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

Publication ,  Journal Article
Jalbert, JJ; Ritchey, ME; Mi, X; Chen, C-Y; Hammill, BG; Curtis, LH; Setoguchi, S
Published in: Am J Epidemiol
November 1, 2014

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.

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Published In

Am J Epidemiol

DOI

EISSN

1476-6256

Publication Date

November 1, 2014

Volume

180

Issue

9

Start / End Page

949 / 958

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Safety
  • Registries
  • Prostheses and Implants
  • Pharmacoepidemiology
  • Humans
  • Government Regulation
  • Epidemiology
  • Epidemiologic Methods
 

Citation

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Jalbert, J. J., Ritchey, M. E., Mi, X., Chen, C.-Y., Hammill, B. G., Curtis, L. H., & Setoguchi, S. (2014). Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective. Am J Epidemiol, 180(9), 949–958. https://doi.org/10.1093/aje/kwu206
Jalbert, Jessica J., Mary Elizabeth Ritchey, Xiaojuan Mi, Chih-Ying Chen, Bradley G. Hammill, Lesley H. Curtis, and Soko Setoguchi. “Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.Am J Epidemiol 180, no. 9 (November 1, 2014): 949–58. https://doi.org/10.1093/aje/kwu206.
Jalbert JJ, Ritchey ME, Mi X, Chen C-Y, Hammill BG, Curtis LH, et al. Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective. Am J Epidemiol. 2014 Nov 1;180(9):949–58.
Jalbert, Jessica J., et al. “Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.Am J Epidemiol, vol. 180, no. 9, Nov. 2014, pp. 949–58. Pubmed, doi:10.1093/aje/kwu206.
Jalbert JJ, Ritchey ME, Mi X, Chen C-Y, Hammill BG, Curtis LH, Setoguchi S. Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective. Am J Epidemiol. 2014 Nov 1;180(9):949–958.
Journal cover image

Published In

Am J Epidemiol

DOI

EISSN

1476-6256

Publication Date

November 1, 2014

Volume

180

Issue

9

Start / End Page

949 / 958

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Safety
  • Registries
  • Prostheses and Implants
  • Pharmacoepidemiology
  • Humans
  • Government Regulation
  • Epidemiology
  • Epidemiologic Methods