Endobronchial biopsy: a guide for asthma therapy selection in the era of bronchial thermoplasty.

Objective: Bronchial thermoplasty (BT) reduces airway smooth muscle in patients with severe asthma. We developed a novel standardized histologic grading system assessing inflammation and structural remodeling on endobronchial biopsy (EBBx) in severe persistent asthma and evaluated airway structure before and after BT. In addition, we correlated invasive and non-invasive inflammatory markers in severe persistent asthma.

Maternal asthma and microRNA regulation of soluble HLA-G in the airway.

Background: We previously reported an interaction between maternal asthma and the child's HLA-G genotype on the child's subsequent risk for asthma. The implicated single nucleotide polymorphism at +3142 disrupted a target site for the microRNA (miR)-152 family. We hypothesized that the interaction effect might be mediated by these miRs.

Safety and feasibility of bronchial thermoplasty in asthma patients with very severe fixed airflow obstruction: a case series.

Objective: Bronchial thermoplasty (BT) can provide relief for patients with severe, uncontrolled asthma despite maximal medical therapy. However, it is unclear whether BT is safe in patients with very severe airflow obstruction.

Methods: We performed BT in eight patients with severe asthma as defined by Expert Panel Report 3 (EPR-3) guidelines who were poorly controlled despite step 5 therapy.

Confirmatory spirometry for adults hospitalized with a diagnosis of asthma or chronic obstructive pulmonary disease exacerbation.

Background: Objective measurement of airflow obstruction by spirometry is an essential part of the diagnosis of asthma or COPD. During exacerbations, the feasibility and utility of spirometry to confirm the diagnosis of asthma or chronic obstructive pulmonary disease (COPD) are unclear. Addressing these gaps in knowledge may help define the need for confirmatory testing in clinical care and quality improvement efforts.

Stakeholder priorities for comparative effectiveness research in chronic obstructive pulmonary disease: a workshop report.

Comparative effectiveness research (CER) is intended to address the expressed needs of patients, clinicians, and other stakeholders. Representatives of 54 stakeholder groups with an interest in chronic obstructive pulmonary disease (COPD) participated in workshops convened by the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) over a 2-year period. Year 1 focused on chronic care and care coordination.

Obesity is associated with a lower resting oxygen saturation in the ambulatory elderly: results from the cardiovascular health study.

Background: The contribution of obesity to hypoxemia has not been reported in a community-based study. Our hypothesis was that increasing obesity would be independently associated with lower SpO2 in an ambulatory elderly population.

Methods: The Cardiovascular Health Study ascertained resting SpO2 in 2,252 subjects over age 64.

Comparative effectiveness research in chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease affects millions worldwide. It is America's third leading cause of death, and results in significant morbidity and cost. Although many therapies exist and are being developed to alleviate symptoms and decrease morbidity and mortality in chronic obstructive pulmonary disease, most have only been studied in placebo-controlled efficacy studies in highly selected populations.

Effects of positive airway pressure treatment on clinical measures of hypertension and type 2 diabetes.

Purpose: Mechanistic and observational studies support an independent increase in risk of hypertension and abnormal glucose metabolism associated with obstructive sleep apnea (OSA). However, the specific populations and outcomes that improve with treatment of OSA in clinical practice are not established. We examined the effectiveness of OSA treatment on clinical blood pressure and diabetes control measures in men with preexisting systemic hypertension or type 2 diabetes.

Pathologic quantification of connective tissue disease-associated versus idiopathic usual interstitial pneumonia.

Context: Usual interstitial pneumonia (UIP) is a common chronic interstitial pneumonitis. It can occur idiopathically (I-UIP) or in the setting of systemic connective tissue disease (CTD-UIP). Some studies suggest that CTD-UIP has a better prognosis than I-UIP.

Long-acting β2-agonist step-off in patients with controlled asthma.

Background: Because of concerns about the safety of long-acting β(2)-agonist (LABA) use in patients with asthma, withdrawal of the LABA is recommended by the US Food and Drug Administration once asthma is controlled by combination therapy with a LABA and inhaled corticosteroid (ICS).

Objective: To perform a systematic review and meta-analysis assessing evidence supporting the discontinuation of LABA therapy once asthma control has been achieved with a combination of ICS and LABA.

Data Sources: MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched (through August 2010), references of identified studies and selected narrative review articles were evaluated, registries of clinical trials were reviewed, and manufacturers of LABAs were contacted.

The prevalence of clinically-relevant comorbid conditions in patients with physician-diagnosed COPD: a cross-sectional study using data from NHANES 1999-2008.

Background: Treatment of chronic diseases such as chronic obstructive pulmonary disease (COPD) is complicated by the presence of comorbidities. The objective of this analysis was to estimate the prevalence of comorbidity in COPD using nationally-representative data.

Methods: This study draws from a multi-year analytic sample of 14,828 subjects aged 45+, including 995 with COPD, from the National Health and Nutrition Examination Survey (NHANES), 1999-2008.

Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial.

Background: Hospitalized patients frequently misuse their respiratory inhalers, yet it is unclear what the most effective hospital-based educational intervention is for this population.

Objective: To compare two strategies for teaching inhaler use to hospitalized patients with asthma or chronic obstructive pulmonary disease (COPD).

Design: A Phase-II randomized controlled clinical trial enrolled hospitalized adults with physician diagnosed asthma or COPD.

Asthma outcomes: symptoms.

Background: Respiratory symptoms are commonly used to assess the impact of patient-centered interventions.

Objective: At the request of National Institutes of Health (NIH) institutes and other federal agencies, an expert group was convened to propose which measurements of asthma symptoms should be used as a standardized measure in future clinical research studies.

Methods: Asthma symptom instruments were classified as daily diaries (prospectively recording symptoms between research visits) or retrospective questionnaires (completed at research visits).

Adherence to inhaled corticosteroids: an ancillary study of the Childhood Asthma Management Program clinical trial.

Background: Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are limited.

Objective: We sought to compare subjective and objective measurements of children's adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes.

Methods: In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 μg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years.

Outcomes of noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease in the United States, 1998-2008.

Rationale: The patterns and outcomes of noninvasive, positive-pressure ventilation (NIPPV) use in patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease (COPD) nationwide are unknown.

Objectives: To determine the prevalence and trends of noninvasive ventilation for acute COPD.

Methods: We used data from the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample to assess the pattern and outcomes of NIPPV use for acute exacerbations of COPD from 1998 to 2008.

Comparative effectiveness research in lung diseases and sleep disorders: recommendations from the National Heart, Lung, and Blood Institute workshop.

The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, and economic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed.

High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial.

Background: High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).

Methods: Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers.

Patient-related factors associated with hospital discharge to a care facility after critical illness.

Background: Many critically ill patients are transferred to other care facilities instead of to home at hospital discharge.

Objective: To identify patient-related factors associated with hospital discharge to a care facility after critical illness and to estimate the magnitude of risk associated with each factor.

Methods: Retrospective cohort study of 548 survivors of critical illness in a medical intensive care unit.

The validity of International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes for identifying patients hospitalized for COPD exacerbations.

Background: Acute exacerbations of COPD (AE-COPD) are a leading cause of hospitalizations in the United States. To estimate the burden of disease (eg, prevalence and cost), identify opportunities to improve care quality (eg, performance measures), and conduct observational comparative effectiveness research studies, various algorithms based on the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes have been used to identify patients with COPD. However, the validity of these algorithms remains unclear.

Type II diabetes mellitus is associated with decreased measures of lung function in a clinical setting.

Aims: Type II diabetes mellitus has been associated with reduced forced expiratory volume in first second (FEV(1)) and forced vital capacity (FVC). We investigated if this relationship is maintained in a clinical setting, independent of respiratory infections and heart failure.

Methods: Pulmonary function tests and discharge summaries of 639 adults 18-80 years of age, of different races/ethnicities, seen at an urban hospital during a two years period were reviewed.

Effect of a community-wide asthma intervention on appropriate use of inhaled corticosteroids.

Individuals with asthma living in the inner city experience increased asthma morbidity and mortality compared to the US average. The Controlling Asthma in America's Cities Project's Chicago site used a multifaceted approach to improve asthma care. The diverse scope of this project's interventions necessitated the use of novel methods to assess the effect of these interventions on the entire study area.

Misuse of respiratory inhalers in hospitalized patients with asthma or COPD.

Background: Patients are asked to assume greater responsibility for care, including use of medications, during transitions from hospital to home. Unfortunately, medications dispensed via respiratory inhalers to patients with asthma or chronic obstructive pulmonary disease (COPD) can be difficult to use.

Objectives: To examine rates of inhaler misuse and to determine if patients with asthma or COPD differed in their ability to learn how to use inhalers correctly.

Increased risk of venous thromboembolism with a sirolimus-based immunosuppression regimen in lung transplantation.

Background: Sirolimus (rapamycin) is a potent anti-proliferative agent with immunosuppressive properties that is increasingly being used in solid-organ and hematopoietic stem cell transplantation. In addition, this drug is being investigated for treatment of a broad range of disorders, including cardiovascular disease, malignancies, tuberous sclerosis, and lymphangeioleiomyomatosis. In this study, we found an increased risk of venous thromboembolism (VTE) in lung transplant recipients treated with a sirolimus (SIR)-based immunosuppressive regimen.

A call for action: Comparative effectiveness research in asthma.

Comparative effectiveness research (CER) has received considerable research attention in recent months, and efforts to promote CER are part of the newly enacted Patient Protection and Affordable Care Act. In this article we define CER and how it complements traditional efficacy research in asthma and discuss how CER can help provide the basis for rational decision making about the care of individual patients with asthma and how best to deliver this care in real-world settings. We present information about the challenges and opportunities to conduct CER, including enhanced patient registries for observational CER and effectiveness trials (also called pragmatic trials).