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.

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.

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.

The Reliability of Histamine Pharmacodynamic Response Phenotype Classification in Children With Allergic Disease.

We have identified distinct histamine pharmacodynamic response phenotypes in children with allergic disease utilizing histamine iontophoresis with laser Doppler (HILD). These response phenotypes may be relevant in guiding therapeutic decision making for agents targeting the allergic response pathways. However, the reliability of these response phenotypes has not been assessed. Therefore, we performed HILD in children with allergic rhinitis and/or asthma on two to three separate occasions. HILD response-time data were analyzed in NONMEM using a linked effect PKPD model. Examination of observed vs. classified response phenotypes predicted response plots and the sum of residuals. The intraclass correlation coefficient (ICC) was used to determine the reliability of phenotype classification. Eighty-two percent of children exhibited a reliable histamine response phenotype [intraclass correlation coefficient 0.77 (95% CI 0.44-0.93]. These preliminary results suggest moderate reliability of HILD response phenotype in children. Further exploration is needed to determine contributions to phenotype variability.

Pediatric Clinical Endpoint and Pharmacodynamic Biomarkers: Limitations and Opportunities.

Medical research in children typically lags behind that of adult research in both quantity and quality. The conduct of rigorous clinical trials in children can raise ethical concerns because of children's status as a 'vulnerable' population. Moreover, carrying out studies in pediatrics also requires logistical considerations that rarely occur with adult clinical trials. Due to the relatively smaller number of pediatric studies to support evidence-based medicine, the practice of medicine in children is far more reliant upon expert opinion than in adult medicine. Children are at risk of not receiving the same level of benefits from precision medicine research, which has flourished with new technologies capable of generating large amounts of data quickly at an individual level. Although progress has been made in pediatric pharmacokinetics, which has led to safer and more effective dosing, gaps in knowledge still exists when it comes to characterization of pediatric disease and differences in pharmacodynamic response between children and adults. This review highlights three specific therapeutic areas where biomarker development can enhance precision medicine in children: asthma, type 2 diabetes mellitus, and pain. These 'case studies' are meant to update the reader on biomarkers used currently in the diagnosis and treatment of these conditions, and their shortcomings within a pediatric context. Current research on surrogate endpoints and pharmacodynamic biomarkers in the above therapeutic areas will also be described. These cases highlight the current lack in pediatric specific surrogate endpoints and pharmacodynamic biomarkers, as well as the research presently being conducted to address these deficiencies. We finally briefly highlight other therapeutic areas where further research in pediatric surrogate endpoints and pharmacodynamic biomarkers can be impactful to the care of children.