Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.
Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.
复制标题
植入式医疗器械观察性比较有效性研究的方法学考虑：流行病学视角。
DOI：
10.1093/aje/kwu206
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发表时间：
2014
影响因子：
5
通讯作者：
Setoguchi,Soko
中科院分区：
文献类型：
--
作者：
Jalbert,JessicaJ;Ritchey,MaryElizabeth;Mi,Xiaojuan;Chen,Chih-Ying;Hammill,BradleyG;Curtis,LesleyH;Setoguchi,Soko
Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias.
