Core Outcome Set for IgE-mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study 'COMFA'.

BACKGROUND: IgE-mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. METHODS: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two-round online-modified Delphi process followed by hybrid consensus meeting to finalize the COS. RESULTS: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in-person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, 'allergic symptoms' and 'quality of life' achieved consensus for inclusion as 'core' outcomes. CONCLUSION: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes.

The evolution of food protein-induced enterocolitis syndrome: From a diagnosis that did not exist to a condition in need of answers.

OBJECTIVE: Although food protein-induced enterocolitis syndrome (FPIES) was first described approximately 50 years ago and research is increasing, there are still considerable unmet needs in FPIES. This article catalogs the areas of progress and areas for further research. DATA SOURCES: Through our personal experiences in caring for patients with FPIES, our personal research, and a review of the existing FPIES literature as indexed in PubMed, we explored what is known and what is needed in FPIES. STUDY SELECTIONS: The studies that have improved the knowledge of FPIES, defined phenotypes, allowed for better-informed management of FPIES, and laid the groundwork for further research. RESULTS: Further research is needed in the areas of prevalence, natural history, trigger foods, threshold doses, how and when to perform oral food challenges, and immunopathogenesis of this disorder. Development of a biomarker and determination of the best method to treat reactions is also needed. Furthermore, FPIES has a substantial psychosocial and economic impact on families, and more research is needed in developing and implementing ameliorating strategies. CONCLUSION: By partnering together, health care providers, advocacy organizations, and families can continue to advance our understanding and improve the care of patients and families living with FPIES.

International consensus guidelines for the diagnosis and management of food protein-induced enterocolitis syndrome: Executive summary-Workgroup Report of the Adverse Reactions to Foods Committee, American Academy of Allergy, Asthma & Immunology.

Food protein-induced enterocolitis (FPIES) is a non-IgE cell- mediated food allergy that can be severe and lead to shock. Despite the potential seriousness of reactions, awareness of FPIES is low; high-quality studies providing insight into the pathophysiology, diagnosis, and management are lacking; and clinical outcomes are poorly established. This consensus document is the result of work done by an international workgroup convened through the Adverse Reactions to Foods Committee of the American Academy of Allergy, Asthma & Immunology and the International FPIES Association advocacy group. These are the first international evidence-based guidelines to improve the diagnosis and management of patients with FPIES. Research on prevalence, pathophysiology, diagnostic markers, and future treatments is necessary to improve the care of patients with FPIES. These guidelines will be updated periodically as more evidence becomes available.

Delayed presentation of food protein-induced enterocolitis syndrome (FPIES) to okra in a toddler.

BACKGROUND: Food protein-induced enterocolitis syndrome (FPIES) is a non-immunoglobulin E (IgE) -mediated food allergy predominantly observed in infants and characterized by the delayed onset of vomiting following ingestion of a trigger food. An increase in research and clinical consideration of FPIES has led to the discovery of unique deviations from the standard FPIES triggers and presentations. CASE PRESENTATION: A 34-month-old female patient with a history of consuming okra daily presented to medical attention after developing classic FPIES symptoms to okra beginning at 14-months of age. CONCLUSIONS: Recently, awareness about the varied nature of FPIES clinical presentation has come to light. This case is the first to describe FPIES to the fruit okra that developed over a 12-month time span after previously tolerating the food. This case serves to emphasize the importance of understanding the range of FPIES symptoms to improve recognition and expedite best practice recommendations.

When Supplemental Formula Is Essential: Overcoming Barriers to Hypoallergenic Formula Access for Patients With Food Allergies.

For food-allergic patients, hypoallergenic formulas (HFs) are medically indicated, often a primary component of the diet and essential for patient safety, health, nutrition, and overall well-being. Yet, food allergy is not included among the conditions mandated for coverage under federal health programs and private health insurance. The 2022 infant formula crisis has affected many North American families and has particularly influenced patients with food allergies who rely on a limited number of safe HF brands to safely meet their nutritional needs for growth and development. The current formula shortage further highlights the longstanding difficulties faced by families with food allergies in accessing HF. Within this context, this article focuses on chronic barriers faced by patients with food allergies in accessing HF and proposes potential solutions. Legislation is desperately needed to address HF affordability through changes in insurance reimbursement and disparities in access to HF among individuals with food allergy.

The Psychosocial Impact of Food Protein-Induced Enterocolitis Syndrome.

BACKGROUND: Little is known about the psychosocial impact of food protein-induced enterocolitis syndrome (FPIES). OBJECTIVE: To characterize quality of life, stress, worry, anxiety, and self-efficacy in caregivers of children with FPIES and affected children, and determine risk factors for increased psychosocial burden. METHODS: Surveys completed by caregiver-members of the International FPIES Association at a conference (n = 42) and online (n = 368) were analyzed. RESULTS: There was significant burden, stress, worry, and anxiety among caregivers. There was a positive correlation among Food Allergy Quality of Life-Parental Burden, Perceived Stress Scale-10, Penn State Worry Questionnaire, and Beck Anxiety Inventory scores, and these were negatively associated with Food Allergy Self-Efficacy for Parents (FASE-P) scores. Lower income was associated with poorer caregiver health-related quality of life (HRQoL) (P = .039) and lower FASE-P (P = .028). Greater number of food groups avoided correlated moderately with poorer HRQoL (r = 0.386; P < .001), higher anxiety among preschoolers (r = 0.262; P = .013) and parents (r = 0.594, P = .025). Avoiding cow's milk due to FPIES was associated with poorer caregiver HRQoL (P < .001), higher stress (P = .001), and lower FASE-P (P = .013). Caregivers whose child was not attending daycare/school due to FPIES had poorer HRQoL (P < .001), higher stress (P < .014), and worry (P = .004). Compared with published cohorts of caregivers of children with IgE-mediated food allergy, the burden of FPIES on caregivers was significantly higher (mean = 3.4 vs 3.0; P < .001) and self-efficacy was significantly lower (mean = 63.9 vs 76.1; P < .001). CONCLUSIONS: There is increased stress, worry, anxiety, and reduced HRQoL and self-efficacy among caregivers of children with FPIES and increased general anxiety among preschoolers. Additional research is needed to inform effective psychosocial interventions.

Food protein-induced enterocolitis syndrome from the parent perspective.

PURPOSE OF REVIEW: To describe the obstacles that parents face when caring for a child with food protein-induced enterocolitis syndrome (FPIES) and discuss initiatives of key importance to the FPIES community. RECENT FINDINGS: Findings from a previous survey indicate that 80% of pediatricians have little or no knowledge of FPIES, suggesting that awareness is severely lacking among frontline providers. A preliminary study also indicates that the condition can have a profound effect on quality of life for patients and families. SUMMARY: FPIES is a rare but growing condition that poses significant personal and familial challenges for parents before and after diagnosis. Increased efforts from the medical community are needed to raise awareness among medical providers, establish improved criteria and guidelines for diagnosis and management, increase understanding through research, and offer parent information and support at every stage.