Provocation After Nurse-Directed Assessment (PANDA) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nurse-led penicillin allergy delabelling service, Allergist-led penicillin allergy delabelling service.
- Who it may be relevant to
- Registry conditions: Drug Allergy, Penicillin Allergy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Diagnostic test 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. - Diagnostic test 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.
Primary outcome measures
- Delabelling Success Rate [Time frame: 6 months]
Secondary outcome measures (5)
- Health-Related Quality of Life [Time frame: 6 months]
- Antibiotic Usage Rate [Time frame: 6 months]
- Age Group Analysis [Time frame: 6 months]
- Immunocompetence Status [Time frame: 6 months]
- Initial vs. Recurrent Labeling [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Hong Kong · 4 centers
- Prince of Wales Hospital — Hong Kong
- Princess Margaret Hospital — Hong Kong
- Queen Elizabeth Hospital — Hong Kong
- Queen Mary Hospital — Hong Kong
Publications
- 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
Identifiers
NCT: NCT07127835 · PANDAstudy