相关实验视频

Updated: Jun 22, 2025

An In Vitro Hemodynamic Loop Model to Investigate the Hemocytocompatibility and Host Cell Activation of Vascular Medical Devices

An In Vitro Hemodynamic Loop Model to Investigate the Hemocytocompatibility and Host Cell Activation of Vascular Medical Devices

Published on: August 21, 2020

医疗器械特性是否包括在HTA方法指南和报告中? 一个简短的回顾简短的回顾

Rituparna Basu¹, Simon Eggington², Natalie Hallas³

¹Medtronic, Boston, MA, USA.

Applied health economics and health policy

|July 4, 2024

概括

卫生技术评估 (HTA) 机构不一致地评估独特的医疗器械 (MD) 特性,如学习曲线和创新. 未来的HTA需要更明确的指导来评估MD的影响.

科学领域:

医疗技术评估 (HTA) 是指对医疗技术进行评估.
医疗器械 (MD) 的评估
医疗保健政策与创新医疗保健政策与创新

背景情况:

与药品相比,医疗器械 (MD) 具有不同的属性,包括学习曲线 (LC),增量创新 (II),动态定价 (DP) 和组织影响 (OI).
当前的卫生技术评估 (HTA) 框架可能无法充分捕捉到这些独特的MD特征.

研究的目的:

评估HTA机构在何种程度上经常评估并将特定的MD特征纳入其指导方针和报告.
识别目前用于评估MD的HTA方法的缺口.

主要方法:

来自14个选定的HTA机构和5个HTA网络的HTA方法指南的系统审查.
对16个选定的MD的HTA报告进行分析,以确定MD特定特征的包含.
进行关于该主题的叙事文献综述.

主要成果:

在HTA机构和网络中不一致地包含MD特征 (LC,II,DP,OI).
虽然NICE和EUnetHTA等一些机构在指南中承认了这些特征,但它们在评估中的应用有所不同.
文献审查表明,在评估医疗药师时,HTA从业人员显著缺乏方法指导.

结论:

在HTA过程中对独特的医疗器械特性进行例行评估和整合时,存在一个显著的差距.
制定明确的指导和框架对于制造商提供适当的证据和HTA机构全面评估MD影响至关重要.
解决这些复杂性对于未来的强大的医疗器械HTA至关重要.

更多相关视频

Automated Contraction Analysis of Human Engineered Heart Tissue for Cardiac Drug Safety Screening

Automated Contraction Analysis of Human Engineered Heart Tissue for Cardiac Drug Safety Screening

Published on: April 15, 2017

Hemocompatibility Testing of Blood-Contacting Implants in a Flow Loop Model Mimicking Human Blood Flow

Hemocompatibility Testing of Blood-Contacting Implants in a Flow Loop Model Mimicking Human Blood Flow

Published on: March 5, 2020

相关概念视频

Hazard Ratio

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...

Healthcare Associated Infections II: Preventive Measures

Healthcare Associated Infections II: Preventive Measures

Essential infection prevention measures are based on the knowledge of the infection chain, the modes of transmission in healthcare settings, and the use of the best practices in all healthcare settings. Compulsory public reporting of healthcare-associated infection rates is needed to allow individuals and the community to make informed choices regarding selecting a healthcare facility.
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...