Arlington Heights and Springfield, Ill.; and Ann Arbor, Mich. From the American Society of Plastic Surgeons; the Department of Surgery, Southern Illinois University; The Plastic Surgery Foundation; and the Section of Plastic Surgery, Department of Surgery, University of Michigan Health System.
Plast Reconstr Surg. 2013 Jul;132(1):159e-167e. doi: 10.1097/PRS.0b013e3182910cf4.
Clinical data registries are commonly used worldwide and are implemented for a variety of purposes ranging from physician or facility clinic logs for tracking patients, to collecting outcomes data, to measuring quality improvement or safety of medical devices. In the United States, the U.S. Food and Drug Administration has used data collected through registries to facilitate the drug and device regulatory process, for ongoing surveillance during the product life cycle, and for disease appraisals. Furthermore, the Centers for Medicare and Medicaid Services, in certain instances, bases registry participation and submitting data to registries as factors for reimbursement decisions. The purpose of this article is to discuss the use of clinical data registries; the role that medical specialty societies, in particular, the American Society of Plastic Surgeons and The Plastic Surgery Foundation, can have in the development and management of registries; and the opportunities for registry use in plastic surgery. As outcomes data are becoming essential measures of quality health care delivery, participation in registry development and centralized data collection has become a critical task for plastic surgery to engage in to proactively participate in the national quality and performance measurement agenda.
临床数据注册中心在全球范围内被广泛使用，其用途多种多样，从用于跟踪患者的医生或医疗机构门诊日志，到收集结果数据，再到衡量医疗设备的质量改进或安全性。在美国，美国食品和药物管理局 (U.S. Food and Drug Administration) 已经利用通过注册中心收集的数据来促进药物和设备的监管程序，在产品生命周期中进行持续监测，并进行疾病评估。此外，医疗保险和医疗补助服务中心 (Centers for Medicare and Medicaid Services) 在某些情况下，将注册中心的参与度和向注册中心提交数据作为报销决策的因素。本文旨在讨论临床数据注册中心的使用；特别是医学专业协会，如美国整形外科学会和整形外科学基金会，在注册中心的开发和管理中可以发挥的作用；以及注册中心在整形外科学中的使用机会。随着结果数据成为衡量医疗保健服务质量的重要指标，参与注册中心的开发和集中数据收集已成为整形外科学的一项关键任务，以积极参与国家质量和绩效衡量议程。
