A Reproducible and Standardised Clinical Registry for Clinical and Economic Outcomes of Heart Transplantation Patients

This study describes the creation and implementation of a prospective, reproducible and standardised clinical registry of outpatients who underwent heart transplantation.  Methods and Results: The following steps were carried out: i) data were standardised in accordance with national and international standard data elements, ii) an initial data collection and clinical research workflow was developed, iii) electronic case reports were developed in accordance with the HIPAA privacy rule using REDCap, iv) pilot testing and validation of the data collection, clinical research workflows and case report forms was undertaken, and v) an automated data quality report was developed using REDCap. All patients undergoing heart transplantation in a reference cardiology hospital were included. Patients were excluded if they did not agree to participate in the study. The registry was designed to become multicentre in the future. Data were collected from the moment of the inclusion (hospital admission), at hospital discharge, and 1, 3 and 6 months and yearly after surgery. Clinical and cost-related outcomes included all-causes mortality, cardiovascular mortality, non-fatal myocardial infarction, stroke, hospital admissions, visits to the emergency department, organ rejection, infection, need for re-operation, any adverse event, costs related to treatment and procedures, and quality of life.   Conclusions: This registry represents a powerful tool for assisting quality improvement, healthcare services management, technology assessment, health policies and clinical research since it contains comprehensive and representative data of the clinical practice and allows for interoperability and data integration with other datasets.