在医疗保险的覆盖范围内考虑和要求的研究的特征与证据开发计划
Maryam Mooghali1,2, Osman Moneer3, Guneet Janda4
1Department of Internal Medicine, Yale New Haven Hospital, New Haven, CT, USA.
Clinical trials (London, England)
|February 8, 2025
概括
医疗保险的"覆盖与证据开发计划"产生了更高质量的临床研究. 与初始的国家覆盖率确定研究相比,这些研究具有更多的随机化,更大的患者群体和对临床结果的关注.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床试验设计 临床试验设计
- 卫生政策分析 卫生政策分析
背景情况:
- 医疗保险和医疗补助服务中心于2005年建立了证据开发覆盖范围 (CED),以评估证据有限的项目和服务.
- 医学发展中心要求参与经批准的临床研究,以确定服务是否符合要求.
研究的目的:
- 将CED批准的研究的证据质量与用于初始国家覆盖率确定 (NCD) 的研究进行比较.
主要方法:
- 确定CED所涵盖的项目/服务及其相关研究.
- 在PubMed和谷歌学者中搜索了CED批准的研究的主要终点结果.
- 审查了NCD决策备忘录,以确定用于初始覆盖决策的原始研究研究.
- 描述和比较CED批准的研究和NCD研究.
主要成果:
- 目前,CED已支持26项项目/服务,其中包括196项非传染性疾病研究和116项CED批准的研究 (2005-2023年).
- 与NCD研究相比,CED批准的临床试验更有可能随机化 (93.2%与52.5%相比),专注于临床结果 (87.9%与65.8%相比),并招募医疗保险受益者 (25.9%与3.1%相比).
- 经CED批准的研究中患者人数较多 (中位数为302人,相比100人).
- 在CED批准的研究中,有一半还没有公开报告初级终点结果.
结论:
- 与那些告知初始覆盖决策的临床研究相比,CED计划成功地促进了更强大的临床研究的产生.
- 虽然CED提高了研究设计,但仍有机会改善研究结果的传播.
- 建议进一步加强研究设计,并在CED框架下及时报告结果.
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