Archetype development and governance methodologies for the electronic health record

[ES] La interoperabilidad semántica de la información sanitaria es un requisito imprescindible para la sostenibilidad de la atención sanitaria, y es fundamental para afrontar los nuevos retos sanitarios de un mundo globalizado. Esta tesis aporta nuevas metodologías para abordar algunos de los aspectos fundamentales de la interoperabilidad semántica, específicamente aquellos relacionados con la definición y gobernanza de modelos de información clínica expresados en forma de arquetipo. Las aportaciones de la tesis son: - Estudio de las metodologías de modelado existentes de componentes de interoperabilidad semántica que influirán en la definición de una metodología de modelado de arquetipos. - Análisis comparativo de los sistemas e iniciativas existentes para la gobernanza de modelos de información clínica. - Una propuesta de Metodología de Modelado de Arquetipos unificada que formalice las fases de desarrollo del arquetipo, los participantes requeridos y las buenas prácticas a seguir. - Identificación y definición de principios y características de gobernanza de arquetipos. - Diseño y desarrollo de herramientas que brinden soporte al modelado y la gobernanza de arquetipos. Las aportaciones de esta tesis se han puesto en práctica en múltiples proyectos y experiencias de desarrollo. Estas experiencias varían desde un proyecto local dentro de una sola organización que requirió la reutilización de datos clínicos basados en principios de interoperabilidad semántica, hasta el desarrollo de proyectos de historia clínica electrónica de alcance nacional.[CA] La interoperabilitat semàntica de la informació sanitària és un requisit imprescindible per a la sostenibilitat de l'atenció sanitària, i és fonamental per a afrontar els nous reptes sanitaris d'un món globalitzat. Aquesta tesi aporta noves metodologies per a abordar alguns dels aspectes fonamentals de la interoperabilitat semàntica, específicament aquells relacionats amb la definició i govern de models d'informació clínica expressats en forma d'arquetip. Les aportacions de la tesi són: - Estudi de les metodologies de modelatge existents de components d'interoperabilitat semàntica que influiran en la definició d'una metodologia de modelatge d'arquetips. - Anàlisi comparativa dels sistemes i iniciatives existents per al govern de models d'informació clínica. - Una proposta de Metodologia de Modelatge d'Arquetips unificada que formalitza les fases de desenvolupament de l'arquetip, els participants requerits i les bones pràctiques a seguir. - Identificació i definició de principis i característiques de govern d'arquetips. - Disseny i desenvolupament d'eines que brinden suport al modelatge i al govern d'arquetips. Les aportacions d'aquesta tesi s'han posat en pràctica en múltiples projectes i experiències de desenvolupament. Aquestes experiències varien des d'un projecte local dins d'una sola organització que va requerir la reutilització de dades clíniques basades en principis d'interoperabilitat semàntica, fins al desenvolupament de projectes d'història clínica electrònica d'abast nacional.[EN] Semantic interoperability of health information is an essential requirement for the sustainability of healthcare, and it is essential to face the new health challenges of a globalized world. This thesis provides new methodologies to tackle some of the fundamental aspects of semantic interoperability, specifically those aspects related to the definition and governance of clinical information models expressed in the form of archetypes. The contributions of the thesis are: - Study of existing modeling methodologies of semantic interoperability components that will influence in the definition of an archetype modeling methodology. - Comparative analysis of existing clinical information model governance systems and initiatives. - A proposal of a unified Archetype Modeling Methodology that formalizes the phases of archetype development, the required participants, and the good practices to be followed. - Identification and definition of archetype governance principles and characteristics. - Design and development of tools that provide support to archetype modeling and governance. The contributions of this thesis have been put into practice in multiple projects and development experiences. These experiences vary from a local project inside a single organization that required a reuse on clinical data based on semantic interoperability principles, to the development of national electronic health record projects.This thesis was partially funded by the Ministerio de Economía y Competitividad, ayudas para contratos para la formación de doctores en empresas “Doctorados Industriales”, grant DI-14-06564 and by the Agencia Valenciana de la Innovación, ayudas del Programa de Promoción del Talento – Doctorados empresariales (INNODOCTO), grant INNTA3/2020/12.Moner Cano, D. (2021). Archetype development and governance methodologies for the electronic health record [Tesis doctoral]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/16491

Clinical Data Reuse or Secondary Use: Current Status and Potential Future Progress

Objective: To perform a review of recent research in clinical data reuse or secondary use, and envision future advances in this field. Methods: The review is based on a large literature search in MEDLINE (through PubMed), conference proceedings, and the ACM Digital Library, focusing only on research published between 2005 and early 2016. Each selected publication was reviewed by the authors, and a structured analysis and summarization of its content was developed. Results: The initial search produced 359 publications, reduced after a manual examination of abstracts and full publications. The following aspects of clinical data reuse are discussed: motivations and challenges, privacy and ethical concerns, data integration and interoperability, data models and terminologies, unstructured data reuse, structured data mining, clinical practice and research integration, and examples of clinical data reuse (quality measurement and learning healthcare systems). Conclusion: Reuse of clinical data is a fast-growing field recognized as essential to realize the potentials for high quality healthcare, improved healthcare management, reduced healthcare costs, population health management, and effective clinical research

Exporting data from an openEHR repository to standard formats

With the healthcare sector computerization, a large amount of data is produced from medical encounters, therapeutic outcomes and other aspects of healthcare provider’s organizations current activity. Decision support systems cover several methodologies and approaches that may be applied to the healthcare sector and, since that they store and analyze data in a tabular format, it becomes necessary to assure that data sources with different data representations can be used to feed these systems. The present work focuses on the development of a methodology to export data from an openEHR repository to standard formats through a software tool which adapts itself to different data sources for later exploration in statistical and decision support systems. From use case and requirements analysis to the efective development of the tool, several steps were performed to document progress and to ground conclusions regarding operational test data. Obtained results indicate that this data export is feasible, but also highlight the need to define parameters so that the tool may function.Com a informatização do sector da saúde, uma grande quantidade de dados é produzida a partir de encontros médicos, resultados terapêuticos e outros aspectos da actividade corrente dos prestadores de cuidados. Os sistemas de apoio à decisão englobam várias metodologias e abordagens que se podem aplicar ao sector da saúde e, sendo que esses sistemas armazenam e analisam dados em formato tabular, torna-se necessário assegurar que fontes de dados com diferentes representações de informação podem ser utilizadas para alimentar estes sistemas. O presente trabalho debruça-se no desenvolvimento de uma metodologia para a exportação de dados de um repositório openEHR para formatos standard através de uma ferramenta de software que se adapte às diferentes fontes de dados para posterior análise em sistemas estatísticos e de apoio à decisão. Desde a análise de casos de uso e requerimentos até ao efectivo desenvolvimento da ferramenta, vários passos foram dados para documentar o progresso e fundamentar conclusões respeitantes aos dados dos testes operacionais. Os resultados obtidos indicam que esta exportação é exequível, mas evidenciam também a necessidade de definir parâmetros para que a ferramenta possa funcionar

A Two-Level Identity Model To Support Interoperability of Identity Information in Electronic Health Record Systems.

The sharing and retrieval of health information for an electronic health record (EHR) across distributed systems involves a range of identified entities that are possible subjects of documentation (e.g., specimen, clinical analyser). Contemporary EHR specifications limit the types of entities that can be the subject of a record to health professionals and patients, thus limiting the use of two level models in healthcare information systems that contribute information to the EHR. The literature describes several information modelling approaches for EHRs, including so called “two level models”. These models differ in the amount of structure imposed on the information to be recorded, but they generally require the health documentation process for the EHR to focus exclusively on the patient as the subject of care and this definition is often a fixed one. In this thesis, the author introduces a new identity modelling approach to create a generalised reference model for sharing archetype-constrained identity information between diverse identity domains, models and services, while permitting reuse of published standard-based archetypes. The author evaluates its use for expressing the major types of existing demographic reference models in an extensible way, and show its application for standards-compliant two-level modelling alongside heterogeneous demographics models. This thesis demonstrates how the two-level modelling approach that is used for EHRs could be adapted and reapplied to provide a highly-flexible and expressive means for representing subjects of information in allied health settings that support the healthcare process, such as the laboratory domain. By relying on the two level modelling approach for representing identity, the proposed design facilitates cross-referencing and disambiguation of certain demographics standards and information models. The work also demonstrates how it can also be used to represent additional clinical identified entities such as specimen and order as subjects of clinical documentation

Ontology-based data integration between clinical and research systems

Data from the electronic medical record comprise numerous structured but uncoded elements, which are not linked to standard terminologies. Reuse of such data for secondary research purposes has gained in importance recently. However, the identification of relevant data elements and the creation of database jobs for extraction, transformation and loading (ETL) are challenging: With current methods such as data warehousing, it is not feasible to efficiently maintain and reuse semantically complex data extraction and trans-formation routines. We present an ontology-supported approach to overcome this challenge by making use of abstraction: Instead of defining ETL procedures at the database level, we use ontologies to organize and describe the medical concepts of both the source system and the target system. Instead of using unique, specifically developed SQL statements or ETL jobs, we define declarative transformation rules within ontologies and illustrate how these constructs can then be used to automatically generate SQL code to perform the desired ETL procedures. This demonstrates how a suitable level of abstraction may not only aid the interpretation of clinical data, but can also foster the reutilization of methods for un-locking it

Computing Healthcare Quality Indicators Automatically: Secondary Use of Patient Data and Semantic Interoperability

Harmelen, F.A.H. van [Promotor]Keizer, N.F. de [Copromotor]Cornet, R. [Copromotor]Teije, A.C.M. [Copromotor

CLINICAL DATA WAREHOUSE: A REVIEW

Clinical decisions are crucial because they are related to human lives. Thus, managers and decision makers inthe clinical environment seek new solutions that can support their decisions. A clinical data warehouse (CDW) is animportant solution that is used to achieve clinical stakeholders’ goals by merging heterogeneous data sources in a centralrepository and using this repository to find answers related to the strategic clinical domain, thereby supporting clinicaldecisions. CDW implementation faces numerous obstacles, starting with the data sources and ending with the tools thatview the clinical information. This paper presents a systematic overview of purpose of CDWs as well as the characteristics;requirements; data sources; extract, transform and load (ETL) process; security and privacy concerns; design approach;architecture; and challenges and difficulties related to implementing a successful CDW. PubMed and Google Scholarare used to find papers related to CDW. Among the total of 784 papers, only 42 are included in the literature review. Thesepapers are classified based on five perspectives, namely methodology, data, system, ETL tool and purpose, to findinsights related to aspects of CDW. This review can contribute answers to questions related to CDW and providerecommendations for implementing a successful CDW

Combining ontologies and rules with clinical archetypes

Al igual que otros campos que dependen en gran medida de las funcionalidades ofrecidas por las tecnologías de la información y las comunicaciones (IT), la biomedicina y la salud necesitan cada vez más la implantación de normas y mecanismos ampliamente aceptados para el intercambio de datos, información y conocimiento. Dicha necesidad de compatibilidad e interoperabilidad va más allá de las cuestiones sintácticas y estructurales, pues la interoperabilidad semántica es también requerida. La interoperabilidad a nivel semántico es esencial para el soporte computarizado de alertas, flujos de trabajo y de la medicina basada en evidencia cuando contamos con la presencia de sistemas heterogéneos de Historia Clínica Electrónica (EHR). El modelo de arquetipos clínicos respaldado por el estándar CEN/ISO EN13606 y la fundación openEHR ofrece un mecanismo para expresar las estructuras de datos clínicos de manera compartida e interoperable. El modelo ha ido ganando aceptación en los últimos años por su capacidad para definir conceptos clínicos basados en un Modelo de Referencia común. Dicha separación a dos capas permite conservar la heterogeneidad de las implementaciones de almacenamiento a bajo nivel, presentes en los diferentes sistemas de EHR. Sin embargo, los lenguajes de arquetipos no soportan la representación de reglas clínicas ni el mapeo a ontologías formales, ambos elementos fundamentales para alcanzar la interoperabilidad semántica completa pues permiten llevar a cabo el razonamiento y la inferencia a partir del conocimiento clínico existente. Paralelamente, es reconocido el hecho de que la World Wide Web presenta requisitos análogos a los descritos anteriormente, lo cual ha fomentado el desarrollo de la Web Semántica. El progreso alcanzado en este terreno, con respecto a la representación del conocimiento y al razonamiento sobre el mismo, es combinado en esta tesis con los modelos de EHR con el objetivo de mejorar el enfoque de los arquetipos clínicos y ofrecer funcionalidades que se corresponden con nivel más alto de interoperabilidad semántica. Concretamente, la investigación que se describe a continuación presenta y evalúa un enfoque para traducir automáticamente las definiciones expresadas en el lenguaje de definición de arquetipos de openEHR (ADL) a una representación formal basada en lenguajes de ontologías. El método se implementa en la plataforma ArchOnt, que también es descrita. A continuación se estudia la integración de dichas representaciones formales con reglas clínicas, ofreciéndose un enfoque para reutilizar el razonamiento con instancias concretas de datos clínicos. Es importante ver como el acto de compartir el conocimiento clínico expresado a través de reglas es coherente con la filosofía de intercambio abierto fomentada por los arquetipos, a la vez que se extiende la reutilización a proposiciones de conocimiento declarativo como las utilizadas en las guías de práctica clínica. De esta manera, la tesis describe una técnica de mapeo de arquetipos a ontologías, para luego asociar reglas clínicas a la representación resultante. La traducción automática también permite la conexión formal de los elementos especificados en los arquetipos con conceptos clínicos equivalentes provenientes de otras fuentes como son las terminologías clínicas. Dichos enlaces fomentan la reutilización del conocimiento clínico ya representado, así como el razonamiento y la navegación a través de distintas ontologías clínicas. Otra contribución significativa de la tesis es la aplicación del enfoque mencionado en dos proyectos de investigación y desarrollo clínico, llevados a cabo en combinación con hospitales universitarios de Madrid. En la explicación se incluyen ejemplos de las aplicaciones más representativas del enfoque como es el caso del desarrollo de sistemas de alertas orientados a mejorar la seguridad del paciente. No obstante, la traducción automática de arquetipos clínicos a lenguajes de ontologías constituye una base común para la implementación de una amplia gama de actividades semánticas, razonamiento y validación, evitándose así la necesidad de aplicar distintos enfoques ad-hoc directamente sobre los arquetipos para poder satisfacer las condiciones de cada contexto

An Extended Semantic Interoperability Model for Distributed Electronic Health Record Based on Fuzzy Ontology Semantics

Semantic interoperability of distributed electronic health record (EHR) systems is a crucial problem for querying EHR and machine learning projects. The main contribution of this paper is to propose and implement a fuzzy ontology-based semantic interoperability framework for distributed EHR systems. First, a separate standard ontology is created for each input source. Second, a unified ontology is created that merges the previously created ontologies. However, this crisp ontology is not able to answer vague or uncertain queries. We thirdly extend the integrated crisp ontology into a fuzzy ontology by using a standard methodology and fuzzy logic to handle this limitation. The used dataset includes identified data of 100 patients. The resulting fuzzy ontology includes 27 class, 58 properties, 43 fuzzy data types, 451 instances, 8376 axioms, 5232 logical axioms, 1216 declarative axioms, 113 annotation axioms, and 3204 data property assertions. The resulting ontology is tested using real data from the MIMIC-III intensive care unit dataset and real archetypes from openEHR. This fuzzy ontology-based system helps physicians accurately query any required data about patients from distributed locations using near-natural language queries. Domain specialists validated the accuracy and correctness of the obtained resultsThis work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT) (NRF-2021R1A2B5B02002599)S

Clinical foundations and information architecture for the implementation of a federated health record service

Clinical care increasingly requires healthcare professionals to access patient record information that may be distributed across multiple sites, held in a variety of paper and electronic formats, and represented as mixtures of narrative, structured, coded and multi-media entries. A longitudinal person-centred electronic health record (EHR) is a much-anticipated solution to this problem, but its realisation is proving to be a long and complex journey. This Thesis explores the history and evolution of clinical information systems, and establishes a set of clinical and ethico-legal requirements for a generic EHR server. A federation approach (FHR) to harmonising distributed heterogeneous electronic clinical databases is advocated as the basis for meeting these requirements. A set of information models and middleware services, needed to implement a Federated Health Record server, are then described, thereby supporting access by clinical applications to a distributed set of feeder systems holding patient record information. The overall information architecture thus defined provides a generic means of combining such feeder system data to create a virtual electronic health record. Active collaboration in a wide range of clinical contexts, across the whole of Europe, has been central to the evolution of the approach taken. A federated health record server based on this architecture has been implemented by the author and colleagues and deployed in a live clinical environment in the Department of Cardiovascular Medicine at the Whittington Hospital in North London. This implementation experience has fed back into the conceptual development of the approach and has provided "proof-of-concept" verification of its completeness and practical utility. This research has benefited from collaboration with a wide range of healthcare sites, informatics organisations and industry across Europe though several EU Health Telematics projects: GEHR, Synapses, EHCR-SupA, SynEx, Medicate and 6WINIT. The information models published here have been placed in the public domain and have substantially contributed to two generations of CEN health informatics standards, including CEN TC/251 ENV 13606