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Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.
Am J Epidemiol. 2014 Nov 01; 180(9):949-58.AJ

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.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

25255810

Citation

Jalbert, Jessica J., et al. "Methodological Considerations in Observational Comparative Effectiveness Research for Implantable Medical Devices: an Epidemiologic Perspective." American Journal of Epidemiology, vol. 180, no. 9, 2014, pp. 949-58.
Jalbert JJ, Ritchey ME, Mi X, et al. Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective. Am J Epidemiol. 2014;180(9):949-58.
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. American Journal of Epidemiology, 180(9), 949-58. https://doi.org/10.1093/aje/kwu206
Jalbert JJ, 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. PubMed PMID: 25255810.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Methodological considerations in observational comparative effectiveness research for implantable medical devices: 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,Soko, Y1 - 2014/09/25/ PY - 2014/9/27/entrez PY - 2014/9/27/pubmed PY - 2014/12/17/medline KW - United States Food and Drug Administration KW - comparative effectiveness KW - epidemiologic methods KW - medical device epidemiology KW - pharmacoepidemiology KW - prostheses and implants SP - 949 EP - 58 JF - American journal of epidemiology JO - Am. J. Epidemiol. VL - 180 IS - 9 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. SN - 1476-6256 UR - https://www.unboundmedicine.com/medline/citation/25255810/Methodological_considerations_in_observational_comparative_effectiveness_research_for_implantable_medical_devices:_an_epidemiologic_perspective_ L2 - https://academic.oup.com/aje/article-lookup/doi/10.1093/aje/kwu206 DB - PRIME DP - Unbound Medicine ER -