Management of Standardised, Interoperable Clinical Registries: Visioning Quality of Care and Clinical Research

Abstract

Objective: To describe the implementation of a hospital sector dedicated to conduct clinical registries. Methods and Results: In 2014 a Sector was founded in the Clinical Research Centre specifically to design and manage clinical registries. Over the past two years we have participated in many adult and paediatric multicentre studies as a site collecting data, and have designed and implemented 14 clinical registries, including local and multicentre studies. The clinical registries include in-hospital and outpatient studies on acute myocardial infarction, cardiovascular rehabilitation, systemic hypertension, pacemaker and implantable cardioverter defibrillator, electrophysiology and ablation procedures, heart failure, cardiac transplantation, percutaneous cardiac intervention for left main coronary artery stenosis, percutaneous cardiac intervention with drug eluting stents, paediatric systemic hypertension, infectious endocarditis, clinical trials patients, paediatric cardiovascular prevention and adult cardiovascular surgery. The databases were built taking into consideration national and international standardised data elements to allow for interoperability among datasets, clinical and research workflows, and are in accordance with the HIPAA (Health Insurance Portability and Accountability Act) privacy rule. Currently, these registries hold data on more than five thousand patients. Integration with other clinical and costs datasets within institutions are underway. Data are used for quality assistance control and research. Conclusion: The Clinical Registry Sector has provided data for measuring quality of care and effectiveness. Additionally, the methodology used for building the clinical registries allow for  interoperability among systems maximising the potential of its use.