Data Linkage from Clinical to Study Databases via an R Data Warehouse User Interface. Experiences from a Large...

Area of Science:

• Clinical Informatics
• Health Data Management
• Cardiology Research

Background:

• Clinical study data is often manually transferred from routine care to Case Report Forms (CRF) and Electronic Data Capture (EDC) systems.
• Manual data transfer is time-consuming and prone to errors, impacting study efficiency.

Purpose of the Study:

• To enhance clinical documentation for acute decompensated heart failure studies.
• To automate data transfer from Hospital Information Systems (HIS) via a Data Warehouse (DWH) to EDC systems.
• To improve data accuracy and reduce manual effort in clinical research.

Main Methods:

• Leveraged an existing clinical Data Warehouse (DWH) and extended it with new data domains.
• Developed an R user interface for accessing, transforming, and preparing study-specific variables from the DWH.
• Established a data flow from HIS to DWH to EDC, including patient labeling and daily data updates.

Main Results:

• Successfully implemented an automated data flow for clinical study documentation.
• Initialized 296 patients in the EDC system using pseudonymized data from the DWH.
• Populated EDC records with clinical heart failure data, vital parameters, and ward stay information.

Conclusions:

• The developed DWH-EDC linkage system enables comprehensive data access and transformation.
• Demonstrated the feasibility of this automated approach for large clinical studies with complex visit schedules.
• Highlights the potential for improved data management in clinical research.