评估医疗器械:从验证角度进行定性研究.
1IQ Health Science Department, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.
概括
卫生技术评估 (HTA) 机构经常使用医疗器械的药物评估方法,阻碍了采用新方法. 克服实际和基于实践者的挑战需要对HTA目标进行重新评估和进行制度变革.
科学领域:
- 医疗技术评估 (HTA) 是指对医疗技术进行评估.
- 医疗器械评估 医疗器械评估
- 开发方法论 开发方法论
背景情况:
- 医疗器械的当前健康技术评估 (HTA) 实践在很大程度上依赖于最初为药品开发的方法.
- 这种依赖在适应医疗器械的独特特征方面带来了挑战.
研究的目的:
- 探索医疗器械当前的卫生技术评估 (HTA) 程序和方法.
- 了解HTA从业人员对适当方法的看法以及采用新方法的挑战.
- 检查规范性承诺对采用新HTA方法对设备的影响.
主要方法:
- 一项在线调查,分发给国际卫生技术评估机构网络的成员.
- 与调查受访者和参与过导管大动脉植入评估的从业人员进行深入采访.
- 方法由"做健康技术评估的价值观"的方法,承认HTA的价值负载的性质.
主要成果:
- 医疗技术评估机构主要使用以药物为中心的医疗器械评估程序和方法.
- 时间,决策者的要求,法律框架和指导方针等实际限制阻碍了采用新的方法.
- 实践者对基于证据的医学原则的承诺也构成了方法创新的障碍.
结论:
- 有一个公认的需要适应HTA的医疗器械评估的方法.
- 实施方法变更需要在社区范围内就HTA的作用,责任和目标进行讨论.
- 机构背景和政策调整是必要的,以促进医疗器械HTA新方法的采用.
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