从现实世界证据概念的认识论陷到现实世界的证据概念
Leonardo Y Kasputis Zanini1, Diego Adão1, Gabriela C L Martins1
1Department of Surgery. Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp), São Paulo - SP, Brazil.
Journal of clinical epidemiology
|February 3, 2026
概括
术语"现实世界"证据 (RWE) 创造了客观性的错觉,因为所有数据收集都涉及研究人员的干预和偏见. 研究人员应该使用精确的研究标签,而不是模糊的"现实世界"术语,以提高科学透明度.
科学领域:
- 科学研究的认识论.
- 卫生科学中的方法论.
- 科学哲学的科学哲学.
背景情况:
- 术语"现实世界"证据 (RWE) 越来越多地用于随机对照试验 (RCT) 外的数据.
- RWE缺乏标准化的定义和坚实的认识论基础.
- 当前的术语意味着RWE比受控实验更好地捕捉客观真理,从而破坏了透明度.
研究的目的:
- 批判性地分析"现实世界"证据的认识论基础.
- 探索科学数据收集中的"现实的幻觉".
- 倡导透明的科学术语.
主要方法:
- 基于批判性认识论分析的评论.
- 检查RWE的哲学基础.
- 分析数据收集作为一个积极的,干预性的过程.
主要成果:
- RWE收集是一种积极的干预,而不是一个中立的过程,引入结构偏差.
- 无论是RCT还是观察性研究,由于观察者效应,都无法获得绝对真理.
- 追求"真实"的证据导致了情境构造,而不是客观真理.
结论:
- "现实世界"的标签是一种修辞构造,掩盖了研究设计,并创造了客观性的错觉.
- 所有的科学研究都受到方法的限制; "现实世界"的说法是错误的.
- 放弃RWE术语,以准确的研究标签和披露数据限制来促进透明度.
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