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骨科手术中的数据库与登记研究:第2部分:临床登记数据。

Database and Registry Research in Orthopaedic Surgery: Part 2: Clinical Registry Data.

作者信息

Pugely Andrew J, Martin Christopher T, Harwood Jared, Ong Kevin L, Bozic Kevin J, Callaghan John J

机构信息

Department of Orthopaedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 01008 JPP, Iowa City, IA 52242. E-mail address for A.J. Pugely:

Department of Orthopaedics, Ohio State University Hospital, 376 West 10th Avenue Suite 725, Columbus, OH 43210.

出版信息

J Bone Joint Surg Am. 2015 Nov 4;97(21):1799-808. doi: 10.2106/JBJS.O.00134.

DOI:10.2106/JBJS.O.00134
PMID:26537168
Abstract

The use of large-scale national databases for observational research in orthopaedic surgery has grown substantially in the last decade, and the data sets can be categorized as either administrative claims or clinical registries. Clinical registries contain secondary data on patients with a specific diagnosis or procedure. The data are typically used for patient outcome surveillance to improve patient safety and health-care quality. Registries used in orthopaedic research exist at the regional, national, and international levels, and many were designed to specifically collect outcomes relevant to orthopaedics, such as short-term surgical complications, longer-term outcomes (implant survival or reoperations), and patient-reported outcomes. Although heterogeneous, clinical registries-in contrast to claims data-typically have a more robust list of variables, with relatively precise prospective data input, management infrastructure, and reporting systems. Some weaknesses of clinical registries include a smaller number of patients, inconstant follow-up duration, and use of sampling methods that may limit generalizability. Within the U.S., national joint registry adoption has lagged international joint registries. Given the changing health-care environment, it is likely that clinical registries will provide valuable information that has the potential to influence clinical practice improvement and health-care policy in the future.

摘要

在过去十年中,用于骨科手术观察性研究的大规模国家数据库的使用显著增加,这些数据集可分为行政索赔数据或临床登记数据。临床登记数据包含患有特定诊断或接受特定手术患者的二级数据。这些数据通常用于患者结局监测,以提高患者安全和医疗质量。骨科研究中使用的登记数据存在于地区、国家和国际层面,许多登记数据旨在专门收集与骨科相关的结局,如短期手术并发症、长期结局(植入物存活或再次手术)以及患者报告的结局。尽管临床登记数据存在异质性,但与索赔数据相比,其通常具有更丰富的变量列表,具有相对精确的前瞻性数据输入、管理基础设施和报告系统。临床登记数据的一些缺点包括患者数量较少、随访时间不一致以及使用可能限制普遍性的抽样方法。在美国,国家关节登记数据的采用落后于国际关节登记数据。鉴于不断变化的医疗环境,临床登记数据很可能会提供有价值的信息,有可能在未来影响临床实践改进和医疗政策。

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