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.

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.

Development and Validation of the Anaphylaxis Quality of Life Scale for Adults.

BACKGROUND: Anaphylaxis is a severe and potentially life-threatening allergic reaction that can have a detrimental impact on quality of life (QoL). There are no validated scales to measure the impact of anaphylaxis on QoL of adults. OBJECTIVE: The aim of this study was to develop and assess the reliability and validity of a QoL scale for adults with anaphylaxis (Anaphylaxis Quality of Life Scale for Adults [A-QoL-Adults]). METHODS: All participants were recruited from a specialist allergy clinic and had a confirmed diagnosis of anaphylaxis (as per the World Allergy Organization diagnostic criteria) to food, drugs, venom, or latex or had spontaneous anaphylaxis. Interviews were conducted with 13 adults; data were analyzed using thematic analysis to extract items for a QoL scale. A prototype QoL scale was then completed by 115 participants alongside validated scales to measure generic QoL (World Health Organization Quality of Life Scale [Brief Version] [WHOQoL BREF]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), and stress (Perceived Stress Scale [PSS]). RESULTS: The A-QoL-Adults scale has 21 items demonstrating excellent internal reliability (Cronbach α = 0.96). Factor analysis produced 3 subscales: Emotional Impact; Social Impact; and Limitations on Life. Each has excellent internal reliability (0.92, 0.92, and 0.91, respectively). Poorer anaphylaxis-related QoL (total A-QoL-Adults score and subscale scores) correlated significantly with poorer general QoL and greater anxiety, depression, and stress (all P < .01 with medium-to-large effect sizes). CONCLUSIONS: The A-QoL-Adults scale is a reliable measure of QoL in adults with anaphylaxis and shows good construct validity. It will offer health care professionals a means to further understand the impact of anaphylaxis on adult patients and could help direct and monitor allergy management and the need for further psychological intervention.

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.

Current transition management of adolescents and young adults with allergy and asthma: a European survey.

BACKGROUND: Transition from parent-delivered to self-management is a vulnerable time for adolescents and young adults (AYA) with allergy and asthma. There is currently no European guideline available for healthcare professionals (HCPs) on transition of these patients and local/national protocols are also mostly lacking. METHODS: European HCPs working with AYA with allergy and asthma were invited to complete an online survey assessing challenges of working with these patients, current transition practices and access to specific healthcare resources. RESULTS: A total of 1179 responses from 41 European countries were collected. Most HCPs (86%) reported a lack of a transition guideline and a lack of a transition process (20% paediatric HCPs, 50% of adult HCPs, 56% HCP seeing all ages). Nearly half (48%) acknowledged a lack of an established feedback system between paediatric and adult medical services. Many respondents never routinely asked about mental health issues such as self-harm or depression and are not confident in asking about self-harm (66.6%), sexuality (64%) and depression (43.6%). The majority of HCPs (76%) had not received specific training in the care of AYA although 87% agreed that transition was important for AYA with allergy and asthma. CONCLUSION: Although there was agreement that transition is important for AYA with allergy and asthma, there are crucial limitations and variations in the current provision of transition services across Europe. Standardisation of AYA management and specific training are required. This should improve management and continuity of care during adolescence and into adulthood to achieve the best healthcare outcomes.

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.

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.

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.

Impact of atopic dermatitis on quality of life in adults: a systematic review and meta-analysis.

Atopic dermatitis (AD) can affect quality of life (QoL) of adult patients in whom the condition can be severe and persistent. There are currently no systematic reviews of the impact of AD on adults. This paper provides the first systematic literature review and meta-analysis of the impact of AD on QoL in adults. A systematic search was conducted using MEDLINE, Scopus, and Web of Science for articles published until October 2018. Inclusion criteria were a clinical diagnosis of AD, adult patients, and QoL as an outcome measure. Interventions were excluded. A total of 32 studies were included. While QoL was assessed using Dermatology Life Quality Index (DLQI) in 25 studies, there was heterogeneity in the tools used to measure disease severity across studies. Meta-analysis of the seven studies that used the SCORAD to measure disease severity showed severity to be significantly related to poorer QoL. The remaining 18 studies also showed increased disease severity significantly related to poorer QoL. When compared to healthy controls, AD patients demonstrated significantly lower QoL, but findings were mixed in studies that compared QoL in AD to other skin conditions. The findings highlight the significant impact that AD has on QoL in adults and the need for validated and relevant QoL measures to be implemented in clinical assessments for AD. Areas that require further research include an exploration of gender differences in QoL and the use of longitudinal study designs to explore factors that may cause differences in QoL ratings.

"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.

The Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL): Development and preliminary validation.

Polycystic ovary syndrome is an endocrine disorder amongst women, which can negatively impact quality of life. Research proposes that a more sensitive PCOS quality of life measure is needed. This study aims to develop and initially validate a quality of life scale for women with the condition in the United Kingdom. Women with PCOS (n = 714) took part in the development and initial validation of the 35-item polycystic ovary syndrome quality of life scale (PCOSQOL)(α = .95). Subscales include Impact of PCOS (α = .95), Infertility (α = .95), Hirsutism (α = .97) and Mood (α = .89). The PCOSQOL scale represents aspects of quality of life important to women with PCOS and may be more sensitive for use in the clinical and research settings.

Anaphylaxis and Clinical Utility of Real-World Measurement of Acute Serum Tryptase in UK Emergency Departments.

BACKGROUND: British guidelines recommend that serial acute serum tryptase measurements be checked in all adults and a subset of children presenting with anaphylaxis. This is the first study reporting the clinical utility of acute serum tryptase in a "real-world" emergency department (ED) setting following the publication of the World Allergy Organization (WAO) criteria for anaphylaxis. OBJECTIVES: To (1) assess sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of acute serum tryptase in anaphylaxis; (b) determine factors associated with higher acute serum tryptase levels; and (c) audit compliance of acute serum tryptase measurement in the ED. METHODS: The methods used were retrospective electronic search for ED admissions to 3 acute care hospitals in Birmingham, UK, with anaphylaxis in 2012 using wide search terms followed by scrutiny of electronic clinical records and application of the WAO diagnostic criteria for anaphylaxis. Patients with an acute serum tryptase measurement were included in the analysis. RESULTS: Acute serum tryptase level was measured in 141 of 426 (33.1%) cases. Mean time from the onset of symptoms to the measurement of acute serum tryptase level was 4 hours 42 minutes (SD ± 05:03 hours) and no patients had serial measurements conforming to British guidelines. Acute serum tryptase level of more than 12.4 ng/mL (75th centile) was associated with a sensitivity, specificity, PPV, and NPV of 28%, 88%, 0.93, and 0.17, respectively. Multiple regression analysis showed that male sex (odds ratio, 2.66; P = .003) and hypotension (odds ratio, 7.08; P = .001) predicted higher acute serum tryptase level. CONCLUSIONS: An acute serum tryptase level of more than 12.4 ng/mL in an ED setting carries high PPV and specificity, but poor sensitivity and NPV.