Provocation After Nurse-Directed Assessment (PANDA) Study

Обзор

The study aims to evaluate the effectiveness and safety of a collaborative nurse-allergist approach in penicillin allergy delabeling services. It also seeks to assess the impact on patients' quality of life and compare resource utilization and cost-effectiveness between the nurse-allergist collaborative approach and the traditional allergist-led approach.

Подробное описание

This study hypothesizes that by involving both nurses and allergists in the delabeling process and categorizing patients based on risk levels, it will achieve comparable success rates, safety, and improvements in patients' quality of life. This approach is expected to offer superior advantages in terms of time efficiency, resource utilization, and cost-effectiveness compared to traditional allergist-led services.

Вмешательства

• Диагностический тест Nurse-led penicillin allergy delabelling service
  Patients in this group undergo risk assessment and categorization by nurses to identify low-risk individuals for delabeling. For these patients, nurses will collaborate with allergists in the delabeling process.
• Диагностический тест Allergist-led penicillin allergy delabelling service
  Patients assigned to this group will undergo risk assessment and delabeling led by allergists for both low-risk and high-risk cases.

Первичные конечные точки

• Delabelling Success Rate [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Health-Related Quality of Life [Срок оценки: 6 months]
• Antibiotic Usage Rate [Срок оценки: 6 months]
• Age Group Analysis [Срок оценки: 6 months]
• Immunocompetence Status [Срок оценки: 6 months]
• Initial vs. Recurrent Labeling [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Receiving inpatient or outpatient treatment at a participating hospital during the study period;
• Possessing a documented penicillin allergy label;
• Underwent penicillin allergy evaluation by the nurse-allergist collaborative approach or the traditional allergist-led approach
• Demographic and clinical data required for the study available.

Критерии исключения

• Patients unable to provide a complete medication history or history of penicillin allergy;
• Patients with only emergency or short-term treatment records;
• Patients who have taken steroids, antihistamines, or similar medications within the last 3 days.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Гонконг · 4 центра

• Prince of Wales Hospital — Гонконг
• Princess Margaret Hospital — Гонконг
• Queen Elizabeth Hospital — Гонконг
• Queen Mary Hospital — Гонконг

Публикации

• Schnyder B, Pichler WJ. Mechanisms of drug-induced allergy. Mayo Clin Proc. 2009 Mar;84(3):268-72. doi: 10.4065/84.3.268. PMID 19252115
• Abrams EM, Khan DA. Diagnosing and managing drug allergy. CMAJ. 2018 Apr 30;190(17):E532-E538. doi: 10.1503/cmaj.171315. No abstract available. PMID 29712672
• Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997 Jan 22-29;277(4):301-6. PMID 9002492
• Pourpak Z, Fazlollahi MR, Fattahi F. Understanding adverse drug reactions and drug allergies: principles, diagnosis and treatment aspects. Recent Pat Inflamm Allergy Drug Discov. 2008 Jan;2(1):24-46. doi: 10.2174/187221308783399289. PMID 19075990
• Patton K, Borshoff DC. Adverse drug reactions. Anaesthesia. 2018 Jan;73 Suppl 1:76-84. doi: 10.1111/anae.14143. PMID 29313907

Идентификаторы

NCT: NCT07127835 · PANDAstudy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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