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医疗器械技术指南制定:需考虑的问题。

Guideline Development for Medical Device Technology: Issues for Consideration.

机构信息

University Medical Center Ljubljana, University of Ljubljana, Ljubljana, Slovenia.

University of Arizona College of Medicine-Tucson, AZ, USA.

出版信息

J Diabetes Sci Technol. 2023 Nov;17(6):1698-1710. doi: 10.1177/19322968221093355. Epub 2022 May 7.

Abstract

Advances in the development of innovative medical devices and telehealth technologies create the potential to improve the quality and efficiency of diabetes care through collecting, aggregating, and interpreting relevant health data in ways that facilitate more informed decisions among all stakeholder groups. Although many medical societies publish guidelines for utilizing these technologies in clinical practice, we believe that the methodologies used for the selection and grading of the evidence should be revised. In this article, we discuss the strengths and limitations of the various types of research commonly used for evidence selection and grading and present recommendations for modifying the process to more effectively address the rapid pace of device and technology innovation and new product development.

摘要

创新型医疗器械和远程医疗技术的发展为通过收集、汇总和解释相关健康数据,提高糖尿病护理的质量和效率提供了可能,从而使所有利益相关者群体能够做出更明智的决策。尽管许多医学协会都发布了关于在临床实践中使用这些技术的指南,但我们认为,用于选择和分级证据的方法应该进行修订。在本文中,我们讨论了常用于证据选择和分级的各种研究类型的优缺点,并提出了修改该过程的建议,以更有效地应对设备和技术创新以及新产品开发的快速步伐。

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Guideline Development for Medical Device Technology: Issues for Consideration.医疗器械技术指南制定:需考虑的问题。
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