Search

The use and shareability of Clinical Quality Language (CQL) artefacts is an important aspect in enabling the exchange and interoperability of clinical data to support both clinical decisions and research in the medical informatics field. This paper, while basing on use cases and synthetic data, developed purposeful CQL reusable libraries to showcase the possibilities of multidisciplinary teams and how CQLs could be best used to support clinical decision making.

Improving the interoperability of healthcare information systems is a crucial clinical care issue involving disparate but coexisting information systems. However, healthcare organizations are also facing the dilemma of choosing the right ETL tool and architecture pattern as data warehouse enterprises. This article gives an overview of current ETL tools for healthcare data integration. In addition, we demonstrate three ETL processes for clinical data integration using different ETL tools and architecture patterns, which map data from various data sources (e.g. MEONA and ORBIS) to diverse standards (e.g. FHIR and openEHR). Depending on the project’s technical requirements, we choose our ETL tool and software architecture pattern to boost team efficiency.

Interoperability and portability of healthcare data to enable research in the healthcare sector is an important factor towards precision medicine and a learning health system. With many safety-nets put in place like the European General Data Protection Regulation, and local standards like the broad consent set up by the German Medical Informatics Initiative, management and compliance to these standards across all systems and clinical data repositories becomes a daunting task. An appropriate process needs to be established especially when patient data is transferred to and from different systems and standards. On extraction and transforming, an appropriate method of loading the modified data to a destination where it can be read and accessed needs to be established besides functional compliance by the repository systems. This paper makes recommendations in relation to data load strategies while working with FHIR server-based data marts.

The primary intention of any scientific work is to share the gained knowledge and to contribute to the knowledge and progress in the scientific domain. The wide range of journals and conferences, each with specific submission requirements, can be difficult to navigate, especially for young scientists without extensive experience. But a suitable publication strategy can be helpful, especially at the beginning of a scientific career. Using the annual conference of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS) e.V. as an example, this editorial highlights fundamental differences, advantages and disadvantages, as well as assistance in selecting the right form of submission.

(1) Background: New sensor technologies in wearables and other consumer health devices open up promising opportunities to collect real-world data. As cardiovascular diseases remain reason number one for disease and mortality worldwide, cardiology offers potent monitoring use-cases with patients in their out-of-hospital daily routine. Therefore, the aim of this systematic review is to investigate the status quo of studies monitoring patients with cardiovascular risks and patients suffering from cardiovascular diseases in a telemedical setting using not only a smartphone-based app, but also consumer health devices such as wearables and other sensor-based devices. (2) Methods: A literature search was conducted across five databases and the results were examined according to the study protocols, technical approaches and qualitative and quantitative parameters measured. (3) Results: Out of 166 articles, 8 studies were included in this systematic review. These cover interventional and observational monitoring approaches in the area of cardiovascular diseases, heart failure and atrial fibrillation using various app, wearable and health device combination. (4) Conclusions: Depending on the researcher’s motivation a fusion of apps, patient reported outcome measures and non-invasive sensors can be orchestrated in a meaningful way adding major contributions to monitoring concepts for both, individual patients and larger cohorts.

Background The field of eHealth has a history of more than 20 years. During that time, many different eHealth services were developed. However, factors influencing the adoption of such services were seldom the main focus of analyses. For this reason, organizations adopting and implementing eHealth services seem not to be fully aware of the barriers and facilitators influencing the integration of eHealth services into routine care. Objective The objective of this work is to provide (1) a comprehensive list of relevant barriers to be considered and (2) a list of facilitators or success factors to help in planning and implementing successful eHealth services. Methods For this study, a twofold approach was applied. First, we gathered experts’ current opinions on facilitators and barriers in implementing eHealth services via expert discussions at two health informatics conferences held in Europe. Second, we conducted a systematic literature analysis concerning the barriers and facilitators for the implementation of eHealth services. Finally, we merged the results of the expert discussions with those of the systematic literature analysis. Results Both expert discussions (23 and 10 experts, respectively) identified 15 barriers and 31 facilitators, whereas 76 barriers and 268 facilitators were found in 38 of the initial 56 articles published from 12 different countries. For the analyzed publications, the count of distinct barriers reported ranged from 0 to 40 (mean 10.24, SD 8.87, median 8). Likewise, between 0 and 48 facilitators were mentioned in the literature (mean 9.18, SD 9.33, median 6). The combination of both sources resulted in 77 barriers and 292 facilitators for the adoption and implementation of eHealth services. Conclusions This work contributes a comprehensive list of barriers and facilitators for the implementation and adoption of eHealth services. Addressing barriers early, and leveraging facilitators during the implementation, can help create eHealth services that better meet the needs of users and provide higher benefits for patients and caregivers.

BACKGROUND The field of eHealth has a history of more than 20 years. During that time, many different eHealth services were developed. However, factors influencing the adoption of such services were seldom the main focus of analyses. For this reason, organizations adopting and implementing eHealth services seem not to be fully aware of the barriers and facilitators influencing the integration of eHealth services into routine care. OBJECTIVE The objective of this work is to provide (1) a comprehensive list of relevant barriers to be considered and (2) a list of facilitators or success factors to help in planning and implementing successful eHealth services. METHODS For this study, a twofold approach was applied. First, we gathered experts’ current opinions on facilitators and barriers in implementing eHealth services via expert discussions at two health informatics conferences held in Europe. Second, we conducted a systematic literature analysis concerning the barriers and facilitators for the implementation of eHealth services. Finally, we merged the results of the expert discussions with those of the systematic literature analysis. RESULTS Both expert discussions (23 and 10 experts, respectively) identified 15 barriers and 31 facilitators, whereas 76 barriers and 268 facilitators were found in 38 of the initial 56 articles published from 12 different countries. For the analyzed publications, the count of distinct barriers reported ranged from 0 to 40 (mean 10.24, SD 8.87, median 8). Likewise, between 0 and 48 facilitators were mentioned in the literature (mean 9.18, SD 9.33, median 6). The combination of both sources resulted in 77 barriers and 292 facilitators for the adoption and implementation of eHealth services. CONCLUSIONS This work contributes a comprehensive list of barriers and facilitators for the implementation and adoption of eHealth services. Addressing barriers early, and leveraging facilitators during the implementation, can help create eHealth services that better meet the needs of users and provide higher benefits for patients and caregivers.

Summary Introduction: This article is part of the Focus Theme of Methods of Information in Medicine on the German Medical Informatics Initiative. HiGHmed brings together 24 partners from academia and industry, aiming at improvements in care provision, biomedical research and epidemiology. By establishing a shared information governance framework, data integration centers and an open platform architecture in cooperation with independent healthcare providers, the meaningful reuse of data will be facilitated. Complementary, HiGHmed integrates a total of seven Medical Informatics curricula to develop collaborative structures and processes to train medical informatics professionals, physicians and researchers in new forms of data analytics. Governance and Policies: We describe governance structures and policies that have proven effective during the conceptual phase. These were further adapted to take into account the specific needs of the development and networking phase, such as roll-out, carerelated aspects and our focus on curricula development in Medical Inform atics. Architectural Framework and Methodology: To address the challenges of organizational, technical and semantic interoperability, a concept for a scalable platform architecture, the HiGHmed Platform, was developed. We outline the basic principles and design goals of the open platform approach as well as the roles of standards and specifications such as IHE XDS, openEHR, SNOMED CT and HL7 FHIR. A shared governance framework provides the semantic artifacts which are needed to establish semantic interoperability. Use Cases: Three use cases in the fields of oncology, cardiology and infection control will demonstrate the capabilities of the HiGHmed approach. Each of the use cases entails diverse challenges in terms of data protection, privacy and security, including clinical use of genome sequencing data (oncology), continuous longitudinal monitoring of physical activity (cardiology) and cross-site analysis of patient movement data (infection control). Discussion: Besides the need for a shared governance framework and a technical infrastructure, backing from clinical leaders is a crucial factor. Moreover, firm and sustainable commitment by participating organizations to collaborate in further development of their information system architectures is needed. Other challenges including topics such as data quality, privacy regulations, and patient consent will be addressed throughout the project.

Telemedizinische Systeme werden bereits heute in vielen Bereichen zur verbesserten Patientenversorgung eingesetzt. Aufgrund fehlender Standardisierung sind diese Losungen aber selten interoperabel. International anerkannte Standards konnen hier Abhilfe schaffen. Mit Integrating the Healthcare Enterprise (IHE) befasst sich eine weltweite Initiative aus Anwendern und Herstellern im Gesundheitswesen mit der Nutzung von definierten Standards fur konkrete Anwendungsfalle durch Beschreibung in sogenannten Profilen. Ziel des vorliegenden Beitrags ist es aufzuzeigen, inwieweit sich telemedizinische Anwendungsfalle mit IHE-Profilen umsetzen lassen. Auf Basis einer Literaturrecherche werden beispielhafte Telemedizinanwendungen beschrieben und die technischen Moglichkeiten der IHE-Profile dargestellt. Diese werden dann auf ihre Nutzbarkeit hin untersucht und anhand beispielhafter telemedizinischer Architekturen gepruft. Sowohl fur einrichtungsubergreifende Akten (z. B. Heidelberger PEPA) als auch fur die aktenlose Punkt-zu-Punkt-Kommunikation lassen sich IHE-Profile identifizieren. In der Aktenwelt ist schon heute das Cross-Enterprise Document Sharing (XDS-) Profil verbreitet. Die Punkt-zu-Punkt-Kommunikation lasst sich mittels IHE Cross-Enterprise Document Media Interchange (XDM) unterstutzen. IHE-basierte Telemedizinanwendungen bieten die Moglichkeit, Behandler durch einrichtungsubergreifende Akten mit Informationen uber den Patienten zu versorgen und gleichzeitig Einsparpotenziale durch Wiederverwendbarkeit der Schnittstellen in anderen Szenarien zu nutzen. Aktuelle telemedizinische Anwendungen stosen bei der Interoperabilitat noch an ihre Grenzen. Mit IHE-Profilen konnen, bis auf die synchrone Kommunikation, alle relevanten Telemedizinszenarien umgesetzt werden.

Summary Objective: (1) To define features and data items of a Patient Recruitment System (PRS); (2) to design a generic software architecture of such a system covering the requirements; (3) to identify implementation options available within different Hospital Information System (HIS) environments; (4) to implement five PRS following the architecture and utilizing the implementation options as proof of concept. Methods: Existing PRS were reviewed and interviews with users and developers conducted. All reported PRS features were collected and prioritized according to their published success and user’s request. Common feature sets were combined into software modules of a generic software architecture. Data items to process and transfer were identified for each of the modules. Each site collected implementation options available within their respective HIS environment for each module, provided a prototypical implementation based on available implementation possibilities and supported the patient recruitment of a clinical trial as a proof of concept. Results: 24 commonly reported and requested features of a PRS were identified, 13 of them prioritized as being mandatory. A UML version 2 based software architecture containing 5 software modules covering these features was developed. 13 data item groups processed by the modules, thus required to be available electronically, have been identified. Several implementation options could be identified for each module, most of them being available at multiple sites. Utilizing available tools, a PRS could be implemented in each of the five participating German university hospitals. Conclusion: A set of required features and data items of a PRS has been described for the first time. The software architecture covers all features in a clear, well-defined way. The variety of implementation options and the prototypes show that it is possible to implement the given architecture in different HIS environments, thus enabling more sites to successfully support patient recruitment in clinical trials. Citation: Trinczek B, Köpcke F, Leusch T, Majeed RW, Schreiweis B, Wenk J, Bergh B, Ohmann C, Röhrig R, Prokosch HU, Dugas M. Design and multicentric implementation of a generic software architecture for patient recruitment systems re-using existing HIS tools and routine patient data. Appl Clin Inf 2014; 5: 264–283 http://dx.doi.org/10.4338/ACI-2013-07-RA-0047

Objectives Reusing data from electronic health records for clinical and translational research and especially for patient recruitment has been tackled in a broader manner since about a decade. Most projects found in the literature however focus on standalone systems and proprietary implementations at one particular institution often for only one singular trial and no generic evaluation of EHR systems for their applicability to support the patient recruitment process does yet exist. Thus we sought to assess whether the current generation of EHR systems in Germany provides modules/tools, which can readily be applied for IT-supported patient recruitment scenarios. Methods We first analysed the EHR portfolio implemented at German University Hospitals and then selected 5 sites with five different EHR implementations covering all major commercial systems applied in German University Hospitals. Further, major functionalities required for patient recruitment support have been defined and the five sample EHRs and their standard tools have been compared to the major functionalities. Results In our analysis of the site's hospital information system environments (with four commercial EHR systems and one self-developed system) we found that – even though no dedicated module for patient recruitment has been provided – most EHR products comprise generic tools such as workflow engines, querying capabilities, report generators and direct SQL-based database access which can be applied as query modules, screening lists and notification components for patient recruitment support. A major limitation of all current EHR products however is that they provide no dedicated data structures and functionalities for implementing and maintaining a local trial registry. Conclusions At the five sites with standard EHR tools the typical functionalities of the patient recruitment process could be mostly implemented. However, no EHR component is yet directly dedicated to support research requirements such as patient recruitment. We recommend for future developments that EHR customers and vendors focus much more on the provision of dedicated patient recruitment modules.

Background Computerized clinical trial recruitment support is one promising field for the application of routine care data for clinical research. The primary task here is to compare the eligibility criteria defined in trial protocols with patient data contained in the electronic health record (EHR). To avoid the implementation of different patient definitions in multi-site trials, all participating research sites should use similar patient data from the EHR. Knowledge of the EHR data elements which are commonly available from most EHRs is required to be able to define a common set of criteria. The objective of this research is to determine for five tertiary care providers the extent of available data compared with the eligibility criteria of randomly selected clinical trials. Methods Each participating study site selected three clinical trials at random. All eligibility criteria sentences were broken up into independent patient characteristics, which were then assigned to one of the 27 semantic categories for eligibility criteria developed by Luo et al. We report on the fraction of patient characteristics with corresponding structured data elements in the EHR and on the fraction of patients with available data for these elements. The completeness of EHR data for the purpose of patient recruitment is calculated for each semantic group. Results 351 eligibility criteria from 15 clinical trials contained 706 patient characteristics. In average, 55% of these characteristics could be documented in the EHR. Clinical data was available for 64% of all patients, if corresponding data elements were available. The total completeness of EHR data for recruitment purposes is 35%. The best performing semantic groups were ‘age’ (89%), ‘gender’ (89%), ‘addictive behaviour’ (74%), ‘disease, symptom and sign’ (64%) and ‘organ or tissue status’ (61%). No data was available for 6 semantic groups. Conclusions There exists a significant gap in structure and content between data documented during patient care and data required for patient eligibility assessment. Nevertheless, EHR data on age and gender of the patient, as well as selected information on his disease can be complete enough to allow for an effective support of the manual screening process with an intelligent preselection of patients and patient data.