高风险医疗器械注册表中的患者报告结果措施:一个范围审查
Aesthetic surgery journal. Open forum
|April 23, 2024
概括
在高风险医疗器械注册表中,患者报告的结果指标 (PROM) 在预测长期结果方面未得到充分利用. 需要更多的研究来了解为什么PROM很少被用于预测,这阻碍了它们作为现实世界的证据的使用.
科学领域:
- 医疗器械研究 医疗器械研究
- 患者的治疗结果.
- 医疗信息学 医疗信息学
背景情况:
- 患者报告的结果测量 (PROM) 对于评估医疗器械性能至关重要.
- 它们在高风险医疗器械注册表中的应用,特别是用于预测目的,仍然未得到充分探索.
研究的目的:
- 进行范围审查,评估PROM在高风险医疗器械注册表中的实用性和预测能力.
- 在此背景下,确定PROM使用的当前方法和结果.
主要方法:
- 在多个数据库 (Ovid Medline,Embase,APA PsychINFO,Cochrane Library,Scopus) 中进行了全面的文献搜索.
- 选了423个标题/摘要,评估了262个全文,确定了76篇相关论文.
- 包括的注册表涵盖了骨科,心脏,阴茎和的网状设备.
主要成果:
- 主要使用PROM作为结果指标 (比较队列或时间点),而不是用于预测.
- 只有15篇论文考虑了PROMs的预测能力,使用了各种各样的分析方法.
- 很少有研究使用PROM来预测长期患者和临床结果.
结论:
- 需要在高风险设备注册表中推进PROM集成方法,以改善临床决策.
- 需要进一步调查,以了解PROMs在长期数据中用于预测分析的不足.
- 这种理解对于利用PROM数据作为监管目的的现实世界证据至关重要.
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