Asthma management and control in the United States: results of the 2009 Asthma Insight and Management survey.

Past asthma surveys have shown suboptimal management and control of asthma in the United States. No major survey of asthma management has been conducted since the Third Expert Panel Report for the National Asthma Education and Prevention Program (NAEPP) guidelines on diagnosis and treatment of asthma (August 2007). This study was designed to report asthma management and control results from the Asthma Insight and Management survey of U.S. patients and physicians. A telephone-based survey was conducted during 2009 in 2500 patients with asthma, aged ≥12 years, and 309 physicians (104 allergists, 54 pulmonologists, 101 family practitioners, and 50 internists). Patients' asthma control perceptions (71% "completely controlled" or "well controlled") were inconsistent with their NAEPP control level as determined by self-reported symptoms (29% well controlled). Patients and physicians had low expectations for effective asthma management; patients considered asthma well managed if rescue medication was used three times per week (46%), urgent care visits occurred twice per year (67%), or emergency department visits occurred once per year (60%). Asthma-related syncope, seizure, intensive care unit admission, and intubation were associated with uncontrolled asthma based on NAEPP guidelines. Respiratory specialists (allergists/pulmonologists) implemented asthma management recommendations more than other physicians surveyed. However, only 22% of patients visited a specialist for usual asthma care and 48% had never visited a specialist. Despite detailed NAEPP guidance, asthma management and control in U.S. patients is unsatisfactory. Improved asthma control assessment (impairment and risk) and implementation of NAEPP management recommendations are needed to improve asthma control and outcomes.

Asthma burden in the United States: results of the 2009 Asthma Insight and Management survey.

Updated guidelines and new treatments for asthma have become available since the last major survey of asthma management in the United States was completed ∼11 years ago. The Asthma Insight and Management (AIM) survey was conducted to assess the current status of asthma burden in the United States. A geographically stratified screening of 60,682 households provided a national sample of 2500 patients with current asthma (2186 adults aged ≥18 years; 314 adolescents aged 12-17 years). A national sample of 1004 adults without current asthma was interviewed for comparison with the adult asthma population, and 309 asthma health care providers were surveyed for their opinions about the burden of asthma. Asthma prevalence in the United States was estimated at 8%. Twice as many adult asthma patients rated their health as "only fair," "poor," or "very poor," or experienced limitations in activity because of health problems, compared with the general population. Asthma also frequently caused negative emotional symptoms in patients. Most patients experienced asthma throughout the year (63%) and symptoms within the 4 weeks before the summer survey (68%). Overall, 41% of patients responded that asthma interfered with their/their child's life "some" or "a lot". During the year before the survey, 69% of patients experienced at least one severe asthma episode. Asthma burden in the United States remains high despite the availability of updated treatment guidelines and new therapies. Asthma care in the United States remains suboptimal, indicating the need for continued improvements in patient management.

Patient and physician asthma deterioration terminology: results from the 2009 Asthma Insight and Management survey.

Long-term achievement of asthma control is dependent in part on the use of mutually understandable asthma terminology in all verbal and written patient-physician communications. Using data from the Asthma Insight and Management (AIM) survey, the objective of this analysis is to provide a contemporary depiction of asthma deterioration terminology as used by current asthma patients and physicians in the United States. As part of the 2009 AIM survey, current asthma patients (≥12 years of age; weighted n = 2499) and physicians (n = 309) were queried about their recognition, understanding, and/or use of the terms "asthma attack," "asthma flare-up," and "asthma exacerbation" in telephone interviews. Nearly all patients had heard the term "asthma attack" (97%), but relatively few had heard the term "asthma exacerbation" (24%); 71% had heard "asthma flare-up." In contrast, physicians reported using the term "asthma attack" least (65%) and the term "asthma exacerbation" most (77%) when discussing asthma with their patients; 70% reported using "asthma flare-up." Among patients familiar with "asthma flare-up" and "asthma exacerbation" (n = 502), only 38% said that the terms mean the same thing; nearly all physicians (94%) said that the terms mean the same thing. Collectively, data from the AIM survey suggest that patients and physicians use different asthma deterioration terminology and, more importantly, that they do not necessarily understand each other's terms. Standardizing asthma deterioration terminology may help optimize asthma patient-physician communication to improve patient understanding of written asthma action plans and therefore, enhance patient outcomes.

Comparison of the Asthma in America and Asthma Insight and Management surveys: did asthma burden and care improve in the United States between 1998 and 2009?

Significant changes in asthma treatment guidelines and therapies occurred between the period of time in which the Asthma in America (AIA) and Asthma Insight and Management (AIM) surveys were conducted: 1998 and 2009, respectively. This study compares asthma burden and management in 1998 and 2009. Both surveys were telephone based and conducted across the United States. The AIA survey included 2509 patients with asthma (aged <1 year to 89 years old), 512 physicians, and 1000 adults from the general population. The AIM survey included 2500 patients (aged ≥12 years), 309 physicians, and 1090 adults from the general population. Patient responses were weighted to match the entire population of U.S. patients with asthma. The impact of asthma burden and care on the general population and on asthma patients was slightly lower or unchanged in the AIM survey versus the AIA survey. Acute care use (hospitalizations, emergency department visits, or other urgent care visits) was common in AIA (36%) and AIM (34%) surveys. Most physicians were aware of guidelines in AIA (90%) and AIM (96%), but fewer "always" followed them (AIA, 36%; AIM, 28%). Spirometry was often used to aid in diagnosis by asthma care specialists (AIA, 73%; AIM, 76%) but infrequently by nonsubspecialists (AIA, 27%; AIM, 38%). Most physicians prescribed inhaled corticosteroids (ICSs) for mild (AIA, 70%; AIM, 83%) or moderate (AIA, 89%; AIM, 83%) persistent asthma. In the AIM survey, 38% of specialists prescribed ICSs combined with a long-acting ß2-agonist for moderate asthma. The state of U.S. asthma care and clinical outcomes changed little from 1998 to 2009.

GOLD in Practice: Chronic Obstructive Pulmonary Disease Treatment and Management in the Primary Care Setting.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality. Early detection and appropriate treatment and management of COPD can lower morbidity and perhaps mortality. Clinicians in the primary care setting provide the majority of COPD care and are pivotal in the diagnosis and management of COPD. In this review, we provide an overview of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020 report, with a focus on the management of COPD in the primary care setting. We discuss the pathophysiology of COPD; describe COPD risk factors, signs, and symptoms that may facilitate earlier diagnosis of COPD; and reinforce the importance of spirometry use in establishing the diagnosis of COPD. Disease monitoring, as well as a review of the 2020 GOLD treatment recommendations, is also discussed. Patients and families are important partners in COPD management; therefore, we outline simple steps that may assist them in caring for those affected by COPD. Finally, we discuss nonpharmacological treatment options for COPD, COPD monitoring tools that may aid in the evaluation of disease progression and response to therapy, and the importance of developing a COPD action plan on an individualized basis.

Strategies to Reduce Errors Associated with 2-Component Vaccines.

The high incidence of error reports received by the US Food and Drug Administration (FDA) involving 2-component vaccines led to collaboration between the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). This collaborating group sought to further understand errors associated with all 2-component vaccines (i.e. vaccine components provided by the manufacturer in physically separate containers) and to provide safe practice strategies for storing, preparing, dispensing, and administering these vaccines as intended. Fourteen available 2-component vaccines were identified. The ISMP National Vaccine Errors Reporting Program (VERP) and the FDA Vaccine Adverse Event Reporting System (VAERS) were searched from the initiation of each respective reporting system through December 31, 2019. The three vaccines with the most reported reconstitution errors in the VERP and VAERS are Menveo® (meningococcal), Pentacel® (DTaP, Polio, Haemophilus influenzae type b), and ActHIB® [H. influenzae type b (Hib)]. Manufacturers should design labeling and packaging of vaccines to provide ease of storage and fail-safe preparation to prevent 2-component vaccine errors. Implementing risk reduction strategies, such as training healthcare professionals and affixing storage bin labels, remind healthcare professionals to mix the 2-components and facilitate appropriate administration.

Oxygen therapy in advanced COPD: in whom does it work?

Supplemental oxygen therapy is commonly used in patients with advanced chronic obstructive pulmonary disease (COPD) and severe hypoxemia at rest. Use of oxygen in these patients is justified by studies showing a mortality benefit. However, the use of oxygen in other patients with advanced COPD has not clearly been established. Long-term studies assessing not only mortality but also other outcomes that are important to patients and physicians such as dyspnea, health status, and exercise capacity are lacking. This article reviews the available studies of the use of supplemental oxygen in patients with less severe hypoxemia at rest during the day, hypoxemia occurring only at night, and hypoxemia occurring only with exercise. With the knowledge that studies in patients with advanced COPD and less severe hypoxemia are limited, recommendations are provided on oxygen use in these groups of patients.

Tiotropium Respimat Efficacy and Safety in Asthma: Relationship to Age.

BACKGROUND: Data are limited on the differential response to long-acting bronchodilators in older versus younger adults with asthma. OBJECTIVE: To determine whether the response to tiotropium Respimat differed in older versus younger patients with asthma. METHODS: Post hoc analyses of 4 randomized, double-blind, placebo-controlled studies in adults with asthma were carried out. Two studies compared tiotropium Respimat 5 µg once daily with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting ß2-agonist (ie, severe asthma). The other 2 evaluated tiotropium Respimat 2.5 or 5 µg once daily, salmeterol 50 µg twice daily, or placebo, all added to medium-dose ICS (moderate asthma). Data were analyzed in 2 pools: (1) severe and (2) moderate asthma. Efficacy end points: trough and peak FEV1; trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage, all at week 24. One set of analyses was performed with age as a continuous covariate; the second was conducted in categories less than 40, 40 to 60, and more than 60 years, with treatment-by-age subgroup interaction P values obtained. Safety was analyzed in age categories. RESULTS: Across the age categories, treatment-by-age subgroup interaction P values for trough FEV1 were .13 and .77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the 2 continuum analyses. The other end points (including safety) were also not impacted by age. CONCLUSIONS: Once-daily tiotropium Respimat add-on to ICS or ICS/long-acting ß2-agonist therapy was effective and well tolerated in patients with asthma independent of age.

A review of the role of FEV1 in the COPD paradigm.

Historically, spirometry has been the objective measure used to confirm a symptom-based clinical suspicion of COPD. The third National Health and Nutrition Examination Survey (NHANES III) created a strong rationale for early identification and intervention in COPD by documenting the ability of spirometry to detect mild airflow problems in many asymptomatic smokers. Predicted values for spirometry, however, must be adjusted to account for variations in age, gender, height, ethnicity and race. Many experts agree that NHANES III reference equations are much better suited to COPD practice than most other predicted value standards. However, standards other than NHANES III have been adopted in current medical guidelines; standards that may inappropriately classify younger adults as normal and older adults as abnormal, potentially leading to widespread misdiagnosis and mis-directed therapies in clinical practice. Despite the shortcomings of established diagnostic predicted values, spirometry remains the best available tool for early and accurate diagnosis of COPD in those at risk for the disease, and is also useful in conjunction with other modalities in patients with established disease to determine prognosis and assessing therapeutic benefits. In the clinical trial settings, as well as in day-to-day practice, spirometry results should be combined with other endpoints in order to better reflect overall patient status. This review highlights key medical evidence surrounding both usefulness and limitations of FEV(1) in the setting of COPD.

Office Spirometry in Primary Care for the Diagnosis and Management of COPD: National Lung Health Education Program Update.

The use of office spirometry was recommended by the National Lung Health Education Program (NLHEP) consensus conference in 1999 for detection and management of COPD. Since that time, spirometry utilization has increased, but its role in the diagnosis of COPD is still evolving. This update reviews the role of spirometry for screening and case finding in COPD as well as for asthma. Spirometry has been used for disease management in patients with airway obstruction, with varying results. The diagnostic criteria for COPD using spirometry have also evolved in the past 17 years, with differences arising between the Global Initiative for Chronic Obstructive Lung Disease and NLHEP recommendations. More sophisticated spirometers as well as new reference equations are widely available. Standardization guidelines from the American Thoracic Society/European Respiratory Society published in 2005 provide a robust framework for performing and interpreting spirometry, but clinicians still need hands-on training and meaningful feedback to perform high-quality spirometry in the office setting.

Acute alcohol intake impairs lung inflammation by changing pro- and anti-inflammatory mediator balance.

Previous studies have shown that alcohol (ethanol [EtOH]) intoxication impairs lung immunity by affecting cytokines pivotal to the inflammatory process. The objective of this study was to test the hypothesis that acute alcohol intoxication impairs lung innate immunity by downregulating the expression of proinflammatory mediators while simultaneously upregulating anti-inflammatory mediators. EtOH was administered to the mice 0.5h prior to an intratracheal injection of Escherichia coli lipopolysaccharide (LPS). The animals were killed either 4 or 24h after LPS to recover plasma, lungs, and bronchoalveolar lavage fluid. Lung inflammatory cytokines tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1beta), IL-6, macrophage inhibitory factor (MIF), IL-10, TGF-beta, and receptors for TNF-alpha, IL-1beta, IL-6, and TGF-beta as well as glycoprotein (gp)130 and corticosterone (CS) levels were evaluated at mRNA and protein level. While the mRNA expression and the soluble TNF-Rp55 levels were significantly upregulated by EtOH, LPS-induced TNF-alpha activity, TNF-Rp55 mRNA expression, and soluble TNF-Rp55 levels were significantly suppressed. The LPS-induced expression of IL-1beta, IL-6, MIF, gp130, and receptors IL-1RI, IL-1RII, and IL-6Ralpha were also significantly impaired by EtOH. EtOH increased significantly the basal IL-10 activity at 3h, which continued to remain elevated even at 24h. The EtOH effect on IL-10 activity persisted even in LPS-challenged mice. EtOH and LPS augmented lung CS levels independently of each other. EtOH suppressed upregulation of TGF-beta1 mRNA expression by LPS and blocked completely LPS-induced TGF-beta1 secretion. In conclusion, the data suggest that the suppression of acute lung inflammation by EtOH intoxication is largely due to impairment by EtOH of proinflammatory cytokine signaling at the levels of cytokine expression and secretion as well as receptor expression and soluble receptor activity. The augmentation by EtOH of anti-inflammatory mediators' secretion most likely shifts the cytokine balance in the anti-inflammatory direction.

Respiratory Compromise as a New Paradigm for the Care of Vulnerable Hospitalized Patients.

Acute respiratory compromise describes a deterioration in respiratory function with a high likelihood of rapid progression to respiratory failure and death. Identifying patients at risk for respiratory compromise coupled with monitoring of patients who have developed respiratory compromise might allow earlier interventions to prevent or mitigate further decompensation. The National Association for the Medical Direction of Respiratory Care (NAMDRC) organized a workshop meeting with representation from many national societies to address the unmet needs of respiratory compromise from a clinical practice perspective. Respiratory compromise may arise de novo or may complicate preexisting lung disease. The group identified distinct subsets of respiratory compromise that present similar opportunities for early detection and useful intervention to prevent respiratory failure. The subtypes were characterized by the pathophysiological mechanisms they had in common: impaired control of breathing, impaired airway protection, parenchymal lung disease, increased airway resistance, hydrostatic pulmonary edema, and right-ventricular failure. Classification of acutely ill respiratory patients into one or more of these categories may help in selecting the screening and monitoring strategies that are most appropriate for the patient's particular pathophysiology. Standardized screening and monitoring practices for patients with similar mechanisms of deterioration may enhance the ability to predict respiratory failure early and prevent its occurrence.

Global Initiative on Obstructive Lung Disease (GOLD) classification of lung disease and mortality: findings from the Atherosclerosis Risk in Communities (ARIC) study.

OBJECTIVE: To determine whether a modified Global Initiative on Obstructive Lung Diseases (GOLD) classification of chronic obstructive pulmonary disease (COPD) predicts mortality in a cohort of subjects followed for up to 11 years. METHODS: We analyzed data from 15,759 adult participants, aged 43-66 years at baseline, in the Atherosclerosis Risk in Communities (ARIC) study. All baseline and follow-up data were available for 15,440 (97.9%) of the initial participants. We classified subjects using a modification of the GOLD criteria for COPD (prebronchodilator forced expiratory volume in 1s (FEV(1)) stratification of disease severity), and added a "restricted" category (FEV(1)/FVC>70% and FVC<80% predicted). We used Cox proportional hazard models to determine the risk of impaired lung function on subsequent mortality, after adjusting for age, race, sex and smoking status. RESULTS: 1242 (8.0%) subjects died by the end of 1997. The overall rate of death was 8.9 per 1000 person years, but varied from 5.4/1000 among normal subjects to 42.9/1000 among subjects with GOLD Stage 3 or 4 COPD. After adjusting for covariates, all GOLD categories, along with the restricted category, predicted a higher risk of death: GOLD Stage 3 or 4, hazard ratio (HR) 5.7, 95% confidence interval (CI) 4.4, 7.3; GOLD Stage 2 HR 2.4, 95% CI 2.0, 2.9; GOLD Stage 1 HR 1.4, 95% CI 1.1, 1.6; GOLD Stage 0 HR 1.5, 95% CI 1.3, 1.8; and restricted HR 2.3, 95% CI 1.9, 2.8. CONCLUSION: The modified GOLD classification system of COPD predicts mortality in this cohort of middle-aged Americans followed for up to 11 years.

The role of body mass index and diabetes in the development of acute organ failure and subsequent mortality in an observational cohort.

INTRODUCTION: Several studies have shown a correlation between body mass index (BMI) and both the development of critical illness and adverse outcomes in critically ill patients. The goal of our study was to examine this relationship prospectively with particular attention to the influence of concomitant diabetes mellitus (DM). METHODS: We analyzed data from 15,408 participants in the Atherosclerosis Risk in Communities (ARIC) study for this analysis. BMI and the presence of DM were defined at baseline. We defined 'acute organ failure' as those subjects who met a standard definition with diagnostic codes abstracted from hospitalization records. Outcomes assessed included the following: risk of the development of acute organ failure within three years of the baseline examination; in-hospital death while ill with acute organ failure; and death at three years among all subjects and among those with acute organ failure. RESULTS: At baseline, participants with a BMI of at least 30 were more likely than those in lower BMI categories to have DM (22.4% versus 7.9%, p < 0.01). Overall, BMI was not a significant predictor of developing acute organ failure. The risk for developing acute organ failure was increased among subjects with DM in comparison with those without DM (2.4% versus 0.7%, p < 0.01). Among subjects with organ failure, both in-hospital mortality (46.5% versus 12.2%, p < 0.01) and 3-year mortality (51.2% versus 21.1%, p < 0.01) was higher in subjects with DM. CONCLUSION: Our findings suggest that obesity by itself is not a significant predictor of either acute organ failure or death during or after acute organ failure in this cohort. However, the presence of DM, which is related to obesity, is a strong predictor of both acute organ failure and death after acute organ failure.

Plasma PGE-2 levels and altered cytokine profiles in adherent peripheral blood mononuclear cells in non-small cell lung cancer (NSCLC).

INTRODUCTION: PGE-2 is constitutively produced by many non-small cell lung cancers (NSCLC) and its immunosuppressive effects have been linked to altered immune responses in lung cancer. We asked whether elevated levels of plasma PGE-2 correlated with monocyte IL10 production in the NSCLC environment. Looking for correlation in NSCLC patient blood we assayed plasma from NSCLC patients for PGE2 and IL10; we further evaluated production of IL10 by adherent mononuclear cells from a subset of these patients looking for an altered cytokine profile. RESULTS: Our initial in vitro experiments show that monocyte IL10 induction correlates with tumor cell PGE-2 production, confirming similar reports in the literature. Data show plasma PGE-2 levels in 38 NSCLC patients are elevated compared to normal controls. Plasma IL10 levels were not significantly elevated; however, adherent monocytes derived from NSCLC patient blood did produce significantly more IL10 in 24 hr primary culture than those from normal controls (p < 0.01). The association of elevated plasma PGE-2 and monocyte derived IL-10 was not significant. CONCLUSIONS: Elevated plasma PGE-2 and monocyte IL10 production are associated with NSCLC. The biological significance to elevated PGE-2 levels in NSCLC are unclear. Further investigation of each as a nonspecific marker for NSCLC tumor is warranted.

The pathophysiology of airway dysfunction.

Asthma and chronic obstructive pulmonary disease (COPD) are distinct inflammatory disorders with differing pathophysiologic mechanisms, different clinical courses, and, therefore, distinct treatment strategies. Whereas in asthma airflow limitation is typically episodic and reversible, airflow limitation in COPD is progressive and only partially reversible. In contrast to asthma, which is characterized by an elevated number of eosinophils in the blood and the accumulation of elevated numbers of activated eosinophils, mast cells, and CD4+ T(H)2-lymphocytes in the lungs, the primary inflammatory cells present in the lungs of patients with stable COPD are neutrophils, macrophages, and CD8+ lymphocytes. Bronchoconstriction in COPD is largely regulated by cholinergically mediated vagal tone, and the pathologic processes of COPD further reduce airway patency. Bronchodilators, most notably anticholinergics, are recommended as first-line pharmacologic therapy for COPD. Proper use of inhaled anticholinergic medications has been shown to lead to significant reversibility of acetylcholine-mediated bronchoconstriction during both stable disease and exacerbations of COPD. For patients with asthma, current guidelines recommend anti-inflammatory medications, specifically inhaled corticosteroids and leukotriene-modifiers, as first-line therapy, making these agents the mainstay of asthma therapy. In contrast, the current guidelines for COPD management recommend that inhaled anti-inflammatory agents be tried in patients with COPD only as second-line therapy for patients who have severe to very severe airflow obstruction with frequent exacerbations and who remain symptomatic despite maximized bronchodilation with multiple inhaled bronchodilators. Hence, it is extremely important to understand the differences between the underlying pathogenesis and pathophysiology of COPD and those of asthma, as these differences dictate the implementation of distinctly different treatment options for these 2 diseases.

Empyema caused by trichomonas.

Empyema is one of the potential complications of lower respiratory tract infections. Very rarely, in predisposed individuals, empyema can be caused by Trichomonas species, of which Trichomonas tenax appears to be the most common cause. Here, we present a case of trichomonal empyema in a 56-year-old man and review the available literature of this rare occurrence.

The National Lung Health Education Program: roots, mission, future directions.

The National Lung Health Education Program (NLHEP), founded in 1997, is a national health care initiative to promote early diagnosis of chronic obstructive pulmonary disease and related disorders. NLHEP creates and provides lung health publications for laypeople and health professionals and develops and conducts workshops for health care professionals, to promote clinician expertise in office spirometry and spirogram interpretation, and to increase everyone's awareness of the effects of smoking and the availability of smoking-cessation programs, support systems, and treatments. The American Association for Respiratory Care (AARC) has been a NLHEP partner from the beginning, and now those 2 organizations are adding another dimension to their partnership: AARC is going to take over all NLHEP administrative functions.

Management of the symptomatic patient.

Chronic obstructive pulmonary disease (COPD) is both preventable and treatable. There has been a significant reduction in premature morbidity and mortality from heart disease and stroke, the number 1 and 3 killers in the United States, respectively, largely because of efforts to increase both clinician and public awareness of these diseases. Early and aggressive management of COPD has not yet reached the same level. Primary care professionals are in the forefront in the early detection, prevention, and treatment of this serious national health problem.