Exploring openEHR-based clinical guidelines in acute stroke care and research

Largely speaking, health information systems today are not able to exchange data between each other and understand the data’s meaning automatically by means of their information technology components. This lack of ‘interoperability’ also leads to patients experiencing an undesired discontinuity in their care. This thesis is a part of a health informatics field which tackles interoperability barriers by offering standardised information models for electronic health records. More specifically, this work explores possibilities of combining standardised information models offered by the openEHR interoperability approach with knowledge from evidence-based clinical practice guidelines. The applied methodology includes openEHR archetypes, the openEHR reference information model, standard medical terminologies such as SNOMED CT, the international stroke treatment registry SITS, a newly developed model for representing guideline knowledge (the ‘Care Entry-Network Model’), and rules authored in the Guideline Definition Language, a formalism recently endorsed by openEHR as a part of its specifications. The study design used is based on evaluating the work done by means of retrospectively checking the compliance of completed patient cases with guidelines from the domain of acute stroke management in Europe, both experimentally and using thousands of real patient cases from SITS. Our overall findings are that i) the Care Entry-Network Model facilitates an intermediate step between narrative guideline text and computer-interpretable guidelines to be deployed in openEHR systems, ii) the Guideline Definition Language is practicable for creating and automatically running openEHR-based computer-interpretable guidelines, where we also provide detailed accounts of our employed GDL technologies, and iii) the Guideline Definition Language combined with real patient data from patient data registries can generate new clinical knowledge, which in our case has benefited stroke carers and researchers working with acute stroke thrombolysis. In conclusion, using our methodology, health care stakeholders would get evidence-based knowledge components in their electronic health records based on shareable, well maintainable information and knowledge models in the form of archetypes and GDL rules respectively. However, our approach still needs to be tested at the point of clinical decision making and compared to other approaches for providing exchangeable computer-interpretable guidelines

DETAILED CLINICAL MODELS AND THEIR RELATION WITH ELECTRONIC HEALTH RECORDS

Tesis por compendio[EN] Healthcare domain produces and consumes big quantities of people's health data. Although data exchange is the norm rather than the exception, being able to access to all patient data is still far from achieved. Current developments such as personal health records will introduce even more data and complexity to the Electronic Health Records (EHR). Achieving semantic interoperability is one of the biggest challenges to overcome in order to benefit from all the information contained in the distributed EHR. This requires that the semantics of the information can be understood by all involved parties. It has been stablished that three layers are needed to achieve semantic interoperability: Reference models, clinical models (archetypes), and clinical terminologies. As seen in the literature, information models (reference models and clinical models) are lacking methodologies and tools to improve EHR systems and to develop new systems that can be semantically interoperable. The purpose of this thesis is to provide methodologies and tools for advancing the use of archetypes in three different scenarios: - Archetype definition over specifications with no dual model architecture native support. Any EHR architecture that directly or indirectly has the notion of detailed clinical models (such as HL7 CDA templates) can be potentially used as a reference model for archetype definition. This allows transforming single-model architectures (which contain only a reference model) into dual-model architectures (reference model with archetypes). A set of methodologies and tools has been developed to support the definition of archetypes from multiple reference models. - Data transformation. A complete methodology and tools are proposed to deal with the transformation of legacy data into XML documents compliant with the archetype and the underlying reference model. If the reference model is a standard then the transformation is a standardization process. The methodologies and tools allow both the transformation of legacy data and the transformation of data between different EHR standards. - Automatic generation of implementation guides and reference materials from archetypes. A methodology for the automatic generation of a set of reference materials is provided. These materials are useful for the development and use of EHR systems. These reference materials include data validators, example instances, implementation guides, human-readable formal rules, sample forms, mindmaps, etc. These reference materials can be combined and organized in different ways to adapt to different types of users (clinical or information technology staff). This way, users can include the detailed clinical model in their organization workflow and cooperate in the model definition. These methodologies and tools put clinical models as a key part of the system. The set of presented methodologies and tools ease the achievement of semantic interoperability by providing means for the semantic description, normalization, and validation of existing and new systems.[ES] El sector sanitario produce y consume una gran cantidad de datos sobre la salud de las personas. La necesidad de intercambiar esta información es una norma más que una excepción, aunque este objetivo está lejos de ser alcanzado. Actualmente estamos viviendo avances como la medicina personalizada que incrementarán aún más el tamaño y complejidad de la Historia Clínica Electrónica (HCE). La consecución de altos grados de interoperabilidad semántica es uno de los principales retos para aprovechar al máximo toda la información contenida en las HCEs. Esto a su vez requiere una representación fiel de la información de tal forma que asegure la consistencia de su significado entre todos los agentes involucrados. Actualmente está reconocido que para la representación del significado clínico necesitamos tres tipos de artefactos: modelos de referencia, modelos clínicos (arquetipos) y terminologías. En el caso concreto de los modelos de información (modelos de referencia y modelos clínicos) se observa en la literatura una falta de metodologías y herramientas que faciliten su uso tanto para la mejora de sistemas de HCE ya existentes como en el desarrollo de nuevos sistemas con altos niveles de interoperabilidad semántica. Esta tesis tiene como propósito proporcionar metodologías y herramientas para el uso avanzado de arquetipos en tres escenarios diferentes: - Definición de arquetipos sobre especificaciones sin soporte nativo al modelo dual. Cualquier arquitectura de HCE que posea directa o indirectamente la noción de modelos clínicos detallados (por ejemplo, las plantillas en HL7 CDA) puede ser potencialmente usada como modelo de referencia para la definición de arquetipos. Con esto se consigue transformar arquitecturas de HCE de modelo único (solo con modelo de referencia) en arquitecturas de doble modelo (modelo de referencia + arquetipos). Se han desarrollado metodologías y herramientas que faciliten a los editores de arquetipos el soporte a múltiples modelos de referencia. - Transformación de datos. Se propone una metodología y herramientas para la transformación de datos ya existentes a documentos XML conformes con los arquetipos y el modelo de referencia subyacente. Si el modelo de referencia es un estándar entonces la transformación será un proceso de estandarización de datos. La metodología y herramientas permiten tanto la transformación de datos no estandarizados como la transformación de datos entre diferentes estándares. - Generación automática de guías de implementación y artefactos procesables a partir de arquetipos. Se aporta una metodología para la generación automática de un conjunto de materiales de referencia de utilidad en el desarrollo y uso de sistemas de HCE, concretamente validadores de datos, instancias de ejemplo, guías de implementación , reglas formales legibles por humanos, formularios de ejemplo, mindmaps, etc. Estos materiales pueden ser combinados y organizados de diferentes modos para facilitar que los diferentes tipos de usuarios (clínicos, técnicos) puedan incluir los modelos clínicos detallados en el flujo de trabajo de su sistema y colaborar en su definición. Estas metodologías y herramientas ponen los modelos clínicos como una parte clave en el sistema. El conjunto de las metodologías y herramientas presentadas facilitan la consecución de la interoperabilidad semántica al proveer medios para la descripción semántica, normalización y validación tanto de sistemas nuevos como ya existentes.[CA] El sector sanitari produeix i consumeix una gran quantitat de dades sobre la salut de les persones. La necessitat d'intercanviar aquesta informació és una norma més que una excepció, encara que aquest objectiu està lluny de ser aconseguit. Actualment estem vivint avanços com la medicina personalitzada que incrementaran encara més la grandària i complexitat de la Història Clínica Electrònica (HCE). La consecució d'alts graus d'interoperabilitat semàntica és un dels principals reptes per a aprofitar al màxim tota la informació continguda en les HCEs. Açò, per la seua banda, requereix una representació fidel de la informació de tal forma que assegure la consistència del seu significat entre tots els agents involucrats. Actualment està reconegut que per a la representació del significat clínic necessitem tres tipus d'artefactes: models de referència, models clínics (arquetips) i terminologies. En el cas concret dels models d'informació (models de referència i models clínics) s'observa en la literatura una mancança de metodologies i eines que en faciliten l'ús tant per a la millora de sistemes de HCE ja existents com per al desenvolupament de nous sistemes amb alts nivells d'interoperabilitat semàntica. Aquesta tesi té com a propòsit proporcionar metodologies i eines per a l'ús avançat d'arquetips en tres escenaris diferents: - Definició d'arquetips sobre especificacions sense suport natiu al model dual. Qualsevol arquitectura de HCE que posseïsca directa o indirectament la noció de models clínics detallats (per exemple, les plantilles en HL7 CDA) pot ser potencialment usada com a model de referència per a la definició d'arquetips. Amb açò s'aconsegueix transformar arquitectures de HCE de model únic (solament amb model de referència) en arquitectures de doble model (model de referència + arquetips). S'han desenvolupat metodologies i eines que faciliten als editors d'arquetips el suport a múltiples models de referència. - Transformació de dades. Es proposa una metodologia i eines per a la transformació de dades ja existents a documents XML conformes amb els arquetips i el model de referència subjacent. Si el model de referència és un estàndard llavors la transformació serà un procés d'estandardització de dades. La metodologia i eines permeten tant la transformació de dades no estandarditzades com la transformació de dades entre diferents estàndards. - Generació automàtica de guies d'implementació i artefactes processables a partir d'arquetips. S'hi inclou una metodologia per a la generació automàtica d'un conjunt de materials de referència d'utilitat en el desenvolupament i ús de sistemes de HCE, concretament validadors de dades, instàncies d'exemple, guies d'implementació, regles formals llegibles per humans, formularis d'exemple, mapes mentals, etc. Aquests materials poden ser combinats i organitzats de diferents maneres per a facilitar que els diferents tipus d'usuaris (clínics, tècnics) puguen incloure els models clínics detallats en el flux de treball del seu sistema i col·laborar en la seua definició. Aquestes metodologies i eines posen els models clínics com una part clau del sistemes. El conjunt de les metodologies i eines presentades faciliten la consecució de la interoperabilitat semàntica en proveir mitjans per a la seua descripció semàntica, normalització i validació tant de sistemes nous com ja existents.Boscá Tomás, D. (2016). DETAILED CLINICAL MODELS AND THEIR RELATION WITH ELECTRONIC HEALTH RECORDS [Tesis doctoral no publicada]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/62174TESISCompendi

Interoperability of clinical decision-support systems and electronic health records using archetypes: a case study in clinical trial eligibility

Clinical decision-support systems (CDSSs) comprise systems as diverse as sophisticated platforms to store and manage clinical data, tools to alert clinicians of problematic situations, or decision-making tools to assist clinicians. Irrespective of the kind of decision-support task CDSSs should be smoothly integrated within the clinical information system, interacting with other components, in particular with the electronic health record (EHR). However, despite decades of developments, most CDSSs lack interoperability features. We deal with the interoperability problem of CDSSs and EHRs by exploiting the dual-model methodology. This methodology distinguishes a reference model and archetypes. A reference model is represented by a stable and small object-oriented model that describes the generic properties of health record information. For their part, archetypes are reusable and domain-specific definitions of clinical concepts in the form of structured and constrained combinations of the entities of the reference model. We rely on archetypes to make the CDSS compatible with EHRs from different institutions. Concretely, we use archetypes for modelling the clinical concepts that the CDSS requires, in conjunction with a series of knowledge-intensive mappings relating the archetypes to the data sources (EHR and/or other archetypes) they depend on. We introduce a comprehensive approach, including a set of tools as well as methodological guidelines, to deal with the interoperability of CDSSs and EHRs based on archetypes. Archetypes are used to build a conceptual layer of the kind of a virtual health record (VHR) over the EHR whose contents need to be integrated and used in the CDSS, associating them with structural and terminology-based semantics. Subsequently, the archetypes are mapped to the EHR by means of an expressive mapping language and specific-purpose tools. We also describe a case study where the tools and methodology have been employed in a CDSS to support patient recruitment in the framework of a clinical trial for colorectal cancer screening. The utilisation of archetypes not only has proved satisfactory to achieve interoperability between CDSSs and EHRs but also offers various advantages, in particular from a data model perspective. First, the VHR/data models we work with are of a high level of abstraction and can incorporate semantic descriptions. Second, archetypes can potentially deal with different EHR architectures, due to their deliberate independence of the reference model. Third, the archetype instances we obtain are valid instances of the underlying reference model, which would enable e.g. feeding back the EHR with data derived by abstraction mechanisms. Lastly, the medical and technical validity of archetype models would be assured, since in principle clinicians should be the main actors in their development.This research has been supported by the Spanish Ministry of Education through Grant PR2010-0279, and by Universitat Jaume I through Project P1182009-38. Additionally, this research has been supported by the Spanish Ministry of Science and Innovation under Grant TIN2010-21388-C02-01, and by the Spanish Ministry of Economy and Competitiveness under grant PTQ-11-04987.Marcos, M.; Maldonado Segura, JA.; Martinez-Salvador, B.; Boscá Tomás, D.; Robles Viejo, M. (2013). Interoperability of clinical decision-support systems and electronic health records using archetypes: a case study in clinical trial eligibility. Journal of Biomedical Informatics. 46(4):676-689. https://doi.org/10.1016/j.jbi.2013.05.004S67668946

Comparing the APGAR score representation in HL7 and OpenEHR formalisms.

International audienceSemantic interoperability, a prerequisite to eHealth projects, relies on sharing both information and knowledge models between information systems. Two of the standards of information models are HL7 v3 and the European norm, EN13606/OpenEHR. The paper compares both standards on a fragment of the prenatal medical record, the APGAR score. Two factors are compared: the formal representation of both information models, and the binding to knowledge models. The HL7v3 perinatality DMIM specification and the OpenEHR APGAR archetype were used. HL7v3 appears to be more formal than OpenEHR and able to represent in an easier way the clinical context. For both standards, the binding to reference terminologies such as LOINC is poor. We provide recommendations to improve the standards