JHU-Clin Trans Valid

JHU-Clin 反式有效

基本信息

批准号：
10441424
负责人：
CHARLOTTE Ann GAYDOS
金额：
$ 23.36万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-30 至 2023-09-12
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10441424
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 Resource-limited setting 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 distributed archives experience health care delivery high risk implementation barriers implementation evaluation 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

项目摘要

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) 诊断可以对公共健康、医疗保健系统和患者相关的结果。基于实验室的 STI 诊断测试，周期长时间仍然是资源丰富环境中的护理标准；诊断通常在患者接受治疗后返回离开诊所，损害了提供者确保治疗和中断传播的能力。综合征型管理仍然是资源匮乏地区和紧急情况下性传播感染治疗的护理标准科室和紧急护理机构导致患者过度治疗和治疗不足的比例很高症状。尽管使用功能原型进行了许多新的 POC STI 测试，但开发人员仍面临着重大挑战商业化的障碍，其中包括有限地获取患者样本进行测试和适当的用于性能测试的临床护理环境。获取最终用户对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至关重要。了解 POC STI 测试如何进行融入临床工作流程，在不中断护理的情况下提供及时诊断，可以改变对患者的护理通过确保同一次就诊的诊断确定性和针对性治疗来实现性传播感染。实施的具体障碍包括缺乏有关不同环境中新测试的性能特征的数据以及缺乏提供者对 POC STI 测试的认识。我们开发了方法和工具来评估 POCT 的 STD 表现，不同环境下的最终用户对 POC 测试的可接受性和可用性。临床科的工作翻译和验证核心将遵循三个核心目标：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) 描述和评估性传播疾病 POCT 的实施，包括最终用户对偏好、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服务和/或公共卫生结果的影响，以及 3) 制定可持续的、为开发人员和最终用户提供可搜索的 STI 诊断观察数据库。我们的中心允许开发者开发管道的各个阶段进行一站式购物；来自早期迭代测试的样本我们精心策划的生物样本库，可在包括城市急诊科在内的各种环境中进行临床测试，乌干达资源匮乏的青少年门诊诊所，以及通过互联网进行自我采样。我们将根据每个站点特定的最终用户需求来解决特定站点的目标。这种临床翻译验证核心将加速新的 POC STI 测试的开发，这些测试将准确、快速通过了。