24-Hour Helpline Access for Food Allergic Reaction Treatment Advice in Children Prescribed Epinephrine Auto-Injectors: Randomised Controlled Trial

Rationale Anaphylaxis is a life-threatening paediatric emergency. Many food allergic patients are unsure when to use their epinephrine auto-injectors. This contributes to a low quality of life and worse outcomes in the setting of an acute allergic reaction. We assessed the effectiveness of 24-hr telephone access to specialist advice in improving their quality of life. Methods 52 children (<16 years) with food allergy, trained in epinephrine 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 Quality of Life Questionnaire (FAQLQ). Participants were then centrally randomised for a period of 6 months to the 24-hr telephone specialist support line or to usual care. The primary outcome measure of interest was a change in FAQLQ scores, at 1 and 6 months post-randomisation, compared to baseline. Analysis was performed, blind to group allocation, on an intention-to-treat basis using a 2×3 repeated measures within-between analysis of variance. Results FAQLQ scores, equal at baseline, changed over time with a significant difference evident at 6 months but not at 1 month between study arms (F=6.376; p <0.05). The mean square of the differences between the groups was 8.8 points. Post hoc analysis suggests children with prior anaphylaxis and females derived most benefit from the intervention. Conclusions 24h helpline access significantly improved disease-specific quality of life over a 6 month period, compared to usual care. To our knowledge this is one of the world’s first randomised clinical trials in the management of children at high risk of anaphylaxis.