Asthma Outcome Measures Research Articles

Patient-reported outcome measures in severe asthma: an expert consensus

Objective The study aimed to reach a consensus on the most relevant patient-reported outcomes (PROs), the corresponding measures (PROMs), and measurement frequency during severe asthma patient follow-up. Methods Two Delphi rounds were conducted. The questionnaire was developed based on a systematic literature review, a focus group with patients, and a nominal group with experts. It assessed PROs’ relevance and the appropriateness (A) and feasibility (F) of PROMs using a Likert scale (1=totally agree; 9=totally disagree). The consensus was established when ≥75% of participants agreed (1-3) or disagreed (7-9). Results Sixty-three professionals (25 hospital pharmacists, 14 allergists, 13 pulmonologists, and 11 nurses) and 5 patients answered the Delphi questionnaire. A consensus was reached on all PROs regarding their relevance. Experts agreed on the use of ACT (A:95.24%; F:95.24%), mini AQLQ (A:93.65; F:79.37%), mMRC dyspnea scale (A:85.71%; F:85.71%), TAI (A:92.06%; F:85.71%), MMAS (A:75.40%; F:82%), and the dispensing register (A:96.83%; F:92.06%). Also considered suitable were: SNOT-22 (A:90.48%; F:73.80%), PSQI (A:82.54; F:63.90%), HADS (A:82.54; F:64%), WPAI (A:77.78%; F:49.20%), TSQM-9 (A:79.37; F:70.50%) and knowledge of asthma questionnaire (A:77%; F:68.80%); however, their use in clinical practice was considered unfeasible. Panelists also agreed on the appropriateness of EQ-5D, which was finally included despite being considered unfeasible (A: 84.13%; F:67.20%) in clinical practice. Agreement was reached on using ACT, TAI, mMRC, and a dispensing register every three months; mini-AQLQ and MMAS every six months; and EQ-5D every twelve months. Conclusion This consensus paves the way toward patient-centered care, promoting the development of strategies supporting routine assessment of PROs in severe asthma management.

Asthma Outcome Measures Before and After the COVID-19 Outbreak Among the Pediatric Population in a Community Hospital.

BackgroundThe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is a global health threat that has affected patient care enormously. Moderate to severe asthma was listed as a risk factor for severe SARS-CoV-2 disease by the Centers for Disease Control. Little is known about the impact of the pandemic on asthma control in children, particularly African American children.ObjectiveThe present study sought to determine how changes during the coronavirus disease 2019 (COVID-19) pandemic affected asthma metrics in a majority African American pediatric population at a pediatric pulmonology clinic in a community hospital in New York.MethodsThis is a retrospective, pre-post, comparative cross-sectional study that included children three to 18 years of age with a known diagnosis of asthma followed in a pulmonary clinic. Data were gathered from electronic medical records. Subjects were selected if they presented to a pulmonology clinic within a certain time window both before and after the outbreak of the COVID-19 pandemic. Outcome variables included asthma medication statistics and healthcare utilization statistics.ResultsInclusion criteria were met by 104 pediatric patients. The majority were African American. Emergency department visits, primary physician visits, and hospitalizations significantly decreased in the post-COVID study group compared to the pre-COVID control group.ConclusionAmong a majority African American pediatric population, there were significant improvements in asthma outcomes after COVID-19 societal changes when compared to before COVID-19 based on outcome variables.

Community Health Workers in Home Visits and Asthma Outcomes

The authors demonstrate that a Centers for Medicare and Medicaid Services (CMS) funded Community Asthma Initiative transition from a mixed nurse-community health worker model to a nurse supervised community health worker model could engender enhanced outcomes for hospitalizations and missed school and parent and/or guardian missed workdays.In the study, researchers included 389 patients were enrolled under the CMS grant from 2013–2015 at Boston Children’s Hospital and 733 Medicaid patients enrolled from 2005–2012 (comparison group).The 2 groups were compared at baseline, 6 months, and 12 months post enrollment for 5 asthma outcome measures: emergency department visits, hospitalizations, physical activity limitations, missed school days, and parent and/or guardian missed workdays. These measures were analyzed as dichotomous variables by using logistic regression, with the numbers of occurrences as continuous variables. A 13 question survey composed of activity and emotional health subscales was used to assess quality of life changes.The CMS group demonstrated more improvement in asthma outcomes, compared with the comparison group. They had a greater odds of decreased hospitalization (odds ratio: 3.13 [95% confidence interval: 1.49 to 6.59]), missed school days (odds ratio: 1.91 [95% confidence interval: 1.09 to 3.36]), and parent and/or guardian missed workdays (odds ratio: 2.72 [95% confidence interval: 1.15 to 6.41]). One year post enrollment, the CMS group experienced enhancement in all measured QoL parameters (all P values were <.01)The transition of the Community Asthma Initiative to a nurse supervised community health worker model for home visits resulted in positive impacts on asthma outcomes and quality of life.In the study, the authors highlight that home visits by nurse supervised community health workers can benefit pediatric asthma control and quality of life. The study is limited by fact that patient data were from 2 different time frames and the lack of spirometry testing to provide a more precise assessment of asthma control. The data supports that community engagement and home visits can be effective strategies to contain health care use and costs.

Socio-demographics and asthma prevalence, management, and outcomes among children 1\u201311 years of age in California

BackgroundAsthma disproportionately affects minority and low-income children. We examined asthma prevalence, management and outcomes, focusing on race/ethnicity and acculturation of parents (particularly English language proficiency).MethodsThis cross-sectional, correlational analysis used a de-identified population-based survey, the California Health Interview Survey, for years 2001–2015. Survey-weighted analysis with SAS 9.4 was used to determine asthma prevalence among children 1 to 11 years of age. Descriptive analysis was conducted, adjusting for survey design and combination of multiple years of data. The Pearson test, using design-based F values was used to determine statistically significant differences between those having/not having a doctor diagnosis of asthma. Multivariable logistic regression, with jackknife approach to obtain confidence intervals, was used to examine associations of child and parental characteristics with asthma prevalence, management, and outcomes.ResultsThe 61,625 completed surveys represented an estimated annual population of 5.7 million children, of which 12.9 % had asthma. There were significant (p < 0.001) differences by age, gender, race, and language proficiency, with higher asthma prevalence for children 6 to 11 years of age (15.5 %), males (15.3 %), African Americans (19.5 %), and parents speaking English very well (14.1 %). Compared to children whose parents spoke English very well, those whose parents spoke English not well or not at all were less likely to achieve optimal asthma management, i.e. to have received a management plan from doctor (OR 0.30; 95 % Confidence Interval 0.20–0.46)), to be currently taking medication to control asthma (OR 0.52; 95 % CI 0.36–0.74)), or to be not confident in ability to control asthma (OR 3.10; 95 % CI 1.49–6.42). Children whose parents spoke English fairly well rather than very well had worse outcomes, i.e. were more likely to have an emergency room visit in past 12 months (OR 1.92; 95 % CI 1.03–3.61) and were more likely to miss school due to asthma in past 12 months (OR 0.71; 1.01–2.94).ConclusionsSocio-demographics had a limited role in explaining differences across a handful of asthma management and outcome measures in California. Parental English language proficiency had the most consistent influence, underscoring the need for culturally and linguistically competent care.

Efficacy of Prednisolone in Recovery from Acute Bronchiolitis: Study in a Tertiary Care Hospital, Dhaka, Bangladesh

<i>Introduction</i>: Acute bronchiolitis is a condition where patients are presenting with breathing difficulties, cough, poor feeding, and irritability. Treatment of bronchiolitis have many controversies. Most trials of bronchiolitis treatment suffer from 2 constraints: possible inclusion of patients with asthma and inconsistent outcome measures. <i>The aim of the study was</i> to determine the efficacy of prednisolone in recovery from acute bronchiolitis who have a family history of atopy. <i>Material & Methods</i>: This randomized double blind placebo controlled trial (RCT) was conducted in the department of pediatrics Dhaka Medical College Hospital (DMCH) from July 2008 to June 2010. Sixty (60) bronchiolitis patients having family history of atopy were included in his study. Prednisolone and placebo were packaged in identical envelops with separate code number given by the guide and the code number were recorded in a preformed questionnaire. The trial was so planned that neither the parents nor the investigator were aware of group allocation. The collected data were analyzed thoroughly by SPSS program version of 16.0 software. Informed written consent from parents or legal guardians was taken and ethical clearance was obtained from the ethical review committee of Dhaka Medical College to conduct the research works. <i>Results</i>: In our study, mean age of the patients of this series were 3.68 months (±1.29SD) and 3.52 month’s (±1.1SD) in prednisolone and placebo group respectively. Use of accessory muscle score was assessed twice at 8 am and 8 pm each day for three days. On first assessment at day 1 the score was similar in both the treatment groups (P>.05). More people in Prednisolone arm recovered within 3 days then the placebo group. The difference is statistically significant (P<.01). <i>Conclusion</i>: Three-day oral prednisolone treatment was effective in accelerating clinical recovery (Fast breathing, use of accessory muscle, wheezing) in acute bronchiolitis cases who had family history of atopy.

Dupilumab Efficacy in Patients With Uncontrolled, Moderate-to-Severe Allergic Asthma

J Corren, M Castro, T O’Riordan. J Allergy Clin Immunol Pract . 2020;8(2):516–526 IL-4 and IL-13 are drivers of type 2 inflammation, including IgE-mediated allergic inflammation in asthma. Dupilumab blocks the shared receptor component for IL-4 and IL-13, inhibiting subsequent signaling of cytokines which drive type 2 inflammation. This study evaluated the effect of dupilumab on asthma outcome measures in subgroups of patients with asthma. This study is a post hoc analysis of patients enrolled in a phase 3, randomized, double-blind, placebo-controlled study of efficacy and safety of dupilumab, which enrolled adolescents and adults ≥12 years with physician-diagnosed asthma receiving treatment with a medium-to-high …

PREVALENCE OF ASTHMA CONTROL AND THE ASSOCIATED DISEASE BURDEN IN US PATIENTS WITH ASTHMA TREATED WITH A FIXED-DOSE COMBINATION OF INHALED CORTICOSTEROID AND LONG-ACTING BETA2-AGONIST

SESSION TITLE: Obstructive Lung Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: It is estimated that most patients with asthma in the US are suboptimally controlled; however, real-world data describing asthma control in the treated population is sparse. The primary aim of this study was to quantify asthma control in patients treated with a fixed-dose combination (FDC) of inhaled corticosteroid/long-acting β2-agonist (ICS/LABA). METHODS: 2250 commercially insured patients with ≥1 ICD-10-CM (asthma diagnosis code), aged ≥18 years, with ≥2 pharmacy claims for FDC ICS/LABA from Mar 1, 2018–Feb 28, 2019 (≥1 of those claims in the last 6 months) were identified in the Optum Research Database and invited by mail to complete a cross-sectional survey. Patients with COPD or other lung diseases were excluded. Questions on asthma, sociodemographics and patient-reported outcome (PRO) measures were included. Asthma-related PROs measured asthma control (Asthma Control Test [ACT] and Asthma Control Questionnaire-6 [ACQ-6]), asthma-related quality of life (QoL; mini-AQLQ), and general health status (EQ-5D-3L). Responses were linked to medical and pharmacy claims for 12-months before and including the date of survey completion (baseline) for all respondents in order to estimate adherence and describe healthcare resource utilization. RESULTS: 464 patients returned the survey (22.2% response rate), of which 428 met all eligibility criteria, including self-reported healthcare provider asthma diagnosis. Most were female (66.8%) and White (88.3%). Mean (SD) age was 50 (12) years; mean body mass index was 30 (7) kg/m2, median age at asthma diagnosis was 21 (IQR: 7–40) years. Using ACT, 36.4% of patients were poorly or somewhat controlled, while 40.9% reported shortness of breath once or twice a week in the past 4 weeks. According to the ACQ-6, 55.6% were uncontrolled or partially controlled. 61.2% of patients had ≥1 asthma-related ambulatory visit (physician office or outpatient setting) at baseline. Those with poorly controlled asthma were more likely to have an asthma-related outpatient visit (22.6%), versus somewhat controlled and controlled patients (8.5% and 3.7%, respectively). Adherence (medication possession ratio ≥0.80 for FDC ICS/LABA) was observed in 42.3% of patients. Overall health status (EQ-5D-3L index utility score) and asthma-related QoL were significantly higher with better asthma control. CONCLUSIONS: 36%–56% of patients self-reported as inadequately controlled and symptomatic using ACT or ACQ, despite FDC ICS/LABA. Poor asthma control was associated with increased healthcare resource utilization, poorer overall health status and reduced asthma-related QoL. CLINICAL IMPLICATIONS: There is a subset of patients with unmet medical needs who may benefit from additional therapy options. Funding: GSK HO-17-17252. DISCLOSURES: Employee relationship with GSK Please note: >$100000 Added 05/18/2020 by Andrew Fowler, source=Web Response, value=Salary Employee relationship with Optum Please note: >$100000 Added 04/21/2020 by Alyssa Goolsby Hunter, source=Web Response, value=Salary *At the time of the analysis relationship with GlaxoSmithKline Please note: >$100000 Added 04/21/2020 by David Hinds, source=Web Response, value=Salary Removed 04/21/2020 by David Hinds, source=Web Response Employee relationship with BioMarin Pharmaceuticals Please note: >$100000 Added 04/21/2020 by David Hinds, source=Web Response, value=Salary Employee at the time of the analysis relationship with GlaxoSmithKline Please note: >$100000 Added 04/21/2020 by David Hinds, source=Web Response, value=Salary former employee, owns shares relationship with GSK Please note: >$100000 Added 05/23/2020 by Laurie Lee, source=Web Response, value=shares Employee relationship with CSL Behring Please note: >$100000 Added 05/23/2020 by Laurie Lee, source=Web Response, value=Salary Employee relationship with GSK Please note: $1-$1000 Added 05/07/2020 by Wilhelmine Meeraus, source=Web Response, value=Salary Employee relationship with GSK Please note: $1-$1000 Added 05/07/2020 by Wilhelmine Meeraus, source=Web Response, value=Stocks/Shares Employee relationship with Optum Please note: $20001 - $100000 Added 05/14/2020 by Sharanya Murali, source=Web Response, value=Salary stock holder relationship with GlaxoSmithKline Please note: >$100000 Added 05/21/2020 by Leah Sansbury, source=Web Response, value=Salary Removed 05/21/2020 by Leah Sansbury, source=Web Response Employee relationship with GlaxoSmithKline Please note: >$100000 Added 05/21/2020 by Leah Sansbury, source=Web Response, value=Salary stock holder relationship with GlaxoSmithKline Please note: $20001 - $100000 Added 05/21/2020 by Leah Sansbury, source=Web Response, value=Stock Employee relationship with GlaxoSmithKiline Please note: >$100000 Added 05/01/2020 by Maggie Tabberer, source=Web Response, value=Salary Stock holding relationship with GlaxoSmithKline Please note: $5001 - $20000 Added 05/01/2020 by Maggie Tabberer, source=Web Response, value=Value of Stock and dividends Employee relationship with Optum Please note: $1001 - $5000 Added 04/21/2020 by John White, source=Web Response, value=Salary Removed 05/15/2020 by John White, source=Web Response Employee relationship with Optum Please note: >$100000 Added 05/15/2020 by John White, source=Web Response, value=Salary Employee relationship with GlaxoSmithKline Please note: >$100000 Added 04/17/2020 by Shiyuan Zhang, source=Web Response, value=Salary

Geospatial-temporal analysis of the impact of ozone on asthma rescue inhaler use

RationaleAsthma is one of the most common chronic respiratory diseases in the United States. Several outdoor air pollutants have been associated with asthma morbidity. Previous studies of the effects of short-term air pollution exposure have been limited by potential exposure misclassification and limited spatial and temporal resolution of asthma outcome measures. ObjectivesWe aimed to assess the association of short-term air pollutant exposure with the use of short-acting beta-2 agonists (SABA) for asthma by monitoring the time and place of occurrence with electronic medication monitors. MethodsIn a cohort of adults and children with asthma (n = 287; 60% female), we deployed electronic medication monitors fitted to metered-dose inhalers to monitor SABA use, capturing the date, time and location of use. We assigned pollutant exposures based on each actuation’s time and location (4-h mean measures for ozone and particulate matter of 2.5 µm or smaller (PM2.5)), assessed associations using generalized linear models and explored age-specific effects. Measurements and Main ResultsAmbient ozone exposure was positively associated with SABA use (p = 0.01). Age-specific associations were identified (interaction p = 0.01), with a larger increase in SABA use for children (11.3%; 95% CI: 7.0%–18.2%) than adults (8.4%; 95% CI: 6.4%–11.0%) per IQR increase of ozone (16.8 ppb). ConclusionsThese findings support existing evidence that short-term exposure to ozone can cause morbidity in individuals with asthma, and suggest that ozone exposures below the current U.S. EPA standard may be associated with increased SABA use.

Bariatric surgery: a potential cure for asthma?

Asthma incidence and severity are increased in obese populations. Systematic reviews have shown benefit from weight-loss interventions on asthma outcomes, but the role of bariatric surgery is still unclear. In this review, cohorts of obese asthmatic patients undergoing bariatric surgery were examined regarding different asthma outcomes. The available data on patients who were followed up showed improvements in asthma control, exacerbation risk, asthma-related hospitalisation, medication use and airway hyperresponsiveness, with some patients not requiring further treatment for asthma. Follow-up duration was variable, being mostly of 1 year, with some studies reporting long-term outcomes after 5 years. The studies reviewed had many limitations, including small numbers of patients, lack of control arm in some studies and lack of standardisation of asthma diagnosis, classification and outcome measures, in addition to possible reporting bias. Data on small numbers of patients also show the possibility of benefit exclusively in nonallergic asthma. Larger, more stringent clinical trials are needed before recommending bariatric surgery for treatment of asthma.

The Impact of Environmental Chronic and Toxic Stress on Asthma.

Several factors have been associated with the development of asthma and asthma-related morbidity and mortality. Exposures in the environment such as allergens and air pollutants have traditionally been linked to the risk of asthma and asthma outcomes. More recent literature has identified chronic psychosocial stress as an additional environmental exposure to consider in relation to asthma. Adverse childhood events (ACEs) and chronic and toxic stress have been associated with chronic diseases such as cardiovascular disease, cancer, and chronic obstructive pulmonary disease. Chronic stress has also been shown to result in biological changes such as expression of immunologic genes, changes in expression of the beta-adrenergic (B2AR) and the glucocorticoid receptor (GR-α) genes, cytokine regulation, and alterations in the hypothalamic pituitary axis and cortisol levels which all may affect asthma pathophysiology and therapeutic response among patients exposed to chronic stress. Recent research has revealed associations between ACEs and chronic and toxic stress and asthma risk in pre-conception to early childhood as well as morbidity and response to asthma treatments among pediatric and adult age groups. As some populations are more significantly impacted by asthma such as racial and ethnic minority groups, the influence of psychosocial stress has also been explored as a potential factor responsible for observed disparities in asthma prevalence and outcomes among these groups which also experience higher rates of psychosocial stress. Racial discrimination has specifically been shown to affect asthma-related outcomes among minority groups. Interventions to address the impact of chronic and toxic stress such as yoga and meditation have been shown to improve asthma outcome measures. Chronic and toxic stress is an important environmental exposure to further consider as we continue to explore the differences in underlying asthma pathophysiology leading to various disease phenotypes among patients and clinical/therapeutic response to interventions and treatments.

Efficacy and Safety of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps: Results from the Randomized Phase 3 Sinus-24 Study

Dupilumab, a human IL-4R-α mAb inhibiting IL-4 and IL-13, key drivers of type 2-mediated inflammation, is approved for uncontrolled moderate-to-severe atopic dermatitis in adults and in the USA for patients aged ≥12 years with moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma. In a phase 2a study, dupilumab improved endoscopic, radiologic, clinical, and patient-reported outcomes in chronic rhinosinusitis with nasal polyps (CRSwNP) patients. For the first time we report results from a phase 3 dupilumab study (SINUS-24; NCT02912468) in severe CRSwNP patients (with/without comorbid asthma) on daily intra-nasal mometasone furoate (MFNS). Adults with CRSwNP previously treated with systemic corticosteroids (SCS) and/or surgery (n = 276) were randomized 1:1 to subcutaneous dupilumab 300mg or placebo every 2 weeks for 24 weeks. Outcomes included change from baseline to Week 24 in nasal polyp score (NPS), patient-reported nasal congestion (NC), CT Lund-Mackay (LMK), UPSIT smell test, SNOT-22, FEV1, and ACQ-6 scores. Mean [SD] baseline values were comparable in dupilumab/placebo for NPS (5.64 [1.23] / 5.86 [1.31]), NC (2.26[0.57]/2.45[0.55]), LMK (18.55 [4.55] / 19.55 [4.26]), UPSIT (14.68 [8.66] / 14.44[8.31]), and SNOT-22 (48.00 [20.16] / 50.87[20.22]). Dupilumab significantly (P<0.0001) improved NPS (−2.06), NC (−0.89), LMK (−7.44), UPSIT (+10.56), and SNOT-22 (−21.12) from baseline to Week 24 (LS-mean differences vs placebo). Dupilumab treatment reduced SCS use/NP surgery (P<0.001), and in comorbid asthma patients (58.3%) improved lung function (FEV1; P<0.001) and asthma control (ACQ-6; P<0.0001). The most common adverse event occurring at higher frequency with dupilumab was epistaxis (7.7% vs 3.0% placebo). Add-on dupilumab to MFNS significantly improved endoscopic, radiologic, clinical, and patient-reported sino-nasal outcomes, and asthma outcome measures in severe CRSwNP patients, and was well-tolerated.

Performance of the Asthma Impact on Quality of Life Scale (A-IQOLS) in diverse asthma research populations and demographic subgroups

The Asthma Impact on Quality of Life Scale (A-IQOLS) assesses the patient-perceived negative effect of asthma on quality of life. Its standard error of measurement is known; it has strong construct, convergent, and divergent validity; and it provides information that is unique among asthma outcome measures. We sought to characterize the psychometric properties of the A-IQOLS and its suitability for use in demographically and clinically diverse adult asthmatic populations. Data from participants in 5 independent asthma studies, with samples ranging from patients with well-controlled moderate asthma to patients with severe poorly controlled asthma, were pooled to determine the psychometric performance of A-IQOLS scores overall and in multiple demographic, disease status, and study subgroups. Pooled sample (n=597) age averaged 45years; 66% were female, 65% were white, 22% were African American, 11% were Hispanic, and 11% had a high school education or less. The rated importance of its underlying life dimensions and associations between A-IQOLS scores and lung function, symptom, Asthma Control Test, Juniper Mini Asthma Quality of Life Questionnaire, and Marks Asthma Quality of Life Questionnaire scores was very similar, regardless of patients' demographic and clinical characteristics. A-IQOLS scores discriminated among the individual study samples, as well as other patient-reported symptom and functional status measures. Distribution and anchor-based considerations suggest an A-IQOLS minimum clinically important difference in the vicinity of 0.50 and not less than 0.33 scale score units. A-IQOLS is valid for research and potentiallyclinical use in demographically and clinically diverse patients.

A new measure to assess asthma's effect on quality of life from the patient's perspective

The Asthma Impact on Quality of Life Scale (A-IQOLS) assesses the negative effect of asthma on quality of life (QoL) from the patient's perspective by using dimensions of Flanagan's Quality of Life Scale (QOLS), a measure of current QoL. We sought to determine and compare the psychometric properties of the A-IQOLS and QOLS, including their sensitivities to differences and change in asthma status. In a test-retest design (3- to 5-week interval) adults with persistent asthma underwent spirometry and were administered the A-IQOLS, other asthma outcome measures (Asthma Control Test, Asthma Symptom Utility Index, and the Marks and Juniper Asthma Quality of Life Questionnaires), and the QOLS. Participants' (n=147) mean age was 49years, 76% were white, 12% were Hispanic, and 65% were female. A-IQOLS and QOLS scores were significantly correlated with other asthma outcomes scores, except FEV1, but shared relatively low common variance with these measures. A-IQOLS but not QOLS score changes were significantly correlated with changes in asthma outcomes. An A-IQOLS standard error of measurement of 0.27 implies that a within-person score change of ±0.73 or greater constitutes a true change. The QOLS standard error of measurement was 0.43. A-IQOLS provides a reliable, valid, and unique assessment of the patient-perceived negative effect of asthma on QoL that is suitable for use in asthma clinical research and potentially in clinical care. Further studies are needed in diverse patient populations. QOLS, a measure of current QoL, is less sensitive to disease status changes but might be useful in characterizing study populations, in treatment adherence research, and as a clinical and research tool in patients with multiple, severe, and/or life-limiting chronic conditions.

Psychological treatment of comorbid asthma and panic disorder in Latino adults: Results from a randomized controlled trial

Confusion between panic and asthma symptoms can result in serious self-management errors. A cognitive behavior psychophysiological therapy (CBPT) intervention was culturally adapted for Latinos consisting of CBT for panic disorder (PD), asthma education, differentiation between panic and asthma symptoms, and heart rate variability biofeedback. An RCT compared CBPT to music and relaxation therapy (MRT), which included listening to relaxing music and paced breathing at resting respiration rates. Fifty-three Latino (primarily Puerto Rican) adults with asthma and PD were randomly assigned to CBPT or MRT for 8 weekly sessions. Both groups showed improvements in PD severity, asthma control, and several other anxiety and asthma outcome measures from baseline to post-treatment and 3-month follow-up. CBPT showed an advantage over MRT for improvement in adherence to inhaled corticosteroids. Improvements in PD severity were mediated by anxiety sensitivity in CBPT and by depression in MRT, although earlier levels of these mediators did not predict subsequent improvements. Attrition was high (40%) in both groups, albeit comparable to CBT studies targeting anxiety in Latinos. Additional strategies are needed to improve retention in this high-risk population. Both CBPT and MRT may be efficacious interventions for comorbid asthma-PD, and CBPT may offer additional benefits for improving medication adherence.

Telemedicine is as effective as in-person visits for patients with asthma

BackgroundAccess to asthma specialists is a problem, particularly in rural areas, thus presenting an opportunity for management using telemedicine. ObjectiveTo compare asthma outcomes during 6 months in children managed by telemedicine vs in-person visits. MethodsChildren with asthma residing in 2 remote locations were offered the choice of an in-person visit or a telemedicine session at a local clinic. The telemedicine process involved real-time use of a Remote Presence Solution (RPS) equipped with a digital stethoscope, otoscope, and high-resolution camera. A telefacilitator operated the RPS and performed diagnostic and educational procedures, such as spirometry and asthma education. Children in both groups were assessed initially, after 30 days, and at 6 months. Asthma outcome measures included asthma control using validated tools (Asthma Control Test, Childhood Asthma Control Test, and Test for Respiratory and Asthma Control in Kids) and patient satisfaction (telemedicine group only). Noninferiority analysis of asthma control was performed using the minimally important difference of an adjusted asthma control test that combined the 3 age groups. ResultsOf 169 children, 100 were seen in-person and 69 via telemedicine. A total of 34 in-person and 40 telemedicine patients completed all 3 visits. All had a small, although statistically insignificant, improvement in asthma control over time. Telemedicine was noninferior to in-person visits. Most of the telemedicine group subjects were satisfied with their experience. ConclusionChildren with asthma seen by telemedicine or in-person visits can achieve comparable degrees of asthma control. Telemedicine can be a viable alternative to traditional in-person physician-based care for the treatment and management of asthma.

The effect of geographic access on severe health outcomes for pediatric asthma

Access to medical care and severe pediatric asthma outcomes vary with geography, but the relationship between them has not been studied. We sought to evaluate the relationship between geographic access and health outcomes for pediatric asthma. The severe outcome measures include emergency department (ED) visits and hospitalizations for children with an asthma diagnosis in Georgia and North Carolina. We quantify asthma prevalence, outcome measures, and factors included in the statistical model using multiple data sources. We calculate geographic access to primary and asthma specialist care using optimization models. We estimate the association between outcomes and geographic access in the presence of other factors using logistic regression. The model is used to project the reduction in severe outcomes with improvement in access. The association between access and outcomes for pediatric asthma depends on the type of outcome measure, type of care, and variations in other factors. The expression of this association is also different for the 2 states. Access to primary care plays a larger role than access to specialist care in explaining Georgia ED visits, whereas the reverse applies for hospitalizations. In North Carolina access to both primary and specialist care are statistically significant in explaining the variability in ED visits. The variation in the association between estimated access and outcomes affects the projected reductions of severe outcomes with access improvement. Thus applying one intervention would not have the same level of improvement across geography. Interventions must be tailored to target regions with the potential to deliver the highest effect to gain maximum benefit.

A systematic review and meta‐analysis of asthma outcomes following endoscopic sinus surgery for chronic rhinosinusitis

Patients suffering from both chronic rhinosinusitis (CRS) and asthma demonstrate improved asthma outcomes when upper airway inflammation is controlled with medications. It is unclear if similar benefits exist when the upper airway is treated surgically. This study presents a systematic review and meta-analysis to assess the effects of endoscopic sinus surgery (ESS) on asthma outcomes. Ovid MEDLINE and the Cochrane databases were searched to identify studies examining asthma outcomes in patients with CRS following ESS. Included studies involved a cohort of at least 5 patients and reported at least 1 postoperative asthma outcome. Twenty-two studies involving a total of 891 patients were identified. Mean follow-up across all studies was 26.4 months. Patients reported improved overall asthma control in 76.1% (95% confidence interval [CI], 71.9% to 80.3%) of cases. The frequency of asthma attacks decreased in 84.8% (95% CI, 76.6% to 93.0%) of patients and the number of hospitalizations decreased in 64.4% (95% CI, 53.3% to 75.6%). Decreased use of oral corticosteroids was seen in 72.8% (95% CI, 67.5% to 78.1%) of patients; inhaled corticosteroid use decreased in 28.5% (95% CI, 22.6% to 34.5%) and bronchodilator use decreased in 36.3% (95% CI, 28.9% to 43.7%) of patients. Mean improvement in predicted forced expiratory volume at 1 second (FEV1 ) was 1.62%, but was not statistically significant (p = 0.877). ESS in patients with concomitant bronchial asthma improves clinical asthma outcome measures, but not lung function testing. Difficulty conducting controlled clinical trials of ESS limits the strength of conclusions which can be reached.

Advances in pediatric asthma in 2012: Moving toward asthma prevention

Last year's "Advances in pediatric asthma: moving forward" concluded the following: "Now is also the time to utilize information recorded in electronic medical records to develop innovative disease management plans that will track asthma over time and enable timely decisions on interventions in order to maintain control that can lead to disease remission and prevention." This year's summary will focus on recent advances in pediatric asthma on modifying disease activity, preventing asthma exacerbations, managing severe asthma, and risk factors for predicting and managing early asthma, as indicated in Journal of Allergy and Clinical Immunology publications in 2012. Recent reports continue to shed light on methods to improve asthma management through steps to assess disease activity, tools to standardize outcome measures in asthma, genetic markers that predict risk for asthma and appropriate treatment, and interventions that alter the early presentation of asthma to prevent progression. We are well on our way to creating a pathway around wellness in asthma care and also to use new tools to predict the risk for asthma and take steps to not only prevent asthma exacerbations but also to prevent the early manifestations of the disease and thus prevent its evolution to severe asthma.

Leukotriene B4 receptor locus gene characterisation and association studies in asthma

BackgroundPolymorphisms spanning genes involved in the production of leukotriene B4 (LTB4) e.g. ALOX5AP and LTA4H are associated with asthma susceptibility, suggesting a role for LTB4 in disease. The contribution of LTB4receptor polymorphism is currently unknown. The aim of this study was to characterise the genes for the two pivotal LTB4 receptors, LTB4R1 and LTB4R2 in lung tissue and determine if polymorphisms spanning these genes are associated with asthma and disease severity.MethodsRapid amplification of cDNA ends (RACE) was used to characterise the LTB4R1 and LTB4R2 gene structure in lung. The LTB4R1/2 locus on chromosome 14q11.2 was screened for polymorphic variation. Six LTB4R single nucleotide polymorphisms (SNPs) were genotyped in 370 Caucasian asthma families and 299 Adult Asthma Individuals (n=1877 total) and were evaluated for association with asthma and severity (BTS) outcome measures using Family Based Association Test, linear regression and chi square.ResultsLTB4R1 has complex mRNA arrangement including multiple 5′-untranslated exons, suggesting additional levels of regulation. Three potential promoter regions across the LTB4R1/2 locus were identified with some airway cell specificity. 22 SNPs (MAF>0.01) were validated across the LTB4R locus in the Caucasian population. LTB4R1 and LTB4R2 SNPs were not associated with asthma susceptibility, FEV1 or severity.ConclusionsLTB4R1 and LTB4R2 shows splice variation in the 5′-untranslated region and multiple promoter regions. The functional significance of this is yet to be determined. Both receptor genes were shown to be polymorphic. LTB4R polymorphisms do not appear to be susceptibility markers for the development of asthma in Caucasian subjects.

Asthma outcome measures

Asthma is a common chronic disease with underlying inflammation of the airway. Advances in science have led to increased understanding of the heterogeneous nature of asthma and its complex mechanisms. Traditionally, asthma-practice guidelines have focused on optimizing lung function and the US FDA has required increases in lung function and reduction of exacerbation as primary outcomes in clinical trials of new asthma therapeutics. Improved lung function is a critical indicator of bronchodilator therapy, but the importance of long-term asthma control while maintained on controller medication is increasingly emphasized. The NIH asthma guidelines suggest the use of patient-reported outcomes, including health-related quality-of-life measures, to assess asthma control. Clinical practices and research studies concerning asthma can benefit from harmonizing the major outcome measures so that comparisons across studies can be made. In this article, we review common asthma outcome measures with a focus on recent efforts to harmonize outcomes for therapeutic clinical trials in asthma.