Abstract:
: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.
journal_name
Am J Epidemioljournal_title
American journal of epidemiologyauthors
Jalbert JJ,Ritchey ME,Mi X,Chen CY,Hammill BG,Curtis LH,Setoguchi Sdoi
10.1093/aje/kwu206subject
Has Abstractpub_date
2014-11-01 00:00:00pages
949-58issue
9eissn
0002-9262issn
1476-6256pii
kwu206journal_volume
180pub_type
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