Malarial Retinopathy Screening System for Improved Diagnosis of Cerebral Malaria

疟疾视网膜病变筛查系统可改善脑型疟疾的诊断

• 批准号: 10002542
• 负责人: Simon Harding
• 金额: $ 41.2万
• 依托单位: VISIONQUEST BIOMEDICAL INC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10002542
• 关键词: 5 year old; Address; Affect; Africa; African; Algorithmic Software; Algorithms; Artificial Intelligence; Caring; Cellular Phone; Cerebral Malaria; Child; Clinic; Clinical; Clinical Research; Computer software; Computers; Country; Data; Data Set; Detection; Development; Devices; Diabetic Retinopathy; Diagnosis; Diagnostic; Disease; Effectiveness; Enrollment; Expert Systems; Foundations; Goals; Grant; Health; Health Personnel; Healthcare; Image Analysis; Incidence; Lesion; Letters; Life; Malaria; Malawi; Medicine; Ophthalmologist; Ophthalmology; Ophthalmoscopy; Optics; Outcome; Pathology; Patients; Performance; Persons; Pharmacy facility; Phase; Poison; Predictive Value; Price; Reporting; Research; Retinal; Retinal Diseases; Safety; Scientist; Seasons; Series; Site; Specificity; Symptoms; Syndrome; System; Test Result; Testing; Uganda; Validation; Work; Zambia; base; clinical Diagnosis; clinical research site; cost; cost effectiveness; design; diagnostic accuracy; experience; imaging capabilities; improved; improved outcome; innovation; insight; malaria infection; mortality; performance site; portability; programs; prospective; prototype; research study; response; retinal imaging; screening; smartphone Application; software development; software systems; success; usability

Summary Cerebral malaria (CM) is a life-threatening clinical syndrome associated with malarial infection. Annually, malaria affects more than 200 million people and claims the lives of over 440,000 people worldwide, mostly African children. As a consequence of the high incidence of CM, it is often misdiagnosed for other pathologies with similar symptoms, leading to a high false positive rate for CM and incorrect treatment. An accurate means to confirm the presence of CM or to investigate for a non-malarial illness is critically needed to improve outcomes. Since Malarial retinopathy (MR) is greater than 90% specific and sensitive to the presence of CM once clinically diagnosed, retinal screening for MR represents an effective means to assist in and improve the specificity of CM diagnosis. VisionQuest Biomedical and its collaborators have assembled a team of inter-disciplinary scientists with considerable experience in automated retinal image analysis, clinical ophthalmology with specialized research in malarial retinopathy (MR), and cerebral malaria diagnosis (CM). This team will develop and test ASPIRE, a system for detection of MR consisting of automated MR detection software integrated with a low-cost and portable retinal camera. Our proposed ASPIRE system will augment, not replace, the current CM diagnostic standard; increasing the accuracy of CM diagnoses, leading to a smaller number of false positive outcomes. In Phases I and II, the research team at VisionQuest Biomedical developed the automated MR detection software and interfaced it with a handheld retinal camera. The resulting clinical prototype of ASPIRE was tested onsite in a health-clinic in Africa, which demonstrated excellent performance and usability for detecting MR, without the need of an ophthalmic expert. In Phase II-B, the MR detection system will be refined, productized, and the resulting commercial prototype will be validated on prospective datasets. We will accomplish this through three specific aims. In the first aim, the software system for MR detection will be adapted and improved to work with low-cost and portable iNview camera. In the second aim, we will refine iNview’s driver-software and integrate the camera with MR detection software to produce the first commercial prototype. The third aim will focus on collecting the retinal image data for algorithm testing as well as for validating the commercial prototype in an observational clinical study to be conducted at nine clinical sites in Malawi, Uganda, and Zambia in Africa.

总结 脑型疟疾（CM）是一种与疟疾感染相关的危及生命的临床综合征。 疟疾每年影响2亿多人，夺去44万多人的生命 全世界的人，大部分是非洲儿童。由于CM的高发病率， 经常被误诊为具有类似症状的其他病理，导致高假阳性率。 CM阳性率和不正确治疗。确认CM存在的准确方法 或调查非疟疾疾病是非常必要的，以改善结果。以来 疟疾视网膜病变（MR）是大于90%的特异性和敏感性的存在CM一次 临床诊断，视网膜筛查MR是一种有效的手段，以帮助和 提高CM诊断的特异性。 VisionQuest Biomedical及其合作者组建了一个跨学科团队， 在自动化视网膜图像分析、临床 眼科学，专门研究疟疾视网膜病变（MR）和脑型疟疾 诊断（CM）。该团队将开发和测试ASPIRE，一种用于检测MR的系统 包括自动化MR检测软件与低成本便携式视网膜 相机我们提出的ASPIRE系统将增加，而不是取代，目前的CM诊断 标准;提高CM诊断的准确性，导致更少的假 积极的成果。 在第一阶段和第二阶段，VisionQuest Biomedical的研究团队开发了自动MR 检测软件并将其与手持式视网膜相机连接。临床结果 ASPIRE的原型在非洲的一家健康诊所进行了现场测试，结果表明， 用于检测MR的性能和可用性，而不需要眼科专家。同相 II-B，将对MR检测系统进行细化、产品化，并由此实现商业化 原型将在前瞻性数据集上进行验证。我们将通过三个 具体目标。在第一个目标中，将调整用于MR检测的软件系统， 改进后可与低成本便携式iNview摄像头配合使用。在第二个目标中，我们将改进 iNview的驱动软件，并将摄像头与MR检测软件集成， 第一个商业原型。第三个目标将集中在收集视网膜图像数据， 算法测试以及在观察性临床试验中验证商业原型 研究将在非洲马拉维、乌干达和赞比亚的9个临床地点进行。