The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several important risk and prognostic factors in major chronic diseases. A random sample of 45,000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, are taking part in an extensive baseline assessment at one dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting major organ system function and structures including extensive imaging examinations. The protocol includes validate self-reports via questionnaires regarding lifestyle and environmental conditions, dietary habits, physical condition and activity, sexual dysfunction, professional life, psychosocial context and burden, quality of life, digital media use, occupational, medical and family history as well as healthcare utilization. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to gather valid prevalence and incidence, and to develop complex models predicting health outcomes based on a multitude of examination data, imaging, biomarker, psychosocial and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia are invited for a visit to conduct an additional MRI examination of either heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and surveys as well as related individual routine data from involved health and pension insurances. The study is targeting the complex relationship between biologic and psychosocial risk and resilience factors, chronic disease, health care use, survivorship and health as well as favorable and bad prognosis within a unique, large-scale long-term assessment with the perspective of further examinations after 6 years in a representative European metropolitan population.
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.
COVID-19 has challenged the healthcare systems worldwide. To quickly identify successful diagnostic and therapeutic approaches large data sharing approaches are inevitable. Though organizational clinical data are abundant, many of them are available only in isolated silos and largely inaccessible to external researchers. To overcome and tackle this challenge the university medicine network (comprising all 36 German university hospitals) has been founded in April 2020 to coordinate COVID-19 action plans, diagnostic and therapeutic strategies and collaborative research activities. 13 projects were initiated from which the CODEX project, aiming at the development of a Germany-wide Covid-19 Data Exchange Platform, is presented in this publication. We illustrate the conceptual design, the stepwise development and deployment, first results and the current status.
Background The harmonization and standardization of digital medical information for research purposes is a challenging and ongoing collaborative effort. Current research data repositories typically require extensive efforts in harmonizing and transforming original clinical data. The Fast Healthcare Interoperability Resources (FHIR) format was designed primarily to represent clinical processes; therefore, it closely resembles the clinical data model and is more widely available across modern electronic health records. However, no common standardized data format is directly suitable for statistical analyses, and data need to be preprocessed before statistical analysis. Objective This study aimed to elucidate how FHIR data can be queried directly with a preprocessing service and be used for statistical analyses. Methods We propose that the binary JavaScript Object Notation format of the PostgreSQL (PSQL) open source database is suitable for not only storing FHIR data, but also extending it with preprocessing and filtering services, which directly transform data stored in FHIR format into prepared data subsets for statistical analysis. We specified an interface for this preprocessor, implemented and deployed it at University Hospital Erlangen-Nürnberg, generated 3 sample data sets, and analyzed the available data. Results We imported real-world patient data from 2016 to 2018 into a standard PSQL database, generating a dataset of approximately 35.5 million FHIR resources, including “Patient,” “Encounter,” “Condition” (diagnoses specified using International Classification of Diseases codes), “Procedure,” and “Observation” (laboratory test results). We then integrated the developed preprocessing service with the PSQL database and the locally installed web-based KETOS analysis platform. Advanced statistical analyses were feasible using the developed framework using 3 clinically relevant scenarios (data-driven establishment of hemoglobin reference intervals, assessment of anemia prevalence in patients with cancer, and investigation of the adverse effects of drugs). Conclusions This study shows how the standard open source database PSQL can be used to store FHIR data and be integrated with a specifically developed preprocessing and analysis framework. This enables dataset generation with advanced medical criteria and the integration of subsequent statistical analysis. The web-based preprocessing service can be deployed locally at the hospital level, protecting patients’ privacy while being integrated with existing open source data analysis tools currently being developed across Germany.
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