Early adverse drug event signal detection within population-based health networks using sequential methods: key methodologic considerations
Early adverse drug event signal detection within population-based health networks using sequential methods: key methodologic considerations
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DOI：
10.1002/pds.1706
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发表时间：
2009-03-01
影响因子：
2.6
通讯作者：
Platt, Richard
中科院分区：
文献类型：
--
作者：
Brown, Jeffrey S.;Kulldorff, Martin;Platt, Richard
目的对基于人群的卫生网络进行主动监测，可以提高不良事件（AE）检测的及时性。我们的目标是扩大我们以前的信号检测工作，通过调查信号检测的替代study specification.Methods的效果，我们比较了各种研究规格下的信号检测性能，使用历史数据从九个健康计划参与HMO研究网络的中心，教育和治疗研究（CERT）。分析了5对代表普遍接受的与AE相关的药物-事件对和2对代表“阴性对照”的药物-事件对。与事件用户和事件AE的定义相关的替代研究规范进行了评估，并与我们以前的研究结果进行了比较。结果放宽事件AE排除标准，（1）包括先前门诊诊断感兴趣的成员，（2）减半（至90天）确定事件暴露和诊断的时间窗口增加了受监视的成员数量，暴露天数和诊断数减少约10- 20%。替代规格往往会导致早期的信号检测10-16个月，更多的暴露和事件进入analysis.Conclusions的可能后果本文提供了额外的初步信息进行前瞻性的安全监测，使用健康计划数据和顺序分析方法。我们的研究结果支持继续调查使用健康计划数据和序贯分析方法作为一个潜在的重要贡献，积极的药物安全性监测。版权所有（C）2009约翰威利父子有限公司
Purpose Active surveillance of population-based health networks may improve the timeliness of detection of adverse events (AEs). Our objective was to expand our previous signal detection work by investigating the effect on signal detection of alternative study specifications.Methods We compared the signal detection performance under various study specifications using historical data from nine health plans involved in the HMO Research Network's Center for Education and Research on Therapeutics (CERT). Five drug-event pairs representing generally accepted associations with an AE and two pairs representing "negative controls" were analyzed. Alternative study specifications related to the definition of incident users and incident AEs were assessed and compared to our previous findings.Results Relaxing the incident AE exclusion criteria by (1) including members with prior outpatient diagnoses of interest and (2) halving (to 90 days) the time window specified to define incident exposure and diagnoses increased the number of members under surveillance and as a consequence increased the number of exposed days and diagnoses by about 10-20%. The alternative specifications tend to result in earlier signal detection by 10-16 months, a likely consequence of more exposures and events entering the analysis.Conclusions This paper provides additional preliminary information related to conducting prospective safety monitoring using health plan data and sequential analytic methods. Our findings support continued investigation of using health plan data and sequential analytic methods as a potentially important contribution to active drug safety surveillance. Copyright (C) 2009 John Wiley & Sons, Ltd.