在儿科随机对照试验中利用真实世界证据
本文是关于常规收集数据（RCD）研究系列的社论部分，探讨如何利用真实世界证据改进儿科随机对照试验（RCT）的设计、实施和适用性。文章指出儿科RCT面临招募困难和伦理复杂性等挑战，而来自电子健康记录、医院管理数据和药房记录的常规收集数据可为解决这些问题提供新途径。
要点
- 儿科随机对照试验面临受试者招募困难和伦理复杂性等特殊挑战
- 真实世界证据可通过常规收集数据改进儿科RCT的设计与实施
- 常规收集数据包括电子健康记录、医院管理数据和药房记录
核心结论
- 真实世界证据可改善儿科随机对照试验在全球不同医疗环境中的设计、实施和适用性
研究设计与样本
- 本文为关于常规收集数据研究系列的社论部分
- 系列其他文章将探讨真实世界证据在观察性研究中的应用及特定分析方法
主要发现
- 儿科随机对照试验的开展受到招募挑战和伦理复杂性等因素影响
- 常规收集数据在研究中的应用日益受到关注
临床怎么用
- 可利用电子健康记录、医院管理数据和药房记录等常规收集数据开展儿科研究
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
Randomised controlled trials (RCTs) provide the highest level of evidence by rigorously evaluating treatments to ensure clinical decisions are grounded in robust data that improve patient outcomes. However, in paediatrics, certain factors can make their conduct more difficult, including recruitment challenges and ethical complexities. There is growing interest in using real-world evidence through routinely collected data (RCD) to improve the design, delivery and applicability of paediatric RCTs across diverse healthcare settings worldwide. This editorial is part of a series on RCD-enabled studies and their analysis. Other articles will explore the use of real-world evidence in observational research and examine specific analytical methods, including interrupted time series and difference in differences. Opportunities for using RCD in paediatric research RCD refers to data collected during the delivery of routine healthcare, recorded in electronic health records (EHRs), hospital administrative data and pharmacy records. Though its use in research varies, RCD holds...
引用
- Archives of Disease in Childhood：Harnessing real-world evidence in paediatric randomised controlled trials
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。