Oklahoma Shared Clinical and Translational Resources

1摘要 2电子健康记录(EHR)与研究信息学的完全集成有望成为 3临床和转化研究(CTR)社区和公众的革命性飞跃 4这个社区渴望获得的健康益处。到目前为止，太多的学术医疗中心 5(AMC)依赖于不能很好地通信的完全不同的数据系统，抑制了研究 6产能和生产力。障碍包括识别和及时招生的能力有限 7名符合条件的患者参加临床试验，复杂的临床试验工作流程通常需要多个 8个系统、手动审查和容易出错的复制，以及无法快速共享 9并与外部研究伙伴整合数据。幸运的是，缓解这些问题的软件工具 10个担忧正在变得普遍存在。该提案描述了4项信息学创新， 11利用快速医疗互操作性资源(FHIR)技术解决关键信息学问题 目前阻碍研究增长的12个缺陷。这些创新包括：(A)界面 13将EHR中记录的严重不良事件(SAE)信息与监管机构 14种形式的临床试验管理系统(CTMS)；(B)在 15个FHIR应用程序，用于在研究案例报告中自动填充图表摘要信息 16种表格；(C)试点测试应急系统，用于人工增强的电子审查 17非结构化医疗记录；和(D)开发提供mCODE的编码管道 18个标准来研究高质量的癌症登记。这些创新寻求推动 19患者安全，减少数据收集负担，更有效和公平的队列发现， 20和更高的灵活性和外部数据共享伙伴关系的质量。拟议的工作将 21个高级目标最初在俄克拉何马州的IDEA-CTR奖中推广。具体地说，目标是 生物统计学、流行病学和研究设计(BERD)和临床资源(CR)中的22篇 将增加23个核心，通过(1)扩大临床和翻译研究的能力 24通过新的队列、登记和 25个资料库，(2)加强患者对CTR研究的招募，以及(3)广泛提供 26向OSCTR调查人员和学者提供电子监管协助。

1 ABSTRACT 2 Full integration of electronic health records (EHR) with research informatics promises to be a 3 revolutionary leap for the clinical and translational research (CTR) community and the public 4 health benefits this community aspires to attain. To date, far too many academic medical centers 5 (AMC) rely on disparate data systems that do not communicate well, inhibiting research 6 capacity and productivity. Barriers include limited capacities to identify and timely enroll 7 eligible patients in clinical trials, complex clinical trial workflows often requiring multiple 8 systems, manual review, and error-prone duplication, and an inability to expeditiously share 9 and consolidate data with external research partners. Fortunately, software tools that allay these 10 concerns are becoming widely available. The proposal describes 4 informatics innovations that 11 utilize Fast Healthcare Interoperability Resource (FHIR) technology to address key informatics 12 deficiencies that currently impede research growth. These innovations include (a) an interface 13 that integrates serious adverse event (SAE) information logged in EHR with the regulatory 14 forms of a clinical trial management system (CTMS); (b) implementation of the REDCap on 15 FHIR application to automatically populate chart abstraction information in to study case report 16 forms; (c) pilot test the EMERSE system for human-augmented electronic review of 17 unstructured medical notes; and (d) development of coding pipelines that delivery mCODE 18 standards to research quality cancer registries. These innovations seek to drive improvements in 19 patient safety, reduced burden of data collections, more efficient and equitable cohort discovery, 20 and greater agility and quality of external data sharing partnerships. The work proposed will 21 advance aims originally promoted in Oklahoma’s IDEA-CTR award. Specifically, the objectives 22 of the Biostatistics, Epidemiology, and Research Design (BERD) and Clinical Resources (CR) 23 Cores will be elevated with expanded capacity for clinical and translation research through (1) 24 greater access to clinical and epidemiologic research data via new cohorts, registries, and 25 repositories, (2) enhanced recruitment of patients to CTR studies, and (3) widely available 26 electronic regulatory assistance to OSCTR investigators and scholars.