare or commercial claims data, there is a relationship between complexity as determined by pulmonary and non-pulmonary comorbid conditions and the prevalence of exacerbations and utilization of healthcare services. Identification of COPD patients at highest risk of exacerbations using complexity stratification may facilitate improved disease management by targeting those most in need of treatment.

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.

The role of combination inhaled corticosteroid/long-acting beta-agonist therapy in COPD management.

Chronic obstructive pulmonary disease (COPD) is now the fourth leading cause of death, affects an estimated 24 million Americans, and accounts for over ten million physician and emergency department (ED) visits and hospitalisations each year. The diagnosis and management of COPD falls largely to primary care practitioners. Previously, COPD management options were limited, but newer treatments have been shown to slow lung deterioration, reduce symptoms and preserve quality of life. Combination therapy with an inhaled corticosteroid and a long-acting beta2-agonist (ICS/LABA) is an effective therapy for COPD that, compared to other therapies, has been shown to reduce exacerbations, hospitalisations, ED visits and health care costs. This review focuses on the role of combination ICS/LABA therapy in managing COPD, including indications, potential benefits and considerations that affect therapy decisions.

Comparative Causal Analysis of the Effects of Long-Acting Muscarinic Antagonist Versus No Long-Acting Bronchodilator Use on Readmission or Mortality After Hospitalization for Chronic Obstructive Pulmonary Disease.

BACKGROUND: Retrospective observational studies may provide real-world evidence about long-acting muscarinic receptor antagonist (LAMA) effectiveness in reducing mortality or COPD-related readmission risk after a COPD hospitalization. Causal inference and competing risk statistical procedures aid in managing confounding and competing outcome events that complicate retrospective analyses. OBJECTIVE: To compare COPD-related readmission and mortality risk among patients receiving a LAMA versus patients receiving no long-acting bronchodilator ("no LABD") within 30 days post-discharge. METHODS: This retrospective observational analysis of patients (aged ≥ 40 years) hospitalized for COPD used claims data (years 2004-2012). Events occurring during the period from 31 days through 12 months post-discharge were compared. The hazard ratio (HR) for the combined outcome of COPD-related readmission or mortality was estimated using Cox regression. Confounding was addressed using inverse probability of treatment weighting (IPTW). The competing risk of non-COPD-related readmission was considered. RESULTS: 10,405 COPD patients were included (LAMA = 751, no LABD = 9654). IPTW achieved a balanced sample (10,518 LAMA, 10,405 no LABD). Unweighted HR (LAMA vs no LABD) for COPD-related readmission or death, adjusted for age, sex, comorbidities, and baseline utilization, was 1.00 [95% confidence interval (CI) 0.84, 1.20]. Weighted (IPTW) adjusted HR was 0.94 (95% CI 0.88, 1.00). Unweighted and weighted HRs further adjusted for competing risk were 0.97 (95% CI 0.82, 1.16) and 0.91 (0.86, 0.98), respectively. CONCLUSIONS: Bias by indication and comorbidities make the measurement of retrospective COPD treatment effectiveness difficult. Using IPTW and additionally considering the competing event risk, LAMA use was associated with a small reduction in risk for COPD-related readmission or death over the period from 31 days to 12 months post-discharge.

Budesonide/formoterol therapy: effective and appropriate use in asthma and chronic obstructive pulmonary disease.

Aim: Quality, real-world comparative effectiveness (CE) studies of asthma and chronic obstructive pulmonary disease therapy efficacy are scarce. We identified and evaluated peer-reviewed CE and appropriate-use evaluations of budesonide/formoterol combination (BFC) maintenance therapy. Materials & methods: Analyses were limited to retrospective, real-world utilization studies of BFC delivered by pressurized metered-dose inhalers. Results: In a CE study of BFC versus fluticasone/salmeterol combinations (FSC) in asthma, BFC users had fewer total exacerbations. In appropriate-use studies of asthma treatment, BFC patients were consistently more likely to meet treatment escalation recommendations. BFC comparisons with FSC or tiotropium for chronic obstructive pulmonary disease found differences in exacerbation rates and rescue inhaler use. Conclusion: We found available, good quality BFC CE and appropriate-use articles; however, all had limitations.

Burden of concomitant asthma and COPD in a Medicaid population.

BACKGROUND: Asthma and COPD can significantly affect patients and pose a substantial economic burden for both patients and managed-care plans. This study compares utilization outcomes in patients with asthma, COPD, or co-occurring asthma and COPD in a Medicaid population, and assesses the incremental burden of COPD in patients with asthma. METHODS: We queried medical claims of Medicaid patients aged 40 to 64 years with asthma and/or COPD filed between January 1, 2001, and December 31, 2003, from encounter data. COPD patients were identified based on at least one claim with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) codes 491, 492, 496; and asthma patients were identified on the basis of ICD-9 code 493 as diagnosis. We analyzed annual utilization and cost of hospitalizations, physician, and outpatient services attributable to asthma and/or COPD. RESULTS: The analysis included a total of 3,072 asthma, 3,455 COPD, and 2,604 COPD/asthma patients. COPD/asthma co-occurring disease has higher utilization of any service type than either disease alone. Compared with asthma patients, COPD patients were 16% and 51% more likely to use physician (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.01 to 1.34) and inpatient services (OR, 1.51; 95% CI, 1.31 to 1.74), respectively; and 60% less likely to use outpatient services (OR, 0.40; 95% CI, 0.35 to 0.46). Compared with asthma patients, COPD patients and COPD/asthma co-occurring patients cost 50% (OR, 1.50; 95% CI, 1.3 to 1.74) and five times (OR, 5.25; 95% CI, 4.59 to 6.02) more for total medical services, respectively. CONCLUSION: Our data suggest that patients with COPD and co-occurring COPD/asthma were sicker and used more medical services than asthma patients. The incremental burden of COPD to patients with asthma is significant.

The direct medical costs of undiagnosed chronic obstructive pulmonary disease.

OBJECTIVE: To estimate the costs of undiagnosed chronic obstructive pulmonary disease (COPD) by describing inpatient, outpatient, and pharmacy utilization in the years before and after the diagnosis. METHODS: A total of 6,864 patients who were enrolled in the Lovelace Health Plan for at least 12 months during the study period (January 1, 1999 through December 31, 2004) were identified. The first date that utilization was attributed to COPD was considered the first date of diagnosis. Each COPD case was matched to up to three age- and sex-matched controls. All utilization and direct medical costs during the study period were compiled monthly and compared based on the time before and after the initial diagnosis. RESULTS: Total costs were higher by an average of $1,182 per patient in the 2 years before the initial COPD diagnosis, and $2,489 in the 12 months just before the initial diagnosis, compared to matched controls. Most of the higher cost for undiagnosed COPD was attributable to hospitalizations. Inpatient costs did not increase after the diagnosis was made, but approximately one-third of admissions after the diagnosis were attributed to respiratory disease. Outpatient and pharmacy costs did not differ substantially between cases and matched controls until just a few months before the initial diagnosis, but remained 50% to 100% higher than for controls in the 2 years after diagnosis. CONCLUSIONS: Undiagnosed COPD has a substantial impact on health-care costs and utilization in this integrated managed care system, particularly for hospitalizations.

A comparison of health-care costs in patients with chronic obstructive pulmonary disease using lightweight portable oxygen systems versus traditional compressed-oxygen systems.

BACKGROUND: Lightweight portable oxygen systems are commonly preferred by patients over compressed-oxygen systems that use E-size cylinders. However, cost is often perceived as a barrier to the prescription of lightweight portable oxygen systems. OBJECTIVE: To compare the overall health-care costs of patients with COPD who used lightweight portable oxygen systems to those who used E-cylinder systems. METHODS: All the patients who used either a lightweight portable oxygen system, an E-cylinder system, or an E-cylinder system, then a lightweight portable oxygen system, for at least 12 months during the study period (January 1, 1999, to December 30, 2004) were identified from the administrative database of our regional managed-care system. All direct medical utilization and costs were captured for at least the first 12 months that supplemental oxygen was dispensed. Other clinical factors that affect costs (including age, sex, ethnicity, and comorbidities) were examined and adjusted for. RESULTS: Of the 2,725 patients who met the inclusion criteria, 203 used only a lightweight portable oxygen system, 2,268 used only an E-cylinder system, and 254 switched from an E-cylinder system to a lightweight portable oxygen system. Among the patients who used only the lightweight portable oxygen system, the median total medical costs in the first year were nonsignificantly lower than those who used an E-cylinder system ($6,515/y vs $9,503/y). The cost difference remained nonsignificant after adjustment for clinical factors. Among the patients who switched from one system to the other in the first year, mean monthly health-care costs while using the lightweight portable oxygen system ($1,428) were not significantly different than when using the E-cylinder system ($1,396). CONCLUSIONS: The type of oxygen system used did not significantly affect overall cost of care in patients with COPD on long-term oxygen therapy.

COPD as a lung disease with systemic consequences--clinical impact, mechanisms, and potential for early intervention.

The natural course of chronic obstructive pulmonary disease (COPD) is complicated by the development of systemic consequences and co-morbidities. These may be major features in the clinical presentation of COPD, prompting increasing interest. Systemic consequences may be defined as non-pulmonary manifestations of COPD with an immediate cause-and-effect relationship, whereas co-morbidities are diseases associated with COPD. The major systemic consequences/co-morbidities now recognized are: deconditioning, exercise intolerance, skeletal muscle dysfunction, osteoporosis, metabolic impact, anxiety and depression, cardiovascular disease, and mortality. The mechanisms by which these develop are unclear. Probably many factors are involved. Two appear of paramount importance: systemic inflammation, which presents in some patients with stable disease and virtually all patients during exacerbations, and inactivity, which may be a key link to most COPD-related co-morbidities. Further studies are required to determine the role of inflammatory cells/mediators involved in systemic inflammatory processes in causing co-morbidities; the link between activity and co-morbidities; and how COPD therapy may affect activity. Both key mechanisms appear to be influenced significantly by COPD exacerbations. Importantly, although the prevalence of systemic consequences increases with increasing severity of airflow obstruction, both systemic consequences and co-morbidities are already present in the Global Initiative for Chronic Obstructive Lung Disease Stage II. This supports the concept of early intervention in chronic obstructive pulmonary disease. Although at present early intervention studies in COPD are lacking, circumstantial evidence suggests that current treatments may influence events leading to the systemic consequences and co-morbidities, and thus may affect the clinical manifestations of the disease.

Claims-based risk model for first severe COPD exacerbation.

OBJECTIVES: To develop and validate a predictive model for first severe chronic obstructive pulmonary disease (COPD) exacerbation using health insurance claims data and to validate the risk measure of controller medication to total COPD treatment (controller and rescue) ratio (CTR). STUDY DESIGN: A predictive model was developed and validated in 2 managed care databases: Truven Health MarketScan database and Reliant Medical Group database. This secondary analysis assessed risk factors, including CTR, during the baseline period (Year 1) to predict risk of severe exacerbation in the at-risk period (Year 2). METHODS: Patients with COPD who were 40 years or older and who had at least 1 COPD medication dispensed during the year following COPD diagnosis were included. Subjects with severe exacerbations in the baseline year were excluded. Risk factors in the baseline period were included as potential predictors in multivariate analysis. Performance was evaluated using C-statistics. RESULTS: The analysis included 223,824 patients. The greatest risk factors for first severe exacerbation were advanced age, chronic oxygen therapy usage, COPD diagnosis type, dispensing of 4 or more canisters of rescue medication, and having 2 or more moderate exacerbations. A CTR of 0.3 or greater was associated with a 14% lower risk of severe exacerbation. The model performed well with C-statistics, ranging from 0.711 to 0.714. CONCLUSIONS: This claims-based risk model can predict the likelihood of first severe COPD exacerbation. The CTR could also potentially be used to target populations at greatest risk for severe exacerbations. This could be relevant for providers and payers in approaches to prevent severe exacerbations and reduce costs.

Survival of COPD patients using inhaled corticosteroids and long-acting beta agonists.

We conducted a historical cohort study to examine the relationship between survival and use of inhaled corticosteroids (ICS) and/or long-acting beta agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD). All COPD patients aged 40 years who were enrolled in one of two regional managed care organizations during 1995-2000, and who had 90 days use of an ICS and/or LABA (N=1288) or of a short-acting bronchodilator (N=397), were identified. Of patients treated with ICS and/or LABA, 14.4% died during the follow-up period, as compared to 28.2% of comparison patients (P<0.01). In a Cox proportional hazards model that controlled for age, sex, comorbidities, COPD severity, and asthma status, a reduced risk of death was found for ICS treatment (HR 0.59 [95% CI 0.46-0.78]), LABA (HR 0.55 [0.34-0.89]), and ICS plus LABA treatment (HR 0.34 [0.21-0.56]). A second model that excluded any patient who also had an ICD-9 code for asthma (N=840) still found improved survival among those using the combination of ICS plus LABA (HR 0.35 [CI 0.17-0.71]). Additional analyses that varied the exposure criteria also found a consistent treatment benefit. Inclusion of ICS or bronchodilator treatment during the follow-up period as a time-dependent function appears to negate the survival benefit; however, the underlying assumptions for valid time-dependent modeling are clearly violated in this situation. In conclusion, we found that COPD patients who used ICS alone or in combination with LABA had substantially improved survival even after adjustment for asthma and other confounding factors.

An algorithm for the identification of undiagnosed COPD cases using administrative claims data.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major cause of death in the United States, but most persons who have airflow obstruction have never been diagnosed with lung disease. This undiagnosed COPD negatively affects health status, and COPD patients may have increased health care utilization several years before the initial diagnosis of COPD is made. OBJECTIVE: To investigate whether utilization patterns derived from analysis of administrative claims data using a discriminant function algorithm could be used to identify undiagnosed COPD patients. METHODS: Each patient who had a new diagnosis of COPD during the study period (N = 2,129) was matched to as many as 3 control subjects by age and gender. Controls were assigned an index date that was identical to that of the corresponding case, and then all health care utilization for cases and controls for the 24 months prior to the initial COPD diagnosis was compared using logistic regression models. Factors that were significantly associated with COPD were then entered into a discriminant function algorithm. This algorithm was then validated using a separate patient population. RESULTS: In the main model, 19 utilization characteristics were significantly associated with preclinical COPD, although most of the power of the discriminant function algorithm was concentrated in a few of these factors. The main model was able to identify COPD patients in the validation population of adult subjects aged 40 years and older (N = 41,428), with a sensitivity of 60.5% and specificity of 82.1%, even without having information on the history of tobacco use for the majority of the group. Models developed and tested on only 12 months of utilization data performed similarly. CONCLUSION: Discriminant function algorithms based on health care utilization data can be developed that have sufficient positive predictive value to be used as screening tools to identify individuals at risk for having undiagnosed COPD.

Validation of a New Risk Measure for Chronic Obstructive Pulmonary Disease Exacerbation Using Health Insurance Claims Data.

RATIONALE: Current chronic obstructive pulmonary disease (COPD) exacerbation risk prediction models are based on clinical data not easily accessible to national quality-of-care organizations and payers. Models developed from data sources available to these organizations are needed. OBJECTIVES: This study aimed to validate a risk measure constructed using pharmacy claims in patients with COPD. Administrative claims data were used to construct a risk model to test and validate the ratio of controller (maintenance) medications to total COPD medications (CTR) as an independent risk measure for COPD exacerbations. The ability of the CTR to predict the risk of COPD exacerbations was also assessed. METHODS: This was a retrospective study using health insurance claims data from the Truven MarketScan database (2006-2011), whereby exacerbation risk factors of patients with COPD were observed over a 12-month period and exacerbations monitored in the following year. Exacerbations were defined as moderate (emergency department or outpatient treatment with oral corticosteroid dispensings within 7 d) or severe (hospital admission) on the basis of diagnosis codes. Models were developed and validated using split-sample data from the MarketScan database and further validated using the Reliant Medical Group database. The performance of prediction models was evaluated using C-statistics. MEASUREMENTS AND MAIN RESULTS: A total of 258,668 patients with COPD from the MarketScan database were included. A CTR of greater than or equal to 0.3 was significantly associated with a reduced risk for any (adjusted odds ratio [OR], 0.91; 95% confidence interval [CI], 0.85-0.97); moderate (OR, 0.93; 95% CI, 0.87-1.00), or severe (OR, 0.87; 95% CI, 0.80-0.95) exacerbation. The CTR, at a ratio of greater than or equal to 0.3, was predictive in various subpopulations, including those without a history of asthma and those with or without a history of moderate/severe exacerbations. The C-statistics ranged from 0.750 to 0.761 for the development set and 0.714 to 0.761 in the validation sets, indicating the CTR performed well in predicting exacerbation risk. CONCLUSIONS: The ratio of controller to total medications dispensed for COPD is a measure that can easily be calculated using only pharmacy claims data. A CTR of greater than or equal to 0.3 can potentially be used as a quality-of-care measurement for prevention of exacerbations.