Towards Implementation of OMOP in a German University Hospital Consortium.

BACKGROUND: In 2015, the German Federal Ministry of Education and Research initiated a large data integration and data sharing research initiative to improve the reuse of data from patient care and translational research. The Observational Medical Outcomes Partnership (OMOP) common data model and the Observational Health Data Sciences and Informatics (OHDSI) tools could be used as a core element in this initiative for harmonizing the terminologies used as well as facilitating the federation of research analyses across institutions. OBJECTIVE: To realize an OMOP/OHDSI-based pilot implementation within a consortium of eight German university hospitals, evaluate the applicability to support data harmonization and sharing among them, and identify potential enhancement requirements. METHODS: The vocabularies and terminological mapping required for importing the fact data were prepared, and the process for importing the data from the source files was designed. For eight German university hospitals, a virtual machine preconfigured with the OMOP database and the OHDSI tools as well as the jobs to import the data and conduct the analysis was provided. Last, a federated/distributed query to test the approach was executed. RESULTS: While the mapping of ICD-10 German Modification succeeded with a rate of 98.8% of all terms for diagnoses, the procedures could not be mapped and hence an extension to the OMOP standard terminologies had to be made.Overall, the data of 3 million inpatients with approximately 26 million conditions, 21 million procedures, and 23 million observations have been imported.A federated query to identify a cohort of colorectal cancer patients was successfully executed and yielded 16,701 patient cases visualized in a Sunburst plot. CONCLUSION: OMOP/OHDSI is a viable open source solution for data integration in a German research consortium. Once the terminology problems can be solved, researchers can build on an active community for further development.

Prenatal screening using maternal serum alpha-fetoprotein, human chorionic gonadotropin, and unconjugated estriol: two-year experience in a health maintenance organization.

The objective of this study was to evaluate a 2-year experience in a health maintenance organization with mid-trimester maternal serum screening with alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), and unconjugated estriol (UE) as a screen for fetal Down's syndrome. Women at 15-20 weeks gestation were offered triple marker screening. A patient-specific second trimester risk of 1:295 for Down's syndrome was used as a threshold for referral. Women at risk for trisomy 18 were identified by a protocol with fixed low cutoffs. The AFP threshold for referral for neural tube defects (NTD) was 2.0 multiples of the median (MoM). Patients at risk were offered ultrasonography, genetic counseling, and prenatal diagnosis. A total of 6,474 samples were drawn. The initial screen positive rate for Down's syndrome was 7.1%. After ultrasound evaluation, 351 (5.7%) of the remaining 6,197 women were still at risk for Down's syndrome. After genetic counseling, 292 (4.7%) women underwent prenatal diagnosis. Overall, 12 of 16 (75%) cases of Down's syndrome were detected antenatally by triple marker screening. Using AFP alone, only 3 of 14 (21%) cases of Down's syndrome in women under 35 years would have been detected. We detected 1 abnormal karyotype (including one 45, X) for every 22 amniocenteses performed for abnormal Down's syndrome screening. For trisomy 18, 13 women (0.2%) were at risk and, of these, 3 cases were diagnosed. All 6 cases of NTD during the study period were detected by AFP after identifying 3.8% of women as at risk. In conclusion, in the setting of a health maintenance organization where abnormal screening tests were managed by a single referral center, triple marker screening was effective not only for screening for fetal Down's syndrome, but also for trisomy 18 and NTD.