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Objective There is a high prevalence of obesity in people with asthma, and obesity is associated with poorly controlled asthma. Significant weight loss might improve asthma control: the purpose of this study was to investigate patient characteristics and factors that might affect implementation of a weight loss and/or roflumilast intervention, to target both obesity and asthma. Methods A cross‐sectional study of people with obesity and poorly controlled asthma performed at 13 sites across the United States. Results One hundred and two people participated in this study. Median BMI was 37 (IQR 35–42). The majority, 55%, were African American and 76% were female. Fifty two percent had very poorly controlled asthma. Most participants were quite sedentary (70% reported being inactive or participating only in light‐intensity activities according to the Stanford Brief Activity Survey). Participants reported significant impairments related to physical function on the Impact of Weight on Quality of Life‐Lite questionnaire (median score 67 [IQR 41–84]). Thirty‐five percent of participants reported mild, and 2 % moderate, depressive symptoms as assessed by the Patient Health Questionnaire‐9. Conclusions Poorly controlled asthma and obesity often affect minority populations and are associated with significant impairments in health related to physical function and low levels of physical activity that might complicate efforts to lose weight. Interventions targeted at poorly controlled asthma associated with obesity in the United States need to address factors complicating health in underserved communities, such as increasing opportunities for physical activity, while also managing activity limitations related to the combination of asthma and obesity.

Background: Often patients with chronic obstructive pulmonary disease (COPD) receive poor quality care with limited access to pulmonologists. We tested a novel intervention, INtegrating Care After Exacerbation of COPD (InCasE), that improved patient outcomes after hospitalization for COPD. InCasE used population-based identification of patients for proactive e-consultation by pulmonologists, and tailored recommendations with pre-populated orders timed to follow-up with primary care providers (PCPs). Although adoption by PCPs was high, we do not know how PCPs experienced the intervention. Objective: Our objective was to assess PCPs’ experience with proactive pulmonary e-consults after hospitalization for COPD. Methods: We conducted a convergent mixed methods study among study PCPs at 2 medical centers and 10 outpatient clinics. PCPs underwent semi-structured interviews and surveys. We performed descriptive analyses on quantitative data and inductive and deductive coding based on prespecified themes of acceptability, appropriateness, and feasibility for qualitative data. Key Results: We conducted 10 interviews and 37 PCPs completed surveys. PCPs perceived InCasE to be acceptable and feasible. Facilitators included the proactive consult approach to patient identification and order entry. PCPs also noted the intervention was respectful and collegial. PCPs had concerns regarding appropriateness related to an unclear role in communicating recommendations to patients. PCPs also noted a potential decrease in autonomy if overused. Conclusion: This evaluation indicates that a proactive e-consult intervention can be deployed to collaboratively manage the health of populations with COPD in a way that is acceptable, appropriate, and feasible for primary care. Lessons learned from this study suggest the intervention may be transferable to other settings and specialties.

BACKGROUND: Implementation of effective smoking cessation interventions in lung cancer screening has been identified as a high-priority research gap, but knowledge of current practices to guide process improvement is limited due to the slow uptake of screening and dearth of data to assess cessation-related practices and outcomes under real-world conditions. OBJECTIVE: To evaluate cessation treatment receipt and 1-year post-screening cessation outcomes within the largest integrated healthcare system in the USA—the Veterans Health Administration (VHA). Design Observational study using administrative data from electronic medical records (EMR). Patients Currently smoking Veterans who received a first lung cancer screening test using low-dose CT (LDCT) between January 2014 and June 2018. Main Outcomes Tobacco treatment received within the window of 30 days before and 30 days after LDCT; 1-year quit rates based on EMR Smoking Health Factors data 6–18 months after LDCT. Key Results Of the 47,609 current smokers screened (95.3% male), 8702 (18.3%) received pharmacotherapy and/or behavioral treatment for smoking cessation; 531 (1.1%) received both. Of those receiving pharmacotherapy, only one in four received one of the most effective medications: varenicline (12.1%) or combination nicotine replacement therapy (14.3%). Overall, 5400 Veterans quit smoking—a rate of 11.3% (missing=smoking) or 13.5% (complete case analysis). Treatment receipt and cessation were associated with numerous sociodemographic, clinical, and screening-related factors. CONCLUSIONS: One-year quit rates for Veterans receiving lung cancer screening in VHA are similar to those reported in LDCT clinical trials and cohort studies (i.e., 10–17%). Only 1% of Veterans received the recommended combination of pharmacotherapy and counseling, and the most effective pharmacotherapies were not the most commonly received ones. The value of screening within VHA could be improved by addressing these treatment gaps, as well as the observed disparities in treatment receipt or cessation by race, rurality, and psychiatric conditions. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07011-0.

The Hospital Readmissions Reduction Program (HRRP) was developed and implemented by the Centers for Medicare & Medicaid Services to curb the rate of 30-day hospital readmissions for certain common, high-impact conditions. In October 2014, COPD became a target condition for which hospitals were penalized for excess readmissions. The appropriateness, utility, and potential unintended consequences of the metric have been a topic of debate since it was first enacted. Nevertheless, there is evidence that hospital policies broadly implemented in response to the HRRP may have been responsible for reducing the rate of readmissions following COPD hospitalizations even before it was added as a target condition. Since the addition of the COPD condition to the HRRP, several predictive models have been developed to predict COPD survival and readmissions, with the intention of identifying modifiable risk factors. A number of interventions have also been studied, with mixed results. Bundled care interventions using the electronic health record and patient education interventions for inhaler education have been shown to reduce readmissions, whereas pulmonary rehabilitation, follow-up visits, and self-management programs have not been consistently shown to do the same. Through this program, COPD has become recognized as a public health priority. However, 5 years after COPD became a target condition for HRRP, there continues to be no single intervention that reliably prevents readmissions in this patient population. Further research is needed to understand the long-term effects of the policy, the role of competing risks in measuring quality, the optimal postdischarge care for patients with COPD, and the integrated use of predictive modeling and advanced technologies to prevent COPD readmissions.

Rationale: Patients with chronic obstructive pulmonary disease (COPD) and anxiety or depression experience more symptoms and exacerbations than patients without these comorbidities. Failure to provide beneficial COPD therapies to appropriate patients (underuse) and provision of potentially harmful therapies to patients without an appropriate indication (overuse) could contribute to respiratory symptoms and exacerbations. Anxiety and depression are known to affect the provision of health services for other comorbid conditions; therefore, underuse or overuse of therapies may explain the increased risk of severe symptoms among these patients. Objectives: To determine whether diagnosed anxiety and depression, as well as significant anxiety and depression symptoms, are associated with underuse and overuse of appropriate COPD therapies. Methods: We analyzed data from a multicenter prospective cohort study of 2,376 participants (smokers and control subjects) enrolled between 2010 and 2015. We identified two subgroups of participants, one at risk for inhaled corticosteroid (ICS) overuse and one at risk for long-acting bronchodilator (LABD) underuse based on the 2011 Global Initiative for Chronic Obstructive Lung Disease statement. Our primary outcomes were self-reported overuse and underuse. Our primary exposures of interest were self-reported anxiety and depression and significant anxiety and depression symptoms. We adopted a propensity-score method with inverse probability of treatment weighting adjusting for differences in prevalence of confounders and performed inverse probability of treatment weighting logistic regression to evaluate all associations between the exposures and outcomes. Results: Among the 1,783 study participants with COPD confirmed by spirometry, 667 (37.4%) did not have an indication for ICS use, whereas 985 (55.2%) had an indication for LABD use. Twenty-five percent (n = 167) of patients reported ICS use, and 72% (n = 709) denied LABD use in each subgroup, respectively. Neither self-reported anxiety and depression nor significant anxiety and depression symptoms were associated with overuse or underuse. At least 50% of patients in both subgroups with significant symptoms of anxiety or depression did not report a preexisting mental health diagnosis. Conclusions: Underuse of LABDs and overuse of ICSs are common but are not associated with comorbid anxiety or depression diagnosis or symptoms. Approximately one-third of individuals with COPD experience anxiety or depression, and most are undiagnosed. There are significant opportunities to improve disease-specific and patient-centered treatment for individuals with COPD.

Rationale: Hypoxemia associated with acute exacerbations of chronic obstructive pulmonary disease (COPD) often resolves with time. Current guidelines recommend that patients recently discharged with supplemental home oxygen after hospitalization should not have renewal of the prescription without assessment for hypoxemia. Understanding patterns of home oxygen reassessment is an opportunity to improve quality and value in home oxygen prescribing and may provide future targets for deimplementation. Objectives: We sought to measure the frequency of home oxygen reassessment within 90 days of hospitalization for COPD and determine the potential population eligible for deimplementation. Methods: We performed a cohort study of patients ≥40 years hospitalized for COPD at five Veterans Affairs facilities who were prescribed home oxygen at discharge. Our primary outcome was the frequency of reassessment within 90 days by oxygen saturation (Sp(O(2))) measurement. Secondary outcomes included the proportion of patients potentially eligible for discontinuation (Sp(O(2)) > 88%) and patients in whom oxygen was discontinued. Our primary exposures were treatment with long-acting bronchodilators, prior history of COPD exacerbation, smoking status, and pulmonary hypertension. We used a mixed-effects Poisson model to measure the association between patient-level variables and our outcome, clustered by site. We also performed a positive deviant analysis using chart review to uncover system processes associated with high-quality oxygen prescribing. Results: A total of 287 of 659 (43.6%; range 24.8–78.5% by site) patients had complete reassessment within 90 days. None of our patient-level exposures were associated with oxygen reassessment. Nearly half of those with complete reassessment were eligible for discontinuation on the basis of Medicare guidelines (43.2%; n = 124/287). When using the newest evidence available by the Long-Term Oxygen Treatment Trial, most of the cohort did not have resting hypoxemia (84.3%; 393/466) and would be eligible for discontinuation. The highest-performing Veterans Affairs facility had four care processes to support oxygen reassessment and discontinuation, versus zero to one at all other sites. Conclusions: Fewer than half of patients prescribed home oxygen after a COPD exacerbation are reassessed within 90 days. New system processes supporting timely reassessment and discontinuation of unnecessary home oxygen therapy could improve the quality and value of care.

Background Although inhaled therapy reduces exacerbations among patients with COPD, the effectiveness of providing inhaled treatment per risk stratification models remains unclear. Research Question Are inhaled regimens that align with the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy associated with clinically important outcomes? Study Design and Methods We conducted secondary analyses of Long-term Oxygen Treatment Trial (LOTT) data. The trial enrolled patients with COPD with moderate resting or exertional hypoxemia between 2009 and 2015. Our exposure was the patient-reported inhaled regimen at enrollment, categorized as either aligning with, undertreating, or potentially overtreating per the 2017 GOLD strategy. Our primary composite outcome was time to death or first hospitalization for COPD. Additional outcomes included individual components of the composite outcome and time to first exacerbation. We generated multivariable Cox proportional hazard models across strata of GOLD-predicted exacerbation risk (high vs low) to estimate between-group hazard ratios for time to event outcomes. We adjusted models a priori for potential confounders, clustered by site. Results The trial enrolled 738 patients (73.4% men; mean age, 68.8 years). Of the patients, 571 (77.4%) were low risk for future exacerbations. Of the patients, 233 (31.6%) reported regimens aligning with GOLD recommendations; most regimens (54.1%) potentially overtreated. During a 2.3-year median follow-up, 332 patients (44.9%) experienced the composite outcome. We found no difference in time to composite outcome or death among patients reporting regimens aligning with recommendations compared with undertreated patients. Among patients at low risk, potential overtreatment was associated with higher exacerbation risk (hazard ratio, 1.42; 95% CI, 1.09-1.87), whereas inhaled corticosteroid treatment was associated with 64% higher risk of pneumonia (incidence rate ratio, 1.64; 95% CI, 1.01-2.66). Interpretation Among patients with COPD with moderate hypoxemia, we found no difference in clinical outcomes between inhaled regimens aligning with the 2017 GOLD strategy compared with those that were undertreated. These findings suggest the need to reevaluate the effectiveness of risk stratification model-based inhaled treatment strategies.

STUDY OBJECTIVES: Incorporating registered nurses (RN-level) into obstructive sleep apnea (OSA) management decisions has the potential to augment the workforce and improve patient access, but the appropriateness of such task-shifting in typical practice is unclear. METHODS: Our medical center piloted a nurse triage program for sleep medicine referrals. Using a sleep specialist-designed decision-making tool, nurses triaged patients referred for initial sleep studies to either home sleep apnea test (HSAT) or in-laboratory polysomnography (PSG). During the first 5 months of the program, specialists reviewed all nurse triages. We compared agreement between specialists and nurses. RESULTS: Of 280 consultations triaged by nurses, nurses deferred management decisions to sleep specialists in 6.1% (n = 17) of cases. Of the remaining 263 cases, there was 88% agreement between nurses and specialists (kappa 0.80, 95% confidence interval 0.74–0.87). In the 8.8% (n = 23) of cases where supervising specialists changed sleep study type, specialists changed from HSAT to PSG in 16 cases and from PSG to HSAT in 7. The most common indication for change in sleep study type was disagreement regarding OSA pretest probability (n = 14 of 23). Specialists changed test instructions in 3.0% (n = 8) of cases, with changes either related to the use of transcutaneous carbon dioxide monitoring (n = 4) or adaptive servo-ventilation (n = 4). CONCLUSIONS: More than 80% of sleep study triages by registered nurses in a supervised setting required no sleep specialist intervention. Future research should focus on how to integrate nurses into the sleep medicine workforce in a manner that maximizes efficiency while preserving or improving patient outcomes. CITATION: Donovan LM, Fernandes LA, Williams KM, et al. Agreement of sleep specialists with registered nurses’ sleep study orders in supervised clinical practice. J Clin Sleep Med. 2020;16(2):279–283.

Inhaled corticosteroid (ICS) use among patients with COPD increases the risk of pneumonia and other complications. Current recommendations limit ICS use to patients with frequent or severe COPD exacerbations. However, use of ICS among patients with COPD is common and may be occurring both among those with mild disease (overuse) and those misdiagnosed with COPD (misuse). To identify patients without identifiable indication for ICS and assess patient and provider characteristics associated with potentially inappropriate to targeted in de-implementation efforts We performed a cross-sectional study of patients with COPD in the Veterans Affairs (VA) system with recent spirometry. After setting an index date, we identified individuals with a clinical diagnosis of COPD who had spirometry completed in the prior 5 years. We excluded individuals with an appropriate indication for ICS based on the 2017 GOLD statement, including asthma and a recent history of frequent or severe exacerbations. ICS use without identifiable indication We identified 26,536 patients with COPD without an identifiable indication for ICS. Nearly ¼ of patients (n = 6330) filled ≥2 prescriptions for ICS in the year prior to the index date. We found that older age (adjusted prevalence ratio [APR] 1.06 per decade, 95% confidence interval [CI] 1.04–1.08), white race (APR 1.11, 95% CI 1.05–1.19), and more primary care visits (APR 1.05 per visit, 95% CI 1.03–1.07) were associated with increased likelihood of potentially inappropriate use. Primary care clinic complexity and provider training were not associated with ICS use. Among patients misdiagnosed with COPD, we found that 14% used ICS. Potentially inappropriate ICS use is common among patients with and without airflow obstruction who are diagnosed with COPD. We identified patient comorbidities and patterns of healthcare utilization that increase the likelihood of ICS use that could be targeted for system-level de-implementation interventions.

Rationale: Inhaled corticosteroids (ICS) are not first-line therapy for patients with chronic obstructive pulmonary disease (COPD) at low risk of exacerbations, but they are commonly prescribed despite evidence of harm. We consider ICS prescription in this population to be of “low value.” The association of low-value ICS with subsequent healthcare utilization and costs is unknown. Understanding this relationship could inform efforts to reduce the delivery of low-value care. Objectives: To determine whether low-value ICS prescribing is associated with higher outpatient healthcare utilization and costs among patients with COPD who are at low risk of exacerbation. Methods: We performed a cohort study between January 1, 2010, and December 31, 2018, identifying a cohort of veterans with COPD who performed pulmonary function tests (PFTs) at 21 Veterans Affairs medical centers nationwide. Patients were defined as having low exacerbation risk if they experienced less than two outpatient exacerbations and no hospital admissions for COPD in the year before PFTs. Our primary exposure was the receipt of an ICS prescription in the 3 months before the date of PFTs. Our primary outcomes were outpatient utilization and outpatient costs in the 1 year after PFTs. For inference, we generated negative binomial models for utilization and generalized linear models for costs, adjusting for confounders. Results: We identified a total of 31,551 patients with COPD who were at low risk of exacerbation. Of these patients, 9,742 were prescribed low-value ICS (mean [standard deviation (SD)] age, 69 [9] yr), and 21,809 were not prescribed low-value ICS (mean [SD] age, 68 [9] yr). Compared with unexposed patients, those exposed to low-value ICS had 0.53 more encounters per patient per year (95% confidence interval CI, 0.23–0.83) and incurred $154.72 higher costs/patient/year (95% CI, $45.58–$263.86). Conclusions: Low-value ICS prescription was associated with higher subsequent outpatient healthcare utilization and costs. Potential mechanisms for the observed association are that 1) low-value ICS may be a marker of poor respiratory symptom control, 2) there is confounding by indication, or 3) low-value ICS results in increased drug costs or utilization. Health systems should identify low-value ICS prescriptions as a target to improve value-based care.

BackgroundAlthough inhaled therapy reduces exacerbations among patients with COPD, the effectiveness of providing inhaled treatment per risk stratification models remains unclear.Research questionAre inhaled regimens that align with the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy associated with clinically important outcomes?Study design and methodsWe conducted secondary analyses of Long-term Oxygen Treatment Trial (LOTT) data. The trial enrolled patients with COPD with moderate resting or exertional hypoxemia between 2009 and 2015. Our exposure was the patient-reported inhaled regimen at enrollment, categorized as either aligning with, undertreating, or potentially overtreating per the 2017 GOLD strategy. Our primary composite outcome was time to death or first hospitalization for COPD. Additional outcomes included individual components of the composite outcome and time to first exacerbation. We generated multivariable Cox proportional hazard models across strata of GOLD-predicted exacerbation risk (high vslow) to estimate between-group hazard ratios for time to event outcomes. We adjusted models a priori for potential confounders, clustered by site.ResultsThe trial enrolled 738 patients (73.4%men; mean age, 68.8 years). Of the patients, 571 (77.4%) were low risk for future exacerbations. Of the patients, 233 (31.6%) reported regimens aligning with GOLD recommendations; most regimens (54.1%) potentially overtreated. During a 2.3-year median follow-up, 332 patients (44.9%) experienced the composite outcome. We found no difference in time to composite outcome or death among patients reporting regimens aligning with recommendations compared with undertreated patients. Among patients at low risk, potential overtreatment was associated with higher exacerbation risk (hazard ratio, 1.42; 95%CI, 1.09-1.87), whereas inhaled corticosteroid treatment was associated with 64%higher risk of pneumonia (incidence rate ratio, 1.64; 95%CI, 1.01-2.66).InterpretationAmong patients with COPD with moderate hypoxemia, we found no difference in clinical outcomes between inhaled regimens aligning with the 2017 GOLD strategy compared with those that were undertreated. These findings suggest the need to reevaluate the effectiveness of risk stratification model-based inhaled treatment strategies.

BackgroundThe volume of specialty care referrals often outstrips specialists’ capacity. The Department of Veterans Affairs launched a system of referral coordination to augment our workforce, empowering registered nurses to use decision support tools to triage specialty referrals. While task shifting may improve access, there is limited evidence regarding the relative quality of nurses’ triage decisions to ensure such management is safe.ObjectiveWithin the specialty of sleep medicine, we compared receipt of contraindicated testing for obstructive sleep apnoea (OSA) between patients triaged to sleep testing by nurses in the referral coordination system (RCS) relative to our traditional specialist-led system (TSS).MethodsPatients referred for OSA evaluation can be triaged to either home sleep apnoea testing (HSAT) or polysomnography, and existing guidelines specify patients for whom HSAT is contraindicated. In RCS, nurses used a decision support tool to make triage decisions for sleep testing but were instructed to seek specialist oversight in complex cases. In TSS, specialists made triage decisions themselves. We performed a single-centre retrospective cohort study of patients without OSA who were referred to sleep testing between September 2018 and August 2019. Patients were assigned to triage by RCS or TSS in quasirandom fashion based on triager availability at time of referral. We compared receipt of contraindicated sleep tests between groups using a generalised linear model adjusted for day of the week and time of day of referral.ResultsRCS triaged 793 referrals for OSA evaluation relative to 1787 by TSS. Patients with RCS triages were at lower risk of receiving potentially contraindicated sleep tests relative risk 0.52 (95% CI 0.29 to 0.93).ConclusionOur results suggest that incorporating registered nurses into triage decision-making may improve the quality of diagnostic care for OSA.

The Hospital Readmissions Reduction Program (HRRP) was developed and implemented by the Centers for Medicare & Medicaid Services to curb the rate of 30-day hospital readmissions for certain common, high-impact conditions. In October 2014, COPD became a target condition for which hospitals were penalized for excess readmissions. The appropriateness, utility, and potential unintended consequences of the metric have been a topic of debate since it was first enacted. Nevertheless, there is evidence that hospital policies broadly implemented in response to the HRRP may have been responsible for reducing the rate of readmissions following COPD hospitalizations even before it was added as a target condition. Since the addition of the COPD condition to the HRRP, several predictive models have been developed to predict COPD survival and readmissions, with the intention of identifying modifiable risk factors. A number of interventions have also been studied, with mixed results. Bundled care interventions using the electronic health record and patient education interventions for inhaler education have been shown to reduce readmissions, whereas pulmonary rehabilitation, follow-up visits, and self-management programs have not been consistently shown to do the same. Through this program, COPD has become recognized as a public health priority. However, 5 years after COPD became a target condition for HRRP, there continues to be no single intervention that reliably prevents readmissions in this patient population. Further research is needed to understand the long-term effects of the policy, the role of competing risks in measuring quality, the optimal postdischarge care for patients with COPD, and the integrated use of predictive modeling and advanced technologies to prevent COPD readmissions.

Rationale: Decreasing medication overuse represents an opportunity to avoid harm and costs in the era of value-based purchasing. Studies of inhaled corticosteroids (ICS) overuse in chronic obstructive pulmonary disease (COPD) have examined prevalent use. Understanding initiation of low-value ICS among complex patients with COPD may help shape deadoption efforts. Objectives: Examine ICS initiation among a cohort with low exacerbation risk COPD and test for associations with markers of patient and health system complexity. Methods: Between 2012 and 2016, we identified veterans with COPD from 21 centers. Our primary outcome was first prescription of ICS. We used the care assessment needs (CAN) score to assess patient-level complexity as the primary exposure. We used a time-to-event model with time-varying exposures over 1-year follow-up. We tested for effect modification using selected measures of health system complexity. Results: We identified 8,497 patients with COPD without an indication for ICS and did not have baseline use (inception cohort). Follow-up time was four quarters. Patient complexity by a continuous CAN score was associated with new dispensing of ICS (hazard ratio = 1.17 per 10-unit change; 95% confidence interval = 1.13–1.21). This association demonstrated a dose–response when examining quartiles of CAN score. Markers of health system complexity did not modify the association between patient complexity and first use of low-value ICS. Conclusions: Patient complexity may represent a symptom burden that clinicians are attempting to mitigate by initiating ICS. Lack of effect modification by health system complexity may reflect the paucity of structural support and low prioritization for COPD care.

Evaluate consequences of intermediate to high risk of undiagnosed obstructive sleep apnea (OSA) among individuals with chronic obstructive pulmonary disease (COPD).Using data from the Long Term Oxygen Treatment Trial (LOTT), we assessed OSA risk at study entry among patients with COPD. We compared outcomes among those at intermediate to high risk (modified STOP-BANG score ≥ 3) relative to low risk (score3) for OSA. We compared risk of mortality or first hospitalization with proportional hazard models, and incidence of COPD exacerbations using negative binomial regression. We adjusted analyses for demographics, body mass index, and comorbidities. Last, we compared St. George Respiratory Questionnaire and Quality of Well-Being Scale results between OSA risk groups.Of the 222 participants studied, 164 (74%) were at intermediate to high risk for OSA based on the modified STOP-BANG score. Relative to the 58 low-risk individuals, the adjusted hazard ratio of mortality or first hospitalization was 1.61 (95% confidence interval 1.01-2.58) for those at intermediate to high risk of OSA. Risk for OSA was also associated with increased frequency of COPD exacerbations (adjusted incidence rate ratio: 1.78, 95% confidence interval 1.10-2.89). Respiratory symptoms by St. George Respiratory Questionnaire were 5.5 points greater (Among individuals with COPD, greater risk for undiagnosed OSA is associated with poor outcomes. Increased recognition and management of OSA in this group could improve outcomes.

Benzodiazepines are associated with mortality and poor outcomes among patients with chronic obstructive pulmonary disease (COPD), but use of benzodiazepines for dyspnea among patients with end-stage disease may confound this relationship.Assess the mortality risks of long-term benzodiazepine exposure among patients with COPD and comorbid post-traumatic stress disorder (PTSD), patients with chronic nonrespiratory indications for benzodiazepines.We identified all patients with COPD and PTSD within the Veteran's Health Administration between 2010 and 2012. We calculated propensity scores for benzodiazepine use and compared overall and cause-specific mortality of patients with long-term (≥90 d) benzodiazepine use relative to matched patients without use. Secondary analyses assessed propensity-adjusted survival by characteristics of benzodiazepine exposure.Among 44,555 eligible patients with COPD and PTSD, 23.6% received benzodiazepines long term. In the matched sample of 19,552 patients, we observed no mortality difference (hazard ratio [HR] for long-term use, 1.06; 95% confidence interval [CI], 0.95-1.18) but greater risk of death by suicide among those with long-term use (HR, 2.33; 95% CI, 1.14-4.79). Among matched and unmatched patients, short-term benzodiazepine use, but not long-term use, was associated with increased mortality (short-term: HR, 1.16; 95% CI, 1.05-1.28; long-term: HR, 1.03; 95% CI, 0.94-1.13).Risks for respiratory compromise related to long-term benzodiazepine use in COPD may be less than previously estimated, but short-term use of benzodiazepines could still pose a mortality risk. Suicide associated with benzodiazepine use in this population warrants further investigation.

Chronic obstructive pulmonary disease (COPD) is the third leading cause of hospital readmissions in the United States. The quality of care delivered to patients with COPD is known to be lacking across the care continuum, and may contribute to high rates of readmission. As part of the response to these issues, the Centers for Medicare and Medicaid instituted a penalty for 30-day readmissions as part of their Hospital Readmission Reduction Program in October 2014. At the time the penalty was instated, there was little published evidence on effective hospital-based programs to reduce readmissions after acute exacerbations of COPD. Even now, several years later, few published programs exist, and we continue to lack consistent approaches that lead to improved readmission rates. In addition, there was concern that the penalty would widen health disparities. Despite the dearth of published evidence to reduce readmissions beyond available COPD guidelines, many hospitals across the United States began to develop and implement programs, based on little evidence, due to the financial penalty. We, therefore, assembled a diverse group of clinicians, researchers, payers, and program leaders from across the country to present and discuss approaches that had the greatest potential for success. We drew on expertise from ongoing readmission reduction programs, implementation methodologies, and stakeholder perspectives to develop this Workshop Report on current best practices and models for addressing COPD hospital readmissions.

Quality of chronic obstructive pulmonary disease (COPD) care is thought to be an important intermediate process to improve the well-being of patients admitted to hospital for exacerbation. We sought to examine the quality of inpatient COPD care and the associations with readmission and mortality. We performed a cohort study of 2,364 veterans aged over 40 and hospitalized for COPD between 2005 and 2011 at five Department of Veterans Affairs hospitals. We examined whether patients received six guideline recommended care items including short-acting bronchodilators, corticosteroids, antibiotics, positive-pressure ventilation (in cases of acute hypercarbic respiratory failure), chest imaging, and arterial blood gas measurement. Our primary outcome was all-cause hospital readmission or death within 30 days. Overall quality of care was not significantly associated with readmission or death (acute care aOR 0.98; 95% CI 0.87-1.11; ICU aOR 0.89; 95% CI 0.71-1.13). Delivery of corticosteroids and antibiotics was associated with reduced odds of readmission and death (aOR 0.77; 95% CI 0.61-0.92). Few patients received all of the recommended care items (18% of acute care, 38% of ICU patients). Quality of care did not vary by race or sex but did vary significantly across sites and did not improve over time. Our composite measure of COPD care quality was not associated with readmission or death. Further efforts are needed to improve care delivery to patients hospitalized with COPD.

Rationale: Hospital readmissions are an important cause of morbidity and mortality among patients with chronic obstructive pulmonary disease (COPD). Although comorbidities are associated with outcomes in COPD, it is unknown how they affect treatment choices. Objectives: We sought to examine whether comorbidity was associated with readmission, mortality, and delivery of in-hospital treatment for COPD exacerbations. Methods: We performed a cohort study of veterans hospitalized with a COPD exacerbation to six Veterans Affairs hospitals between 2005 and 2011. We collected comorbidities in the year before hospitalization. We defined our primary outcome as readmission and/or mortality within 30 days of discharge, and treatment quality as receipt of systemic corticosteroids and respiratory antibiotics during the index hospitalization. Results: A total of 2,391 patients were included. Each one-point increase in Charlson index was associated with greater odds of readmission or death (adjusted odds ratio [aOR], 1.24; 95% confidence interval [CI], 1.18–1.30) and reduced odds of receiving treatment with steroids and antibiotics (aOR, 0.90; 95% CI, 0.85–0.95), in adjusted analyses. Patients with comorbid congestive heart failure (aOR, 0.64; 95% CI, 0.52–0.79), coronary artery disease (aOR, 0.73; 95% CI, 0.60–0.89), and chronic kidney disease (aOR, 0.74; 95% CI, 0.55–0.99) were less likely to receive corticosteroids and antibiotic treatment than patients without those comorbidities. We did not identify any comorbidity that was associated with increased odds of receiving appropriate therapies. Conclusions: Comorbidity was associated with 30-day readmission and mortality, and with delivery of fewer treatments known to be beneficial among patients with COPD exacerbation.

Patient-centered outcomes research (PCOR) represents a paradigm shift in research methods aimed to create the body of evidence that supports clinical practice and informs health care decisions. PCOR integrates patients and other key stakeholders including family members, policy makers, clinicians, and patient advocates and advocacy groups as research partners throughout all stages of the research process. The importance of PCOR has received increased recognition, yet there is little evidence available to help guide researchers interested in the design and conduct of PCOR. In May 2014, we convened a workshop to identify key issues related to designing, conducting, and disseminating findings from PCOR studies. Workshop participants included a diverse group of patients, patient advocates, clinicians (physicians, nurses, psychologists, and advanced practice providers), researchers, administrators, and funders within and beyond the pulmonary, critical care, and sleep medicine communities. Participants identified important issues and considerations to address when undertaking PCOR. In this report, we summarize the results of this workshop to inform members of the pulmonary, sleep, and critical care community interested in participating in PCOR. Key findings include the following: 1) requirements for research to be considered PCOR; 2) the potential significant impact of PCOR on patients, clinicians, and researchers; 3) guiding principles and practical strategies to form successful patient-centered research partnerships, conduct PCOR, and disseminate study results to a broad audience of stakeholders; 4) benefits and challenges of PCOR for researchers; and 5) resources available within the American Thoracic Society to help with the conduct of PCOR.

Introduction Initiating treatment with continuous positive airway pressure (CPAP) traditionally relies on in-person visits with trained therapists to provide hands-on instruction regarding CPAP usage and mask fit. To overcome geographic barriers and reduce COVID-19 transmission, health systems increasingly rely on remote set-ups of mailed equipment. Despite a strong rationale for the mailed approach, relative effectiveness is unclear. Methods Our VA medical center shifted from in-person to mailed CPAP dispensation during the COVID-19 pandemic in March 2020. Using VA administrative and wireless CPAP usage data, we assembled a cohort of patients with newly diagnosed obstructive sleep apnea (OSA) who initiated CPAP for the first time from July 2019 to August 2020. Our primary outcome was mean nightly usage over the first 90 days. We compared patients with in-person vs. mailed CPAP dispensation using generalized linear models adjusted for age, gender, race, and Charlson Comorbidity Index. Among patients with >1 hour of overall usage, we compared secondary outcomes of leak, apnea hypopnea index (AHI), and obstructive/central apnea indices. Results We identified 693 patients with newly diagnosed OSA whose CPAP was provided in-person and 296 who had CPAP mailed. Nightly usage in the first 90 days was modest in both groups (in-person: 149.7, mailed: 152.9 min/night), and we did not detect a difference in adjusted models (+7.6 min/night, 95%CI -13.6–28.8). We also did not detect a difference in 95th percentile leak (-1.2 liter/minute, 95%CI -3.3-0.9). Device-detected AHI was relatively low overall (in-person: 3.2, mailed: 4.1 events/hour), but was greater in the mailout group (+1.0/hour, 95%CI 0.2–1.7). AHI differences appeared to be driven by obstructive (+0.5/hour, 95%CI 0.2–0.8) but not central events (-0.1, 95% CI -0.2–0.4). Risk of AHI>5 was comparable between groups (in-person: 17.3%, mailed: 19.0%, OR 1.2, 95%CI 0.8–1.7). Conclusion We were able to switch from an in-person to a mail-based system of CPAP initiation without a change in CPAP adherence or mask leak. While AHI was slightly greater in the mailed group, the clinical significance of this finding is unclear. Future work will need to evaluate the impact of remote CPAP dispensation on patient-centered outcomes. Support (if any) VA Health Services Research and Development, CDA 18–187

Introduction: Many barriers exist to integrating smoking cessation into delivery of lung cancer screening including limited provider time and patient misconceptions.Aims: To demonstrate that proactive outreach from a telephone counsellor outside of the patient's usual care team is feasible and acceptable to patients.Methods: Smokers undergoing lung cancer screening were approached for a telephone counselling study. Patients agreeing to participate in the intervention (n = 27) received two telephone counselling sessions. A 30-day follow-up evaluation was conducted, which also included screening participants receiving usual care (n = 56).Results/Findings: Most (89%) intervention participants reported being satisfied with the proactive calls, and 81% reported the sessions were helpful. Use of behavioural cessation support programs in the intervention group was four times higher (44%) compared to the usual care group (11%); Relative Risk (RR) = 4.1; 95% CI: 1.7 to 9.9), and seven-day abstinence in the intervention group was double (19%) compared to the usual care group (7%); RR = 2.6; 95% CI: 0.8 to 8.9).Conclusions: This practical telephone-based approach, which included risk messages clarifying continued risks of smoking in the context of screening results, suggests such messaging can boost utilisation of evidence-based tobacco treatment, self-efficacy, and potentially increase the likelihood of successful quitting.

Rationale: Symptoms of insomnia and anxiety are common among patients with chronic obstructive pulmonary disease (COPD), especially among patients with comorbid mental health disorders such as post-traumatic stress disorder (PTSD). Benzodiazepines provide temporary relief of these symptoms, but guidelines discourage routine use of benzodiazepines because of the serious risks posed by these medications. A more thorough understanding of guideline-discordant benzodiazepine use will be critical to reduce potentially inappropriate prescribing and its associated risks. Objectives: Examine the national prevalence, variability, and center correlates of long-term benzodiazepine prescriptions for patients with COPD and comorbid PTSD. Methods: We identified patients with COPD and PTSD between 2010 and 2012 who received care within the Department of Veterans Affairs. We used a mixed-effects logistic regression model to assess center predictors of long-term benzodiazepine prescriptions (≥90 d), while accounting for patient characteristics. Results: Of 43,979 patients diagnosed with COPD and PTSD at 129 centers, 24.4% were prescribed benzodiazepines long term, with use varying from 9.5% to 49.4% by medical center. Patients with long-term prescriptions were more likely to be white (90.1% vs. 80.7%) and have other mental health comorbidities, including generalized anxiety disorder (31.3% vs. 16.5%). Accounting for patient mix and characteristics, long-term benzodiazepine use was associated with lower patient-reported access to mental health care (odds ratio, 0.54; 95% confidence interval, 0.37–0.80). Conclusions: Long-term benzodiazepine prescribing is common among patients at high risk for complications, although this practice varies substantially from center to center. Poor access to mental health care is a potential driver of this guideline inconsistent use.

Inhaled corticosteroid (ICS) use among patients with COPD increases the risk of pneumonia and other complications. Current recommendations limit ICS use to patients with frequent or severe COPD exacerbations. However, use of ICS among patients with COPD is common and may be occurring both among those with mild disease (overuse) and those misdiagnosed with COPD (misuse).To identify patients without identifiable indication for ICS and assess patient and provider characteristics associated with potentially inappropriate to targeted in de-implementation efforts DESIGN: We performed a cross-sectional study of patients with COPD in the Veterans Affairs (VA) system with recent spirometry.After setting an index date, we identified individuals with a clinical diagnosis of COPD who had spirometry completed in the prior 5 years. We excluded individuals with an appropriate indication for ICS based on the 2017 GOLD statement, including asthma and a recent history of frequent or severe exacerbations.ICS use without identifiable indication KEY RESULTS: We identified 26,536 patients with COPD without an identifiable indication for ICS. Nearly ¼ of patients (n = 6330) filled ≥2 prescriptions for ICS in the year prior to the index date. We found that older age (adjusted prevalence ratio [APR] 1.06 per decade, 95% confidence interval [CI] 1.04-1.08), white race (APR 1.11, 95% CI 1.05-1.19), and more primary care visits (APR 1.05 per visit, 95% CI 1.03-1.07) were associated with increased likelihood of potentially inappropriate use. Primary care clinic complexity and provider training were not associated with ICS use. Among patients misdiagnosed with COPD, we found that 14% used ICS.Potentially inappropriate ICS use is common among patients with and without airflow obstruction who are diagnosed with COPD. We identified patient comorbidities and patterns of healthcare utilization that increase the likelihood of ICS use that could be targeted for system-level de-implementation interventions.

Many smokers admitted for chronic obstructive pulmonary disease (COPD) are not given smoking cessation medications at discharge. The reasons behind this are unclear, and may reflect an interplay of patient characteristics, health disparities, and the receipt of inpatient tobacco control processes. We aimed to assess potential disparities in treatment for tobacco use following discharge for COPD, examined in the context of inpatient tobacco control processes. Smokers aged ≥ 40 years, admitted for treatment of a COPD exacerbation within the VA Veterans Integrated Service Network 20, identified using ICD-9 discharge codes and admission diagnoses from 2005–2012. The outcome was any tobacco cessation medication dispensed within 48 hours of discharge. We assessed potential predictors administratively up to 1 year prior to admission. We created the final logistic regression model using manual model building, clustered by site. Variables with p

Introduction Professional societies recommend providers assess sleep symptoms in COPD, but it is unclear if this occurs. We aimed to evaluate OSA symptom assessment and documentation among patients with COPD, and the patient and provider characteristics associated with this assessment. Methods We conducted a cross-sectional study of adults aged ≥40 years with clinically diagnosed COPD and no prior diagnosis of OSA. We selected patients receiving care at two academic general internal medicine clinics between 6/1/2011 - 6/1/2013. We abstracted charts to assess how often OSA symptoms such as snoring, somnolence, witnessed apneas, or gasping/choking arousals were documented as present or absent. We performed multivariable mixed-effects logistic regression to assess associations of patient and primary care provider (PCP) factors with assessment of OSA symptoms. Patient factors included demographics, body mass index, comorbidities, healthcare utilization, and severity of COPD, and PCP factors including demographics, degree, and years of experience. Results Of 523 patients with COPD, only 26 (5.0%) had documentation of OSA symptom assessment within a one-year period. In mixed effects models, only referral to general pulmonary clinic was associated with the assessment of OSA symptoms (OR: 4.56, 95% CI 1.28-15.52). Among the 26 individuals who had OSA symptoms assessed, 9 (34.6%) reported snoring, 15 (57.7%) reported daytime somnolence, 2 (7.7%) reported gasping/choking arousals, and 5 (19.2%) reported witnessed apneas. Among those assessed for OSA symptoms, providers referred 11 (42.3%) for formal sleep consultation. Conclusion Providers rarely document OSA symptoms for patients with COPD in primary care clinic, but assessment is greater among those with pulmonary specialty consultation. Given time constraints in primary care, external facilitation of sleep symptom assessment may improve symptom recognition and receipt of appropriate services. Support NIH 5K23HL111116-05, VA Center of Innovation for Veteran-Centered and Value-Driven Care.

Chronic obstructive pulmonary disease (COPD) is among the most common medical diagnoses among Veterans. More than 50% of Veterans diagnosed with mild-to-moderate COPD are prescribed inhaled corticosteroids despite recommendations for use restricted to patients with frequent exacerbations. We explored primary care providers’ experiences prescribing inhaled corticosteroids among patients with mild-to-moderate COPD as part of a quality improvement initiative. We used a sequential mixed-methods evaluation approach to understand factors influencing primary care providers’ inhaled corticosteroid prescribing for patients with mild-to-moderate COPD. Participants were recruited to participate in qualitative interviews and structured surveys. We used a purposive sample of primary care providers from 13 primary care clinics affiliated with two urban Veteran Health Administration healthcare systems. Interviews were transcribed and analyzed using content analysis. Qualitative findings informed a subsequent survey. Surveys were administered through REDCap and analyzed descriptively. Key qualitative and quantitative findings were compared. Participants reported they were unaware of current evidence and recommendations for prescribing inhaled corticosteroids; for example, 46% of providers reported they were unaware of risks of pneumonia. Providers reported they are generally unable to keep up with the current literature due to the broad scope of primary care practice. We also found primary care providers may be reluctant to change inherited prescriptions, even if they thought inhaled corticosteroid therapy might not be appropriate. Inhaled corticosteroid prescribing in this patient population is partly due to primary care providers’ lack of knowledge about the potential harms and availability of alternative therapies. Our findings suggest that efforts to expand access by increasing the number of prescribing providers a patient potentially sees could make it more difficult to de-implement harmful prescriptions. Our findings also corroborate prior findings that awareness of current evidence-based guidelines is likely an important part of medical overuse.

BACKGROUND Patients admitted for chronic obstructive pulmonary disease (COPD) commonly continue to smoke. The utilization and effectiveness of tobacco cessation medications after discharge is largely unknown. We sought to examine whether pharmacologic treatment of tobacco use following admission for COPD was associated with smoking cessation at 6 to 12 months. METHODS Multivariable logistic regression analysis of a cohort of 1334 smokers, discharged from hospital with a COPD exacerbation between 2005 and 2012, identified administratively within the Veterans Affairs Veterans Integrated Service Network-20, adjusted for variables chosen a priori. Our primary exposure was treatment with any 1 or combination of smoking cessation medications within 90 days of discharge determined from pharmacy records, with the outcome of smoking cessation at 6 to 12 months after discharge. MEASUREMENTS AND MAIN RESULTS Four hundred fifty (33.7%) of the patients were dispensed a smoking cessation medication, with 53.4% receiving a nicotine patch alone. Overall, 19.8% of patients reported quitting smoking at 6 to 12 months. Compared to those not receiving medications, the odds of quitting were not greater among patients dispensed any single or combination of smoking cessation medications within 90 days of discharge (odds ratio [OR]: 0.88, 95% confidence interval [CI]: 0.74-1.04). Among patients treated with medications compared to nicotine patch alone, varenicline (OR: 2.44, 95% CI: 1.48-4.05) was associated with increased odds of cessation, and short-acting nicotine replacement therapy alone (OR: 0.66, 95% CI: 0.51-0.85) was associated with decreased odds of cessation. CONCLUSIONS Treatment was provided to a minority of subjects and was not associated with cessation, with potential differences observed in effectiveness between medications. Systems-based changes may improve delivery of this key intervention. Journal of Hospital Medicine 2016;11:257–263. © 2015 Society of Hospital Medicine

Author(s): Attia, Engi F; McGinnis, Kathleen A; Feemster, Laura C; Akgun, Kathleen M; Butt, Adeel A; Graber, Christopher J; Fine, Michael J; Goetz, Matthew B; Rodriguez-Barradas, Maria C; Pisani, Margaret A; Tindle, Hilary A; Brown, Sheldon T; Soo Hoo, Guy W; Rimland, David; Gibert, Cynthia L; Huang, Laurence; Freiberg, Matthew S; Hough, Catherine L; Crothers, Kristina | Abstract: BackgroundPulmonary infections remain more common in HIV-infected (HIV+) compared with uninfected individuals. The increase in chronic lung diseases among aging HIV+ individuals may contribute to this persistent risk. We sought to determine whether chronic obstructive pulmonary disease (COPD) is an independent risk factor for different pulmonary infections requiring hospitalization among HIV+ patients.MethodsWe analyzed data from 41,993 HIV+ Veterans in the nationwide Veterans Aging Cohort Study Virtual Cohort from 1996 to 2009. Using International Classification of Diseases, Ninth Revision codes, we identified baseline comorbid conditions, including COPD, and incident community-acquired pneumonia (CAP), pulmonary tuberculosis (TB), and Pneumocystis jirovecii pneumonia (PCP) requiring hospitalization within 2 years after baseline. We used multivariable Poisson regression to determine incidence rate ratios (IRRs) associated with COPD for each type of pulmonary infection, adjusting for comorbidities, CD4 cell count, HIV viral load, smoking status, substance use, vaccinations, and calendar year at baseline.ResultsUnadjusted incidence rates of CAP, TB, and PCP requiring hospitalization were significantly higher among persons with COPD compared to those without COPD (CAP: 53.9 vs. 19.4 per 1000 person-years; TB: 8.7 vs. 2.8; PCP: 15.5 vs. 9.2; P ≤ 0.001). In multivariable Poisson regression models, COPD was independently associated with increased risk of CAP, TB, and PCP (IRR: 1.94, 95% confidence interval [CI]: 1.64 to 2.30; IRR: 2.60, 95% CI: 1.70 to 3.97; and IRR: 1.48, 95% CI: 1.10 to 2.01, respectively).ConclusionsCOPD is an independent risk factor for CAP, TB, and PCP requiring hospitalization among HIV+ individuals. As the HIV+ population ages, the growing burden of COPD may confer substantial risk for pulmonary infections.

Quality improvement (QI) is a required component of fellowship training in pulmonary, critical care, and sleep medicine. However, little is known about how training programs approach QI education.We sought to understand the perceptions of pulmonary, critical care, and sleep medicine training program directors toward QI education.We developed and fielded an internet survey of pulmonary, critical care, and sleep medicine training program directors during 2013. Survey domains included program characteristics, the extent of trainee and faculty involvement in QI, attitudes toward QI education, and barriers to successful QI education in their programs.A total of 75 program directors completed the survey (response rate = 45.2%). Respondents represented both adult (n = 43, 57.3%) and pediatric (n = 32, 42.7%) programs. Although the majority of directors (n = 60, 80.0%) reported substantial fellow involvement in QI, only 19 (26.0%) reported having a formal QI education curriculum. QI education was primarily based around faculty mentoring (n = 46, 61.3%) and lectures (n = 38, 50.7%). Most directors agreed it is an important part of fellowship training (n = 63, 84.0%). However, fewer reported fellows were well integrated into ongoing QI activities (n = 45, 60.0%) or graduating fellows were capable of carrying out independent QI (n = 28, 50.7%). Key barriers to effective QI education included lack of qualified faculty, lack of interest among fellows, and lack of time.Training program directors in pulmonary, critical care, and sleep medicine value QI education but face substantial challenges to integrating it into fellowship training.

BACKGROUND Despite guideline recommendations, patients suspected of having COPD often are treated empirically instead of undergoing spirometry to confirm airflow obstruction (AFO). Accurate diagnosis and treatment are essential to provide high-quality, value-oriented care. We sought to identify predictors associated with AFO among patients with and treated for COPD prior to performance of confirmatory spirometry. METHODS We identified a cohort of veterans with spirometry performed at Pacific Northwest Department of Veterans Affairs medical centers between 2003 and 2007. We included only patients with empirically diagnosed COPD in the 2 years prior to spirometry who were also taking inhaled medication to treat COPD in the 1 year prior to spirometry. We used relative risk regression analysis to identify predictors of AFO. RESULTS Among patients empirically treated for COPD (N = 3, 209), 62% had AFO. Risk factors such as older age, prior smoking status, and underweight status were associated with AFO on spirometry. In contrast, comorbidities often associated with somatic symptoms were associated with absence of AFO and included congestive heart failure, depression, diabetes, obesity, and sleep apnea. CONCLUSIONS Comorbidities associated with somatic complaints of dyspnea were associated with a lower risk of having airflow limitations, suggesting that empirical diagnosis and treatment of COPD may lead to inappropriate treatment of individuals who do not have AFO.

Rationale: The goal of shared decision making is to match patient preferences, including evaluation of potential future outcomes, with available management options. Yet, it is unknown how patients with smoking-related thoracic diseases or their surrogates display future-oriented thinking.

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

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.To compare the magnitude and correlates of sleep disturbance between smokers with preserved pulmonary function and those with airflow obstruction.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.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 FEVAmong 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

Most patients with a clinical diagnosis of COPD have not had spirometry to confirm airflow obstruction (AFO). Overweight and obese patients report more dyspnea than normal weight patients, which may be falsely attributed to AFO. We sought to determine whether overweight and obese patients who received a clinical diagnosis of COPD were more likely to receive a misdiagnosis (ie, lack of AFO on spirometry) and be subsequently treated with inhaled medications.The cohort comprised US veterans with COPD (International Classification of Diseases, 9th Revision, code; inhaled medication use; or both) and spirometry measurements from one of three Pacific Northwest Veterans Administration Medical Centers. The measured exposures were overweight and obesity (defined by BMI categories). Outcomes were (1) AFO on spirometry and (2) escalation or deescalation of inhaled therapies from 3 months before spirometry to 9 to 12 months after spirometry. We used multivariable logistic regression with calculation of adjusted proportions for all analyses.Fifty-two percent of 5,493 veterans who had received a clinical diagnosis of COPD had AFO. The adjusted proportion of patients with AFO decreased as BMI increased (P.01 for trend). Among patients without AFO, those who were overweight and obese were less likely to remain off medications or to have therapy deescalated (adjusted proportions: normal weight, 0.69 [95% CI, 0.64-0.73]; overweight, 0.62 [95% CI, 0.58-0.65; P = .014]; obese, 0.60 [95% CI, 0.57-0.63; P = .001]).Overweight and obese patients are more likely to be given a misdiagnosis of COPD and not have their inhaled medications deescalated after spirometry demonstrated no AFO. Providers may be missing potential opportunities to recognize and treat other causes of dyspnea in these patients.

Rationale: Little is known about symptom assessment around the time of lung cancer diagnosis. The purpose of this pilot study was to assess symptoms within 2 months of diagnosis and the frequency with which clinicians addressed symptoms among a cohort of veterans (n = 20) newly diagnosed with lung cancer. We administered questionnaires and then reviewed medical records to identify symptom assessment and management provided by subspecialty clinics for 6 months following diagnosis. Results: Half (50%) of the patients were diagnosed with early-stage non–small-cell lung cancer (NSCLC), stage I or II. At baseline, 45% patients rated their overall symptoms as severe. There were no significant differences in symptoms among patients with early- or late-stage NSCLC or small-cell lung cancer. Of the 212 clinic visits over 6 months, 70.2% occurred in oncology. Clinicians most frequently addressed pain although assessment differed by clinic. Conclusions: Veterans with newly diagnosed lung cancer report significant symptom burden. Despite ample opportunities to address patients’ symptoms, variations in assessment exist among subspecialty services. Coordinated approaches to symptom assessment are likely needed among patients newly diagnosed with lung cancer.