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.

中文翻译：

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一种新颖的患者报告结局工具，用于评估花生口服免疫疗法的副作用。

背景

用花生口服免疫疗法（OIT）治疗的患者可能会出现不良反应，尤其是在加药期间。

目的

为了开发花生口服免疫疗法日记（SEPOD）的副作用，该电子问卷调查了花生OIT在临床试验中的每日副作用。

方法

SEPOD的内容和设计是通过经验文献回顾以及与3位过敏/免疫学专家的会议而获得的。对24名6-17岁的花生过敏（14名接受花生OIT治疗）的儿科患者进行了访谈，以确认内容并告知修订。对6-11岁的儿童进行了照顾者访谈。

结果

SEPOD是在文献回顾和专家访谈之后起草的；最初的测量方法包括2个SEPOD版本，12-17岁儿童的患者报告结局（PRO）版本以及6-11岁儿童的由照顾者管理的PRO（CarePRO）版本以及有关照顾者问卷管理的说明。预计小儿患者对两种药物的反应均独立。病人访谈表明，即使是大声朗读，一些较小的孩子（即6-8岁）也难以理解问题。因此，针对该年龄段开发了护理人员管理的结局（CareO）版本，其内容与CarePRO版本相同。最终的电子SEPOD涵盖了7个领域的23种花生OIT副作用：胃肠道，皮肤病，瘙痒，鼻/呼吸道，

结论

这项研究得出了SEPOD，这是一种具有多种给药方法的新型临床结果评估工具，可用于评估儿科患者在临床试验中所经历的花生OIT的副作用。