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

Jessica J. Jalbert, Mary Elizabeth Ritchey, Xiaojuan Mi, Chih Ying Chen, Bradley G. Hammill, Lesley H. Curtis, Soko Setoguchi Iwata

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)949-958
Number of pages10
JournalAmerican journal of epidemiology
Volume180
Issue number9
DOIs
StatePublished - Nov 1 2014

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Comparative Effectiveness Research
Equipment and Supplies
Pharmacoepidemiology
Epidemiology
Safety
Information Storage and Retrieval
Delivery of Health Care

All Science Journal Classification (ASJC) codes

  • Epidemiology

Keywords

  • United States Food and Drug Administration
  • comparative effectiveness
  • epidemiologic methods
  • medical device epidemiology
  • pharmacoepidemiology
  • prostheses and implants

Cite this

Jalbert, Jessica J. ; Ritchey, Mary Elizabeth ; Mi, Xiaojuan ; Chen, Chih Ying ; Hammill, Bradley G. ; Curtis, Lesley H. ; Setoguchi Iwata, Soko. / Methodological considerations in observational comparative effectiveness research for implantable medical devices : An epidemiologic perspective. In: American journal of epidemiology. 2014 ; Vol. 180, No. 9. pp. 949-958.
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Methodological considerations in observational comparative effectiveness research for implantable medical devices : An epidemiologic perspective. / Jalbert, Jessica J.; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih Ying; Hammill, Bradley G.; Curtis, Lesley H.; Setoguchi Iwata, Soko.

In: American journal of epidemiology, Vol. 180, No. 9, 01.11.2014, p. 949-958.

Research output: Contribution to journalArticle

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