Prospective Clinical Registry to Evaluate Clinical Outcomes of Hypertension Patients in a Multidisciplinary Clinic
Michelle Dornelles Santarém, Patrícia de Oliveira Dias, Suimara dos Santos, Clarissa Garcia Rodrigues, Sílvia Goldmeier
Abstract
Michelle Dornelles Santarém, Patrícia de Oliveira Dias, Suimara dos Santos, Clarissa Garcia Rodrigues, Sílvia Goldmeier
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.
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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.
Key concepts: Medicine, Electronic data capture, Multidisciplinary approach, Health Insurance Portability and Accountability Act, Interoperability, Workflow, Data collection, Disease registry