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Leveraging the entire cohort in drug safety monitoring: part 1 methods for sequential surveillance that use regression adjustment or weighting to control confounding in a multisite, rare event, distributed data setting.

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第一作者： Jennifer C,Nelson

第一单位： Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA; Department of Biostatistics, University of Washington, Seattle, WA, USA. Electronic address: Jen.Nelson@kp.org.

作者： Jennifer C,Nelson ^[1] ; Ernesto,Ulloa-Pérez ^[2] ; Jennifer F,Bobb ^[2] ; Judith C,Maro ^[3]

作者单位： Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA; Department of Biostatistics, University of Washington, Seattle, WA, USA. Electronic address: Jen.Nelson@kp.org. ^[1] Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA; Department of Biostatistics, University of Washington, Seattle, WA, USA. ^[2] Department of Population Medicine, Harvard Medical School, Boston, MA, USA; Harvard Pilgrim Health Care Institute, Boston, MA, USA. ^[3]

关键词 Active surveillance Distributed databases Drug safety Group sequential Pharmacoepidemiology Statistical methods

医学主题词药物副反应报告系统(Adverse Drug Reaction Reporting Systems);药物监测(Drug Monitoring);人类(Humans);产品监测, 售后(Product Surveillance, Postmarketing)

DOI 10.1016/j.jclinepi.2019.04.012

PMID 31108199

发布时间 2020-05-20

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准确一般字义偏差语意偏离译文作用小提交