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

IF 3 2区 医学 Q1 ORTHOPEDICS Journal of Orthopaedics and Traumatology Pub Date : 2023-09-16 DOI:10.1186/s10195-023-00732-4
Simona Pascucci, Francesco Langella, Michela Franzò, Marco Giovanni Tesse, Enrico Ciminello, Alessia Biondi, Eugenio Carrani, Letizia Sampaolo, Gustavo Zanoli, Pedro Berjano, Marina Torre
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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.

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国家脊柱外科登记的特点和目标:全球公认的标准尚未达到。范围审查和补充调查的结果。
背景:植入式手术被广泛用于解决一些健康问题。国家登记处是植入式装置监测和警戒的重要工具。2017年,欧盟鼓励成员国建立“特定类型器械的注册和数据库”,以评估器械的安全性和性能,并确保其可追溯性。脊柱植入装置显著影响患者安全和公众健康;脊柱登记可能有助于改善手术结果。本研究旨在绘制现有国家脊柱外科登记系统的分布图,突出其特点和组织标准,为建立其他国家脊柱外科登记系统提供重要参考。方法:使用Embase、PubMed/Medline、Scopus和Web of Science数据库对2000年1月至2020年12月出版物中的术语“registry”、“register”、“implantable”以及与脊柱疾病和国家注册相关的所有术语和同义词进行范围搜索。后来通过网络搜索和收集进一步详细信息的特别调查更新并最终确定了这一搜索。结果:纳入了62篇同行评议的文章,这些文章与7个国家脊柱登记处有关,其中6个目前是活跃的。通过网络搜索发现了另外三个活跃的国家登记处。9个选定的国家登记处是在1998年至2021年之间建立的。他们收集手术过程的数据,并使用患者报告的结果测量(PROMs)进行随访。结论:我们的研究确定了9个目前活跃的国家脊柱外科登记处。然而,全球公认的脊柱手术登记标准尚未建立。因此,在国际上努力提高注册中心之间的结果可比性是非常可取的。我们希望骨科数据评估小组(ODEP)最近发起的建立国际合作的倡议能够满足这些需求。
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来源期刊
Journal of Orthopaedics and Traumatology
Journal of Orthopaedics and Traumatology Medicine-Orthopedics and Sports Medicine
CiteScore
4.30
自引率
0.00%
发文量
56
审稿时长
13 weeks
期刊介绍: The Journal of Orthopaedics and Traumatology, the official open access peer-reviewed journal of the Italian Society of Orthopaedics and Traumatology, publishes original papers reporting basic or clinical research in the field of orthopaedic and traumatologic surgery, as well as systematic reviews, brief communications, case reports and letters to the Editor. Narrative instructional reviews and commentaries to original articles may be commissioned by Editors from eminent colleagues. The Journal of Orthopaedics and Traumatology aims to be an international forum for the communication and exchange of ideas concerning the various aspects of orthopaedics and musculoskeletal trauma.
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