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 language | English (US) |
|---|---|
| Pages (from-to) | 949-958 |
| Number of pages | 10 |
| Journal | American journal of epidemiology |
| Volume | 180 |
| Issue number | 9 |
| DOIs | |
| State | Published - Nov 1 2014 |
Fingerprint
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
}
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 journal › Article
TY - JOUR
T1 - Methodological considerations in observational comparative effectiveness research for implantable medical devices
T2 - An epidemiologic perspective
AU - Jalbert, Jessica J.
AU - Ritchey, Mary Elizabeth
AU - Mi, Xiaojuan
AU - Chen, Chih Ying
AU - Hammill, Bradley G.
AU - Curtis, Lesley H.
AU - Setoguchi Iwata, Soko
PY - 2014/11/1
Y1 - 2014/11/1
N2 - 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.
AB - 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.
KW - United States Food and Drug Administration
KW - comparative effectiveness
KW - epidemiologic methods
KW - medical device epidemiology
KW - pharmacoepidemiology
KW - prostheses and implants
UR - http://www.scopus.com/inward/record.url?scp=84911058648&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84911058648&partnerID=8YFLogxK
U2 - https://doi.org/10.1093/aje/kwu206
DO - https://doi.org/10.1093/aje/kwu206
M3 - Article
C2 - 25255810
VL - 180
SP - 949
EP - 958
JO - American Journal of Epidemiology
JF - American Journal of Epidemiology
SN - 0002-9262
IS - 9
ER -