Primary care referral patterns for patients with asthma: analysis of real-world data.

OBJECTIVE: To identify features related to management of patients prior to referral from primary care physicians (PCPs) to pulmonologists and allergists. METHODS: This is an analysis of patient claims data from Symphony Health (2013-2018). To characterize referrals, a longitudinal cohort included 12 months with no asthma claims prior to the index date, followed by 36 months of observation. We also assessed a cross-sectional cohort for 12 months at the end of the observational period to characterize disease control and treatment patterns. Referral was defined as the first appearance of a claim from an allergist or pulmonologist for a patient's initial visit for asthma. Descriptive statistics were used to analyze the data. RESULTS: The majority of patients with asthma were managed by PCPs (60%), followed by pulmonologists (16%) and allergists (8%). Forty-three percent had uncontrolled asthma. Only 8% were referred to specialists within the first 24 months after initial diagnosis, of which 76% were seen by pulmonologists and 24% by allergists. Referrals resulted in treatment change in 55%-68% of the cases. Patients who received a referral were more likely to be on oral corticosteroids (OCS) and/or have more hospitalizations/ED visits. CONCLUSIONS: About one-third of the patients managed by PCPs received intermittent and/or chronic OCS prior to referral, which may be an indication of uncontrolled disease. The referral patterns in this analysis illustrate underutilization of specialists in the consultation and management of patients with uncontrolled asthma.

The role of ACT score in mepolizumab discontinuation.

BACKGROUND: Mepolizumab is a therapy for severe asthma. We have little knowledge of the characteristics of people in the US that discontinue mepolizumab in clinical care. OBJECTIVE: To investigate the real-world efficacy and time to clinical discontinuation of mepolizumab, we evaluated individuals with asthma started on mepolizumab at the Cleveland Clinic. We hypothesized that individuals that discontinue mepolizumab have more severe and uncontrolled asthma at baseline. METHODS: Between 2016 and 2022, patients who started on mepolizumab consented to be assessed over 18 months. At baseline, a questionnaire including demographic and medical history was collected. Laboratory findings such as ACT score, FENO (Fractional Excretion of Nitric Oxide), and spirometry were recorded. At the conclusion of the observation period, the participants were divided into two categories: Group A and Group B. RESULTS: Group B [N = 28] discontinued mepolizumab (p < 0.05) at an average of 5.8 months (SD 4.2 months). Group A [N = 129] stayed on the therapy for at least 1 year. A participant with an ACT score less than 13 has an odds ratio of 6.64 (95% CI, 2.1 - 26.0) of discontinuing mepolizumab therapy. For a male, the odds of discontinuing mepolizumab therapy is 3.39 (95% CI, 1.1-11.2). CONCLUSION: In this real-world study, we find that high eosinophil count may not be adequate in screening which individuals will benefit from mepolizumab. Up to 17% of patients fail therapy within 6 months, with male sex and low ACT score increasing risk of mepolizumab discontinuation at Cleveland Clinic.

Life Course of Asthma.

Asthma is a heterogeneous chronic airway disease that can vary over a lifetime. Although broad categories of asthma by severity and type have been constructed, there remains a tremendous opportunity to discover an approach to managing asthma with additional factors in mind. Many in the field have suggested and are pursuing a novel paradigm shift in how asthma might be better managed, considering the life course of exposures, management priorities, and predicted trajectory of lung function growth. This approach will require a more holistic view of prenatal, postnatal, adolescence, hormonal and gender aspects, and the aging process. In addition, the environment, externally and internally, including in one's genetic code and epigenetic changes, are factors that affect how asthma progresses or becomes more stable in individuals. This chapter focuses on the various influences that may, to differing degrees, affect people with asthma, which can develop at any time in their lives. Shifting the paradigm of thought and strategies for care and advocating for public policies and health delivery that focus on this philosophy is paramount to advance asthma care for all.

The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions.

Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.

Dietary patterns in patients with asthma and their relationship with asthma-related emergency room visits: NHANES 2005-2016.

RATIONALE: Extensive interdependencies exist between dietary intake, metabolic dysregulation, and asthma; however, the dietary pattern in adults with asthma remains unknown. OBJECTIVES: To evaluate the association between dietary patterns and asthma ER visits and explore the effect of the interaction between race and diet on asthma. METHODS: Using NHANES data, we compared dietary patterns between adults with asthma with and without asthma-related emergency room (ER) visits in the previous year, and between subjects of different races. The 2015 Healthy Eating Index (HEI-2015) was used to assess alignment between dietary patterns and the 2015-2020 Dietary Guideline for Americans. RESULTS: Among 1681 individuals included in the study, 193 reported asthma-related ER visit. Patients with asthma had low fruit and vegetable intake, and a low mean (SE) HEI-2015 score [52.6 (0.53)]. Individuals with asthma-related ER visits had lower vegetable consumption compared to those without (median 0.61 vs. 0.85 cup equivalents). Furthermore, non-Hispanic Blacks (NHB) reported lower amount of vegetable (median cup equivalent 0.58 vs. 0.89) and fruit intake (0.17 vs. 0.39) and had a lower HEI-2015 score (49.9 vs. 52.9) comparing to non-Hispanic Whites. No association was discovered between dietary patterns and ER visits in multivariable analysis, or significant interactions between diet and race in predicting the need for ER visits. CONCLUSIONS: Dietary patterns in adult with current asthma are frequently misaligned with current dietary guidelines. Patients with asthma-related ER visits and of NHB race had lower vegetable consumption; however, the associations disappeared in multivariable analysis. The impact of diet on asthma is not straightforward and deserves further investigation.Supplemental data for this article is available online at at www.tandfonline.com/ijas.

Use of Fractional Exhaled Nitric Oxide to Guide the Treatment of Asthma: An Official American Thoracic Society Clinical Practice Guideline.

Background: The fractional exhaled nitric oxide (FENO) test is a point-of-care test that is used in the assessment of asthma. Objective: To provide evidence-based clinical guidance on whether FENO testing is indicated to optimize asthma treatment in patients with asthma in whom treatment is being considered. Methods: An international, multidisciplinary panel of experts was convened to form a consensus document regarding a single question relevant to the use of FENO. The question was selected from three potential questions based on the greatest perceived impact on clinical practice and the unmet need for evidence-based answers related to this question. The panel performed systematic reviews of published randomized controlled trials between 2004 and 2019 and followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence-to-decision framework to develop recommendations. All panel members evaluated and approved the recommendations. Main Results: After considering the overall low quality of the evidence, the panel made a conditional recommendation for FENO-based care. In patients with asthma in whom treatment is being considered, we suggest that FENO is beneficial and should be used in addition to usual care. This judgment is based on a balance of effects that probably favors the intervention; the moderate costs and availability of resources, which probably favors the intervention; and the perceived acceptability and feasibility of the intervention in daily practice. Conclusions: Clinicians should consider this recommendation to measure FENO in patients with asthma in whom treatment is being considered based on current best available evidence.

An Examination of the Intersection of Climate Change, the Physician Specialty Workforce, and Graduate Medical Education in the U.S.

Issue: As U.S. healthcare systems plan for future physician workforce needs, the systemic impacts of climate change, a worldwide environmental and health crisis, have not been factored in. The current focus on increasing the number of trained physicians and optimizing efficiencies in healthcare delivery may be insufficient. Graduate medical education (GME) priorities and training should be considered in order to prepare a climate-educated physician workforce. Evidence: We used a holistic lens to explore the available literature regarding the intersection of future physician workforce needs, GME program priorities, and resident education within the larger context of climate change. Our interinstitutional, transdisciplinary team brought perspectives from their own fields, including climate science, climate and health research, and medical education to provide recommendations for building a climate-educated physician workforce. Implications: Acknowledging and preparing for the effects of climate change on the physician workforce will require identification of workforce gaps, changes to GME program priorities, and education of trainees on the health and societal impacts of climate change. Alignment of GME training with workforce considerations and climate action and adaptation initiatives will be critical in ensuring the U.S. has a climate-educated physician workforce capable of addressing health and healthcare system challenges. This article offers a number of recommendations for physician workforce priorities, resident education, and system-level changes to better prepare for the health and health system impacts of climate change.

The asthma evidence base: a call for core outcomes in interventional trials.

OBJECTIVES: Biologic therapies are emerging as an option to treat a subset of patients with severe asthma, however no direct comparison between these agents has been conducted. Furthermore, heterogeneity of outcomes in clinical trials makes it difficult to compare these agents and traditional therapies. The extent to which this heterogeneity exists has major implications for evidence-based decisions and is yet to be fully reported. We conducted a literature search to examine outcomes currently being used in clinical trials for asthma. DATA SOURCES: The Cochrane Library and Clinicaltrials.gov were searched for clinical trials of asthma interventions. STUDY SELECTIONS: We limited our search to phase 2 through 4 clinical trials in adults, as early-phase trials tend to have pharmacodynamic and pharmacokinetic endpoints as primary outcomes. Interventions for acute exacerbations were excluded. RESULTS: We identified 117 studies and subsequently identified 111 outcomes. The most prevalent outcomes were asthma control and symptom severity, FEV1, and change in ACQ scale. Twenty patient-reported outcomes instruments were identified and de-facto standard asthma outcomes and PROs were under-reported in examined literature. Existing quality of life tools did not capture the day-to-day experience or the unique treatment burden from oral corticosteroids for patient with severe asthma. Compounding the absence of trials directly comparing therapies, the significant variation we identified in outcome definitions and measurement create hurdles to effectively compare traditional and biologic therapies. CONCLUSION: With the growing number of clinical trials evaluating advanced therapies such as biologics, a wide range of primary and secondary outcomes are evaluated. A core outcome set created by relevant stakeholders is needed to collectively evaluate pooled outcomes in order to allow more meaningful comparisons of asthma therapies and to incorporate the patient experience.

Associations of Air Pollution and Pediatric Asthma in Cleveland, Ohio.

Air pollution has been associated with poor health outcomes and continues to be a risk factor for respiratory health in children. While higher particulate matter (PM) levels are associated with increased frequency of symptoms, lower lung function, and increase airway inflammation from asthma, the precise composition of the particles that are more highly associated with poor health outcomes or healthcare utilization are not fully elucidated. PM is measured quantifiably by current air pollution monitoring systems. To better determine sources of PM and speciation of such sources, a particulate matter (PM) source apportionment study, the Cleveland Multiple Air Pollutant Study (CMAPS), was conducted in Cleveland, Ohio, in 2009-2010, which allowed more refined assessment of associations with health outcomes. This article presents an evaluation of short-term (daily) and long-term associations between motor vehicle and industrial air pollution components and pediatric asthma emergency department (ED) visits by evaluating two sets of air quality data with healthcare utilization for pediatric asthma. Exposure estimates were developed using land use regression models for long-term exposures for nitrogen dioxide (NO2) and coarse (i.e., with aerodynamic diameters between 2.5 and 10 µm) particulate matter (PM) and the US EPA Positive Matrix Factorization receptor model for short-term exposures to fine (<2.5 µm) and coarse PM components. Exposure metrics from these two approaches were used in asthma ED visit prevalence and time series analyses to investigate seasonal-averaged short- and long-term impacts of both motor vehicles and industry emissions. Increased pediatric asthma ED visits were found for LUR coarse PM and NO2 estimates, which were primarily contributed by motor vehicles. Consistent, statistically significant associations with pediatric asthma visits were observed, with short-term exposures to components of fine and coarse iron PM associated with steel production. Our study is the first to combine spatial and time series analysis of ED visits for asthma using the same periods and shows that PM related to motor vehicle emissions and iron/steel production are associated with increased pediatric asthma visits.

Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma.

BACKGROUND: Mepolizumab has demonstrated favorable safety and efficacy profiles in placebo-controlled trials of 12 months' duration or less; however, long-term data are lacking. OBJECTIVE: We sought to evaluate the long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma (SEA). METHODS: COLUMBA (Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects, NCT01691859) was an open-label extension study in patients with SEA previously enrolled in DREAM (Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma, NCT01000506). Patients received 100 mg of subcutaneous mepolizumab every 4 weeks plus standard of care until a protocol-defined stopping criterion was met. Safety end points included frequency of adverse events (AEs), serious AEs, and AEs of special interest. Efficacy end points included annualized exacerbation rates, changes from baseline in Asthma Control Questionnaire 5 scores, and blood eosinophil counts. Immunogenicity was also assessed. RESULTS: Overall, 347 patients were enrolled for an average of 3.5 years (maximum, 4.5 years; total exposure, 1201 patient-years). On-treatment AEs were reported in 94% of patients (exposure-adjusted rate, 3688 events/1000 patient-years). The most frequently reported on-treatment AEs were respiratory tract infection, headache, bronchitis, and asthma worsening. Seventy-nine (23%) patients experienced 1 or more on-treatment serious AEs; there were 6 deaths, none of which were assessed as related to mepolizumab. For patients with 156 weeks or greater enrollment, the exacerbation rate was 0.74 events/y (weeks 0-156), a 56% reduction from the off-treatment period between DREAM and COLUMBA. For all patients, at the first postbaseline assessment, the mean Asthma Control Questionnaire 5 score was reduced by 0.47 points, and blood eosinophil counts were reduced by 78%, with similar improvements maintained throughout the study. The immunogenicity profile (8% anti-drug antibodies) was consistent with previous studies. CONCLUSION: These data support the long-term safety and efficacy of mepolizumab in patients with SEA.

The Association Between Leukotriene-Modifying Agents and Suicidality: A Review of Literature.

BACKGROUND: In 2008 Food and Drug Administration issued a warning regarding a possible association between leukotriene-modifying agents and suicidality. OBJECTIVE: The warning remains controversial and this review of literature is an attempt to examine the evidence on the matter. METHODS: Literature search on PubMed. RESULTS: The data supporting a relationship between leukotriene-modifying agents and suicidality comes primarily from reviews of individual safety reports in adverse event databases; it is subject to considerable reporting bias and does not control for confounding factors. Case-control and cohort studies as well as data from clinical trials do not support an association between leukotriene-modifying agents and suicidality. The data from ecological studies offers strong evidence of a lack of positive association between leukotriene-modifying agents and suicide outcomes (attempts and deaths) at the population level. Furthermore, there is no pharmacological mechanism that would explain an association between the two. CONCLUSION: Overall, the weight of higher quality evidence casts doubt on the association (especially at population level), but is not enough to conclusively disprove the association at an individual level.

Long-term outcomes of bronchial thermoplasty in subjects with severe asthma: a comparison of 3-year follow-up results from two prospective multicentre studies.

Bronchial thermoplasty is an endoscopic therapy for severe asthma. The previously reported, randomised sham-controlled AIR2 (Asthma Intervention Research 2) trial showed a significant reduction in severe asthma exacerbations, emergency department visits and hospitalisations after bronchial thermoplasty. More "real-world" clinical outcome data is needed.This article compares outcomes in bronchial thermoplasty subjects with 3 years of follow-up from the ongoing, post-market PAS2 (Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma) study with those from the AIR2 trial.279 subjects were treated with bronchial thermoplasty in the PAS2 study. We compared the first 190 PAS2 subjects with the 190 bronchial thermoplasty-treated subjects in the AIR2 trial at 3 years of follow-up. The PAS2 subjects were older (mean age 45.9 versus 40.7 years) and more obese (mean body mass index 32.5 versus 29.3 kg·m-2) and took higher doses of inhaled corticosteroids (mean dose 2301 versus 1961 µg·day-1). More PAS2 subjects had experienced severe exacerbations (74% versus 52%) and hospitalisations (15.3% versus 4.2%) in the 12 months prior to bronchial thermoplasty. At year 3 after bronchial thermoplasty, the percentage of PAS2 subjects with severe exacerbations, emergency department visits and hospitalisations significantly decreased by 45%, 55% and 40%, respectively, echoing the AIR2 results.The PAS2 study demonstrates similar improvements in asthma control after bronchial thermoplasty compared with the AIR2 trial despite enrolling subjects who may have had poorer asthma control.

Cost effectiveness of bronchial thermoplasty in patients with severe uncontrolled asthma.

RATIONALE: Based on its clinical effectiveness, bronchial thermoplasty (BT) was approved by the Food and Drug Administration in 2010 for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well-controlled with inhaled corticosteroids and long-acting beta-agonist medicines. OBJECTIVE: Assess the 10 year cost-effectiveness of BT for individuals with severe uncontrolled asthma. METHODS: Using a Markov decision analytic model, the cost-effectiveness of BT was estimated. The patient population involved a hypothetical cohort of 41-year-old patients comparing BT to usual care over a 10-year time frame. The main outcome measure was cost in 2013 dollars per additional quality adjusted life year (QALY). RESULTS: Treatment with BT resulted in 6.40 QALYs and $7512 in cost compared to 6.21 QALYs and $2054 for usual care. The incremental cost-effectiveness ratio for BT at 10 years was $29,821/QALY. At a willingness to pay per QALY of $50,000, BT continues to be cost effective unless the probability of severe asthma exacerbation drops below 0.63 exacerbation per year or the cost of BT rises above $10,384 total for all three bronchoscopic procedures needed to perform thermoplasty and to cover the entire bronchial tree (baseline = $6690). CONCLUSIONS: BT is a cost-effective treatment for asthmatics at high risk of exacerbations. Continuing to follow asthmatics treated with BT beyond 5 years will help inform longer efficacy and support its cost-effectiveness.

An association between L-arginine/asymmetric dimethyl arginine balance, obesity, and the age of asthma onset phenotype.

RATIONALE: Increasing body mass index (BMI) has been associated with less fractional exhaled nitric oxide (Fe(NO)). This may be explained by an increase in the concentration of asymmetric dimethyl arginine (ADMA) relative to L-arginine, which can lead to greater nitric oxide synthase uncoupling. OBJECTIVES: To compare this mechanism across age of asthma onset groups and determine its association with asthma morbidity and lung function. METHODS: Cross-sectional study of participants from the Severe Asthma Research Program, across early- (<12 yr) and late- (>12 yr) onset asthma phenotypes. MEASUREMENTS AND MAIN RESULTS: Subjects with late-onset asthma had a higher median plasma ADMA level (0.48 µM, [interquartile range (IQR), 0.35-0.7] compared with early onset, 0.37 µM [IQR, 0.29-0.59], P = 0.01) and lower median plasma l-arginine (late onset, 52.3 [IQR, 43-61] compared with early onset, 51 µM [IQR 39-66]; P = 0.02). The log of plasma L-arginine/ADMA was inversely correlated with BMI in the late- (r = -0.4, P = 0.0006) in contrast to the early-onset phenotype (r = -0.2, P = 0.07). Although Fe(NO) was inversely associated with BMI in the late-onset phenotype (P = 0.02), the relationship was lost after adjusting for L-arginine/ADMA. Also in this phenotype, a reduced L-arginine/ADMA was associated with less IgE, increased respiratory symptoms, lower lung volumes, and worse asthma quality of life. CONCLUSIONS: In late-onset asthma phenotype, plasma ratios of L-arginine to ADMA may explain the inverse relationship of BMI to Fe(NO). In addition, these lower L-arginine/ADMA ratios are associated with reduced lung function and increased respiratory symptom frequency, suggesting a role in the pathobiology of the late-onset phenotype.

Measuring exhaled nitric oxide when diagnosing and managing asthma.

Measuring the concentration of nitric oxide in the exhaled breath may have several roles in patients with suspected or confirmed asthma: as an adjunctive test for the disease, as a test to determine whether patients with asthma are likely to respond to inhaled corticosteroids, as a way to monitor and adjust this therapy, and as a way to estimate the likelihood of exacerbations. However, it is not very sensitive or specific and should not be used by itself, but rather in conjunction with clinical signs and symptoms. The authors address the role of measuring exhaled nitric oxide in the diagnosis and management of asthma and provide guidance for its appropriate use.

Nitrogen dioxide, an EPA parameter, may forecast the incidence of asthma exacerbations across urban areas: An observational study.

RATIONALE: Efforts to reduce nitrogen dioxide (NO2 ) have the potential to reduce the morbidity and mortality related to asthma in children. We analyze the associations of pediatric hospital admission rates for asthma with Environmental Protection Agency (EPA) NO2  parameters at the patient zip code level. METHODS: We identified zip codes that had EPA monitors which monitored NO2  levels located in states with high asthma burden. We used the Healthcare Cost and Utilization Project (HCUP) State Inpatient Database (SID) to identify patients who were <17 years of age with diagnosis codes for asthma. We compared NO2  levels at the zip code level with the number of patients hospitalized for asthma from the HCUP SID database. RESULTS: Data from zip codes in Buffalo, Detroit, Phoenix, and Tucson from 2009 to 2011 demonstrated that the monthly mean NO2  levels predicted pediatric asthma hospital admission rates in six monitored zip codes in these four cities with time series modeling (Buffalo zip code 14206, p = 0.0089; Detroit zip code 48205, p = 0.0179; Phoenix zip code 85006, p = 0.0433; Phoenix zip code 85009, p = 0.0007; Phoenix zip code 85015, p = 0.0036; Tucson zip code 85711, p = 0.0004). CONCLUSION: Pediatric admissions to the hospital for asthma exacerbations mirror the cyclic and seasonal pattern of NO2  levels in the cities of Detroit, Buffalo, Phoenix, and Tucson. While traffic density may be higher in cities with periodicity of NO2  and asthma exacerbations, other factors could be contributing to high NO2  levels.

Health Disparities: Interventions for Pulmonary Disease - A Narrative Review.

There is expansive literature documenting the presence of health disparities, but there are disproportionately few studies describing interventions to reduce disparity. In this narrative review, we categorize interventions to reduce health disparity in pulmonary disease within the US health care system to support future initiatives to reduce disparity. We identified 211 articles describing interventions to reduce disparity in pulmonary disease related to race, income, or sex. We grouped the studies into the following four categories: biologic, educational, behavioral, and structural. We identified the following five main themes: (1) there were few interventional trials compared with the breadth of studies describing health disparities, and trials involving patients with asthma who were Black, low income, and living in an urban setting were overrepresented; (2) race or socioeconomic status was not an effective marker of individual pharmacologic treatment response; (3) telehealth enabled scaling of care, but more work is needed to understand how to leverage telehealth to improve outcomes in marginalized communities; (4) future interventions must explicitly target societal drivers of disparity, rather than focusing on individual behavior alone; and (5) individual interventions will only be maximally effective when specifically tailored to local needs. Much work has been done to catalog health disparities in pulmonary disease. Notable gaps in the identified literature include few interventional trials, the need for research in diseases outside of asthma, the need for high quality effectiveness trials, and an understanding of how to implement proven interventions balancing fidelity to the original protocol and the need to adapt to local barriers to care.

Breaking Through Barriers: Factors That Influence Behavior Change Toward Leadership for Women in Academic Medicine.

Under-representation of women in leadership at Academic Medical Centers (AMCs) is a known challenge such that, in 2021, women made up only 28% of department chairs. AMCs are addressing the dearth of women leaders through targeted programming to create leadership pipelines of qualified women. The FLEX Leadership Development Program at the Case Western Reserve University (CWRU) School of Medicine prepares women faculty for increased leadership opportunities. FLEX includes the opportunity to leverage executive coaching to accomplish individual goals. The FLEX program has the explicit goal of increasing the number of women in visible leadership positions in academic medicine and health sciences. Semi-structured interviews were conducted with 25 graduates from seven FLEX cohorts (2012-2018). Participants reflected diversity in academic rank, terminal degree, racial/ethnic background, years of employment, and institutional affiliation. Interviews consisted of eight questions with additional probes to elicit lived experiences. Analysis consisted of two-stage open- and axial-coding of interview transcripts to understand: What factors facilitated behavior change following FLEX training? The analysis revealed five overarching themes: (1) Communication skills; (2) Self-Efficacy; (3) Networking; (4) Situational Awareness; and (5) Visioning. FLEX graduates reported achieving both personal and professional growth by drawing upon peer networks to proactively seek new leadership opportunities. These results suggest that the enduring benefits of the FLEX Program include improved communication skills, expanded situational awareness and relational capacity, greater self-efficacy and self-confidence, improved networking with an understanding of the value of networking. All these factors led FLEX graduates to have greater visibility and to engage with their colleagues more effectively. Similarly, FLEX graduates could better advocate for themselves and for others as well as paying it forward to mentor and train the next generation of faculty. Finally, participants learned to re-evaluate their goals and their career vision to be able to envision themselves in greater leadership roles. The five factors that strongly influenced behavior change provide valuable constructs for other programs to examine following leadership development training. Ongoing studies include examining successful leadership position attainment, personal goal attainment, and measuring changes in leadership self-efficacy.

Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study.

BACKGROUND: Bronchial thermoplasty is a device-based treatment for subjects ≥ 18 years of age with severe asthma poorly controlled with inhaled corticosteroids and long-acting beta-agonists. The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2) study collected data on patients with severe asthma undergoing this procedure. RESEARCH QUESTION: What are the 5-year efficacy and safety results in patients with severe asthma who have undergone bronchial thermoplasty? STUDY DESIGN AND METHODS: This was a prospective, open-label, observational, multicenter study conducted in the United States and Canada. Subjects 18 to 65 years of age who were taking inhaled corticosteroids ≥ 1,000 µg/d (beclomethasone or equivalent) and long-acting beta-agonists ≥ 80 µg/d (salmeterol or equivalent) were included. Severe exacerbations, hospitalization, ED visits, and medication usage were evaluated for the 12 months prior to and at years 1 through 5 posttreatment. Spirometry was evaluated at baseline and at years 1 through 5 posttreatment. RESULTS: A total of 284 subjects were enrolled at 27 centers; 227 subjects (80%) completed 5 years of follow-up. By year 5 posttreatment, the proportion of subjects with severe exacerbations, ED visits, and hospitalizations was 42.7%, 7.9%, and 4.8%, respectively, compared with 77.8%, 29.4%, and 16.1% in the 12 months prior to treatment. The proportion of subjects on maintenance oral corticosteroids decreased from 19.4% at baseline to 9.7% at 5 years. Analyses of subgroups based on baseline clinical and biomarker characteristics revealed a statistically significant clinical improvement among all subgroups. INTERPRETATION: Five years after treatment, subjects experienced decreases in severe exacerbations, hospitalizations, ED visits, and corticosteroid exposure. All subgroups demonstrated clinically significant improvement, suggesting that bronchial thermoplasty improves asthma control in different asthma phenotypes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT01350336; URL: www. CLINICALTRIALS: gov.

Diabetes Mellitus Is Associated with Worse Outcome in Patients Hospitalized for Asthma.

BACKGROUND: Asthma is a prevalent disease with a high economic cost. More than 50% of its direct cost relates to asthma hospitalizations. Diabetes mellitus (DM) is a significant comorbidity in asthmatic patients, yet its impact on asthma-related hospitalizations is unknown. OBJECTIVE: To compare the outcome of asthma-related hospitalizations in patients with and without DM. METHODS: Using Healthcare Cost and Utilization Project Nationwide Readmissions Database, we analyzed data of all adults with index admission for asthma and with no other chronic pulmonary conditions, and compared outcomes between patients with and without DM. Weighted regression analysis was used to determine the impact of DM on hospitalization outcomes. All multivariate regression models were adjusted for patient demographics, socioeconomic status, and chronic medical comorbidities. RESULTS: A total of 717,200 asthmatic patients were included, with 202,489 (28.3%) having DM. Diabetic patients were older and had more comorbidities. When hospitalized for asthma, diabetic patients had increased hospital length of stay, cost, and risk for 30-day all-cause and asthma-related readmission. They also had a higher risk for developing nonrespiratory complications during their hospital stay compared with nondiabetic patients. The risk of mortality was similar between the 2 groups. CONCLUSIONS: Patients hospitalized for asthma with coexisting DM had increased hospital length of stay, cost, and risk for readmission. Interventions are urgently needed to reduce the risk for hospital admission and readmission in patients with coexisting DM and asthma. These interventions would have profound economic and societal impact.