Prospective Clinical Registry to Evaluate Clinical Outcomes of Hypertension Patients in a Multidisciplinary Clinic

Abstract

Introduction: clinical registries are necessary to define public policies for treatment and prevention, by providing highly accurate and interoperable data. Objective: to describe the implementation of a prospective, computerised, interoperable and multidisciplinary clinical registry to evaluate the clinical practice and outcomes of hypertensive patients. Methods: prospective observational study designed as a clinical registry carried out in a multidisciplinary hypertension clinic, in Brazil. A multi-professional team attends the patients. The database included patients with primary hypertension, above 18 years of age. Patients who had undergone surgery, a stroke, myocardial infarction, or renal failure were excluded. Variables were defined in accordance with national and international variables to allow interoperability. Results: the RE-HYPER registry was implemented by following the steps: (1) Data standardisation. The dataset included all applicable standardised data elements published by the American Heart Association / American College of Cardiology, and Brazilian national datasets standards; (2) Development of an initial data collection and clinical research workflow; (3) Development of electronic case reports (CRF) using REDCap (Research Electronic Data Capture) and in accordance with the HIPAA (Health Insurance Portability and Accountability Act) privacy rule; (4) Pilot testing and validation of the data collection and clinical research workflows and CRFs, and (5) Development of automated data quality report using REDCap. Discussion: Due to the magnitude of this disease in the world, this study becomes relevant to clinical practice. Conclusion:  The study showed reproducible standards and solutions that can be applied in the implementation of health records, allowing data integration between health and research services.