PIH5 DEVELOPMENT OF THE SIDE EFFECTS OF PEANUT ORAL IMMUNOTHERAPY DIARY (SEPOD)

Oral immunotherapy (OIT), an investigational treatment for peanut allergy, induces desensitization through daily, controlled exposure. We developed a clinical outcome assessment (COA) to measure daily allergic side effects of peanut OIT in children (6-17 years). A concept-focused literature review and clinical expert meetings identified peanut OIT-related side effects to inform development of the Side Effects of Peanut OIT Diary (SEPOD). The SEPOD was initially designed as a patient-reported outcome (PRO), with a caregiver-administered version for patients 6-12 years. Concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted using a semi-structured guide in 2 waves with patients (6-17 years) and their caregivers (patients 6-12 years) to confirm relevant side effects for measurement and evaluate respondent understanding of the SEPOD. Interviews were audio-recorded, transcribed, coded and analysed. Results informed the final SEPOD. A literature review and expert meetings (N=3) informed SEPOD item selection. We conducted 24 interviews in 2 waves with patients who have peanut allergy (14 patients were exposed to peanut OIT). CE results confirmed comprehensiveness of SEPOD concepts and provided evidence of saturation. Based on wave 1 CD findings, clarifying text revisions were made to improve comprehension for younger patients. After wave 2, for patients 6-8 years, the caregiver-administered PRO was modified to allow caregiver (observer) report when patient self-report was not possible and to record report source (parent or child). The final SEPOD includes 23 items assessing peanut OIT side effects: 4 gastrointestinal, 2 dermatological, 5 itching, 5 nasal/respiratory, 4 swelling, 2 pain, and 1 dizziness. This study yielded a new content-valid COA with various methods of administration to assess side effects of peanut OIT in a pediatric population.