A CDISC+HL7-based oncology clinical research EHR system

项目概述/摘要：对自愿参与临床试验方案的患者进行临床护理和研究过程的综合协调变得越来越重要，但主要障碍是缺乏满足功能需求和联邦监管要求的电子健康记录（EHR）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，这个问题在概念和实施层面都是一个难题。然而，健康信息学模型和软件工程方法的最新进展使解决这一问题更加可行。对于临床服务，卫生级别7 （HL7）制定了高级规范，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）制定了操作数据模型（ODM）和研究数据制表模型（SDTM）等规范。为了实现这一目标，医疗决策逻辑公司（MDLogix）开发了一个基于模型驱动体系结构的开发平台（“MDLogixMDA”），使这些健康信息学模型能够更有效地创建和不断发展软件产品。该提案计划使用MDLogixMDA平台创建一个EHR系统（“HealthDataWorks”），该系统将支持肿瘤中心的临床和研究过程。核心创新是在MDLogixMDA平台中结合实现HL7 RIM和CDISC ODM和SDTM。基于该平台，I期产品的重点将是创建一套软件应用模块，以支持将患者与多种肿瘤临床试验方案相匹配并进行最佳分配的过程。项目描述：提高肿瘤临床试验的效率将加快新知识的开发和新知识在癌症治疗中的应用。该项目的产品重点是创建一套软件应用模块，支持将患者与多种肿瘤临床试验方案匹配并优化分配的过程。模型驱动的软件工程方法将通过更容易地为应用程序（如基于实践的临床试验、集成诊断规则、临床指南的传播和使用以及调度和计费功能）创建模块化扩展，实现快速部署和更广阔的市场机会。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。使用公共标准和关注于支持与现有系统的互操作性将促进软件的采用。

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.