Food Allergy-related Quality Of Life Research Articles

280 Estimating Latent Attitudinal and Behavioral Risk Profiles and Associations with Food Allergy-Related Quality of Life

OBJECTIVES/GOALS: Childhood food allergy (FA) is a chronic condition that can profoundly impact patient and caregiver quality of life (QoL). Risk factors for impaired FA-related QoL remain largely unknown. This study aims to estimate latent profiles of caregiver attitudes and behaviors, and examine if group membership correlates with established QoL outcomes. METHODS/STUDY POPULATION: This project is subsumed under the FORWARD study (5R01AI130348-04), a multisite longitudinal cohort study conducted at four major pediatric medical centers. Eligible participants include caregivers of children ages 12 years and under who identify as Black or White and have at least one physician-diagnosed FA. Participants complete intake surveys, annual clinical visits, and quarterly surveys administered via REDCap. As of November 2022, 413 Non-Hispanic Black and 486 Non-Hispanic White participants were enrolled. RESULTS/ANTICIPATED RESULTS: We anticipate that specific latent profiles will emerge based on caregiver-reported attitudes and behaviors. We predict these profiles will demonstrate configural, metric, and scalar invariance across key sociodemographic strata (e.g., child race/ethnicity, household income, caregiver educational attainment, and child sex). Relatedly, we anticipate that sociodemographic factors, such as race, sex, ethnicity, parental education, and income, will significantly predict group membership. Finally, we predict that latent profile membership will be associated with different levels of quality of life, as assessed by the parental food allergy-related quality of life questionnaire (FAQLQ-PF-10) and other validated measures of FA-related psychosocial burden. DISCUSSION/SIGNIFICANCE: Given the psychosocial burden associated with FA, and limited mental health resources for patients and families, it is essential to improve understanding of how caregiver attitudes influence behavior and disease management outcomes. In so doing, we will inform the development and implementation of tailored interventions for those at highest risk.

IMPACT OF ACCESS TO ALLERGEN-FREE FOOD OPTIONS THROUGH WIC ON FOOD ALLERGY-RELATED QUALITY OF LIFE

<h3>Introduction</h3> Childhood food allergies and the buying of allergen-free foods may pose significant social and financial burdens to families. The impact of limited access to allergen-free options on quality of life is unclear. <h3>Methods</h3> We conducted a cross-sectional survey assessing sociodemographics, the financial burden of accessing allergen-free foods, and the Food Allergy Quality of Life Questionnaire among caregivers of children 0-17 years old with food allergies. <h3>Results</h3> Fifty-three caregivers of children with allergies to one (22.6%) or multiple (77.4%) foods participated. The most common food allergies reported were peanuts (66.0%), tree nuts (62.2%), hen's egg (49.1%), milk (26.4%), sesame seed (24.5%), and soybean (22.6%). Twenty-six respondents (49.0%) used government-sponsored nutritional support programs (WIC or SNAP). Among respondents who used WIC/SNAP, 46.4% were always able to find allergen-free options. FAQLQ summary scores were similar among respondents who were always able to find allergen-free options through WIC/SNAP (1.91±0.48) and those who did not use WIC/SNAP at all (2.23±0.28), but higher in those who were not always able to find allergen-free alternatives through WIC/SNAP (3.11±0.33; [F(2,50)=3.81, p=0.028]). Difficulty obtaining allergen-free options through WIC/SNAP was reported by caregivers of children with allergies to soybean (100.0%), milk (85.7%), sesame seed (75.0%), hen's egg (69.2%), tree nuts (64.3%), and peanuts (58.8%). <h3>Conclusion</h3> In this study of families affected by food allergies, we found that inconsistent access to allergy-safe food through WIC/SNAP was common and associated with poor food allergy-related quality of life. These findings highlight a potential opportunity for advocacy through food allergy-friendly initiatives government-sponsored nutritional support programs.

Psychotherapeutic Treatment for Psychosocial Concerns Related to Food Allergy: Current Treatment Approaches and Unmet Needs

Psychosocial concerns, such as anxiety and decreased quality of life, are common among patients with food allergy and their caregivers. There is evidence that childhood anxiety disorders are at the outset of a "cascade of psychopathology," highlighting the importance of early recognition and treatment. Provision of psychological services is needed, beginning with a thorough assessment of food allergy-related quality of life, subjective perceptions of food allergy severity, and environmental factors. Implementation of patient-centered cognitive-behavioral, medical coping, and motivational interviewing strategies may promote healthy food allergy management and adjustment. We present 2 cases, a mother of a young child with food allergy and a young boy preparing for oral immunotherapy treatment, who received psychological services for food allergy-related anxiety. For each, treatment resulted in decreased anxiety and improved food allergy management/oral immunotherapy treatment engagement. We also discuss unmet food allergy-related psychosocial needs, including the lack of food allergy-specific anxiety measures, psychosocial domains that warrant investigation (trauma, feeding concerns), development of supportive interventions for patients engaging in allergen immunotherapy, and the lack of adequate mental health providers with food allergy expertise.

Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial

Peanut allergy is the leading cause of food-related anaphylaxis. Current management options can negatively affect food allergy-related quality of life. We aimed to investigate the efficacy of an investigational oral biologic drug (AR101). The AR101 Trial in Europe Measuring Oral Immunotherapy Success in peanut-allergic children (ARTEMIS) trial was a multicentre, double-blind, randomised, placebo-controlled phase 3 trial done at 18 hospitals in Ireland, France, Germany, Italy, Spain, Sweden, and the UK. Children and adolescents with peanut allergy, aged 4-17 years, who developed dose-limiting symptoms to 300 mg or less peanut protein (equivalent to approximately one peanut kernel) during a double-blind placebo-controlled food challenge test at study entry were enrolled. Participants were randomly assigned (3:1) to receive daily doses of either AR101 oral immunotherapy (AR101 group) or a taste-masked placebo (placebo group). All participants, investigators, and care providers were masked to treatment allocation until the study was completed. Doses were increased every 2 weeks over 6 months until a dose of 300 mg was reached and maintained for 3 months. The primary endpoint was the proportion of participants in the intention-to-treat or safety population (defined as those participants who had been randomly assigned and had received at least one dose of the assigned drug) who could consume a single dose of 1000 mg (cumulative dose 2043 mg) peanut protein without developing dose-limiting allergic symptoms at an exit double-blind placebo-controlled food challenge after 9 months of treatment. Additional endpoints included safety (ie, the frequency and severity of adverse events) and changes in food allergy-related quality of life, assessed by use of age-appropriate Food Allergy Quality of Life Questionnaires (FAQLQs) and the Food Allergy Independent Measure (FAIM). The study is registered with ClinicalTrials.gov, NCT03201003, and is completed. Between June 12, 2017, and Feb 15, 2018, 227 patients were screened, of whom 175 were randomly assigned to the AR101 group (n=132) and the placebo group (n=43). All primary and secondary endpoints were met. 77 (58%) of 132 participants in the AR101 group tolerated 1000 mg peanut protein at the exit food challenge versus one (2%) of 43 participants in the placebo group (AR101-placebo treatment difference 56·0% [95% CI 44·1-65·2], p<0·0001). Adverse events were reported by almost all participants. The maximum severity of adverse events reported was mild or moderate for most participants who received AR101 (mild, 66 [50%] of 132 participants; moderate, 63 [48%]; and severe, one [1%]) or placebo (mild, 24 [56%] of 43 participants; moderate, 18 [42%]; severe, none). Participants aged 8-12 years in the AR101 group reported improvements that exceeded the minimum clinically important difference between the two groups across all FAQLQ domains. Additionally, participants in the AR101 group and their caregivers reported improvements that exceeded the minimum clinically important difference in FAIM domains related to the perceived likelihood and outcomes of a severe allergic reaction. AR101 oral immunotherapy treatment led to rapid desensitisation to peanut protein, with a predictable safety profile that improved with treatment, and an associated improvement in self-reported and caregiver-reported food allergy-related quality of life. These patient-oriented outcomes provide invaluable data to help physicians, patients, and caregivers make informed, shared decisions on the management of peanut allergy. Aimmune Therapeutics.

Peanut Oral Immunotherapy: a Current Perspective.

Purpose of the ReviewPeanut oral immunotherapy (OIT) is one of the most studied experimental therapies for food allergy. With the recently FDA-approved peanut product, Palforzia, the goal of this article is to review the most recent data from clinical trials, discuss recent trends, and anticipate future developments.Recent FindingsThe latest research suggests that peanut OIT could be a promising option for peanut-allergic patients, with the majority of participants in research studies achieving the primary efficacy endpoint of desensitization, as well as sustained unresponsiveness in select populations. Some studies also showed improvements in food allergy-related quality of life. However, peanut OIT is not without risk or side effects, including potentially serious allergic reactions.SummaryFuture research will need to evaluate the short- and long-term effectiveness of the therapy in the real-world setting, predictors of important treatment outcomes, and the use of adjunctive therapies that may mitigate some of these allergic reactions.

Factors Affecting Food Allergy-Related Quality of Life From Parents' Perception in Turkish Children.

PurposeFood allergy (FA) affects the daily lives of children and parents in varying degrees. The Food Allergy Quality of Life Questionnaire-Parent Form (FAQLQ-PF) is a valid and reliable instrument to assess the quality of life (QoL) of children from parents' perception. The aim of this study was to validate and determine the reliability of the Turkish FAQLQ-PF and to assess QoL in food-allergic children.MethodsChildren aged between 0 and 12 years and diagnosed with immunoglobulin E (IgE)-mediated FA for at least 1 month were enrolled. The English FAQLQ-PF was translated into Turkish according to the World Health Organization guidelines. The Food Allergy Independent Measure and the Turkish Child Health Questionnaire-Parent Form 50 were used for construct validity.ResultsOne hundred and fifty-seven patients participated. The median age of patients and FA duration were 2.4 years (1.2–5.2 years, interquartile-ranges) and 2 years (0.8–5.1), respectively. Ninety-six (61.1%) patients had anaphylaxis. The Cronbach's alpha coefficient and intra-class correlation coefficient for test-retest reliability was good for all age groups of children (<4, 4–6, and 7–12 years). Patients with either asthma or anaphylaxis had worse scores than others. Total scores of FAQLQ-PF tended to increase with age. Patients aged 7–12 had the highest total scores among all patients (2.2±0.1, 3.0±0.2, and 3.3±0.3 for <4, 4–6, and 7–12 years, respectively, P<0.001, P for trend <0.001). Other factors causing the poor QoL were cow's milk allergy, sibling allergy, mother's age over 30 years, mother's high education level and lower number of persons in household.ConclusionsThe Turkish FAQLQ-PF is a valid and reliable scale. FA-related QoL was significantly worse with age. Coexistent asthma, anaphylaxis regardless of its severity, cow's milk allergy, sibling allergy and the older and educated mothers seem to poorly affect QoL.

Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy

Eliciting doses (EDs) of allergenic foods can be defined by the distribution of threshold doses for subjects within a specific population. The ED05 is the dose that elicits a reaction in 5% of allergic subjects. The predicted ED05 for peanut is 1.5mg of peanut protein (6mg of whole peanut). We sought to validate the predicted peanut ED05 (1.5mg) with a novel single-dose challenge. Consecutive eligible children with peanut allergy in 3 centers were prospectively invited to participate, irrespective of previous reaction severity. Predetermined criteria for objective reactions were used to identify ED05 single-dose reactors. Five hundred eighteen children (mean age, 6.8years) were eligible. No significant demographic or clinical differences were identified between 381 (74%) participants and 137 (26%) nonparticipants or between subjects recruited at each center. Three hundred seventy-eight children (206 male) completed the study. Almost half the group reported ignoring precautionary allergen labeling. Two hundred forty-five (65%) children experienced no reaction to the single dose of peanut. Sixty-seven (18%) children reported a subjective reaction without objective findings. Fifty-eight (15%) children experienced signs of a mild and transient nature that did not meet the predetermined criteria. Only 8 (2.1%; 95% CI, 0.6%-3.4%) subjects met the predetermined criteria for an objective and likely related event. No child experienced more than a mild reaction, 4 of the 8 received oral antihistamines only, and none received epinephrine. Food allergy-related quality of life improved from baseline to 1month after challenge regardless of outcome (η2=0.2, P<.0001). Peanut skin prick test responses and peanut- and Ara h 2-specific IgE levels were not associated with objective reactivity to peanut ED05. A single administration of 1.5mg of peanut protein elicited objective reactions in fewer than the predicted 5% of patients with peanut allergy. The novel single-dose oral food challenge appears clinically safe and patient acceptable, regardless of the outcome. It identifies the most highly dose-sensitive population with food allergy not otherwise identifiable by using routinely available peanut skin prick test responses or specific IgE levels, but this single-dose approach has not yet been validated for risk assessment of individual patients.

Differences in empowerment and quality of life among parents of children with food allergy

BackgroundLiving with food allergy has been found to adversely affect quality of life. Previous studies of the psychosocial impact of food allergy on caregivers have focused on mothers. ObjectiveTo describe differences in food allergy-related quality of life (FAQOL) and empowerment of mothers and fathers of a large cohort of children with food allergy. MethodsEight hundred seventy-six families of children with food allergy were studied. Food allergy was defined by stringent criteria, including reaction history, skin prick testing, and specific IgE. Parental empowerment and FAQOL were assessed by the adapted Family Empowerment and FAQOL—Parental Burden scales. Parental scores were compared by Wilcoxon signed rank test. Multiple regression models examined the association of parental empowerment with FAQOL. ResultsMothers reported greater empowerment (P < .001) and lower FAQOL (P < .001) compared with fathers, regardless of allergen severity, type, or comorbidities. However, parental empowerment was not significantly associated with FAQOL for mothers or fathers. Although parents of children with peanut, cow milk, egg, and tree nut allergies were similarly empowered, milk and egg allergies were associated with lower FAQOL (P < .01). Parental concern in the QOL assessment was greatest for items involving fear of allergen exposure outside the home. ConclusionParental empowerment and FAQOL vary significantly among mothers and fathers of children with food allergy. Greater effects on FAQOL were seen for milk and egg compared with other food allergies. Although parents of children with food allergy might be empowered to care for their child, they continue to experience impaired FAQOL owing to fears of allergen exposure beyond their control.

The effect of provision of an adrenaline autoinjector on quality of life in children with food allergy

Management of food allergy involves allergen avoidance and for some patients, provision of an adrenaline autoinjector (AAI). Food allergy is associated with a reduced quality of life.1 The type of food allergen, sex or age of subject, and number of foods allergic to have been reported to further impair food allergy-related quality of life (FAQOL).1,2 It is unclear whether the provision of an AAI affects FAQOL.

Highly accurate prediction of food challenge outcome using routinely available clinical data

Serum specific IgE or skin prick tests are less useful at levels below accepted decision points. We sought to develop and validate a model to predict food challenge outcome by using routinely collected data in a diverse sample of children considered suitable for food challenge. The proto-algorithm was generated by using a limited data set from 1 service (phase 1). We retrospectively applied, evaluated, and modified the initial model by using an extended data set in another center (phase 2). Finally, we prospectively validated the model in a blind study in a further group of children undergoing food challenge for peanut, milk, or egg in the second center (phase 3). Allergen-specific models were developed for peanut, egg, and milk. Phase 1 (N = 429) identified 5 clinical factors associated with diagnosis of food allergy by food challenge. In phase 2 (N = 289), we examined the predictive ability of 6 clinical factors: skin prick test, serum specific IgE, total IgE minus serum specific IgE, symptoms, sex, and age. In phase 3 (N = 70), 97% of cases were accurately predicted as positive and 94% as negative. Our model showed an advantage in clinical prediction compared with serum specific IgE only, skin prick test only, and serum specific IgE and skin prick test (92% accuracy vs 57%, and 81%, respectively). Our findings have implications for the improved delivery of food allergy-related health care, enhanced food allergy-related quality of life, and economized use of health service resources by decreasing the number of food challenges performed.

A questionnaire to measure quality of life in families with a food-allergic child

RATIONALE: There are no disease-specific instruments to measure food allergy-related quality of life. We developed an instrument to measure parental burden associated with having a food-allergic child: the Food Allergy Quality of Life - Parental Burden (FAQL-PB) questionnaire.