医疗器械技术评估的领域与方法：一项系统综述
Domains and Methods of Medical Device Technology Evaluation: A Systematic Review.
作者信息
Toscas Fotini Santos, Blas Daiana Laurenci Orth, Teixeira Leidy Anne Alves, Santos Marisa da Silva, Dias Eduardo Mario
机构信息
Technology Center for SUS/SP, Institute of Health (CTS-IS), and Radiology Program, Faculty of Medicine, State University of São Paulo (USP), São Paulo, SP, Brazil.
Health Technology Assessment Center, Faculty of Technology of Sorocaba (Fatec-SO), Sorocaba, SP, Brazil.
出版信息
Public Health Rev. 2024 Jul 24;45:1606343. doi: 10.3389/phrs.2024.1606343. eCollection 2024.
OBJECTIVES
Identify, through a systematic review, the main domains and methods to support health technology assessment of Medical Devices (MD) from the perspective of technological incorporation into healthcare systems.
METHODS
Performed structured searches in MEDLINE, Embase, BVS, Cochrane Library, and Web of Science for full studies published between 2017 and May 2023. Selection, extraction, and quality assessment were performed by two blinded reviewers, and discrepancies were resolved by a third reviewer.
RESULTS
A total of 5,790 studies were retrieved, of which 41 were included. We grouped the identified criteria into eight domains for the evaluations.
CONCLUSION
Overall, studies discuss the need to establish specific methods for conducting HTA in MD. Due to the wide diversity of MD types, a single methodological guideline may not encompass all the specificities and intrinsic characteristics of the plurality of MD. Studies suggest using clustering criteria through technological characterization as a strategy to make the process as standardized as possible.
目的
通过系统评价，从医疗技术融入医疗保健系统的角度，确定支持医疗器械卫生技术评估的主要领域和方法。
方法
在MEDLINE、Embase、BVS、Cochrane图书馆和科学网中对2017年至2023年5月发表的完整研究进行结构化检索。由两名盲法评审员进行筛选、提取和质量评估，分歧由第三名评审员解决。
结果
共检索到5790项研究，其中41项被纳入。我们将确定的标准分为八个评估领域。
结论
总体而言，研究讨论了为医疗器械开展卫生技术评估建立特定方法的必要性。由于医疗器械类型的广泛多样性，单一的方法指南可能无法涵盖多种医疗器械的所有特殊性和内在特征。研究建议通过技术特征使用聚类标准作为一种策略，以使过程尽可能标准化。
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