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Abstract：
OBJECTIVE: The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of \'point-of-care\' tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling.
METHODS: This prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC.
RESULTS: N = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors.
CONCLUSIONS: DPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings.
METHODS: This prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC.
RESULTS: N = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors.
CONCLUSIONS: DPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings.
摘要：
目的：不准确的青霉素过敏标签（PAL）的巨大负担是抗菌药物耐药性的重要驱动因素。过敏专家不足和缺乏“护理点”测试放大了这一点。我们调查了非过敏医疗保健专业人员（HCPs）提供直接口服青霉素挑战（DPC）用于青霉素过敏去标记的可行性。
方法：这项前瞻性观察性研究是在英格兰的三家医院进行的，涉及三种环境（急性医学，术前和血液学-肿瘤学)。对PAL患者进行筛查并分层为低风险/高风险。低风险患者（非免疫介导的症状，良性皮疹,耐受阿莫西林以来和家族史）接受了DPC。
结果：筛选了N=2257个PAL，1054人符合条件；接近643人，373拒绝，270份同意，259份风险分层(低风险=155；高风险=104)。126例低危患者接受DPC，122（96.8％）被去标记，没有严重的过敏反应。从筛查到同意的转化率为12％[在急性和选择性设置中分别为3.3％和17.9％；在血液学-肿瘤学和手术前设置中，同意的赔率分别为3.42（p<0.001）和5.53（p<0.001）。研究进展失败的常见原因包括难以接触到患者，临床不稳定/医疗原因，缺乏同意的能力和心理因素。
结论：DPC可以通过非过敏HCP递送。高比例的PAL患者在研究途径中没有进展。需要在护理途径的最佳点递送DPC的策略以增强摄取。选择性设置比DPC的急性设置提供更大的机会。DPC的安全性和简单性适合英国以外的医疗保健系统采用，包括在资源有限的设置中。
背景：NIHR129069。
方法：这项前瞻性观察性研究是在英格兰的三家医院进行的，涉及三种环境（急性医学，术前和血液学-肿瘤学)。对PAL患者进行筛查并分层为低风险/高风险。低风险患者（非免疫介导的症状，良性皮疹,耐受阿莫西林以来和家族史）接受了DPC。
结果：筛选了N=2257个PAL，1054人符合条件；接近643人，373拒绝，270份同意，259份风险分层(低风险=155；高风险=104)。126例低危患者接受DPC，122（96.8％）被去标记，没有严重的过敏反应。从筛查到同意的转化率为12％[在急性和选择性设置中分别为3.3％和17.9％；在血液学-肿瘤学和手术前设置中，同意的赔率分别为3.42（p<0.001）和5.53（p<0.001）。研究进展失败的常见原因包括难以接触到患者，临床不稳定/医疗原因，缺乏同意的能力和心理因素。
结论：DPC可以通过非过敏HCP递送。高比例的PAL患者在研究途径中没有进展。需要在护理途径的最佳点递送DPC的策略以增强摄取。选择性设置比DPC的急性设置提供更大的机会。DPC的安全性和简单性适合英国以外的医疗保健系统采用，包括在资源有限的设置中。
背景：NIHR129069。
