Psychosocial Mediators of Change and Patient Selection Factors in Oral Immunotherapy Trials.

Health-related quality of life (HRQL) is influenced by physiological, psychological, and environmental variables and can be best understood by considering the interactions of factors that cut across multiple levels. One of the most important issues relating to treatment in food allergy is to identify, describe, and define predictors that may contribute to modify HRQL outcomes. The research presented demonstrates that measures of HRQL are able to distinguish key features of known groups (e.g. relating to reaction severity, treatment, allergen type/number, expectation of outcome) and delineate impact on hitherto unknown groups (e.g. relating to personality types and coping styles). This heterogeneity may explain why HRQL or other patient-related outcomes may differ in individuals during, or following any treatment or intervention. Patient-reported outcomes are relatively poorly defined to date. Since HRQL has only been studied in relatively few oral immunotherapy trials to date, primarily looking at caregiver HRQL, it is unclear which factors, measures, or subscales are most predictive of short- and/or long-term treatment outcomes for which type of patient, and which time points for measurement are most informative. A standardised protocol that incorporates HRQL and other relevant patient-related outcome measures and agreed definitions of outcomes would allow for the comparison of efficacy of food allergy treatments between centres, trials, or countries. Further evidence-based research aimed at exploring the effects of interventions on outcomes in food allergy is needed, including the influence of patient and parent factors on protocol design. To this end, it is vital that patient-related outcomes such as improved HRQL are seen as a primary outcome and are measured at multiple intervals during the trial duration and beyond. The creative use of methods and designs (both qualitative and quantitative) to better understand the role of HRQL in immunotherapy treatment trials will enable improved modelling of the costs, risks, and benefits of any treatment. Systematic analysis and modelling of antecedent factors, mediators, and outcomes will be important to boost intervention effects and to maximise the overall benefits of treatment.

The urgent need for a harmonized severity scoring system for acute allergic reactions.

The accurate assessment and communication of the severity of acute allergic reactions are important to patients, clinicians, researchers, the food industry, and public health and regulatory authorities. Severity has different meanings to different stakeholders with patients and clinicians rating the significance of particular symptoms very differently. Many severity scoring systems have been generated, most focusing on the severity of reactions following exposure to a limited group of allergens. They are heterogeneous in format, none has used an accepted developmental approach, and none has been validated. Their wide range of outcome formats has led to difficulties with interpretation and application. Therefore, there is a persisting need for an appropriately developed and validated severity scoring system for allergic reactions that work across the range of allergenic triggers and address the needs of different stakeholder groups. We propose a novel approach to develop and then validate a harmonized scoring system for acute allergic reactions, based on a data-driven method that is informed by clinical and patient experience and other stakeholders' perspectives. We envisage two formats: (i) a numerical score giving a continuum from mild to severe reactions that are clinically meaningful and are useful for allergy healthcare professionals and researchers, and (ii) a three-grade-based ordinal format that is simple enough to be used and understood by other professionals and patients. Testing of reliability and validity of the new approach in a range of settings and populations will allow eventual implementation of a standardized scoring system in clinical studies and routine practice.

Factors increasing the risk for a severe reaction in anaphylaxis: An analysis of data from The European Anaphylaxis Registry.

BACKGROUND: Preventive measures to decrease the frequency and intensity of anaphylactic events are essential to provide optimal care for allergic patients. Aggravating factors may trigger or increase the severity of anaphylaxis and therefore need to be recognized and avoided. OBJECTIVE: To identify and prioritize factors associated with an increased risk of developing severe anaphylaxis. METHODS: Data from the Anaphylaxis Registry (122 centers in 11 European countries) were used in logistic regression models considering existing severity grading systems, elicitors, and symptoms to identify the relative risk of factors on the severity of anaphylaxis. RESULTS: We identified higher age and concomitant mastocytosis (OR: 3.1, CI: 2.6-3.7) as the most important predictors for an increased risk of severe anaphylaxis. Vigorous physical exercise (OR: 1.5, CI: 1.3-1.7), male sex (OR: 1.2, CI: 1.1-1.3), and psychological burden (OR: 1.4, CI: 1.2-1.6) were more often associated with severe reactions. Additionally, intake of beta-blockers (OR: 1.9, CI: 1.5-2.2) and ACE-I (OR: 1.28, CI: 1.05, 1.51) in temporal proximity to allergen exposition was identified as an important factor in logistic regression analysis. CONCLUSION: Our data suggest it may be possible to identify patients who require intensified preventive measures due to their relatively higher risk for severe anaphylaxis by considering endogenous and exogenous factors.

Thin-for-gestational age infants are at increased risk of neurodevelopmental delay at 2†years.

BACKGROUND: Infants born small-for-gestational age (SGA) are at increased risk of developmental difficulties. Identifying those most at risk is challenging. We examined the effect of neonatal body composition and customised birthweight centiles on neurocognitive and behavioural outcomes at age 2. STUDY DESIGN: Prospective cohort study of term infants from the Cork BASELINE Birth Cohort Study classified into the following exposure groups: a birth weight <10th customised centile (SGA, n=51); body fat percentage at birth <10th centile (thin-for-gestational age (TGA, n=51)) or both SGA and TGA infants (small- and thin-for-gestational age (STGA), n=13). The SGA, TGA and STGA groups were compared with a reference (unexposed) group of appropriate-for-gestational age (AGA, n=189) infants. Outcome was assessed at 24 months using the Bayley Scales of Infant Development Version III and the Child Behaviour Checklist. RESULTS: Outcomes in the SGA infants did not differ significantly from the AGA group. TGA infants had significantly lower scores across all three domains, with a 0.35, 0.38 and 0.41 SD reduction in language, cognitive and motor scale scores, respectively. STGA infants had poorer cognitive outcome with a median cognitive scale score of 90 (IQR 85-95) compared with 95 (IQR 90-100) in the AGA reference group, p=0.005. The adjusted OR of developmental delay at 2 years was 5.00 (95% CI 1.46 to 17.13, p=0.010) in the STGA group. CONCLUSION: TGA infants, in particular those born STGA, are at increased risk of developmental delay at 2 years compared with the AGA infants.

Impact of maternal, antenatal and birth-associated factors on iron stores at birth: data from a prospective maternal-infant birth cohort.

BACKGROUND/OBJECTIVES: Low serum ferritin concentrations at birth, which reflect neonatal iron stores, track through to early childhood and have been associated with poorer neurodevelopmental outcomes. We aimed to identify maternal, antenatal and birth-associated factors that influence iron stores at birth in a prospective maternal-infant birth cohort. SUBJECTS/METHODS: In a population-based, longitudinal, birth cohort in Ireland, 413 maternal-infant dyads with prospectively collected lifestyle and clinical data from 15 weeks' gestation had umbilical cord serum ferritin concentrations measured. Regression models were developed to identify independent factors associated with cord ferritin concentrations. RESULTS: Median (IQR) cord ferritin concentrations were 185.7 (131.7, 385.5) µg/l, and 8% (n=33) of infants had low iron stores (ferritin <76 µg/l) at birth. Maternal obesity (BMI ⩾30 kg/m2) at 15 weeks' gestation (adj. estimate (95% confidence interval (CI)): -66.4 (-106.9, -25.9) µg/l, P<0.0001) and delivery by caesarean section (-38.8 (-70.2, -7.4) µg/l, P=0.016) were inversely associated with cord ferritin concentrations. In addition, maternal smoking at 15 weeks' gestation (adj. odds ratio (95% CI): 2.9 (1.2, 7), P=0.020) and being born small-for-gestational age (3.4 (1.3, 8.9), P=0.012) were associated with an increased risk of low iron stores (ferritin <76 µg/l) at birth. CONCLUSIONS: We have identified a number of potentially modifiable lifestyle factors that influence iron stores at birth, with the important role of overall maternal health and lifestyle during pregnancy highlighted. Public health policies targeting women of child-bearing age to improve nutrition and health outcomes should be prioritised for the health of the next generation.

Health-related quality of life in food allergy : Impact, correlates, and predictors.

In food allergy, since the likelihood of a fatal reaction is low but fear, uncertainty, and lifestyle restrictions high, health-related quality of life (HRQL) may be a more meaningful measure of outcome in research and practice. HRQL is influenced by physiological, psychological, and environmental variables and can be best understood by considering the interactions of factors that cut across multiple levels. In this article we review both quantitative and qualitative research findings to provide an in-depth picture of the impact of food allergy on the concerns and the everyday lives of children, teens, adults, and parents. Research on factors that are related to, and impact on, HRQL is also discussed. We conclude by exploring some methodological and design issues in relation to the measurement of HRQL in food allergy and offer some recommendations for research and practice.

Prebiotic-supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high-risk infants: a randomized controlled trial.

BACKGROUND: Prevention guidelines for infants at high risk of allergic disease recommend hydrolysed formula if formula is introduced before 6 months, but evidence is mixed. Adding specific oligosaccharides may improve outcomes. OBJECTIVE: To evaluate whether partially hydrolysed whey formula containing oligosaccharides (0.8 g/100 ml) (pHF-OS) can prevent eczema in high-risk infants [ISRCTN65195597]. METHODS: We conducted a parallel-group, multicentre, randomized double-blind controlled trial of pHF-OS vs standard cow's milk formula. Infants with a family history of allergic disease were randomized (stratified by centre/maternal allergy) to active (n = 432) or control (n = 431) formula until 6 months of age if formula was introduced before 18 weeks. Primary outcome was cumulative incidence of eczema by 12 months in infants randomized at 0-4 weeks (375 pHF-OS, 383 control). Secondary outcomes were cumulative incidence of eczema by 12 or 18 months in all infants randomized, immune markers at 6 months and adverse events. RESULTS: Eczema occurred by 12 months in 84/293 (28.7%) infants allocated to pHF-OS at 0-4 weeks of age, vs 93/324 (28.7%) control (OR 0.98 95% CI 0.68, 1.40; P = 0.90), and 107/347 (30.8%) pHF-OS vs 112/370 (30.3%) control in all infants randomized (OR 0.99 95% CI 0.71, 1.37; P = 0.94). pHF-OS did not change most immune markers including total/specific IgE; however, pHF-OS reduced cow's milk-specific IgG1 (P < 0.0001) and increased regulatory T-cell and plasmacytoid dendritic cell percentages. There was no group difference in adverse events. CONCLUSION: pHF-OS does not prevent eczema in the first year in high-risk infants. The immunological changes found require confirmation in a separate cohort.

Parental physical and lifestyle factors and their association with newborn body composition.

OBJECTIVE: To investigate the parental physical and lifestyle determinants of newborn body composition. DESIGN: Prospective cohort study. SETTING: Cork University Maternity Hospital, a tertiary referral hospital in Cork, Ireland. POPULATION: All babies were recruited as part of a prospective birth cohort, Babies After SCOPE: Evaluating the Longitudinal Impact Using Neurological and Nutritional Endpoints (BASELINE). These babies were recruited from women who had participated in the Screening of Pregnancy Endpoints (SCOPE) study Ireland, a prospective, multicentre cohort study METHODS: Multivariate linear regression was used to analyse the effect of a range of maternal and paternal physical and lifestyle features on neonatal body fat percentage (BF%). MAIN OUTCOME MEASURES: Neonatal BF%. Neonatal adiposity was assessed within 48 hours of birth using air displacement plethysmography (PEAPOD(®) ). RESULTS: In all, 1243 infants were enrolled in the study. Increasing maternal body mass index (adjusted mean difference 0.09; 0.04, 0.15) and waist height ratio (adjusted mean difference 6.59; 0.27, 12.92) were significantly associated with increased neonatal BF%. In contrast, maternal smoking was associated with reduced neonatal BF% compared with non smokers (adjusted mean difference -0.55; -1.07, -0.03). Infant sex significantly altered neonatal BF%, with female infants having higher neonatal BF% compared with male infants (adjusted mean difference 1.98; 1.54, 2.53). No association was observed between paternal body mass index (BMI), paternal age or paternal smoking and neonatal BF%. CONCLUSIONS: Maternal smoking, BMI, waist height ratio and infant sex were associated with altered BF%. TWEETABLE ABSTRACT: Maternal smoking, BMI, waist height ratio and infant sex are associated with altered neonatal body fat percentage.

Patterns of adaptation to children's food allergies.

BACKGROUND: Families with food allergy (FA) are at risk of reduced quality of life and elevated anxiety. A moderate level of anxiety may be beneficial to sustain vigilance for food avoidance; however, excessive anxiety may increase risk for burden and maladjustment. The current study presents a framework for understanding the patterns of adaptation to FA across families and to identify typologies of families that would benefit from intervention. METHODS: Participants included 57 children, 6-12 years old with documented FA, and their mothers. Families were assessed using the Food Allergy Management and Adaptation Scale. Families also completed measures of quality of life, anxiety, FA management, and psychosocial impairment. RESULTS: A hierarchical cluster analysis revealed that 56 of the 57 families of food-allergic children were categorized into four groups that differed on their adequacy of family FA management, levels of anxiety, and balanced psychosocial functioning: balanced responders (n = 23; 41%), high responders (n = 25; 45%), and low responders (n = 3; 5%). The fourth group, anxious high responders (n = 5; 9%), was characterized by extremely high maternal FA anxiety scores and low scores for balanced integration of FA management and psychosocial functioning. Families in clusters differed across illness and psychosocial outcome variables. CONCLUSION: Families with FA were characterized by patterns of FA management, anxiety, and ability to integrate FA demands into daily life. Identified adaptation patterns correspond with clinical impressions and provide a framework for identifying families in need of intervention.

Eating behaviour and weight status at 2 years of age: data from the Cork BASELINE Birth Cohort Study.

BACKGROUND/OBJECTIVES: To conduct an analysis of associations between eating behaviours and weight status in 2-year-old children. SUBJECTS/METHODS: Data were collected prospectively in the maternal-infant dyad Cork BASELINE Birth Cohort Study. The weight status of children aged 2 years (n=1189) was assigned using the International Obesity Task Force BMI cutoffs using measured heights and weights. Eating behaviours were assessed using the Children's Eating Behaviour Questionnaire (CEBQ). RESULTS: Eighty percent of children were of normal weight, 14% were overweight or obese and 6% were underweight. From the CEBQ, food approach behaviours including Enjoyment of Food (odds ratio (OR)=1.90, 95% confidence interval (CI)=1.46-2.48) and Food Responsiveness (OR=1.73, 95% CI=1.47-2.03) were associated with overweight/obesity (all P<0.001). The food avoidant behaviours of Satiety Responsiveness (OR=2.03, 95% CI=1.38-2.98) and Slowness in Eating (OR=1.44, 95% CI=1.01-2.04) were associated with underweight at 2 years (all P<0.05). CONCLUSIONS: Eating behaviours are associated with weight status as early as 2 years of age.

The effects of food allergy on quality of life.

The majority of research on food allergy has been bio-medical in orientation, focusing on issues such as the molecular structure of allergens, or aimed at methods of diagnosis. In the last decade, there has been a growing interest in the development of questionnaires that measure the impact of food allergy on health-related quality of life (HRQL). These studies have provided insight into the everyday burden of living with food allergy and have suggested ways that HRQL can be improved. The EuroPrevall project (europrevall@bbsrc.ac.uk) has given great impetus to research in the area of HRQL. In addition to clinical research on the prevalence, mechanisms and causes of food allergy, research output in the area of psycho-social impact has included HRQL measures for all age groups and examination of the socio-economic impact of food allergy. In this chapter, we review the literature on the impact of food allergy on children, teens and their parents; the majority of this data was generated over the life of the EuroPrevall project. We then examine both quantitative and qualitative research findings to provide an in-depth picture of the impact of food allergy on the concerns and everyday lives of children, teens, adults and parents. Research on factors that are related to and impact HRQL is also discussed. There is a strong emphasis throughout the chapter on developmental considerations of food allergy, spanning from infants to adults. We conclude by discussing methodological issues in relation to the measurement of HRQL in relation to food allergy. We offer some recommendations for future research and practice on HRQL so that HRQL measures can reach their full potential in research, practice and policy, with the help of the findings in this review. Overall, the findings suggest that food allergy has a strong impact on HRQL in terms of social, dietary, and psychological factors. 'Rules' and restrictions ostensibly apply to food, but because food is such an integral part of everyday life, these restrictions extend far beyond 'mealtimes'. Therefore, social events are experienced differently and have a different meaning for those living with food allergy, giving rise to feelings of exclusion and difference when compared to those without allergy. Children, teens, and parents need to cope with normal developmental changes as well as with the food allergy, placing them under increased psycho-social stress and leading to adverse effects on HRQL and coping. To address and attempt to alleviate such stressors, both quantitative and qualitative research suggests that targeting uncertainty should be a major goal for health professionals working with children, teens and families with a food allergy. Remarkable similarities in response to food allergy across countries suggest that policies and programmes that address quality of life issues may be relevant to many different populations. An in-depth understanding of the relationship between a diagnosis of food allergy and HRQL, as well as the factors that impact it, will ultimately lead to the promotion of earlier, more effective preventive strategies and interventions that are focused on maximising optimal health development and quality of life.

Predictors of health-related quality of life of European food-allergic patients.

BACKGROUND: Although food allergy has universally been found to impair HRQL, studies have found significant differences in HRQL between countries, even when corrected for differences in perceived disease severity. However, little is known about factors other than disease severity which may contribute to HRQL in food-allergic patients. Therefore, the aim of this study was to identify factors which may predict HRQL of food-allergic patients and also to investigate the specific impact of having experienced anaphylaxis and being prescribed an EAI on HRQL. METHODS: A total of 648 European food-allergic patients (404 adults, 244 children) completed an age-specific questionnaire package including descriptive questions. Multivariable regression analyses were performed to develop models for predicting HRQL of these patients. RESULTS: For adults, the prediction model accounted for 62% of the variance in HRQL and included perceived disease severity, type of symptoms, having a fish or milk allergy, and gender. For children, the prediction model accounted for 28% of the variance in HRQL and included perceived disease severity, having a peanut or soy allergy, and country of origin. For both adults and children, neither experiencing anaphylaxis nor being prescribed an epinephrine auto-injector (EAI) contributed to impairment of HRQL. CONCLUSIONS: In this study, food allergy-related HRQL may be predicted to a greater extent in adults than in children. Allergy to certain foods may cause greater HRQL impairment than others. Country of origin may affect HRQL, at least in children. Experiencing anaphylaxis or being prescribed an EAI has no impact on HRQL in either adults or children.

First European data from the network of severe allergic reactions (NORA).

BACKGROUND: Occurrence, elicitors and treatment of severe allergic reactions are recognized and reported differently between countries. We aimed to collect standardized data throughout Europe on anaphylaxis referred for diagnosis and counselling. METHODS: Tertiary allergy, dermatology and paediatric units in 10 European countries took part in this pilot phase of the first European Anaphylaxis Registry, from June 2011 to March 2014. An online questionnaire was used to collect data on severe allergic reactions based on the medical history and diagnostics. RESULTS: Fifty-nine centres reported 3333 cases of anaphylaxis, with 26.7% below 18 years of age. Allergic reactions were mainly caused by food (children and adults 64.9% and 20.2%, respectively) and insect venom (20.2% and 48.2%) and less often by drugs (4.8% and 22.4%). Most reactions occurred within 30 min of exposure (80.5%); a delay of 4+ hours was mainly seen in drug anaphylaxis (6.7%). Symptom patterns differed by elicitor, with the skin being affected most often (84.1%). A previous, usually milder reaction to the same allergen was reported by 34.2%. The mainstay of first-line treatment by professionals included corticoids (60.4%) and antihistamines (52.8%). Only 13.7% of lay- or self-treated reactions to food and 27.6% of insect anaphylaxis received on-site adrenaline. CONCLUSION: This pilot phase of a pan-European registry for severe allergic reactions provides for the first time data on anaphylaxis throughout Europe, demonstrates its potential functionality and allows a comparison of symptom patterns, elicitors and treatment habits between referral centres and countries.

EAACI food allergy and anaphylaxis guidelines: managing patients with food allergy in the community.

The European Academy of Allergy and Clinical Immunology (EAACI) Food Allergy and Anaphylaxis Guidelines, managing patients with food allergy (FA) in the community, intend to provide guidance to reduce the risk of accidental allergic reactions to foods in the community. This document is intended to meet the needs of early-childhood and school settings as well as providers of non-prepackaged food (e.g., restaurants, bakeries, takeaway, deli counters, and fast-food outlets) and targets the audience of individuals with FA, their families, patient organizations, the general public, policymakers, and allergists. Food allergy is the most common trigger of anaphylaxis in the community. Providing children and caregivers with comprehensive information on food allergen avoidance and prompt recognition and management of allergic reactions are of the utmost importance. Provision of adrenaline auto-injector devices and education on how and when to use these are essential components of a comprehensive management plan. Managing patients at risk of anaphylaxis raises many challenges, which are specific to the community. This includes the need to interact with third parties providing food (e.g., school teachers and restaurant staff) to avoid accidental exposure and to help individuals with FA to make safe and appropriate food choices. Education of individuals at risk and their families, their peers, school nurses and teachers as well as restaurant and other food retail staff can reduce the risk of severe/fatal reactions. Increased awareness among policymakers may improve decision-making on legislation at local and national level.

Disease-specific health-related quality of life instruments for IgE-mediated food allergy.

This is one of seven interlinked systematic reviews undertaken on behalf of the European Academy of Allergy and Clinical Immunology as part of their Guidelines for Food Allergy and Anaphylaxis, which focuses on instruments developed for IgE-mediated food allergy. Disease-specific questionnaires are significantly more sensitive than generic ones in measuring the response to interventions or future treatments, as well as estimating the general burden of food allergy. The aim of this systematic review was therefore to identify which disease-specific, validated instruments can be employed to enable assessment of the impact of, and investigations and interventions for, IgE-mediated food allergy on health-related quality of life (HRQL). Using a sensitive search strategy, we searched seven electronic bibliographic databases to identify disease-specific quality of life (QOL) tools relating to IgE-mediated food allergy. From the 17 eligible studies, we identified seven disease-specific HRQL instruments, which were then subjected to detailed quality appraisal. This revealed that these instruments have undergone formal development and validation processes, and have robust psychometric properties, and therefore provide a robust means of establishing the impact of food allergy on QOL. Suitable instruments are now available for use in children, adolescents, parents/caregivers, and adults. Further work must continue to develop a clinical minimal important difference for food allergy and for making these instruments available in a wider range of European languages.

EAACI Food Allergy and Anaphylaxis Guidelines. Food allergy health-related quality of life measures.

Instruments have been developed and validated for the measurement of health-related quality of life in patients with food allergy. This guideline has been prepared by the European Academy of Allergy and Clinical Immunology's (EAACI) Guidelines for Food Allergy and Anaphylaxis Group. It draws on a systematic review of the literature on quality of life instruments for food allergy and the Appraisal of Guidelines for Research & Evaluation (AGREE II) guideline development process. Guidance is provided on the use of such instruments in research, and the current limitations of their use in clinical practice are described. Gaps in current knowledge as well as areas of future interest are also discussed. This document is relevant to healthcare workers dealing with food-allergic patients, scientists engaging in food allergy research and policy makers involved in regulatory aspects concerning food allergy and safety.

Automated detection of perturbed cardiac physiology during oral food allergen challenge in children.

This paper investigates the fully automated computer-based detection of allergic reaction in oral food challenges using pediatric ECG signals. Nonallergic background is modeled using a mixture of Gaussians during oral food challenges, and the model likelihoods are used to determine whether a subject is allergic to a food type. The system performance is assessed on the dataset of 24 children (15 allergic and 9 nonallergic) totaling 34 h of data. The proposed detector correctly classified all nonallergic subjects (100% specificity) and 12 allergic subjects (80% sensitivity) and is capable of detecting allergy on average 17 min earlier than trained clinicians during oral food challenges, the gold standard of allergy diagnosis. Inclusion of the developed allergy classification platform during oral food challenges recorded would result in a 30% reduction of doses administered to allergic subjects. The results of study introduce the possibility to halt challenges earlier which can safely advance the state of clinical art of allergy diagnosis by reducing the overall exposure to the allergens.

Twenty four-hour helpline access to expert management advice for food-allergy-triggered anaphylaxis in infants, children and young people: a pragmatic, randomized controlled trial.

BACKGROUND: Anaphylaxis is a life-threatening emergency. If promptly administered, adrenaline is potentially life-saving. Many food-allergic-children/carers are unsure when to use their adrenaline autoinjectors, contributing to a low quality of life and worse outcomes in the setting of an acute allergic reaction. OBJECTIVES: The aim of this study was to assess the effectiveness of 24-hour telephone access to specialist clinical advice on disease-specific quality of life. METHODS: A pragmatic two-arm, parallel-group randomized control trial was conducted. Children/carers (<16 years) with food allergy, trained in adrenaline auto-injector use, were recruited from a hospital-based paediatric allergy clinic. Baseline disease-specific quality of life was ascertained using the validated Food-Allergy-Related Quality-of-Life Questionnaire (FAQLQ), either Parent Form, Child Form or Teenager Form depending on child's age. Participants were then centrally randomized for a 6-month period to 24-hour telephone specialist support line or to usual care. The primary outcome measure was a change in FAQL scores, at one and 6 months postrandomization, compared with baseline. The minimum clinically important difference (MCID) in score is 0.5. RESULTS: Fifty two children/carers were recruited. FAQL scores remained static in the control group across the three time points. Scores gradually improved in the intervention group, with a significant difference seen at 6 months (T1-T3 Mean difference = -1.5, (CI 0.87-2.25) P < 0.005] Follow-up questionnaires, 6 months after the intervention was removed, T4, showed sustained significant difference between the groups (control M = 3.0; intervention M = 1.1[t = -4.113, P < 0.05]). CONCLUSION: The 24-hour helpline improved food-allergy-specific quality of life in children. Six-month intervention support resulted in sustained benefits for at least a further 6 months.