实用证据和随机试验的性质
Perrine Janiaud1, Lars G Hemkens2
1Department of Clinical Research, University of Bern, Bern, Switzerland; Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland.
实用性试验常常被误解,主要关注表面特征,而不是其核心目的. 本文阐明实用试验的本质及其与随机试验的联系,以改善证据的解释.
科学领域:
- 临床试验方法
- 基于证据的医学
- 科学哲学
背景情况:
- 实用试验正在获得认可,但经常被误解.
- 表面的特征,如"现实世界"的设置被误认为是定义特征.
- 错误的观念可能会使人忽视实用主义的本质.
研究的目的:
- 澄清临床研究中的实用方法的关键要素.
- 重新强调实用试验与随机试验的原始性质之间的关系.
- 将教学,研究和证据解释重新聚焦在实用证据的本质上.
主要方法:
- 审查实用主义的哲学起源及其医学应用.
- 重温随机试验的基本性质.
- 区分评估治疗决策和理解它们的机制.
主要成果:
- 目前对医学随机试验的看法已经失去了实用性的重点.
- 解释性设计特征,如遮蔽和粘附控制,往往被误解为定义特征.
- 发现了常见的实用试验误解.
结论:
- 实用试验不是通过表面特征来定义,而是通过其核心方法来定义.
- 需要回到实用证据和随机试验的本质.
- 了解关键特征对于产生医疗实践中有用的实用证据至关重要.
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