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: 10163064
• 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/10163064
• 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; 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; 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/文摘