在禾中找到针头:优先级临床实用性评分 (CUSP),用于识别具有最高临床实用性的自发报告的自动化方法
Vijay Kara1, Greg Powell2, Olivia Mahaux3
1GSK, 980 Great West Road, London, TW8 9GS, UK. vijay.x.kara@gsk.com.
Drug safety
|August 3, 2023
概括
一个自动化的临床实用性优先级评分 (CUSP) 系统有助于药监专家有效审查大量个体病例安全报告 (ICSR). 该工具优先考虑关键的安全数据,提高药监督评估的速度.
科学领域:
- 药监和药物安全 药监和药物安全
- 医疗信息学 医疗信息学
- 临床数据分析 临床数据分析
背景情况:
- 对不良事件的自发报告激增,这给药监督专家的手册审查带来了挑战.
- 越来越多的个体病例安全报告 (ICSR) 需要有效的优先级方法来进行临床评估.
- 现有的工具专注于ICSR的完整性和监管实用性,但缺乏用于优先级的自动临床实用性评分.
研究的目的:
- 开发和验证一种自动化的方法,即临床实用性优先级评分 (CUSP),用于优先考虑安全数据的临床评估.
- 在处理大量报告时,提高药物监督中病例系列审查的速度.
- 为药监专家提供一个工具,以便更好地管理和评估安全数据.
主要方法:
- CUSP的方法是作为一个自动化评分系统而开发的.
- 该CUSP系统在与已知导致标签更改的五种药物事件对相关的ICSR参考数据集上进行了测试.
- 在具有不同特征的药物事件对中评估了CUSP的性能.
主要成果:
- 在CUSP系统中,区分了"关键案例"和"低效用案例",其中"关键案例"通常获得更高的分数 (平均分数为19.7比17.3).
- 对"关键案例"的CUSP分数的分布与所有案例相比偏向于更高的值.
- 对于确定"关键病例"的CUSP的预测能力在不同的药物事件对中有所不同,在某些对中显示出更高的准确性.
结论:
- 开发的CUSP系统代表了一种新的自动化方法来评分ICSRs的临床实用性.
- 这种自动化评分系统可以有效地支持ICSR在药物监测中的临床审查的优先级.
- CUSP提供了一种对手册审查的补充方法,提高了营销后监测的效率.
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