Food Allergy Quality Of Life Questionnaires Research Articles

Online, group, low-intensity psychological intervention for adults, children, and parents with food allergy

BackgroundFood allergy (FA) impairs psychological wellbeing because of constant vigilance, planning and preparation, dietary and social restrictions, and fear of accidental ingestion, though psychological interventions are sparse. ObjectiveTo examine online, group, low-intensity psychological interventions for adults, children, young people (CYP), and parents with food allergies. MethodsThe randomized controlled trials assessed the feasibility and signal of the efficacy of a psychological intervention for adults, CYP, and parents with FA. Participants were randomized to receive the psychological intervention or treatment as usual. The intervention consisted of two, 3-hour manualized online sessions spaced 1 week apart. All participants completed relevant Food Allergy Quality of Life Questionnaires (FAQLQ) and worry (Penn State Worry Questionnaires), in addition to exploratory outcomes, at baseline, 1 month, and 3 months. ResultsA total of 129 participants (n = 44 adults, n = 52 CYP, and n = 33 parents) were recruited and randomized; 95 (74%) (n = 36 adults, n = 35 CYP, and n = 24 parents) were retained at 3 months. Owing to baseline differences, mean change was used for parent and CYP outcomes. The psychological intervention demonstrated large FAQLQ benefits across adults (g = −1.12, 95% CI −0.41 to −1.28), CYP (g = 1.23, 95% CI 0.51-1.95), and parents (g = 1.43, 95% CI 0.54-2.30) compared with controls at 3-months. ConclusionThis study provides encouraging findings regarding the feasibility of online, group, low-intensity psychological interventions, in terms of recruitment and retention as well as a signal of efficacy on FAQLQ. A definitive trial including health economic analysis and FA-specific psychological measures with consideration of best routes to implementation, is warranted. Trial RegistrationClinicaltrials.gov Identifiers: NCT04763889 (adults), NCT04770727 (CYP), and NCT04774796 (parents).

The Short Food Allergy Quality of Life Questionnaire (FAQLQ-12) for Adults

The Food Allergy Quality of Life Questionnaire (FAQLQ) is the most widely used measure to assess health-related quality of life in food allergy (FA). However, its length can lead to a series of disadvantages, such as reduced or incomplete participation and boredom and disengagement, affecting data quality, reliability, and validity. In the present research, we shortened the well-known FAQLQ for adults, and proposed the FAQLQ-12. We applied gold-standard statistical analyses, mixing classic test theory and item response theory (IRT) to identify relevant items for the new short form, and confirm its structure fit and reliability. More specifically, discrimination, difficulty, and information levels (IRT), confirmatory factor analysis, Pearson's correlations, and reliability analysis (McDonald's omega and Cronbach's alpha). We chose the items with the highest discrimination values to compose the shortened FAQLQ, as they were among the ones with the best difficulty levels and the highest amount of individual information. We retained three items per factor, as this number allows for acceptable reliability levels, resulting in twelve items. The FAQLQ-12 presented a better model fit in comparison to the complete version. The correlation patterns and reliability levels were similar for both 29 and 12-versions. Although the full version of the FAQLQ remains a gold-standard measure to assess food allergy quality of life, the FAQLQ-12 is introduced as a powerful and beneficial alternative. It can help participants, researchers, and clinicians in specific settings, such as dealing with time and budget limitations, and providing high-quality and reliable responses.

Children and caregiver proxy quality of life from peanut oral immunotherapy trials.

Health-related quality of life (HRQoL) is significantly and substantially reduced in individuals with peanut allergy due to many factors associated with unanticipated or potentially fatal reactions. Further insight on the impact of peanut oral immunotherapy in managing peanut allergy on HRQoL is needed. The aim of this analysis was to assess effects of peanut (Arachis hypogaea) allergen powder-dnfp (PTAH), a biologic drug for peanut oral immunotherapy, on HRQoL from three phase 3 and two follow-on trials of PTAH. HRQoL assessments from participants aged 4-17 in the PALISADE (ARC003), ARC004 (PALISADE follow-on), ARTEMIS (ARC010), RAMSES (ARC007), and ARC011 (RAMSES follow-on) trials were included in this analysis. Responses on the Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM) were evaluated by age group and respondent (self or caregiver proxy). Data were analyzed with descriptive statistics and Student t tests. Baseline FAQLQ and FAIM total scores appeared comparable between PTAH- and placebo-treated participants. Self and caregiver proxy-reported total scores on the FAQLQ for PTAH-treated participants generally improved at trial exit versus baseline; FAIM total scores improved throughout all trials. The tendency for improvement in FAQLQ total scores from baseline for PTAH appeared larger in self versus caregiver proxy-reports. Between treatment groups, PTAH was generally favored in the PALISADE and ARTEMIS trials; differences varied in the RAMSES trial based on age and respondent types. PTAH for the management of peanut allergy in children appeared to have a beneficial effect on HRQoL in trials. Improvements were seen despite rigors of trial participation.

HEALTH-RELATED QUALITY OF LIFE IN CHILDREN AND CAREGIVER PROXIES FROM TRIALS OF PEANUT ORAL IMMUNOTHERAPY

<h3>Introduction</h3> We assessed health-related quality of life (HRQoL) of pediatric participants across phase 3 and follow-on trials for peanut (<i>Arachis hypogaea</i>) allergen powder-dnfp (PTAH). <h3>Methods</h3> HRQoL data were analyzed from PALISADE (ARC003), ARC004 (PALISADE follow-on; daily dosing cohorts), ARTEMIS (ARC010), RAMSES (ARC007), and ARC011 (RAMSES follow-on) using the Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM). Assessments were completed by caregiver proxies of participants aged 4-17 years and participants aged 8-17 years at prespecified time points. Scores were summarized descriptively, and mean changes were reported for between groups (PTAH vs placebo) and within groups (PTAH only) from the screening to exit visit. <h3>Results</h3> Baseline FAQLQ and FAIM mean total scores appeared comparable between placebo- and PTAH-treated participants. Self- and caregiver proxy-reported total scores on the FAQLQ and FAIM for PTAH-treated participants generally improved over time from baseline to exit throughout all trials (<b>Table</b>). PTAH was generally favored in PALISADE and ARTEMIS versus placebo. PTAH-treated participants reported statistically significant changes in scores for self-reported responses (mean change) versus placebo for domains relating to allergy avoidance and dietary restrictions (-1.46 for ages 8-12, ARTEMIS) and risk of accidental exposure (-1.44 for ages 8-12, ARTEMIS) on the FAQLQ, and death (-0.91 for ages 8-12, PALISADE; -1.29 for ages 13-17; ARTEMIS) and severe reaction (-0.77 for ages 8-12, RAMSES; -1.57 for ages 13-17, ARTEMIS) on the FAIM. <h3>Conclusion</h3> PTAH for peanut allergy management appeared to be associated with an improvement in reported HRQoL in children.

IMPACT OF INTRODUCING SUBGROUPS OF TREE NUTS VERSUS COMPLETE AVOIDANCE ON QUALITY OF LIFE

<h3>Introduction</h3> Tree nut allergies can impact quality of life (QoL) of children and their caregivers. Many patients are only allergic to a subgroup of tree nuts and may be cleared to eat other tree nuts. However, data on the QoL impact of introducing limited subgroups of tree nuts versus complete avoidance is sparse. <h3>Methods</h3> This longitudinal observational prospective study evaluated change in QoL score in tree nut allergic patients at baseline while avoiding all tree nuts, versus after successful oral food challenge (OFC) for individual tree nut subgroups. Pediatric patients and their caregivers were given the Food Allergy Quality of Life Questionnaire (FAQLQ) before and one month after OFC. 27 patients were enrolled, with 7 who completed both baseline and post-challenge FAQLQ. Higher score indicates worse QoL. <h3>Results</h3> Of the children that underwent tree nut challenge, the mean parent or teen FAQLQ score at baseline and post-challenge was 1.51 and 1.56, respectively. Some families declined individual tree nut challenge. Characteristics of these patients versus those who proceeded with OFC were examined. There were no statistical differences in parental FAQLQ, race, health insurance, history of tree nut reaction, comorbid peanut allergy, comorbid asthma, or comorbid eczema. Those who proceeded with OFC had a significantly higher rate of comorbid allergic rhinitis versus those who declined <h3>Conclusion</h3> Quality of life did not significantly improve after patients were cleared of a single tree nut subgroup allergy label. Shared decision making with patients and guardians should be employed when deciding on tree nut subgroup challenges.

IMPACT OF EARLY BAKED EGG CHALLENGE ON LIFE QUALITY IN EGG-ALLERGIC PATIENTS VERSUS EGG AVOIDANCE

<h3>Introduction</h3> This study aims to evaluate the outcomes and impact of a flexible-dose early baked egg challenge on the quality of life for egg-allergic pediatric patients and their caregivers versus those who practice strict egg avoidance. <h3>Methods</h3> Patients were screened via chart review to determine eligibility and were enrolled during clinic visits and via phone call. Enrolled patients and caregivers provided written consent and completed a validated disease-specific health-related quality of life questionnaire, the Food Allergy Quality of Life Questionnaire (FAQLQ). The questionnaire evaluated the emotional impact of allergy, food anxiety, as well as social and dietary limitations. <h3>Results</h3> Twenty-six patients were included in the study (15 male, 11 female). Twenty-five patients were six years or younger, with one greater than eight years old. Twelve patients underwent a baked egg challenge versus fourteen who practiced complete egg avoidance. Patients were challenged to a baked egg recipe of the families' choice based on skin testing with the foods. Analysis of the two-sample t-test determined that patients who practice strict egg avoidance had higher FAQLQ scores compared to patients who have incorporated baked egg into their diet. The mean FAQLQ-PF score for egg avoidant patients was found to be 2.808 (SD 1.570) compared to 1.413 (SD 1.072) for baked egg tolerant patients (p=0.014). <h3>Conclusion</h3> Strict egg avoidance demonstrated a greater impairment in quality of life than those who have undergone a baked egg challenge and continue to incorporate baked egg into their diet.

Validation of the food allergy quality of life questionnaire series in Chinese families with food-allergic children.

Anxiety from accidental exposure and vigilant dietary monitoring impair the quality of life (QoL) of food-allergic patients. A comprehensive food allergy-specific questionnaire allows patients to accurately report their QoL. This study validated the Food Allergy Quality of Life Questionnaire (FAQLQ) series and assessed the QoL of Chinese food-allergic patients and their caregivers. FAQLQ series developed by EuroPrevall consists of four separate questionnaires for parents, children, adolescents and adults. All questionnaires were translated into traditional Chinese by standard forward and backward methods. A cross-sectional study was conducted on food-allergic patients and children's parents using an age-appropriate questionnaire. The performance indices of FAQLQ and their correlation with independent measures of food allergy were analyzed, and factor analysis was performed to confirm the factor structure of FAQLQ questionnaires. Cross-sectional validation was performed on 214 participants, with 40 reassessed for test-retest reliability. Overall scores for the FAQLQ series had good internal consistency with Cronbach's α ≥.90. Good construct validity was demonstrated by correlations between FAQLQ-Parent Form, FAQLQ-Child Form, FAQLQ-Teenager Form, FAQLQ-Adult Form and Food Allergy Independent Measure (FAIM) scores, except in 0- to 3-year-old children. Test-retest analyses revealed a significant correlation between total FAQLQ score, parent-reported FAIM and food anxiety domain in 4-6 years, and between total score and FAIM in 7-12 years. Exploratory factor analysis categorized items in the FAQLQ series into three to four domains. FAQLQ series provide a valid and reliable measure for QoL in Chinese food-allergic patients and caregivers, except for parents of children aged 0-3 years. Items for all FAQLQ questionnaires are categorized into different functional domains in our population.

Improvements in Quality of Life in Children Following Epicutaneous Immunotherapy (EPIT) for Peanut Allergy in PEPITES and PEOPLE Studies

Peanut allergy is associated with impaired food allergy quality of life (FAQL). Food allergy quality of life questionnaires (FAQLQs) are used to provide insight into the burdens associated with food allergy and may be used as an outcome measure instrument. In the current study, researchers examined FAQL changes after treatment with epicutaneous immunotherapy (EPIT) for peanut allergy.Data from children between the ages of 4 to 11 years who completed 12 months of therapy during the phase 3 Peanut EPIT Efficacy and Safety Study (PEPITES) and the first 12 months of the follow-on open-label extension study PEPITES Open-Label Extension Study (PEOPLE) were included in this study. PEPITES was a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of the epicutaneous peanut patch (DBV712 250μg) in 356 children. Enrolled patients had physician-diagnosed peanut allergy and reacted to ≤300 mg of peanut protein on entry double-blind placebo-controlled food challenge (DBPCFC). Participants were randomly assigned 2:1 to receive a DBV712 250μg epicutaneous peanut patch or placebo patch daily for 12 months. The PEOPLE study is designed to evaluate the long-term safety, tolerability, and efficacy of DBV712 250 μg for up to 5 years of treatment. A total of 298 children enrolled in the PEOPLE study.FAQL was prospectively measured at baseline, month 12 (before DBPCFC, with treatment allocation blinded), and month 24 (before DBPCFC for children initially randomly assigned to placebo, with treatment unblinded) by using the Food Allergy Quality of Life Questionnaire Parent Proxy Form (FAQLQ-PF) for children aged ≤12 years, and the Food Allergy Quality of Life Questionnaire Child Form (FAQLQ-CF) for children aged ≥8 years. FAQL assessments were assessed by analysis of covariance, according to between-group and in-group differences by longitudinal controlled repeated-measure analysis. FAQL assessments were also analyzed post hoc by linear regression analysis by using changes in mean and domain-specific FAQLQ-PF and FAQLQ-CF scores from baseline to month 24 as the dependent variable and treatment group and month 12 FAQLQ assessments as independent variables.FAQLQs were analyzed from placebo (FAQLQ-PF: 96; FAQLQ-CF: 47) and treatment participants (FAQLQ-PF: 209; FAQLQ-CF: 105). At 24 months, global FAQL scores were significantly improved in the treatment group (least squares mean [LSM]: 0.34 [P = .008] and 0.46 [P = .023]). At 24 months, there were significant FAQLQ-PF score improvements in patients initially randomly assigned to treatment who met the efficacy primary end point (n = 74; LSM: 0.55 [P < .001]) and in participants with any eliciting dose (ED) increase (n = 127; LSM, 0.66; P < .001). Improvements in FAQLQ-PF were observed in social dietary limitations, food-related anxiety, and emotional impact domains. Improvements in FAQLQ-CF were observed in risk of accidental exposure and allergen avoidance domains.EPIT was associated with significant global and domain-specific FAQL improvement, largely driven by increases in ED.These findings suggest that EPIT had a meaningful impact on the lives of patients and caregivers. Although there may be some bias toward positive survey responses from caregivers and patients who were satisfied with their outcomes, this encouraging study reveals a measurable modality for capturing outcome perceptions. Additional study of ongoing peanut EPIT is needed to better understand the clinical relationship between intermediate and long-term ED changes, efficacy, safety, and FAQL.

Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy.

BackgroundThe benefit of daily administration of Peanut (Arachis hypogaea) Allergen Powder‐dnfp (PTAH)—formerly AR101—has been established in clinical trials, but limited data past the first year of treatment are available. This longitudinal analysis aimed to explore the impact of continued PTAH therapeutic maintenance dosing (300 mg/day) on efficacy, safety/tolerability, and food allergy‐related quality of life.MethodsWe present a subset analysis of PALISADE‐ARC004 participants (aged 4–17 years) who received 300 mg PTAH daily for a total of ~1.5 (Group A, n = 110) or ~2 years (Group B, n = 32). Safety assessments included monitoring the incidence of adverse events (AEs), accidental exposures to food allergens, and adrenaline use. Efficacy was assessed by double‐blind, placebo‐controlled food challenge (DBPCFC); skin prick testing; peanut‐specific antibody assays; and Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM) scores.ResultsContinued maintenance with PTAH increased participants’ ability to tolerate peanut protein: 48.1% of completers in Group A (n = 50/104) and 80.8% in Group B (n = 21/26) tolerated 2000 mg peanut protein at exit DBPCFC without dose‐limiting symptoms. Immune biomarkers showed a pattern consistent with treatment‐induced desensitization. Among PTAH‐continuing participants, the overall and treatment‐related exposure‐adjusted AE rate decreased throughout the intervention period in both groups. Clinically meaningful improvements in FAQLQ and FAIM scores over time suggest a potential link between increased desensitization as determined by the DBPCFC and improved quality of life.ConclusionsThese results demonstrate that daily PTAH treatment for peanut allergy beyond 1 year leads to an improved safety/tolerability profile and continued clinical and immunological response.

Health-related quality of life of food-allergic children compared with healthy controls and other diseases.

Food allergy is a potentially life-threatening disease, affecting up to 10% of the pediatric population. The aim of our study was to assess the health-related quality of life (HRQL) of food-allergic patients compared with the general population and patients with other chronic diseases with dietary or allergic burden, in a cross-sectional study. We recruited patients aged 8-17years diagnosed with food allergy and matched healthy controls recruited in schools. We also included patients with asthma, inflammatory bowel disease, celiac disease, diabetes, obesity, and eating disorders. We used the CHQ-CF87 questionnaire for generic HRQL assessment. Food allergy HRQL was also assessed using specific questionnaires: Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM). One hundred and thirty-five food-allergic children, 255 children with chronic diseases, and 463healthy controls were included in the analyses. Food-allergic patients had a better HRQL than healthy controls in the Behavior (BE), Bodily Pain (BP), Family Activities (FA), and Mental Health (MH) domains and a worse HRQL in the General Health Perception (GH) domain (p=.048). Food-allergic patients exhibited a better HRQL than patients affected by other chronic diseases, notably diabetes. Although an epinephrine autoinjector had been prescribed to 87.4% of the food-allergic children, only 54.2% of them carried it at all times. Food-allergic patients display overall good HRQL compared with the general population and those with other diseases with daily symptoms and treatments, in line with recent improvements in food allergy management.

Dissemination of EAACI food allergy guidelines using a flexible, practical, whole school allergy awareness toolkit.

BackgroundEssential training for emergency adrenaline auto‐injector administration alone provides an inadequate safeguard in school environments. Recent UK deaths have reinforced the urgency for embedding whole school (WS) allergy awareness to minimise risk. We documented the development of a practical, flexible WS Food Allergy Awareness Toolkit for UK secondary schools.MethodsWe used a multidisciplinary participatory action research methodology, involving successive modification and retesting of a pragmatic toolkit in 3 case study schools. A School Allergy Action Group drives WS risk assessment, helping schools gradually implement best practice policy in line with their particular needs. Additional schools self‐piloted the resulting toolkit with only remote monitoring. School surveys, based on EAACI guidelines were developed to identify priorities and assess change.ResultsEffectiveness of the resulting process toolkit, now available online, was independently demonstrated via pre/post‐intervention questionnaires from 24/10 pupils with food allergy (FA) and 97/6 pupils without FA, respectively. Pearson correlational analysis showed strong negative relationships between Food Allergy Quality of Life Questionnaire (FAQLQ) at T0 and School Support (SS) at T0 (r = −0.8, P<0.01), and between SS and Self‐Efficacy (SE) (r = 0.73, P<0.05). Mean FAQLQ scores improved between T0 (3.3) and T1 (2.5). SE improved for those with FA (mean difference = 1.0). In those without FA, SE (mean difference = 0.9) and Attitudes and Knowledge (mean difference = 0.7) also improved.ConclusionsFull stakeholder involvement in toolkit development encourages usage and, therefore, improves WS community awareness; reduces risk of reactions; fosters a more accepting societal attitude and empowers pupils with/without allergies to self‐manage effectively.

Quality of life is lower in adults labeled with childhood-onset food allergy than in those with adult-onset food allergy

BackgroundImmunoglobulin E–mediated food allergy (FA) affects children and adults with variable age of onset. Phenotype and quality of life (QoL) differences between childhood-onset FA (COFA) and adult-onset FA (AOFA) are not known. ObjectiveTo identify phenotypic and QoL differences between AOFA and COFA. MethodsA cross-sectional study of adults (≥18 years old) seen at Northwestern Memorial HealthCare clinics between 2002 and 2017 with an International Classification of Diseases ninth and tenth revision diagnosis of FA. Subjects completed a FA history survey and a FA QoL questionnaire. FA characteristics and QoL scores were compared between groups. ResultsAmong 294 consented subjects, 202 had a clinical history consistent with labeled immunoglobulin E–mediated FA. The onset of FA symptoms occurred before age 18 years (COFA) in 80 subjects and after age 18 years in 122 (AOFA) subjects. Shellfish reactions were most common in AOFA-labeled subjects (28%), whereas tree nut reactions were the most common in COFA-labeled subjects (55%) compared with other triggers. Hives (68% vs 52%, P = .03), facial swelling (69% vs 50%, P = .009), wheezing (56% vs 29%, P < .001), and vomiting (41% vs 22%, P = .005) were more often observed in COFA compared with AOFA. Total QoL was significantly reduced in COFA compared with AOFA (3.6 vs 3.0, P = .003) along with specific domains related to the following: allergen avoidance and dietary restriction (3.7 vs 3.1, P = .006), emotional impact (3.9 vs 3.2, P = .003), and risk of accidental exposure (3.6 vs 2.8, P = .001). ConclusionThere are differences in specific food triggers and symptoms in adult-onset and childhood-onset labeled FA. Adults labeled with childhood-onset FA have reduced QoL.

PRS76 Selection of Health-Related Quality of Life Measures for Food Allergy

Food allergy (FA) poses a substantial burden on patients and their families, with reported physical and emotional impacts that can significantly influence daily life. Multiple disease-specific patient-reported outcome measures (PROMs) have been developed to measure the impact of FA on health-related quality of life (HRQoL). This review aimed to identify suitable PROMs to enable the assessment of interventions on the HRQoL impacts of patients with FAs. A literature search was performed in Medline and Embase from Jan 2010-April 2020. Key words like “food allergy” and “HRQoL” identified PROMs developed or used in patients with FA. Psychometric properties including content validity, reliability, validity, responsiveness and interpretability, were evaluated in accordance with the FDA PRO Guidance (2009). A total of 1028 abstracts were identified and 241 were selected for full-text review resulting in a list of 46 PROMs. They were classified as generic (n=22), allergy specific (n=2), FA-specific (n=19), and treatment satisfaction-specific (n=3). From the FA-specific PROMs, only 7 were conceptually relevant for further evaluation— Food Allergy Quality of Life Questionnaire (FAQLQ), Food Allergy Independent Measure (FAIM), Food-Pet-Allergy in Children Questionnaire (PFAC), Food Allergy Quality of Life Assessment Tool for Adolescents (FAQL-teen), You and Your Food Allergy, Food Intolerance Quality of Life Questionnaire (FIQLQ) and Pediatric Food Allergy Quality of Life Questionnaire (PFA-QL). You and Your Food Allergy, FAQLQ, PFAC, FAQL-teen involved patient’s qualitative inputs to establish content validity. All measures showed internal consistency (reliability) to be above 0.70 threshold; in terms of validity, PROMs moderately (0.30-0.70) correlated with existing measures. Only the FAQLQs showed both responsiveness to change and interpretability, key attributes for use in clinical trials. The FAQLQs validated for measuring HRQoL in FA have relevant conceptual coverage and adequate psychometric strength. Therefore, FAQLQs are suitable for further exploration of the impact of interventions within FA clinical trials.

Quality of Life in Food Allergic Children: Results From 174 Quality-Of-Life Patient Questionnaires

JM Miller, AC Blackman, HT Wang. Ann Allerg Asthma Immunol . 2020:124(4):379–384 The authors investigated the effect of food allergy on quality of life (FAQoL), factors associated with worse FAQoL, and the differences in FAQoL between adolescents versus younger children with food allergy. Children aged 0 to 17 years with a food allergy were recruited from the Allergy Clinic at Texas Children’s Hospital from June 2017–June 2019. 150 children (aged 0–12) and 24 adolescents (13–17) participated. Patients who had outgrown their food allergy were excluded. Eighty-eight percent of children and 95.8% of adolescents were peanut allergic. Forty-seven percent of children and 79.2% of adolescents had experienced anaphylaxis. Parents completed the food allergy quality of life questionnaire (FAQLQ)-Parent form as a proxy for children 0–12 years. Adolescents, age 13 to 17 years, completed the FAQLQ-teenager form. The FAQLQs use a 7-point Likert scale and higher scores reflect worse QoL. The FAQLQs measure …

Improvements in Quality of Life in Children Following Epicutaneous Immunotherapy (EPIT) for Peanut Allergy in the PEPITES and PEOPLE Studies

Food allergy quality of life (FAQL) is impaired in children with peanut allergy. Food Allergy Quality of Life Questionnaires (FAQLQs) provide disease-specific insight into the burden of peanut allergy and potential FAQL changes after peanut immunotherapy. To examine FAQL changes in children after treatment with epicutaneous immunotherapy for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). FAQL was prospectively measured using the FAQLQ parent proxy form (Food Allergy Quality of Life Questionnaire-Parent Proxy Form [FAQLQ-PF], for children aged ≤12 years) and child form (Food Allergy Quality of Life Questionnaire-Child Form [FAQLQ-CF], child rated if aged ≥8 years) during the 12-month double-blind, randomized, controlled Peanut EPIT Efficacy and Safety Study (PEPITES) trial and the initial 12 months of the open-label PEPITES Open Label Extension Study (PEOPLE) follow-up study. Data were analyzed for between-group differences after treatment unblinding. FAQLQs from placebo participants (FAQLQ-PF: 96; FAQLQ-CF: 47) and treatment group participants (FAQLQ-PF: 209; FAQLQ-CF: 105) were analyzed. Twenty-four-month global FAQL scores (FAQLQ-PF/FAQLQ-CF) were significantly improved in the treatment group versus the placebo group (least squares mean, 0.34, P= .008, and 0.46, P= .023, respectively). At 24 months, there was significant FAQLQ-PF score improvement in participants initially randomized to treatment who met the efficacy primary end point (n= 74; least squares mean, 0.55; P< .001) and in participants with any eliciting dose increase (n=127; least squares mean, 0.66; P < .001). FAQLQ-PF improvements were observed in social dietary limitations (P= .002), food-related anxiety (P= .029), and emotional impact (P= .048) domains. FAQLQ-CF improvements were observed in risk of accidental exposure (P= .002) and allergen avoidance (P= .04) domains. Nearly all outcomes met a nontreatment context minimal clinically important difference previously cited for FAQLQ. Epicutaneous immunotherapy treatment was observed to be associated with significant global and domain-specific FAQL improvement (FAQLQ-PF/FAQLQ-CF), largely driven by increases in eliciting dose, in children with peanut allergy.

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.

Quality of life in food allergic children: Results from 174 quality-of-life patient questionnaires

BackgroundFood allergies are becoming a global concern and pose a significant burden on allergic children and their family, with reported physical and emotional effects. ObjectiveTo investigate the effect of food allergy on patients′ quality of life (QoL), to identify any characteristics associated with worse QoL, and to directly compare the effect of food allergies on the QoL of adolescents vs younger children. MethodsChildren 0 to 17 years old with a physician-confirmed food allergy diagnosis were invited to participate by completing the validated Food Allergy Quality of Life Questionnaire (FAQLQ). The FAQLQ form for children 10 to 12 years old was completed by the parent (proxy report), whereas the FAQLQ form for adolescents was completed by the adolescent (self-report). Scores were compared using the Wilcoxon rank sum test. Independent median regressions were used to test association between potential risk factors and QoL outcomes. ResultsIn our cohort, the median FAQLQ score was significantly higher (reflecting lower QoL) in adolescents compared with children (4.7 vs 3.5, P = .007). The median social and dietary limitations score (5.2 vs 4, P = .002) and the median emotional impact score (3.8 vs 3.1, P = .02) were also higher in adolescents. Limitations in family activities because of food allergy had a negative effect on QoL. ConclusionFood allergic adolescents are affected more than younger children (based on parental report) in terms of QoL, with a direct reflection on all areas of their daily life (emotional, dietary, and social). In addition, limitations in family activities because of the child′s food allergy significantly worsen the QoL and well being of all family members.

Quality of life associated with maternal anxiety disorder in Russian children and adolescents with food allergy.

Food allergy negatively impacts the quality of life (QoL) and has been associated with increased maternal anxiety. There is currently a lack of data assessing QoL of food-allergic children and adolescents in Russia. We aimed to evaluate the performance of the Food Allergy Quality of Life Questionnaire (FAQLQ) measures in a Russian sample of children, adolescents, and mothers and to investigate association between child QoL and maternal general anxiety. FAQLQ and Food Allergy Independent Measures (FAIM) were translated to Russian to be completed by participants. Mothers also filled the General Anxiety Disorder (GAD-7) questionnaire. Reliability, construct, and discriminant validity of the FAQLQs and association between FAQLQ scores and general anxiety were assessed. A total of 142 participants completed FAQLQ and FAIM. In total, 126 mothers completed GAD-7 questionnaire. All FAQLQs showed excellent internal consistency (α>0.94). The means for the FAQLQ-PF, FAQLQ-CF, and FAQLQ-TF varied according to the number of foods avoided, severity of symptoms, and FAIM and GAD scores (ηp2 0.40 P<.001). One in 5 mothers had GAD-7 score indicative of moderate-to-severe anxiety. Association strength between GAD and FAQLQ increased with age. GAD score was associated with FAQLQ-PF score, controlling for multiple confounders. The FAQLQ showed good reliability and validity in Russian. This study identified number of foods avoided and reported reaction severity being associated with greater QoL impairment in Russian children and adolescents affected by food allergy. The significant association found between general anxiety in parents and QoL in children and adolescents has practice, screening, and resource implications.

Food allergy-related concerns during the transition to self-management

BackgroundCompared to non-allergic individuals, food allergic individuals have impaired health-related quality of life (HRQL). However, effects of gender and age are unclear. The objective of our study was to describe associations between allergies to common foods and HRQL with consideration to gender and age.MethodsAdolescents and adults (N = 137; 49.6% males) with specialist-diagnosed allergy to milk, egg and/or wheat completed age-appropriate versions of the Food Allergy Quality of Life Questionnaire (FAQLQ). We pooled common questions and calculated overall- and domain-specific HRQL in association with number and severity of symptoms and time elapse since worst reaction.ResultsIn the entire study population, HRQL was not affected by gender or age, whereas gender-specific age categories affected HRQL among males only. For example, males 18–39 years had worse overall- (β = 0.77; 95% CI 0.08–1.45) and domain-specific HRQL vs. males < 18 years. Among participants with 1–3 food allergy symptoms, no associations were found. Among participants with 4–6 symptoms, the domain allergen avoidance and dietary restrictions was worse among older participants (e.g. 40+ years: β = 0.71; 95% CI 0.05–1.37 vs. < 18 years), and males 18–39 vs. < 18 years. Among participants with severe symptoms, females vs. males, and participants 18–39 vs. < 18 years had worse HRQL. At least 4 years since worst reaction was associated with worse HRQL for participants 40+ years vs. < 18 years, and older males vs. males < 18 years. Nearly all differences exceeded the clinical relevance threshold of ≥ 0.5.ConclusionsAssociations between allergies to common foods and HRQL are affected by gender and age. Most affected are males 18–39 years. Among females, HRQL is more stable across age groups.

Development and preliminary validation of the food intolerance Quality of Life Questionnaire (FIQLQ): Adult Form.

Approximately 20% of children and adults avoid certain foods because of perceived food intolerance. Valid and reliable health-related quality of life instruments are needed to measure changes following clinical, therapeutic or policy interventions. However, there are no disease-specific quality of life instruments for adults with food intolerances. To develop the Food Intolerance Quality of Life Questionnaire FIQLQ. Then to conduct psychometric validation including reliability and construct validity. We adapted the existing Food Allergy Quality of Life questionnaire (FAQLQ) for interviews with 14 adults with food intolerance. For preliminary psychometric validation, 229 adults with food intolerances completed the online electronic version of FIQLQ. The resultant FIQLQ had 18 items which loaded onto 3 subscales-Emotional Impact, Social and Dietary Restrictions, Reactions and Avoidance. Each subscale had excellent internal consistency reliability (Cronbach's α 0.81-0.94). Content, convergent and construct validity was supported by significant correlations of FIQLQ subscale scores with hypothesised variables including age, numbers of symptoms and level of stress experienced due to intolerance. The FIQLQ has good reliability, construct validity and internal consistency. It is short and easy to use, providing a good tool for evaluating quality of life in the clinical research setting and to inform health and regulatory policies.