The RE-Endo Registry: A Prospective, Interoperable, Standardised Clinical Registry of Infective Endocarditis Patients

Abstract

Purpose: To describe the creation and implementation of the RE-Endo, a prospective, interoperable, highly scalable and standardised clinical registry of patients with infective endocarditis Methods and Results: We developed the RE-Endo through the following steps: i) data standardisation in accordance with national and international standard variables to allow for interoperability among systems; ii)  development of an initial data collection and clinical research workflow; iii) development of electronic case reports using REDCap (Research Electronic Data Capture) and in accordance with the HIPAA (Health Insurance Portability and Accountability Act) privacy rule; iv) pilot test and validation of the data collection and clinical research workflows and CRFs; v) development of automated data quality report using REDCap. Data collection occurs at the outpatient department at the moment of inclusion and every 12 months during the follow-up (phone calls and visits to the outpatients department).  Conclusions: The RE-Endo Registry represents a comprehensive database capable to represent real clinical practice favouring clinical research, technology assessment, services management and health policies.