现实世界研究:它们是什么,不是什么
1Dept. of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India.
Indian journal of psychological medicine
|September 29, 2023
概括
在临床研究中严格的患者选择增强了内部有效性,但限制了概括性. 现实世界的研究旨在提高外部有效性,但患者和设置可变性仍然是挑战.
科学领域:
- 临床研究方法论 临床研究方法论
- 医疗保健服务研究 医疗服务研究
- 流行病学 流行病学
背景情况:
- 临床研究依赖于严格的患者选择标准,以确保内部有效性和安全性.
- 这种严格的选择过程往往导致患者群体和治疗环境与典型的临床实践有很大不同.
- 因此,传统临床研究结果的概括性或外部有效性往往是有限的.
研究的目的:
- 批判性地评估"现实研究"的概念和实用性,以提高临床研究的外部有效性.
- 检查传统研究和现实研究中概括发现的固有局限性.
- 区分传统的研究措施和真实的现实世界评估.
主要方法:
- 研究设计原则的概念分析,专注于内部与外部有效性.
- 传统研究中的患者选择标准和治疗环境与现实研究的比较.
- 讨论"现实世界患者"和"现实世界环境"的性质及其对概括性的影响.
主要成果:
- 传统研究通过控制变量来增强内部有效性,但由于患者样本和设置非代表性,因此损害了外部有效性.
- "现实世界研究"试图通过包括不那么受限制的患者群体和各种设置来提高外部有效性.
- 然而",现实世界患者"和"现实世界环境"之间的显著异质性仍然限制了研究结果的概括性.
结论:
- 现实世界研究的感知魅力是一种幻觉,因为研究结果仍然局限于研究的特定人群和环境.
- 在研究中使用的措施,如神经心理测试,可能不反映现实世界的功能,与日常生活或生活质量的措施不同.
- 提高临床研究的外部有效性需要仔细考虑患者群体,治疗设置和结果措施.
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