严重不良事件:在加拿大临床环境中对纳拉乔因果关系评估工具的可复制性和验证性研究
Pallavi Pradhan1,2, Sonia Corbin2,3, Shweta Todkar2,3
1Departement of Anatomy, University of Quebec at Trois-Rivieres, Trois-Rivieres, Quebec, Canada.
Journal of evaluation in clinical practice
|April 25, 2025
概括
纳兰乔工具在临床环境中对严重不良事件 (SAE) 的评估表现出良好的可靠性和有效性. 这种系统方法确保了一致的因果关系评估,提高了医疗保健中的患者安全.
科学领域:
- 临床药理学 临床药理学
- 患者安全研究 患者安全研究
- 健康结果的健康结果.
背景情况:
- 严重不良事件 (SAE) 影响5%-10%的住院患者,引发了严重的患者安全问题.
- 对SAE的因果关系评估至关重要,但医疗保健专业人员 (HCP) 判断与标准化工具的可复制性仍然不清楚.
研究的目的:
- 在使用Naranjo工具时评估SAE因果关系评估的可复制性.
- 在加拿大临床环境中验证Naranjo工具的性能.
主要方法:
- 在北克的一家医院对SAE患者进行试点回顾性队列研究 (2021年).
- 两个审查员使用Naranjo工具对12个随机选择的SAE进行独立因果关系评估.
- 评价者之间的可靠性和标准有效性的评估,包括敏感性和特异性计算.
主要成果:
- 观察到高的评审者之间的可靠性 (加权卡帕=0.92) 和评审者之间的良好一致性 (卡帕=0.84).
- 纳兰乔工具显示了与专家意见的显著正相关性 (rs=0.208,p<0.001).
- 二元分类产生了高灵敏度 (1.00) 和中等特异性 (0.31).
结论:
- 纳兰乔工具是可靠的和有效的临床使用在评估SAE因果关系.
- 该工具成功地分类了涉及SAE发生的药物产品.
- 建议进一步实时进行大规模研究,以确认性能和实用性.
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