基于设备的高血压治疗的临床试验设计原则和结果定义:高血压学术研究联盟的一份共识文件
David E Kandzari1, Felix Mahfoud1,2, Michael A Weber3
1Piedmont Heart Institute, Atlanta, GA (D.E.K.).
Circulation
|March 14, 2022
概括
基于设备的疗法提供了新的高血压治疗方法. 标准化临床试验设计和定义对于比较结果和推动这些创新方法的研究至关重要.
科学领域:
- 心血管医学
- 高血压研究
- 医疗设备开发
背景情况:
- 血压失控和不服药的高发病率需要新的高血压治疗方法.
- 基于设备的疗法正在扩大,需要标准化的临床试验方法.
- 现有的试验设计缺乏一致性,阻碍了可比性和数据汇总.
研究的目的:
- 建立基于设备的高血压治疗的临床试验设计和结果定义的共识原则.
- 应对高血压治疗新技术的挑战.
- 促进世界主要死亡和残疾原因的研究的一致性.
主要方法:
- 综合高血压学术研究联盟 (HARC) 的不断发展的证据和专家共识.
- 包括临床试验设计和方法的监管观点.
- 为研究设计和结果定义制定实用共识原则.
主要成果:
- 建议使用标准化的血压评估方法.
- 不仅仅是血压的有效性指标.
- 在临床研究中定义安全结果的指导方针.
结论:
- 在基于设备的高血压研究中,标准化对于试验可比性和数据可聚性至关重要.
- 该文件为评估新兴高血压技术提供了框架.
- 通过这些原则将促进高血压的有效治疗方法的开发.
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