Ethics and sample size
Ethics and sample size
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DOI：
10.1093/aje/kwi014
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发表时间：
2005-01-15
影响因子：
5
通讯作者：
McCulloch, CE
中科院分区：
文献类型：
--
作者：
Bacchetti, P;Wolf, LE;McCulloch, CE
人们普遍认为，如果研究的样本量不够大，无法确保足够的功效，那么研究就是不道德的。作者研究了样本量如何影响决定研究伦理可接受性的平衡：参与者接受的负担与研究预期产生的临床或科学价值之间的平衡。随着样本量的增加，每名参与者的平均预计负担保持不变，但如果假设其与功效成正比或与置信区间宽度成反比，则预计研究值不会像样本量那样迅速增加。这意味着每个参与者的价值随着样本量的增加而下降，因此较小的研究具有更有利的预测价值与参与者负担的比率。因此，研究受试者的伦理治疗不需要考虑研究把握度是否低于80%或90%的传统目标。低功率并不意味着研究不道德。该分析仅涉及伦理可接受性，而不是最优性;大型研究可能出于伦理原因以外的原因而需要。
The belief is widespread that studies are unethical if their sample size is not large enough to ensure adequate power. The authors examine how sample size influences the balance that determines the ethical acceptability of a study: the balance between the burdens that participants accept and the clinical or scientific value that a study can be expected to produce. The average projected burden per participant remains constant as the sample size increases, but the projected study value does not increase as rapidly as the sample size if it is assumed to be proportional to power or inversely proportional to confidence interval width. This implies that the value per participant declines as the sample size increases and that smaller studies therefore have more favorable ratios of projected value to participant burden. The ethical treatment of study participants therefore does not require consideration of whether study power is less than the conventional goal of 80% or 90%. Lower power does not make a study unethical. The analysis addresses only ethical acceptability, not optimality; large studies may be desirable for other than ethical reasons.