Scarcity of medical ethics research in allergy and immunology: A review and call to action.

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.

Volunteerism Addressing Environmental Disparities in Allergy (VAEDIA): The presidential initiative to combat environmental injustice in allergy and immunology-a Work Group Report of the AAAAI VAEDIA task force.

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.

Understanding Health Equity in Patient-Reported Outcomes.

Patient-reported outcomes (PROs) are measures of patients' health that are conveyed directly by individual patients. These measures serve as instruments to evaluate the impact of interventions on any aspect of patients' health, from specific symptoms to broader quality of life indicators. However, their effectiveness relies on capturing relevant factors accurately. Whereas they are commonly used in clinical trials, PROs extend their influence across health care settings, informing clinicians, health care payers, regulators, and administrators to guide quality improvement and reimbursement decisions. Neglecting health equity considerations in PRO development and implementation widens health disparities, leading to biased interpretations, medical mismanagement, and poor health outcomes among marginalized groups. To foster equitable health care, efforts must focus on considering the values of underrepresented populations in PRO design, addressing barriers to completion, enhancing representation in research, providing cultural competency training for clinicians, and allocating research funding to support health equity research. By addressing these issues, advances can be made toward fostering inclusive, equitable health care for all individuals.

Benefits of Aeroallergen Testing on Oral Corticosteroid Bursts in Adults with Asthma.

BACKGROUND: Aeroallergen testing can improve precision care for persistent asthma and is recommended by the U.S. clinical guidelines. How testing benefits diverse populations of adults with asthma, and the importance of the testing modality used, are not fully understood. OBJECTIVE: We sought to evaluate whether receipt of aeroallergen testing was associated with a reduction in oral corticosteroid (OCS) bursts. METHODS: We used electronic health record data to conduct a retrospective, observational cohort study of adults with asthma who were prescribed an inhaled corticosteroid and had an Allergy/Immunology visit in a large health system between 1/1/2017-6/30/2022. Negative binomial regression models were used to evaluate whether OCS bursts in the 12-month period after an initial visit were reduced for patients who received aeroallergen testing. We also measured differences in benefit after excluding patients with chronic obstructive pulmonary disease (COPD) and smoking histories, and whether testing receipt was via skin prick or serum. RESULTS: 668/1,383 (48.3%) patients received testing. Receipt of testing was not associated with fewer bursts in all patients (incidence rate ratio (IRR)=0.83 versus no testing, p=0.059), but it was among never smokers without COPD (417/844 tested, IRR=0.68, p=0.004). The receipt of skin testing was associated with fewer bursts in all patients (418/1,383 tested, IRR=0.77, p=0.02) and among never smokers without COPD (283/844 tested, IRR=0.59 versus no testing, p=0.001). CONCLUSION: Guideline-concordant aeroallergen testing in the context of Allergy/Immunology care was associated with clinical benefit in a real-life, diverse cohort of adults with asthma. This benefit varied according to patient comorbidities and the testing modality.

An Ethical Framework for Allergy and Immunology.

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.

Asthma morbidity measures across Black ethnic subgroups.

BACKGROUND: Black adults are disproportionately affected by asthma and are often considered a homogeneous group in research studies despite cultural and ancestral differences. OBJECTIVE: We sought to determine if asthma morbidity differs across adults in Black ethnic subgroups. METHODS: Adults with moderate-severe asthma were recruited across the continental United States and Puerto Rico for the PREPARE (PeRson EmPowered Asthma RElief) trial. Using self-identifications, we categorized multiethnic Black (ME/B) participants (n = 226) as Black Latinx participants (n = 146) or Caribbean, continental African, or other Black participants (n = 80). African American (AA/B) participants (n = 518) were categorized as Black participants who identified their ethnicity as being American. Baseline characteristics and retrospective asthma morbidity measures (self-reported exacerbations requiring systemic corticosteroids [SCs], emergency department/urgent care [ED/UC] visits, hospitalizations) were compared across subgroups using multivariable regression. RESULTS: Compared with AA/B participants, ME/B participants were more likely to be younger, residing in the US Northeast, and Spanish speaking and to have lower body mass index, health literacy, and <1 comorbidity, but higher blood eosinophil counts. In a multivariable analysis, ME/B participants were significantly more likely to have ED/UC visits (incidence rate ratio [IRR] = 1.34, 95% CI = 1.04-1.72) and SC use (IRR = 1.27, 95% CI = 1.00-1.62) for asthma than AA/B participants. Of the ME/B subgroups, Puerto Rican Black Latinx participants (n = 120) were significantly more likely to have ED/UC visits (IRR = 1.64, 95% CI = 1.22-2.21) and SC use for asthma (IRR = 1.43, 95% CI = 1.06-1.92) than AA/B participants. There were no significant differences in hospitalizations for asthma among subgroups. CONCLUSIONS: ME/B adults, specifically Puerto Rican Black Latinx adults, have higher risk of ED/UC visits and SC use for asthma than other Black subgroups.

Health literacy and asthma: An update.

The US Department of Health and Human Services has defined health literacy (HL) as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. Structural and social determinants of health lead to low HL in approximately 36% of adults in the United States, where this condition is most prevalent in racial and ethnic minorities, economically disadvantaged communities, and immigrants with limited English proficiency. In turn, low HL can worsen asthma outcomes through direct effects (eg, nonadherence to or incorrect use of medications) and indirect effects (eg, an unhealthy diet leading to obesity, a risk factor for asthma morbidity). The purpose of this update is to examine evidence from studies on low HL and health and asthma outcomes published in the last 12 years, identify approaches to improve HL and reduce health disparities in asthma, and discuss future directions for research in this area under the conceptual framework of a socioecological model that illustrates the multifactorial and interconnected complexity of this public health issue at different levels.

Factors associated with aeroallergen testing among adults with asthma in a large health system.

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.

Trust and virtual communication during the COVID-19 pandemic for adults with asthma from low-income neighborhoods: What have we learned?

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.

Factors Associated With Asthma Biologic Prescribing and Primary Adherence Among Adults in a Large Health System.

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.

Low parental numeracy and severe asthma exacerbations in a prospective study of Puerto Rican youth.

BACKGROUND: Numeracy is the mathematical knowledge required to understand and act on instructions from health care providers. Whether persistently low parental numeracy is linked to childhood asthma exacerbations is unknown. OBJECTIVE: To evaluate whether low parental numeracy at 2 time points is associated with asthma exacerbations and worse lung function in Puerto Rican youth. METHODS: Prospective study of 225 youth with asthma in San Juan (PR) who participated in 2 visits approximately 5.3 years apart, with the first at ages 6 to 14 years and the second at ages 9 to 20 years. Parental numeracy was assessed with a modified version of the Asthma Numeracy Questionnaire (score range = 0-3 points), and persistently low parental numeracy was defined as a score less than or equal to 1 point at both visits. Asthma exacerbation outcomes included more than or equal to 1 emergency department (ED) visit, more than or equal to 1 hospitalization, and more than or equal to 1 severe exacerbation (≥1 ED visit or ≥1 hospitalization) for asthma in the year before the second visit. Spirometry was conducted using an EasyOne spirometer (NDD Medical Technologies, Andover, Massachusetts). RESULTS: In an analysis adjusting for age, sex, parental education, use of inhaled corticosteroids, and the time between study visits, persistently low parental numeracy was associated with more than or equal to 1 ED visit for asthma (odds ratio [ORs], 2.17; 95% confidence interval [CI], 1.10-4.26), more than or equal to 1 hospitalization for asthma (OR, 3.92; 95% CI, 1.42-10.84), and more than or equal to 1 severe asthma exacerbation (OR, 1.99; 95% CI, 1.01-3.87) in the year before the follow-up visit. Persistently low parental numeracy was not significantly associated with change in lung function measures. CONCLUSION: Persistently low parental numeracy is associated with asthma exacerbation outcomes in Puerto Rican youth.

Reducing Health Disparities in Asthma: How Can Progress Be Made.

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.

New considerations of health disparities within allergy and immunology.

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.

Stakeholder engagement in eight comparative effectiveness trials in African Americans and Latinos with asthma.

BACKGROUND: The effects of stakeholder engagement, particularly in comparative effectiveness trials, have not been widely reported. In 2014, eight comparative effectiveness studies targeting African Americans and Hispanics/Latinos with uncontrolled asthma were funded by the Patient-Centered Outcomes Research Institute (PCORI) as part of its Addressing Disparities Program. Awardees were required to meaningfully involve patients and other stakeholders. Using specific examples, we describe how these stakeholders substantially changed the research protocols and in other ways participated meaningfully as full partners in the development and conduct of the eight studies. METHODS: Using the method content analysis of cases, we identified themes regarding the types of stakeholders, methods of engagement, input from the stakeholders, changes made to the research protocols and processes, and perceived benefits and challenges of the engagement process. We used summaries from meetings of the eight teams, results from an engagement survey, and the final research reports as our data source to obtain detailed information. The descriptive data were assessed by multiple reviewers using inductive and deductive qualitative methods and discussed in the context of engagement literature. RESULTS: Stakeholders participated in the planning, conduct, and dissemination phases of all eight asthma studies. All the studies included clinicians and community representatives as stakeholders. Other stakeholders included patients with asthma, their caregivers, advocacy organizations, and health-system representatives. Engagement was primarily by participation in advisory boards, although six of the eight studies (75%) also utilized focus groups and one-on-one interviews. Difficulty finding a time and location to meet was the most reported challenge to engagement, noted by four of the eight teams (50%). Other reported challenges and barriers to engagement included recruitment of stakeholders, varying levels of enthusiasm among stakeholders, controlling power dynamics, and ensuring that stakeholder involvement was reflected and had true influence on the project. CONCLUSION: Engagement-driven modifications led to specific changes in study design and conduct that were felt to have increased enrollment and the general level of trust and support of the targeted communities. The level of interaction described, between investigators and stakeholders in each study and between investigator-stakeholder groups, is-we believe-unprecedented and may provide useful guidance for other studies seeking to improve the effectiveness of community-driven research.

The goal of comparative clinical effectiveness research is to compare healthcare options and learn which work best for patients depending on their preferences and circumstances. Research efforts can be more effective when researchers engage stakeholders, such as patients, healthcare providers, and other members of the community­especially those communities or groups targeted by the planned research. Stakeholders can give their input throughout the research process to make sure the study will address questions and concerns that are most important and useful for participants. In 2014, the PCORI funded eight research studies that evaluated various ways to help African Americans and Hispanics/Latinos with poorly controlled asthma. These groups are underrepresented in asthma research but have higher rates of and more severe asthma for reasons that are poorly understood. The goal of this report is to show how stakeholders­including patients with asthma from these underrepresented groups, healthcare providers who care for patients with asthma, key representatives from the communities and others­participated as full partners in the eight studies and helped to improve the overall quality of the research and the relationship between the researchers and the community.

Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making.

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.

Clinic navigation and home visits to improve asthma care in low income adults with poorly controlled asthma: Before and during the pandemic.

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.