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Record W4410211478 · doi:10.1177/00185787251337626

Unpacking Oral Challenge Protocols: A Descriptive Epidemiologic Study of Reactions, Predictors, and Practices for Delabeling Low-Risk Penicillin Allergies Leveraging Data from a Systematic Review and Meta-Analysis

2025· review· en· W4410211478 on OpenAlex
Mira Maximos, Ryan Pelletier, Sameer Elsayed, Colleen J. Maxwell, Sherilyn K. D. Houle, Brie McConnell, John‐Michael Gamble

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.

Bibliographic record

VenueHospital Pharmacy · 2025
Typereview
Languageen
FieldMedicine
TopicDrug-Induced Adverse Reactions
Canadian institutionsWestern UniversityWomen's College HospitalUniversity of Waterloo
Fundersnot available
KeywordsMedicineMeta-analysisPsychological interventionPenicillinDescriptive statisticsAllergyAdverse effectRandomized controlled trialSystematic reviewIntensive care medicineMEDLINEInternal medicineImmunologyAntibioticsPsychiatry

Abstract

fetched live from OpenAlex

Background: Oral challenges with amoxicillin or other penicillins are safe and effective for delabeling low-risk penicillin allergy histories. While approximately 90% of reported penicillin allergies can be safely delabeled, detailed data on reaction frequency, types, and timing during and after delabeling interventions remain limited. Such data are crucial to optimizing protocols and integrating oral challenges into routine practice. This study aims to characterize the interventions commonly used for oral challenge, classify reported reactions, and identify reported predictors of hypersensitivity reactions in randomized controlled trials and quasi-experimental studies involving an oral challenge for patients with low-risk penicillin allergies. Methods: This study leverages data from a systematic review and meta-analysis assessing the effectiveness of oral challenge interventions in patients with low-risk penicillin allergies. This descriptive analysis summarizes the adverse reactions experienced among patients in published studies who received oral challenge. Participant demographics, intervention protocols, frequency, type, and timing of post-challenge adverse reactions are reported. Reactions are categorized as immediate, delayed, or other, with frequencies summarized using descriptive statistics. A random effects meta-analysis quantifies a pooled adverse reaction rate. Predictors of hypersensitivity reactions were synthesized narratively. Results: Across 26 studies (2 randomized trials, 24 quasi-experimental studies) evaluating an oral challenge for patients with a low-risk penicillin allergy, the average participant age was 56 years, with a predominance of females (61%) and limited ethnic diversity with 88% reported or identifying as White. Amoxicillin was the most frequenty used oral challenge agent, typically administered as a single 250 mg oral dose. The incidence of reaction or non-delabeling was 4% (95% Confidence Interval 3%, 6%), I 2 = 43%, P = .0001. Cutaneous manifestations, such as rashes, were the most frequent reactions. Delayed reactions, primarily mild maculopapular rashes, were uncommon and managed with antihistamines or topical steroids. Risk factors for oral challenge reactions included higher baseline allergy burden and shorter intervals to oral challenge since the index reaction. Conclusion: Oral challenge strategies to delabel low-risk penicillin allergies can involve single doses of amoxicillin or other penicillins with monitoring protocols that can be managed in ambulatory settings. However, although these delabeling strategies are becoming more prevalent, continued study of standardized protocols and follow-up are essential for effective and replicable delabeling strategies. Future research should prioritize diverse populations and equity-driven frameworks to improve generalizability to all individuals and to resource limited settings.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.004
metaresearch head score (Gemma)0.010
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Meta-analysis · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.627
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0040.010
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0110.001
Bibliometrics0.0010.001
Science and technology studies0.0000.000
Scholarly communication0.0000.001
Open science0.0010.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.435
GPT teacher head0.509
Teacher spread0.073 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it