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.

项目总结/摘要 急性传染性结膜炎是世界范围内最常见的儿科感染之一，然而， 这种感染的微生物原因知之甚少。尽管据估计， 儿童结膜炎是由病毒引起的，超过80%的急性结膜炎儿童被处方， 眼用抗生素这是一个令人担忧的问题，因为耐抗生素结膜炎的发病率正在增加， 8%的儿童对眼用抗生素有不良反应， 造成巨大的医疗保健和社会经济负担。最近，FDA批准了一种即时护理快速 腺病毒结膜炎的抗原检测试验已经成为可能。这个测试是10.50美元，非侵入性的， 在诊所环境中，可以在15分钟内完成。这项测试的实施可能会大大 减少儿童眼用抗生素的使用。然而，该测试的当前效用是有限的，因为： (1)缺乏评价该年龄组结膜炎的病毒和细菌原因的数据;（2） 细菌和病毒并发感染未知;（3）快速点的临床敏感性和特异性 尚未评估儿童腺病毒检测的护理;（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。该提案旨在满足关键的 需要通过（1）确定结膜炎的病毒和细菌原因， （2）临床验证儿童中的快速护理点腺病毒结膜炎测试;以及 (3)估计减少不必要的抗生素处方的百分比和成本效益， 在整个卫生保健系统实施腺病毒结膜炎快速诊断测试。这个项目是 该候选人在快速传染病的验证和使用方面的兴趣和经验的顶峰 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 培养该候选人成为临床和转化研究的独立主要研究者， 在儿科传染病诊断的实施和评估方面的专业知识。导师制， 教学课程、研讨会和拟议研究的完成将满足 研究者，包括在设计和大规模，多中心临床试验，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 在上述领域具有丰富研究经验和专题专业知识的导师和顾问， 确保她成功地实现所述的具体目标和职业目标。