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关于对良性前列腺增生症手术治疗的随机对照试验中的功率估计和样本大小计算的系统审查

Daniel Akintelure¹, Regina U Agada², Simon Akintelure³

¹Urology, Royal Gwent Hospital, Newport, GBR.

|December 16, 2025

概括

随着时间的推移,良性前列腺增生 (BPH) 手术试验中的样本大小计算和功率报告得到了改进,特别是在最小侵入性技术中. 然而,近一半的试验仍然缺乏这些关键细节,影响了结果的可靠性.

科学领域:

泌尿器科泌尿器科泌尿器科泌尿器科
临床试验方法论临床试验方法论
手术研究的研究.

背景情况:

随机对照试验 (RCT) 对于评估良性前列腺增生症 (BPH) 手术干预至关重要.
随机试验结果的有效性在很大程度上取决于适当的样本大小确定和功率估计.
对这些参数的不充分报告可能会损害试验结果的解释性.

研究的目的:

系统地审查BPH手术RCT中样本大小计算 (SSC) 和功率报告的流行率,方法严谨性和时间趋势.
评估干预类型对SSC和功率报告实践的影响.

主要方法:

在PubMed和Cochrane CENTRAL系统搜索关于BPH手术治疗的RCT.
数据提取包括SSC和功率估计,α水平,功率值,出版年和干预类型的报告.
根据干预类别进行子组分析和使用Pearson的千平方测试进行统计测试.

主要成果:

包括56个RCT;53.6%报告SSC和功率估计,而46.4%没有.
随着时间的推移,SSC的报告得到了改善,从33.3% (1991-2000年) 提高到64.0% (2011-2020年).
研究新型最小侵入性外科治疗 (nMIST) 的试验显示,与非MIST试验 (31.3%) 相比,SSC报告显著增加 (62.5%).

结论:

在三十年的BPH手术RCT中,SSC和功率报告的逐渐但有意义的改进显而易见.
近一半的发表试验仍然遗漏了关键的方法细节,引发了人们对结论可靠性的担忧.
加强对报告标准的遵守,更严格的编辑政策和研究人员培训对于透明和可重复的证据是必要的.

关键词:

良性前列腺增生症 (BPH)测试功率测试功率测试功率测试随机的临床试验随机的临床试验统计学统计学统计学统计学泌尿外科手术泌尿外科手术

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