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Background: Individuals with chronic obstructive pulmonary disease (COPD) are often at risk for or have comorbid cardiovascular disease and are likely to die of cardiovascular-related causes. Objectives: To prioritize a list of research topics related to the diagnosis and management of patients with COPD and comorbid cardiovascular diseases (heart failure, atherosclerotic vascular disease, and atrial fibrillation) by summarizing existing evidence and using consensus-based methods. Methods: A literature search was performed. References were reviewed by committee co-chairs. An international, multidisciplinary committee, including a patient advocate, met virtually to review evidence and identify research topics. A modified Delphi approach was used to prioritize topics in real time on the basis of their potential for advancing the field. Results: Gaps spanned the translational science spectrum from basic science to implementation: 1) disease mechanisms; 2) epidemiology; 3) subphenotyping; 4) diagnosis and management; 5) clinical trials; 6) care delivery; 7) medication access, adherence, and side effects; 8) risk factor mitigation; 9) cardiac and pulmonary rehabilitation; and 10) health equity. Seventeen experts participated, and quorum was achieved for all votes (>80%). Of 17 topics, ≥70% agreement was achieved for 12 topics after two rounds of voting. The range of summative Likert scores was −15 to 25. The highest priority was "Conduct pragmatic clinical trials with patient-centered outcomes that collect both pulmonary and cardiac data elements." Health equity was identified as an important topic that should be embedded within all research. Conclusions: We propose a prioritized research agenda with the purpose of stimulating high-impact research that will hopefully improve outcomes among people with COPD and cardiovascular disease. [ABSTRACT FROM AUTHOR]

The article discusses a study examining trends in chronic obstructive pulmonary disease prevalence, incidence, and health services use in younger adults in Ontario, Canada, 2006–2016. It mentions that the differences in trends across age groups all due to possible system-level inequities due to age, suggesting that current practices are not benefitting younger adults to the same extent as others.

Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy.Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine.Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines.Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (replacement); 2) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (complementary); or 3) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; "sequential").Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions. [ABSTRACT FROM AUTHOR]

Background: This document provides clinical recommendations for the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). It represents a collaborative effort on the part of a panel of expert COPD clinicians and researchers along with a team of methodologists under the guidance of the American Thoracic Society.Methods: Comprehensive evidence syntheses were performed on all relevant studies that addressed the clinical questions and critical patient-centered outcomes agreed upon by the panel of experts. The evidence was appraised, rated, and graded, and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach.Results: After weighing the quality of evidence and balancing the desirable and undesirable effects, the guideline panel made the following recommendations: 1) a strong recommendation for the use of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) combination therapy over LABA or LAMA monotherapy in patients with COPD and dyspnea or exercise intolerance; 2) a conditional recommendation for the use of triple therapy with inhaled corticosteroids (ICS)/LABA/LAMA over dual therapy with LABA/LAMA in patients with COPD and dyspnea or exercise intolerance who have experienced one or more exacerbations in the past year; 3) a conditional recommendation for ICS withdrawal for patients with COPD receiving triple therapy (ICS/LABA/LAMA) if the patient has had no exacerbations in the past year; 4) no recommendation for or against ICS as an additive therapy to long-acting bronchodilators in patients with COPD and blood eosinophilia, except for those patients with a history of one or more exacerbations in the past year requiring antibiotics or oral steroids or hospitalization, for whom ICS is conditionally recommended as an additive therapy; 5) a conditional recommendation against the use of maintenance oral corticosteroids in patients with COPD and a history of severe and frequent exacerbations; and 6) a conditional recommendation for opioid-based therapy in patients with COPD who experience advanced refractory dyspnea despite otherwise optimal therapy.Conclusions: The task force made recommendations regarding the pharmacologic treatment of COPD based on currently available evidence. Additional research in populations that are underrepresented in clinical trials is needed, including studies in patients with COPD 80 years of age and older, those with multiple chronic health conditions, and those with a codiagnosis of COPD and asthma. [ABSTRACT FROM AUTHOR]

Background: Mounting evidence indicates that out-of-pocket costs for prescription medications, particularly among low- and middle-income patients with chronic diseases, are imposing financial burden, reducing medication adherence, and worsening health outcomes. This problem is exacerbated by a paucity of generic alternatives for prevalent lung diseases, such as asthma and chronic obstructive pulmonary disease, as well as high-cost medicines for rare diseases, such as cystic fibrosis. Affordability and access challenges are especially salient in the United States, as citizens of many other countries pay lower prices for and have greater access to prescription medications.Methods: The American Thoracic Society convened a multidisciplinary committee comprising experts in health policy pharmacoeconomics, behavioral sciences, and clinical care, along with individuals providing industry and patient perspectives. The report and its recommendation were iteratively developed over a year of in-person, telephonic, and electronic deliberation.Results: The committee unanimously recommended the establishment of a publicly funded, politically independent, impartial entity to systematically draft evidence-based pharmaceutical policy recommendations. The goal of this entity would be to generate evidence and action steps to ensure people have equitable and affordable access to prescription medications, to maximize the value of public and private pharmaceutical expenditures on health, to support novel drug development within a market-based economy, and to preserve clinician and patient choice regarding personalized treatment. An immediate priority is to examine the evidence and make recommendations regarding the need to have essential medicines with established clinical benefit from each drug class in all Tier 1 formularies and propose recommendations to reduce barriers to timely generic drug availability.Conclusions: By making explicit, evidence-based recommendations, the entity can support the establishment of coherent national policies that expand access to affordable medications, improve the health of patients with chronic disease, and optimize the use of public and private resources. [ABSTRACT FROM AUTHOR]

Rationale: The burden of advanced chronic obstructive pulmonary disease (COPD) is high globally; however, little is known about how often end-of-life strategies are used by this population.Objectives: To describe trends in the use of end-of-life care strategies by people with advanced COPD in Ontario, Canada.Methods: A population-based repeated cross-sectional study examining end-of-life care strategies in individuals with advanced COPD was conducted. Annual proportions of individuals who received formal palliative care, long-term oxygen therapy, or opioids from 2004 to 2014 were determined. Results were age and sex standardized and stratified by age, sex, socioeconomic status, urban/rural residence, and immigrant status. Measurement/Main Results: There were 151,912 persons with advanced COPD in Ontario between 2004 and 2014. Use of formal palliative care services increased 1% per year from 5.3% in 2004 to 14.3% in 2014 (P value for trend < 0.001), whereas use of long-term oxygen therapy increased 1.1% per year from 26.4% in 2004 to 35.3% in 2013 (P value for trend < 0.001). The use of opioids was relatively stable (40.0% in 2004 and 41.8% in 2014; P value for trend = 0.08). Younger individuals were less likely to use formal palliative care services and long-term oxygen therapy. Males were less likely than females to receive long-term oxygen therapy and opioids.Conclusions: The proportion of people with advanced COPD using end-of-life strategies, although increasing, remains low. Efforts should focus on increasing access to such strategies and educating patients and providers of their benefits. [ABSTRACT FROM AUTHOR]

Chronic obstructive pulmonary disease (COPD) is regarded as one of the leading causes of morbidity and mortality across the world, yet its proper diagnosis remains a challenge. Community-based population studies conducted in North and South America, Europe, Australia, and Asia have revealed that 10% to 12% of adults aged 40 years or older have evidence of persistent airflow limitation on spirometry, but only 20% to 30% of these subjects have been diagnosed with COPD. These studies collectively suggest that approximately 70% of COPD worldwide may be underdiagnosed. Conversely, other studies have shown that between 30% and 60% of patients with a previous physician diagnosis of COPD do not actually have the disease, and hence they have been overdiagnosed. In this review, we define under- and overdiagnosis and explore the prevalence and the burden of under- and overdiagnosis of COPD on both patients and healthcare systems. We further describe potential solutions to reduce the incidence of under- and overdiagnosis of COPD. [ABSTRACT FROM AUTHOR]

Asthma is diagnosed on the basis of respiratory symptoms of wheeze, cough, chest tightness, and/or dyspnea together with physiologic evidence of variable expiratory airflow limitation. The prevalence of asthma varies widely around the world, ranging from 0.2% to 21.0% in adults and from 2.8% to 37.6% in 6- to 7-year-old children. Population-based studies in children, adults, and the elderly suggest that from 20% to 70% of people with asthma in the community remain undiagnosed and hence untreated. Underdiagnosis of asthma has been found to be associated with underreporting of respiratory symptoms by patients to physicians as well as poor socioeconomic status. On the opposite side of the spectrum, studies of patients with physician-diagnosed asthma suggest that 30-35% of adults and children diagnosed with asthma do not have current asthma, suggesting that asthma is also overdiagnosed in the community. Overdiagnosis of current asthma can occur because of physicians' failure to confirm variable airflow limitation at the time of diagnosis or when sustained clinical remission of disease goes unrecognized. In this review, we define under- and overdiagnosis and explore the prevalence and burden of under- and overdiagnosis of asthma both in patients and within healthcare systems. We further describe potential solutions to prevent under- and overdiagnosis of asthma. [ABSTRACT FROM AUTHOR]

Rationale: Characterization of the dynamic nature of posthospital risk in chronic obstructive pulmonary disease (COPD) is needed to provide counseling and plan clinical services.Objectives: To analyze risk of readmission and death after discharge for COPD among Medicare beneficiaries aged 65 years and older and to determine the association between ventilator support and risk trajectory.Methods: We computed daily absolute risks of hospital readmission and death for 1 year after discharge for COPD, stratified by ventilator support. We determined the time required for risks to decline by 50% from maximum daily values after discharge and for daily risks to plateau. We compared risks with those found in the general elderly population.Measurements and Main Results: Among 2,340,637 hospitalizations, the readmission rate at 1 year was 64.2%, including 63.5%, 66.0%, and 64.1% among those receiving invasive, noninvasive, and no ventilation, respectively. Among 1,283,069 hospitalizations, mortality at 1 year was 26.2%, including 45.7%, 41.8%, and 24.4% among those same respective groups. Daily risk of readmission declined by 50% within 28, 39, and 43 days and plateaued at 46, 54, and 61 days among those receiving invasive, noninvasive, and no ventilation, respectively. Risk of death declined by 50% by 3, 4, and 17 days and plateaued by 21, 18, and 24 days in the same respective groups. Risks of hospitalization and death were significantly higher after discharge for COPD than among the general Medicare population.Conclusions: Discharge from the hospital is associated with prolonged risks of readmission and death that vary with need for ventilator support. Interventions limited to the first month after discharge may be insufficient to improve longitudinal outcomes. [ABSTRACT FROM AUTHOR]

Rationale: Varenicline aids in smoking cessation but has also been associated with serious adverse events.Objectives: The aim of this study was to determine the risks of cardiovascular and neuropsychiatric events after varenicline receipt in a real-world setting.Methods: A population-based, self-controlled risk interval study using linked universal health administrative data from the diverse, multicultural population of Ontario, Canada, was conducted. In two separate analyses, new varenicline users between September 1, 2011 and February 15, 2014 were observed from 1 year before to 1 year after varenicline receipt. The relative incidences of cardiovascular and neuropsychiatric hospitalizations and emergency department visits in the 12 weeks after varenicline receipt (the risk interval) compared with the remaining observation period (the control interval) were estimated in two separate fixed-effect conditional Poisson regressions. Sensitivity analyses tested the robustness of the results.Measurements and Main Results: Among 56,851 new users of varenicline, 6,317 cardiovascular and 10,041 neuropsychiatric hospitalizations and emergency department visits occurred from 1 year before to 1 year after receipt. The incidence of cardiovascular events was 34% higher in the risk compared with the control interval (relative incidence, 1.34; 95% confidence interval, 1.25-1.44). Findings were consistent in sensitivity analyses, most notably in those without any history of previous cardiovascular disease. The relative incidence of neuropsychiatric events was marginally significant in the primary (relative incidence, 1.06; 95% confidence interval, 1.00-1.13) but not all sensitivity analyses.Conclusions: Varenicline appears to be associated with an increased risk of cardiovascular but not neuropsychiatric events. [ABSTRACT FROM AUTHOR]

Rationale: Despite emerging evidence that obstructive sleep apnea (OSA) may cause metabolic disturbances independently of other known risk factors, it remains unclear whether OSA is associated with incident diabetes. Objectives: To evaluate whether risk of incident diabetes was related to the severity and physiologic consequences of OSA. Methods: A historical cohort study was conducted using clinical and provincial health administrative data. All adults without previous diabetes referred with suspected OSA who underwent a diagnostic sleep study at St. Michael's Hospital (Toronto, Canada) between 1994 and 2010 were followed through health administrative data until May 2011 to examine the occurrence of diabetes. All OSA-related variables collected from the sleep study were examined as predictors in Cox regression models, controlling for sex, age, body mass index, smoking status, comorbidities, and income. Measurements and Main Results: Over a median follow-up of 67 months, 1,017 (11.7%) of 8,678 patients developed diabetes, giving a cumulative incidence at 5 years of 9.1% (95% confidence interval, 8.4-9.8%). In fully adjusted models, patients with apnea-hypopnea index (AHI) greater than 30 had a 30% higher hazard of developing diabetes than those with AHI less than 5. Among other OSA-related variables, AHI in rapid eye movement sleep and time spent with oxygen saturation less than 90% were associated with incident diabetes, as were heart rate, neck circumference, and sleep time. Conclusions: Among people with OSA, and controlling for multiple confounders, initial OSA severity and its physiologic consequences predicted subsequent risk for incident diabetes. [ABSTRACT FROM AUTHOR]

The article presents the discussion on randomized clinical trials (RCTs) producing high-quality evidence for making inferences about the causal effects of an intervention on outcomes.

The article presents the discussion on well-performed randomized clinical trials (RCTs) producing high-quality evidence for making inferences about the causal effects of an intervention on outcomes updating the framework as new evidence.