QL4MDR: a GraphQL query language for ISO 11179-based metadata repositories.

BACKGROUND: Heterogeneous healthcare instance data can hardly be integrated without harmonizing its schema-level metadata. Many medical research projects and organizations use metadata repositories to edit, store and reuse data elements. However, existing metadata repositories differ regarding software implementation and have shortcomings when it comes to exchanging metadata. This work aims to define a uniform interface with a technical interlingua between the different MDR implementations in order to enable and facilitate the exchange of metadata, to query over distributed systems and to promote cooperation. To design a unified interface for multiple existing MDRs, a standardized data model must be agreed on. The ISO 11179 is an international standard for the representation of metadata, and since most MDR systems claim to be at least partially compliant, it is suitable for defining an interface thereupon. Therefore, each repository must be able to define which parts can be served and the interface must be able to handle highly linked data. GraphQL is a data access layer and defines query techniques designed to navigate easily through complex data structures. RESULTS: We propose QL4MDR, an ISO 11179-3 compatible GraphQL query language. The GraphQL schema for QL4MDR is derived from the ISO 11179 standard and defines objects, fields, queries and mutation types. Entry points within the schema define the path through the graph to enable search functionalities, but also the exchange is promoted by mutation types, which allow creating, updating and deleting of metadata. QL4MDR is the foundation for the uniform interface, which is implemented in a modern web-based interface prototype. CONCLUSIONS: We have introduced a uniform query interface for metadata repositories combining the ISO 11179 standard for metadata repositories and the GraphQL query language. A reference implementation based on the existing Samply.MDR was implemented. The interface facilitates access to metadata, enables better interaction with metadata as well as a basis for connecting existing repositories. We invite other ISO 11179-based metadata repositories to take this approach into account.

Telematics in acute trauma care.

Each year, 20,000 people in Germany die because of a traffic accident. Altogether, yearly productivity loss caused by these injuries is estimated to be around 5 billion Euros. International and national studies revealed the trauma center level of the primary hospital as the major predictor for trauma related mortality. In 2006 the German Society for Trauma Surgery (DGU) called its members to form regionally based networks for the exchange of data among hospitals engaged in trauma care. In April 2008 the north-west region of Germany with 49 hospitals, three hospitals in the Netherlands, and local emergency services founded the "TraumaNetwork NorthWest (TNNW). The major goals of the TNNW are: 1) to shorten the time between accident and admission to the appropriate hospital, 2) to create effective means of communication, and 3) to implement common pre- and in-hospital standards for trauma care. Since the needed application software is not commercially available, a team of computer and medical specialists has been formed for its development. Once the software is in place, a pre- and post-analysis will be performed to study the consequences of the application on transportation time and injury-related mortality within the region. The project is recognized as a pilot project by the DGU and if it is successful is meant to be adapted across Germany.

A Generic Method and Implementation to Evaluate and Improve Data Quality in Distributed Research Networks.

BACKGROUND: With the increasing personalization of clinical therapies, translational research is evermore dependent on multisite research cooperations to obtain sufficient data and biomaterial. Distributed research networks rely on the availability of high-quality data stored in local databases operated by their member institutions. However, reusing data documented by independent health providers for the purpose of care, rather than research ("secondary use"), reveal a high variability in terms of data formats, as well as poor data quality, across network sites. OBJECTIVES: The aim of this work is the provision of a process for the assessment of data quality with regard to completeness and syntactic accuracy across independently operated data warehouses using common definitions stored in a central (network-wide) metadata repository (MDR). METHODS: For assessment of data quality across multiple sites, we employ a framework of so-called bridgeheads. These are federated data warehouses, which allow the sites to participate in a research network. A central MDR is used to store the definitions of the commonly agreed data elements and their permissible values. RESULTS: We present the design for a generator of quality reports within a bridgehead, allowing the validation of data in the local data warehouse against a research network's central MDR. A standardized quality report can be produced at each network site, providing a means to compare data quality across sites, as well as to channel feedback to the local data source systems, and local documentation personnel. A reference implementation for this concept has been successfully utilized at 10 sites across the German Cancer Consortium. CONCLUSIONS: We have shown that comparable data quality assessment across different partners of a distributed research network is feasible when a central metadata repository is combined with locally installed assessment processes. To achieve this, we designed a quality report and the process for generating such a report. The final step was the implementation in a German research network.

Exploiting Distributed, Heterogeneous and Sensitive Data Stocks while Maintaining the Owner's Data Sovereignty.

BACKGROUND: To achieve statistical significance in medical research, biological or data samples from several bio- or databanks often need to be complemented by those of other institutions. For that purpose, IT-based search services have been established to locate datasets matching a given set of criteria in databases distributed across several institutions. However, previous approaches require data owners to disclose information about their samples, raising a barrier for their participation in the network. OBJECTIVE: To devise a method to search distributed databases for datasets matching a given set of criteria while fully maintaining their owner's data sovereignty. METHODS: As a modification to traditional federated search services, we propose the decentral search, which allows the data owner a high degree of control. Relevant data are loaded into local bridgeheads, each under their owner's sovereignty. Researchers can formulate criteria sets along with a project proposal using a central search broker, which then notifies the bridgeheads. The criteria are, however, treated as an inquiry rather than a query: Instead of responding with results, bridgeheads notify their owner and wait for his/her decision regarding whether and what to answer based on the criteria set, the matching datasets and the specific project proposal. Without the owner's explicit consent, no data leaves his/her institution. RESULTS: The decentral search has been deployed in one of the six German Centers for Health Research, comprised of eleven university hospitals. In the process, compliance with German data protection regulations has been confirmed. The decentral search also marks the centerpiece of an open source registry software toolbox aiming to build a national registry of rare diseases in Germany. CONCLUSIONS: While the sacrifice of real-time answers impairs some use-cases, it leads to several beneficial side effects: improved data protection due to data parsimony, tolerance for incomplete data schema mappings and flexibility with regard to patient consent. Most importantly, as no datasets ever leave their institution, owners can reject projects without facing potential peer pressure. By its lower barrier for participation, a decentral search service is likely to attract a larger number of partners and to bring a researcher into contact with the right potential partners.

Functions of an electronic health record.

The functionality of a personal electronic health record (EHR) may vary from a simple web-based interface for interactive data entry and data review up to a much more powerful system, additionally supporting electronic data/document communication between clinical information systems of primary care practitioners or hospitals, and even reminder-based support for the empowered citizen to actively take care of his/her health, based on relevant disease management programs. It is a means of supporting patient empowerment. Since storage and communication of data in an EHR involves sensitive personal health data, it is necessary to implement specific security and access management requirements for each of these functions.

The new navigation in EHRs: enabling teamwork of professionals and patients.

After development of a state of the art electronic health record, which is accessible via the internet and belongs to a patient, who can manage access to it, the methods of introducing it into routine use in the environment of children's oncology is the theme of this paper. The new navigation in an EHR intends a shared use for the patient, relatives, and different HCPs. The laboratory devices were equipped with an HL7-interface to send messages to the HIS. These messages are combined in documents according to the CDA and sent to the EHR. In a similar way referral letters are uploaded directly from the HIS. Several information resources are used to enlighten the patient and help to enable him to become a member of a team for collaborative care. The varying roles of patient and HCPs lead to some very interesting questions, which have to be answered by a following study.

IT Infrastructure Components for Biobanking.

OBJECTIVE: Within translational research projects in the recent years large biobanks have been established, mostly supported by homegrown, proprietary software solutions. No general requirements for biobanking IT infrastructures have been published yet. This paper presents an exemplary biobanking IT architecture, a requirements specification for a biorepository management tool and exemplary illustrations of three major types of requirements. METHODS: We have pursued a comprehensive literature review for biobanking IT solutions and established an interdisciplinary expert panel for creating the requirements specification. The exemplary illustrations were derived from a requirements analysis within two university hospitals. RESULTS: The requirements specification comprises a catalog with more than 130 detailed requirements grouped into 3 major categories and 20 subcategories. Special attention is given to multitenancy capabilities in order to support the project-specific definition of varying research and bio-banking contexts, the definition of workflows to track sample processing, sample transportation and sample storage and the automated integration of preanalytic handling and storage robots. CONCLUSION: IT support for biobanking projects can be based on a federated architectural framework comprising primary data sources for clinical annotations, a pseudonymization service, a clinical data warehouse with a flexible and user-friendly query interface and a biorepository management system. Flexibility and scalability of all such components are vital since large medical facilities such as university hospitals will have to support biobanking for varying monocentric and multicentric research scenarios and multiple medical clients.

User acceptance of and satisfaction with a personal electronic health record.

OBJECTIVE: With akteonline.de a patient owned Electronic Health Record (EHR) has been implemented that combines both data from clinical information systems and data entered by the patient. In addition the EHR supports information exchange/communication controlled by the user. The EHR thus offers the potential to place the patient into a more empowered position. This impact on patient empowerment and the implementation of additional features is to be investigated. Additionally, the user satisfaction is to be evaluated regarding patients' acceptance and utilization of the system. METHOD: Users were divided into three groups, two of which received different training on the functionalities of akteonline.de. A quantitative study employing an online-questionnaire and considering all registered users was conducted. RESULTS: Users evaluated the internet based system to be feasible and the navigation to be suitable, yet additional training for users regarding particular features seems to be required and also for hospital staff in general. The proposed add-ons were approved of. The study also showed positive effects on patient empowerment.