The Clinical and Economic Impact of Penicillin Allergy

青霉素过敏的临床和经济影响

• 批准号: 9921287
• 负责人: Kimberly Gold Blumenthal
• 金额: $ 13.72万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-22 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9921287
• 关键词: Accident and Emergency department; Address; Allergic; Allergic Reaction; Antibiotic Resistance; Antibiotics; Antimicrobial Resistance; Bioinformatics; Biometry; Cephalosporins; Chiroptera; Clinical; Clinical Immunology; Clostridium difficile; Code; Colitis; Communicable Diseases; Complement; Cost Effectiveness Analysis; Data; Databases; Doctor of Medicine; Doctor of Philosophy; Dose; Drug Hypersensitivity; Economic Burden; Economics; Educational workshop; Electronic Health Record; Ensure; Environment; Epidemiology; Evaluation; Frequencies; Funding; General Hospitals; Goals; HIV; Health; Health Policy; Healthcare; Healthcare Systems; Hypersensitivity; Hypersensitivity skin testing; Immune; Immunology; Infection; Infection Control; Inpatients; Intensive Care Units; Internal Medicine; International; Intervention; Investigation; Journals; K-Series Research Career Programs; Knowledge; Lead; Literature; London; Manuscripts; Massachusetts; Master of Science; Mediating; Medical; Medicine; Mentors; Mentorship; Methods; Modeling; Monobactams; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Outcome; Outcomes Research; Outpatients; Patient Care; Patient Self-Report; Patient-Focused Outcomes; Patients; Peer Review; Penicillin Allergy; Penicillins; Perioperative; Pharmaceutical Preparations; Phenotype; Physician Executives; Policies; Population; Positioning Attribute; Prevalence; Public Health; Public Health Schools; Publications; Reaction; Recording of previous events; Reporting; Research; Research Personnel; Research Proposals; Research Training; Resistance; Resources; Risk; Safety; Schools; Science; Surgical Wound Infection; Testing; Text; Training; Training Activity; United States National Institutes of Health; Universities; Untranslated RNA; Work; adverse drug reaction; beta-Lactams; care costs; career; clinical epidemiology; cohort; combat; cost; cost effective; cost effectiveness; design; economic impact; electronic data; epidemiology study; genetic linkage analysis; health care quality; healthcare-associated infections; improved; instructor; medical schools; models and simulation; mortality; multidisciplinary; programs; simulation; skills; success; undergraduate student

Project Summary Candidate Kimberly G. Blumenthal, MD is an Assistant in Medicine in the Allergy and Clinical Immunology Unit at Massachusetts General Hospital (MGH) and an Instructor of Medicine at Harvard Medical School (HMS). After her undergraduate training in economics at Columbia University and the London School of Economics, she received her M.D. from Yale University. Dr. Blumenthal began working with Rochelle P. Walensky, MD, MPH and the Medical Practice Evaluation Center (MPEC) at MGH after completion of her clinical training at MGH in Internal Medicine and Allergy/Immunology. Dr. Blumenthal studies drug allergy epidemiology and impact on patient care; she has authored 13 total manuscripts, with 7 first-authored peer-reviewed manuscripts, including publications in the Journal of Allergy and Clinical Immunology and Clinical Infectious Diseases. Dr. Blumenthal is completing a Masters of Science in Epidemiology at the Harvard T.H. Chan School of Public Health. Dr. Blumenthal's goal is to become a national leader in drug allergy with methods expertise in clinical epidemiology and decision science. Mentorship, Training Activities, and Environment Dr. Blumenthal will perform the work outlined in this proposal at MGH under the mentorship of Rochelle P. Walensky, MD, MPH and co-mentorship of Aleena Banerji, MD. Dr. Walensky, Co-director of MPEC, is a nationally-recognized expert in decision science whose research has motivated national and international policies related to testing and treatment of Human Immunodeficiency Virus. Dr. Walensky has been NIH-funded since 2006; she has served as a mentor to over 5 prior K awardees, and has successfully transitioned fellows to independent R01-funded research careers. Dr. Banerji is a nationally-recognized expert in drug allergy with expertise in epidemiology and outcomes research. Dr. Blumenthal's research will benefit from the specific expertise of collaborators: Carlos A. Camargo, MD, DrPH (epidemiology), Robert A. Parker, ScD (biostatistics), Stephen Resch, PhD (resource utilization), Li Zhou, MD, PhD (bioinformatics) and Erica S. Shenoy, MD, PhD (infection control). Dr. Blumenthal has organized a Scientific Advisory Board, chaired by Dr. Camargo, that includes: Andrew D. Luster, MD, PhD, Katrina A. Armstrong, MD, MSCE and David W. Bates, MD, MSc. To complement the expertise of her mentors, collaborators and advisors, Dr. Blumenthal will complete didactic courses to acquire new research skills, including linkage and analysis of large databases, resource utilization analysis and simulation modeling and cost-effectiveness analysis. The collaborative opportunities, intellectual environment, and resources available to Dr. Blumenthal are outstanding and will provide her with a clear path to independent research success. Research Penicillin (PCN) allergy is reported by over 10% of the U.S. population, though a self-reported PCN allergy infrequently reflects an actual inability to tolerate PCNs and other β-lactam antibiotics (e.g., cephalosporins). Unnecessary use of β-lactam alternative antibiotics may lead to more antimicrobial resistance and healthcare-associated infections, as well as higher costs. Although the prevalence of self-reported PCN allergy does not equate with true PCN hypersensitivity, PCNs and other β-lactam antibiotics are the most common cause of drug hypersensitivity reactions, the immune-mediated subset of adverse drug reactions (ADRs). ADRs have a large impact on patient morbidity, mortality and cost of care. PCN allergy evaluation with skin testing can distinguish between patients with and without true PCN hypersensitivity. Implementation of a history-appropriate PCN skin testing may improve clinical outcomes and the efficiency of resource use. The K01 scientific program, The Clinical and Economic Impact of Penicillin Allergy, has three specific aims that lie at the research intersection of Allergy/Immunology, Infectious Diseases and healthcare policy, and align with national priorities including curbing antimicrobial resistance and improving healthcare quality and safety: 1) To assess the clinical and economic impact of reported PCN allergy in a large U.S. healthcare system using a large patient cohort combined from separate internal databases. 2) To determine the frequency, predictors and healthcare resource impact of PCN and cephalosporin hypersensitivity reactions in the outpatient setting using an internal cohort of patients prescribed PCNs or cephalosporins over a 10-year period. 3) To project the clinical outcomes, budgetary impact and cost-effectiveness of implementing a PCN skin testing program in the U.S. using a simulation model. Completion of this research proposal and training plan will position Dr. Blumenthal for an independent research career as a drug allergy expert with methods skills in clinical epidemiology and decision science.

项目摘要 候选人金伯利·G·布鲁门撒尔，医学博士，过敏和临床免疫科医学助理 马萨诸塞州总医院(MGH)和哈佛医学院(HMS)的医学讲师。 在哥伦比亚大学和伦敦经济学院接受经济学本科培训后， 她在耶鲁大学获得医学博士学位。布鲁门撒尔博士开始与医学博士罗谢尔·P·瓦伦斯基合作， 公共卫生硕士和医疗实践评估中心(MPEC)在完成临床培训后在MGH 内科和过敏/免疫学硕士学位。布鲁门塔尔博士研究药物过敏流行病学和 对病人护理的影响；她总共撰写了13篇手稿，其中7篇是第一作者的同行评议 稿件，包括发表在《过敏与临床免疫学与临床感染学》杂志上的论文 疾病。布鲁门撒尔博士即将在哈佛大学完成流行病学理学硕士学位 公共卫生学院。布鲁门撒尔博士的目标是成为药物过敏方法方面的全国领导者 临床流行病学和决策科学方面的专业知识。 导师、培训活动和环境布鲁门撒尔博士将执行本报告中概述的工作 在罗谢尔·P·瓦伦斯基(Rochelle P.Walensky)医学博士、公共卫生硕士和Aleena共同指导下在MGH的提案 马里兰州班纳吉瓦伦斯基博士是MPEC的联席董事，是全国公认的决策科学专家，他 研究推动了与人类疾病检测和治疗相关的国家和国际政策 免疫缺陷病毒。自2006年以来，瓦伦斯基博士一直由美国国立卫生研究院资助；她曾担任过5个以上 之前的K奖获得者，并已成功地将研究员过渡到由R01资助的独立研究职业。Dr。 Banerji是国家公认的药物过敏专家，在流行病学和结果研究方面拥有专业知识。 布鲁门撒尔博士的研究将受益于合作者的特定专业知识：卡洛斯·A·卡马戈，医学博士， 博士(流行病学)，Robert A.Parker，SCD(生物统计学)，Stephen Resch，博士(资源利用)，Li 周，医学博士(生物信息学)和Erica S.Shenoy，医学博士，博士(感染控制)。布鲁门撒尔博士已经 组织了一个科学咨询委员会，由卡马戈博士担任主席，成员包括：安德鲁·D·卢斯特，医学博士，博士， Katrina A.Armstrong医学博士和David W.Bates医学硕士为了补充她导师的专业知识， 合作者和顾问，布鲁门撒尔博士将完成授课课程，以获得新的研究技能， 包括大型数据库的链接和分析、资源利用率分析和仿真建模以及 成本效益分析。协作机会、智力环境和可用资源 对布鲁门撒尔博士来说，这些都是杰出的，将为她提供一条通往独立研究成功的明确道路。 超过10%的美国人报告了研究性青霉素(PCN)过敏，尽管自我报告的PCN 过敏反应很少反映出实际不能耐受PCNS和其他β-内酰胺类抗生素(例如， 头孢菌素类)。不必要地使用β-内酰胺类替代抗生素可能会导致更多的耐药性 以及与医疗保健相关的感染，以及更高的成本。尽管自我报告的PCN的流行率 过敏并不等同于真正的PCN超敏反应，PCNS和其他β-内酰胺类抗生素是最多的 药物过敏反应的常见原因，即免疫介导的药物不良反应亚类 (ADRS)。ADR对患者的发病率、死亡率和医疗成本有很大影响。PCN过敏性评估 皮肤测试可以区分患有和不患有真正的PCN过敏症的患者。实施一种 与病史相适应的PCN皮肤测试可能会改善临床结果和资源利用效率。这个 K01科学计划，青霉素过敏的临床和经济影响，有三个具体的目标 在过敏/免疫学、传染病和医疗保健政策的研究交叉点，并与 国家优先事项包括遏制抗菌素耐药性和提高医疗质量和安全： 1)评估报告的PCN过敏在美国大型医疗系统中的临床和经济影响 使用从独立的内部数据库组合而来的大型患者队列。 2)确定PCN和头孢菌素的使用频率、预测因素和医疗资源影响 在门诊环境中使用开PCN或PCN的患者的内部队列中的过敏反应 头孢菌素类药物，为期10年。 3)预测实施PCN皮肤的临床结果、预算影响和成本效益 在美国使用模拟模型测试程序。 完成这项研究提案和培训计划将使布鲁门塔尔博士能够进行独立研究 作为一名药物过敏专家，具有临床流行病学和决策科学的方法技能。