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Spontaneous adverse event signaling methods: classification and use with health care treatment products.
Epidemiologic Reviews ( IF 5.5 ) Pub Date : 2002-08-24 , DOI: 10.1093/oxfordjournals.epirev.a000802
J A Clark 1 , S L Klincewicz , P E Stang
Affiliation  

AE signal detection and its techniques are part of the continuum of public health surveillance, borrowing from both its theory and application (171). Like public health surveillance networks, whose major goals are to identify early signs of new outbreaks, pinpoint new organisms, and monitor designated illnesses, AE signaling and surveillance systems attempt to provide early warnings of previously unsuspected product-AE pairs, hypothesize potential drug-event relations, identify populations "at risk," and facilitate case ascertainment and definition. In both examples, definitive research is often subsequently undertaken to quantify the strength of relations that may be proposed. As with any public health surveillance effort, AE surveillance provides an infrastructure for the ongoing collection of health data and its direct integration into the health regulatory policy (172), including its keystone role in risk assessment and management. However, unlike many surveillance systems, postmarketing AE systems collect case information that is often relatively incomplete and imperfect, estimate exposure based on surrogate values (e.g., sales data), and are used by both governmental and the private sector for preventive planning. These factors make AE signaling and surveillance more ambiguous, regulatory oriented, and complex than its disease counterparts (173). Despite such issues, AE signaling methods continue to evolve in extent, complexity, and acceptance (4, 131, 174). Undoubtedly, this is largely due to the widespread practical experience that has been gained with spontaneous reporting systems over the past 4 decades and the cumulative usefulness that has been demonstrated.

中文翻译:

自发的不良事件信号传递方法:分类和与保健治疗产品一起使用。

AE信号检测及其技术是公共卫生监测连续性的一部分,借鉴了其理论和应用(171)。像公共卫生监视网络一样,其主要目标是识别新的暴发的早期迹象,查明新的生物并监视指定的疾病,而AE信号和监视系统则试图对先前未曾怀疑的产品AE对提供预警,并假设潜在的毒品事件关系,确定处于“危险中”的人群,并促进案例的确定和定义。在这两个例子中,通常随后进行确定性研究以量化可能提出的关系的强度。与任何公共卫生监视工作一样,AE监视为持续收集健康数据并将其直接整合到健康监管政策中提供了基础设施(172),包括其在风险评估和管理中的关键作用。但是,与许多监视系统不同,售后AE系统收集的案例信息通常相对不完整且不完善,根据替代值(例如,销售数据)估算暴露程度,并被政府和私营部门用于预防性计划。这些因素使AE信号和监测比其疾病对应物更加含混,面向监管和复杂(173)。尽管存在此类问题,但AE信号方法在范围,复杂性和接受性方面仍在不断发展(4、131、174)。无疑,
更新日期:2019-11-01
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