背景:医疗保健提供者之间的跨机构互操作性仍然是全球范围内反复出现的挑战。德国医学信息学倡议,德国37所大学医院的合作,旨在通过定义用于跨机构交换医疗保健数据的快速医疗保健互操作性资源(FHIR)配置文件来实现合作伙伴站点之间的互操作性,核心数据集(CDS)。当前的CDS及其扩展模块定义了代表患者健康护理记录的元素。德国所有大学医院在提供基于CDS的标准化格式的常规数据方面都取得了重大进展。此外,健康中心研究平台,德国医学研究数据可行性工具门户网站,允许医学研究人员查询许多参与医院的可用CDS数据项。
目的:在本研究中,我们旨在评估一种新颖的方法,该方法将当前自上而下生成的FHIR配置文件与通过分析各个实例数据获得的自下而上生成的知识相结合。这使我们能够使用从差异分析中获得的信息得出用于迭代细化FHIR配置文件的选项。
方法:我们开发了FHIR验证管道,并选择从原始CDS配置文件中获得更多限制性配置文件。此决定是由于需要更紧密地与中央可行性平台的搜索本体的特定假设和要求保持一致。虽然最初的CDS配置文件提供了一个通用框架,适用于广泛的医学信息学用例,它们缺乏特异性来模拟医学研究人员必不可少的细微差别标准。这方面的一个关键例子是需要准确地表示特定的实验室编码和值的相互依赖性。验证结果使我们能够识别临床站点的实例数据与可行性平台指定并在将来解决的配置文件之间的差异。
结果:共有20所大学医院参与了这项研究。历史因素,缺乏协调,广泛的源系统,编码的大小写敏感性是识别出差异的一些原因。而在我们的案例研究中,条件,Procedures,和医药由于德国对计费的立法要求,在实例数据的编码上具有较高的统一性,我们发现,由于编码和值之间的相互依赖性,实验室值对数据协调构成重大挑战.
结论:虽然CDS实现了互操作性,联邦数据访问面临不同的挑战,需要在配置文件中更多的特异性来对实例数据进行假设。我们进一步认为,进一步协调实例数据可以显着降低所需的回顾性协调工作。我们认识到,差异不能仅在临床现场解决;因此,我们的发现具有广泛的影响,需要在多个层面上和不同利益相关者采取行动。
BACKGROUND: Cross-institutional interoperability between health care providers remains a recurring challenge worldwide. The German Medical Informatics Initiative, a collaboration of 37 university hospitals in Germany, aims to enable interoperability between partner sites by defining Fast Healthcare Interoperability Resources (FHIR) profiles for the cross-institutional exchange of health care data, the Core Data Set (CDS). The current CDS and its extension modules define elements representing patients\' health care records. All university hospitals in Germany have made significant progress in providing routine data in a standardized format based on the CDS. In addition, the central research platform for health, the German Portal for Medical Research Data feasibility tool, allows medical researchers to query the available CDS data items across many participating hospitals.
OBJECTIVE: In this study, we aimed to evaluate a novel approach of combining the current top-down generated FHIR profiles with the bottom-up generated knowledge gained by the analysis of respective instance data. This allowed us to derive options for iteratively refining FHIR profiles using the information obtained from a discrepancy analysis.
METHODS: We developed an FHIR validation pipeline and opted to derive more restrictive profiles from the original CDS profiles. This decision was driven by the need to align more closely with the specific assumptions and requirements of the central feasibility platform\'s search ontology. While the original CDS profiles offer a generic framework adaptable for a broad spectrum of medical informatics use cases, they lack the specificity to model the nuanced criteria essential for medical researchers. A key example of this is the necessity to represent specific laboratory codings and values interdependencies accurately. The validation results allow us to identify discrepancies between the instance data at the clinical sites and the profiles specified by the feasibility platform and addressed in the future.
RESULTS: A total of 20 university hospitals participated in this study. Historical factors, lack of harmonization, a wide range of source systems, and case sensitivity of coding are some of the causes for the discrepancies identified. While in our case study, Conditions, Procedures, and Medications have a high degree of uniformity in the coding of instance data due to legislative requirements for billing in Germany, we found that laboratory values pose a significant data harmonization challenge due to their interdependency between coding and value.
CONCLUSIONS: While the CDS achieves interoperability, different challenges for federated data access arise, requiring more specificity in the profiles to make assumptions on the instance data. We further argue that further harmonization of the instance data can significantly lower required retrospective harmonization efforts. We recognize that discrepancies cannot be resolved solely at the clinical site; therefore, our findings have a wide range of implications and will require action on multiple levels and by various stakeholders.