Pittrow Robert David, Dewald Oliver, Harig Frank, Kaemmerer-Suleiman Ann-Sophie, Suleiman Mathieu, Pittrow Leonard Bernhard, Achenbach Stephan, Freiberger Annika, Freilinger Sebastian, Pittrow Benjamin Alexander, Kaulitz Renate, Kaemmerer Harald
Department of Cardiac Surgery, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Department of Medicine 2-Cardiology and Angiology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Cardiovasc Diagn Ther. 2025 Apr 30;15(2):455-464. doi: 10.21037/cdt-2024-579. Epub 2025 Apr 23.
Registries have become pivotal in medical research, offering a robust foundation for understanding disease incidence, treatment patterns, and patient outcomes across diverse populations. By aggregating real-world data (RWD), registries provide invaluable insights into real-world evidence (RWE), shaping clinical guidelines, healthcare policies, and regulatory decisions. Their widespread acceptance underscores their scientific validity and their role in driving evidence-based medicine, ultimately improving healthcare outcomes. In cardiology, particularly within the specialized field of congenital heart disease (CHD), national and international registries have emerged as indispensable tools. They enable the systematic collection of data on patient demographics, disease progression, therapeutic interventions, and long-term outcomes. These datasets support a range of purposes, including observational studies, quality improvement initiatives, and regulatory assessments of medical devices or pharmaceuticals. Establishing a high-quality registry requires meticulous planning and adherence to established guidelines. Professional organizations, such as the European Society of Cardiology (ESC) and the American Heart Association (AHA), offer detailed guidance documents for setting up and managing registries. Additionally, various checklists and frameworks exist to evaluate and ensure registry quality, aiding researchers in optimizing data reliability and utility. With advancements in digital health, the potential of electronic health records (EHRs) to complement or replace traditional registries is increasingly explored. EHRs offer a dynamic, real-time data collection mechanism, reducing redundancy and operational costs while maintaining data accuracy. However, considerations around interoperability, data privacy, and standardization remain critical in leveraging EHRs for registry purposes.
注册登记在医学研究中已变得至关重要，为了解不同人群的疾病发病率、治疗模式和患者预后提供了坚实基础。通过汇总真实世界数据（RWD），注册登记提供了关于真实世界证据（RWE）的宝贵见解，塑造了临床指南、医疗政策和监管决策。它们的广泛接受凸显了其科学有效性以及在推动循证医学方面的作用，最终改善了医疗结果。在心脏病学领域，尤其是在先天性心脏病（CHD）的专业领域，国家和国际注册登记已成为不可或缺的工具。它们能够系统地收集患者人口统计学、疾病进展、治疗干预和长期预后的数据。这些数据集支持一系列目的，包括观察性研究、质量改进计划以及对医疗设备或药物的监管评估。建立一个高质量的注册登记需要精心规划并遵守既定指南。专业组织，如欧洲心脏病学会（ESC）和美国心脏协会（AHA），提供了关于建立和管理注册登记的详细指导文件。此外，还存在各种清单和框架来评估和确保注册登记的质量，帮助研究人员优化数据的可靠性和实用性。随着数字健康的进步，电子健康记录（EHR）补充或取代传统注册登记的潜力正得到越来越多的探索。电子健康记录提供了一种动态的实时数据收集机制，在保持数据准确性的同时减少了冗余和运营成本。然而，在将电子健康记录用于注册登记目的时，围绕互操作性、数据隐私和标准化的考虑仍然至关重要。
