当现代试验是务实和解释性的时,它们最有用 - - 没有连续性
Perrine Janiaud1, Lars G Hemkens2
1Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland; Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Journal of clinical epidemiology
|October 13, 2024
概括
实用和解释性临床试验的概念不再是连续性的极端. 新型数字健康技术使实用和解释性试验问题的平行评估成为可能,从而导致更具信息性的试验设计.
科学领域:
- 临床试验设计 临床试验设计
- 生物医学研究生物医学研究
- 医疗卫生技术 技术 技术
背景情况:
- 50多年前,Schwartz和Lellouch引入的"务实"和"解释性"试验术语代表了试验设计的不同方法.
- 传统上,实用试验为临床实践决策提供了信息,而解释性试验则阐明了干预机制,通常被视为连续的对立端.
- 医疗保健和研究领域的数字化正在重塑临床试验方法.
研究的目的:
- 根据现代技术进步,挑战实用和解释性试验设计之间的连续性概念.
- 为理解实用和解释性试验维度提出一个新的概念框架.
- 突出新技术如何促进设计更具信息性的临床试验.
主要方法:
- 分析试验设计的传统连续概念的局限性.
- 审查影响试验设计实用主义和解释主义的关键特征.
- 引入一个新的概念框架,将解释性设计特征视为基本特征,并评估其侵入性和充分性.
主要成果:
- 医疗保健和临床研究的数字化为试验设计开辟了新的途径,使传统的连续概念变得过时.
- 常规收集的真实世界数据,分散的试验技术和数字生物标志物允许在对护理的最小干扰下观察结果.
- 这些进步使得在同一个试验中可以同时解决务实和解释性问题.
结论:
- 实用主义和解释主义应该被视为不同的但兼容的维度,而不是连续性的终点.
- 试验设计的多维方法,结合新技术,可以产生更有信息的研究.
- 这种范式转变通过优化试验信息性,促进了更好的临床和监管决策.
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