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Comments and Concerns on the LASER Trial
JAMA Surgery ( IF 15.7 ) Pub Date : 2021-10-01 , DOI: 10.1001/jamasurg.2021.2250
Sergio A Acuna 1 , Fahima Dossa 1 , Tyler R Chesney 1, 2
Affiliation  

To the Editor In clinical trial design, the minimal clinically important difference (MCID) is used in sample size calculations to ensure enough statistical power to detect the smallest difference needed to justify changing patient treatment. Unfortunately, because these calculations are based on probabilities of hypothetical findings, clinical trials can produce statistically significant results for differences smaller than those considered clinically important. To avoid implementing changes based on statistical differences that are not clinically meaningful, it is important to consider if the MCID falls within the 95% CI of the effect estimate.1



中文翻译:

对 LASER 试验的评论和关注

致编辑在临床试验设计中,最小临床重要差异 (MCID) 用于样本量计算,以确保有足够的统计能力来检测证明改变患者治疗所需的最小差异。不幸的是,因为这些计算是基于假设发现的概率,所以临床试验可以产生具有统计学意义的结果,其差异小于那些被认为具有临床重要性的差异。为避免基于无临床意义的统计差异实施更改,重要的是要考虑 MCID 是否在效果估计的 95% CI 范围内。1

更新日期:2021-10-13
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