Racial and Ethnic Representation in Food Allergen Immunotherapy Trial Participants: A Systematic Review.

Importance: The lack of inclusion of diverse population samples in food allergy immunotherapy clinical trials not only leads to decreased applicability to the general population in terms of results and treatments but can also be seen as a broader social injustice contributing to inequity within the health care system. Objectives: To investigate the racial and ethnic distribution of participants included in food allergy immunotherapy clinical trials, and determine whether the racial and ethnic representation in trials accurately reflects the patients who experience food allergy. Evidence Review: Data were collected from articles found on PubMed and ClinicalTrials.gov using key terms of food hypersensitivity, food allergy, and immunotherapy, while also incorporating specific criteria such as clinical trials conducted within the last 5 years with children aged from birth to 18 years old. Articles were selected based on their relevance to the research question. Main outcomes were totals and percentages of trial participants by race and ethnicity, stratified by pediatric trials, site of study, and National Institutes of Health funding. Findings: Thirty-five articles were initially identified, of which 34 were classified as human clinical trials. Of these trials, 26 met criteria of an original randomized clinical trial and included racial and ethnic demographics for analysis in the study. Among trials included, the majority of the 3689 participants identified as White (2640 participants [72.0%]), followed by Black or African American (293 participants [8.0%]), Asian (239 participants [6.0%]), multiple races or other (210 participants [6.0%]), Hispanic or Latino (96 participants [3.0%]), American Indian (3 participants [<1.0%]), and Native American or Pacific Islander (3 participants [<1.0%]). We observed differences in racial and ethnic inclusion by study site (US vs external to US) and funding support (National Institutes of Health vs industry or other non-National Institutes of Health sources). Conclusions and Relevance: In this systematic review of racial and ethnic diversity in food allergy immunotherapy trials, there was a lack of diversity relative to the overall food allergy burden among Black and Hispanic patients, indicating important gaps in the conduct of pediatric clinical trials, especially for treatments that are meant for use in broad populations where significant race- and ethnicity-related disparities exist. Working to correct this disparity will not only increase the usefulness of future clinical trial data but can further assist in alleviating public health inequities.

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.

The impact of skin color and tone on histamine iontophoresis and Doppler flowmetry measurements as a pharmacodynamic biomarker.

The phenotypical manifestations of asthma among children are diverse and exhibit varying responses to therapeutic interventions. There is a need to develop objective biomarkers to improve the characterization of allergic and inflammatory responses relevant to asthma to predict therapeutic treatment responses. We have previously investigated histamine iontophoresis with laser Doppler flowmetry (HILD) as a potential surrogate biomarker that characterizes histamine response and may be utilized to guide the treatment of allergic and inflammatory disease. We have identified intra-individual variability of HILD response type among children and adults with asthma and that HILD response type varied in association with racial classification. As laser Doppler flowimetry may be impacted by skin color, we aimed to further validate the HILD method by determining if skin color or tone is associated with observed HILD response type differences. We conducted an observational study utilizing quantification of skin color and tone obtained from photographs of the skin among participants during HILD assessments via the RGB color model. We compared RGB values across racial, ethnic, and HILD response type via the Kruskal-Wallis test and calculated Kendall rank correlation coefficient to evaluate the relationship between RGB composite scores and HILD pharmacodynamic measures. We observed that RGB scores differed among racial groups and histamine response phenotypes (p < 0.05). However, there was a lack of correlation between the RGB composite score and HILD pharmacodynamic measures (r values 0.1, p > 0.05). These findings suggest that skin color may not impact HILD response variations, necessitating further research to understand previously observed differences across identified racial groups.

Committing to genomic answers for all kids: Evaluating inequity in genomic research enrollment.

PURPOSE: Persistent inequities in genomic medicine and research contribute to health disparities. This analysis uses a context-specific and equity-focused strategy to evaluate enrollment patterns for Genomic Answers for Kids (GA4K), a large, metropolitan-wide genomic study on children. METHODS: Electronic health records for 2247 GA4K study participants were used to evaluate the distribution of individuals by demographics (race, ethnicity, and payor type) and location (residential address). Addresses were geocoded to produce point density and 3-digit zip code maps showing local and regional enrollment patterns. Health system reports and census data were used to compare participant characteristics with reference populations at different spatial scales. RESULTS: Racial and ethnic minoritized and populations with low-income were underrepresented in the GA4K study cohort. Geographic variation demonstrates inequity in enrollment and participation among children from historically segregated and socially disadvantaged communities. CONCLUSION: Our findings illustrate inequity in enrollment related to both GA4K study design and structural inequalities, which we suspect may exist for similar US-based studies. Our methods provide a scalable framework for continually evaluating and improving study design to ensure equitable participation in and benefits from genomic research and medicine. The use of high-resolution, place-based data represents a novel and practical means of identifying and characterizing inequities and targeting community engagement.

The evolving landscape of immunotherapy for the treatment of allergic conditions.

Allergic conditions, such as asthma, chronic urticaria, atopic dermatitis (AD), and eosinophilic esophagitis, have long been treated with oral and topical steroids which resulted in negative off-target effects. However, newer biologic medications are increasingly being developed and approved for treatment of these conditions. These medications have a variety of mechanisms of action to target pathophysiology specific to these diseases. As biologics become more targeted, fewer off-target effects are seen improving tolerability for patients as well as expanded options for treatment of these conditions. This review discusses monoclonal antibody therapies (omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, and tralokinumab) including their safety and use in asthma, chronic urticaria, AD, and eosinophilic esophagitis.

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.

Diversity, Equity, and Inclusion: A Decade of Progress?

The concepts of diversity, equity, and inclusion are fundamental and more recently heavily discussed within medicine, research, and the larger society. There is increasing awareness that diversity of thoughts, perspectives, and backgrounds yields stronger teams and more effective results. There is also increasing awareness that stark inequities from systemic, institutional, and individual levels exist that limit the baseline opportunities for many populations. To close disparity gaps, broad aspects of diversity and promoting equity are required and efforts must be inclusive of those most marginalized. In this Clinical Commentary, we discuss, "How and If progress has been made in Diversity, Equity, Inclusion within the field of Allergy/Asthma/Immunology in the past decade?" We discuss the current state of clinical practice and what has been revealed over the past 10 years; describe our current workforce and what progress has or has not occurred there; and finally, review the state of scientific and medical research.

The Role of Social Determinants of Health in the Use of Telemedicine for Asthma in Children.

Asthma is the most common chronic health condition among children in the United States. The adverse impacts of social determinants of health often manifest in unmet health-related social needs, potentially contributing to worse asthma outcomes. With the onset and rapid spread of coronavirus disease 2019 (COVID-19) and the identification of asthma as a potential risk factor for more severe disease, our asthma program quickly pivoted to a remote-access telemedicine asthma population management platform to best meet the needs of our most at-risk patients. Our practice provides care to a large proportion of Black and Latino/a/e children in urban areas insured by the State Medicaid Program and impacted by unmet social needs. As we pivoted to telemedicine, we consistently reached a greater number of patients and families than prepandemic and observed decreased emergency department visits and hospitalizations. About 1 in 5 families received resource touch points spanning categories of transportation, food and supplies, clothing, utilities, and rent. Overall, families reported positive experiences with telemedicine, including the ability to connect remotely with our social work and resource teams. Telemedicine may be an effective strategy for addressing both the medical and the social needs of children with asthma at risk for worse outcomes.

The relationship between structural racism and COVID-19 related health disparities across 10 metropolitan cities in the United States.

INTRODUCTION: Black, Hispanic, and Indigenous groups have carried the burden of COVID-19 disease in comparison to non-marginalized groups within the United States. It is important to examine the factors that have led to the observed disparities in COVID-19 risk, morbidity, and mortality. We described primary health care access within large US metropolitan cities in relation to COVID-19 rate, race/ethnicity, and income level and hypothesized that observed racial/ethnic disparities in COVID-19 rates are associated with health care provider number. METHODS: We accessed public city health department records for reported COVID-19 cases within 10 major metropolitan cities in the United States and also obtained publicly available racial/ethnic demographic median income and primary health care provider counts within individual zip codes. We made comparisons of COVID-19 case numbers within zip codes based on racial/ethnic and income makeup in relation to primary health care counts. RESULTS: Median COVID-19 rates differed by race/ethnicity and income. There was an inverse relationship between median income and COVID-19 rate within zip codes (rho: -0.515; p<0.001). However, this relationship was strongest within racially/ethnically non-marginalized zip codes relative to those composed mainly of racially/ethnically marginalized populations (rho: -0.427 vs. rho: -0.175 respectively). Health care provider number within zip codes was inversely associated with the COVID-19 rate. (rho: -0.157; p<0.001) However, when evaluated by stratified groups by race the association was only significant within racially/ethnically marginalized zip codes(rho: -0.229; p<0.001). DISCUSSION: COVID-19 case rates were associated with racial/ethnic makeup and income status within zip codes across the United States and likewise, primary care provider access also differed by these factors. However, our study reveals that structural and systemic barriers and inequities have led to disproportionate access to health care along with other factors that require identification. CONCLUSION: These results pose a concern in terms of pandemic progression into the next year and how these structural inequities have impacted and will impact vaccine distribution.

Impact of Social Determinants on the Burden of Asthma and Eczema: Results from a US Patient Survey.

INTRODUCTION: Little is known about how patients with asthma and eczema perceive their medical care and burden of disease. A survey was conducted to evaluate the perceptions among the general patient population with asthma and/or eczema regarding disease and treatment burden and barriers to adequate care. METHODS: An online survey was completed by market research panelists in the USA between March 24, 2020 and April 6, 2020. Eligible participants were at least 18 years of age and endorsed a diagnosis of asthma and/or eczema. Survey responses are described for all participants, by designated racial/ethnic groups, and by income level. RESULTS: In all, 841 participants completed the survey (asthma, n = 554; eczema, n = 398; both, n = 111; White, n = 421; Black, n = 252; Hispanic, n = 95; low income [less than $15,000/year], n = 99; higher income [at least $15,000/year], n = 713). More Black and Hispanic participants than White participants, and more participants with low income than higher income, endorsed health literacy as a barrier (e.g., filling out official documents, understanding written materials). Participants with low income were less likely than participants with higher income to have an asthma action plan (42% vs 53%, respectively) and to discuss asthma control with their healthcare provider (54% vs 69%). Black and Hispanic participants were more likely than White participants to have an emergency department visit (52% and 49% vs 31%, respectively) or hospitalization (31% and 39% vs 16%) for asthma within the last 12 months. Participants reporting low income indicated that they experienced eczema symptoms more frequently than participants with higher income; 35% of low-income participants vs 15% of higher-income participants reported that they had not tried any eczema treatments. Participants in all racial/ethnic and income-level groups reported that their asthma or eczema impacted their lifestyle and daily activities. CONCLUSION: More effective and culturally informed communication and education strategies to improve health information uptake and shared decision-making are needed to reduce the burdens of disease and treatment in highly impacted populations.

Disparities in asthma and eczema outcomes have been described in various populations. However, little is known about how these patient populations perceive their disease management or disease burden. A survey of 841 adults across diverse demographic groups in the USA with asthma and/or eczema was conducted to evaluate overall perceived disease burden and to specifically understand burden experiences by marginalized populations. In general, all participants indicated that asthma and eczema have a negative physical, emotional, and social impact on their lives. Some participants who identified as Black or Hispanic, and those with low income (less than $15,000/year), indicated greater difficulties in filling out paperwork or understanding written materials related to their condition than White participants or those with higher incomes. Black and Hispanic participants tended to receive asthma care in the emergency department or urgent care more than White participants and had more emergency department visits and hospitalizations than White Participants. Participants with low income were less likely to discuss their asthma management with their doctor than those with higher incomes and also indicated potential undertreatment of eczema. These results indicate that Black, Hispanic, or low-income patients may experience barriers to health equity. These barriers include lack of effective communication methods and materials to meet the needs of all patients, as well as the overall lack of quality healthcare access. These challenges must be addressed to overcome social disparities in health.

Preventing Home Medication Administration Errors.

Medication administration errors that take place in the home are common, especially when liquid preparations are used and complex medication schedules with multiple medications are involved; children with chronic conditions are disproportionately affected. Parents and other caregivers with low health literacy and/or limited English proficiency are at higher risk for making errors in administering medications to children in their care. Recommended strategies to reduce home medication errors relate to provider prescribing practices; health literacy-informed verbal counseling strategies (eg, teachback and showback) and written patient education materials (eg, pictographic information) for patients and/or caregivers across settings (inpatient, outpatient, emergency care, pharmacy); dosing-tool provision for liquid medication measurement; review of medication lists with patients and/or caregivers (medication reconciliation) that includes prescription and over-the-counter medications, as well as vitamins and supplements; leveraging the medical home; engaging adolescents and their adult caregivers; training of providers; safe disposal of medications; regulations related to medication dosing tools, labeling, packaging, and informational materials; use of electronic health records and other technologies; and research to identify novel ways to support safe home medication administration.

Outbreak of COVID-19 and interventions in a large jail - Cook County, IL, United States, 2020.

BACKGROUND: Correctional and detention facilities are disproportionately affected by COVID-19 due to shared space, contact between staff and detained persons, and movement within facilities. On March 18, 2020, Cook County Jail, one of the United States' largest, identified its first suspected case of COVID-19 in a detained person. METHODS: This analysis includes SARS-CoV-2 cases confirmed by molecular detection among detained persons and Cook County Sheriff's Office staff. We examined occurrence of symptomatic cases in each building and proportions of asymptomatic detained persons testing positive, and timing of interventions including social distancing, mask use, and expanded testing and show outbreak trajectory in the jail compared to case counts in Chicago. RESULTS: During March 1-April 30, 907 symptomatic and asymptomatic cases of SARS-CoV-2 infection were detected among detained persons (n = 628) and staff (n = 279). Among asymptomatic detained persons in quarantine, 23.6% tested positive. Programmatic activity and visitation stopped March 9, cells were converted into single occupancy beginning March 26, and universal masking was implemented for staff (April 2) and detained persons (April 13). Cases at the jail declined while cases in Chicago increased. DISCUSSION/CONCLUSIONS: Aggressive intervention strategies coupled with widespread diagnostic testing of detained and staff populations can limit introduction and mitigate transmission of SARS-CoV-2 infection in correctional and detention facilities.

The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities.

Asthma is one of the most common underlying diseases in women of reproductive age that can lead to potentially serious medical problems during pregnancy and lactation. A group of key stakeholders across multiple relevant disciplines was invited to take part in an effort to prioritize, strategize, and mobilize action steps to fill important gaps in knowledge regarding asthma medication safety in pregnancy and lactation. The stakeholders identified substantial gaps in the literature on the safety of asthma medications used during pregnancy and lactation and prioritized strategies to fill those gaps. Short-term action steps included linking data from existing complementary study designs (US and international claims data, single drug pregnancy registries, case-control studies, and coordinated systematic data systems). Long-term action steps included creating an asthma disease registry, incorporating the disease registry into electronic health record systems, and coordinating care across disciplines. The stakeholders also prioritized establishing new infrastructures/collaborations to perform research in pregnant and lactating women and to include patient perspectives throughout the process. To address the evidence gaps, and aid in populating product labels with data that inform clinical decision making, the consortium developed a plan to systematically obtain necessary data in the most efficient and timely manner.

Identification of Presymptomatic and Asymptomatic Cases Using Cohort-Based Testing Approaches at a Large Correctional Facility-Chicago, Illinois, USA, May 2020.

BACKGROUND: Coronavirus disease 2019 (COVID-19) continues to cause significant morbidity and mortality worldwide. Correctional and detention facilities are at high risk of experiencing outbreaks. We aimed to evaluate cohort-based testing among detained persons exposed to laboratory-confirmed cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in order to identify presymptomatic and asymptomatic cases. METHODS: During 1-19 May 2020, 2 testing strategies were implemented in 12 tiers or housing units of the Cook County Jail, Chicago, Illinois. Detained persons were approached to participate in serial testing (n = 137) and offered tests at 3 time points over 14 days (day 1, days 3-5, and days 13-14). The second group was offered a single test and interview at the end of a 14-day quarantine period (day 14 group) (n = 87). RESULTS: 224 detained persons were approached for participation and, of these, 194 (87%) participated in ≥1 interview and 172 (77%) had ≥1 test. Of the 172 tested, 19 were positive for SARS-CoV-2. In the serial testing group, 17 (89%) new cases were detected, 16 (84%) on day 1, 1 (5%) on days 3-5, and none on days 13-14; in the day 14 group, 2 (11%) cases were identified. More than half (12/19; 63%) of the newly identified cases were presymptomatic or asymptomatic. CONCLUSIONS: Our findings highlight the utility of cohort-based testing promptly after initiating quarantine within a housing tier. Cohort-based testing efforts identified new SARS-CoV-2 asymptomatic and presymptomatic infections that may have been missed by symptom screening alone.