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

Direct hospitalization costs associated with chronic Hepatitis C in the Valencian Community in 2013

[ES] Fundamentos. Los costes hospitalarios asociados a la Hepatitis Crónica C (HCC) surgen en los estadíos finales de la enfermedad. Su cuantificación es de gran utilidad para estimar la carga de la enfermedad y establecer decisiones de financiación de los nuevos antivirales. Los costes más elevados son motivados por la descompensación de la cirrosis. Métodos. Estudio observacional de corte transversal de los costes hospitalarios de episodios con diagnóstico de HCC en la Comunidad Valenciana en 2013. Fuente de información: Conjunto mínimo básico de datos. Se estimaron los costes según las tarifas establecidas para los GRD (Grupos relacionados por el diagnóstico) asociados a los episodios con diagnóstico de hepatitis C. La supervivencia media de los pacientes desde que se inició la descompensación de su cirrosis se estimó mediante un modelo de Markov, según las probabilidades de evolución de la enfermedad existentes en la literatura. Resultados. Se registraron 4.486 episodios de hospitalización con diagnóstico de HCC, 1.108 fueron debidos a complicaciones de la HCC que generaron 6.713 estancias, tasa de reingresos del 28,2 % y mortalidad del 10,2%. El coste hospitalario ascendió a 8.788.593EUR: 3.306.333EUR correspondieron a Cirrosis (5.273EUR/paciente); 1.060.521EUR a Carcinoma (6.350EUR/ paciente) y 2.962.873EUR a trasplante (70.544EUR/paciente). La comorbilidad por Hepatitis C supuso 1.458.866EUR. Estos costes se mantienen durante una media de 4 años una vez comienza la descompensación de la cirrosis. Conclusiones. La cirrosis por HCC genera un coste muy elevado por hospitalización, la metodología utilizada en la estimación de estos costes a partir de los GRD puede ser de gran utilidad para evaluar la tendencia e impacto económico de esta enfermedad.[EN] Background. Hospital costs associated with Chronic Hepatitis C (HCC) arise in the final stages of the disease. Its quantification is very helpful in order to estimate and check the burden of the disease and to make financial decisions for new antivirals. The highest costs are due to the decompensation of cirrosis. Methods. Cross-sectional observational study of hospital costs of HCC diagnoses in the Valencian Community in 2013 (n= 4,486 hospital discharges). Information source: Minimum basic set of data/ Basic Minimum Data Set. The costs were considered according to the rates established for the DRG (Diagnosis related group) associated with the episodes with diagnosis of hepatitis C. The average survival of patients since the onset of the decompensation of their cirrhosis was estimated by a Markov model, according to the probabilities of evolution of the disease existing in Literatura. Results. There were 4,486 hospital episodes, 1,108 due to complications of HCC, which generated 6,713 stays, readmission rate of 28.2% and mortality of 10.2%. The hospital cost amounted to 8,788,593EUR: 3,306,333EUR corresponded to Cirrhosis (5,273EUR/patient); 1,060,521EUR to Carcinoma (6,350EUR/ patient) and 2,962,873EUR to transplantation (70,544EUR/paciente. Comorbidity was 1,458,866EUR. These costs are maintained for an average of 4 years once the cirrhosis decompensation begins. Conclusions. Cirrhosis due to HCC generates a very high hospitalization¿s costs. The methodology used in the estimation of these costs from the DRG can be very useful to evaluate the trend and economic impact of this disease.Barrachina Martínez, I.; Giner-Durán R; Vivas-Consuelo, D.; ANTONIO LOPEZ RODADO; Maldonado Segura, JA. (2018). Costes de hospitalización asociados a la Hepatitis crónica C en la Comunidad Valenciana en 2013. Revista Española de Salud Pública. 92:1-12. http://hdl.handle.net/10251/124218S1129

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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A., … Robles, M. (2012). Using the ResearchEHR platform to facilitate the practical application of the EHR standards. Journal of Biomedical Informatics, 45(4), 746-762. doi:10.1016/j.jbi.2011.11.004Parker CG Rocha RA Campbell JR . Detailed clinical models for sharable, executable guidelines. Stud Health Technol Inform 2004;107:145–8.Clinical Information Modeling Initiative. http://informatics.mayo.edu/CIMI/index.php/Main_Page (accessed Jun 2013).W3C, OWL2 Web Ontology Language. http://www.w3.org/TR/owl2-overview/ (accessed Jun 2013).European Commission. Semantic interoperability for better health and safer healthcare. Deployment and research roadmap for Europe. ISBN-13: 978-92-79-11139-6, 2009.SemanticHealthNet. http://www.semantichealthnet.eu/ (accessed Jun 2013).Martínez-Costa, C., Menárguez-Tortosa, M., Fernández-Breis, J. T., & Maldonado, J. A. (2009). A model-driven approach for representing clinical archetypes for Semantic Web environments. Journal of Biomedical Informatics, 42(1), 150-164. doi:10.1016/j.jbi.2008.05.005Iqbal AM . An OWL-DL ontology for the HL7 reference information model. Toward useful services for elderly and people with disabilities Berlin: Springer, 2011:168–75.Tao, C., Jiang, G., Oniki, T. A., Freimuth, R. R., Zhu, Q., Sharma, D., … Chute, C. G. (2012). A semantic-web oriented representation of the clinical element model for secondary use of electronic health records data. Journal of the American Medical Informatics Association, 20(3), 554-562. doi:10.1136/amiajnl-2012-001326Heymans, S., McKennirey, M., & Phillips, J. (2011). Semantic validation of the use of SNOMED CT in HL7 clinical documents. Journal of Biomedical Semantics, 2(1), 2. doi:10.1186/2041-1480-2-2Menárguez-Tortosa, M., & Fernández-Breis, J. T. (2013). OWL-based reasoning methods for validating archetypes. Journal of Biomedical Informatics, 46(2), 304-317. doi:10.1016/j.jbi.2012.11.009Lezcano, L., Sicilia, M.-A., & Rodríguez-Solano, C. (2011). Integrating reasoning and clinical archetypes using OWL ontologies and SWRL rules. Journal of Biomedical Informatics, 44(2), 343-353. doi:10.1016/j.jbi.2010.11.005Tao C Wongsuphasawat K Clark K . Towards event sequence representation, reasoning and visualization for EHR data. Proceedings of the 2nd ACM SIGHIT International Health Informatics Symposium (IHI'12). New York, NY, USA: ACM:801–6.Bodenreider O . Biomedical ontologies in action: role in knowledge management, data integration and decision support. IMIA Yearbook of Medical Informatics 2008;67–79.Beale T . Archetypes. 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A school-based physical activity promotion intervention in children: rationale and study protocol for the PREVIENE Project

The lack of physical activity and increasing time spent in sedentary behaviours during childhood place importance on developing low cost, easy-toimplement school-based interventions to increase physical activity among children. The PREVIENE Project will evaluate the effectiveness of five innovative, simple, and feasible interventions (active commuting to/from school, active Physical Education lessons, active school recess, sleep health promotion, and an integrated program incorporating all 4 interventions) to improve physical activity, fitness, anthropometry, sleep health, academic achievement, and health-related quality of life in primary school children. The PREVIENE Project will provide the information about the effectiveness and implementation of different school-based interventions for physical activity promotion in primary school children.The PREVIENE Project was funded by the Spanish Ministry of Economy and Competitiveness (DEP2015-63988-R, MINECO-FEDER). MAG is supported by grants from the Spanish Ministry of Economy and Competitivenes

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Analysis of the process of representing clinical statements for decision-support applications: a comparison of openEHR archetypes and HL7 virtual medical record

[EN] Delivering patient-specific decision-support based on computer-interpretable guidelines (CIGs) requires mapping CIG clinical statements (data items, clinical recommendations) into patients data. This is most effectively done via intermediate data schemas, which enable querying the data according to the semantics of a shared standard intermediate schema. This study aims to evaluate the use of HL7 virtual medical record (vMR) and openEHR archetypes as intermediate schemas for capturing clinical statements from CIGs that are mappable to electronic health records (EHRs) containing patient data and patient-specific recommendations. Using qualitative research methods, we analyzed the encoding of ten representative clinical statements taken from two CIGs used in real decision-support systems into two health information models (openEHR archetypes and HL7 vMR instances) by four experienced informaticians. Discussion among the modelers about each case study example greatly increased our understanding of the capabilities of these standards, which we share in this educational paper. Differing in content and structure, the openEHR archetypes were found to contain a greater level of representational detail and structure while the vMR representations took fewer steps to complete. The use of openEHR in the encoding of CIG clinical statements could potentially facilitate applications other than decision-support, including intelligent data analysis and integration of additional properties of data items from existing EHRs. On the other hand, due to their smaller size and fewer details, the use of vMR potentially supports quicker mapping of EHR data into clinical statements.This study was partially funded by the European Commission 7th Framework Program, grant #287811. It has also been supported by the Spanish Ministry of Economy and Competitiveness and the EU FEDER programme through project TIN2014-53749-C2-1-R and grant PTQ-12-05620González-Ferrer, A.; Peleg, M.; Marcos, M.; Maldonado Segura, JA. (2016). Analysis of the process of representing clinical statements for decision-support applications: a comparison of openEHR archetypes and HL7 virtual medical record. Journal of Medical Systems. 40(7):1-10. https://doi.org/10.1007/s10916-016-0524-3S110407Peleg, M., Computer-interpretable clinical guidelines: a methodological review. J. Biomed. Inform. 46:744–763, 2013.Peleg, M., Shahar, Y., and Quaglini, S., Making healthcare more accessible, better, faster, and cheaper: the MobiGuide Project. Eur. J. e-Pract. 20:5–20, 2014.ISO (2011) ISO 18308:2011. Health Informatics—Requirements for an Electronic Health Record Architecture. http://www.iso.org/iso/catalogue_detail?csnumber=52823 . 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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

Costes de hospitalización asociados a la hepatitis crónica C en la Comunidad Valenciana en 2013

ABSTRACT Background: Hospital costs associated with Hepatitis C (HCC) arise in the final stages of the disease. Its quantification is very helpful in order to estimate and check the burden of the disease and to make financial decisions for new antivirals. The highest costs are due to the decompensation of cirrosis. Methods: Cross-sectional observational study of hospital costs of HCC diagnoses in the Valencian Community in 2013 (n= 4.486 hospital discharges). Information source: Minimum basic set of data/Basic Minimum Data Set. The costs were considered according to the rates established for the DRG associated with the episodes with diagnosis of hepatitis C. The average survival of patients since the onset of the decompensation of their cirrhosis was estimated by a Markov model, according to the probabilities of evolution of the disease existing in Literatura. Results: There were 4.486 hospital episodes, 1,108 due to complications of HCC, which generated 6,713 stays, readmission rate of 28.2% and mortality of 10.2%. The hospital cost amounted to 8,788.593EUR: 3,306.333EUR corresponded to Cirrhosis (5,273EUR/patient); 1,060,521EUR to Carcinoma (6,350EUR/patient) and 2,962,873EUR to transplantation (70.544EUR/paciente. Comorbidity was 1,458,866EUR. These costs are maintained for an average of 4 years once the cirrhosis decompensation begins. Conclusions: Cirrhosis due to HCC generates a very high hospitalization’s costs. The methodology used in the estimation of these costs from the DRG can be very useful to evaluate the trend and economic impact of this disease.RESUMEN Fundamentos: Los costes hospitalarios asociados a la Hepatitis Crónica C (HCC) surgen en los estadíos finales de la enfermedad. Su cuantificación es de gran utilidad para estimar la carga de la enfermedad y establecer decisiones de financiación de los nuevos antivirales. Los costes más elevados son motivados por la descompensación de la cirrosis. Métodos: Estudio observacional de corte transversal de los costes hospitalarios de episodios con diagnóstico de HCC en la Comunidad Valenciana en 2013. Fuente de información: Conjunto mínimo básico de datos. Se estimaron los costes según las tarifas establecidas para los GRD (Grupos relacionados por el diagnóstico) asociados a los episodios con diagnóstico de hepatitis C. La supervivencia media de los pacientes desde que se inició la descompensación de su cirrosis se estimó mediante un modelo de Markov, según las probabilidades de evolución de la enfermedad existentes en la literatura. Resultados: Se registraron 4.486 episodios de hospitalización con diagnóstico de HCC, 1.108 fueron debidos a complicaciones de la HCC que generaron 6.713 estancias, tasa de reingresos del 28,2 % y mortalidad del 10,2%. El coste hospitalario ascendió a 8.788.593EUR: 3.306.333EUR correspondieron a Cirrosis (5.273EUR/paciente); 1.060.521EUR a Carcinoma (6.350EUR/paciente) y 2.962.873EUR a trasplante (70.544EUR/paciente). La comorbilidad por Hepatitis C supuso 1.458.866EUR. Estos costes se mantienen durante una media de 4 años una vez comienza la descompensación de la cirrosis. Conclusiones: La cirrosis por HCC genera un coste muy elevado por hospitalización, la metodología utilizada en la estimación de estos costes a partir de los GRD puede ser de gran utilidad para evaluar la tendencia e impacto económico de esta enfermedad