A CDISC+HL7-based oncology clinical research EHR system

基于 CDISC HL7 的肿瘤临床研究 EHR 系统

• 批准号: 7219103
• 负责人: ALLEN Y. TIEN
• 金额: $ 19.98万
• 依托单位: MEDICAL DECISION LOGIC, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-29 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7219103
• 关键词: clinical research; clinical trials; health; model; oncology

DESCRIPTION (provided by applicant): Project Summary/Abstract: The integrated coordination of clinical care and research processes for patients who volunteer to participate in clinical trial protocols is increasingly important, but a major obstacle has been the absence of a standard model for an Electronic Health Record (EHR) that satisfies functional needs as well as federal regulatory requirements. The complexity of clinical care alone has hindered the creation and widespread adoption of standard Electronic Patient Record (EPR) or Electronic Medical Record (EMR) systems. Coupled with complex biomedical research needs and evolving scientific knowledge, the problem is a difficult 1, at both conceptualization and implementation levels. However, recent progress in health informatics models and in software engineering methods makes tackling this problem more feasible. For clinical services, Health Level 7 (HL7) has developed high-level specifications, in particular the Reference Information Model (RIM). For clinical research, the Clinical Data Interchange Standards Consortium (CDISC) has developed specifications such as the Operational Data Model (ODM) and Study Data Tabulation Model (SDTM). For implementation, Medical Decision Logic, Inc. (MDLogix(tm)) has developed a Model Driven Architecture-based development platform ("MDLogixMDA"), enabling the use of these health informatics models to more efficiently create and continuously evolve software products. This proposal plans use of the MDLogixMDA platform to create an EHR system ("HealthDataWorks") that will support clinical and research processes for oncology centers. A core innovation is the combined implementation of the HL7 RIM and the CDISC ODM and SDTM within the MDLogixMDA platform. Building on this platform, the Phase I product focus will be on creating a set of software application modules that supports the process of matching patients to multiple oncology clinical trial protocols and optimal assignment. Project Narrative: Improving the efficiency of oncology clinical trials will speed up the development of new knowledge and application of that knowledge to the treatment of cancer. The product focus of this project is to create a set of software application modules that supports the process of matching patients to multiple oncology clinical trial protocols and optimal assignment. The model driven software engineering approach will enable rapid deployment and wider market opportunities by making it easier to create modular extensions for applications such as practice-based clinical trials, integrated diagnostic rules, dissemination and use of clinical guidelines, and scheduling and billing functions. The option for virtual centralization can support public health applications for population monitoring, policy development, and intervention programs. Use of public standards and focus on supporting interoperability with an existing system will facilitate adoption of the software.

描述（由申请人提供）：项目摘要/摘要：自愿参加临床试验方案的患者的临床护理和研究过程的综合协调越来越重要，但一个主要障碍是缺乏满足功能需求以及联邦法规要求的电子健康记录（EHR）的标准模型。仅临床护理的复杂性就阻碍了标准电子病历（EPR）或电子病历（EMR）系统的创建和广泛采用。再加上复杂的生物医学研究需求和不断发展的科学知识，这个问题在概念化和执行层面都是一个困难的问题。然而，最近在健康信息学模型和软件工程方法方面的进展使得解决这个问题变得更加可行。对于临床服务，健康7级（HL7）制定了高级别规范，特别是参考信息模型（RIM）。对于临床研究，临床数据交换标准联盟（CDISC）已经开发了操作数据模型（ODM）和研究数据列表模型（SDTM）等规范。为了实施，Medical Decision Logic，Inc.（MDLogix（tm））已经开发了基于模型驱动架构的开发平台（"MDLogixMDA"），使得能够使用这些健康信息学模型来更有效地创建和不断演进软件产品。该提案计划使用MDLogixMDA平台创建EHR系统（"HealthDataWorks"），该系统将支持肿瘤中心的临床和研究流程。一项核心创新是在MDLogixMDA平台中组合实现HL7 RIM和CDISC ODM以及SDTM。在此平台上，I期产品的重点将是创建一组软件应用程序模块，支持将患者与多种肿瘤学临床试验方案和最佳分配相匹配的过程。项目叙述：提高肿瘤学临床试验的效率将加快新知识的开发和这些知识在癌症治疗中的应用。该项目的产品重点是创建一组软件应用程序模块，支持将患者与多个肿瘤学临床试验方案匹配并进行最佳分配的过程。模型驱动的软件工程方法将使快速部署和更广泛的市场机会，使其更容易创建模块化的应用程序，如基于实践的临床试验，集成的诊断规则，传播和使用的临床指南，调度和计费功能。虚拟集中化选项可以支持用于人口监测、政策制定和干预计划的公共卫生应用程序。使用公共标准和注重支持与现有系统的互操作性将促进软件的采用。