PDF(Pubmed)
Abstract：
There are over 8 million central venous access devices inserted each year, many in patients with chronic conditions who rely on central access for life-preserving therapies. Central venous access device-related complications can be life-threatening and add tens of billions of dollars to health care costs, while their incidence is most likely grossly mis- or underreported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for a meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not only with data extraction and harmonization from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data are not recorded, or falsely recorded, at least in part because policy, payment, penalties, proprietary concerns, and workflow burdens discourage completeness and accuracy. We provide a roadmap for the development of health care information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the US Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total life cycle.
摘要：
每年插入超过800万个中心静脉接入装置，许多患有慢性疾病的患者依赖于中央获得维持生命的疗法。与中心静脉接入装置相关的并发症可能危及生命，并增加数百亿美元的医疗费用，而它们的发病率很可能被医疗机构严重误报或漏报。在这份通讯中,我们回顾了损害保留的挑战，交换,并分析必要的数据，以便有意义地理解该临床领域的关键事件和结果。困难不仅在于从电子健康记录中提取数据和协调，国家监测系统,或其他可能存储数据的健康信息存储库。问题是没有记录可靠和适当的数据，或虚假记录，至少部分是因为政策，付款,处罚,专有问题，和工作流程负担阻碍了完整性和准确性。我们为应对这些挑战的医疗保健信息系统和基础设施的发展提供了路线图，在构建标准化术语框架的研究研究的背景下，决策支持,数据捕获,和任务所需的信息交换。此路线图嵌入在更广泛的协调注册网络学习社区中，并由医疗器械流行病学网络推动，由美国食品和药物管理局赞助的公私伙伴关系，随着推进方法的范围，国家和国际基础设施，以及在整个生命周期中评估医疗器械所需的合作伙伴关系。
