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年龄对以吗啡消耗量为终点的急性疼痛试验中样本量计算的影响。

The influence of age on sample size calculation in acute pain trials using morphine consumption as an end point.

机构信息

Rural Clinical School, University of Tasmania, Burnie, Tasmania, Australia.

出版信息

Anesth Analg. 2010 Apr 1;110(4):1186-90. doi: 10.1213/ANE.0b013e3181d2a8e0. Epub 2010 Feb 8.

Abstract

BACKGROUND

Many trials in acute postoperative pain use morphine consumption as an end point. Age has been shown to have a significant influence on morphine consumption but is rarely considered in end point analysis.

METHODS

Simulation was used to investigate the effect of age on the power of various sample sizes to detect differences in morphine consumption in control and study groups.

RESULTS

The sample sizes required for 80% power were approximately twice that predicted by a sample size program when comparing morphine consumption using a t test without adjustment for age.

CONCLUSIONS

The model suggests that variations in age have a profound effect on sample size. Researchers may need to account for this to prevent both type 1 and type 2 error.

摘要

背景

许多急性术后疼痛的试验都以吗啡消耗量作为终点。研究表明,年龄对吗啡消耗量有显著影响,但在终点分析中很少考虑到这一点。

方法

模拟研究了年龄对不同样本量检测对照组和研究组吗啡消耗量差异的影响。

结果

与不调整年龄的 t 检验相比,比较吗啡消耗量时,80%功效所需的样本量大约是样本量程序预测值的两倍。

结论

该模型表明,年龄的变化对样本量有深远的影响。研究人员可能需要对此加以考虑,以防止 I 类和 II 类错误。

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