Routine Anonymized Data for Advanced Ambulatory Health Services Research, RADARplus

用于高级流动医疗服务研究的常规匿名数据，RADARplus

• 批准号: 315084924
• 负责人: Professor Dr. Wolfgang Hoffmann
• 金额: --
• 依托单位: TMF - Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V.
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/315084924?language=en
• 关键词: Routine; Anonymized; Data; Advanced; Ambulatory

The overall aim of the RADAR project is to provide a framework and infrastructure to securely export and process electronic patient records (EPR) data from primary health care practices in a secure and manageable way as a first step towards a large German research data repository. The goal is to make representative, longitudinal de-identified patient and health care data available to researchers, facilitating health services research with high validity and recruitment of patients for further studies or clinical trials. In its first phase, RADAR was able to develop and describe the necessary data protection concepts and procedural and computational routines for collection and pseudonymization of EPR via the BDT interface. These concepts and routines have created a framework and prototype infrastructure to securely export and process EPR data from primary health care practices in a secure and manageable way.In the second phase of the RADAR project, RADARplus, we will consolidate, improve and expand this infrastructure. Two sub-projects will build on existing RADAR processes and improve or expand them. Other sub-projects in RADARplus will develop new infrastructure elements for primary care research. RADARplus can thus be divided into two major work areas:Part 1 – Continuing, adapting and improving the existing RADAR infrastructure and workflows:- Maintenance/continuation of the RADAR infrastructure, including adaptation of the RADAR software with regard to changes in technologies and interfaces.- Improvement of the usability of all processes while maintaining a high level of data protection.- Using focus groups and/or interviews, we will investigate obstacles to general practitioner (GP) recruitment including GPs’ requirements for participating in RADAR.- Development of additional use cases and informational videos for GPs and patients,- Use and evaluation of videos to extend practice involvement in RADAR by recruiting 20 additional GP practices from Lower Saxony.Part 2 – Developing new research infrastructure and techniques:- Conception, development and pilot for digital, paperless informed consent and signature management in GP environments with state-of-the-art technical solutions.- Routine GP data acquisition including the adaptation to current interface developments. We will build a simulated medical practice management software with FHIR interface, which can be queried by the RADARplus software.- With regards to the risk-based anonymization of routine GP data, we will examine the legal determination of identifiability and the boundary to anonymity. On this basis, we will assess various de-identification procedures to determine how they can be used to achieve the legally defined criteria of non-identifiability.- Using the primary care research database, we will develop a research-oriented practice portal based on the existing RADAR infrastructure to create a tailored user interface for both researchers and participating GPs.

RADAR 项目的总体目标是提供一个框架和基础设施，以安全且可管理的方式安全导出和处理来自初级卫生保健实践的电子患者记录 (EPR) 数据，作为迈向德国大型研究数据存储库的第一步。目标是向研究人员提供具有代表性、纵向去识别化的患者和医疗保健数据，促进高有效性的医疗服务研究以及招募患者进行进一步研究或临床试验。在第一阶段，RADAR 能够开发和描述必要的数据保护概念以及通过 BDT 接口收集和假名化 EPR 的程序和计算例程。这些概念和例程创建了一个框架和原型基础设施，以安全且可管理的方式安全地导出和处理来自初级卫生保健实践的 EPR 数据。在 RADAR 项目的第二阶段 RADARplus 中，我们将巩固、改进和扩展该基础设施。两个子项目将建立在现有 RADAR 流程的基础上，并对其进行改进或扩展。 RADARplus 的其他子项目将为初级保健研究开发新的基础设施要素。因此，RADARplus 可以分为两个主要工作领域： 第 1 部分 – 继续、调整和改进现有的 RADAR 基础设施和工作流程：- RADAR 基础设施的维护/延续，包括根据技术和接口的变化调整 RADAR 软件。- 提高所有流程的可用性，同时保持高水平的数据保护。- 通过焦点小组和/或访谈，我们将调查一般性障碍 医生（全科医生）招聘，包括全科医生参与 RADAR 的要求。- 为全科医生和患者开发额外的用例和信息视频，- 通过从下萨克森州招募 20 名额外的全科医生实践，使用和评估视频来扩大对 RADAR 的实践参与。第 2 部分 – 开发新的研究基础设施和技术：- 在全科医生环境中进行数字化、无纸化知情同意书和签名管理的构想、开发和试点 最先进的技术解决方案。- 常规 GP 数据采集，包括适应当前接口开发。我们将构建一个带有FHIR接口的模拟医疗实践管理软件，可以通过RADARplus软件进行查询。 - 关于常规全科医生数据基于风险的匿名化，我们将研究可识别性的法律判定和匿名的边界。在此基础上，我们将评估各种去识别化程序，以确定如何使用它们来实现法律定义的不可识别性标准。-使用初级保健研究数据库，我们将基于现有的 RADAR 基础设施开发一个以研究为导向的实践门户，为研究人员和参与的全科医生创建量身定制的用户界面。