Metke-Jimenez Alejandro, Hansen David
The Australian eHealth Research Centre, CSIRO, Herston, Queensland, Australia.
AMIA Jt Summits Transl Sci Proc. 2019 May 6;2019:54-63. eCollection 2019.
Clinical trials and studies are increasingly using systems, such as REDCap, to capture data in electronic form. However these tools are not designed to mimic the capture of clinical information for regular clinical care and lack support for sharing the data effectively. In this paper we describe the implementation of a transformation engine, FHIRCap, that allows defining rules to map REDCap forms into FHIR resources. To assess the feasibility of the system, a case study with one of the Australian Genomics clinical demonstration projects was done. The case study showed that the transformation language is flexible enough to handle most of the data being captured in REDCap for a typical clinical trial. A number of design issues in the forms were identified and a series of recommendations were provided to enable a more accurate transformation. These results show that it is possible to transform most data in existing REDCap projects to FHIR resources without having to modify the forms. This is significant because it demonstrates that most data in existing clinical trials and studies can be made available in a standardised manner.
临床试验和研究越来越多地使用诸如REDCap等系统以电子形式捕获数据。然而,这些工具并非设计用于模拟常规临床护理中临床信息的捕获,并且缺乏有效共享数据的支持。在本文中,我们描述了一种转换引擎FHIRCap的实现,它允许定义规则将REDCap表单映射为FHIR资源。为评估该系统的可行性,我们对澳大利亚基因组学临床示范项目之一进行了案例研究。案例研究表明,转换语言足够灵活,能够处理典型临床试验中在REDCap中捕获的大多数数据。我们识别出表单中的一些设计问题,并提供了一系列建议以实现更准确的转换。这些结果表明,无需修改表单就可以将现有REDCap项目中的大多数数据转换为FHIR资源。这一点很重要,因为它表明现有临床试验和研究中的大多数数据可以以标准化方式提供。