Human Epidemiology and RespOnse to SARS-CoV-2 (HEROS): Objectives, Design and Enrollment Results of a 12-City Remote Observational Surveillance Study of Households with Children using Direct-to-Participant Methods.

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) is a prospective multi-city 6-month incidence study which was conducted from May 2020-February 2021. The objectives were to identify risk factors for SARS-CoV-2 infection and household transmission among children and people with asthma and allergic diseases, and to use the host nasal transcriptome sampled longitudinally to understand infection risk and sequelae at the molecular level. To overcome challenges of clinical study implementation due to the coronavirus pandemic, this surveillance study used direct-to-participant methods to remotely enroll and prospectively follow eligible children who are participants in other NIH-funded pediatric research studies and their household members. Households participated in weekly surveys and biweekly nasal sampling regardless of symptoms. The aim of this report is to widely share the methods and study instruments and to describe the rationale, design, execution, logistics and characteristics of a large, observational, household-based, remote cohort study of SARS-CoV-2 infection and transmission in households with children. The study enrolled a total of 5,598 individuals, including 1,913 principal participants (children), 1,913 primary caregivers, 729 secondary caregivers and 1,043 other household children. This study was successfully implemented without necessitating any in-person research visits and provides an approach for rapid execution of clinical research.

Design of the Intervention to Reduce Early Peanut Allergy in Children (iREACH): A practice-based clinical trial.

BACKGROUND: Introducing peanut products early can prevent peanut allergy (PA). The "Addendum guidelines for the prevention of PA in the United States" (PPA guidelines) recommend early introduction of peanut products to low and moderate risk infants and evaluation prior to starting peanut products for infants at high risk for PA (those with severe eczema and/or egg allergy). Rapid adoption of guidelines could aid in lowering the prevalence of PA. The Intervention to Reduce Early (Peanut) Allergy in Children (iREACH) trial was designed to promote PPA guideline adherence by pediatric clinicians. METHODS: A two-arm, cluster-randomized, controlled clinical trial was designed to measure the effectiveness of an intervention that included clinician education and accompanying clinical decision support tools integrated in electronic health records (EHR) versus standard care. Randomization was at the practice level (n = 30). Primary aims evaluated over an 18-month trial period assess adherence to the PPA guidelines using EHR documentation at 4- and 6-month well-child care visits aided by natural language processing. A secondary aim will evaluate the effectiveness in decreasing the incidence of PA by age 2.5 years using EHR documentation and caregiver surveys. The unit of observation for evaluations are individual children with clustering at the practice level. CONCLUSION: Application of this intervention has the potential to inform the development of strategies to speed implementation of PPA guidelines.

Epidemiology and the Growing Epidemic of Food Allergy in Children and Adults Across the Globe.

PURPOSE OF REVIEW: Food allergies are immune-mediated, complex disorders, which are the source of increasing health concern worldwide. The goal of this review is to present an updated summary of the food allergy (FA) burden among children and adults across different populations, focusing on research from the past 5 years. RECENT FINDINGS: FAs impact a growing number of global residents-particularly those residing in higher-income, industrialized regions. Moreover, growing epidemiologic evidence suggests that the population health burden of non-IgE-mediated FAs, such as food protein-induced enterocolitis syndrome, may also be higher than previously reported. FA is a complex trait that impacts infants, children, as well as adults across the globe. The population health burden of both IgE- and non-IgE-mediated FAs is likely to grow in the absence of rapid advances and widespread implementation of effective FA prevention and treatment interventions. Systematic epidemiological research initiatives are needed, both nationally and globally, to better understand and reduce the burden of these allergic diseases.

Gut microbiome is associated with asthma and race in children with food allergy.

BACKGROUND: The composition of the gut microbiome has been associated with development of atopic conditions such as food allergy (FA) and asthma. African American or Black children with FA have higher rate of asthma compared to their White counterparts. OBJECTIVE: We sought to investigate whether the diversity and relative abundance (RA) of gut microbiota is different between children with FA from different racial backgrounds living in the same cities. Furthermore, we aimed to understand whether the difference in the gut microbiota is associated with asthma in children with FA. METHODS: We analyzed and compared the stool microbiome of a cohort of Black and White children with FA by shotgun genomic sequencing. RESULTS: A total of 152 children with IgE-mediated FA enrolled onto FORWARD (Food Allergy Outcomes Related to White and African American Racial Differences); 30 Black and 122 White children were included. The RA of several bacteria was associated with race and asthma. Most notably the RA of Bacteroides thetaiotaomicron, Chlamydia thrachomatis, Parabacteroides goldsteinii, and Bacteroides eggerthii were significantly higher, while the RA of Bifidobacterium sp CAG:754, Parabacterium johnsonii, Bacteroides intestinalis, and Bifidobacterium breve were significantly lower in stool samples of Black children compared to White children. Asthma was associated with lower RA of B breve, Bifidobacterium catenulatum, Prevotella copri, Veilloella sp CAG:933, and Bacteroides plebius, and higher RA of 3 Bacteroides species. CONCLUSIONS: The observed variations in the gut microbiota of Black and White children such as differences in the Bacteroides and Bifidobacterium species along with their association to history of asthma in our cohort is indicative of their potential role in the higher rate of asthma observed among Black children with FA.

The epidemiology of multifood allergy in the United States: A population-based study.

BACKGROUND: Immunoglobulin E (IgE)-mediated food allergies (FAs) are increasingly common among US children and adults. Not only can living with FA impose considerable physical health impacts, but it also imposes economic burden and can negatively affect quality of life. Limited data indicate that allergy to multiple foods (multi-FA) also may be common, but much remains unknown about its distribution and determinants. OBJECTIVE: To characterize the prevalence, characteristics, determinants, psychosocial burden, and distribution of multi-FA among a large, nationally representative sample of US children and adults. METHODS: A US population-based survey was administered. Estimates of multi-FA prevalence, conditional frequencies of multi-FA combinations, and associated factors were derived. Latent class analyses were conducted using 9 dichotomized indicators of specific FA prevalence, which were used to determine factors associated with latent class membership and characterize FA-related psychosocial burden within each class. RESULTS: Surveys were completed for 38,408 children and 40,443 adults. Among children and adults meeting established symptom-report criteria for FA, an estimated 40% and 48% had multi-FA, respectively. Among pediatric and adult populations with convincing FAs, the lifetime reported prevalence of physician-diagnosed atopic comorbidities increased significantly as the number of reported current convincing FAs increased, as did the proportion reporting multi-FA-related health care utilization and higher perceived psychosocial burden. Latent class analyses suggested the existence of the following 4 key latent phenotypes of multi-FA: milk and egg-dominant, seafood-dominant, peanut and tree nut-dominant, and broadly multi-food allergic. CONCLUSION: The US population-level burden of multi-FA is high among both children and adults, and data indicate the presence of 4 major phenotypes of multi-FA in both populations.

Risk factors for SARS-CoV-2 infection and transmission in households with children with asthma and allergy: A prospective surveillance study.

BACKGROUND: Whether children and people with asthma and allergic diseases are at increased risk for severe acute respiratory syndrome virus 2 (SARS-CoV-2) infection is unknown. OBJECTIVE: Our aims were to determine the incidence of SARS-CoV-2 infection in households with children and to also determine whether self-reported asthma and/or other allergic diseases are associated with infection and household transmission. METHODS: For 6 months, biweekly nasal swabs and weekly surveys were conducted within 1394 households (N = 4142 participants) to identify incident SARS-CoV-2 infections from May 2020 to February 2021, which was the pandemic period largely before a vaccine and before the emergence of SARS-CoV-2 variants. Participant and household infection and household transmission probabilities were calculated by using time-to-event analyses, and factors associated with infection and transmission risk were determined by using regression analyses. RESULTS: In all, 147 households (261 participants) tested positive for SARS-CoV-2. The household SARS-CoV-2 infection probability was 25.8%; the participant infection probability was similar for children (14.0% [95% CI = 8.0%-19.6%]), teenagers (12.1% [95% CI = 8.2%-15.9%]), and adults (14.0% [95% CI = 9.5%-18.4%]). Infections were symptomatic in 24.5% of children, 41.2% of teenagers, and 62.5% of adults. Self-reported doctor-diagnosed asthma was not a risk factor for infection (adjusted hazard ratio [aHR] = 1.04 [95% CI = 0.73-1.46]), nor was upper respiratory allergy or eczema. Self-reported doctor-diagnosed food allergy was associated with lower infection risk (aHR = 0.50 [95% CI = 0.32-0.81]); higher body mass index was associated with increased infection risk (aHR per 10-point increase = 1.09 [95% CI = 1.03-1.15]). The household secondary attack rate was 57.7%. Asthma was not associated with household transmission, but transmission was lower in households with food allergy (adjusted odds ratio = 0.43 [95% CI = 0.19-0.96]; P = .04). CONCLUSION: Asthma does not increase the risk of SARS-CoV-2 infection. Food allergy is associated with lower infection risk, whereas body mass index is associated with increased infection risk. Understanding how these factors modify infection risk may offer new avenues for preventing infection.

Early intervention and prevention of allergic diseases.

Food allergy (FA) is now one of the most common chronic diseases of childhood often lasting throughout life and leading to significant worldwide healthcare burden. The precise mechanisms responsible for the development of this inflammatory condition are largely unknown; however, a multifactorial aetiology involving both environmental and genetic contributions is well accepted. A precise understanding of the pathogenesis of FA is an essential first step to developing comprehensive prevention strategies that could mitigate this epidemic. As it is frequently preceded by atopic dermatitis and can be prevented by early antigen introduction, the development of FA is likely facilitated by the improper initial presentation of antigen to the developing immune system. Primary oral exposure of antigens allowing for presentation via a well-developed mucosal immune system, rather than through a disrupted skin epidermal barrier, is essential to prevent FA. In this review, we present the data supporting the necessity of (1) an intact epidermal barrier to prevent epicutaneous antigen presentation, (2) the presence of specific commensal bacteria to maintain an intact mucosal immune system and (3) maternal/infant diet diversity, including vitamins and minerals, and appropriately timed allergenic food introduction to prevent FA.

Socioeconomic determinants of food allergy burden: A clinical introduction.

OBJECTIVE: This review characterizes what is currently known about how prevalence, severity, distribution, and management of food allergy (FA) differ across socioeconomic strata and provides guidance for practicing clinicians about how to improve equity in research participation, health care delivery, and patient outcomes through a deeper understanding of the socioeconomic determinants of FA. DATA SOURCES: Epidemiologic and biomedical literature published before April 2022. RESULTS: Socioeconomic status (SES) is a complex concept that encompasses not only economic resources (eg, income, wealth) but also a person's social, economic, and political power and standing, each of which can affect health. However, in many studies of individuals and families with FA, assessment of SES has been limited and often a respondent's membership within a racial and ethnic group is used as a proxy for low SES. As a whole, findings from US population-based studies indicate a consistent trend: those who self-identify as non-Hispanic Black, and to a lesser extent other subpopulations who identify as being of non-White race and ethnicity, experience a greater burden of food-allergic sensitization and disease including higher rates of emergency health care utilization and food-induced anaphylactic fatality as compared with those identifying as non-Hispanic White. CONCLUSION: Reports of FA management and outcomes highlight inequities among specific low SES populations in the United States. Clinicians can and should act to reduce inequities by engaging more diverse populations in clinical research, equitably implementing FA risk screening and prevention, thoughtfully using emerging technologies to ameliorate disparities based on SES in health care delivery and outcomes, and advocating for social change.

Health provider perspectives of electronic medication monitoring in outpatient asthma care: a qualitative investigation using the consolidated framework for implementation research.

OBJECTIVE: Little is known about the implementation challenges health providers might face with the use of digital health in outpatient asthma care. To qualitatively explore the experience of health providers with electronic medication monitoring (EMM) using an implementation science framework. METHODS: Using the Consolidated Framework of Implementation Research (CFIR), we conducted interviews (n = 10) exploring health providers' experience with EMM with asthma patients from 5 primary care or specialty clinics. The EMM tracked albuterol and inhaled corticosteroid (ICS) use, and health providers called parents whenever ICS adherence waned, or albuterol use increased. Interviews were audio-recorded, transcribed, and deductively analyzed using directed content analysis. RESULTS: Health providers reported the intervention's primary advantage, compared with current asthma care, was the ability to monitor medication use at-home. Most felt the intervention improved care delivery. Nurses and medical assistants described a process of phone calls and checking alerts, that had varying levels of administrative burden and complexity. Health providers felt that sustained implementation of the intervention model would require additional employees to handle the administrative and clinical workload. Half of the interviewed providers were unsure if patient needs were met by the intervention, while some cited technology syncing issues, others liked the enhanced interactions for asthma education. CONCLUSION: Health providers reported positive experiences supporting parents and children with asthma using EMM but also highlighted intervention components that needed improvement or refinement to yield successful implementation in outpatient pediatric clinics. Recommendations for enhancing the intervention for a scaled-up implementation were discussed.

The impact of COVID-19 on adolescent wellness in Chicago.

PURPOSE: This study aimed to understand the impact of the initial COVID-19 pandemic remote schooling period on self-reported wellness among adolescents in Chicago. METHODS: Students (n = 55) completed a 22-item wellness questionnaire before (February 2020) and shortly after the onset of the COVID-19 outbreak (April 2020). Precomparisons/postcomparisons (overall and by survey item) were evaluated using two-sided paired t-tests with an alpha level of 0.05. Descriptive statistics were used to evaluate mean scores overall by demographic variables. RESULTS: Significant differences were found in the following areas: Balance (Pre: 7.3, During: 6.4, p = 0.02), Education (Pre: 8.4, During 7.7, p = 0.03) and Friends (Pre:8.0, During: 6.3, p = 0.001). Overall wellness scores varied by demographic variables, though not significantly. CONCLUSIONS: Results suggest the onset of the pandemic impacted students' ability to effectively learn, as well as to maintain balance in their lives and social relationships. Comprehensive support is needed in these areas to promote adolescent wellness.

Outcomes and Factors Associated With Prehospital Treatment of Pediatric Anaphylaxis.

OBJECTIVE: Anaphylaxis is a potentially life-threatening reaction requiring prompt treatment with intramuscular epinephrine (EPI). We sought to describe presenting features of pediatric anaphylaxis and compare patient characteristics and outcomes of children treated with prehospital EPI with those untreated. METHODS: We abstracted data from emergency department (ED) records for children meeting the National Institute of Allergy & Infectious Disease criteria for anaphylaxis (2015-2017) in one tertiary care children's hospital. We analyzed associations between patient characteristics and outcomes and receipt of prehospital EPI using descriptive statistics and multivariate logistic regression. RESULTS: Of 414 children presenting with anaphylaxis, 39.4% received IM EPI and 62.1% received antihistamines before hospital arrival. Children with Medicaid received pre-emergency department EPI less frequently than did children with private insurance (24.5% vs 43.8%, P = 0.001). Factors positively associated with prehospital EPI administration were history of food allergy (odds ratio [OR], 4.4 [95% confidence interval {CI}, 2.4-8.2]) or arrival by emergency medical services (OR, 8.0 [95% CI, 4.2-15.0]). Medicaid insurance was associated with decreased odds of prehospital EPI (OR, 0.33 [95% CI, 0.16-0.66]) and prehospital H1-antihistamine use (OR, 0.30 [95% CI, 0.17-0.56]). Prehospital EPI treatment was also associated with decreased rates of observation (37% vs 63%), inpatient admission (38% vs 62%), and intensive care unit admission (20% vs 80%) compared with no pretreatment (P = 0.03). CONCLUSIONS: Prehospital treatment with EPI remains low, and barriers to optimal treatment are more pronounced in children with public insurance. Prehospital treatment with EPI was associated with decreased morbidity including hospitalization and intensive care unit admission.

The global burden of illness of peanut allergy: A comprehensive literature review.

Peanut allergy (PA) currently affects approximately 2% of the general population of Western nations and may be increasing in prevalence. Patients with PA and their families/caregivers bear a considerable burden of self-management to avoid accidental peanut exposure and to administer emergency medication (adrenaline) if needed. Compared with other food allergies, PA is associated with higher rates of accidental exposure, severe reactions and potentially fatal anaphylaxis. Approximately 7%-14% of patients with PA experience accidental peanut exposure annually, and one-third to one-half may experience anaphylaxis, although fatalities are rare. These risks impose considerably high healthcare utilization and economic costs for patients with PA and restrictions on daily activities. Measures to accommodate patients with PA are often inadequate, with inconsistent standards for food labelling and inadequate safety policies in public establishments such as restaurants and schools. Children with PA are often bullied, resulting in sadness, humiliation and anxiety. These factors cumulatively contribute to significantly reduced health-related quality of life for patients with PA and families/caregivers. Such factors also provide essential context for risk/benefit assessments of new PA therapies. This narrative review comprehensively assessed the various factors comprising the burden of PA.

Parental quality of life and self-efficacy in pediatric asthma.

Objective: Self-efficacy is the personal belief that a behavior can produce a desired result; and in asthma, self-efficacy in asthma care has been related to improvements in asthma outcomes and children's quality of life. To appreciate the full burden of asthma on families, the relationship between parental self-efficacy and quality of life also needs further study. We aim to characterize this relationship.Methods: Secondary analysis of measurements of parents of children with persistent asthma (n = 252; ages 4-17 years) from a large urban area were identified from a randomized trial; the association between baseline assessments of parental quality of life, measured by the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), and parental self-efficacy, measured through the Parental Asthma Management Self-Efficacy Scale (PAMSES), were examined through multivariable linear regression.Results: Parental self-efficacy in asthma was positively associated with quality of life among parents of racially and ethnically diverse children (p = 0.01). Confidence in using medications correctly (p = 0.03), having inhalers during a child's serious breathing problem (p = 0.02), and knowing which medications to use during a child's serious breathing problem (p = 0.04) were associated with a clinically meaningful difference in parental quality of life. Other significant factors associated with parental quality of life included Hispanic/Latino ethnicity (p < 0.01) of the child and Asthma Control Test scores (p < 0.01).Conclusion: The findings suggest that improving parental confidence on when and how to use their child's asthma medications, particularly during an asthma attack, might be clinically meaningful in enhancing parent's quality of life.

Implementation of the Addendum Guidelines for Peanut Allergy Prevention by US allergists, a survey conducted by the NIAID, in collaboration with the AAAAI.

BACKGROUND: In 2017, the Addendum Guidelines for the Prevention of Peanut Allergy were published with recommendations on early introduction of peanut-containing foods based on infants' clinical history. OBJECTIVE: We sought to conduct a nationwide US survey to assess Guidelines implementation among allergists and immunologists who manage infants for food allergy. METHODS: Survey invitations were delivered to 3281 nonretired, US members of the American Academy of Asthma, Allergy & Immunology, board certified in allergy and immunology. The survey assessed awareness and implementation of the Guidelines and barriers to implementation. Descriptive statistics were generated. RESULTS: Twenty-nine percent (946 of 3281) of surveyed allergists/immunologists responded, and 87.1% (825 of 946) of responders met eligibility criteria. Among eligible responders, 97.1% were aware of the Guidelines. Of these, 64.5% reported full implementation of the Guidelines as published, 34.4% reported partial implementation, and 1.1% reported using none of the Guidelines. Barriers to Guidelines use included parental (47.6%) and self (21.8%) concerns about allergic reactions, lack of referrals (33.6%), parents uninterested in early feeding (28.2%), and lack of clinic time (20.9%). The 2 most common deviations from the Guidelines were considering additional factors not specified in the Guidelines such as family history (50.2%) and conducting skin prick testing in non-high-risk children (43.9%). Of respondents using the Guidelines, 45.7% indicated they needed more education or training. CONCLUSIONS: Essentially all allergists/immunologists who responded to the survey reported full or partial Guidelines implementation. Parental concerns and lack of referrals are major identifiable barriers. Improved Guidelines messaging to parents and referring physicians is warranted.

Addressing the social needs of individuals with food allergy and celiac disease during COVID-19: A new practice model for sustained social care.

COVID-19 has led to high rates of food insecurity. Food insecure patients with food allergy and celiac disease are especially vulnerable during the pandemic when foods become limited. This paper describes a practice innovation implemented by a community-based organization, Food Equality Initiative (FEI), whose mission is improving health and ending hunger among individuals with food allergy and celiac disease. FEI responded to the pandemic by converting their in-person pantries to a contactless delivery of safe foods. The practice innovation is discussed in relation to three system-level elements necessary to sustain the integration of social care into the delivery of healthcare.

Knowledge, attitude, and practices of medical clinicians regarding food allergy and anaphylaxis in Hyderabad, India.

BACKGROUND: Food allergy (FA) is a chronic condition of emerging global concern. Surveys have been conducted in numerous countries to assess physician knowledge, attitude, and practices (KAP) pertaining to FA and anaphylaxis, and substantial deficits in their KAP were identified. OBJECTIVE: To assess the KAP of medical clinicians in Hyderabad, India, with respect to FA and anaphylaxis. METHODS: A regionally representative sample of 570 physicians including 113 general practitioners, 123 pediatricians, 110 pulmonologists, 113 dermatologists, and 111 gastroenterologists were recruited from all major institutions in Hyderabad, India. A validated questionnaire was used to assess their KAP. RESULTS: Overall, 90% of questions were correctly answered and differences emerged with respect to specific items, namely the following: (1) the lateral thigh being the preferred location for epinephrine administration (P = .001); (2) a positive skin prick test or radioallergosorbent test is sufficient for FA diagnosis (P = .04); and (3) the appropriate epinephrine dose for a 27-kg child (P = .006). Approximately 95% of the participants in each group were confident in their ability to care for patients with FA, yet 91% desired additional periodic FA training sessions. CONCLUSION: Survey findings suggest that although FA knowledge among South Indian clinicians seems high across all major specialties who care for patients with FA, there are differences in the level of knowledge among them, which in turn reflects the differences in attitude and approach toward their patients. These FA care providers still desire to further participate in continuing medical education efforts in the field of food allergy. Efforts to provide periodic training and education for all FA clinical care providers remain vital in South India.

Epidemiology and Burden of Food Allergy.

PURPOSE OF REVIEW: In recent decades, food allergy has become an increasing concern for families, clinicians, and policymakers. This review aims to summarize what is currently known about the epidemiology and population-level burden of IgE-mediated food allergy, including its effects on quality of life. RECENT FINDINGS: Prevalence surveys, healthcare utilization data, and findings from longitudinal cohort studies across the globe indicate that food allergy imposes a growing societal burden. Worryingly, recent data indicate that food allergies may be more prevalent among adult populations than previously acknowledged, with many reported cases of adult-onset allergies. While it remains unclear how much of the current population-level burden of disease results from true, IgE-mediated allergy, as much epidemiological data does not incorporate clinical confirmation of disease prevalence-it is clear that affected individuals suffer impairments in their quality of life and incur substantial economic costs-beyond the physical health burden imposed by anaphylaxis.

Economic burden of food allergy: A systematic review.

OBJECTIVE: To assess the economic burden of food allergy (FA) worldwide. DATA SOURCES: PubMed MEDLINE, Embase, and Cochrane Central Register of Controlled Trials on the Wiley platform were searched to identify literature that assessed direct, out-of-pocket, and opportunity costs of FA. All databases were searched back to their inception, and no language or date limits were applied. STUDY SELECTIONS: We included primary studies that examined direct medical, out-of-pocket, or opportunity costs and/or lost labor productivity in food allergic adults and/or children and their families. RESULTS: Eleven papers met our inclusion criteria, of which ed7 addressed direct medical, 7 addressed out-of-pocket, and 5 addressed opportunity costs. Estimates were based on data that reflected costs for a patient with FA (individual level) or costs for a household with a food allergic patient (household level). The mean individual-level direct medical costs ($2081) were much higher than the mean household-level costs ($806). The mean individual-level out-of-pocket ($1874) and opportunity ($1038) and opportunity cost were lower than the mean household-level out-of-pocket ($3339) and opportunity ($4881) costs. Household-level estimates of lost opportunity costs imposed the largest economic burden attributable to FA. CONCLUSION: Most of the economic burden studies reviewed measured components of economic burden that are unique to individuals with FA but did so in noncomparable ways. Addressing cost burdens and measuring them using standardized instruments and methods will be critical to better understand the economic burden of FA globally.