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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.

DOI:10.1177/19322968221093355
PMID:35531901
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10658688/
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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Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes.1 型糖尿病患儿闭环控制的随机试验。
N Engl J Med. 2022 Jan 20;386(3):209-219. doi: 10.1056/NEJMoa2111673.
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Glycaemic management in diabetes: old and new approaches.糖尿病的血糖管理:新旧方法
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Type 2 diabetes mellitus in older adults: clinical considerations and management.老年人 2 型糖尿病:临床注意事项与管理。
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Validity of EQ-5D-5L health-related quality of life questionnaire in self-reported diabetes: evidence from a general population survey.EQ-5D-5L 健康相关生活质量问卷在自我报告糖尿病中的有效性:来自一般人群调查的证据。
Health Qual Life Outcomes. 2021 May 5;19(1):138. doi: 10.1186/s12955-021-01780-2.
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The Impact of Treatment Adherence on Quality of Life Among Type 2 Diabetes Mellitus Patients - Findings from a Cross-Sectional Study.治疗依从性对2型糖尿病患者生活质量的影响——一项横断面研究的结果
Patient Prefer Adherence. 2021 Feb 26;15:475-481. doi: 10.2147/PPA.S295012. eCollection 2021.
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Insulin Metrics: Need for Development of Consensus Standards for Reporting of Insulin Dosing Data.胰岛素计量学:报告胰岛素剂量数据共识标准制定的必要性。
Diabetes Technol Ther. 2021 Jul;23(7):522-526. doi: 10.1089/dia.2020.0631. Epub 2021 Mar 29.
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Standardizing Reporting of Glucose and Insulin Data for Patients on Multiple Daily Injections Using Connected Insulin Pens and Continuous Glucose Monitoring.使用连续血糖监测仪的多次每日注射胰岛素笔患者的血糖和胰岛素数据报告的标准化。
Diabetes Technol Ther. 2021 Mar;23(3):221-226. doi: 10.1089/dia.2021.0030. Epub 2021 Feb 17.
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Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial.真实环境中 1 型糖尿病成人闭环胰岛素输注:为期 12 周的多中心、开放标签随机对照交叉试验。
Lancet Digit Health. 2019 May;1(1):e17-e25. doi: 10.1016/S2589-7500(19)30003-2. Epub 2019 May 2.
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Worldwide Epidemiology of Diabetes-Related End-Stage Renal Disease, 2000-2015.2000 - 2015年全球糖尿病相关终末期肾病流行病学
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10
Six Months of Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring in Adults With Type 1 Diabetes: A Randomized, Controlled Trial.《1 型糖尿病成人患者经皮指尖血糖监测的混合闭环与手动胰岛素输注 6 个月的随机对照试验》
Diabetes Care. 2020 Dec;43(12):3024-3033. doi: 10.2337/dc20-1447. Epub 2020 Oct 14.