救急部門でのアレルギー脱lable索プログラムの実装と影響

実験的：Eligible for study risk assessment questionnaire

First, a systematic allergy risk assessment tool will enable stratification of patients' reported symptoms as (1) low risk (eg, isolated urticarial, maculopapular rash, gastrointestinal symptoms) or (2) high risk (eg, anaphylaxis, severe systemic reactions). Only patients classified low risk will be eligible for oral provocation challenge for allergy delabeling. Patients' ineligible for oral provocation challenge because of history of high-risk allergy symptoms or presence of clinical confounders for oral provocation challenge (eg, uncontrolled asthma) will be referred to the SickKids allergy clinic for further evaluation.

他の：Study questionnaire

In the first component of the study, research staff will survey patients for history pertinent to their beta-lactam allergy label. This includes questions regarding any prior evaluations, patients' perception of their allergy label, and clinical details of allergy history. The latter involves an allergy history risk assessment, which will screen patient for high-risk features (eg, new maculopapular rash within 2 hours of administering antibiotic). Presence of any high-risk features will disqualify the patient from subsequent study components.

Finally, the questionnaire will screen for presence of any clinical confounders that would preclude administration of the oral provocation challenge (eg, use of antihistamines within prior 72 hours).

実験的：Eligible for oral challenge in the emergency department

A subset of patients screened with the risk assessment questionnaire will fulfill eligibility criteria to undergo the Oral provocation challenge. Specifically, these will be patients who (1) fulfill several procedural requirements (eg, parent able to observe child for 1 hour after oral provocation challenge), (2) have a previously unevaluated allergy label without high-risk features and without any clinical confounders for the oral provocation challenge, and (3) meet other clinical criteria for oral provocation challenge (eg, vital signs within normal range). These participants will be given a one-time dose of Amoxicillin 17 mg/kg (maximum, 500 mg) and observed for 1 hour for a reaction.

他の：Study questionnaire

In the first component of the study, research staff will survey patients for history pertinent to their beta-lactam allergy label. This includes questions regarding any prior evaluations, patients' perception of their allergy label, and clinical details of allergy history. The latter involves an allergy history risk assessment, which will screen patient for high-risk features (eg, new maculopapular rash within 2 hours of administering antibiotic). Presence of any high-risk features will disqualify the patient from subsequent study components.

Finally, the questionnaire will screen for presence of any clinical confounders that would preclude administration of the oral provocation challenge (eg, use of antihistamines within prior 72 hours).

薬：Amoxicillin

Prospective cohort study of patients presenting to the emergency department with a reported beta-lactam allergy. (1) Allergy history and risk assessment, (2) Oral provocation challenge (if eligible), and (3) Post-discharge follow-up (if received oral provocation challenge or referred to allergy).

The primary outcome will be the proportion of patients delabeled among those given the oral provocation challenge.

In the primary analysis, successful beta-lactam allergy removal will be defined as tolerating oral provocation challenge without any immediate adverse reaction.

低リスクのBLAが報告されている患者の割合（潜在的な影響）

これには、以前の評価、患者のアレルギーラベルに対する認識、アレルギー歴の臨床的詳細に関する質問が含まれます。 後者には、アレルギー履歴リスク評価が含まれ、リスクの高い特徴について患者をスクリーニングします（たとえば、抗生物質を投与してから2時間以内に新しい黄斑型発疹）。 リスクの高い機能が存在すると、その後の研究コンポーネントから患者が失格となります。

最後に、アンケートでは、OPCの投与を排除する臨床的交絡因子の存在を選別します（例えば、72時間以前の抗ヒスタミン薬の使用）。

副作用なしで患者の割合は正常に捨てられました（即時または2週間まで遅延）

成功したBLA除去は、即時の副作用なしにOPCを許容するものとして定義されます。

OPCを受ける患者の中で、アモキシシリンまたは第一世代のセファロスポリンを受け取った、または処方されている患者の割合

OPCに同意する適格な参加者の割合に基づく実現可能性

アレルギーリスク評価とOPCの期間に基づく実現可能性（CRFタイムスタンプを使用して計算）

BLAおよびOPCの患者および介護者の視点

口頭での課題が完了した後、参加者とその介護者は、アレルギーラベルをチャートから削除することに対する口頭課題の安全性と快適性に関する意見を評価するために、調査アンケートに記入します。