统计问题第4问-CSDN博客

文章讨论了影响临床试验样本量计算的四个关键因素：功效、显著性水平、期望检测的效应大小以及主要结局的变异。样本量越大，功效越高；显著性水平越小，所需样本量越大；可检测的小效应需要更大的样本量；变异大则需要更大的样本来抵消噪音。设计严格的入选标准可以减小样本量但可能降低一般化能力。

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第4个问题

Which of the following will affect the sample size calculation for a clinical trial? (There may be more than one correct statement.)

a) Power

b) Significance level

c) Size of effect to detect

d) Variability of primary outcome

Answer：

These are the four pieces of information required for a sample size calculation.

Larger sample sizes will result in increased power.

Formal“significance” may be set at any α value. The smaller the α value chosen as indicating significance the larger will be the required sample size.

Large clinical differences are easier to detect that small ones. The smaller the clinical effect that it is desired to detect, the larger will be the required sample size.

If the outcome measure is highly variable this will act like “noise,” making it difficult to detect the “signal” of the clinical effect. Variability in a continuous measure may be assessed by the standard deviation. The larger this is, the larger will be the required sample size to detect a certain clinical effect. Trials are sometimes designed to reduce variability by using strict inclusion criteria to ensure that people in the trial are more similar (for example, similar stage of illness, similar age, similar ethnicity). This will reduce the required sample size at the expense of reducing wider generalisability.

the answer is a、b、c、d

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