A Privacy Preserving Approach to Feasibility Analyses on Distributed Data Sources in Biomedical Research.

Funding agencies and field experts promote reuse of scientific data and biomaterial beyond the scope of the original project. The availability of research data, however, is limited by the interest of original authors as well as the privacy rights of the study participants, especially in the biomedical sciences. On the other hand, for an available data set to be a useful contribution to the scientific community, it has to be findable and accessible with reasonable effort. Therefore, using the R Shiny library, we designed and implemented a software for data discovery and feasibility analyses with compliance to regulatory and contractual regulations. Due to its genericity, it was successfully tested with heterogeneous data sets and ultimately applied to the data and biomaterial of the German Center for Cardiovascular Research (DZHK). The resulting tool - named the Feasibility Explorer - is publicly available and can be used by researchers to get an overview of data and biomaterial available in the DZHK and to select collectives in the process of submitting a usage application. To implement the rights of participants and original authors, data is integrated by querying the informed consent and not persistently stored. All calculations on the data are performed server-sided and only aggregated information is send to a client, whereas the extent of information was strictly limited to a necessary minimum that allows an applicant to assess whether an application is worthwhile.

Designing meaningful outcome parameters using mobile technology: a new mobile application for telemonitoring of patients with heart failure.

AIMS: Health data captured by commercially available smart devices may represent meaningful patient-reported outcome measures (PROMs) in heart failure (HF) patients. The purpose of this study was to test this hypothesis by evaluating the feasibility of a new telemonitoring concept for patients following initial HF hospitalization. METHODS AND RESULTS: We designed a cardio patient monitoring platform (CPMP) that comprised mobile iOS-based applications for patients' smartphone/smartwatch and the equivalent application on a physicians' tablet. It allowed for safe and continuous data transmission of self-measured physiological parameters, activity data, and patient-reported symptoms. In a prospective feasibility trial with 692 patient days from 10 patients hospitalized for newly diagnosed HF with reduced ejection fraction (mean left ventricular ejection fraction (LVEF) 26.5 ± 9.8%), we examined the CPMP during the first 2 months following discharge (69 ± 15 observation days per patient). The mean daily step count recorded by the mobile devices emerged as a promising new PROM. Its 14 day average increased over the study period (3612 ± 3311 steps/day at study inclusion and 7069 ± 5006 steps/day at end of study; P < 0.0001). It is unique for continuously reflecting real-life activity and correlated significantly with traditional surrogate parameters of cardiac performance including LVEF (r = 0.44; 95% CI 0.07-0.71; P = 0.0232), 6 min walk test (r = 0.67; 95% CI 0.38-0.84; P = 0.0002), and scores in health-related quality of life questionnaires. CONCLUSIONS: We provide the first patient monitoring platform for HF patients that relies on commercially available iOS/watchOS-based devices. Our study suggests it is ready for implementation as a tool for recording meaningful PROMs in future HF trials and telemonitoring.

Architecture of a Biomedical Informatics Research Data Management Pipeline.

In University Medical Centers, heterogeneous data are generated that cannot always be clearly attributed to patient care or biomedical research. Each data set has to adhere to distinct intrinsic and operational quality standards. However, only if high-quality data, tools to work with the data, and most importantly guidelines and rules of how to work with the data are addressed adequately, an infrastructure can be sustainable. Here, we present the IT Research Architecture of the University Medical Center Göttingen and describe our ten years' experience and lessons learned with infrastructures in networked medical research.

Evaluating a Proof-of-Concept Approach of the German Health Telematics Infrastructure in the Context of Discharge Management.

Although national eHealth strategies have existed now for more than a decade in many countries, they have been implemented with varying success. In Germany, the eHealth strategy so far has resulted in a roll out of electronic health cards for all citizens in the statutory health insurance, but in no clinically meaningful IT-applications. The aim of this study was to test the technical and organisation feasibility, usability, and utility of an eDischarge application embedded into a laboratory Health Telematics Infrastructure (TI). The tests embraced the exchange of eDischarge summaries based on the multiprofessional HL7 eNursing Summary standard between a municipal hospital and a nursing home. All in all, 36 transmissions of electronic discharge documents took place. They demonstrated the technical-organisation feasibility and resulted in moderate usability ratings. A comparison between eDischarge and paper-based summaries hinted at higher ratings of utility and information completeness for eDischarges. Despite problems with handling the electronic health card, the proof-of-concept for the first clinically meaningful IT-application in the German Health TI could be regarded as successful.