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近年来，真实世界研究受到了全球相关监管机构、制药工业界和学术界的共同关注。在随机对照试验难以实施的领域，比如小儿外科，真实世界研究不失为一种获得临床证据的有效方法。本文对真实世界研究的相关概念、研究设计类型、统计分析方法等方面进行了系统介绍，并探讨了真实世界研究在小儿外科的应用价值和实践方法，以期为临床相关专业人员正确认识和开展真实世界研究提供参考。“,”In recent years, real-world study has become a common concern of global regulatory agencies, pharmaceutical manufacturers and academic circles. In domains where randomized controlled trials are difficult to conduct, such as pediatric surgery, real-world study acts as an alternative of obtaining clinical evidences. This systematic review introduces basic concepts, study designs and statistical analysis methods of real-world study. Besides the application value and practical instructions of real-world study for pediatric surgery, it provides reference for pediatric surgeons to understand and conduct real-world study correctly.