Ten Topics to Get Started in Medical Informatics Research.

The vast and heterogeneous data being constantly generated in clinics can provide great wealth for patients and research alike. The quickly evolving field of medical informatics research has contributed numerous concepts, algorithms, and standards to facilitate this development. However, these difficult relationships, complex terminologies, and multiple implementations can present obstacles for people who want to get active in the field. With a particular focus on medical informatics research conducted in Germany, we present in our Viewpoint a set of 10 important topics to improve the overall interdisciplinary communication between different stakeholders (eg, physicians, computational experts, experimentalists, students, patient representatives). This may lower the barriers to entry and offer a starting point for collaborations at different levels. The suggested topics are briefly introduced, then general best practice guidance is given, and further resources for in-depth reading or hands-on tutorials are recommended. In addition, the topics are set to cover current aspects and open research gaps of the medical informatics domain, including data regulations and concepts; data harmonization and processing; and data evaluation, visualization, and dissemination. In addition, we give an example on how these topics can be integrated in a medical informatics curriculum for higher education. By recognizing these topics, readers will be able to (1) set clinical and research data into the context of medical informatics, understanding what is possible to achieve with data or how data should be handled in terms of data privacy and storage; (2) distinguish current interoperability standards and obtain first insights into the processes leading to effective data transfer and analysis; and (3) value the use of newly developed technical approaches to utilize the full potential of clinical data.

Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals.

BACKGROUND: Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials. Information technology (IT) support systems-for instance, patient recruitment systems-may help overcome existing challenges and improve recruitment rates, when customized to the user needs and environment. OBJECTIVE: The goal of our study is to describe the status quo of patient recruitment processes and to identify user requirements for the development of a patient recruitment system. METHODS: We conducted a web-based survey with 56 participants as well as semistructured interviews with 33 participants from 10 German university hospitals. RESULTS: We here report the recruitment procedures and challenges of 10 university hospitals. The recruitment process was influenced by diverse factors such as the ward, use of software, and the study inclusion criteria. Overall, clinical staff seemed more involved in patient identification, while the research staff focused on screening tasks. Ad hoc and planned screenings were common. Identifying eligible patients was still associated with significant manual efforts. The recruitment staff used Microsoft Office suite because tailored software were not available. To implement such software, data from disparate sources will need to be made available. We discussed concrete technical challenges concerning patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, and we contributed to the support of developing a successful system. CONCLUSIONS: Identifying eligible patients is still associated with significant manual efforts. To fully make use of the high potential of IT in patient recruitment, many technical and process challenges have to be solved first. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration.

Establishing an Interoperable Clinical Trial Information System Within MIRACUM.

In the long-run we wish to demonstrate the power of linking clinical trial information to routine health records for straightforward patient recruitment - not only at each single hospital but in a large German consortium (called MIRACUM). In such architecture a hospital wide clinical trial registry (CTR) plays a major role. All such site specific CTR however, also need to be interoperable and support automated data provision for a central MIRACUM wide trial registry. Based on a survey of already existing trial information systems at each partner site and a comparison of their functionality, a joint requirement specification was created, a minimal MIRACUM wide trial core dataset was defined and an architecture was designed in which each MIRACUM partner could keep their autonomous system decision. Partners could however also join forces in a cooperative enhancement of a new open source trial registry. Thus, sites with no trial registry could be supported by the others and synergies used. Finally, the newly developed CTR will allow modular site specific add-ons and can also take over the function of the MIRACUM wide trial registry. In this paper we describe the process, how such a consortium-wide CTR was designed and developed, while always keeping cross-site interoperability as a major requirement.