응급실에서 알레르기 비 표지 프로그램의 구현 및 영향

실험적: 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.

다른: 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).

실험적: 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.

다른: 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).

의약품: 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.

위험이 낮은 BLA가보고 된 환자의 비율 (잠재적 영향)

여기에는 사전 평가, 알레르기 레이블에 대한 환자의 인식 및 알레르기 이력에 대한 임상 세부 사항에 관한 질문이 포함됩니다. 후자는 알레르기 이력 위험 평가를 포함하며, 이는 고위험 특징 (예 : 항생제 투여 후 2 시간 이내에 새로운 황반성 발진)을 선별합니다. 고위험 특징의 존재는 후속 연구 구성 요소로부터 환자를 실격시킬 것이다.

마지막으로, 설문지는 OPC의 투여를 방해하는 임상 혼란 자의 존재를 선별합니다 (예 : 72 시간 이내에 항히스타민 제의 사용).

부작용없이 환자의 비율이 성공적으로 박탈되었습니다 (즉시 또는 지연 2 주)

성공적인 BLA 제거는 즉각적인 부작용없이 OPC를 허용하는 것으로 정의됩니다.

OPC를 겪는 환자들 사이에서 아목시실린 또는 1 세대 세 팔로 스포린을 받거나 처방받은 환자의 비율

OPC에 동의하는 적격 참가자의 비율에 따른 타당성

알레르기 위험 평가 및 OPC의 기간에 따른 타당성 (CRF 타임 스탬프를 사용하여 계산)

BLA 및 OPC에 대한 환자 및 간병인 관점

구두 도전이 완료된 후, 참가자와 간병인은 구두 도전의 안전성에 대한 의견과 알레르기 레이블을 차트에서 제거함으로써 편안함에 대한 의견을 평가하기위한 연구 설문지를 완료 할 것입니다.