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

• 批准号: 10439449
• 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
• 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/10439449
• 关键词: 18 year old; Accounting; Acute; Acute Conjunctivitis; Address; 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; Complication; Conduct Clinical Trials; Conjunctivitis; Cost Effectiveness Analysis; Data; Decision Trees; Diagnosis; Diagnostic tests; Economic Burden; Enrollment; 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; age group; antigen detection; antigen test; arm; base; 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; point of care; point of care testing; point-of-care diagnostics; prospective; recruit; social; societal costs; success; superinfection; transmission process

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.

项目摘要/摘要 急性感染性结膜炎是全球最常见的小儿感染之一，但是 这种感染的微生物原因知之甚少。尽管据估计多达90％ 儿童结膜炎的起源是病毒的，超过80％的急性结膜炎的儿童被开了 眼科抗生素。这是一个问题，因为抗菌素抗性结膜炎的发生率正在增加， 8％的儿童对眼科抗生素有不良反应和眼科抗生素的处方 导致巨大的医疗保健和社会经济负担。最近，FDA批准了保健点快速 腺病毒结膜炎的抗原检测测试已获得。该测试为$ 10.50，无创，并且 可以在不到15分钟的诊所环境中完成。该测试的实施可能基本上 减少儿童眼科抗生素的使用。但是，该测试的当前效用是有限的，因为： （1）缺乏该年龄段的病毒性和细菌原因的数据； （2） 细菌和病毒并发感染未知； （3）快速点的临床灵敏度和特异性 尚未评估儿童的腺病毒测试； （4）成本效益分析的广泛分析 尚未进行小儿环境中的测试。该建议旨在满足关键 需要通过（1）确定病毒和细菌的病毒和细菌来改善结膜炎儿童的临床护理 结膜炎儿童； （2）临床验证儿童的快速护理腺病毒结膜测试；和 （3）估计不必要的抗生素处方的百分比和成本效益 跨保健系统的快速腺病毒结膜诊断测试的实施。这个项目是 该候选人在验证和使用快速传染病方面的兴趣和经验的高潮 诊断测试以改善儿童的临床护理。这个职业发展奖的目的是 将此候选人开发为临床和翻译研究的独立首席研究员 在儿科中传染病诊断的实施和评估方面的专业知识。指导， 拟议的研究的教学课程，半手和完成将解决特定的培训需求 研究人员包括大规模，多中心临床试验的设计和进行培训，高级 生物统计分析和成本效益分析。候选人组建了一个多学科团队 具有丰富研究经验的导师和顾问，以及上述领域的专业知识 确保她成功实现既定目标和职业目标。