基于非恒定危险的信号检测方法的最佳显著水平和样本大小
Odile Sauzet1,2,3, Julia Dyck4, Victoria Cornelius5
1Department of Business Administration and Economics, Bielefeld University, Bielefeld, Germany. odile.sauzet@uni-bielefeld.de.
Drug safety
|July 9, 2024
概括
建议使用dWSP-pPWSP测试来检测电子健康记录 (EHR) 中的不良药物反应 (ADR) 信号. 通过使用韦布尔的比例危险模型来确定最优的显著水平和样本大小,以进行可靠的ADR检测.
科学领域:
- 药物监督 药物监督 药物监督
- 生物统计学 生物统计学
- 医疗信息学 医疗信息学
背景情况:
- 在电子健康记录 (EHR) 中检测药物不良反应 (ADR) 信号的统计方法需要最佳的显著水平和样本大小,以获得足够的统计能力.
- 韦布尔的比例危险 (WSP) 测试利用来自EHR的时间到事件数据来检测ADR信号.
研究的目的:
- 为了获得最佳的显著性水平和样本大小,用于在ADR信号检测中应用WSP测试.
- 在样本大小,ADR率和事件时间等各种场景下评估WSP测试的性能.
主要方法:
- 进行了一项模拟研究,以评估不同样本大小和事件率的WSP测试性能.
- 使用接收机操作特征 (ROC) 曲线分析来确定最佳的显著性水平,用于无假设的信号检测.
- 达到80%或90%功率所需的样本大小是近似的.
主要成果:
- 组合双WSP (dWSP) 和功率WSP (pPWSP) 测试,称为dWSP-pPWSP,推具有0.004.4的显著性水平.
- 对于80%的功率,当ADR率等于背景率 (0.1) 时,需要大约60次事件.
- 检测ADR率增加20%的背景率为0.05,需要大约900个事件.
结论:
- 建议使用dWSP-pPWSP测试组合来检测ADR信号.
- 建议dWSP-pPWSP测试的显著性水平为0.004,当普遍应用于不良事件时,无论其具体率如何.
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