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国家脊柱外科登记处的特点和目的:尚未达到全球公认的标准。范围审查和补充调查的结果。

National spine surgery registries' characteristics and aims: globally accepted standards have yet to be met. Results of a scoping review and a complementary survey.

机构信息

Scientific Secretariat of the President's Office, Italian National Institute of Health, Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161, Rome, Italy.

Department of Mechanical and Aerospace Engineering, La Sapienza University of Rome, Rome, Italy.

出版信息

J Orthop Traumatol. 2023 Sep 16;24(1):49. doi: 10.1186/s10195-023-00732-4.

Abstract

BACKGROUND

Surgery involving implantable devices is widely used to solve several health issues. National registries are essential tools for implantable device surveillance and vigilance. In 2017, the European Union encouraged Member States to establish "registries and databanks for specific types of devices" to evaluate device safety and performance and ensure their traceability. Spine-implantable devices significantly impact patient safety and public health; spine registries might help improve surgical outcomes. This study aimed to map existing national spine surgery registries and highlight their features and organisational standards to provide an essential reference for establishing other national registries.

METHODS

A scoping search was performed using the Embase, PubMed/Medline, Scopus, and Web of Science databases for the terms "registry", "register", "implantable", and all terms and synonyms related to spinal diseases and national registries in publications from January 2000 to December 2020. This search was later updated and finalised through a web search and an ad hoc survey to collect further detailed information.

RESULTS

Sixty-two peer-reviewed articles were included, which were related to seven national spine registries, six of which were currently active. Three additional active national registries were found through the web search. The nine selected national registries were set up between 1998 and 2021. They collect data on the procedure and use patient-reported outcome measures (PROMs) for the follow-up.

CONCLUSION

Our study identified nine currently active national spine surgery registries. However, globally accepted standards for developing a national registry of spine surgery are yet to be established. Therefore, an international effort to increase result comparability across registries is highly advisable. We hope the recent initiative from the Orthopaedic Data Evaluation Panel (ODEP) to establish an international collaboration will meet these needs.

摘要

背景

涉及植入装置的手术被广泛用于解决多种健康问题。国家登记处是植入装置监测和警惕的重要工具。2017 年,欧盟鼓励成员国建立“特定类型装置的登记处和数据库”,以评估装置的安全性和性能,并确保其可追溯性。脊柱植入装置对患者安全和公共健康有重大影响;脊柱登记处可能有助于改善手术结果。本研究旨在绘制现有的国家脊柱手术登记处,并强调其特征和组织标准,为建立其他国家登记处提供重要参考。

方法

使用 Embase、PubMed/Medline、Scopus 和 Web of Science 数据库,对 2000 年 1 月至 2020 年 12 月发表的出版物中“登记处”、“登记”、“植入”和与脊柱疾病及国家登记处相关的所有术语和同义词进行了范围搜索。通过网络搜索和特别调查进一步收集详细信息,对该搜索进行了更新和最终确定。

结果

共纳入 62 篇同行评议文章,涉及七个国家脊柱登记处,其中六个目前处于活跃状态。通过网络搜索还发现了另外三个活跃的国家登记处。这九个选定的国家登记处成立于 1998 年至 2021 年之间。它们收集有关手术过程的数据,并在随访中使用患者报告的结果测量(PROMs)。

结论

本研究确定了九个目前处于活跃状态的国家脊柱手术登记处。然而,建立脊柱手术国家登记处的全球公认标准尚未确立。因此,强烈建议国际上努力提高各登记处之间结果的可比性。我们希望最近由骨科数据评估小组(ODEP)发起的建立国际合作的倡议将满足这些需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d4e/10505129/549ea6b014d6/10195_2023_732_Fig1_HTML.jpg

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