动态血糖监测的卫生技术评估及其在日常临床实践中的应用方法
Health Technology Assessments for Flash Glucose Monitoring and How to Use Them in Everyday Clinical Practice.
作者信息
Stueve Magnus, Schnell Oliver
机构信息
1 Johnson & Johnson Medical GmbH, Norderstedt, Germany.
2 Forschergruppe Diabetes e.V., Munich-Neuherberg, Germany.
出版信息
J Diabetes Sci Technol. 2019 May;13(3):584-591. doi: 10.1177/1932296818794668. Epub 2018 Aug 22.
BACKGROUND
Various health technology assessment (HTA) agencies review new medical devices worldwide, and their recommendations can be useful in guiding clinical decision making. However, different agencies use different processes and methodologies, resulting in variation in recommendations.
OBJECTIVES
The objectives were to review full HTAs for a new technology for diabetes management, flash glucose monitoring (FGM), with the aim of summarizing similarities/differences in processes, methodologies, and recommendations from the perspective of everyday clinical practice.
METHODS
A literature review was conducted using online HTA resources.
RESULTS
Four full HTAs were identified (Canary Islands, France, Catalunya, and Norway); one issued a conditional recommendation for patients with type 1 diabetes mellitus (T1DM) with controlled glycated hemoglobin (HbA1c) (Spain; Canary Islands), one issued a broader recommendation for patients with T1DM and T2DM (France), and two reported that there was insufficient evidence to support a recommendation (Spain [Catalunya] and Norway). The most comprehensive and stringent of the available HTAs were those in the Canary Islands and Norway, which included systematic literature reviews (SLRs), consultation with patient groups and clinicians, GRADE evidence quality assessments, and full economic models. Comprehensive HTAs either did not recommend FGM (Norway) or restricted the recommendation to a small subpopulation of the overall diabetes population (Canary Islands).
CONCLUSION
HTAs represent a valuable additional resource for clinicians to consider alongside clinical evidence, guidelines, and consensus papers; however, interpreting recommendations requires an understanding of the processes behind these recommendations. In this review, comprehensive HTAs either recommended for a selected subpopulation based on RCT evidence or found insufficient evidence for a recommendation.
背景
世界各地的各种卫生技术评估（HTA）机构会对新型医疗设备进行审查，其建议有助于指导临床决策。然而，不同机构采用不同的流程和方法，导致建议存在差异。
目的
回顾一项用于糖尿病管理的新技术——动态血糖监测（FGM）的完整卫生技术评估，旨在从日常临床实践的角度总结流程、方法和建议中的异同。
方法
利用在线卫生技术评估资源进行文献综述。
结果
共确定了四项完整的卫生技术评估（加那利群岛、法国、加泰罗尼亚和挪威）；一项对糖化血红蛋白（HbA1c）得到控制的1型糖尿病（T1DM）患者给出了有条件的推荐（西班牙；加那利群岛），一项对T1DM和2型糖尿病（T2DM）患者给出了更广泛的推荐（法国），另外两项报告称没有足够证据支持给出推荐（西班牙[加泰罗尼亚]和挪威）。现有卫生技术评估中最全面、最严格的是加那利群岛和挪威的评估，其中包括系统文献综述（SLR）、与患者群体和临床医生的咨询、GRADE证据质量评估以及完整的经济模型。全面的卫生技术评估要么不推荐FGM（挪威），要么将推荐限制在整个糖尿病患者群体中的一小部分亚组（加那利群岛）。
结论
卫生技术评估是临床医生在考虑临床证据、指南和共识文件之外的一项有价值的额外资源；然而，解读这些建议需要了解其背后的流程。在本综述中，全面的卫生技术评估要么基于随机对照试验（RCT）证据为选定的亚组给出推荐，要么发现没有足够证据给出推荐。
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