Clinical Trans Valid

临床反式有效

• 批准号: 10159905
• 负责人: Lea Widdice
• 金额: $ 16.77万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10159905
• 关键词: Accident and Emergency department; Address; Adolescent; Adopted; Adoption; Antibiotic Resistance; Atlases; Awareness; Bacterial Vaginosis; Biological Assay; Caring; Characteristics; Chlamydia trachomatis; Clinic; Clinical; Clinical Pathways; Clinical Trials; Collaborations; Data; Databases; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Emergency Care; Ensure; Evaluation; Excision; Face; Feedback; Genital; Genitalia; Goals; HIV; Health Personnel; Health behavior; Healthcare; Healthcare Systems; Home; Incubators; Individual; Internet; Interruption; Laboratories; Left; Link; Market Research; Methods; Monitor; Mycoplasma genitalium; Neisseria gonorrhoeae; Oropharyngeal; Outcome; Patients; Performance; Personal Satisfaction; Pharmacy facility; Point of Care Technology; Population; Predictive Value; Primary Health Care; Provider; Public Health; Research; Research Personnel; Resources; Sampling; Sensitivity and Specificity; Serum; Sexually Transmitted Diseases; Simplexvirus; Site; Specimen; Swab; Symptoms; Syndrome; Syphilis; Syphilis Serodiagnosis; Technology; Testing; Time; Trichomonas vaginalis; Uganda; Universities; Urine; Vagina; Validation; Visit; Woman; Work; antenatal; base; biobank; clinical care; clinical practice; clinical research site; clinical translation; commercialization; design; diagnostic accuracy; experience; health care delivery; high risk; improved; men; novel diagnostics; performance tests; point of care; point of care testing; point-of-care diagnosis; practice setting; preference; programs; prospective; prospective test; prototype; recruit; research clinical testing; sample archive; self testing; standard of care; targeted treatment; tool; transmission process; urgent care; usability; validation studies

Summary Point of care (POC) diagnosis of sexually transmitted infections (STIs) can positively impact public health, the healthcare system and patient-related outcomes. Laboratory-based STI diagnostic tests with long turn-around times remain the standard of care in high-resource settings; the diagnosis often returns after the patient has left the clinic compromising the provider's ability to ensure treatment and interrupt transmission. Syndromic management continues to be the standard of care for STI treatment in low-resource settings and in emergency departments and urgent care settings which leads to high rates of over and under treatment for those with symptoms. Despite a number of new POC STI tests with functional prototypes, developers face significant barriers to commercialization, which include limited access to patient samples for testing and appropriate clinical care settings for performance testing. Getting feedback from end-users on prototypes and early designs is also critical for evaluating tests in practice to accelerate adoption. Understanding how POC STI tests can be integrated into clinical work flow to provide timely diagnosis without disrupting care could transform care for STIs by allowing same-visit diagnostic certainty and targeted treatment. Specific barriers to implementation include lack of data regarding performance characteristics of new tests in diverse settings and lack of provider awareness of POC STI tests. We have developed methods and tools to evaluate POCT for STDs performance, acceptability and usability of POC tests among end-users in diverse settings. The work of the Clinical Translation and Validation Core will be guided by three Core aims: 1) To evaluate diagnostic accuracy, usability and acceptability of prototype POC devices for STI diagnosis, 2) To describe and evaluate implementation of POCT for STDs including end-users' assessment of preference, acceptability, usability, and test experience. We will also assess the impact on patient and partners' health, behaviors and well-being as well as the impact on healthcare delivery and/or public health outcomes, and 3) Develop a sustainable, searchable STI Diagnostic Watch database for developers and end-users. Our Center allows developers at all stages of the development pipeline to have one-stop shopping; from early iterative testing with samples from our well-curated biorepository, to clinical testing in diverse settings including an urban emergency department, an adolescent ambulatory clinic, a low-resource setting in Uganda, and by internet access with self-sampling. We will address site-specific aims based on end-user needs particular to each site. This Clinical Translation and Validation Core will accelerate development of new POC STI tests that will be accurate and rapidly adopted.

概括 性传播感染（STI）的护理点（POC）诊断会对公共卫生产生积极影响， 医疗保健系统和与患者有关的结果。基于实验室的STI诊断测试，长期转弯 在高资源环境中，时代仍然是护理标准；诊断经常在患者患有 离开诊所，损害了提供者确保治疗和中断传播的能力。综合征 管理层继续是低资源环境和紧急情况下STI治疗的护理标准 部门和紧急护理环境，导致患有高度和治疗的人 症状。尽管有许多具有功能性原型的新POC STI测试，但开发人员仍面临重要 商业化的障碍，其中包括有限的对患者样品进行测试和适当的访问 用于性能测试的临床护理环境。从最终用户获得原型和早期设计的反馈 对于评估实践中的测试以加速采用也是至关重要的。了解POC STI测试如何 集成到临床工作流程中以提供及时诊断而不破坏护理可以改变护理 通过允许相同访问的诊断确定性和靶向治疗方法。实施的具体障碍 包括缺乏有关各种环境中新测试的性能特征的数据和缺乏提供商的数据 意识到POC STI测试。我们开发了评估POCT的性能性能的方法和工具， 最终用户在不同环境中的POC测试的可接受性和可用性。临床的工作 翻译和验证核心将由三个核心目的指导：1）评估诊断准确性， 用于STI诊断的原型POC设备的可用性和可接受性，2）描述和评估 实施POCT用于性病，包括最终用户的偏好评估，可接受性，可用性和 测试经验。我们还将评估对患者和伴侣的健康，行为和福祉的影响 以及对医疗保健提供和/或公共卫生成果的影响，以及3）发展可持续性， 为开发人员和最终用户搜索的STI诊断观察数据库。我们的中心完全允许开发人员 开发管道的阶段要进行一站式购物；从早期迭代测试，来自 我们经过良好策划的生物措施，在包括城市急诊室在内的各种环境中进行临床测试， 一家青少年的门诊诊所，在乌干达的低资源环境以及通过自我采样的互联网访问。 我们将根据每个站点的最终用户需求需求解决特定网站的目标。这种临床翻译 验证核心将加速新的POC STI测试的开发，这些测试将是准确而快速的 采用。