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

Archetype Modeling Methodology

[EN] Clinical Information Models (CIMs) expressed as archetypes play an essential role in the design and development of current Electronic Health Record (EHR) information structures. Although there exist many experiences about using archetypes in the literature, a comprehensive and formal methodology for archetype modeling does not exist. Having a modeling methodology is essential to develop quality archetypes, in order to guide the development of EHR systems and to allow the semantic interoperability of health data. In this work, an archetype modeling methodology is proposed. This paper describes its phases, the inputs and outputs of each phase, and the involved participants and tools. It also includes the description of the possible strategies to organize the modeling process. The proposed methodology is inspired by existing best practices of CIMs, software and ontology development. The methodology has been applied and evaluated in regional and national EHR projects. The application of the methodology provided useful feedback and improvements, and confirmed its advantages. The conclusion of this work is that having a formal methodology for archetype development facilitates the definition and adoption of interoperable archetypes, improves their quality, and facilitates their reuse among different information systems and EHR projects. Moreover, the proposed methodology can be also a reference for CIMs development using any other formalism.This work was partially funded by grant DI-14-06564 (Doctorados Industriales) of the Ministerio de Economia y Competitividad of Spain. The authors would also thank the participants of all R&D projects that have served to evaluate and improve the presented methodology.Moner Cano, D.; Maldonado Segura, JA.; Robles Viejo, M. (2018). Archetype Modeling Methodology. Journal of Biomedical Informatics. 79:71-81. https://doi.org/10.1016/j.jbi.2018.02.003S71817

Detailed Clinical Models Governance System in a Regional EHR Project

The final publication is available at Springer via http://dx.doi.org/ 10.1007/978-3-319-00846-2_313In this work we present the Concept Oriented Repository (ROC), a system developed for the management of clinical information models, also known as detailed clinical models (DCM). It has been developed to be used in the Electronic Health Record project of the Valencia regional health agency (AVS). The system uses DCMs as a way to define clinical models independently of the healthcare standard chosen by the organization. These definitions create a framework where different actors can come to agreements on which information has to be represented and managed in the project. These concepts can be used later for the definition of technical artifacts (archetypes, templates, forms or message definitions) to be used by AVS information systemsThis work has been funded by Electronic Health History project from Valencia Health Agency (HSEAVS).Boscá Tomás, D.; Marco Ruiz, L.; Moner Cano, D.; Maldonado Segura, JA.; Insa, L.; Robles Viejo, M. (2013). Detailed Clinical Models Governance System in a Regional EHR Project. En XIII Mediterranean Conference on Medical and Biological Engineering and Computing 2013. Springer. 1266-1269. doi:10.1007/978-3-319-00846-2_313S1266126

Utilidad de los arquetipos ISO 13606 para representar modelos clínicos detallados

Objetivo: Evaluar la utilidad de los Arquetipos ISO/CEN 13606 y openEHR en la representación de modelos clínicos detallados. Metodología: como editores de arquetipos se utilizaron LinkERH para ISO/CEN 13606 y los editores de Ocean Informatics y LiU para openEHR. Como caso de uso se representaron los conjuntos de datos identificados en los modelos locales de tres sistemas (hospital, UCI y atención primaria) en el dominio de la úlcera por decúbito, abarcando la observación, evaluación, instrucción y acción. Los conceptos fueron enlazados con terminologías SNOMED CT y MedDRA. Se buscaron arquetipos relacionados con el dominio en los repositorios internacionales para ser reutilizados. Resultados: Se realizó un conjunto de arquetipos equivalentes ISO/CEN 13606 y openEHR, en español e inglés. Los arquetipos proporcionan un formalismo útil para especificar datos de un modelo detallado. Los modelos producidos por las herramientas de edición de arquetipos son comprensibles para los clínicos. Los arquetipos proporcionan un marco para la implementación de las terminologías en la HCE. Se requiere el desarrollo de técnicas para el diseño de arquetipos que garanticen su calidad.Serrano, P.; Moner Cano, D.; Sebastian, T.; Maldonado Segura, JA.; Navalón, R.; Robles Viejo, M.; Gómez, Á. (2009). Utilidad de los arquetipos ISO 13606 para representar modelos clínicos detallados. RevistaeSalud.com. 5(18):100-110. http://hdl.handle.net/10251/61364S10011051

Leveraging electronic healthcare record standards and semantic web technologies for the identification of patient cohorts

Introduction The secondary use of Electronic Healthcare Records (EHRs) often requires the identification of patient cohorts. In this context, an important problem is the heterogeneity of clinical data sources, which can be overcome with the combined use of standardized information models, Virtual Health Records, and semantic technologies, since each of them contributes to solving aspects related to the semantic interoperability of EHR data. Our main objective is to develop methods allowing for a direct use of EHR data for the identification of patient cohorts leveraging current EHR standards and semantic web technologies. Materials and Methods We propose to take advantage of the best features of working with EHR standards and ontologies. Our proposal is based on our previous results and experience working with both technological infrastructures. Our main principle is to perform each activity at the abstraction level with the most appropriate technology available. This means that part of the processing will be performed using archetypes (i.e., data level) and the rest using ontologies (i.e., knowledge level). Our approach will start working with EHR data in proprietary format, which will be first normalized and elaborated using EHR standards and then transformed into a semantic representation, which will be exploited by automated reasoning. Results We have applied our approach to protocols for colorectal cancer screening. The results comprise the archetypes, ontologies and datasets developed for the standardization and semantic analysis of EHR data. Anonymized real data has been used and the patients have been successfully classified by the risk of developing colorectal cancer. Conclusion This work provides new insights in how archetypes and ontologies can be effectively combined for EHR-driven phenotyping. The methodological approach can be applied to other problems provided that suitable archetypes, ontologies and classification rules can be designed.This work was supported by the Ministerio de Economia y Competitividad and the FEDER program through grants TIN2010-21388-C01 and TIN2010-21388-C02. MCLG was supported by the Fundacion Seneca through grant 15555/FPI/2010.Fernández-Breis, JT.; Maldonado Segura, JA.; Marcos, M.; Legaz-García, MDC.; Moner Cano, D.; Torres-Sospedra, J.; Esteban-Gil, A.... (2013). Leveraging electronic healthcare record standards and semantic web technologies for the identification of patient cohorts. Journal of the American Medical Informatics Association. 20(E2):288-296. https://doi.org/10.1136/amiajnl-2013-001923S28829620E2Cuggia, M., Besana, P., & Glasspool, D. (2011). Comparing semi-automatic systems for recruitment of patients to clinical trials. International Journal of Medical Informatics, 80(6), 371-388. doi:10.1016/j.ijmedinf.2011.02.003Sujansky, W. 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Automatic generation of computable implementation guides from clinical information models

Clinical information models are increasingly used to describe the contents of Electronic Health Records. Implementation guides are a common specification mechanism used to define such models. They contain, among other reference materials, all the constraints and rules that clinical information must obey. However, these implementation guides typically are oriented to human-readability, and thus cannot be processed by computers. As a consequence, they must be reinterpreted and transformed manually into an executable language such as Schematron or Object Constraint Language (OCL). This task can be diffi- cult and error prone due to the big gap between both representations. The challenge is to develop a methodology for the specification of implementation guides in such a way that humans can read and understand easily and at the same time can be processed by computers. In this paper, we propose and describe a novel methodology that uses archetypes as basis for generation of implementation guides. We use archetypes to generate formal rules expressed in Natural Rule Language (NRL) and other reference materials usually included in implementation guides such as sample XML instances. We also generate Schematron rules from NRL rules to be used for the validation of data instances. We have implemented these methods in LinkEHR, an archetype editing platform, and exemplify our approach by generating NRL rules and implementation guides from EN ISO 13606, openEHR, and HL7 CDA archetypes. 2015 Elsevier Inc. All rights reserved.Boscá Tomás, D.; Maldonado Segura, JA.; Moner Cano, D.; Robles Viejo, M. (2015). Automatic generation of computable implementation guides from clinical information models. Journal of Biomedical Informatics. 55:143-152. doi:10.1016/j.jbi.2015.04.002S1431525

Patient summary and medicines reconciliation: application of the ISO/CEN EN 13606 standard in clinical practice

The comparison of the patient's current medication list with the medication being ordered when admitted to Hospital, identifying omissions, duplications, dosing errors, and potential interactions, constitutes the core process of medicines reconciliation. Access to the medication the patient is taking at home could be unfeasible as this information is frequently stored in various locations and in diverse proprietary formats. The lack of interoperability between those information systems, namely the Primary Care and the Specialized Electronic Health Records (EHRs), facilitates medication errors and endangers patient safety. Thus, the development of a Patient Summary that includes clinical data from different electronic systems will allow doctors access to relevant information enabling a safer and more efficient assistance. Such a collection of data from heterogeneous and distributed systems has been achieved in this Project through the construction of a federated view based on the ISO/CEN EN13606 Standard for architecture and communication of EHRsThis Project has been funded by the Spanish Health Ministry (Convenio de colaboración para el impulso de prácticas seguras en Centros Sanitarios 2008) and has been awarded with one of the Quality within the Spanish National Health System Prizes 2009.Farfán Sedano, FJ.; Terrón Cuadrado, M.; Castellanos Clemente, Y.; Serrano Balazote, P.; Moner Cano, D.; Robles Viejo, M. (2011). Patient summary and medicines reconciliation: application of the ISO/CEN EN 13606 standard in clinical practice. En Patient Safety Informatics: adverse drug events, human factors and IT tools for patient medication safety. IOS Press. 189-196. doi:10.3233/978-1-60750-740-6-189S18919

Manual práctico de interoperabilidad semántica para entornos sanitarios basada en arquetipos / Adolfo Muñoz Carrera...[et al.]. Madrid: ISCIII, 2013

La necesidad de interoperabilidad en los sistemas públicos de salud como soporte a la continuidad asistencial está plenamente establecida desde hace ya algún tiempo y el uso de la normalización se ha situado como la principal estrategia para conseguirla. Este texto pretende ser un manual práctico para dotar a los profesionales de la salud (tanto tecnológicos como sanitarios, pues ambos están involucrados en el proceso) de las herramientas necesarias para comprender y acometer la interoperabilidad, en el más amplio sentido del término, de sus organizaciones. Respondiendo al objetivo de la practicidad, el libro está dividido en dos partes: la primera descriptiva, donde se muestran los diferentes conceptos tratados en orden creciente de complejidad (y de abstracción), y una segunda que comienza con la descripción de una metodología para dotar a las organizaciones de interoperabilidad y donde se aplican los conceptos vistos anteriormente siguiendo el orden propuesto por dicha metodología, definiendo primeramente los más abstractos y terminando por los más concretos. La introducción define los distintos tipos de interoperabilidad: técnica (que soporta la conexión física de los sistemas), sintáctica (que permite que aquellos se transfieran información), semántica (que hace que los sistemas puedan interpretar automáticamente la información recibida y actúen en onsecuencia) y organizativa (que define el contexto necesario para que las organizaciones puedan cooperar). Muestra los niveles de las organizaciones en los que aplicar los diferentes tipos de interoperabilidad y termina proponiendo una serie de normas a utilizar en cada uno de esos niveles y los profesionales que deben encargarse de estas tareas