A novel patient-reported outcomes instrument assessing the side effects of peanut oral immunotherapy

Ann Allergy Asthma Immunol. 2021 Jan;126(1):61-68. doi: 10.1016/j.anai.2020.07.027. Epub 2020 Jul 31.

Abstract

Background: Patients treated with peanut oral immunotherapy (OIT) may experience adverse reactions, particularly during up-dosing.

Objective: To develop the Side Effects of Peanut Oral Immunotherapy Diary (SEPOD), an electronic questionnaire assessing the daily side effects of peanut OIT in clinical trials.

Methods: Content and design of the SEPOD were informed by empirical literature review and meetings with 3 allergy-immunology experts. Interviews to confirm content and inform revisions were conducted in 24 pediatric patients with peanut allergy (14 treated with peanut OIT) aged 6 to 17 years; children aged 6 to 11 years were interviewed with their caregiver.

Results: The SEPOD was drafted after literature review and expert interviews; the initial measurement approach comprised 2 SEPOD versions, a patient-reported outcome (PRO) version for children aged 12 to 17 years, and a caregiver-administered PRO version for children aged 6 to 11 years with instructions for caregiver questionnaire administration. Pediatric patients were expected to respond independently on both versions. Patient interviews indicated that some younger children (ie, aged 6-8 years) had difficulty understanding questions, even when reading aloud; therefore, a caregiver-administered outcome version, identical in content to the caregiver-administered PRO version, was developed for this age group. The final electronic SEPOD covered 23 peanut OIT side effects within the following 7 domains: gastrointestinal, dermatologic, itching, nasal, and respiratory, swelling (eyelid or periorbital, lip, tongue, and throat), pain (tongue, mouth, and throat), and dizziness.

Conclusion: This study yielded the SEPOD, a new clinical outcome assessment instrument with various methods of administration that can be used to assess the side effects of peanut OIT experienced by pediatric patients in a clinical trial setting.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Allergens / immunology
  • Arachis / immunology
  • Desensitization, Immunologic / adverse effects*
  • Desensitization, Immunologic / methods
  • Expert Testimony
  • Female
  • Humans
  • Male
  • Patient Reported Outcome Measures
  • Peanut Hypersensitivity / epidemiology*
  • Peanut Hypersensitivity / therapy

Substances

  • Allergens