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.

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.

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.

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.

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.

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.

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.

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.

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.

Application of the new GOLD COPD staging system to a US primary care cohort, with comparison to physician and patient impressions of severity.

BACKGROUND: In 2011, the traditional Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD spirometry-based severity classification system was revised to also include exacerbation history and COPD Assessment Test (CAT) and modified Medical Research Council Dyspnea Scale (mMRC) scores. This study examined how COPD patients treated in primary care are reclassified by the new GOLD system compared to the traditional system, and each system's level of agreement with patient's or physician's severity assessments. METHODS: In this US multicenter cross-sectional study, COPD patients were recruited by 83 primary care practitioners (PCPs) to complete spirometry testing and a survey. Patients were classified by the traditional spirometry-based system (stages 1-4) and under the new system (grades A, B, C, D) using spirometry, exacerbation history, mMRC, and/or CAT results. Concordance between physician and patient-reported severity, spirometry stage, and ABCD grade based on either mMRC or CAT scores was examined. RESULTS: Data from 445 patients with spirometry-confirmed COPD were used. As compared to the traditional system, the GOLD mMRC system reclassifies 47% of patients, and GOLD CAT system reclassifies 41%, but the distributions are very different. The GOLD mMRC system resulted in relatively equal distributions by ABCD grade (33%, 22%, 19%, 26%, respectively), but the GOLD CAT system put most into either B or D groups (9%, 45%, 4%, and 42%). The addition of exacerbation history reclassified only 19 additional patients. Agreement between PCPs' severity rating or their patients' self-assessment and the new ABCD grade was very poor (κ=0.17 or less). CONCLUSION: As compared to the traditional system, the GOLD 2011 multidimensional system reclassified nearly half of patients, but how they were reclassified varied greatly by whether the mMRC or CAT questionnaire was chosen. Either way, the new system had little correlation with the PCPs or their patients' impressions about the COPD severity.

The impact of chronic pain on direct medical utilization and costs in chronic obstructive pulmonary disease.

OBJECTIVE: To examine how pain affects health care utilization and direct medical costs in individuals with chronic obstructive pulmonary disease (COPD) compared to patients with other chronic diseases. STUDY DESIGN: A retrospective cohort analysis using administrative data of a managed health care system in the Southwestern US for years 2006-2010. METHODS: COPD patients age ≥40 years were matched to similar patients with other chronic conditions on age, sex, insurance type, and a health care event (outpatient visit, emergency department visit, or inpatient stay). Chronic pain was indicated by pain-associated diagnoses and procedures, or fills for prescription pain medications. The study population was also stratified into those with and without chronic pain to examine clinical factors and costs associated with chronic pain. RESULTS: Seven thousand nine hundred and fifty-two COPD patients (mean age 69 years, 58% women) were matched to 15,904 patients with other chronic disease. COPD patients had significantly higher utilization for pain-related services and for overall services. COPD patients had a higher prevalence of any pain medication use over a 12-month period (41.2% versus 31.5%) and, among those using pain medications, a higher mean number of pain medication prescription fills (10.1 versus 6.4). Factors associated with chronic pain included age 40-65 years, being female, having more than one chronic morbidity, insurance type, some emergency department or hospital utilization, and having either COPD, heart failure, arthritis, or stroke. Among COPD patients, those with chronic pain had a mean annual direct cost for overall utilization of $24,261 versus $10,390 among those without chronic pain (P<0.0001 for all comparisons). CONCLUSION: COPD patients have substantially more utilization for pain medications and pain-related procedures than those with most other chronic diseases. Total direct medical costs among COPD patients who have chronic pain are more than double those of COPD patients without chronic pain. Pain management may be an opportunity for better and more cost-effective care for COPD patients.

Clinical factors, including All Patient Refined Diagnosis Related Group severity, as predictors of early rehospitalization after COPD exacerbation.

BACKGROUND: Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations carry a high risk for early rehospitalization. We wished to identify the basic clinical factors associated with a high risk of rehospitalization, and to see how well the standardized All Patient Refined Diagnosis Related Group (APR-DRG) severity of illness (SOI) subclassification predicted rehospitalization if combined with other simple clinical measures. METHODS: We identified adult patients aged ≥40 years discharged from a major hospital in the Southwestern USA with a COPD discharge diagnosis during the study index period (1 October 2009 to 30 September 2010). Patients readmitted within 30 days ("early rehospitalization") and 90 days ("any rehospitalization") were each compared with those not rehospitalized. Clinical parameters (including demographics, comorbidities) and recent healthcare utilization were examined for their association with rehospitalization. Factors independently associated with rehospitalization were then combined with the index admission APR-DRG SOI assessment using conditional linear regression to find the best models in terms of the highest C-statistic. RESULTS: Among 306 patients hospitalized for COPD, 62 (20.3%) had a rehospitalization within 90 days and 28 (9.2%), an early readmission. An APR-DRG SOI subclassification ≥3 was a modest independent predictor of early or any readmission, with adjusted odds ratios ranging from 2.09 to 3.33. Models that combined the APR-DRG SOI subclassification with clinical factors present before the index hospitalization had strong C-statistics of ≥0.80. Good models without the APR-DRG SOI subclassification but including a history of recent hospitalizations before the index hospitalization were also identified. CONCLUSIONS: An APR-DRG SOI subclassification of ≥3 for the index COPD admission is associated with an increased risk of early rehospitalizations, and can be combined with a few historical clinical factors to create strong predictive models for rehospitalization. This study demonstrates that hospitals can use commonly collected clinical information to help identify COPD patients at a high risk of failure after discharge.

A clinical study of COPD severity assessment by primary care physicians and their patients compared with spirometry.

PURPOSE: Primary care physicians often do not use spirometry to confirm the diagnosis of chronic obstructive pulmonary disease. This project was designed to see how well physicians' impressions about their patients' chronic obstructive pulmonary disease severity correlate with the severity of airflow obstruction measured by spirometry and to assess whether spirometry results subsequently changed the physicians' opinions about chronic obstructive pulmonary disease severity and treatment. METHODS: We performed a multicenter, cross-sectional, observational study conducted in 83 primary care clinics from across the United States. A total of 899 patients with a clinical diagnosis of chronic obstructive pulmonary disease completed a questionnaire and spirometry testing. Physicians completed a questionnaire and case report forms. Concordance among physician ratings, patient ratings, and spirometry results was evaluated. RESULTS: Physicians' chronic obstructive pulmonary disease severity ratings before spirometry were accurate for only 30% of patients with evaluable spirometry results, and disease severity in 41% of patients was underestimated. Physicians also underestimated severity compared with patients' self-assessment among 42% of those with evaluable results. After spirometry, physicians changed their opinions on the severity for 30% of patients and recommended treatment changes for 37%. Only 75% of patients performed at least 1 high-quality spirometry test; however, the physicians' opinions and treatment decisions were similar regardless of suboptimal test results. CONCLUSIONS: Without performing spirometry, physicians are likely to underestimate their patients' chronic obstructive pulmonary disease severity or inadequately characterize their patients' lung disease. Spirometry changed the physicians' clinical impressions and treatments for approximately one third of these patients; thus, spirometry is a valuable tool for chronic obstructive pulmonary disease management in primary care.

Severe COPD Exacerbation Risk and Long-Acting Bronchodilator Treatments: Comparison of Three Observational Data Analysis Methods.

OBJECTIVE: Results from three observational methods for assessing effectiveness of long-acting bronchodilator therapies for reducing severe exacerbations of chronic obstructive pulmonary disease (COPD) were compared: intent-to-treat (ITT), as protocol (AP), and an as-treated analysis that utilized a marginal structural model (MSM) incorporating time-varying covariates related to treatment adherence and moderate exacerbations. STUDY DESIGN AND SETTING: Severe exacerbation risk was assessed over a 2-year period using claims data for patients aged ≥40 years who initiated long-acting muscarinic antagonist (LAMA), inhaled corticosteroid/long-acting beta-agonist (ICS/LABA), or triple therapy (LAMA + ICS/LABA). RESULTS: A total of 5475 COPD patients met inclusion criteria. Six months post-initiation, 53.5 % of patients discontinued using any therapy. The ITT analysis found an increased severe exacerbation risk for triple therapy treatment (hazard ratio [HR] 1.24; 95 % confidence interval [CI] 1.00-1.53). No increased risk was found in the AP (HR 1.00; 95 % CI 0.73-1.36), or MSM analyses (HR 1.11; 95 % CI 0.68-1.81). The MSM highlighted important associations among post-index events. CONCLUSION: Neglecting to adjust for treatment discontinuation may produce biased risk estimates. The MSM approach is a promising tool to compare chronic disease management by illuminating relationships between treatment decisions, adherence, patient choices, and outcomes.

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.

Management of asthma and chronic obstructive pulmonary disease with combination inhaled corticosteroids and long-acting ß-agonists: a review of comparative effectiveness research.

The value of combination therapy with inhaled corticosteroids and long-acting ß-agonists (ICS/LABA) is well recognized in the management of asthma and chronic obstructive pulmonary disease (COPD). Despite differences in the pharmacological properties between two well-established ICS/LABA products (budesonide/formoterol and fluticasone/salmeterol), data from randomized clinical trials (RCTs) and meta-analyses suggest that these two products perform similarly under RCT conditions. In contrast, a few recently reported real-world comparative effectiveness studies have suggested that there are substantial differences between ICS/LABA combination treatments in terms of clinical and healthcare outcomes in patients with asthma or COPD. The purpose of this article is to provide a brief review of the benefits, as well as the limitations, of comparative effectiveness research (CER) in the therapeutic area of asthma and COPD. We conducted a structured literature review of the current CER studies on ICS/LABA combinations in asthma and COPD. These articles were then used to illustrate the unique challenges of CER studies, providing a summary of study results and limitations. We focus particularly on difficult biases and confounding factors that may be introduced before, during, and after the initiation of therapy. Beyond being a review of these two ICS/LABA combination treatments, this article is intended to help those who wish to assess the quality of CER published projects in asthma and COPD, or guide investigators who wish to design new CER studies for chronic respiratory disease treatments.

Functional disorders of the gastrointestinal tract: Cost effectiveness review.

BACKGROUND: The project aim was to review current cost-effectiveness research for each functional gastrointestinal disorder, as defined by the Rome III classification system. METHODS: Biomedical databases were searched for articles with the functional gastrointestinal disorders and their pseudonyms included in the title, abstract, or medical subject headings, plus the terms benefit, cost, effectiveness, outcomes, test, utility, or utilization in any search field. RESULTS: Highly prevalent conditions such as dyspepsia and irritable bowel syndrome have advanced cost-effectiveness analyses including cost-utility studies that have helped support current management guidelines. The rarer functional gastrointestinal disorders have few or no published cost-effectiveness analyses, but the Rome III classification system provides a framework for identifying the specific cost data or outcomes measures available or needed for future research. CONCLUSIONS: The Rome process has provided a useful system for defining the functional gastrointestinal disorders and identifying specific clinical questions to be examined using cost-effectiveness analysis techniques.

Chronic pain and pain medication use in chronic obstructive pulmonary disease. A cross-sectional study.

RATIONALE: Pain is a common problem for patients with chronic obstructive pulmonary disease (COPD). However, pain is minimally discussed in COPD management guidelines. OBJECTIVES: The objective of this study was to describe chronic pain prevalence among patients with COPD compared with similar patients with other chronic diseases in a managed care population in the southwestern United States (age ≥ 40 yr). METHODS: Using data for the period January 1, 2006 through December 31, 2010, patients with COPD were matched to two control subjects without COPD but with another chronic illness based on age, sex, insurance, and healthcare encounter type. Odds ratios (OR) for evidence of chronic pain were estimated using conditional logistic regression. Pulmonary function data for 200 randomly selected patients with COPD were abstracted. MEASUREMENTS AND MAIN RESULTS: Retrospectively analyzed recurrent pain-related utilization (diagnoses and treatment) was considered evidence of chronic pain. The study sample comprised 7,952 patients with COPD (mean age, 69 yr; 42% male) and 15,904 patients with other chronic diseases (non-COPD). Patients with COPD compared with non-COPD patients had a higher percentage of chronic pain (59.8 vs. 51.7%; P < 0.001), chronic use of pain-related medications (41.2 vs. 31.5%; P < 0.001), and chronic use of short-acting (24.2 vs. 15.1%; P < 0.001) and long-acting opioids (4.4 vs. 1.9%; P < 0.001) compared with non-COPD patients. In conditional logistic regression models, adjusting for age, sex, Hispanic ethnicity, and comorbidities, patients with COPD had higher odds of chronic pain (OR, 1.56; 95% confidence interval [CI], 1.43-1.71), chronic use of pain-related medications (OR, 1.60; 95% CI, 1.46-1.74), and chronic use of short-acting or long-acting opioids (OR, 1.74; 95% CI, 1.57-1.92). CONCLUSIONS: Chronic pain and opioid use are prevalent among adults with COPD. This finding was not explained by the burden of comorbidity.

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.

Cardiovascular comorbidity in COPD: systematic literature review.

BACKGROUND: Cardiovascular disease (CVD) is common among patients with COPD. However, it is not clear whether this is due to shared risk factors or if COPD increases the risk for CVD independently. This study aimed to provide a systematic review of studies that investigated the association between COPD and CVD outcomes, assessing any effect of confounding by common risk factors. METHODS: A search was conducted in MEDLINE (via PubMed) for observational studies published between January 1990 and March 2012 reporting cardiovascular comorbidity in patients with COPD (or vice versa). RESULTS: Of the 7,322 citations identified, 25 studies were relevant for this systematic review. Twenty-two studies provided an estimate for CVD risk in COPD, whereas four studies provided estimates of COPD risk in CVD. The crude prevalence for the aggregate CVD category ranged from 28% to 70%, likely due to differences in populations studied and CVD definitions; unadjusted rate ratio (RR) estimates of unspecified CVD among patients with COPD compared with patients without COPD ranged from 2.1 to 5.0. The association between COPD and CVD persisted after adjustment for shared risk factors in the majority of the studies. Two studies found a relationship between the severity of airflow limitation and CVD risk. Increased RRs were observed for individual CVD types, but their estimates varied considerably for congestive heart failure, coronary heart disease, arrhythmias, stroke, arterial hypertension, and peripheral arterial disease. CONCLUSIONS: Available observational data support the hypothesis that COPD is associated with an increased risk of CVD.