Abstract
Introduction: The capture and integration of structured data from point of care into clinical registries has been a challenge. However, this effort is very important toward a qualitative patient care and research. Collection, organization and interpretation of clinical data can help to improve evidence-based medicine practices. Worksheets data capture are prevalent, but, not flexible, protected, workflow pleasant, and user friendly and do not support the creation of standardized and interoperable data. The aim of this study was to design and implement an Electronic Data Capture (EDC) instruments to be use in context of cardiovascular invasive procedures.Material and Methods: This descriptive and developmental study conducted in three phases as follows. (1) data standardization according national and international data element templates published by specialized societies; (2) developing of an initial data collection and clinical research workflow (3), establishing of electronic case reports using Research Electronic Data Capture (REDCap) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.Results: Three case report forms was developed that included demographics, medical history, physical examination, laboratory tests, radiology examinations, Electrophysiology (EP) procedures, as well as medications and follow-up information. Data-entry validation criteria have been implementing in electronic data collection instrument to assure validity and precision when data enter in electronic form.Conclusion: This paper describes the process used to create an EDC application. Data collection applications were successfully develop as an a priori step in a clinical research for assisting data collection and management in a case of cardiovascular EP invasive procedures.
Highlights
The capture and integration of structured data from point of care into clinical registries has been a challenge
Material and Methods: This descriptive and developmental study conducted in three phases as follows. 1) data standardization according national and international data element templates published by specialized societies; 2) developing of an initial data collection and clinical research workflow 3), establishing of electronic case reports using Research Electronic Data Capture (REDCap) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule
Data collection applications were successfully develop as an a priori step in a clinical research for assisting data collection and management in a case of cardiovascular EP invasive procedures
Summary
The capture and integration of structured data from point of care into clinical registries has been a challenge. This effort is very important toward a qualitative patient care and research. Collection, organization and interpretation of clinical data can help to improve evidence-based medicine practices. Quality of medical researches is fully dependent on accuracy and reliability of collected data. Data integration in to clinical research systems in proper way can be a considerable challenge. One important step in medical research is accurate and reliable collection of data to ensure valid results. The validity and reliability of any research project depends on accuracy of collected data [3, 4].
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