Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Jalbert, JJ; Ritchey, ME; Mi, X; Chen, C-Y; Hammill, BG; Curtis, LH; Setoguchi, S

Published Date

  • November 1, 2014

Published In

Volume / Issue

  • 180 / 9

Start / End Page

  • 949 - 958

PubMed ID

  • 25255810

Pubmed Central ID

  • 25255810

Electronic International Standard Serial Number (EISSN)

  • 1476-6256

Digital Object Identifier (DOI)

  • 10.1093/aje/kwu206

Language

  • eng

Conference Location

  • United States