A novel patient-reported outcomes instrument assessing the side effects of peanut oral immunotherapy
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:126 |
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| Enthalten in: |
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology - 126(2021), 1 vom: 05. Jan., Seite 61-68 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Turner-Bowker, Diane M [VerfasserIn] |
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| Links: |
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| Themen: |
Allergens |
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| Anmerkungen: |
Date Completed 01.02.2021 Date Revised 01.02.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.anai.2020.07.027 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM313209332 |
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| 100 | 1 | |a Turner-Bowker, Diane M |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A novel patient-reported outcomes instrument assessing the side effects of peanut oral immunotherapy |
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| 500 | |a Date Revised 01.02.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Patients treated with peanut oral immunotherapy (OIT) may experience adverse reactions, particularly during up-dosing | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Meta-Analysis | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Allergens |2 NLM | |
| 700 | 1 | |a Jalbert, Jessica J |e verfasserin |4 aut | |
| 700 | 1 | |a Krohe, Meaghan |e verfasserin |4 aut | |
| 700 | 1 | |a Yaworsky, Andrew |e verfasserin |4 aut | |
| 700 | 1 | |a Kelly, Masami T |e verfasserin |4 aut | |
| 700 | 1 | |a Padilla, Brad |e verfasserin |4 aut | |
| 700 | 1 | |a Chaston, Emily |e verfasserin |4 aut | |
| 700 | 1 | |a Radin, Allen |e verfasserin |4 aut | |
| 700 | 1 | |a Mastey, Vera |e verfasserin |4 aut | |
| 700 | 1 | |a Nadeau, Kari C |e verfasserin |4 aut | |
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