Connecting healthcare and clinical research: Workflow optimizations through seamless integration of EHR, pseudonymization services and EDC systems
Connecting healthcare and clinical research: Workflow optimizations through seamless integration of EHR, pseudonymization services and EDC systems
复制标题
DOI：
10.1016/j.ijmedinf.2018.09.007
复制
发表时间：
2018-11-01
影响因子：
4.9
通讯作者：
Storck, Michael
中科院分区：
文献类型：
--
作者：
Bruland, Philipp;Doods, Justin;Storck, Michael
目的：近年来，一些项目推动了基于电子健康记录（EHR）数据的常规医疗数据的二次利用。在多中心研究中，使用专用假名化服务进行统一假名处理。医疗保健、临床研究和匿名化系统通常是脱节的。因此，这项研究工作的目的是整合这些应用程序，并评估临床research.Methods的工作流程：我们分析和确定符合立法的自动假名生成和集成到EHR以及电子数据采集（EDC）系统的技术解决方案。Mainzelliste被用作匿名化服务，该服务可作为开源解决方案提供，并符合德国的数据隐私概念。整合的主题是当地的EHR和内部开发的EDC系统。一个时间和运动的研究进行了评估的effects on the workflow.Results：EHR，电子病历服务和EDC系统的集成在技术上是可行的，并导致所有应用程序的碎片化使用较少。从托管在可信第三方的服务中获得生成的缩略语，现在可以在EDC和EHR系统中使用，以进行直接访问和重新识别。90注册迭代的评价表明，文件的时间已显着减少，平均39.6秒（56.3%）从71 +/- 8秒到31 +/- 5秒每注册studypatient.Conclusions：通过将电子病历，电子数据采集和匿名化系统，现在是可行的，以支持多中心研究和注册出一个综合系统的景观在医院内。优化临床研究患者登记的工作流程可以减少重复数据输入和转录错误，以及从临床常规到研究数据收集的无缝过渡。
Objective: In the last years, several projects promote the secondary use of routine healthcare data based on electronic health record (EHR) data. In multicenter studies, dedicated pseudonymization services are applied for unified pseudonym handling. Healthcare, clinical research and pseudonymization systems are generally disconnected. Hence, the aim of this research work is to integrate these applications and to evaluate the workflow of clinical research.Methods: We analyzed and identified technical solutions for legislation compliant automatic pseudonym generation and for the integration into EHR as well as electronic data capture (EDC) systems. The Mainzelliste was used as pseudonymization service, which is available as open source solution and compliant with the data privacy concept in Germany. Subject of the integration was the local EHR and an in-house developed EDC system. A time and motion study was conducted to evaluate the effects on the workflow.Results: Integration of EHR, pseudonymization service and EDC systems is technically feasible and leads to a less fragmented usage of all applications. Generated pseudonyms are obtained from the service hosted at a trusted third party and can now be used in the EDC as well as in the EHR system for direct access and re-identification. The evaluation of 90 registration iterations shows that the time for documentation has been significantly reduced in average by 39.6 s (56.3%) from 71 +/- 8 s to 31 +/- 5 s per registered study patient.Conclusions: By incorporating EHR, EDC and pseudonymization systems, it is now feasible to support multicenter studies and registers out of an integrated system landscape within a hospital. Optimizing the workflow of patient registration for clinical research allows reduction of double data entry and transcription errors as well as a seamless transition from clinical routine to research data collection.