CC BY-NC-ND 4.0 · Appl Clin Inform 2020; 11(03): 374-386
DOI: 10.1055/s-0040-1710023
State of the Art/Best Practice Paper
Georg Thieme Verlag KG Stuttgart · New York

Conceptual Design, Implementation, and Evaluation of Generic and Standard-Compliant Data Transfer into Electronic Health Records

Rogério Blitz
1  Business Unit IT, University Hospital Münster, Münster, Germany
Martin Dugas
2  Institute of Medical Informatics, University of Münster, Münster, Germany
› Author Affiliations
Funding None.
Further Information

Publication History

09 December 2019

31 March 2020

Publication Date:
27 May 2020 (online)


Objectives The objective of this study is the conceptual design, implementation and evaluation of a system for generic, standard-compliant data transfer into electronic health records (EHRs). This includes patient data from clinical research and medical care that has been semantically annotated and enhanced with metadata. The implementation is based on the single-source approach. Technical and clinical feasibilities, as well as cost-benefit efficiency, were investigated in everyday clinical practice.

Methods Münster University Hospital is a tertiary care hospital with 1,457 beds and 10,823 staff who treated 548,110 patients in 2018. Single-source metadata architecture transformation (SMA:T) was implemented as an extension to the EHR system. This architecture uses Model Driven Software Development (MDSD) to generate documentation forms according to the Clinical Data Interchange Standards Consortium (CDISC) operational data model (ODM). Clinical data are stored in ODM format in the EHR system database. Documentation forms are based on Google's Material Design Standard. SMA:T was used at a total of five clinics and one administrative department in the period from March 1, 2018 until March 31, 2019 in everyday clinical practice.

Results The technical and clinical feasibility of SMA:T was demonstrated in the course of the study. Seventeen documentation forms including 373 data items were created with SMA:T. Those were created for 2,484 patients by 283 users in everyday clinical practice. A total of 121 documentation forms were examined retrospectively. The Constructive cost model (COCOMO II) was used to calculate cost and time savings. The form development mean time was reduced by 83.4% from 3,357 to 557 hours. Average costs per form went down from EUR 953 to 158.

Conclusion Automated generic transfer of standard-compliant data and metadata into EHRs is technically and clinically feasible, cost efficient, and a useful method to establish comprehensive and semantically annotated clinical documentation. Savings of time and personnel resources are possible.

Protection of Human and Animal Subjects

This manuscript contains no patient data; therefore, it is not subject to human subject research approval.