Sebastian Garde

Expressing clinical data sets with openEHR archetypes: A solid basis for ubiquitous computing

PURPOSE The purpose of this paper is to analyse the feasibility and usefulness of expressing clinical data sets (CDSs) as openEHR archetypes. For this, we present an approach to transform CDS into archetypes, and outline typical problems with CDS and analyse whether some of these problems can be overcome by the use of archetypes. METHODS Literature review and analysis of a selection of existing Australian, German, other European and international CDSs; transfer of a CDS for Paediatric Oncology into openEHR archetypes; implementation of CDSs in application systems. RESULTS To explore the feasibility of expressing CDS as archetypes an approach to transform existing CDSs into archetypes is presented in this paper. In case of the Paediatric Oncology CDS (which consists of 260 data items) this lead to the definition of 48 openEHR archetypes. To analyse the usefulness of expressing CDS as archetypes, we identified nine problems with CDS that currently remain unsolved without a common model underpinning the CDS. Typical problems include incompatible basic data types and overlapping and incompatible definitions of clinical content. A solution to most of these problems based on openEHR archetypes is motivated. With regard to integrity constraints, further research is required. CONCLUSIONS While openEHR cannot overcome all barriers to Ubiquitous Computing, it can provide the common basis for ubiquitous presence of meaningful and computer-processable knowledge and information, which we believe is a basic requirement for Ubiquitous Computing. Expressing CDSs as openEHR archetypes is feasible and advantageous as it fosters semantic interoperability, supports ubiquitous computing, and helps to develop archetypes that are arguably of better quality than the original CDS.

Requirements engineering in health care: the example of chemotherapy planning in paediatric oncology

Health care is characterized by highly complex processes of patient care that require unusual amount of communication between different health care professionals of different institutions. Sub-optimal processes can significantly impact on the patient’s health, increase the consumption of services and resources and in severe cases can lead to the patient death. For these reasons, requirements engineering for the development of information technology in health care is a complex process as well: without constant and rigorous evaluation, the impact of new systems on the quality of care is unknown and it is possible that badly designed systems significantly harm patients. To overcome these limitations, we present and discuss an approach to requirements engineering that we applied for the development of applications for chemotherapy planning in paediatric oncology. Chemotherapy planning in paediatric oncology is complex and time-consuming and errors must be avoided by all means. In the multi-hospital/multi-trial-centre environment of paediatric oncology, it is especially difficult and time-consuming to analyse requirements. Our approach combines a grounded theory approach with evolutionary prototyping based on the constant development and refinement of a generic domain model, in this case a domain model for chemotherapy planning in paediatric oncology. The prototypes were introduced in medical centres and final results show that the developed generic domain model is adequate.

Can design principles of traditional learning theories be fulfilled by computer-based training systems in medicine: The example of CAMPUS

PURPOSE Computer-based training (CBT) systems offer the potential to efficiently support modern teaching and learning. However, it is still unknown if a similar efficient learning experience built on sound learning theories and corresponding design principles can be created in the complex health care environment. The purpose of this paper is to analyse to what extent learning theories and corresponding design principles are relevant and can successfully be applied in computer-based training in medicine. METHODS We use the case-based CBT system CAMPUS as an example for a CBT system currently used to enhance the medical teaching and learning experience. We apply two well-accepted learning theories (Blooms taxonomy and practice fields) and related design principles to determine to what extent they are relevant and fulfilled in the context of CAMPUS. RESULTS We demonstrate that in principle these learning theories and design principles can be implemented using computer-based training. However, not all design principles can be fulfilled by the system alone; rather the integration of the system into adequate -- traditional or virtual -- teaching and learning environments is essential. CONCLUSIONS Traditional learning theories and design principles are a valuable means in designing adequate CBT systems in medicine. They can be successfully implemented in CBT systems for medical education if the system itself is adequately integrated into teaching and learning environments.

Towards shared patient records: An architecture for using routine data for nationwide research

Ubiquitous information is currently one of the most challenging slogans in medical informatics research. An adequate architecture for shared electronic patient records is needed which can use data for multiple purposes and which is extensible for new research questions. We introduce eardap as architecture for using routine data for nationwide clinical research in a multihospital environment. eardap can be characterized as terminology-based. Main advantage of our approach is the extensibility by new items and new research questions. Once the definition of items for a research question is finished, a consistent, corresponding database can be created without any informatics skills. Our experiences in pediatric oncology in Germany have shown the applicability of eardap. The functions of our core system were in routine clinical use in several hospitals. We validated the terminology management system (TMS) and the module generation tool with the basic data set of pediatric oncology. The multiple usability depends mainly on the quality of item planning in the TMS. High quality harmonization will lead to a higher amount of multiply used data. When using eardap, special emphasis is to be placed on interfaces to local hospital information systems and data security issues.

Systematic planning of patient records for cooperative care and multicenter research

PURPOSE The purpose of this paper is to introduce a method for systematically planning patient records for structured data entry that can be used in cooperative environments (e.g. cooperative care, multicenter trials) in a way that enables multipurpose use and shared data entry. METHODS Design research, formal logic. RESULTS The method suggests five steps: analyze the prevailing documentation infrastructure, provide terminology management system (TMS), provide documentation management system (DMS), plan the logical architecture, provide all necessary tools. CONCLUSIONS The era of eHealth enables cooperative care and collaborative documentation. This can only be efficient if a multiple use and shared entry of data is realized. The task of the medical informatics community is to plan these environments systematically especially in complex environments which are enabled by emerging technologies.

TERMTrial-terminology-based documentation systems for cooperative clinical trials

Within cooperative groups of multi-center clinical trials a standardized documentation is a prerequisite for communication and sharing of data. Standardizing documentation systems means standardizing the underlying terminology. The management and consistent application of terminology systems is a difficult and fault-prone task, which should be supported by appropriate software tools. Today, documentation systems for clinical trials are often implemented as so-called Remote-Data-Entry-Systems (RDE-systems). Although there are many commercial systems, which support the development of RDE-systems there is none offering a comprehensive terminological support. Therefore, we developed the software system TERMTrial which consists of a component for the definition and management of terminology systems for cooperative groups of clinical trials and two components for the terminology-based automatic generation of trial databases and terminology-based interactive design of electronic case report forms (eCRFs). TERMTrial combines the advantages of remote data entry with a comprehensive terminological control.