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

Abstract

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.

Repeated Digitized Assessment of Risk and Symptom Profiles During Inpatient Treatment of Affective Disorder: Observational Study

“…Data were entered via Apple iPads, using the Mobile Patient Survey [31], a web-based multilanguage electronic patient-reported outcome system. The standardized data processing and the standardized data export were realized with the single-source metadata architecture transformation [32], an extension of the electronic health record system which uses Module Driven Software Development to generate standardized apps.…”

Design, Implementation and Feasibility of an Informatics Infrastructure for Standardized Data Acquisition, Transfer, Storage and Export in Psychiatric Clinical Routine

“…The single-source metadata architecture transformation (SMA:T) was used as the software architecture [44]. SMA:T is an extension of the EHR system of the Münster University Hospital and uses Module Driven Software Development [45] to generate standardized applications and interfaces.…”

“…Every SMA:T form has a generic built-in interface for exchanging standardized data. Embedded applications [44] were used as the application type. These are linked to an Operational Data Model (ODM) file in the EHR database, from which a documentation form is generated.…”

“…For multi-center studies, SMA:T needs to be reimplemented in the respective EHR environments. A software blueprint is available [44]. Another important consideration is the potential future enrichment of EHR data with mobile assessments including ecological momentary assessments (EMA) and passive sensor data derived from smartphones.…”

Continuous digital collection of patient-reported outcomes during inpatient treatment for affective disorders – implementation and feasibility

“…Data was entered via Apple iPads, using the Mobile Patient Survey (MoPat; Soto-Rey et al, 2016), a web-based multi-language electronic PRO system. The standardised data processing and the standardised data export were realised with the single-source metadata architecture transformation (SMA:T; Blitz & Dugas, 2020). SMA:T is an extension of the EHR system and uses Module Driven Software Development to generate standardised applications.…”