Quality Requirements for Electronic Health Record Systems*. A Japanese-German Information Management Perspective.

BACKGROUND: For more than 30 years, there has been close cooperation between Japanese and German scientists with regard to information systems in health care. Collaboration has been formalized by an agreement between the respective scientific associations. Following this agreement, two joint workshops took place to explore the similarities and differences of electronic health record systems (EHRS) against the background of the two national healthcare systems that share many commonalities. OBJECTIVES: To establish a framework and requirements for the quality of EHRS that may also serve as a basis for comparing different EHRS. METHODS: Donabedian's three dimensions of quality of medical care were adapted to the outcome, process, and structural quality of EHRS and their management. These quality dimensions were proposed before the first workshop of EHRS experts and enriched during the discussions. RESULTS: The Quality Requirements Framework of EHRS (QRF-EHRS) was defined and complemented by requirements for high quality EHRS. The framework integrates three quality dimensions (outcome, process, and structural quality), three layers of information systems (processes and data, applications, and physical tools) and three dimensions of information management (strategic, tactical, and operational information management). CONCLUSIONS: Describing and comparing the quality of EHRS is in fact a multidimensional problem as given by the QRF-EHRS framework. This framework will be utilized to compare Japanese and German EHRS, notably those that were presented at the second workshop.

Integrating data from multiple sources for data completeness in a web-based registry for pediatric renal transplantation--the CERTAIN Registry.

Patient registries are a useful tool to measure outcomes and compare the effectiveness of therapies in a specific patient population. High data quality and completeness are therefore advantageous for registry analysis. Data integration from multiple sources may increase completeness of the data. The pediatric renal transplantation registry CERTAIN identified Eurotransplant (ET) and the Collaborative Transplant Study (CTS) as possible partners for data exchange. Import and export interfaces with CTS and ET were implemented. All parties reached their projected goals and benefit from the exchange.

A framework for integrating heterogeneous clinical data for a disease area into a central data warehouse.

Structured collection of clinical facts is a common approach in clinical research. Especially in the analysis of rare diseases it is often necessary to aggregate study data from several sites in order to achieve a statistically significant cohort size. In this paper we describe a framework how to approach an integration of heterogeneous clinical data into a central register. This enables site-spanning queries for the occurrence of specific clinical facts and thus supports clinical research. The framework consists of three sequential steps, starting from a formal data harmonization process, to the data transformation methods and finally the integration into a proper data warehouse. We implemented reusable software templates that are based on our best practices in several projects in integrating heterogeneous clinical data. Our methods potentially increase the efficiency and quality for future data integration projects by reducing the implementation effort as well as the project management effort by usage of our approaches as a guideline.

On the seamless, harmonized use of ISO/IEEE11073 and openEHR.

Standardized exchange of clinical information is a key factor in the provision of high quality health care systems. In this context, the openEHR specification facilitates the management of health data in electronic health records (EHRs), while the ISO/IEEE11073 (also referred to as X73PHD) family of standards provides a reference framework for medical device interoperability. Hospitals and health care providers using openEHR require flawless integration of data coming from external sources, such as X73PHD. Hence, a harmonization process is crucial for achieving a seamless, coherent use of those specifications in real scenarios. Such harmonization is the aim of this paper. Thus, the classes and attributes of a representative number of X73PHD specializations for medical devices--weight, temperature, blood pressure, pulse and heart rate, oximetry, and electrocardiograph--along with the X73PHD core document--ISO/IEEE11073-20601--have been analyzed and mapped to openEHR archetypes. The proposed methodology reuses the existing archetypes when possible and suggests new ones--or appropriate modifications--otherwise. As a result, this paper analyzes the inconsistencies found and the implications thereof in the coordinated use of these two standards. The procedure has also shown how existing standards are able to influence the archetype development process, enhancing the existing archetype corpus.

Facilitating secondary use of medical data by using openEHR archetypes.

Clinical trials are of high importance for medical progress. But even though more and more clinical data is available in electronic patient records (EPRs) and more and more electronic data capture (EDC) systems are used in trials, there is still a gap which makes EPR / EDC interoperability difficult and hampers secondary use of medical routine data. The openEHR architecture for Electronic Health Records is based on a two level modeling approach which makes use of 'archetypes'. We want to analyze whether archetypes can help to bridge this gap by building an integrated EPR / EDC system based on openEHR archetypes. We used the 'openEHR Reference Framework and Application' (Opereffa) and existing archetypes for medical data. Furthermore, we developed dedicated archetypes to document study meta data. We developed a first prototype implementation of an archetype based integrated EPR / EDC system. Next steps will be the evaluation of an extended prototype in a real clinical trial scenario. Opereffa was a good starting point for our work. OpenEHR archetypes proved useful for secondary use of health data.

Towards a comprehensive electronic patient record to support an innovative individual care concept for premature infants using the openEHR approach.

PURPOSE: This paper introduces the modelling of a prototype neonatology electronic patient record (EPR) using openEHR archetypes. The EPR is necessary to support the complex communication tasks of the innovative concept of 'Developmental, Family-Centred, Individual Care of Premature Infants and Newborns' established for the Department of Neonatology at Heidelberg University Hospital. METHODS: The data to be documented was analysed and modelled using the five step openEHR data modelling approach (odma). RESULTS: The analysis revealed a total of 1818 items, which could be arranged into 70 clinical concepts. The items and concepts were then mapped to 132 openEHR archetypes. Fifty-eight of these archetypes could be reused either directly or via specialisation from the existing openEHR archetypes. A further 67 archetypes were newly developed. To combine and constrain archetypes for local settings 16 templates were developed. CONCLUSION: By using the five step openEHR data modelling approach, semantic interoperability, and a reduced need for repeated documentation of the same data can be realised. This is of major importance within the hospital as well as for trans-institutional data exchange.

Can an EPR support the concept of family-centred, individualized developmental care of premature infants and newborns?

At the University Children's Hospital Heidelberg the concept of 'Developmental, Family-Centred, Individual Care of Premature Infants and Newborns' was introduced to support optimal growth of premature infants. This interdisciplinary concept requires cooperation of different specialists. A well operating communication is a precondition for such cooperation. As a patient's record is not only used for storing information but also for exchanging information, the question was if a complete electronic patient record (EPR), in contrast to the existing patient's record, could sensibly support this new concept of care. To answer this question the whole communication of the staff in the infants ward was analysed using different observation methods. These observations delivered several issues which showed that an EPR could improve communication and workflow. Therefore an EPR for the neonatology at the University Children's Hospital Heidelberg can now be designed on the basis of our communication concept.

Introducing an innovative, multidisciplinary concept of care - communication problems and possible solutions.

Introducing an innovative, multidisciplinary concept of care means the change of existing structures both in work and communication flows which often involves problems. In this paper we describe exemplary the communication problems which arose during the introduction of the multidisciplinary concept of Family-Centred, Individualized Developmental Care of Premature Infants and Newborns at the Children's Hospital Heidelberg. We suggest workflow adaptations to achieve timeliness of information and present ideas to prevent communication problems e.g. caused by inadequate knowledge of staff. We used interviews, analyzed video-recordings and modified the Communication Observation Method [7] to analyze the present state of communication flows and structures.