在资源有限的环境中使用轻量级临床数据采集和记录系统进行电子数据捕获
Jakob Vielhauer1,2, Ujjwal Mukund Mahajan1, Kristina Adorjan3
1Department of Medicine II, Hospital of the LMU Munich, 81377, Munich, Germany.
Scientific reports
|August 17, 2024
概括
这项研究介绍了一种新的,开源的电子数据捕获 (EDC) 软件用于临床研究. 该系统为临床数据采集提供了一个简单,可扩展和适应的解决方案,克服了现有工具的局限性.
科学领域:
- 临床研究信息学
- 健康数据管理 管理健康数据
- 医学中的软件工程.
背景情况:
- 目前用于临床研究的电子数据捕获 (EDC) 软件通常很昂贵或功能有限.
- 需要可访问,可适应和可扩展的EDC解决方案来促进研究.
- 目前的工具可能无法充分支持简单和轻量级的数据采集.
研究的目的:
- 开发一个新的,开源的EDC软件系统,配备移动客户端用于临床数据采集.
- 创建一个用户友好,可修改和可扩展的解决方案,简化临床研究数据管理.
- 为昂贵且功能有限的EDC软件提供替代方案.
主要方法:
- 使用R编程语言开发了一个模块化的EDC软件和移动客户端.
- 实施了既定的数据标准,基于元数据的接口和数据库结构.
- 设计用于本地或云安装,需要最小的IT专业知识,包括渐进式Web应用程序.
主要成果:
- 在四项涉及1600多名参与者的临床研究中成功展示了该软件的功能.
- 该系统每位参与者管理了多达679个变量的数据.
- 详细介绍了一种简单的服务器安装方法,并强调了更多的用例.
结论:
- 开发的开源EDC软件是多功能,易于部署,高度可修改和可扩展的临床研究.
- 它基于R的开源性质促进了可访问性和社区驱动的发展.
- 该系统有效地解决了对轻量级和可适应的临床数据捕获解决方案的需求.
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