DEVELOPMENT OF THE SIDE EFFECTS OF PEANUT ORAL IMMUNOTHERAPY DIARY (SEPOD)
Author(s)
Turner-Bowker D1, Jalbert J2, Krohe M1, Yaworsky A1, Kelly M1, Padilla B1, Chaston E1, Radin A2, Mastey V2, Nadeau KC3
1Adelphi Values, Boston, MA, USA, 2Regeneron, Tarrytown, NY, USA, 3Stanford University, Stanford, CA, USA
Presentation Documents
OBJECTIVES: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: This study yielded a new content-valid COA with various methods of administration to assess side effects of peanut OIT in a pediatric population.
Conference/Value in Health Info
2019-05, ISPOR 2019, New Orleans, LA, USA
Value in Health, Volume 22, Issue S1 (2019 May)
Code
PIH5
Topic
Clinical Outcomes, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods
Disease
Pediatrics