Introducing a Method for Transformation of Paper-Based Research Data into Concept-Based Representation with openEHR.

Combining research data and clinical routine data is a chance for medical research. We present our method for the transformation of paper-based research data into a concept-based representation. With this representation the study data from research projects can be combined with data from clinical tools with less integration effort. We applied and verified our method using data from a current research study. In this paper we also show our main challenges and lessons learned. Clinical assessment data and study diaries from a long term study (n=24, 3 months observation time each, 17 different clinical assessments) stored on paper were used as the data set. An openEHR-based electronical health record platform was adapted for acquisition and representation of the research data. To avoid transcription errors, the data was entered twice by different student assistants. A third compared and corrected both data sets. Content models (17 archetypes and five templates from openEHR concept) based on clinical assessments were created manually. Web forms for data entry were created automatically on the basis of this concept-based content models. Additionally, form functionalities to support data entry and comparison were implemented. In total, 829 compositions were entered by the student assistants. With our developed method, we are able to represent the study data in a clinical concept-based platform, which means less integration effort for access and processing of research and clinical data. Some minor difficulties occurred during the process. All in all, adapting routine tools, like the EHR platform, seems to be convenient to deal with research data.