The COVID-19 pandemic has caused strains on health systems worldwide disrupting routine hospital services for all non-COVID patients. Within this retrospective study, we analyzed inpatient hospital admissions across 18 German university hospitals during the 2020 lockdown period compared to 2018. Patients admitted to hospital between January 1 and May 31, 2020 and the corresponding periods in 2018 and 2019 were included in this study. Data derived from electronic health records were collected and analyzed using the data integration center infrastructure implemented in the university hospitals that are part of the four consortia funded by the German Medical Informatics Initiative. Admissions were grouped and counted by ICD 10 chapters and specific reasons for treatment at each site. Pooled aggregated data were centrally analyzed with descriptive statistics to compare absolute and relative differences between time periods of different years. The results illustrate how care process adoptions depended on the COVID-19 epidemiological situation and the criticality of the disease. Overall inpatient hospital admissions decreased by 35% in weeks 1 to 4 and by 30.3% in weeks 5 to 8 after the lockdown announcement compared to 2018. Even hospital admissions for critical care conditions such as malignant cancer treatments were reduced. We also noted a high reduction of emergency admissions such as myocardial infarction (38.7%), whereas the reduction in stroke admissions was smaller (19.6%). In contrast, we observed a considerable reduction in admissions for non-critical clinical situations, such as hysterectomies for benign tumors (78.8%) and hip replacements due to arthrosis (82.4%). In summary, our study shows that the university hospital admission rates in Germany were substantially reduced following the national COVID-19 lockdown. These included critical care or emergency conditions in which deferral is expected to impair clinical outcomes. Future studies are needed to delineate how appropriate medical care of critically ill patients can be maintained during a pandemic.

Background To meet the growing importance of real-word data analysis, clinical data and biosamples must be timely made available. Feasibility platforms are often the first contact point for determining the availability of such data for specific research questions. Therefore, a user-friendly interface should be provided to enable access to this information easily. The German Medical Informatics Initiative also aims to establish such a platform for its infrastructure. Although some of these platforms are actively used, their tools still have limitations. Consequently, the Medical Informatics Initiative consortium MIRACUM (Medical Informatics in Research and Care in University Medicine) committed itself to analyzing the pros and cons of existing solutions and to designing an optimized graphical feasibility user interface. Objective The aim of this study is to identify the system that is most user-friendly and thus forms the best basis for developing a harmonized tool. To achieve this goal, we carried out a comparative usability evaluation of existing tools used by researchers acting as end users. Methods The evaluation included three preselected search tools and was conducted as a qualitative exploratory study with a randomized design over a period of 6 weeks. The tools in question were the MIRACUM i2b2 (Informatics for Integrating Biology and the Bedside) feasibility platform, OHDSI’s (Observational Health Data Sciences and Informatics) ATLAS, and the Sample Locator of the German Biobank Alliance. The evaluation was conducted in the form of a web-based usability test (usability walkthrough combined with a web-based questionnaire) with participants aged between 26 and 63 years who work as medical doctors. Results In total, 17 study participants evaluated the three tools. The overall evaluation of usability, which was based on the System Usability Scale, showed that the Sample Locator, with a mean System Usability Scale score of 77.03 (SD 20.62), was significantly superior to the other two tools (Wilcoxon test; Sample Locator vs i2b2: P=.047; Sample Locator vs ATLAS: P=.001). i2b2, with a score of 59.83 (SD 25.36), performed significantly better than ATLAS, which had a score of 27.81 (SD 21.79; Wilcoxon test; i2b2 vs ATLAS: P=.005). The analysis of the material generated by the usability walkthrough method confirmed these findings. ATLAS caused the most usability problems (n=66), followed by i2b2 (n=48) and the Sample Locator (n=22). Moreover, the Sample Locator achieved the highest ratings with respect to additional questions regarding satisfaction with the tools. Conclusions This study provides data to develop a suitable basis for the selection of a harmonized tool for feasibility studies via concrete evaluation and a comparison of the usability of three different types of query builders. The feedback obtained from the participants during the usability test made it possible to identify user problems and positive design aspects of the individual tools and compare them qualitatively.

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Background An essential step in any medical research project after identifying the research question is to determine if there are sufficient patients available for a study and where to find them. Pursuing digital feasibility queries on available patient data registries has proven to be an excellent way of reusing existing real-world data sources. To support multicentric research, these feasibility queries should be designed and implemented to run across multiple sites and securely access local data. Working across hospitals usually involves working with different data formats and vocabularies. Recently, the Fast Healthcare Interoperability Resources (FHIR) standard was developed by Health Level Seven to address this concern and describe patient data in a standardized format. The Medical Informatics Initiative in Germany has committed to this standard and created data integration centers, which convert existing data into the FHIR format at each hospital. This partially solves the interoperability problem; however, a distributed feasibility query platform for the FHIR standard is still missing. Objective This study described the design and implementation of the components involved in creating a cross-hospital feasibility query platform for researchers based on FHIR resources. This effort was part of a large COVID-19 data exchange platform and was designed to be scalable for a broad range of patient data. Methods We analyzed and designed the abstract components necessary for a distributed feasibility query. This included a user interface for creating the query, backend with an ontology and terminology service, middleware for query distribution, and FHIR feasibility query execution service. Results We implemented the components described in the Methods section. The resulting solution was distributed to 33 German university hospitals. The functionality of the comprehensive network infrastructure was demonstrated using a test data set based on the German Corona Consensus Data Set. A performance test using specifically created synthetic data revealed the applicability of our solution to data sets containing millions of FHIR resources. The solution can be easily deployed across hospitals and supports feasibility queries, combining multiple inclusion and exclusion criteria using standard Health Level Seven query languages such as Clinical Quality Language and FHIR Search. Developing a platform based on multiple microservices allowed us to create an extendable platform and support multiple Health Level Seven query languages and middleware components to allow integration with future directions of the Medical Informatics Initiative. Conclusions We designed and implemented a feasibility platform for distributed feasibility queries, which works directly on FHIR-formatted data and distributed it across 33 university hospitals in Germany. We showed that developing a feasibility platform directly on the FHIR standard is feasible.

Background High-quality clinical data and biological specimens are key for medical research and personalized medicine. The Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC) aims to facilitate access to such biological resources. The accompanying ADOPT BBMRI-ERIC project kick-started BBMRI-ERIC by collecting colorectal cancer data from European biobanks. Objectives To transform these data into a common representation, a uniform approach for data integration and harmonization had to be developed. This article describes the design and the implementation of a toolset for this task. Methods Based on the semantics of a metadata repository, we developed a lexical bag-of-words matcher, capable of semiautomatically mapping local biobank terms to the central ADOPT BBMRI-ERIC terminology. Its algorithm supports fuzzy matching, utilization of synonyms, and sentiment tagging. To process the anonymized instance data based on these mappings, we also developed a data transformation application. Results The implementation was used to process the data from 10 European biobanks. The lexical matcher automatically and correctly mapped 78.48% of the 1,492 local biobank terms, and human experts were able to complete the remaining mappings. We used the expert-curated mappings to successfully process 147,608 data records from 3,415 patients. Conclusion A generic harmonization approach was created and successfully used for cross-institutional data harmonization across 10 European biobanks. The software tools were made available as open source.