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Randomized Controlled Trial
. 2017 Mar-Apr;5(2):391-397.e4.
doi: 10.1016/j.jaip.2016.12.016. Epub 2017 Jan 20.

Food-Allergic Adolescents at Risk for Anaphylaxis: A Randomized Controlled Study of Supervised Injection to Improve Comfort with Epinephrine Self-Injection

Eyal Shemesh  1 , Christine D'Urso  2 , Christopher Knight  3 , Melissa Rubes  3 , Kinga M Picerno  2 , Ailie M Posillico  2 , Zara Atal  2 , Rachel A Annunziato  3 , Scott H Sicherer  2
Affiliations
Randomized Controlled Trial

Food-Allergic Adolescents at Risk for Anaphylaxis: A Randomized Controlled Study of Supervised Injection to Improve Comfort with Epinephrine Self-Injection

Eyal Shemesh et al. J Allergy Clin Immunol Pract. 2017 Mar-Apr.

Abstract

Background: Epinephrine self-injection is a key element in the management of food allergy, yet many adolescents report that they may not be able to use the autoinjector when needed. We hypothesized that supervised self-injection with an empty syringe would increase adolescents' comfort with self-injection.

Objective: The objective of this study was to examine the effect of supervised self-injection on self- and parent-reported comfort and anxiety during and after clinic visits in a food allergy center.

Methods: Sixty adolescent/parent pairs were randomized to self-injection versus control (education only). The predefined primary outcome was a self-reported comfort level with the injection before versus after the intervention on a Likert scale with scores of 1 (Not at all comfortable) to 10 (Extremely comfortable). The primary outcome was evaluated via within-group and between-group analyses. Secondary outcomes included adolescent and parent reports before versus after the injection, and changes in quality of life (QoL) and anxiety a month later.

Results: Self-injection was associated with a significant immediate increase in comfort levels (primary outcome; within-group comparison: mean scores: 6.93 preintervention vs 8.37 postintervention, P < .01; between-group ANOVA: 8.37 vs 6.69, P < .01) and with significant improvements in all other predefined (secondary) measures. On follow-up, QoL improved in 52% of intervention patients as compared with 25% of controls; similar differences were observed for anxiety. Those differences were not statistically significant.

Conclusions: A self-injection (with an empty syringe) procedure in a clinic setting improves adolescents' and parents' comfort level with self-injecting. It may translate into substantial clinical benefits should self-injection be needed.

Keywords: Anxiety; Epinephrine; Exposure; Food allergy; Self-management.

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