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Updated: Jun 23, 2025

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在衰老研究中设计和分析实用试验的统计考虑

Ashuin Kammar-García1,2, Liliana Aline Fernández-Urrutia3, Jorge Alberto Guevara-Díaz4

  • 1Dirección de Investigación, Instituto Nacional de Geriatría, Mexico City 10200, Mexico.

Geriatrics (Basel, Switzerland)
|June 26, 2024
PubMed

实用性试验旨在评估干预措施在常规患者护理环境中的有效性，与在受控条件下进行的解释性试验形成对比。在老年研究领域，实用性试验是获取老年人群真实世界证据的重要设计，而老年人群在传统试验中往往代表性不足。本文综述了从频率学派角度出发，实用性试验设计与分析中的统计学考量。在选择因变量时，必须采用对常规医疗具有高度相关性且能提供足够统计效能的结局指标。除传统使用的二分类结局外，有序分类结局可在提升统计效能的同时提供更具实用性的答案。群集随机化设计需谨慎考虑样本量计算与分析方法，尤其是在处理缺失数据和结局变量时。为校正中心效应，推荐使用混合效应模型和广义估计方程（GEEs）进行分析，并已有相应工具可用于样本量估算。多组研究在样本量计算方面面临挑战，需对设计效应进行调整，并考虑多重比较校正方法。次要分析虽常见，但需谨慎对待，因其可能降低统计效能并增加假阳性发现的风险。安全性数据的收集方法应在实用性与数据质量之间取得平衡。总体而言，理解统计学考量对于设计严谨的实用性试验至关重要，此类试验旨在真实世界条件下评估针对老年人群的干预措施。总之，本综述聚焦于设计实用性临床试验时所关注的各类统计学议题，并结合老年研究领域的相关特点进行探讨。 关键词：实用性试验，老年研究，统计学设计，样本量计算，混合效应模型，广义估计方程，群集随机化，多重比较，次要分析，安全性数据

关键词:
年长的老年人年长的老年人气质科学是地球科学.实用临床试验是实用的临床试验.样本的大小 样本大小二次数据分析二次数据分析统计分析是一种统计分析.

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