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 the 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.

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.

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.

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.

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.

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.

Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

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.).

Deconstructing the Way We Use Pulmonary Function Test Race-Based Adjustments.

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.

Methods for Cross-Cultural Communication in Clinic Encounters.

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.

Understanding Autonomy in Patients with Moderate to Severe Asthma.

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.

Primary language and the electronic health record patient portal: Barriers to use among Spanish-speaking adults with asthma.

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.

Feasibility and acceptability of monitoring personal air pollution exposure with sensors for asthma self-management.

BACKGROUND: Exposure to fine particulate matter (PM2.5) increases the risk of asthma exacerbations, and thus, monitoring personal exposure to PM2.5 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 PM2.5 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 PM2.5 measurements at 1-s intervals while walking in Philadelphia neighborhoods in May-August 2018. AirBeam PM2.5 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. PM2.5 measurements were taken using AirBeam sensors on 34 walks that extended through five Philadelphia neighborhoods. The range of sensor PM2.5 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 PM2.5 levels over time and space. CONCLUSIONS: Patients were generally interested in using sensors to monitor their personal exposure to PM2.5 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.