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Objective: To examine the correlation of numerical skills used in patients' self-management of asthma with asthma-related quality of life (AQOL).Methods: Adults with moderate-severe asthma completed the Asthma Numeracy Questionnaire (ANQ), assessments of reading comprehension and self-efficacy, and the mini-Asthma Quality of Life Questionnaire (miniAQLQ). The numeracy-AQOL relationship was evaluated in the context of potential confounders (demographic variables) and mediators (e.g. income and self-efficacy), using tests of correlation then multivariable models to assess for confounders and mediators.Results: 80 adults with moderate or severe asthma were evaluated. Mean ANQ score was 2.3+/-1.2 (range 0-4). ANQ was correlated with miniAQLQ (rho=0.24, p=0.03). This association was sustained (rho=0.27, p=0.02) when controlling for potential confounders significantly associated with AQOL (age, Latino ethnicity). The ANQ-miniAQLQ association was mediated by household income; the correlation was reduced by 81% when adjusting for income (rho=0.05, p=0.65). In contrast, self-efficacy less strongly mediated this association; the correlation was reduced by 26% when controlled for self-efficacy (rho=0.20, p=0.08).Conclusion: Numerical skills needed for asthma self-management influence AQOL primarily through their impact on income and, to a lesser extent, on self-efficacy.Practice Implications: Adults with asthma will benefit from self-management instructions employing the simplest mathematical constructs whose understanding is confirmed by clinicians. [ABSTRACT FROM AUTHOR]

Introduction: Penicillins and other beta-lactam antibiotics are used in greater than one-third of pregnant women as treatment for Group B Streptococcus colonization and prophylaxis for Caesarean sections. Penicillin allergy labels have been associated with increased morbidity in the pregnant population, and penicillin allergy evaluation during pregnancy is now recognized as safe and effective. Yet, demographic characteristics associated with having a penicillin allergy label during pregnancy have not been studied. We aimed to evaluate factors associated with having a penicillin allergy label in a diverse population of pregnant patients., Methods: We performed a retrospective observational study of pregnant patients who had an outpatient visit with Obstetrics and Gynecology and a delivery encounter from 1/1/2020 through 6/30/2022 using electronic health record data in a large health system. We used a multivariable logistic regression model to evaluate factors associated with having a penicillin allergy label., Results: We identified 10,969 pregnant women of whom 940 (8.6%) had a penicillin allergy label. In the multivariable analysis, having a penicillin allergy label was positively associated with age 32-34 years [odds ratio (OR) = 1.31 vs. 18-27 years, p  = 0.02], 35-51 years (OR = 1.41 vs. 18-27 years, p  = 0.002) and having rhinitis, asthma, or eczema (OR = 1.55 vs. none, p  < 0.0005); and negatively associated with Black race (OR = 0.59 vs. White, p  < 0.0005)., Discussion: This study found that Black race was associated with lower likelihood of penicillin allergy label, while older age and atopic conditions were associated with a higher likelihood. This finding may impact health outcomes and interventions related to penicillin allergy in pregnant women., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Buckey, Gleeson, Curley, Feldman, Apter and Fadugba.)

Food allergies and asthma significantly impact individual health and global health care systems. Despite established management protocols for asthma and the emerging use of oral immunotherapy for food allergy, adherence to treatments remains a challenge for health care professionals and patients. This review explores the differences in adherence required of asthma and food-allergy treatments and strategies to improve adherence. We highlight the role of collaborative care coordination among health care professionals in enhancing adherence in asthma and food-allergy management and improving patient outcomes., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Aeroallergen testing can improve precision care for persistent asthma. How testing benefits diverse populations of adults with asthma and the importance of the aeroallergen sensitization and test modality used remain poorly understood., Objective: We evaluated whether aeroallergen testing was associated with a reduction in oral corticosteroid (OCS) bursts., Methods: We used electronic health record data to conduct a retrospective cohort study of adults with asthma who were prescribed an inhaled corticosteroid and had an allergy/immunology visit in a large health system between January 1, 2017, and June 30, 2022. We used negative binomial regression models to evaluate whether testing was associated with fewer OCS bursts in the 12-month period after an initial visit among all patients and those without chronic obstructive pulmonary disease (COPD) and smoking histories. We then repeated these analyses while considering effects of sensitization to aeroallergen categories and whether the testing was via skin prick or serum-specific IgE., Results: A total of 684 (48.4%) of 1,412 patients underwent testing. Testing was not associated with fewer bursts overall (incidence rate ratio [IRR] = 0.84 vs no testing, P  = .08), but it was among never smokers without COPD (461 of 927 tested, IRR = 0.69, P  = .005). Among never smokers without COPD, sensitization to 5-7 aeroallergen categories (IRR = 0.57 vs no test, P  = .003) and receipt of skin prick tests (IRR = 0.58 vs no test, P  < .0005) were associated with fewer bursts., Conclusion: Aeroallergen testing was associated with reduced OCS bursts among adults with asthma who were never smokers without COPD. This association varied according to aeroallergen sensitization and test modality used., Competing Interests: Research reported in this publication was supported by the 10.13039/100000002National Institutes of Health (NIH) National Heart, Lung, and Blood Institute under awards R01HL162354 and K24HL115354; and the 10.13039/100000066National Institute of Environmental Health Sciences under awards T32ES019851 and P30ES013508. Additional funding was provided by the Pennsylvania Allergy Education Research Fund and the 10.13039/100006093Patient-Centered Outcomes Research Institute 25 under award AS-1307-05218. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the report. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or other funding agencies. Disclosure of potential conflict of interest: K. H. Morales owns stock in Altria Group, British American Tobacco, and Phillip Morris International. The rest of the authors declare that they have no relevant conflicts of interest., (© 2024 The Authors.)

Many trials are designed to collect outcomes at or around pre-specified times after randomization. If there is variability in the times when participants are actually assessed, this can pose a challenge to learning the effect of treatment, since not all participants have outcome assessments at the times of interest. Furthermore, observed outcome values may not be representative of all participants' outcomes at a given time. Methods have been developed that account for some types of such irregular and informative assessment times; however, since these methods rely on untestable assumptions, sensitivity analyses are needed. We develop a sensitivity analysis methodology that is benchmarked at the explainable assessment (EA) assumption, under which assessment and outcomes at each time are related only through data collected prior to that time. Our method uses an exponential tilting assumption, governed by a sensitivity analysis parameter, that posits deviations from the EA assumption. Our inferential strategy is based on a new influence function-based, augmented inverse intensity-weighted estimator. Our approach allows for flexible semiparametric modeling of the observed data, which is separated from specification of the sensitivity parameter. We apply our method to a randomized trial of low-income individuals with uncontrolled asthma, and we illustrate implementation of our estimation procedure in detail., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Biometric Society.)

Background: In the United States, Black and Latino children with asthma are more likely than White children with asthma to require emergency department visits or hospitalizations because of an asthma exacerbation. Although many cite patient-level socioeconomic status and access to health care as primary drivers of disparities, there is an emerging focus on a major root cause of disparities-systemic racism. Current conceptual models of asthma disparities depict the historical and current effects of systemic racism as the foundation for unequal exposures to social determinants of health, environmental exposures, epigenetic factors, and differential healthcare access and quality. These ultimately lead to biologic changes over the life course resulting in asthma morbidity and mortality. Methods: At the 2022 American Thoracic Society International Conference, a diverse panel of experts was assembled to identify gaps and opportunities to address systemic racism in childhood asthma research. Panelists found that to examine and address the impacts of systemic racism on children with asthma, researchers and medical systems that support biomedical research will need to 1 ) address the current gaps in our understanding of how to conceptualize and characterize the impacts of systemic racism on child health, 2 ) design research studies that leverage diverse disciplines and engage the communities affected by systemic racism in identifying and designing studies to evaluate interventions that address the racialized system that contributes to disparities in asthma health outcomes, and 3 ) address funding mechanisms and institutional research practices that will be needed to promote antiracism practices in research and its dissemination. Results: A thorough literature review and expert opinion discussion demonstrated that there are few studies in childhood asthma that identify systemic racism as a root cause of many of the disparities seen in children with asthma. Community engagement and participation in research studies is essential to design interventions to address the racialized system in which patients and families live. Dissemination and implementation studies with an equity lens will provide the multilevel evaluations required to understand the impacts of interventions to address systemic racism and the downstream impacts. To address the impacts of systemic racism and childhood asthma, there needs to be increased training for research teams, funding for studies addressing research that evaluates the impacts of racism, funding for diverse and multidisciplinary research teams including community members, and institutional and financial support of advocating for policy changes based on study findings. Conclusions: Innovative study design, new tools to identify the impacts of systemic racism, community engagement, and improved infrastructure and funding are all needed to support research that will address impacts of systemic racism on childhood asthma outcomes.

Background: Allergic sensitization to mold is a risk factor for poor asthma outcomes, but whether it accounts for disparities in asthma outcomes according to race or socioeconomic status is not well-studied., Objective: To identify factors associated with allergic sensitization to molds and evaluate associations of sensitization to molds with asthma exacerbations after stratifying by race., Methods: We conducted a retrospective cohort study of adults with asthma who had an outpatient visit to a large health system between January 1, 2017 and June 30, 2023 and received aeroallergen testing to Aspergillus fumigatus, Penicillium, Alternaria, and Cladosporium. We used logistic regression models to evaluate factors associated with mold sensitization and the effect of mold sensitization on asthma exacerbations in the 12 months before testing, overall and then stratified by race., Results: A total of 2732 patients met the inclusion criteria. Sensitization to each mold was negatively associated with being a woman (odds ratios [ORs] ≤ 0.59, P ≤ .001 in 5 models) and positively associated with the Black race (ORs ≥ 2.16 vs White, P < .0005 in 5 models). In the full cohort, sensitization to molds was not associated with asthma exacerbations (ORs = 0.95-1.40, P ≥ .003 in 5 models and all above the corrected P value threshold). Among 1032 Black patients, sensitization to A fumigatus, but not to other molds, was associated with increased odds of asthma exacerbations (OR = 2.04, P < .0005)., Conclusion: Being a man and Black race were associated with allergic sensitization to molds. Sensitization to A fumigatus was associated with asthma exacerbations among Black patients but not the overall cohort, suggesting that A fumigatus allergy is a source of disparities in asthma outcomes according to race., Competing Interests: Disclosures Dr Morales owns stock in Altria Group, Inc, British American Tobacco PLC, and Phillip Morris International, Inc. The remaining authors have no conflicts of interest to report., (Copyright © 2024 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Medical ethics is relevant to the clinical practice of allergy and immunology regardless of the type of patient, disease state, or practice setting. When engaging in clinical care, performing research, or enacting policies on the accessibility and distribution of healthcare resources, physicians regularly make and justify decisions using the fundamental principles of medical ethics. Thus, knowledge of these principles is paramount for allergists/immunologists. To date, there has been a shortage of medical ethics research in allergy and immunology. This review describes this scarcity, highlights publication trends over time, and advocates for additional support for research and training in medical ethics with a focus on topics germane to the practice of allergy and immunology., Competing Interests: Disclosures Dr Apter is an associate editor of the Journal of Allergy and Clinical Immunology and a consultant for UpToDate. The remaining authors have no conflicts of interest to report. Dr Buckey received support from the Pennsylvania Allergy Education Research Fund Grant. Dr Apter received support from the Patient-Centered Outcomes Research Institute and the Heart, Lung, and Blood Institute of the National Institutes of Health (Grant R01HL 143364). Dr Sacta received funding from the Gail Slap Pediatrics Fellowship Award., (Copyright © 2024 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Many vulnerable people lose their health or lives each year as a result of unhealthy environmental conditions that perpetuate medical conditions within the scope of allergy and immunology specialists' expertise. While detrimental environmental factors impact all humans globally, the effect is disproportionately more profound in impoverished neighborhoods. Environmental injustice is the inequitable exposure of disadvantaged populations to environmental hazards. Professional medical organizations such as the American Academy of Allergy, Asthma & Immunology (AAAAI) are well positioned to engage and encourage community outreach volunteer programs to combat environmental justice. Here we discuss how environmental injustices and climate change impacts allergic diseases among vulnerable populations. We discuss pathways allergists/immunologists can use to contribute to addressing environmental determinants by providing volunteer clinical service, education, and advocacy. Furthermore, allergists/immunologists can play a role in building trust within these communities, partnering with other patient advocacy nonprofit stakeholders, and engaging with local, state, national, and international nongovernmental organizations, faith-based organizations, and governments. The AAAAI's Volunteerism Addressing Environmental Disparities in Allergy (VAEDIA) is the presidential task force aiming to promote volunteer initiatives by creating platforms for discussion and collaboration and by funding community-based projects to address environmental injustice., Competing Interests: Disclosure statement Disclosure of potential conflict of interest: M. Mahdavinia reports research support from the National Institutes of Health (NIH), Food Allergy Research and Education (FARE), Optinose Foundation, Brinson Foundation, and Institute for Translation Medicine in Chicago. J. A. Poole receives funding from the Department of Defense and the National Institute of Occupational Safety and Health; has received research regents from AstraZeneca; and acts as site principal investigator (PI) for clinical studies for asthma, sinus disease, and urticaria involving GlaxoSmithKline, AstraZeneca, Regeneron Pharmaceuticals, and CellDex Therapeutics. A. J. Apter receives research support from the NIH and the Patient-Centered Outcomes Research Institute. A. A. Pappalardo has served on the medical advisory board for Takeda, Eli Lilly, and Sanofi Regeneron; has received grant funding from the NIH, Agency for Health Research and Quality, and FARE; and has acted as a consultant for Optum/United Health Group. E. C. Matsui has received research support from the NIH. J. A. Bernstein is site PI and consultant for Sanofi Regeneron, AstraZeneca, GSK, Novartis, Genentech, Biocryst, Pharming, Takeda, CSL Behring, Ionis, Biomarin, Blueprint Medicine, Cogent, Celldex, Escient, Jasper Pharmaceuticals, Amgen, Kalvista, and Pharvaris; is president of American Academy of Allergy, Asthma & Immunology (AAAAI), World Allergy Organization, and Interasma; and Hereditory Angioedema medical advisory board. The rest of the authors declare that they have no relevant conflicts of interest., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Ethical dilemmas routinely occur in the clinical practice of allergy and immunology. These ethical questions stem from the range of conditions and the different populations cared for by Allergists/Immunologists. Hence, medical ethics is not an esoteric concept, but a practical skill physicians exercise regularly. Moreover, an ethics-centered approach may improve patient safety and outcomes. This article describes key principles of bioethics and illustrates an ethical framework that physicians can use in their conversations with patients. Utilization of this ethical framework is demonstrated through applying it to 4 unique clinical scenarios encountered by Allergists/Immunologists from different practice settings. The ethical framework for allergy and immunology is a technique to navigate ethically complex decisions that arise in routine clinical practice., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Aeroallergen testing informs precision care for adults with asthma, yet the epidemiology of testing in this population remains poorly understood., Objective: We sought to identify factors associated with receiving aeroallergen testing, the results of these tests, and subsequent reductions in exacerbation measures among adults with asthma., Methods: We used electronic health record data to conduct a retrospective, observational cohort study of 30,775 adults with asthma who had an office visit with a primary care provider or an asthma specialist from January 1, 2017, to August 26, 2022. We used regression models to identify (1) factors associated with receiving any aeroallergen test and tests to 9 allergen categories after the index visit, (2) factors associated with positive test results, and (3) reductions in asthma exacerbation measures in the year after testing compared with before testing., Results: Testing was received by 2201 patients (7.2%). According to multivariable models, receiving testing was associated with having any office visit with an allergy/immunology specialist during the study period (odds ratio [OR] = 91.3 vs primary care only [ P  < .001]) and having an asthma emergency department visit (OR = 1.62 [ P  = .004]) or hospitalization (OR = 1.62 [ P  = .03]) in the year before the index visit. Age 65 years or older conferred decreased odds of testing (OR = 0.74 vs age 18-34 years [ P  = .008]) and negative test results to 6 categories ( P  ≤ .04 for all comparisons). Black race conferred increased odds of testing (OR =1.22 vs White race [ P  = .01]) and positive test results to 8 categories ( P  < .04 for all comparisons). Exacerbation measures decreased after testing., Conclusion: Aeroallergen testing was performed infrequently among adults with asthma and was associated with reductions in asthma exacerbation measures., (© 2023 The Authors.)

Background: Low-income and marginalized adults disproportionately bear the burden of poor asthma outcomes. One consequence of the structural racism that preserves these inequities is decreased trust in government and health care institutions., Objective: We examined whether such distrust extended to health care providers during the pandemic., Methods: We enrolled adults living in low-income neighborhoods who had required a hospitalization, an emergency department visit, or a prednisone course for asthma in the prior year. Trust was a dichotomized measure derived from a 5-item questionnaire with a 5-point Likert scale response. The items were translated to the binary variable "strong" versus "weak" trust. Communication was measured using a 13-item questionnaire with a 5-point Likert scale. Logistic regression was used to examine the association between communication and trust, controlling for potential confounders., Results: We enrolled 102 patients, aged 18 to 78 years; 87% were female, 90% were Black, 60% had some post-high school education, and 57% were receiving Medicaid. Of the 102 patients, 58 were enrolled before the March 12, 2020, pandemic start date, and 70 (69%) named doctors as their most trusted source of health information. Strong trust was associated with a negative response to the statement "It is hard to reach a person in my doctor's office by phone." There was no evidence of an association between the overall communication scores and trust. Satisfaction with virtual messaging was weaker among those with less trust., Conclusions: These patients trust their physicians, value their advice, and need to have accessible means of communication., (Copyright © 2023 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: The availability of asthma biologics may not benefit all patients equally., Objective: We sought to identify patient characteristics associated with asthma biologic prescribing, primary adherence, and effectiveness., Methods: A retrospective, observational cohort study of 9,147 adults with asthma who established care with a Penn Medicine asthma subspecialist was conducted using Electronic Health Record data from January 1, 2016, to October 18, 2021. Multivariable regression models were used to identify factors associated with (1) receipt of a new biologic prescription; (2) primary adherence, defined as receiving a dose in the year after receiving the prescription, and (3) oral corticosteroid (OCS) bursts in the year after the prescription., Results: Factors associated with a new prescription, which was received by 335 patients, included being a woman (odds ratio [OR] 0.66; P = .002), smoking currently (OR 0.50; P = .04), having an asthma hospitalization in the prior year (OR 2.91; P < .001), and having 4+ OCS bursts in the prior year (OR 3.01; P < .001). Reduced primary adherence was associated with Black race (incidence rate ratio 0.85; P < .001) and Medicaid insurance (incidence rate ratio 0.86; P < .001), although most in these groups, 77.6% and 74.3%, respectively, still received a dose. Nonadherence was associated with patient-level barriers in 72.2% of cases and health insurance denial in 22.2%. Having more OCS bursts after receiving a biologic prescription was associated with Medicaid insurance (OR 2.69; P = .047) and biologic days covered (OR 0.32 for 300-364 d vs 14-56 d; P = .03)., Conclusions: In a large health system, primary adherence to asthma biologics varied by race and insurance type, whereas nonadherence was primarily explained by patient-level barriers., (Copyright © 2023. Published by Elsevier Inc.)

Health disparities (recently defined as a health difference closely linked with social, economic, and/or environmental disadvantage) in asthma continue despite the presence of safe and effective treatment. For example, in the United States, Black individuals have a hospitalization rate that is 6× higher than that for White individuals, and an asthma mortality rate nearly 3× higher. This article will discuss the current state of health disparities in asthma in the United States. Factors involved in the creation of these disparities (including unconscious bias and structural racism) will be examined. The types of asthma interventions (including case workers, technological advances, mobile asthma clinics, and environmental remediation) that have and have not been successful to decrease disparities will be reviewed. Finally, current resources and future actions are summarized in a table and in text, providing information that the allergist can use to make an impact on asthma health disparities in 2023., (Copyright © 2023 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

The pandemic, political upheavals, and social justice efforts in our society have resulted in attention to persistent health disparities and the urgent need to address them. Using a scoping review, we describe published updates to address disparities and targets for interventions to improve gaps in care within allergy and immunology. These disparities-related studies provide a broad view of our current understanding of how social determinants of health threaten patient outcomes and our ability to advance health equity efforts in our field. We outline next steps to improve access to care and advance health equity for patients with allergic/immunologic diseases through actions taken at the individual, community, and policy levels, which could be applied outside of our field. Key among these are efforts to increase the diversity among our trainees, providers, and scientific teams and enhancing efforts to participate in advocacy work and public health interventions. Addressing health disparities requires advancing our understanding of the interplay between social and structural barriers to care and enacting the needed interventions in various key areas to effect change., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. All rights reserved.)

The Food and Drug Administration is tasked with evaluating the efficacy and safety of a drug. Despite having a regimented appraisal process in place, safety evidence can emerge during clinical trials as well as from observations and studies conducted after the drug has been on the market, which might require a boxed warning. The boxed warning is the most severe warning that the Food and Drug Administration can give to an approved drug. It is commonly referred to as a Black Box Warning because it is outlined in the package insert by a thick black box to garner the attention of prescribers and patients. There are currently more than 400 medications that have boxed warnings, and the information addressing major risks associated with a particular drug may, appropriately or inappropriately, influence patient and clinician decision making. Health care professionals must use the best evidence and clinical judgment in determining whether to prescribe medications with these warnings. Use of an approved drug at dosages or for indications other than what it was originally licensed for is referred to as "off-label" and is legal, commonplace, and may be evidence-based. All drugs may expose patients to possible harm, so prescribers have an obligation to discuss the best available evidence regarding benefits and harms so that patients can participate in shared decision making., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Objectives: To assess electronic health record patient portal use among Spanish-speaking patients with asthma compared to English-speaking patients and identify barriers to use., Methods: Using data collected for a PCORI-funded randomized controlled trial to increase patient portal use in low-income adults with uncontrolled asthma, we estimated the association between portal use, measured using surveys and actual user login data, and primary language. Open-ended survey responses were grouped into common themes., Results: Among 301 adults with asthma: age 18-87, 90% female, 17% Spanish speakers; 44% had no portal use during the study. Spanish speakers were less likely to have ever heard of the patient portal than English speakers ( p =.001) and reported more difficulty navigating the portal ( p <.001). Spanish speakers with low health literacy had less portal use (31%) than their English-speaking counterparts (51%) ( p =.02). Compared to high-literacy English speakers, the odds of using the portal for low-literacy Spanish speakers were 0.34 (95% CI 0.14, 0.84) ( p =.02). Three-quarters of Spanish speakers cited barriers to portal use compared to one-quarter of English speakers, and many suggested creating a Spanish version to improve user-friendliness., Conclusions: English-only patient portals may not meet the needs of Spanish-speaking patients with uncontrolled asthma. Health systems serving Spanish-speaking communities should implement patient portals in Spanish.

Asthma-related deaths, hospitalizations, and emergency visits are more numerous among low-income patients, yet management guidelines do not address this high-risk group's special needs. We recently demonstrated feasibility, acceptability, and preliminary evidence of effectiveness of two interventions to improve access to care, patient-provider communication, and asthma outcomes: 1) Clinic Intervention (CI): study staff facilitated patient preparations for office visits, attended visits, and afterwards confirmed patient understanding of physician recommendations, and 2) Home Visit (HV) by community health workers for care coordination and informing clinicians of home barriers to managing asthma. The current project, denominated "HAP3," combines these interventions for greater effectiveness, delivery of guideline-based asthma care, and asthma control for low-income patients recruited from 6 primary care and 3 asthma specialty practices. We assess whether patients of clinicians receiving guideline-relevant, real-time feedback on patient health and home status have better asthma outcomes. In a pragmatic factorial longitudinal trial, HAP3 enrolls 400 adults with uncontrolled asthma living in low-income urban neighborhoods. 100 participants will be randomized to each of four interventions: (1) CI, (2) CI with HVs, (3) CI and real-time feedback to asthma clinician of guideline-relevant elements of patients' current care, or (4) both (2) and (3). The outcomes are asthma control, quality of life, ED visits, hospitalizations, prednisone bursts, and intervention costs. The COVID-19 pandemic struck 6.5 months into recruitment. We describe study development, design, methodology, planned analysis, baseline findings and adaptions to achieve the original aims of improving patient-clinician communication and asthma outcomes despite the markedly changed pandemic environment., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations., Methods: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed., Results: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups., Conclusions: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.)., (Copyright © 2022 Massachusetts Medical Society.)

Successful cross-cultural communication is critical for adequate exchange of ideas with our patients. Our communities have become more diverse, and thus, the necessity has increased. The murder of George Floyd and other atrocities have sparked recognition of the need to address social injustice and racism and as we fight the ongoing coronavirus disease 2019 (COVID-19) pandemic. Allergist-immunologists are uniquely trained to explain the complex immunology of COVID-19 to patients, but they have less experience discussing issues of health equity. Here, we explore critical components of patient-provider communication: communicating with those for whom English is a second language, advising patients with limited health literacy, and understanding nonbiomedical views of health and wellness. Two barriers to communication are discussed: implicit bias and structural racism. Finally, we consider how the recent innovations in technology, the electronic health record including its patient portal and the use of telemedicine, have both impeded and improved communication. We offer suggestions as to what we could do to address these in our own local communities that would ensure better understanding and exchange of health information. This perspective grew out of an effort by the American Academy of Allergy, Asthma, and Immunology (AAAAI) Committee on the Underserved to provide training in cross-cultural communication., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Race is a social construct. It is used in medical diagnostic algorithms to adjust the readout for spirometry and other diagnostic tests. The authors review historic evidence about the origins of race adjustment in spirometry, and recent attention to the lack of scientific evidence for their continued use. Existing reference values imply that White patients have better lung function than non-White patients. They perpetuate the historical assumptions that human biological functions of the lung should be calculated differently on the basis of racial-skin color without considering the difficulty of using self-identified race. More importantly, they fail to consider the important effects of environmental exposures, socioeconomic differences, health care access, and prenatal factors on lung function. In addition, the use of "race adjustment" implies a White standard to which other non-White values need "adjustment." Because of the spirometric guidelines in place, the current diagnostic prediction adjustment practice may have untoward effects on patients not categorized as "White," including underdiagnosis in asthma and restrictive lung disease, undertreatment with lung transplant, undercompensation in workers compensation cases, and other unintended consequences. Individuals, institutions, national organizations, and policymakers should carefully consider the historic basis, and reconsider the current role of an automated, race-based adjustment in spirometry., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Autonomy is the ability of patients to make informed medical decisions. Autonomy is rooted in disease state understanding. Medical ethics, especially the principle of autonomy, plays an important role in health care delivery when caring for diverse populations., Objective: To identify patient characteristics that influence autonomy., Methods: A total of 295 adults with moderate to severe asthma completed 2 surveys at the beginning of a 1-year randomized clinical trial. The Navigating Ability 2 and Inhaled Corticosteroids Knowledge questionnaires were combined to create a 21-question assessment of autonomy with possible scores ranging from 10 to 105. Linear regression was performed on the derived autonomy score predicted by patient baseline characteristics., Results: Comparison revealed statistically significant differences in baseline autonomy scores in patients who reported Spanish as their primary language (P = .01), patients with diabetes (P = .01), and those with depressive symptoms (P = .03) at -11.4 (95% CI, -20.5 to -2.3), -4.8 (95% CI, -8.3 to -1.3), and -3.1 (95% CI, -5.9 to -0.3) points, respectively. Non-Hispanic White participants on average were found to have 8.2 (95% CI, 4.5 to 12.0) points higher autonomy scores compared with non-Hispanic Black participants (Bonferroni-adjusted P < .01). Patients with higher functional health literacy had higher autonomy scores (coefficient = 0.24; 95% CI, 0.1 to 0.4; P < .01)., Conclusions: Autonomy is associated with comorbidities, demographics, and literacy. These results may reflect differences in social, educational, and economic opportunities encountered by patients. Further investigation is needed to assess and understand how socioeconomic and educational factors influence autonomy. By identifying differences in autonomy based on baseline patient characteristics, this project serves as an initial step in adjusting current and developing new treatment guidelines and interventions to improve patient autonomy., (Copyright © 2021 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Exposure to fine particulate matter (PM 2.5 ) increases the risk of asthma exacerbations, and thus, monitoring personal exposure to PM 2.5 may aid in disease self-management. Low-cost, portable air pollution sensors offer a convenient way to measure personal pollution exposure directly and may improve personalized monitoring compared with traditional methods that rely on stationary monitoring stations. We aimed to understand whether adults with asthma would be willing to use personal sensors to monitor their exposure to air pollution and to assess the feasibility of using sensors to measure real-time PM 2.5 exposure., Methods: We conducted semi-structured interviews with 15 adults with asthma to understand their willingness to use a personal pollution sensor and their privacy preferences with regard to sensor data. Student research assistants used HabitatMap AirBeam devices to take PM 2.5 measurements at 1-s intervals while walking in Philadelphia neighborhoods in May-August 2018. AirBeam PM 2.5 measurements were compared to concurrent measurements taken by three nearby regulatory monitors., Results: All interview participants stated that they would use a personal air pollution sensor, though the consensus was that devices should be small (watch- or palm-sized) and light. Patients were generally unconcerned about privacy or sharing their GPS location, with only two stating they would not share their GPS location under any circumstances. PM 2.5 measurements were taken using AirBeam sensors on 34 walks that extended through five Philadelphia neighborhoods. The range of sensor PM 2.5 measurements was 0.6-97.6 μg/mL (mean 6.8 μg/mL), compared to 0-22.6 μg/mL (mean 9.0 μg/mL) measured by nearby regulatory monitors. Compared to stationary measurements, which were only available as 1-h integrated averages at discrete monitoring sites, sensor measurements permitted characterization of fine-scale fluctuations in PM 2.5 levels over time and space., Conclusions: Patients were generally interested in using sensors to monitor their personal exposure to PM 2.5 and willing to share personal sensor data with health care providers and researchers. Compared to traditional methods of personal exposure assessment, sensors captured personalized air quality information at higher spatiotemporal resolution. Improvements to currently available sensors, including more reliable Bluetooth connectivity, increased portability, and longer battery life would facilitate their use in a general patient population., (© 2021. The Author(s).)

Health disparities are health differences linked with economic, social, and environmental disadvantage. They adversely affect groups that have systematically experienced greater social or economic obstacles to health. Renewed efforts are needed to reduced health disparities in the United States, highlighted by the disparate impact on racial minorities during the coronavirus pandemic. Institutional or systemic patterns of racism are promoted and legitimated through accepted societal standards, and organizational processes within the field of medicine, and contribute to health disparities. Herein, we review current evidence regarding health disparities in allergic rhinitis, asthma, atopic dermatitis, food allergy, drug allergy, and primary immune deficiency disease in racial and ethnic underserved populations. Best practices to address these disparities involve addressing social determinants of health and adopting policies to improve access to specialty care and treatment for the underserved through telemedicine and community partnerships, cross-cultural provider training to reduce implicit bias, inclusion of underserved patients in research, implementation of culturally competent patient education, and recruitment and training of health care providers from underserved communities. Addressing health disparities requires a multilevel approach involving patients, health providers, local agencies, professional societies, and national governmental agencies., (Copyright © 2021. Published by Elsevier Inc.)

Background: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

The coronavirus disease pandemic and the growing movements for social and racial equality have increased awareness of disparities in American health care that exist on every level. Social determinants of health, structural racism, and implicit bias play major roles in preventing health equity. We begin with the larger picture and then focus on examples of systemic and health inequities and their solutions that have special relevance to allergy-immunology. We propose a 4-prong approach to address inequities that requires (1) racial and ethnic inclusivity in research with respect to both participants and investigators, (2) diversity in all aspects of training and practice, (3) improvement in communication between clinicians and patients, and (4) awareness of the social determinants of health. By communication we mean sensitivity to the role of language, cultural background, and health beliefs in physician-patient interactions and provision of training and equipment so that the use of telecommunication can be a resource for all patients. The social determinants of health are the social factors that affect health and the success of health care, such as adequacy of housing and access to nutritious foods. Using this 4-prong approach we can overcome health disparities., (Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Few interventions have targeted low-income adults with moderate to severe asthma despite their high mortality., Objective: To assess whether a patient advocate (PA) intervention improves asthma outcomes over usual care (UC)., Methods: This 2-armed randomized clinical trial recruited adults with moderate to severe asthma from primary care and asthma-specialty practices serving low-income neighborhoods. Patients were randomized to 6 months of a PA intervention or UC. PAs were recent college graduates anticipating health care careers, who coached, modeled, and assisted participants with preparations for asthma-related medical visits, attended visits, and confirmed participants' understanding of provider recommendations. Participants were followed for at least a year for patient-centered asthma outcomes: asthma control (primary outcome), quality of life, prednisone requirements, emergency department visits, and hospitalizations., Results: There were 312 participants. Their mean age was 51 years (range, 19-93 years), 69% were women, 66% African American, 8% Hispanic/Latino, 62% reported hospitalization for asthma in the year before randomization, 21% had diabetes, and 61% had a body mass index of 30 or more. Asthma control improved over 12 months, more in the intervention group (-0.45 [95% CI, -0.67 to -0.21]) than in the UC group (-0.26 [95% CI, -0.53 to -0.01]), and was sustained at 24 months but with no statistical difference between groups. The 6-month rate of emergency department visits decreased in the intervention (-0.90 [95% CI, -1.56 to -0.42]) and UC (-0.42 [95% CI, -0.72 to -0.06]) groups over 12 months. The cost of the PA program was $1521 per patient. Only 64% of those assigned had a PA visit., Conclusions: A PA may be a promising intervention to improve and sustain outcomes in this high-risk population if expanded to address factors that make keeping appointments difficult., (Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Introduction: Asthma evidence-based interventions (EBI) are implemented in the home, school, community or primary care setting. Although families are engaged in one setting, they often have to navigate challenges in another setting. Objective: Our objective is to design and implement a comprehensive plan which integrates EBI's and connects the four sectors in underserved communities such as Philadelphia. Methods: September 2015-April 2016 we implemented a three-pronged strategy to understand needs and resources of the community including 1) focus groups and key informant interviews, 2) secondary data analysis and 3) pilot testing for implementation to determine gaps in care, and opportunities to overcome those gaps. Results: Analysis of the focus group and key informant responses showed themes: diagnosis fear, clinician time, home and school asthma trigger exposures, school personnel training and communication gaps across all four sectors. EBI's were evaluated and selected to address identified themes. Pilot testing of a community health worker (CHW) intervention to connect home, primary care and school resulted in an efficient transfer of asthma medications and medication administration forms to the school nurse office for students with uncontrolled asthma addressing a common delay leading to poor asthma management in school. Conclusion: Thus far there has been limited success in reducing asthma disparities for low-income minority children. This study offers hope that strategically positioning CHWs may work synergistically to close gaps in care and result in improved asthma control and reduced asthma disparities.

Inadequate inhaler technique in persistent asthma is frequently reported. However, there is little consensus on inhaler checklists, and critical elements of technique are not uniformly described. In addition, inhaler error rates and risk factors for poor technique are variable across studies. This Clinical Commentary Review summarizes the literature on inhaler design, use, and interventions to improve technique. Our aim is to help clinicians identify patients with poor inhaler technique, recognize the most important errors, and correct technique using evidence-based interventions., (Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Patient-clinician communication, essential for favorable asthma outcomes, increasingly relies on information technology including the electronic heath record-based patient portal. For patients with chronic disease living in low-income neighborhoods, the benefits of portal communication remain unclear., Objective: To describe portal activities and association with 12-month outcomes among low-income patients with asthma formally trained in portal use., Methods: In a longitudinal observational study within a randomized controlled trial, 301 adults with uncontrolled asthma were taught 7 portal tasks: reviewing upcoming appointments, scheduling appointments, reviewing medications, locating laboratory results, locating immunization records, requesting refills, and messaging. Half the patients were randomized to receive up to 4 home visits by community health workers. Patients' portal use by activities, rate of usage over time, frequency of appointments with asthma physicians, and asthma control and quality of life were assessed over time and estimated as of 12 months from randomization., Results: Fewer than 60% of patients used the portal independently. Among users, more than half used less than 1 episode per calendar quarter. The most frequent activities were reading messages and viewing laboratory results and least sending messages and making appointments. Higher rates of portal use were not associated with keeping regular appointments during follow-up, better asthma control, or higher quality of life at 12-month postintervention., Conclusions: Patients with uncontrolled asthma used the portal irregularly if at all, despite in-person training. Usage was not associated with regular appointments or with clinical outcomes. Patient portals need modification to accommodate low-income patients with uncontrolled asthma., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Poor inhaler technique has been shown to be associated with less asthma control and increased health care utilization. Little is known about the impact of inhaler technique on the most vulnerable patients., Objective: This study examined inhaler technique in low-income, inner-city adults with uncontrolled asthma., Methods: Inhaler technique data and other patient characteristics were evaluated in adults drawn from 2 studies conducted at the University of Pennsylvania. Subjects were from low-income Philadelphia neighborhoods and had uncontrolled asthma. Baseline characteristics were collected. Inhaler technique was rated by research coordinators who were trained with written materials., Results: In 584 adults, 56% of metered dose inhaler users and 64% of dry powder inhaler users had adequate visually assessed inhaler technique. Inhaler technique did not vary by reading comprehension or numeracy levels., Conclusions: In this group of patients with uncontrolled asthma, visually assessed inhaler technique was adequate in more than one-half. Although incorrect inhaler technique is generally common and must be routinely addressed, this study suggests that other factors that lead to poor control must be identified., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Introduction : In an ongoing study, a new clinical role adapted from a patient navigator called the patient advocate (PA) met with patients before medical visits, attended appointments and afterwards reviewed provider instructions. This qualitative analysis examines the perspectives of PAs and providers regarding their experiences with patients to understand how a PA can help patients and providers achieve better asthma control. Methods : PAs recorded journal entries about their experiences with patients. Provider focus groups and interviews were conducted by researchers and transcribed. Analysis was based on the Grounded Theory approach for qualitative research, using open and then focused coding. Two researchers independently coded these sources until intercoder agreement was achieved. Results : Upon review of 31 journal entries on PA experiences with 24 patients and transcripts from 2 provider focus groups and 12 provider interviews, 5 themes emerged surrounding asthma care and self-management: medication adherence, follow-up, communication, social determinants of health and time. While patients shared with PAs specific socioeconomic barriers to medication adherence and follow-up, providers often did not know about these problems and cited barriers to communication. Time restrictions on medical visits further limited communication. Conclusions : Perspectives reported here illustrate a gap in knowledge and understanding between patients and providers. The PA's unique relationship with patients and presence inside and outside of medical visits allowed them to learn contextual patient information unknown to providers. PAs and providers cited numerous ways PAs can help to improve patient-provider mutual understanding.

Background: Asthma disproportionately affects low-income and minority adults. In an era of electronic records and Internet-based digital devices, it is unknown whether portals for patient-provider communication can improve asthma outcomes., Objective: We sought to estimate the effect on asthma outcomes of an intervention using home visits (HVs) by community health workers (CHWs) plus training in patient portals compared with usual care and portal training only., Methods: Three hundred one predominantly African American and Hispanic/Latino adults with uncontrolled asthma were recruited from primary care and asthma specialty practices serving low-income urban neighborhoods, directed to Internet access, and given portal training. Half were randomized to HVs over 6 months by CHWs to facilitate competency in portal use and promote care coordination., Results: One hundred seventy (56%) patients used the portal independently. Rates of portal activity did not differ between randomized groups. Asthma control and asthma-related quality of life improved in both groups over 1 year. Differences in improvements over time were greater for the HV group for all outcomes but reached conventional levels of statistical significance only for the yearly hospitalization rate (-0.53; 95% CI, -1.08 to -0.024). Poor neighborhoods and living conditions plus limited Internet access were barriers for patients to complete the protocol and for CHWs to make HVs., Conclusion: For low-income adults with uncontrolled asthma, portal access and CHWs produced small incremental benefits. HVs with emphasis on self-management education might be necessary to facilitate patient-clinician communication and to improve asthma outcomes., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Asthma is a chronic inflammatory lung disease that affects 18.7 million U.S. adults. Electronic health records (EHRs) are a unique source of information that can be leveraged to understand factors associated with asthma in real-life populations. In this study, we identify demographic factors and comorbidities associated with asthma exacerbations among adults according to EHR-derived data and compare these findings to those of epidemiological studies., Methods: We obtained University of Pennsylvania Hospital System EHR-derived data for asthma encounters occurring between 2011 and 2014. Regression analyses were performed to model asthma exacerbation frequency as explained by age, sex, race/ethnicity, health insurance type, smoking status, body mass index (BMI) and various comorbidities. We analyzed data from the National Health and Nutrition Examination Survey (NHANES) from 2001 to 2012 to compare findings with those from the EHR-derived data., Results: Based on data from 9068 adult patients with asthma, 33.37% had at least one exacerbation over the four-year study period. In a proportional odds logistic regression predicting number of exacerbations during the study period (levels: 0, 1-2, 3-4, 5+ exacerbations), after controlling for age, race/ethnicity, sex, health insurance type, and smoking status, the highest odds ratios (ORs) of significantly associated factors were: chronic bronchitis (2.70), sinusitis (1.50), emphysema (1.39), fluid and electrolyte disorders (1.35), class 3 obesity (1.32), and diabetes (1.28). An analysis of NHANES data showed associations for class 3 obesity , anemia and chronic bronchitis with exacerbation frequency in an adjusted model controlling for age, race/ethnicity, sex, financial class and smoking status., Conclusions: EHR-derived data is helpful to understand exacerbations in real-life asthma patients, facilitating design of detailed studies and interventions tailored for specific populations., Competing Interests: Analysis of EHR-derived data was approved by the University of Pennsylvania Institutional Review Board under protocol 824789. A waiver of informed consent to analyze this de-identified data was obtained pursuant to 45 CRF 46.116(d). The NHANES was approved by the Institutional Review Board of the National Center for Health Statistics of the CDC. Informed consent was obtained from all NHANES participants.Not Applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This review summarizes some of the most significant advances in asthma research over the past year. We first focus on novel discoveries in the mechanism of asthma development and exacerbation. This is followed by a discussion of potential new biomarkers, including the use of radiographic markers of disease. Several new biologics have become available to the clinician in the past year, and we summarize these advances and how they can influence the clinical delivery of asthma care. After this, important findings in the genetics of asthma and heterogeneity in phenotypes of the disease are explored, as is the role the environment plays in shaping the development and exacerbation of asthma. Finally, we conclude with a discussion of advances in health literacy and how they will affect asthma care., (Copyright © 2018 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: This review will inform updated National Asthma Education and Prevention Program clinical practice guidelines., Objective: We sought to evaluate the effectiveness of allergen reduction interventions on asthma outcomes., Methods: We systematically searched the "gray literature" and 5 bibliographic databases. Eligible studies included systematic reviews, randomized controlled trials, and nonrandomized interventional studies. Risk of bias was assessed by using the Cochrane Risk of Bias instrument and the Newcastle-Ottawa scale. The evidence base was assessed by using the approach of the Agency for Healthcare Research and Quality's Evidence-based Practice Center program., Results: Fifty-nine randomized and 8 nonrandomized trials addressed 8 interventions: acaricide, air purification, carpet removal, high-efficiency particulate air filtration (HEPA) vacuums, mattress covers, mold removal, pest control, and pet removal. Thirty-seven studies evaluated single-component interventions, and 30 studies assessed multicomponent interventions. Heterogeneity precluded meta-analysis. For most interventions and outcomes, the evidence base was inconclusive or showed no effect. No interventions were associated with improvement in validated asthma control measures or pulmonary physiology. Exacerbations were diminished in multicomponent studies that included HEPA vacuums or pest control (moderate strength of evidence [SOE] for both). Quality of life improved in studies of air purifiers (SOE: low) and in multicomponent studies that included HEPA vacuums (SOE: moderate) or pest control (SOE: low)., Conclusions: Single interventions were generally not associated with improvement in asthma measures, with most strategies showing inconclusive results or no effect. Multicomponent interventions improved various outcomes, but no combination of specific interventions appears to be more effective. The evidence was often inconclusive because of a lack of studies. Further research is needed comparing the effect of indoor allergen reduction interventions on validated asthma measures, with sufficient population sizes to detect clinically meaningful differences., (Copyright © 2018 American Academy of Allergy, Asthma & Immunology. All rights reserved.)

Purpose of Review: Comparative efficacy trials are designed to evaluate the harms and benefits of health care in a research environment. There is increasing interest in the results of comparative effectiveness trials, which are intended to fill gaps in evidence to inform decision-making in real-life clinical environments. The objective of this report is to review various tools to classify trials along the efficacy to effectiveness continuum., Recent Findings: Three tools [Pragmatic-Explanatory Continuum Indicator Summary (PRECIS), PRECIS-2, and PRAgmatic Clinical Trial Assessment Scale (PRACTAS)] are available that use a star diagram to illustrate where each element of a clinical trial design falls along the efficacy to effectiveness continuum (e.g., selectivity of eligibility criteria, supports to promote participant adherence). The number and type of design element to be classified varies (e.g., 10 elements for PRECIS and PRACTAS vs. nine elements for PRECIS-2; only the PRACTAS tool includes stakeholder engagement). There is substantial interrater reliability when using all three tools and interrater reliability varies across the different design elements (intraclass correlation of coefficient 0.4-0.8)., Summary: The PRECIS, PRECIS-2, and PRACTAS tools are options when classifying trials along the efficacy to effectiveness continuum. Researchers and decision-making stakeholders are likely to disagree about the extent to which clinical trials employ efficacy or effectiveness designs.