Rapid diagnostic tests for adenovirus conjunctivitis in children: An epidemiologic, clinical, and cost-effectiveness evaluation

儿童腺病毒结膜炎的快速诊断检测：流行病学、临床和成本效益评估

基本信息

批准号：
10647693
负责人：
Holly Frost
金额：
$ 15.24万
依托单位：
DENVER HEALTH AND HOSPITAL AUTHORITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-10 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10647693
关键词：
18 year old Accounting Acute Acute Conjunctivitis Adenoviruses Adverse event Adverse reactions Age Antibiotic Resistance Antibiotics Antigens Antimicrobial Resistance Bacteria Bacterial Infections Biological Assay Biometry Caregivers Child Child Care Childhood Clinic Clinical Clinical Research Clinical Sensitivity Clinical effectiveness Communicable Diseases Communities Community Health Complication Conduct Clinical Trials Conjunctivitis Cost Effectiveness Analysis Data Day Care Decision Trees Diagnosis Diagnostic tests Economic Burden Ensure Epidemiology Evaluation FDA approved Goals Health Health Care Sector Health system Healthcare Healthcare Systems Incidence Infection K-Series Research Career Programs Mentors Mentorship Modeling Multi-Institutional Clinical Trial Multicenter Studies Outpatients Patients Pediatrics Pharmaceutical Preparations Polymerase Chain Reaction Predictive Value Principal Investigator Rapid diagnostics Research Research Personnel Schools Sensitivity and Specificity Site Specificity Surveys Swab Testing Training Translational Research United States Upper Respiratory Infections Validation Viral Viral Conjunctivitis Virus Virus Diseases Visit Work age group antigen detection antigen test arm career clinical care comparative cost effectiveness conjunctiva cost effective cost effectiveness cost estimate cost-effectiveness evaluation design detection platform detection test disease diagnostic dysbiosis experience follow-up improved incremental cost-effectiveness interest microbial multidisciplinary ocular microbiome participant enrollment point of care point of care testing point-of-care diagnostics prospective recruit social societal costs success superinfection transmission process

项目摘要

PROJECT SUMMARY/ABSTRACT Acute infectious conjunctivitis is one of the most common pediatric infections worldwide, however, the microbial causes of this infection are poorly understood. Though it has been estimated that up to 90% of conjunctivitis in children is viral in origin, over 80% of children with acute conjunctivitis are prescribed an ophthalmic antibiotic. This is a concern because incidence of antimicrobial resistant conjunctivitis is increasing, 8% of children have an adverse reaction to ophthalmic antibiotics, and prescription of ophthalmic antibiotics results in a large health care and social economic burden. Recently, an FDA approved point-of-care rapid antigen detection test for adenovirus conjunctivitis has become available. The test is $10.50, non-invasive, and can be completed in less than 15 minutes in the clinic setting. Implementation of this test may substantially reduce the use of ophthalmic antibiotics in children. The current utility of this test is limited, however, because: (1) data evaluating viral and bacterial causes of conjunctivitis in this age group are lacking; (2) rates of bacterial and viral concurrent infections are unknown; (3) the clinical sensitivity and specificity of the rapid point of care adenovirus test in children has not been assessed; and (4) cost effectiveness analysis for wide spread implementation of the test in pediatric settings has not been conducted. This proposal aims to meet the critical need to improve clinical care for children with conjunctivitis by (1) determining the viral and bacterial causes of conjunctivitis children; (2) clinically validating a rapid point of care adenovirus conjunctivitis test in children; and (3) estimating the percent reduction in unnecessary antibiotic prescriptions and cost-effectiveness of implementation of rapid adenovirus conjunctivitis diagnostic tests across health care systems. This project is the culmination of this candidate’s interest and experience in the validation and use of rapid infectious disease diagnostic tests to improve clinical care for children. The objective of this career development award is to develop this candidate into an independent principal investigator in clinical and translational research with expertise in the implementation and evaluation of infectious disease diagnostics in pediatrics. Mentorship, didactic coursework, seminars, and completion of the proposed study will address specific training needs of the investigator including training in the design and conduct of large-scale, multi-center clinical trials, advanced biostatistical analysis, and cost-effectiveness analysis. The candidate has assembled a multidisciplinary team of mentors and advisors with extensive research experience and topical expertise in the above realms to ensure her success in achieving the stated specific aims and career goals.

项目概要/摘要急性传染性结膜炎是全世界最常见的儿科感染之一，然而，人们对这种感染的微生物原因知之甚少，但据估计高达 90%。儿童结膜炎的起源是病毒，超过 80% 的急性结膜炎儿童接受了这是一个令人担忧的问题，因为抗生素耐药性结膜炎的发病率正在增加， 8%儿童对眼科抗生素有不良反应，眼科抗生素处方最近，FDA 批准了一项即时护理快速治疗，造成巨大的医疗保健和社会经济负担。腺病毒结膜炎抗原检测测试现已上市，该测试价格为 10.50 美元，非侵入性。在诊所环境中可以在不到 15 分钟内完成该测试的实施可能会大大缩短。然而，减少儿童眼科抗生素的使用目前该测试的效用有限，因为： (1) 缺乏评估该年龄组结膜炎的病毒和细菌原因的数据；(2) 发生率；细菌和病毒并发感染未知；（3）快速点的临床敏感性和特异性；尚未对儿童中腺病毒检测的护理进行评估；以及（4）广泛传播的成本效益分析；尚未在儿科环境中实施该测试，旨在满足关键要求。需要通过以下方式改善儿童结膜炎的临床护理：（1）确定结膜炎的病毒和细菌原因儿童结膜炎；(2) 临床验证儿童腺病毒结膜炎快速检测；以及 (3) 估计不必要的抗生素处方的减少百分比和成本效益该项目是在整个医疗保健系统中实施快速腺病毒结膜炎诊断测试。该候选人对快速传染病的验证和使用的兴趣和经验的顶峰改善儿童临床护理的诊断测试该职业发展奖的目的是将该候选人发展为临床和转化研究的独立首席研究员儿科传染病诊断的实施和评估方面的专业指导，教学课程、研讨会和拟议研究的完成将满足学生的具体培训需求研究者，包括设计和进行大规模、多中心临床试验、高级候选人组建了一个多学科团队。在上述领域拥有研究经验和专题专业知识的广泛导师和顾问确保她成功实现既定的具体目标和职业目标。

项目成果

期刊论文数量（27）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

COVID-19 and Acute Otitis Media in Children: A Case Series.

COVID-19 和儿童急性中耳炎：案例系列。

DOI：
发表时间：
2022
期刊：
影响因子：
0
作者：
Frost, Holly M;Sebastian, Thresia;Keith, Amy;Kurtz, Melanie;Dominguez, Samuel R;Parker, Sarah K;Jenkins, Timothy C
通讯作者：
Jenkins, Timothy C

Reducing Ophthalmic Antibiotic Use for Non-severe Conjunctivitis in Children.

减少儿童非严重结膜炎眼科抗生素的使用。

DOI：
发表时间：
2023-09-27
期刊：
影响因子：
3.2
作者：
Sebastian, Thresia;Durfee, Josh;Wittmer, Nancy;Jack, Jessica;Keith, Amy;Jenkins, Timothy C;Frost, Holly M
通讯作者：
Frost, Holly M

Sustaining outpatient antimicrobial stewardship: Do we need to think further outside the box?

维持门诊抗菌药物管理：我们是否需要跳出框框进一步思考？