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

项目摘要/摘要 急性传染性结膜炎是全球最常见的儿科感染之一，然而， 这种感染的微生物原因还知之甚少。尽管据估计，高达90%的 儿童结膜炎是由病毒引起的，超过80%的儿童急性结膜炎是由 眼科抗生素。这是一个令人担忧的问题，因为抗菌素耐药性结膜炎的发病率正在增加， 8%的儿童对眼科抗生素和眼科抗生素处方有不良反应 造成很大的医疗保健和社会经济负担。最近，一家FDA批准的快速护理点 对腺病毒结膜炎的抗原检测试验已经成为可能。这项测试的费用是10.50美元，非侵入性，而且 在诊所环境下可以在不到15分钟的时间内完成。该测试的实施基本上可以 减少儿童眼科抗生素的使用。然而，这项测试目前的效用是有限的，因为： (1)缺乏评估该年龄段结膜炎的病毒和细菌病因的数据；(2) 细菌和病毒同时感染尚不清楚；(3)快速穴位的临床敏感性和特异性 (4)广泛传播的成本-效果分析 尚未在儿科环境中实施该测试。这项建议旨在满足关键的 需要通过(1)确定儿童结膜炎的病毒和细菌原因来改善儿童结膜炎的临床护理 儿童结膜炎；(2)临床验证儿童快速看护点腺病毒结膜炎试验；以及 (3)估算不必要的抗生素处方减少率和成本-效果 在卫生保健系统中实施快速腺病毒结膜炎诊断测试。这个项目是 这位候选人对快速传染病的验证和使用的兴趣和经验达到了顶峰 诊断性测试，以改善儿童的临床护理。这个职业发展奖的目标是 将此候选人培养为临床和转化性研究的独立首席研究员 儿科传染病诊断学的实施和评估方面的专业知识。导师关系， 教学课程、研讨会和拟议研究的完成将满足以下方面的具体培训需求 研究人员，包括设计和实施大规模、多中心临床试验的培训，高级 生物统计分析和成本效益分析。这位候选人已经组建了一个多学科团队 在上述领域拥有丰富研究经验和专题专业知识的导师和顾问 确保她成功实现所述的具体目标和职业目标。

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.