Digital Healthcare Empowering Europeans R. Cornet et al. (Eds.) 2015 European Federation for Medical Informatics (EFMI). This article is published online with Open Access by IOS Press and distributed under the terms of the Creative Commons Attribution Non-Commercial License. doi:10.3233/978-1-61499-512-8-877 Development of ISO 13606 archetypes for the standardisation of data registration in the Primary Care environment Jesús BARROS CASTRO a,1, Alejandro LAMELO ALFONSÍN a, Javier PRIETO CEBREIRO MD b, Dolores RIMADA MORA a, Lino CARRAJO GARCÍA and Guillermo VÁZQUEZ GONZÁLEZ a a Avances en Telemedicina e Informática Sanitaria (ATIS). Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas. Universidade da Coruña (UDC). As Xubias, 15006. A Coruña, España b Servicio de Atención Primaria. Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas. Universidade da Coruña (UDC). As Xubias, 15006. A Coruña, España 877 Abstract. On daily procedures, companies and organizations produce a wide quantity of data. Medical information doubles every five years approximately, and most of this information has no structure and cannot be utilised. Information obtained during Primary Health Care (PC) consultations is expected to be standardized and organised following instructions made by archetype 13606 of the International Organization for Standardization (ISO) in order to guarantee the Continuity of Care as well as the potential use of these data for secondary purposes, such as investigation or statistics. This study was designed to investigate the feasibility of representing the information collected in Primary Care consultations in a structured and normalized way. A key difference to other approaches is that the intended solution is, to the best of our knowledge, the first one to register all the information collected in this area. The participation of the Primary Health Care service (PC) from Complejo Hospitalario Universitario de A Coruña (CHUAC) has been of vital importance in this project as it has provided the necessary clinical knowledge and it has allowed us to verify the effectiveness obtained in actual environments. The archetypes developed can be reused in a wide range of projects. As an example of use, we have used these archetypes to create an intelligent system that generates organised reports based on the information dictated on a medical consultation which, afterwards, can be analysed from an analytical point of view. Keywords. Electronic Health Record, primary health care, standardization, multilingualism, Continuity of Care, Clinical Decision Support Systems. Introduction In Spain, data collection during PC consultations has no standardized procedure and it is collected as free text, which complicates its analytical use. 1 Corresponding author: jesus.barros.castro@sergas.es
878 J. Barros Castro et al. / Development of ISO 13606 Archetypes We used ISO-13606, a European norm developed by the European Committee for Standardization (CEN) which was afterwards adopted by ISO. It is a standard with solid scientific bases focused on keeping the semantic interoperability during the communication of electronic medical reports [1]. Nowadays, the Spanish Health Ministry is developing the first attempts to introduce the use of this standard, which provides a value added to this project as it foresees future needs. Difference between Medicine and other environments is the complexity of its knowledge and the velocity it changes. These types of standards use a dual model architecture which allows us to separate information from clinical knowledge. Information means data collected about a particular entity, which does not change over time and that are collected in the system. Clinical knowledge evolves constantly during time due the progress of the work and the investigation developed in this area. Information gets structured by a Reference Model (RM) which allows us to represent in a consistent way any type of information collected on an Electronic Health Record (EHR) [2]. The knowledge model is based on the concept of an archetype, element that allows us to formally represent the clinical concepts and also it lets us exchange and interpret data in a semantic way while it establishes a series of restrictions over the RM (assigning names, including meanings, setting cardinalities, choosing between types of data, units, ranges, etc.). In this architecture, the extract is the way to denominate the object that is transferred, which carries the clinical information. Once we have collected the necessary clinical knowledge, we have developed a library formed by a set of archetypes, concepts and terminologies which allow us to collect the knowledge extracted during consultations in a database designed with a level of normalization focused on the clinical interoperability, which can be completely reused. We have used this solution within the SIGAIM project, being developed by Coremain, Arcade Consultores and Ayco, a medical report generation system in which the physician dictates its report and, by the use of a system of Natural Language Processing, relevant concepts are extracted (symptoms, symbols, diseases, diagnoses, drugs, etc.). Dictation allows the physician to save time in the elaboration of the report for the patient's record. This reduces the time used to carry on the same duties during medical assistance which improves the quality of the service. Relevant concepts are linked with the archetypes created beforehand and the information is registered as an instance of the reference model of ISO 13606. Once the information is collected using this normalized way, it can be consulted using the query language AQL (Archetype Query Language) [3]. This language is designed to collect and recover clinical data on EHR systems based on archetypes. In order to allow semantic interoperability between systems, a Java library that implants the standard and creates extracts based on archetypes required by external clients is created. 1. Methods Archetypes can be linked to medical terminologies (in its ontology section), which is the way to give them semantic meaning. As our first step, we identified the necessary terminologies in the PC scenario in order to create a resulting product that can be semantically interoperable in the same area. SNOMED-CT [4], ICD-10 [5] and ICPC-2 [6] terminologies have been used and a map between them has been created as long as it was possible.
We continue with the modelling of concepts of the domain using ISO 13606 archetypes. In order to accomplish this, an expert of the medical domain from the PC service at CHUAC has provided us all the relevant information that can be collected in a clinical consultation. We have focused in one of the most used reports employed during scheduled consultations (SOAP notes [7]). Basically it is a type of report used on the daily practice, in which the physician writes a list of notes on a patient's EHR. It is divided into four sections: J. Barros Castro et al. / Development of ISO 13606 Archetypes 879 Subjective: Data given by the patient that cannot be confirmed objectively. Objective: Symbols, measurements and observations carried out by the doctor. Assessment: Medical diagnoses related to the clinical episode. Plan: Indications for the treatment that will be carried out by the patient. In order to compile this information we have modelled the concept SOAP note medical report. We need to define a set of archetypes that would be listed in the following section. Archetypes are defined by a formal language called Archetype Definition Language (ADL) [8]; nowadays it is in its version 1.4. The norm specifies the use of a sub-group of data defined by ISO 21090, used to represent and exchange basic concepts that can be found on health environments and that can help to exchange information on these kinds of systems. 2. Results As a result, we have obtained a reusable solution that allows us to perform the record of data in medical consultations using a standardized formula. Below we sum up some of the elements to record in the case of the clinic report SOAP note. Document data: type of document, date of issue, person in charge; organization data: healthcare centre, identification of the organization; patient data: ID card, code on the Spanish National Health System, Medical Record Number; medical data: symptoms, related events, examinations, diagnoses, medication, therapeutic recommendations. The obtained solution has been published on a public repository (http://www.inibic.es/grupos/atis/arquetipos) in order to understand the information collected that we have modelled during PC consultations and that will allow keeping working in a collaborative way. For the design of the archetypes we have used a top-down approach: we have thought about the most general case and we have modelled it. Private documents have been used during the testing stage. We have followed a methodology considered to be a good practical guide which consists on the decision of what is going to be modelled, the compilation of information of the domain, its reuse, the implementation of archetypes, link to the terminologies and diffusion.
880 J. Barros Castro et al. / Development of ISO 13606 Archetypes Table 1. List of ISO 13606 archetypes. Archetype CEN-EN13606-COMPOSITION.SOAPNoteMedicalReport.v1.adl CEN-EN13606-.Subjective.v1.adl CEN-EN13606-.Objective.v1.adl CEN-EN13606-.Assessment.v1.adl CEN-EN13606-.TherapeuticPlan.v1.adl CEN-EN13606-.AbdominalExamination.v1.adl CEN-EN13606-.GeneralAppearanceExamination.v1.adl CEN-EN13606-.CardiovascularExamination.v1.adl CEN-EN13606-.NeckExamination.v1.adl CEN-EN13606-.MentalStateExamination.v1.adl CEN-EN13606-.PhysicalExamination.v1.adl CEN-EN13606-.GenitourinaryExamination.v1.adl CEN-EN13606-.MusculoskeletalExamination.v1.adl CEN-EN13606-.OphthalmologicalExamination.v1.adl CEN-EN13606-.OtorhinolaryngologistExaminatio.v1.adl CEN-EN13606-.SkinExamination.v1.adl CEN-EN13606-.NervousSystemExamination.v1.adl CEN-EN13606-.ThoracicExamination.v1.adl CEN-EN13606-.DemographicsPerson.v1.adl CEN-EN13606-.Diagnosis.v1.adl CEN-EN13606-.IdentificationPerson.v1.adl CEN-EN13606-.Medication.v1.adl CEN-EN13606-.BehaviourPlan.v1.adl CEN-EN13606-.BloodPressure.v1.adl CEN-EN13606-.BodyTemperature.v1.adl CEN-EN13606-.Recommendation.v1.adl RM Class COMPOSITION 3. Discussion The creation of this archetype repository is part of a project that has accomplished using ISO 13606 in the standardization of data record during PC consultations and also it has allowed us to share information between systems developing medical extracts according to the norm. As the system is under deployment, it has already no effect on quality or cost efficiency at this time, but its standalone effectiveness has been tested with approximately 300 real SOAP notes of 5 different practitioners, changing from information without structure into structured and standardized information. In the next few months we would like that the system would be evaluated in real environment. This solution can be reused and applied to other environments that need to record this type of information, providing the necessary logic to work with these archetypes. Besides the normalization of the information register, we have achieved to obtain a data model that can be used for statistics and research purposes and that will allow to create applications that use the same model of data to create clinical decision support systems. The top-down approach that we have used is, from our point of view, the best for this environment because, although it requires more time to be generated, it allows us to adapt archetypes into particular cases (the domain is too large) and can be reused. We have taken a methodology that includes the following steps. The decision of what is going to be modelled: we had very clear which were the objective and the context, that is, to model a group of archetypes that could record data during PC consultations. Medical information compilation is provided by CHUAC'S PC service together with the scientific literature. We could not reuse archetypes from already
J. Barros Castro et al. / Development of ISO 13606 Archetypes 881 existent repositories since the data types are changing and there were no repositories that were using the new data types (ISO 21090) specified on the norm, although we have gleaned some ideas from the openehr Clinical Knowledge Manager (CKM) [9]. The implementations of the archetypes have been carried out by choosing the correct classes of the RM. Now we discuss a series of quality guidelines defined by Dipak Kalra [10]. It is very clear in which cases these archetypes must be used, to record data during PC consultations. Archetypes are flexible enough to fulfil our necessities since they are reusable components and can be used in different reports that need to record the aforementioned information, even if changing the scenario. They are consistent with the already existing archetypes. All the modelled concepts have a solid scientific base both in the general medical field and the medical propaedeutic and semiology. They are related to three well-known terminologies, SNOMED-CT due its relevance and ICD-10 and ICPC-2 due their relevance on PC. Nowadays they are not accepted by any organism, although they are expected to be approved by Sergas (Servicio Galego de Saúde, Galicia, Spain). The resultant archetypes have been validated and their operation has been confirmed, the result has been documented and its translation is pending. Acknowledgements The SIGAIM Project has been financed by Centro para el Desarrollo Tecnológico Industrial (CDTI) and the European Regional Development Fund (ERDF), supported by Ministerio de Economía y Competitividad, and Consejería de Economía e Industria de la Xunta de Galicia through Axencia Galega de Innovación (GAIN). References [1] The EN 13606 Association, http://www.en13606.org/the-ceniso-en13606-standard. Last accessed: 2014/10/12. [2] Adolfo Muñoz Carrero et al., Manual práctico de interoperabilidad semántica para entornos sanitarios basada en arquetipos. Unidad de investigación en Telemedicina y e-salud, Madrid. Julio de 2013. [3] OpenEHR Archetype Query Language Description http://www.openehr.org/wiki/display/spec/archetype+query+language+description. Last accessed: 2014/10/12 [4] International Health Termonology Standards Development Organisation (IHTSDO), http://www.ihtsdo.org/snomed-ct/. Last accessed: 2014/10/16. [5] Ahmadian L, van Engen-Verheul M, Bakhshi-Raiez F, Peek N, Cornet R, de Keizer N. The role of standardized data and terminological systems in computerized clinical decision support systems: Litterature review and survey. Int J Med Inform. 2011 Feb;80(2): 81-93. [6] International Classification of Primary Care, Second edition: http://www.who.int/classifications/icd/adaptations/icpc2/en/. Last accessed: 2014/10/16 [7] Wikipedia: SOAP Note, http://en.wikipedia.org/wiki/soap_note. Last accessed: 2014/10/16. [8] T. Beale, S. Heard. Archetype Definition Language. The OpenEHR Foundation. March 2007. [9] OpenEHR - Clinical Knowledge Manager: http://www.openehr.org/ckm/, lasts accessed: 2014/10/20 [10] Kalra D, Tapuria A, Austin T, De Moor G. Quality requirements for EHR Archetypes. Stud Health Technol Inform. 2012; 180: p. 48-52.