随机对照试验中常见误区辨识与应对

Common Misconceptions in Randomized Controlled Trials

随机对照试验是评估不同干预措施疗效和常见不良反应的标准设计方案,但我国随机对照试验在研究设计、实施、效应指标选择、数据分析和结果解释等方面仍有提升空间。本文从随机对照试验实施的关键技术、结果展示和结果解读3方面分析了6点常见误区,期望帮助临床研究者明确随机化概念,正确实施随机分配方法和分配方案隐藏、正确理解随机对照试验中的基线平衡问题、合理选择效应指标、正确解读研究结果的统计学意义和临床意义,以生产更多高质量的随机对照试验证据,同时避免被误导。

A well-conducted randomized controlled trial( RCT) is considered the gold standard for comparing the efficacy and common adverse events of different interventions. However,for China’s RCTs,there is still room for the improvement in research design,implementation,selection of effective measures,data analysis,and interpretation of results. In this article,we present six misunderstandings or errors to help clinicians in clarifying the concept of randomization,correctly implementing the process of randomization and concealment of allocation,understanding the baseline imbalance in RCTs,reasonably selecting effective measuers,and correctly interpreting the statistical significance and clinical significance in an effort to produce more RCTs of highquality and protect clinicians from potentially misleading presentations and interpretations of research findings.