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.

Psychological support needs for children with food allergy and their families: A systematic review.

This systematic review aimed to review the evidence for psychological support for children with food allergies and their families, identify effective psychological interventions, and highlight the support needs for this group. A systematic search was undertaken across six databases (up to October 2023). Articles were checked by three reviewers for inclusion. Study data were extracted, and quality was assessed using the Mixed Methods Appraisal Tool. A narrative synthesis was undertaken. A total of 11 papers were included (n = 838 participants). Intervention types were based on cognitive behavioral therapy (CBT; n = 7); psycho-education (n = 1); peer mentoring (n = 1); self-regulation theory (n = 1); and coping (n = 1). Two interventions were for children only, three were for children and parents and six for parents only. Cognitive behavioral therapy-based interventions with highly anxious parents or children or those facilitated by a psychologist showed significant improvements with moderate-to-large effect sizes. The one self-help CBT-based online program showed no effects. Other intervention types reported mainly trends in improvement due to small sample sizes. Most interventions were aimed at supporting children or parents in day-to-day management of food allergy, measuring outcomes such as quality of life, self-efficacy, anxiety, worry, and depression. One intervention was designed to assist with oral immunotherapy outcomes. The majority of the studies had small sample sizes and were feasibility or proof-of-concept studies. Available research evidence points to effectiveness of facilitated CBT-based interventions for those that have high food allergy-related anxiety, but as many studies have small sample sizes and few report effect sizes, no firm conclusions can yet be drawn. A stepped care approach is likely to be useful for this population. Research using large interventional designs, particularly for children and adolescents, are needed.

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.

Peanut allergy impact on productivity and quality of life (PAPRIQUA): Caregiver-reported psychosocial impact of peanut allergy on children.

BACKGROUND: Limited research has examined the impact of peanut allergy (PA) on children using validated instruments to assess psychosocial burden and the factors influencing burden. OBJECTIVE: The PAPRIQUA study aimed to assess the caregiver-reported impact of living with PA on children's health-related quality of life (HRQL), correlations between PA severity and child's sex, and associations of caregivers' sex and anxiety with the proxy report of their child's HRQL and to identify significant predictors of a child's HRQL. METHODS: A cross-sectional survey of caregivers of children with mild, moderate and severe PA, based on caregiver perception, was conducted in the United Kingdom. Participants were recruited through a survey recruitment panel; a maximum quota of 20% who rated their child's PA as mild was set to ensure population diversity; however, the quota was not required as few participants considered their child's PA mild. The survey, funded by Aimmune Therapeutics, included sociodemographic and clinical questions, the EQ-5D-Y, Hospital Anxiety and Depression Scale, Food Allergy Quality of Life Questionnaire-Parent Form (FAQLQ-PF) and Food Allergy Independent Measure (FAIM). RESULTS: One hundred caregivers of children with PA (aged 4-15 years) completed the survey. Child's sex was not associated with proxy-reported burden. For younger children (aged 4-10 years), there was no effect of PA severity; parents of older children (aged 11-15 years) reported low to higher burden for their child on the EQ-5D-Y and FAQLQ-PF dependent upon PA severity. For all measures of child burden except the EQ-5D-Y, two or more reactions in the past 12 months and parental anxiety significantly predicted higher levels of burden for the child (P < .05-P < .001). Experiencing a life-threatening event in the past 12 months significantly predicted EQ-5D-Y proxy utility (P < .01). CONCLUSIONS AND CLINICAL RELEVANCE: Caregivers report that children with PA experience high levels of psychosocial burden, particularly those with more severe PA and a reaction history. Interventions to decrease caregiver anxiety and reaction frequency may help reduce the child's burden. Self-report studies in children with PA would help confirm these findings.

The effectiveness of interventions to improve self-management for adolescents and young adults with allergic conditions: A systematic review.

BACKGROUND: This systematic review aimed to review the literature on interventions for improving self-management and well-being in adolescents and young adults (11-25 years) with asthma and allergic conditions. METHODS: A systematic literature search was undertaken across eight databases. References were checked by two reviewers for inclusion. Study data were extracted, and their quality was assessed in duplicate. A narrative synthesis was undertaken. RESULTS: A total of 30 papers reporting data from 27 studies were included. Interventions types were psychological (k = 9); e-health (k = 8); educational (k = 4); peer-led (k = 5); breathing re-training (k = 1). All interventions were for asthma. Psychological interventions resulted in significant improvements in the intervention group compared with the control group for self-esteem, quality of life, self-efficacy, coping strategies, mood and asthma symptoms. E-Health interventions reported significant improvements for inhaler technique, adherence and quality of life. General educational interventions demonstrated significantly improved quality of life, management of asthma symptoms, controller medication use, increased use of a written management plan and reduction in symptoms. The peer-led interventions included the Triple A (Adolescent Asthma Action) programme and a peer-led camp based on the Power Breathing Programme. Improvements were found for self-efficacy, school absenteeism and quality of life. CONCLUSION: Although significant improvements were seen for all intervention types, many were small feasibility or pilot studies, few studies reported effect sizes and no studies for allergic conditions other than asthma met the inclusion criteria. Research using large longitudinal interventional designs across the range of allergic conditions is required to strengthen the evidence base.

Can we define a level of protection for allergic consumers that everyone can accept?

Substantial progress has been made in characterising the risk associated with exposure to allergens in food. However, absence of agreement on what risk is tolerable has made it difficult to set quantitative limits to manage that risk and protect allergic consumers effectively. This paper reviews scientific progress in the area and the diverse status of allergen management approaches and lack of common standards across different jurisdictions, including within the EU. This lack of regulation largely explains why allergic consumers find Precautionary Allergen Labelling confusing and cannot rely on it. We reviewed approaches to setting quantitative limits for a broad range of food safety hazards to identify the reasoning leading to their adoption. This revealed a diversity of approaches from pragmatic to risk-based, but we could not find clear evidence of the process leading to the decision on risk acceptability. We propose a framework built around the criteria suggested by Murphy and Gardoni (2008) for approaches to defining tolerable risks. Applying these criteria to food allergy, we concluded that sufficient knowledge exists to implement the framework, including sufficient expertise across the whole range of stakeholders to allow opinions to be heard and respected, and a consensus to be achieved.

"It's not an illness, it's just bad luck": The impact of anaphylaxis on quality of life in adults.

BACKGROUND: An increasing number of adults are being diagnosed with anaphylaxis, but its impact on health-related quality of life (HRQol) is not known. OBJECTIVE: The aim of this study was to explore the impact of anaphylaxis on HRQoL of newly diagnosed adults. METHODS: Interviews were conducted with 13 adults (aged 40-71; five males) with anaphylaxis (meeting WAO diagnostic criteria) to drugs, food, venom or spontaneous anaphylaxis, recruited using purposive sampling from allergy clinics in Birmingham, UK. Data were transcribed verbatim and analysed using thematic analysis. RESULTS: Four themes were generated from the analysis: the journey from fear to frustration; the need to maintain a healthy identity; control over uncertainty; and the supportive role of others. Participants described their first experiences of anaphylaxis as frightening. Managing the condition was associated with frustration and anxiety, in part due to uncertainty regarding when anaphylaxis might occur. Participants did not consider their allergy as an illness and wanted to retain an identity as a healthy person. They felt a strong need to have control over their anaphylaxis so that it did not take over their lives. The support from others was extremely important, but a lack of understanding of anaphylaxis sometimes hindered that support. CONCLUSIONS AND CLINICAL RELEVANCE: Anaphylaxis has an adverse impact on the HRQoL of adults irrespective of the cause. More information about anaphylaxis and its management from healthcare professionals may help patients gain a sense of control over their condition and reduce the worry and anxiety associated with it.

Parental self-efficacy in managing food allergy and mental health predicts food allergy-related quality of life.

BACKGROUND: Food allergy has been shown to have a significant impact on quality of life (QoL) and can be difficult to manage in order to avoid potentially life-threatening reactions. Parental self-efficacy (confidence) in managing food allergy for their child might explain variations in QoL. This study aimed to examine whether self-efficacy in parents of food allergic children was a good predictor of QoL of the family. METHODS: Parents of children with clinically diagnosed food allergy completed the Food Allergy Self-Efficacy Scale for Parents (FASE-P), the Food Allergy Quality of Life Parental Burden Scale (FAQL-PB), the GHQ-12 (to measure mental health) and the Food Allergy Independent Measure (FAIM), which measures perceived likelihood of a severe allergic reaction. RESULTS: A total of 434 parents took part. Greater parental QoL was significantly related to greater self-efficacy for food allergy management, better mental health, lower perceived likelihood of a severe reaction, older age in parent and child and fewer number of allergies (all p < 0.05). Food allergy self-efficacy explained more of the variance in QoL than any other variable and self-efficacy related to management of social activities and precaution and prevention of an allergic reaction appeared to be the most important aspects. CONCLUSIONS: Parental self-efficacy in management of a child's food allergy is important and is associated with better parental QoL. It would be useful to measure self-efficacy at visits to allergy clinic in order to focus support; interventions to improve self-efficacy in parents of food allergic children should be explored.

Impact of suspected food allergy on emotional distress and family life of parents prior to allergy diagnosis.

BACKGROUND: Food allergy is associated with psychological distress in both child and parent. It is unknown whether parental distress is present prior to clinical diagnosis or whether experiences at clinic can reduce any distress present. This study aimed to assess anxiety and depression in parents and the impact of suspected food allergy on the lives of families before and after a visit to an allergy clinic. METHODS: One hundred and twenty-four parents visiting an allergy clinic for the first time to have their child assessed for food allergy completed a study-specific questionnaire and the Hospital Anxiety and Depression Scale; 50 parents completed these 4-6 wk later in their own home. RESULTS: Most parents (86.4%) reported suspected food allergy had an impact on their family life prior to clinic attendance; 76% had made changes to their child's diet. 32.5% of parents had mild-to-severe anxiety before their clinic visit; 17.5% had mild-to-moderate depression. Post-clinic, 40% had mild-to-severe anxiety; 13.1% had mild-to-moderate depression. There were no significant differences in anxiety (p = 0.34) or depression scores (p = 0.09) before and after the clinic visit. CONCLUSIONS: Anxiety and depression is present in a small proportion of parents prior to diagnosis of food allergy in their child and this does not reduce in the short term after the clinic visit. Identification of parents at risk of suffering from distress is needed and ways in which we communicate allergy information before and at clinic should be investigated to see if we can reduce distress.

The psychosocial impact of an activity holiday for young children with severe food allergy: a longitudinal study.

BACKGROUND: Food allergy has been shown to severely affect quality of life (QoL) in children and their families. The Anaphylaxis Campaign U.K. supports families with allergic children and as part of that support ran an activity holiday for those with food allergy. This study investigated the effectiveness of this activity holiday for reducing anxiety and improving QoL and food allergy management for these children. METHODS: Measures were taken at baseline, at the start of the activity holiday, at the end of the holiday, at 3 and 6 months follow-up. Children (n = 24) completed a paediatric food allergy-specific QoL questionnaire (PFA-QL), a generic QoL questionnaire (PedsQL, the Spence Children's Anxiety Scale (SCAS) and the children's health locus of control (CHLC) scale at all stages of the study. RESULTS: There were significant improvements in social QoL, food allergy-specific QoL, total CHLC and internal locus of control scores over time (p > 0.05). There were significant decreases in powerful others locus of control, total anxiety and obsessive compulsive disorder scores (p < 0.05). Greater anxiety significantly correlated with poorer QoL at all time points; no correlations with locus of control were significant at the 3- and 6-month follow-up. CONCLUSIONS: The activity holiday was of significant benefit to the children who took part, providing support for the need for activity holidays such as this for children with severe food allergy. Ways in which adaptive locus of control and improved quality of life can be facilitated need to be further explored.

Validation of the Paediatric Food Allergy Quality of Life Questionnaire (PFA-QL).

BACKGROUND: The Paediatric Food Allergy Quality of Life Questionnaire (PFA-QL) was the first tool to be developed for assessing health-related quality of life (QoL) in children with food allergy. It has been used in a number of published studies, but has not been validated. OBJECTIVE: The aim of the current study was to validate child (PFA-QL) and parent-proxy (PFA-QL-PF) versions of the scale in a specialist allergy clinic and in parents of children with food allergy. METHODS: For the clinic sample, a generic QoL scale (PedsQL) and the PFA-QL were completed by 103 children (age 6-16 yrs) with peanut or tree nut allergy; test-retest reliability of the PFA-QL was tested in 50 stable patients. For the non-clinical sample, 756 parents of food allergic children completed the PFA-QL-PF, the Child Health Questionnaire (CHQ-PF50), Food Allergy Quality of Life Parental Burden Scale (FAQL-PB) and a Food Allergy Impact Measure. RESULTS: The PFA-QL and PFA-QL-PF had good internal consistency (α's of 0.77-0.82), and there was moderate-to-good agreement between the generic- and disease-specific questionnaires. The PFA-QL was stable over time in the clinic sample, and in both samples, girls were reported to have poorer QoL than boys. CONCLUSIONS: The PFA-QL and PFA-QL-PF are reliable and valid scales for use in both clinical and non-clinical populations. Unlike other available tools, they were developed and validated in the UK and thus provide a culture-specific choice for research, clinical trials and clinical practice in the UK. Validation in other countries is now needed.

Validation of the Food Allergy Quality of Life-Parental Burden Questionnaire in the UK.

PURPOSE: Food allergy can have a profound effect on quality of life (QoL) of the family. The Food Allergy Quality of Life-Parental Burden Questionnaire (FAQL-PB) was developed on a US sample to assess the QoL of parents with food allergic children. The aim of this study was to examine the reliability and validity of the FAQL-PB in a UK sample and to assess the effect of asking about parental burden in the last week compared with parental burden in general, with no time limit for recall given. METHODS: A total of 1,200 parents who had at least one child with food allergy were sent the FAQL-PB and the Child Health Questionnaire (CHQ-PF50); of whom only 63% responded. RESULTS: Factor analysis of the FAQL-PB revealed two factors: limitations on life and emotional distress. The total scale and the two sub-scales had high internal reliability (all α > 0.85). There were small to moderate but significant correlations between total FAQL-PB scores and health and parental impact measures on the CHQ-PF50 (p < 0.01). Significantly greater parental burden was reported for the no-time limited compared with the time-limited version (p < 0.01). CONCLUSIONS: The FAQL-PB is a reliable and valid measure for use in the UK. The scale could be used in clinic to assess the physical and emotional quality of life in addition to the impact on total quality of life.

Prospective Analysis of the Temporal Relationship between Psychological Distress and Atopic Dermatitis in Female Adults: A Preliminary Study.

Atopic dermatitis (AD) has been associated with psychological distress, but few studies have examined the causal relationships. This study aimed to investigate whether stress, anxiety, or depression could lead to an increase in AD severity or vice versa in adults using a longitudinal study design. Daily diaries measuring psychological stress were completed over four weeks; validated questionnaires measuring stress, anxiety, depression, and AD severity were completed weekly for twelve weeks. Thirty-six participants (all female, aged 18-46 years) were recruited; complete data were returned from 19. Stress and disease severity were significantly correlated when measured daily and weekly for the duration of the study. Cross-lagged panel model (CLPM) analyses identified that for the weekly measures, stress, anxiety, and depression on week X significantly predicted disease severity on week X + 1. Disease severity on week X also predicted psychological stress, anxiety and depression on week X + 1 for the majority of the twelve weeks. There appears to be a bi-directional relationship between stress, anxiety and depression, and AD severity in women. High levels of distress should be identified so that optimum management strategies can be implemented to reduce the risk of increased AD severity and the resulting impact severity might have on psychological wellbeing.

Beliefs about food allergies in adolescents aged 11-19 years: A systematic review.

Aims: Research suggests of people with food allergy (FA), adolescents have the highest risk of fatal allergic reactions to food, yet understanding of this population and how they manage their condition is limited. Understanding beliefs and how they affect behaviour could inform ways to reduce risk taking behaviour and fatal reactions in adolescents. This systematic review aimed to explore beliefs adolescents hold about their FA, and how these may be associated with FA management. Demographics: Adolescents aged 11-19 years with FA. Methodology: A systematic search of seven databases was conducted. Papers of any design were included that reported on the beliefs about FA in adolescents aged 11-19 years. Data was systemised by narrative thematic analysis. Findings: 20 studies were included. Themes included navigating FA in different environments, carriage and use of adrenaline auto-injectors, management of the risk of anaphylaxis, behaviour and understanding of others, and food-allergic identity. Implications: Adolescents with FA hold a variety of condition beliefs; some beliefs were related to behaviour that could lead to an allergic reaction, while other beliefs were related to protective behaviours. Further research into understanding adolescent beliefs in order to inform clinical management and reduce the risk of potential fatal reactions is essential.