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解决外科手术治疗的纵向组成部分
Chelsea J Messinger1,2, Arin L Madenci3,4, Kerollos Nashat Wanis3,5
1Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA. chelsea_messinger@hms.harvard.edu.
European journal of epidemiology
|September 4, 2023
概括
手术治疗是复杂的,而不是单一的事件. 准确解释试验结果需要测量患者遵守所有手术前和术后护理组件.
科学领域:
- 心血管外科心血管外科
- 临床试验设计 临床试验设计
- 因果推理因果推理
背景情况:
- 手术治疗通常被视为研究中的点干预.
- 术后护理和患者坚持治疗显著影响结果,但经常被忽视.
- 像PARTNER 3和Evolut Low Risk这样的里程碑式试验突出了手术干预研究的复杂性.
研究的目的:
- 重新评估手术治疗作为纵向过程,而不是点干预.
- 讨论不同手术后疗法的影响和对试验解释的坚持.
- 为设计和分析手术干预试验提出改进建议.
主要方法:
- 在因果推理研究中对外科治疗策略的审查.
- 在里程碑性试验 (例如,TAVR与SAVR) 中对术后治疗变化和坚持的分析.
- 讨论如何预期治疗效果估计受到外科手术期间组件的影响.
主要成果:
- 手术干预包括关键的术前和术后阶段.
- 对术后疗法的不完全遵守可能会对治疗效果的解释产生偏见.
- 目前的试验设计可能过于简化了外科手术的性质.
结论:
- 手术治疗应该被概念化为纵向过程.
- 试验设计必须指定和测量对外科手术期间护理的遵守.
- 改善对坚持性的报告对于在手术试验中准确的因果推断至关重要.
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