Diagnosing and predicting risk in children with SARS-CoV-2- related illness

诊断和预测患有 SARS-CoV-2 相关疾病的儿童的风险

• 批准号: 10653509
• 负责人: JANE C BURNS
• 金额: $ 40万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10653509
• 关键词: 2019-nCoV; Address; COVID-19 pandemic; Cardiogenic Shock; Case Study; Child; Clinical; Clinical Data; Clinical Sciences; Collaborations; Computer software; Data; Data Science; Development; Diagnosis; Diagnostic tests; Disease Progression; Electronic Health Record; FDA Emergency Use Authorization; Fast Healthcare Interoperability Resources; Feedback; Fever; Funding; Health Personnel; Interview; Machine Learning; Medical Device; Mucocutaneous Lymph Node Syndrome; Multisystem Inflammatory Syndrome in Children; Outcome; Output; Patients; Phase; Physicians; Risk; SARS-CoV-2 exposure; Sampling; Severity of illness; Structure; System; base; clinical decision support; commercialization; diagnostic tool; inflammatory marker; patient safety; preference; prognostic assays; simulation; support tools; tool

In the wake of COVID-19 pandemic, Multisystem Inflammatory Syndrome in Children (MIS-C) has evolved as a new threat to children exposed to SARS-CoV-2. Currently there are no diagnostic tests to readily identify these patients nor are there tools to predict disease progression. Through established, funded, multi-center consortia in the U.S. (CHARMS: Characterization of MIS-C and its Relationship to Kawasaki Disease funded by PCORI) and the UK (DIAMONDS), we have collected clinical data and samples to support development and testing of diagnostic and prognostic tests for MIS-C. In phase 1 of this project (R61HD105590, years 1-2), we used these data to devise machine learning-based clinical decision support tool (KIDMATCH) to assist clinicians in diagnosis of MIS-C and other causes of fever in children. This proposal focuses on the development of a Software as a Medical Device (SaMD) and clinical deployment of this SaMD in a clinical setting. Additionally, we aim to develop a quality management system (QMS) to minimize and manage unintentional outcomes related to patient safety as required for FDA regulatory approval. To this end, this proposal aims to further develop a cross-platform SMART- on-FHIR app for display of the KIDMATCH outputs for integration within electronic health records. In close collaboration between our clinical and data science teams, we will evaluate the KIDMATCH app set-up, user workflow and physician preferences through structured interviews, simulations, and direct feedback. Finally, we aim to complete an ongoing application for Emergency Use Authorization (EUA) to enable wider deployment and commercialization of the KIDMATCH SaMD. The synergistic expertise of the investigative team in this proposal provides a unique opportunity to create diagnostic tools for children suffering from the spectrum of SARS- CoV-2 illnesses. 1

在COVID-19大流行之后，儿童多系统炎症综合征（MIS-C） 对接触SARS-CoV-2的儿童来说是一种新的威胁。目前没有诊断 也没有工具来预测疾病的进展。通过 在美国建立，资助，多中心联盟（CHARMS：MIS-C和 它与川崎病的关系由PCARI资助）和英国（钻石），我们有 收集临床数据和样本，以支持诊断和 MIS-C的预后测试。在本项目的第1阶段（R61 HD 105590，1-2年），我们使用了这些 设计基于机器学习的临床决策支持工具（KIDMATCH）， 临床医生诊断MIS-C和其他儿童发烧原因。该提案的重点是 软件即医疗器械（SaMD）的开发和该SaMD的临床部署 在临床环境中。此外，我们的目标是建立质量管理体系（QMS）， 根据FDA要求，最大限度地减少和管理与患者安全相关的意外结局 监管批准。为此，本提案旨在进一步开发跨平台SMART- on-FHIR应用程序，用于显示KIDMATCH输出，以便集成到电子健康记录中。 在我们的临床和数据科学团队的密切合作下，我们将评估 KIDMATCH应用程序设置，用户工作流程和医生偏好通过结构化访谈， 模拟和直接反馈。最后，我们的目标是完成一个正在进行的申请， 紧急使用授权（EUA），以实现更广泛的部署和商业化 KIDMATCH SaMD.本提案中调查小组的协同专长提供了 这是一个独特的机会，可以为患有SARS的儿童创造诊断工具- CoV-2疾病 1

项目成果

Diagnosis of Multisystem Inflammatory Syndrome in Children by a Whole-Blood Transcriptional Signature.

• DOI: 10.1093/jpids/piad035
• 发表时间: 2023-06-30
• 期刊: Journal of the Pediatric Infectious Diseases Society
• 影响因子: 3.2