心脏外科随机试验设计,实施和分析的方法标准:美国心脏协会的科学声明
Circulation
|December 6, 2021
概括
在心脏手术中进行随机对照试验需要谨慎的计划. 本声明审查了标准,并提供了有效设计,实施和分析这些复杂的临床试验的建议.
科学领域:
- 心脏病学
- 临床试验方法
- 外科研究
背景情况:
- 心脏手术中的随机对照试验 (RCT) 面临着独特的方法障碍.
- 有效的试验设计和实施对于该领域的可靠证据产生至关重要.
研究的目的:
- 审查心脏手术RCT设计和实施的关键标准.
- 为进行和解释心脏手术试验提供建议.
主要方法:
- 对临床试验方法的现有标准和最佳实践的审查.
- 根据心脏手术试验中发现的挑战制定建议.
主要成果:
- 关键考虑因素包括研究问题的适用性,临床平衡,患者队列代表性和实践变化.
- 建议强调预先定义的干预/终点,适当的干预交付,高度的后续完整性和量身定制的分析技术.
结论:
- 解决方法上的挑战对于心脏手术试验的成功至关重要.
- 坚持推的做法将提高试验结果的质量和解释性.
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