确定腹部核心健康质量的价值合作支持监管决策
B K Poulose1, E Avila-Tang2, H Schwartzman3
1Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH, USA. benjamin.poulose@osumc.edu.
腹部核心健康质量协作 (ACHQC) 的现实证据显著降低了监管决策的成本和时间表. 这种协作式的合作.
科学领域:
- 改善外科手术的质量
- 医疗保健服务研究 医疗服务研究
- 监管科学 监管科学
背景情况:
- 腹部核心健康质量协作 (ACHQC) 是一个国家注册机构,收集有关修复的数据.
- 现实世界的证据 (RWE) 在监管决策中发挥着越来越重要的作用.
- 传统的市场后研究可能是昂贵和耗时的.
研究的目的:
- 为了量化 ACHQC 为监管提交所产生的 RWE 的价值.
- 为了比较ACHQC数据分析的成本和时间效率与传统的市场后研究.
主要方法:
- 两个回顾性队列评估将ACHQC分析与反事实传统的市场后研究进行了比较.
- 根据45 010名患者的数据计算了成本和时间的节省.
- 确定了投资回报率 (ROI) 和成本节约的百分比.
主要成果:
- 与传统研究相比,ACHQC对20种网状产品的分析节省了1.3-2.2万美元和3至4.8年.
- 对于机器人辅助腹修复的标签扩展分析显示,投资回报率为11-461%,节省了5.1年的时间.
- 这些发现凸显了通过ACHQC数据利用获得的显著效率.
结论:
- 利用ACHQC现实世界的证据为监管决策节省了大量的成本和时间.
- ACHQC数据为传统的市场后监测和研究提供了有价值的替代方案.
- 协作证明了监管应用的投资回报率很高.
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