Publications by authors named "Giselle Mosnaim"

55 Publications

A multi-stakeholder Delphi consensus core outcome set for clinical trials in moderate-to-severe asthma (coreASTHMA).

Ann Allergy Asthma Immunol 2021 Mar 26. Epub 2021 Mar 26.

Center for Medical Technology Policy, Baltimore, Maryland.

Background: Treatments for long-term control of asthma have improved and include a promising but expensive class of biologic therapies. However, the clinical trials evaluating these and other novel treatments have utilized a variety of different outcomes to evaluate efficacy. The evolution of asthma care calls for a re-examination of outcomes that are most important to patients and other stakeholders.

Objective: The coreASTHMA project sought to develop a core set of outcomes to be measured in phase 3 and phase 4 clinical drug trials in patients with moderate-to-severe asthma.

Methods: We utilized a robust and in-depth multi-stakeholder consensus process bringing together patients, clinicians, regulators, payers, health technology assessors, researchers, and product developers to reach consensus on outcomes. We employed a modified Delphi method to reach consensus, an approach adapted from the Core Outcome Measures in Effectiveness Trials Initiative aligned with contemporary methodological standards for core outcome set development.

Results: The following outcomes were included in the final core set: severe asthma exacerbation, change in asthma control, asthma-specific or severe asthma-specific quality of life, asthma-specific hospital stay (i.e. >24 hour stays at any level of care) or admission, and asthma-specific emergency department visit.

Conclusion: These five outcomes represent a minimum set of core outcomes for use in phase 3 and phase 4 clinical drug trials in moderate-to-severe asthma. Consistent collection of these outcomes as minimum, independent of whether additional heterogeneous primary or secondary outcomes are included, will allow for meaningful comparisons across clinical trials of the effect of asthma therapies.
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http://dx.doi.org/10.1016/j.anai.2021.03.022DOI Listing
March 2021

Digital Health Technology in Asthma: A Comprehensive Scoping Review.

J Allergy Clin Immunol Pract 2021 Feb 27. Epub 2021 Feb 27.

Woodland Clinic Medical Group, Allergy Department, Dignity Health, Woodland, Calif.

Background: A variety of digital intervention approaches have been investigated for asthma therapy during the past decade, with different levels of interactivity and personalization and a range of impacts on different outcome measurements.

Objective: To assess the effectiveness of digital interventions in asthma with regard to acceptability and outcomes and evaluate the potential of digital initiatives for monitoring or treating patients with asthma.

Methods: We evaluated digital interventions using a scoping review methodology through a literature search and review. Of 871 articles identified, 121 were evaluated to explore intervention characteristics, the perception and acceptability of digital interventions to patients and physicians, and effects on asthma outcomes. Interventions were categorized by their level of interactivity with the patient.

Results: Interventions featuring non-individualized content sent to patients appeared capable of promoting improved adherence to inhaled corticosteroids, but with no identified improvement in asthma burden; and data-gathering interventions appeared to have little effect on adherence or asthma burden. Evidence of improvement in both adherence and patients' impairment due to asthma were seen only with interactive interventions involving two-way responsive patient communication. Digital interventions were generally positively perceived by patients and physicians. Implementation was considered feasible, with certain preferences for design and features important to drive use.

Conclusions: Digital health interventions show substantial promise for asthma disease monitoring and personalization of treatment. To be successful, future interventions will need to include both inhaler device and software elements, combining accurate measurement of clinical parameters with careful consideration of ease of use, personalization, and patient engagement aspects.
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http://dx.doi.org/10.1016/j.jaip.2021.02.028DOI Listing
February 2021

Media Influence on Anxiety, Health Utility, and Health Beliefs Early in the SARS-CoV-2 Pandemic-a Survey Study.

J Gen Intern Med 2021 Feb 24. Epub 2021 Feb 24.

Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.

Background: The psychological effects from the COVID-19 pandemic and response are poorly understood.

Objective: To understand the effects of the pandemic and response on anxiety and health utility in a nationally representative sample of US adults.

Design: A de-identified, cross-sectional survey was administered at the end of April 2020. Probability weights were assigned using estimates from the 2018 American Community Survey and Integrated Public Use Microdata Series Estimates.

Participants: US adults 18-85 years of age with landline, texting-enabled cellphone, or internet access.

Intervention: Seven split-half survey blocks of 30 questions, assessing demographics, COVID-19-related health attitudes, and standardized measures of generalized self-efficacy, anxiety, depression, personality, and generic health utility.

Main Measures: State/Trait anxiety scores, EQ-5D-3L Visual Analog Scale (VAS) score, and demographic predictors of these scores.

Key Results: Among 4855 respondents, 56.7% checked COVID-19-related news several times daily, and 84.4% at least once daily. Only 65.7% desired SARS-CoV-2 vaccination for themselves, and 70.1% for their child. Mean state anxiety (S-anxiety) score was significantly higher than mean trait anxiety (T-anxiety) score (44.9, 95%CI 43.5-46.3 vs. 41.6, 95%CI 38.7-44.5; p = 0.03), with both scores significantly higher than previously published norms. In an adjusted regression model, less frequent news viewing was associated with significantly lower S-anxiety score. Mean EQ-5D-3L VAS score for the population was significantly lower vs. established US normative data (71.4 CI 67.4-75.5, std. error 2 vs. societal mean 80, std. error 0.1; p < 0.001). EQ-5D-3L VAS score was bimodal (highest with hourly and no viewing) and significantly reduced with less media viewership in an adjusted model.

Conclusions: Among a nationally representative sample, there were higher S-anxiety and lower EQ-5D-3L VAS scores compared to non-pandemic normative data, indicative of a potential detrimental acute effect of the pandemic. More frequent daily media viewership was significantly associated with higher S-anxiety but also predictive of higher health utility, as measured by EQ-5D-3L VAS scores.
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http://dx.doi.org/10.1007/s11606-020-06554-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7904294PMC
February 2021

Psychosocial Moderators and Outcomes of a Randomized Effectiveness Trial for Child Asthma.

J Pediatr Psychol 2021 Feb 22. Epub 2021 Feb 22.

Institute for Health Research and Policy, University of Illinois at Chicago.

Objective: Psychosocial factors play a role in child asthma morbidity and disparities, but their impact on asthma intervention effectiveness is less understood. This study examined how child, parent, and family psychosocial factors moderated asthma response to, and changed in response to, 2 community asthma interventions among urban minority youth.

Methods: Asthma Action at Erie was a randomized comparative effectiveness trial examining a community health worker (CHW) home intervention versus certified asthma educator (AE-C) services for children aged 5-16 with uncontrolled asthma (N = 223; mean age = 9.37, SD = 3.02; 85.2% Hispanic). Asthma control was assessed via the Asthma Control Test (ACT)/childhood ACT and activity limitation. Baseline child/parent depression and posttraumatic stress disorder (PTSD) symptoms, family chaos, and social support were examined as treatment moderators. We also tested intervention effects on psychosocial outcomes.

Results: For parents with higher baseline depression symptoms, youth in the CHW group had greater ACT improvement by 24 months (7.49 points) versus AE-C (4.76 points) and 51% reduction in days of limitation by 6 months versus AE-C (ß = -0.118; p = .0145). For higher parent PTSD symptoms, youth in CHW had 68% fewer days of limitation at 24 months versus AE-C (ß = -0.091; p = .0102). Psychosocial outcomes did not vary by group, but parent depression, parent and child PTSD symptoms, and social support improved for all.

Conclusions: CHW intervention was associated with improved asthma control among families with higher parent strain. Findings have implications for utilizing tailored CHW home interventions to optimize asthma outcomes in at-risk families.
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http://dx.doi.org/10.1093/jpepsy/jsab011DOI Listing
February 2021

A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients.

Eur Respir J 2020 Dec 17. Epub 2020 Dec 17.

GlaxoSmithKline R&D, Brentford, UK.

Suboptimal adherence to maintenance therapy contributes to poor asthma control and exacerbations. This study evaluated the effect of different elements of a connected inhaler system (CIS), comprising clip-on inhaler sensors, a patient-facing app, and a healthcare professional (HCP) dashboard, on adherence to asthma maintenance therapy.This was an open-label, parallel-group, 6-month, randomised controlled trial in adults with uncontrolled asthma (Asthma Control Test (ACT) score <20) on fixed-dose inhaled corticosteroid/long-acting beta-agonist maintenance therapy (n=437). All received fluticasone furoate/vilanterol ELLIPTA dry powder maintenance and salbutamol/albuterol metered dose rescue inhalers with a sensor attached to each inhaler. Participants were randomised to one of five CIS study arms (1:1:1:1:1) reflecting the recipient of the data feedback from the sensors: 1) Maintenance use to participants and HCPs (N=87); 2) Maintenance use to participants (N=88); 3) Maintenance and rescue use to participants and HCPs (N=88); 4) Maintenance and rescue use to participants (N=88); 5) No feedback (control) (N=86).For the primary endpoint, observed mean adherence (sd) to maintenance therapy over months 4-6, was 82.2% (16.58) (n=83) in the "maintenance to participants and HCPs" arm and 70.8% (27.30) (n=85) in the control arm and the adjusted LS mean (se) was 80.9% (3.19) and 69.0% (3.19), respectively (study arm difference: 12.0% (95% CI: 5.2%, 18.8%; p<0.001)). Adherence was also significantly greater in the other CIS arms control. Mean percentage of rescue medication-free days (months 4-6) was significantly greater in participants receiving data on their rescue use compared with control. ACT scores improved in all study arms with no significant differences between groups.A CIS can improve adherence to maintenance medication and reduce rescue medication use in patients with uncontrolled asthma.
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http://dx.doi.org/10.1183/13993003.03103-2020DOI Listing
December 2020

The Impact of Patient Self-Monitoring Via Electronic Medication Monitor and Mobile App Plus Remote Clinician Feedback on Adherence to Inhaled Corticosteroids: A Randomized Controlled Trial.

J Allergy Clin Immunol Pract 2021 Apr 16;9(4):1586-1594. Epub 2020 Nov 16.

Department of Pediatrics, Section of Allergy and Immunology and Pulmonary and Sleep Medicine, University of Colorado School of Medicine and the Breathing Institute, Children's Hospital Colorado, Aurora, Colo.

Background: Poor adherence to inhaled corticosteroids (ICSs) and overuse of short-acting beta-agonists (SABAs) are associated with increased asthma morbidity.

Objective: To assess whether patient self-monitoring via electronic medication monitoring and smartphone application plus remote clinician feedback influences ICS and SABA use.

Methods: Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study. Inhalers were fitted with electronic medication monitoring to track real-time usage. After a 14-day baseline, participants were randomly assigned to the treatment group where they received reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback. Linear mixed models compared the baseline percentage of SABA-free days and ICS adherence to the last 14 study days.

Results: Participants (n = 100) had a mean age of 48.5 years, 80% were female, 68% white, and 80% privately insured. The percentage of SABA-free days increased significantly in the treatment group (19%; 95% CI, 12 to 26; P < .01) and nonsignificantly in the control group (6%, 95% CI, -3 to 16; P = .18), representing a 13% (95% CI, 1-26; P = .04) difference. ICS adherence changed minimally in the treatment group (-2%; 95% CI, -7 to 3; P = .40), but decreased significantly (-17%; 95% CI, -26 to -8; P < .01) in the control group, representing a 15% (95% CI, 4 to 25; P < .01) difference.

Conclusions: Patient self-monitoring via a digital platform plus remote clinician feedback maintained high baseline ICS adherence and decreased SABA use.
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http://dx.doi.org/10.1016/j.jaip.2020.10.064DOI Listing
April 2021

Reply to "Opportunities to enhance the AAAAI Physician Burnout Survey".

J Allergy Clin Immunol Pract 2020 09;8(8):2839-2840

Division of Pulmonary, Allergy, and Critical Care, Department of Medicine, NorthShore University Health System, Evanston, Ill.

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http://dx.doi.org/10.1016/j.jaip.2020.05.029DOI Listing
September 2020

Work Group Report: COVID-19: Unmasking Telemedicine.

J Allergy Clin Immunol Pract 2020 09 27;8(8):2461-2473.e3. Epub 2020 Jun 27.

Division of Pulmonary, Allergy and Critical Care, Department of Medicine, NorthShore University HealthSystem, Evanston, Ill. Electronic address:

Telemedicine adoption has rapidly accelerated since the onset of the COVID-19 pandemic. Telemedicine provides increased access to medical care and helps to mitigate risk by conserving personal protective equipment and providing for social/physical distancing to continue to treat patients with a variety of allergic and immunologic conditions. During this time, many allergy and immunology clinicians have needed to adopt telemedicine expeditiously in their practices while studying the complex and variable issues surrounding its regulation and reimbursement. Some concerns have been temporarily alleviated since March 2020 to aid with patient care in the setting of COVID-19. Other changes are ongoing at the time of this publication. Members of the Telemedicine Work Group in the American Academy of Allergy, Asthma & Immunology (AAAAI) completed a telemedicine literature review of online and Pub Med resources through May 9, 2020, to detail Pre-COVID-19 telemedicine knowledge and outline up-to-date telemedicine material. This work group report was developed to provide guidance to allergy/immunology clinicians as they navigate the swiftly evolving telemedicine landscape.
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http://dx.doi.org/10.1016/j.jaip.2020.06.038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320693PMC
September 2020

Reply to "Challenges to pediatric services during COVID-19 pandemic: A London, UK perspective".

J Allergy Clin Immunol Pract 2020 09 24;8(8):2835-2836. Epub 2020 Jun 24.

Geisel School of Medicine and Dartmouth-Hitchcock Medical Center, Lebanon, NH. Electronic address:

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http://dx.doi.org/10.1016/j.jaip.2020.06.026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7313511PMC
September 2020

The Adoption and Implementation of Digital Health Care in the Post-COVID-19 Era.

J Allergy Clin Immunol Pract 2020 Sep 22;8(8):2484-2486. Epub 2020 Jun 22.

Propeller Health, San Francisco, Calif. Electronic address:

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http://dx.doi.org/10.1016/j.jaip.2020.06.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308018PMC
September 2020

Clinical and Economic Outcomes in Patients with Persistent Asthma Who Attain Healthcare Effectiveness and Data Information Set Measures.

J Allergy Clin Immunol Pract 2020 Nov - Dec;8(10):3443-3454.e2. Epub 2020 Jun 18.

Real World Insights, IQVIA, Cambridge, Mass.

Background: Attainment of asthma-specific US Healthcare Effectiveness Data and Information Set (HEDIS) quality measures may be associated with improved clinical outcomes and reduced economic burden.

Objective: We examined the relationship between the attainment of HEDIS measures asthma medication ratio (AMR) and medication management for people with asthma (MMA) on clinical and economic outcomes.

Methods: This retrospective claims database analysis linked to ambulatory electronic medical records enrolled US patients aged ≥5 years with persistent asthma between May 2015 and April 2017. The attainment of AMR ≥0.5 and MMA ≥75% was determined over a 1-year premeasurement period. Asthma exacerbations and asthma-related health care costs were evaluated during the subsequent 12-month measurement period, comparing patients attaining 1 or both measures with those not attaining either.

Results: In total, 32,748 patients were included, 75.2% of whom attained AMR (n = 24,388) and/or MMA (n = 12,042) during the premeasurement period. Fewer attainers of 1 or more HEDIS measures had ≥1 asthma-related hospitalizations, emergency department visit, corticosteroid burst, or exacerbation (4.9% vs 7.3%; 9.6% vs 18.2%; 43.8% vs 51.6%; 14.3% vs 23.3%, respectively; all P < .001) compared with nonattainers. In adjusted analyses, HEDIS attainment was associated with a lower likelihood of exacerbations (odds ratio: 0.63, [95% confidence interval: 0.60-0.67]; P < .001). The attainment of ≥1 HEDIS measures lowered total and asthma-related costs, and asthma exacerbation-related health care costs per patient relative to nonattainers (cost ratio: 0.87, P < .001; 0.96, P = .02; and 0.59, P < .001, respectively). Overall and asthma-specific costs were lower for patients attaining AMR, but not MMA.

Conclusions: HEDIS attainment was associated with significantly improved asthma outcomes and lower asthma-specific costs.
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http://dx.doi.org/10.1016/j.jaip.2020.06.012DOI Listing
June 2020

A Phased Approach to Resuming Suspended Allergy/Immunology Clinical Services.

J Allergy Clin Immunol Pract 2020 Jul - Aug;8(7):2125-2134. Epub 2020 May 22.

Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo. Electronic address:

In early 2020, the first US and Canadian cases of the novel severe acute respiratory syndrome coronavirus 2 infection were detected. In the ensuing months, there has been rapid spread of the infection. In March 2020, in response to the virus, state/provincial and local governments instituted shelter-in-place orders, and nonessential ambulatory care was significantly curtailed, including allergy/immunology services. With rates of new infections and fatalities potentially reaching a plateau and/or declining, restrictions on provision of routine ambulatory care are lifting, and there is a need to help guide the allergy/immunology clinician on how to reinitiate services. Given the fact that coronavirus disease 2019 will circulate within our communities for months or longer, we present a flexible, algorithmic best-practices planning approach on how to prioritize services, in 4 stratified phases of reopening according to community risk level, as well as highlight key considerations for how to safely do so. The decisions on what services to offer and how fast to proceed are left to the discretion of the individual clinician and practice, operating in accordance with state and local ordinances with respect to the level of nonessential ambulatory care that can be provided. Clear communication with staff and patients before and after all changes should be incorporated into this new paradigm on continual change, given the movement may be forward and even backward through the phases because this is an evolving situation.
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http://dx.doi.org/10.1016/j.jaip.2020.05.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242939PMC
July 2020

Health and Economic Outcomes of Home Maintenance Allergen Immunotherapy in Select Patients with High Health Literacy during the COVID-19 Pandemic: A Cost-Effectiveness Analysis During Exceptional Times.

J Allergy Clin Immunol Pract 2020 Jul - Aug;8(7):2310-2321.e4. Epub 2020 May 14.

Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo. Electronic address:

Background: Allergen immunotherapy (AIT) is safe and effective but is typically administered under strict clinic observation to mitigate the risk of a systemic reaction to immunotherapy (SRIT). However, in the setting of the global coronavirus disease 2019 pandemic, alternative care models should be explored.

Objective: To evaluate the cost-effectiveness of home immunotherapy self-administration (HITSA) in a highly idealized circumstance for provision of maintenance AIT in a shelter-in-place or other scenarios of unforeseen reduction in nonessential medical services.

Methods: Markov modeling was used to compare in-office clinic AIT in selected patients using cohort analysis and microsimulation from the societal and health care perspectives.

Results: Assuming similar SRIT rates, HITSA was found to be a cost-effective option with an incremental cost-effectiveness ratio of $44,554/quality-adjusted life-year when considering both incremental epinephrine autoinjector costs and coronavirus disease 2019 risks. Excluding epinephrine autoinjector costs, HISTA dominated other options. However, outside of pandemic considerations, HITSA was not cost-effective (incremental cost-effectiveness ratio, $198,877,286) at annual epinephrine autoinjector costs above $287. As the incremental HITSA SRIT rate increased above 15%, clinic AIT was the most cost-effective strategy. Excluding both pandemic risks and risk of motor vehicle accident fatality from round-trip clinic transit, clinic AIT dominated other strategies. Clinic AIT was the more cost-effective option at very high fatality relative risk for HITSA or at very low annual risk of contracting coronavirus disease 2019.

Conclusions: Under idealized assumptions HITSA can be a safe and cost-effective option during a global pandemic in appropriately selected patients provided home rates of SRIT remain stable.
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http://dx.doi.org/10.1016/j.jaip.2020.05.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7224677PMC
July 2020

Add-on tiotropium versus step-up inhaled corticosteroid plus long-acting beta-2-agonist in real-world patients with asthma.

Allergy Asthma Proc 2020 07 15;41(4):248-255. Epub 2020 May 15.

Allergy and Immunology, The Allergy and Asthma Center, East Providence, Rhode Island.

A step-up approach (increasing inhaled corticosteroid [ICS] dose and/or add-on treatment) is recommended for asthma that is uncontrolled despite ICS plus long-acting beta-2-agonist (LABA) combination treatment. Understanding the impact of different treatment options on health outcomes can help guide treatment decision-making. To compare the effectiveness of add-on tiotropium 1.25 µg (two puffs once daily) versus an increased ICS plus LABA dose in a real-world cohort of patients with asthma initiated on ICS plus LABA. De-identified data from patients ages ≥12 years and with asthma who were initiated on ICS plus LABA, and then had tiotropium added (Tio group; index date) or an ICS plus LABA dose increased (inc-ICS group; index date) were collected from two medical and pharmacy claims data bases (2014-2018). To account for population/group differences, propensity score matching was performed. The primary end point was the exacerbation risk after the index date. Secondary end points included exacerbation rates 6 and 12 months postindex, health-care resource utilization, costs, and short-acting beta-2-agonist (SABA) refills 12 months postindex. Overall, 7857 patients (Tio group, 2619; inc-ICS group, 5238) were included. The exacerbation risk was 35% lower in the Tio group than in the inc-ICS group (hazard ratio 0.65 [95% confidence interval, 0.43-0.99]; p = 0.044). Exacerbation rates in the Tio group also were significantly lower within 6 and 12 months postindex (64% and 73%, respectively). All-cause and asthma-related emergency department (ED) visits were 47% and 74% lower, respectively (p < 0.0001 for both), and all-cause and asthma-related hospitalizations were 48% (p < 0.01) and 76% (p < 0.001) lower, respectively, in the Tio group. Also, significantly fewer patients in the Tio group versus the inc-ICS group required SABA refills (56% versus 67%, p < 0.0001). Add-on tiotropium significantly decreased the risk and rate of exacerbations, decreased all-cause and asthma-related ED visits and hospitalizations, and reduced SABA refills compared with increasing the ICS plus LABA dose. The findings supported the use of add-on tiotropium for patients with uncontrolled asthma taking ICS plus LABA.
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http://dx.doi.org/10.2500/aap.2020.41.200036DOI Listing
July 2020

Relative efficacy and safety of inhaled corticosteroids in patients with asthma: Systematic review and network meta-analysis.

Ann Allergy Asthma Immunol 2020 08 14;125(2):163-170.e3. Epub 2020 Apr 14.

National Jewish Health, Denver, Colorado. Electronic address:

Background: Inhaled corticosteroids (ICSs) are recommended as first-line controller medications for persistent asthma. However, guidelines on the initial ICS doses, step-up and step-down algorithms, and when to switch to combination therapy vary.

Objective: To understand the ideal starting doses of ICS therapy based on current evidence and to systematically compare low, moderate, and high starting doses of ICSs as monotherapy and in combination with long-acting β-agonists with respect to efficacy and safety.

Methods: MEDLINE, Embase, and Cochrane databases were searched for relevant English-language articles published from 1980 to November 17, 2018. Randomized controlled trials with adult, steroid-naive, ICS-free (for ≥4 weeks) patients with asthma and a duration of 4 weeks or longer with an ICS treatment arm (monotherapy or combination therapy) were included. Separate fixed-effects Bayesian network meta-analyses were conducted on the extracted data for peak expiratory flow, forced expiratory volume in 1 second, nighttime rescue medication use, nighttime symptom score, and study withdrawal because of an adverse event.

Results: A total of 31 randomized controlled trials were analyzed. All starting doses of ICSs were comparable with respect to nighttime rescue medication use, nighttime symptom score, change in forced expiratory volume in 1 second, and study withdrawal because of an adverse event. Significant improvement in morning peak expiratory flow was observed with high-dose ICSs and with low- and moderate-dose ICSs and long-acting β-agonists than with low-dose ICSs.

Conclusion: Overall, a high starting dose of ICSs had no additional clinical benefit in 3 of the 4 efficacy parameters compared with low or moderate ICS doses for controlling moderate to severe asthma but might have potential safety concerns.
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http://dx.doi.org/10.1016/j.anai.2020.04.006DOI Listing
August 2020

Clinician Wellness During the COVID-19 Pandemic: Extraordinary Times and Unusual Challenges for the Allergist/Immunologist.

J Allergy Clin Immunol Pract 2020 06 4;8(6):1781-1790.e3. Epub 2020 Apr 4.

Geisel School of Medicine and Dartmouth-Hitchcock Medical Center, Lebanon, NH. Electronic address:

The global spread of coronavirus disease 2019 (COVID-19) has caused sudden and dramatic societal changes. The allergy/immunology community has quickly responded by mobilizing practice adjustments and embracing new paradigms of care to protect patients and staff from severe acute respiratory syndrome coronavirus 2 exposure. Social distancing is key to slowing contagion but adds to complexity of care and increases isolation and anxiety. Uncertainty exists across a new COVID-19 reality, and clinician well-being may be an underappreciated priority. Wellness incorporates mental, physical, and spiritual health to protect against burnout, which impairs both coping and caregiving abilities. Understanding the stressors that COVID-19 is placing on clinicians can assist in recognizing what is needed to return to a point of wellness. Clinicians can leverage easily accessible tools, including the Strength-Focused and Meaning-Oriented Approach to Resilience and Transformation approach, wellness apps, mindfulness, and gratitude. Realizing early warning signs of anxiety, depression, substance abuse, and posttraumatic stress disorder is important to access safe and confidential resources. Implementing wellness strategies can improve flexibility, resilience, and outlook. Historical parallels demonstrate that perseverance is as inevitable as pandemics and that we need not navigate this unprecedented time alone.
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http://dx.doi.org/10.1016/j.jaip.2020.04.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7129776PMC
June 2020

COVID-19: Pandemic Contingency Planning for the Allergy and Immunology Clinic.

J Allergy Clin Immunol Pract 2020 05 26;8(5):1477-1488.e5. Epub 2020 Mar 26.

Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo. Electronic address:

In the event of a global infectious pandemic, drastic measures may be needed that limit or require adjustment of ambulatory allergy services. However, no rationale for how to prioritize service shut down and patient care exists. A consensus-based ad-hoc expert panel of allergy/immunology specialists from the United States and Canada developed a service and patient prioritization schematic to temporarily triage allergy/immunology services. Recommendations and feedback were developed iteratively, using an adapted modified Delphi methodology to achieve consensus. During the ongoing pandemic while social distancing is being encouraged, most allergy/immunology care could be postponed/delayed or handled through virtual care. With the exception of many patients with primary immunodeficiency, patients on venom immunotherapy, and patients with asthma of a certain severity, there is limited need for face-to-face visits under such conditions. These suggestions are intended to help provide a logical approach to quickly adjust service to mitigate risk to both medical staff and patients. Importantly, individual community circumstances may be unique and require contextual consideration. The decision to enact any of these measures rests with the judgment of each clinician and individual health care system. Pandemics are unanticipated, and enforced social distancing/quarantining is highly unusual. This expert panel consensus document offers a prioritization rational to help guide decision making when such situations arise and an allergist/immunologist is forced to reduce services or makes the decision on his or her own to do so.
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http://dx.doi.org/10.1016/j.jaip.2020.03.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7195089PMC
May 2020

Implementation Lessons From a Randomized Trial Integrating Community Asthma Education for Children.

J Ambul Care Manage 2020 Apr/Jun;43(2):125-135

University of Illinois at Chicago (Drs Martin, Bisarini, Weinstein, and Walton and Ms Rosales); Erie Family Health Center, Chicago, Illinois (Dr Roy); and Northshore University Health System, Evanston, Illinois (Dr Mosnaim).

This study characterized and compared the implementation of clinically integrated community health workers (CHWs) to a certified asthma educator (AE-C) for low-income children with asthma. In the AE-C arm (N = 115), 51.3% completed at least one in-clinic education session. In the CHW arm (N = 108), 722 home visits were completed. The median number of visits was 7 (range, 0-17). Scheduled in-clinic asthma education may not be the optimal intervention for this patient population. CHW visit completion rates suggest that the schedule, location, and content of CHW asthma services better met patients' needs. Seven to 10 visits seemed to be the preferred CHW dose.
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http://dx.doi.org/10.1097/JAC.0000000000000326DOI Listing
February 2020

AAAAI Work Group Report: Physician Wellness in Allergy and Immunology.

J Allergy Clin Immunol Pract 2020 04 14;8(4):1224-1229. Epub 2020 Feb 14.

Division of Pulmonary, Allergy, and Critical Care Medicine, Northshore University Health System, Evanston, Ill.

Background: Physician health and wellness can be negatively impacted by burnout, which, in turn, can lead to medical errors and early retirement. Burnout issues can start in medical school and progress during residency, fellowship, and throughout a physician's career. Previous studies have reported burnout rates between 45% and 54% for US physicians in general. However, there is currently little data regarding health and wellness specifically in the field of allergy and immunology.

Objective: This workgroup report was developed to assess health and wellness in our specialty.

Methods: The American Academy of Allergy, Asthma, and Immunology (AAAAI) electronically distributed an anonymous questionnaire using the validated mini-Z survey to a random sample of 1035 fellows and members. In addition to the mini-Z items, the survey queried personal and professional demographic characteristics, and included open-ended wellness questions.

Results: A total of 138 fellows and members of the AAAAI completed the survey, yielding a 13% response rate. The burnout rate was 35%, which is lower than the national average among US physicians, and is overall encouraging. However, there is room for improvement. Limitations of the study include a small sample size as well as evolving definitions of burnout.

Conclusions: Our results identify specialty specific concerns and can be used to inform the development of tailored interventions to improve wellness and minimize burnout. However, future surveys with a larger sample size are needed to obtain a more robust data set on allergy and immunology specific wellness challenges.
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http://dx.doi.org/10.1016/j.jaip.2020.01.023DOI Listing
April 2020

The impact of caregiver health literacy on healthcare outcomes for low income minority children with asthma.

J Asthma 2020 12 8;57(12):1316-1322. Epub 2019 Aug 8.

Cardiopulmonary Sciences, Rush University, Chicago, IL, USA.

The aim of this exploratory study was to assess the impact of caregiver health literacy (HL) on health care outcomes for their child with asthma. Caregiver dyads across two different healthcare delivery systems completed a battery of validated asthma outcome instruments, including the Newest Vital Sign™ as a measure of HL for the caregivers of children ages 7-18 y. Utilization history was obtained through the electronic medical record. Descriptive analysis with bivariate associations was conducted. There was no direct relationship between HL and asthma outcomes in the 34 Hispanic and African American caregiver-child dyads. However, caregiver health literacy was significantly related to language ( = 0.02). African American English-speaking caregivers, seen in an urban emergency department, demonstrated adequate health literacy. Hispanic Spanish-speaking caregivers, seeking care in a mobile asthma van, showed limited health literacy. There was no significant association between caregivers' HL and routine asthma care visits when language and child age were controlled. Assessing patient factors can identify persons at risk who need additional support to negotiate the healthcare system when providing care for a child with asthma.
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http://dx.doi.org/10.1080/02770903.2019.1648507DOI Listing
December 2020

Development and validation of an asthma exacerbation prediction model using electronic health record (EHR) data.

J Asthma 2020 12 8;57(12):1339-1346. Epub 2019 Aug 8.

Department of Family Medicine, Case Western Reserve University/University Hospitals, Cleveland, OH, USA.

Asthma exacerbations are associated with significant morbidity, mortality, and cost. Accurately identifying asthma patients at risk for exacerbation is essential. We sought to develop a risk prediction tool based on routinely collected data from electronic health records (EHRs). From a repository of EHRs data, we extracted structured data for gender, race, ethnicity, smoking status, use of asthma medications, environmental allergy testing BMI status, and Asthma Control Test scores (ACT). A subgroup of this population of patients with asthma that had available prescription fill data was identified, which formed the primary population for analysis. Asthma exacerbation was defined as asthma-related hospitalization, urgent/emergent visit or oral steroid use over a 12-month period. Univariable and multivariable statistical analysis was completed to identify factors associated with exacerbation. We developed and tested a risk prediction model based on the multivariable analysis. We identified 37,675 patients with asthma. Of those, 1,787 patients with asthma and fill data were identified, and 979 (54.8%) of them experienced an exacerbation. In the multivariable analysis, smoking (OR = 1.69, CI: 1.08-2.64), allergy testing (OR = 2.40, CI: 1.54-3.73), obesity (OR = 1.66, CI: 1.29-2.12), and ACT score reflecting uncontrolled asthma (OR = 1.66, CI: 1.10-2.29) were associated with increased risk of exacerbation. The area-under-the-curve (AUC) of our model in a combined derivation and validation cohort was 0.67. Despite use of rigorous methodology, we were unable to produce a predictive model with an acceptable degree of accuracy and AUC to be clinically useful.
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http://dx.doi.org/10.1080/02770903.2019.1648505DOI Listing
December 2020

Family Chaos and Asthma Control.

Pediatrics 2019 08 9;144(2). Epub 2019 Jul 9.

Institute for Health Research and Policy, and.

Objectives: Asthma is a highly prevalent childhood chronic disease, with particularly high rates among poor and minority youth. Psychosocial factors have been linked to asthma severity but remain poorly understood. This study examined (1) relationships between parent and child depression and posttraumatic stress disorder (PTSD) symptoms, family functioning, and child asthma control in a sample of urban minority youth with uncontrolled asthma and (2) family functioning as a pathway linking parent depression and asthma outcomes.

Methods: Data were drawn from the baseline cohort of a randomized trial testing community interventions for children aged 5 to 16 with uncontrolled asthma ( = 223; mean age = 9.37, SD = 3.02; 85.2% Hispanic). Asthma control was defined by using the Asthma Control Test and Childhood Asthma Control Test, activity limitation, and previous-12-month asthma severity. Psychosocial measures included parent and child depression and PTSD symptoms, family chaos, and parent social support.

Results: Parent and child depression symptoms, but not PTSD, were associated with worse asthma control (β = -.20 [SE = 0.06] and β = -.12 [SE = -.03]; < .001). Family chaos corresponded to worse asthma control, even when controlling for parent and child depression (β = -.33; [SE = 0.15]; < .05), and was a mediator of the parent depression-asthma path. Emotional triggers of asthma also mediated the parent depression-asthma relationship.

Conclusions: Findings highlight family chaos as a mechanism underlying the relationship between parent depression and child asthma control. Addressing parent and child depression, family routines, and predictability may optimize asthma outcomes.
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http://dx.doi.org/10.1542/peds.2018-2758DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6855822PMC
August 2019

Asthma Control-Time to Rethink Definitions and Criteria.

J Allergy Clin Immunol Pract 2019 May - Jun;7(5):1522-1523

Department of Medical and Clinical Affairs, Propeller Health, San Francisco, Calif. Electronic address:

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http://dx.doi.org/10.1016/j.jaip.2019.02.001DOI Listing
May 2020

Harmonized outcome measures for use in asthma patient registries and clinical practice.

J Allergy Clin Immunol 2019 09 9;144(3):671-681.e1. Epub 2019 Mar 9.

Division of Pulmonary, Allergy, and Critical Care Medicine, NorthShore University HealthSystem, Chicago, Ill.

Background: Asthma, a common chronic airway disorder, affects an estimated 25 million persons in the United States and 330 million persons worldwide. Although many asthma patient registries exist, the ability to link and compare data across registries is hindered by a lack of harmonization in the outcome measures collected by each registry.

Objectives: The purpose of this project was to develop a minimum set of patient- and provider-relevant standardized outcome measures that could be collected in asthma patient registries and clinical practice.

Methods: Asthma registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of quality measures and consensus statements. Outcome measures were categorized by using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework. A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings.

Results: Forty-six outcome measures, including those identified from 13 registries, were curated and harmonized into a minimum set of 21 measures in the Outcome Measures Framework categories of survival, clinical response, events of interest, patient-reported outcomes, resource utilization, and experience of care. The harmonized definitions build on existing consensus statements and are appropriate for adult and pediatric patients.

Conclusions: The harmonized measures represent a minimum set of outcomes that are relevant in asthma research and clinical practice. Routine and consistent collection of these measures in registries and other systems would support creation of a national research infrastructure to efficiently address new questions and improve patient management and outcomes.
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http://dx.doi.org/10.1016/j.jaci.2019.02.025DOI Listing
September 2019

Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.

Contemp Clin Trials 2019 04 14;79:55-65. Epub 2019 Feb 14.

NorthShore University HealthSystem, University of Illinois at Chicago, United States.

Objective: To describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago.

Methods: Child/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Data collection occured at baseline, 6-, 12-, 18, and 24-months. The co-primary outcomes included asthma control using the Asthma Control Test/childhood Asthma Control Test (ACT/cACT) and activity limitation over the past 14 days.

Results: A total of 223 participants ages 5-16 years were randomized. The majority of children were in the 5-11 year old range (78.9%). Most caregivers (96.9%) and 44% of children were female. Approximately 85% of caregivers and children reported Hispanic ethnicity and 62.3% reported a household income of ≤ $59,000. Over half (55.7%) had uncontrolled asthma as measured by ACT/cACT; 13.9% had a normal ACT/cACT score but were uncontrolled using the Asthma Control Questionnaire and 20.2% were controlled on both measures but had received oral steroids in the past year for asthma.

Conclusion: The Asthma Action at Erie Trial successfully recruited a largely Hispanic cohort of children with uncontrolled or high-risk asthma to study the differential effects of clinic-based AE-C and home-based CHW interventions. Strengths of the trial include its comparative effectivness design that integrates interventionists and intervention delivery into a clinical setting. Categorizing asthma control in community settings for research purposes presents unique challenges.

Clinical Trial Registration: University of Illinois at Chicago Protocol Record R01HL123797, Asthma Action at Erie TrialClinicalTrials.gov Identifier: NCT02481986 "ClinicalTrials.gov Registration" register@clinicaltrials.gov.
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http://dx.doi.org/10.1016/j.cct.2019.02.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6541387PMC
April 2019

Documentation of asthma control and severity in pediatrics: analysis of national office-based visits.

J Asthma 2020 02 18;57(2):205-216. Epub 2019 Jan 18.

Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, TX, USA.

To evaluate the extent of documentation of asthma control and severity and associated characteristics among pediatric asthma patients in office-based settings. This cross-sectional study utilized data from the 2012-2015 National Ambulatory Medical Care Survey (NAMCS). Patients aged 6-17 years with a diagnosis of asthma were included. Weighted descriptive analysis examined the extent of documentation and uncontrolled asthma; while logistic regression evaluated associated characteristics. Overall, there were 2.47 million (95% confidence interval, 95% CI: 2.04-2.90) average annual visits with asthma as a primary diagnosis. Asthma control and severity was documented in only 36.1% and 33.8% of the visits, respectively. An established patient (odds ratio, OR = 3.81), Hispanic ethnicity (OR = 2.10), chronic sinusitis (OR = 5.59), and visits in the Northeast (OR = 2.12) and Midwest (OR = 2.25) regions had higher odds of documented asthma control status, whereas undocumented asthma severity (OR = 0.02), and visits in spring (OR = 0.34), had lower odds. Osteopathic doctors (OR = 0.18), visits in the Northeast region (OR = 0.23), chronic sinusitis (OR = 0.08), and undocumented asthma control status (OR = 0.03) had lower odds of documented asthma severity, whereas visits in spring (OR = 3.88) and autumn (OR = 3.32) had higher odds. Moderate/severe persistent asthma (OR = 15.35) had higher odds of uncontrolled asthma (as compared to intermittent asthma), while visits in the summer (OR = 0.14) had lower odds. The findings of this study suggest a critical need to increase the documentation of asthma severity and control to improve quality of asthma care in children.
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http://dx.doi.org/10.1080/02770903.2018.1554069DOI Listing
February 2020

Asthma Medication Prescribing Practices in Pediatric Office Visits.

Clin Pediatr (Phila) 2019 04 7;58(4):395-405. Epub 2019 Jan 7.

1 Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, TX, USA.

This cross-sectional study examined how asthma control, demographic, and clinical characteristics are associated with the use of asthma medications in pediatric office visits in the United States. Data from the 2012-2015 National Ambulatory Medical Care Survey included patients aged 6 to 17 years, with asthma as a primary diagnosis (International Classification of Diseases, Ninth Revision, Clinical Modification, code 493.xx). Descriptive weighted analysis evaluated asthma medication use. Multivariable logistic regression examined characteristics associated with asthma prescribing practices. An estimated 2.5 million pediatric office visits were made annually for asthma. The majority of asthma visits involved males (59.3%), children aged 6 to 11 years (54.8%), and whites (73.6%). Several clinical and demographic characteristics contributed to the variations in overall asthma medication use as well as specific drug classes. Lack of documentation of asthma control and uncontrolled asthma were associated with oral corticosteroid and inhaled corticosteroid use in pediatric asthma patients, but not with overall asthma medication use.
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http://dx.doi.org/10.1177/0009922818822980DOI Listing
April 2019