在德国住院护理中利用创新医疗技术:证据是否重要?
Helene Eckhardt1, Susanne Felgner2,3, Marie Dreger2,3
1Department of Health Care Management, Technische Universität Berlin, Straße Des 17. Juni 135, 10623, Berlin, Germany. helene.eckhardt@gmail.com.
Health research policy and systems
|October 2, 2023
概括
德国的新医疗技术在退款之前往往缺乏足够的证据,这会影响患者的福利. 加强市场批准和医疗技术评估 (HTA) 途径至关重要.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 医疗技术评估 医疗技术评估
- 基于证据的医学 基于证据的医学
背景情况:
- 德国的新住院技术的补偿历史上缺乏基于证据的强制性患者益处评估.
- 市场批准直到最近才允许对新技术进行补偿,而没有明确的排除,无论证据如何.
- 这项研究探讨了德国住院护理的证据格局和创新技术的利用.
研究的目的:
- 调查25种创新技术在引入时和随着时间的推移时的证据的类型和演变.
- 探索现有的临床证据与这些技术在德国医院的使用之间的关系.
主要方法:
- 在数据库,注册表,指南和HTA资源中进行系统的文献搜索 (2003-2017年).
- 收集有关资金机制和安全通知的数据.
- 使用描述性和多层次回归分析分析证据量,资金,安全性和利用率 (医院索赔数据).
主要成果:
- 证据差异很大,非比较性研究占主导地位;随机对照试验 (RCT) 很少 (0-19个技术).
- 多年来,一些技术在没有足够的证据基础的情况下被使用.
- 对一些,但不是所有技术,观察到证据和利用之间的相关性.
结论:
- 关于支持新技术的证据及其与随着时间的推移使用的联系,存在着不同的观点.
- 进一步调查资金和安全通知的影响是有必要的.
- 结果强调需要加强市场批准标准,医疗技术评估 (HTA) 途径和证据开发覆盖范围.
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