Changing Patient Mindsets about Non-Life-Threatening Symptoms During Oral Immunotherapy: A Randomized Clinical Trial

BACKGROUND: Oral immunotherapy (OIT) can lead to desensitization to food allergens, but patients can experience treatment-related symptoms of allergic reactions that cause anxiety and treatment dropout. Interventions to improve OIT for patients are needed. OBJECTIVE: To determine whether fostering the mindset that nonelife-threatening symptoms during OIT can signal desensitization improves treatment experience and outcomes. METHODS: In a randomized, blinded, controlled phase II study, 50 children/adolescents (28% girls, aged 7-17 years, M =10.82, standard deviation =3.01) completed 6-month OIT for peanut allergies. Patients and their parent(s) had monthly clinic visits at the Sean N. Parker Center for Allergy and Asthma Research between January 5, 2017, and August 3, 2017. All families received identical symptommanagement training. In a 1: 1 approach, 24 patients and their families were informed that nonelife-threatening symptoms during OIT were unfortunate side effects of treatment, and 26 patients and their families were informed that nonelife-threatening symptoms could signal desensitization. Families participated in activities to reinforce these symptom mindsets. RESULTS: Compared with families informed that symptoms are side effects, families informed that symptoms can signal desensitization were less anxious (B = -0.46, 95% confidence interval [CI]: L0.76 to L0.16; P <.003), less likely to contact staff about symptoms (5/24 [9.4%] vs 27/154 [17.5%] instances; P = .036), experienced fewer nonelife-threatening symptoms as doses increased (B-Interaction = -0.54, 95% CI: L0.83 toL0.27; P <.001), less likely to skip/reduce doses (1/26 [4%] vs 5/24 [21%] patients; P < .065), and showed a greater increase in patient peanut-specific blood IgG4 levels (B-Interaction [0.76, 95% CI: 0.36 to 1.17; P <.001). CONCLUSIONS: Fostering the mindset that symptoms can signal desensitization improves OIT experience and outcomes. Changing how providers inform patients about nonelifethreatening symptoms is a promising avenue for improving treatment. (C) 2019 American Academy of Allergy, Asthma & Immunology