Glocal clinical registries: pacemaker registry design and implementation for global and local...

Area of Science:

• Biomedical Informatics
• Health Data Management
• Clinical Research Infrastructure

Background:

• Standardized and interoperable solutions are essential for managing medical registries.
• Aggregating, reproducing, and accessing data from legacy systems to modern platforms is critical for healthcare and research.

Purpose of the Study:

• To describe a reproducible, scalable, standard framework for device registry implementation.
• To address local data quality and global linking challenges in device registries.

Main Methods:

• Defined data standards and research workflow.
• Developed electronic case report forms using REDCap (Research Electronic Data Capture).
• Collected data, augmented with electronic health records, governmental data, and linked open data.
• Implemented data quality control and disseminated data via a website.

Main Results:

• The framework adopted American College of Cardiology/American Heart Association standards and Clinical Data Interchange Standards Consortium variables.
• Achieved local interoperability between REDCap and Electronic Health Record systems.
• Augmented data with Brazilian government reimbursement values and linked to 130 potentially correlated clinical trials via Linked Clinical Trials (LinkedCT).

Conclusions:

• Demonstrated the application of standard, reproducible solutions for medical registry implementation.
• Created a reusable framework with potential to facilitate data integration between healthcare and research.
• Highlighted the framework's utility for other biomedical registries.