Frid Santiago, Fuentes Expósito Maria Angeles, Grau-Corral Inmaculada, Amat-Fernandez Clara, Muñoz Mateu Montserrat, Pastor Duran Xavier, Lozano-Rubí Raimundo
Medical Informatics Unit, Hospital Clínic de Barcelona, Barcelona, Spain.
Universitat de Barcelona, Barcelona, Spain.
JMIR Med Inform. 2022 Oct 12;10(10):e40344. doi: 10.2196/40344.
There is an increasing need to integrate patient-generated health data (PGHD) into health information systems (HISs). The use of health information standards based on the dual model allows the achievement of semantic interoperability among systems. Although there is evidence in the use of the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) framework for standardized communication between mobile apps and electronic health records (EHRs), the use of European Norm/International Organization for Standardization (EN/ISO) 13606 has not been explored yet, despite some advantages over FHIR in terms of modeling and formalization of clinical knowledge, as well as flexibility in the creation of new concepts.
This study aims to design and implement a methodology based on the dual-model paradigm to communicate clinical information between a patient mobile app (Xemio Research) and an institutional ontology-based clinical repository (OntoCR) without loss of meaning.
This paper is framed within Artificial intelligence Supporting CAncer Patients across Europe (ASCAPE), a project that aims to use artificial intelligence (AI)/machine learning (ML) mechanisms to support cancer patients' health status and quality of life (QoL). First, the variables "side effect" and "daily steps" were defined and represented with EN/ISO 13606 archetypes. Next, ontologies that model archetyped concepts and map them to the standard were created and uploaded to OntoCR, where they were ready to receive instantiated patient data. Xemio Research used a conversion module in the ASCAPE Local Edge to transform data entered into the app to create EN/ISO 13606 extracts, which were sent to an Application Programming Interface (API) in OntoCR that maps each element in the normalized XML files to its corresponding location in the ontology. This way, instantiated data of patients are stored in the clinical repository.
Between December 22, 2020, and April 4, 2022, 1100 extracts of 47 patients were successfully communicated (234/1100, 21.3%, extracts of side effects and 866/1100, 78.7%, extracts of daily activity). Furthermore, the creation of EN/ISO 13606-standardized archetypes allows the reuse of clinical information regarding daily activity and side effects, while with the creation of ontologies, we extended the knowledge representation of our clinical repository.
Health information interoperability is one of the requirements for continuity of health care. The dual model allows the separation of knowledge and information in HISs. EN/ISO 13606 was chosen for this project because of the operational mechanisms it offers for data exchange, as well as its flexibility for modeling knowledge and creating new concepts. To the best of our knowledge, this is the first experience reported in the literature of effective communication of EN/ISO 13606 EHR extracts between a patient mobile app and an institutional clinical repository using a scalable standard-agnostic methodology that can be applied to other projects, data sources, and institutions.
将患者生成的健康数据（PGHD）集成到健康信息系统（HISs）中的需求日益增长。基于双模型的健康信息标准的使用能够实现系统间的语义互操作性。尽管有证据表明可使用快速医疗互操作性资源上的可替代医疗应用和可重用技术（SMART on FHIR）框架实现移动应用与电子健康记录（EHRs）之间的标准化通信，但欧洲标准/国际标准化组织（EN/ISO）13606的使用尚未得到探索，尽管它在临床知识的建模和形式化方面以及在创建新概念的灵活性方面比FHIR具有一些优势。
本研究旨在设计并实施一种基于双模型范式的方法，以在患者移动应用程序（Xemio Research）和基于机构本体的临床知识库（OntoCR）之间无意义损失地传递临床信息。
本文以“欧洲人工智能支持癌症患者（ASCAPE）”项目为框架，该项目旨在使用人工智能（AI）/机器学习（ML）机制来支持癌症患者的健康状况和生活质量（QoL）。首先，定义了“副作用”和“每日步数”变量，并用EN/ISO 13606原型进行表示。接下来，创建了对原型概念进行建模并将其映射到标准的本体，并上传到OntoCR，在那里它们准备好接收实例化的患者数据。Xemio Research在ASCAPE本地边缘使用了一个转换模块，将输入应用程序的数据进行转换，以创建EN/ISO 13606提取物，这些提取物被发送到OntoCR中的一个应用程序编程接口（API），该接口将规范化XML文件中的每个元素映射到本体中的相应位置。通过这种方式，患者的实例化数据存储在临床知识库中。
在2020年12月22日至2022年4月4日期间，成功传递了47名患者的1100份提取物（234/1100，21.3%，副作用提取物；866/1100，78.7%，日常活动提取物）。此外，EN/ISO 13606标准化原型的创建允许重复使用关于日常活动和副作用的临床信息，而通过本体的创建，我们扩展了临床知识库的知识表示。
健康信息互操作性是医疗保健连续性的要求之一。双模型允许在HISs中分离知识和信息。本项目选择EN/ISO 13606是因为它提供的数据交换操作机制，以及其在知识建模和创建新概念方面的灵活性。据我们所知，这是文献中首次报道使用可扩展的与标准无关的方法在患者移动应用程序和机构临床知识库之间有效通信EN/ISO 13606 EHR提取物的经验，该方法可应用于其他项目、数据源和机构。
