Abstract: As the "gold standard" of medical research evidence, randomized controlled trials (RCTs) can significantly enhance the external validity and practical transformability of medical evidence when conducted in primary care community settings. However, the design and implementation of community-based RCTs in the fields of primary care and general practice often face practical constraints, methodological limitations, and insufficient resources. This article aims to introduce and discuss the core design principles, implementation strategies, and key procedures of community RCTs, as well as their precautions and limitations. By integrating domestic and international case studies, the authors analyze the technical details and essential requirements of these trials, providing a valuable reference for conducting robust randomized controlled research in primary care and general practice.

Key words: Randomized controlled trial, Research design, Primary health care, General practice, Case analysis

摘要： 随机对照试验（RCTs）作为目前高质量医学研究的重要方法，在基层社区情景下规范开展，能显著助力医学证据的产生、验证、指南优化、临床实践转化和推广应用。然而，在基本医疗和全科医学领域设计和实施社区RCTs时，常面临诸多条件限制、方法学局限及资源不足等挑战。本文梳理并探讨基层社区背景下RCTs的设计要点、实施方法、关键步骤，以及注意事项和局限性；结合国内外相关研究案例与实施过程，剖析设计细节和优点，为基层医疗和全科医学研究者科学开展RCTs提供有益参考。

关键词: 随机对照试验, 研究设计, 初级卫生保健, 全科医学, 案例解析