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Not Just Another Reporting Guideline? Here's Why READUS-PV is a Major Step Forward.

作者信息

Loke Yoon K

机构信息

Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.

出版信息

Drug Saf. 2024 Jun;47(6):571-573. doi: 10.1007/s40264-024-01441-5. Epub 2024 May 8.

DOI:10.1007/s40264-024-01441-5
PMID:38720115
Abstract
摘要

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Not Just Another Reporting Guideline? Here's Why READUS-PV is a Major Step Forward.不仅仅是另一个报告指南?这就是为什么READUS-PV是向前迈出的重要一步。
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The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration.《使用药物警戒中的个体病例安全报告进行药物安全性信号检测的不适当性分析报告(READUS-PV):解释与说明》。
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Pregnancy related adverse events and congenital disorders associated with fluoroquinolones: A real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS).与氟喹诺酮类药物相关的妊娠不良事件和先天性疾病:对美国食品药品监督管理局不良事件报告系统(FAERS)的一项真实世界药物警戒研究。
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本文引用的文献

1
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration.《使用药物警戒中的个体病例安全报告进行药物安全性信号检测的不适当性分析报告(READUS-PV):解释与说明》。
Drug Saf. 2024 Jun;47(6):585-599. doi: 10.1007/s40264-024-01423-7. Epub 2024 May 7.
2
New Adverse Drug Reaction Signals from 2017 to 2021-Genuine Alerts or False Alarms?2017年至2021年新的药品不良反应信号——真实警报还是虚惊一场?
Pharmacy (Basel). 2024 Feb 10;12(1):33. doi: 10.3390/pharmacy12010033.
3
Pharmacovigilance studies without a priori hypothesis: systematic review highlights inappropriate multiple testing correction procedures.
无先验假设的药物警戒研究:系统评价凸显不适当的多重检验校正程序
J Clin Epidemiol. 2023 Oct;162:127-134. doi: 10.1016/j.jclinepi.2023.08.010. Epub 2023 Aug 31.
4
A meta-epidemiological study found lack of transparency and poor reporting of disproportionality analyses for signal detection in pharmacovigilance databases.一项荟萃流行病学研究发现,药物警戒数据库中信号检测的不均衡分析缺乏透明度和报告质量较差。
J Clin Epidemiol. 2021 Nov;139:191-198. doi: 10.1016/j.jclinepi.2021.07.014. Epub 2021 Jul 27.
5
High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study.在使用不成比例分析来检测安全信号的药物警戒研究中发现自旋的高患病率:一项元流行病学研究。
J Clin Epidemiol. 2021 Oct;138:73-79. doi: 10.1016/j.jclinepi.2021.06.022. Epub 2021 Jun 26.
6
When to publish measures of disproportionality derived from spontaneous reporting databases?何时公布源自自发报告数据库的不成比例性衡量指标?
Br J Clin Pharmacol. 2011 Dec;72(6):909-11. doi: 10.1111/j.1365-2125.2011.04087.x.
7
Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports.使用比例报告比(PRR)从自发药物不良反应报告中生成信号。
Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):483-6. doi: 10.1002/pds.677.