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Rationale: Sleep disturbance frequently affects patients with chronic obstructive pulmonary disease (COPD), and is associated with reduced quality of life and poorer outcomes. Data indicate that smokers with preserved pulmonary function have clinical symptoms similar to those meeting spirometric criteria for COPD, but little is known about the driving factors for sleep disturbance in this population of emerging interest., Objectives: To compare the magnitude and correlates of sleep disturbance between smokers with preserved pulmonary function and those with airflow obstruction., Methods: Using cross-sectional data from the COPD Outcomes-Based Network for Clinical Effectiveness and Research Translation multicenter registry, we identified participants clinically identified as having COPD with a smoking history of at least 20 pack-years and either preserved pulmonary function or airflow obstruction. We quantified sleep disturbance by T-score measured in the sleep disturbance domain of the Patient-Reported Outcomes Information System questionnaire, and defined a minimum important difference as a T-score difference of two points. We performed univariate and multivariable linear regression to evaluate correlates within each group., Results: We identified 100 smokers with preserved pulmonary function and 476 with airflow obstruction. The sleep disturbance T-score was 4.1 points greater among individuals with preserved pulmonary function (95% confidence interval [CI], 2.0-6.3). In adjusted analyses, depression symptom T-score was associated with sleep disturbance in both groups (airflow obstruction: β, 0.61 points; 95% CI, 0.27-0.94; preserved pulmonary function: β, 0.25 points; 95% CI, 0.12-0.38). Of note, lower percent predicted FEV 1 was associated with greater sleep disturbance among those with preserved pulmonary function (β, -0.19 points; 95% CI, -0.31 to -0.07), whereas higher FEV 1 was associated with greater sleep disturbance among individuals with airflow obstruction (β, 0.06 points; 95% CI, 0.01-0.10)., Conclusions: Among smokers with clinically identified COPD, the severity of sleep disturbance is greater among those with preserved pulmonary function compared with those with airflow obstruction. Nonrespiratory symptoms, such as depression, were associated with sleep disturbance in both groups, whereas the relationship of sleep disturbance with FEV 1 differed.

Background: Inhaled therapies are the cornerstone of pharmacologic management for COPD. Each device requires a unique series of steps to be most effective, making appropriate instruction in inhaler technique a key part of the management of COPD., Objectives: Examine characteristics of patients and devices associated with poor technique among patients with COPD., Methods: Cross-sectional study of subjects with COPD using at least one of: metered dose inhaler, Advair Diskus, Spiriva Handihaler, identified from the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) registry. Technique was assessed face-to-face using manufacturer-provided dummy inhalers, with standardized checklists for each device. We used logistic regression to model associations with poor inhaler technique, defined as an error in ≥20% of the steps, as a function of patient characteristics, with educational attainment the primary predictor., Results: 688 individuals meet eligibility criteria, 65.5% had poor technique for at least one device. In adjusted analyses, Black race was associated with poor technique (OR 3.25, 95%CI 1.86-5.67) while greater than high school education was associated with decreased odds of poor technique (OR 0.35, 95%CI 0.17-0.70 for trade school/some college, OR 0.25, 95%CI 0.11-0.61 for college or more, p ≤ 0.001 for test of linear trend). The percentage of errors varied between devices, with subjects making proportionally the most errors for MDIs., Conclusions: Poor inhaler technique is common among individuals with COPD, varies between devices, and is associated with race and educational attainment. Tailored educational interventions to teach inhaler technique should be part of the process of initiating and monitoring inhaled therapies., (Published by Elsevier Ltd.)

Rationale: Smoking cessation is the most important intervention for patients with chronic obstructive pulmonary disease (COPD). What leads smokers with COPD to quit smoking remains unknown., Objectives: We sought to examine the association between respiratory symptoms and other markers of COPD severity with intention to quit smoking among a cohort of patients with probable COPD., Methods: We conducted a cross-sectional study of subjects with COPD or fixed airflow obstruction clinically diagnosed on the basis of pulmonary function testing. The subjects were identified in the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation multicenter registry. The primary outcome was the intention to quit smoking within the next 30 days (yes or no), which was examined using model building with multivariable logistic regression, clustered by study site., Measurements and Main Results: We identified 338 current smokers with COPD via the registry. Of these subjects, 57.4% (n = 194) had confirmed airflow obstruction based on pulmonary function testing. Nearly one-third (29.2%; n = 99) intended to quit smoking in the next 30 days. In adjusted analyses, compared with subjects without airflow obstruction based on pulmonary function testing, subjects with Global Initiative for Chronic Obstructive Lung Disease stage I/II COPD were more likely to be motivated to quit (odds ratio [OR], 1.85; 95% confidence interval [CI], 1.37-2.49), with no association found for subjects with Global Initiative for Chronic Obstructive Lung Disease stage III/IV disease. Among the entire cohort, frequent phlegm (OR, 2.10; 95% CI, 1.22-3.64), cough (OR, 1.74; 95% CI, 1.01-2.99), wheeze (OR, 1.73; 95% CI, 1.09-3.18), and higher modified Medical Research Council dyspnea score (OR, 1.26 per point; 95% CI, 1.13-1.41) were associated with increased odds of intending to quit smoking. Low self-reported health was associated with decreased odds of intending to quit (OR, 0.75; 95% CI, 0.62-0.92)., Conclusions: Frequent cough, phlegm, wheeze, and shortness of breath were associated with intention to quit smoking in the next 30 days, with a less clear relationship for severity of illness graded by pulmonary function testing and self-rated health. These findings can be used to inform the content of tobacco cessation interventions to provide a more tailored approach for patients with respiratory diseases such as COPD.

Rationale: Clinical trials in chronic obstructive pulmonary disease (COPD) usually require evidence of airflow obstruction and clinical risk factors. International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes or patient-reported physician diagnoses are often used for epidemiologic studies and performance improvement programs., Objectives: To evaluate agreement between these case definitions for COPD and to assess the comparability of study populations identified as having COPD not using the clinical trial reference standard., Methods: We recruited patients from the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation multicenter clinical registry in a cross-sectional study. Demographics, clinical, and post-bronchodilator spirometry data were collected at an in-person study visit. The kappa statistic (κ) was used to evaluate agreement. A multivariable logistic regression model was used to identify patient characteristics associated with meeting the trial reference standard., Measurements and Main Results: A total of 998 (82.8%) of 1,206 study participants met at least one case definition for COPD (of the 998: 91% using ICD-9 codes, 73% using patient-reported physician diagnosis, 56% using trial reference standard); agreement between case definitions was poor (κ = 0.20-0.26). Lack of airflow obstruction was the principal (89%) reason patients identified as having COPD did not meet the trial reference standard. Patients who were black (vs. white), obese (vs. normal weight), or had depression (vs. not) were less likely to meet the trial reference standard (odds ratio [95% CI], 0.37 [0.26-0.53], 0.51 [0.34-0.75], 0.53 [0.40-0.71], respectively)., Conclusions: Findings highlight concerns about the applicability of findings in clinical trials to patients meeting other case definitions for 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 <0.01) according to EQ-5D-5L. Related domains on EQ-5D-5L, PROMIS and clinical measures were moderately (r = 0.30-0.49) to strongly (r ≥ 0.50) correlated. A statistically significant trend of decreasing HRQL with more severe lung functions was observed for EQ-5D-5L index scores, EQ-VAS scores, and PROMIS physical function and social roles., Conclusions: Results supported the validity of EQ-5D-5L and PROMIS-43 in COPD patients, and indicate that physical function and social activities decrease with level of lung function by GOLD grade, but not pain, mental health, sleep or fatigue as reported by patients.

Comparative effectiveness research (CER) is intended to address the expressed needs of patients, clinicians, and other stakeholders. Representatives of 54 stakeholder groups with an interest in chronic obstructive pulmonary disease (COPD) participated in workshops convened by the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) over a 2-year period. Year 1 focused on chronic care and care coordination. Year 2 focused on acute care and transitions in care between healthcare settings. Discussions and provisional voting were conducted via teleconferences and e-mail exchanges before the workshop. Final prioritization votes occurred after in-person discussions at the workshop. We used a modified Delphi approach to facilitate discussions and consensus building. To more easily quantify preferences and to evaluate the internal consistency of rankings, the Analytic Hierarchy Process was incorporated in Year 2. Results of preworkshop and final workshop voting often differed, suggesting that prioritization efforts relying solely on requests for topics from stakeholder groups without in-person discussion may provide different research priorities. Research priorities varied across stakeholder groups, but generally focused on studies to evaluate different approaches to healthcare delivery (e.g., spirometry for diagnosis and treatment, integrated healthcare strategies during transitions in care) rather than head-to-head comparisons of medications. This research agenda may help to inform groups intending to respond to CER funding opportunities in COPD. The methodologies used, detailed in the online supplement, may also help to inform prioritization efforts for CER in other health conditions.

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: Hospitalized patients frequently misuse their respiratory inhalers, yet it is unclear what the most effective hospital-based educational intervention is for this population., Objective: To compare two strategies for teaching inhaler use to hospitalized patients with asthma or chronic obstructive pulmonary disease (COPD)., Design: A Phase-II randomized controlled clinical trial enrolled hospitalized adults with physician diagnosed asthma or COPD., Participants: Hospitalized adults (age 18 years or older) with asthma or COPD., Interventions: Participants were randomized to brief intervention [BI]: single-set of verbal and written step-by-step instructions, or, teach-to-goal [TTG]: BI plus repeated demonstrations of inhaler use and participant comprehension assessments (teach-back)., Main Measures: The primary outcome was metered-dose inhaler (MDI) misuse post-intervention (<75% steps correct). Secondary outcomes included Diskus® misuse, self-reported inhaler technique confidence and prevalence of 30-day health-related events., Key Results: Of 80 eligible participants, fifty (63%) were enrolled (BI n=26, TTG n=24). While the majority of participants reported being confident with their inhaler technique (MDI 70%, Diskus® 94%), most misused their inhalers pre-intervention (MDI 62%, Diskus® 78%). Post-intervention MDI misuse was significantly lower after TTG vs. BI (12.5 vs. 46%, p=0.01). The results for Diskus® were similar and approached significance (25 vs. 80%, p=0.05). Participants with 30-day acute health-related events were less common in the group receiving TTG vs. BI (1 vs. 8, p=0.02)., Conclusions: TTG appears to be more effective compared with BI. Patients over-estimate their inhaler technique, emphasizing the need for hospital-based interventions to correct inhaler misuse. Although TTG was associated with fewer post-hospitalization health-related events, larger, multi-centered studies are needed to evaluate the durability and clinical outcomes associated with this hospital-based education.

Background: Acute exacerbations of COPD (AE-COPD) are a leading cause of hospitalizations in the United States. To estimate the burden of disease (eg, prevalence and cost), identify opportunities to improve care quality (eg, performance measures), and conduct observational comparative effectiveness research studies, various algorithms based on the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes have been used to identify patients with COPD. However, the validity of these algorithms remains unclear., Methods: We compared the test characteristics (sensitivity, specificity, positive predictive value, and negative predictive value) of four different coding algorithms for identifying patients hospitalized for an exacerbation of COPD with chart review (reference standard) using a stratified probability sample of 200 hospitalizations at two urban academic medical centers. Sampling weights were used when calculating prevalence and test characteristics., Results: The prevalence of COPD exacerbations (based on the reference standard) was 7.9% of all hospitalizations. The sensitivity of all ICD-9-CM algorithms was very low and varied by algorithm (12%-25%), but the negative predictive value was similarly high across algorithms (93%-94%). The specificity was > 99% for all algorithms, but the positive predictive value varied by algorithm (81%-97%)., Conclusions: Algorithms based on ICD-9-CM codes will undercount hospitalizations for AE-COPD, and as many as one in five patients identified by these algorithms may be misidentified as having a COPD exacerbation. These findings suggest that relying on ICD-9-CM codes alone to identify patients hospitalized for AE-COPD may be problematic.

Background: High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD)., Methods: Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second., Results: Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes., Conclusions: HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population., Trial Registration: ClinicalTrials.gov: NCT00181285.

ICD-9-CM diagnosis codes are increasingly used to estimate the burden of disease, as well as to evaluate the quality of care and outcomes of various conditions. Acute exacerbations of COPD (AE-COPD) are common and associated with substantial health and financial burden in the U.S. Whether published algorithms that employ different combinations of ICD-9-CM codes to identify patients hospitalized for AE-COPD yield similar or different estimates of disease burden is unclear. In this study, the Nationwide Inpatient Sample from years 2000-2006 was used to identify and compare the number of hospitalizations, healthcare utilization, and outcomes for patients hospitalized for AE-COPD in the U.S. AE-COPD was identified using five different published ICD-9-CM algorithms. Estimates of the annual number of hospitalizations for AE-COPD in the U.S. varied more than 2-fold (e.g., 421,000 to 870,000 in 2006). Outcomes and healthcare utilization of patients hospitalized for AE-COPD varied substantially, depending on the algorithm used (e.g., in-hospital mortality 2.0% to 5.1%, total hospital days 2.0 to 5.1 million in 2006). Observed trends in the number of hospitalizations over the 7-year period varied depending on which algorithm was used. In conclusion, the estimated health burden and trends in hospitalizations for AE-COPD in the United States differ, depending on which ICD-9-CM algorithm is used. To improve our understanding of the burden of AE-COPD and to ensure that quality of care initiatives are not misdirected, a validated approach to identifying patients hospitalized for AE-COPD is needed.