title: Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.
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.forename: Jessica J
authors.initials: JJ
authors.lastname: Jalbert
authors.forename: Mary Elizabeth
authors.initials: ME
authors.lastname: Ritchey
authors.forename: Xiaojuan
authors.initials: X
authors.lastname: Mi
authors.forename: Chih-Ying
authors.initials: CY
authors.lastname: Chen
authors.forename: Bradley G
authors.initials: BG
authors.lastname: Hammill
authors.forename: Lesley H
authors.initials: LH
authors.lastname: Curtis
authors.forename: Soko
authors.initials: S
authors.lastname: Setoguchi
mesh_terms: D015982:Bias; D057186:Comparative Effectiveness Research / Q000379:methods*; D015986:Confounding Factors, Epidemiologic; D018795:Device Approval; D057286:Electronic Health Records; D004812:Epidemiologic Methods; D033161:Government Regulation; D006801:Humans; D017891:Pharmacoepidemiology; D019736:Prostheses and Implants / Q000009:adverse effects / Q000706:statistics & numerical data; D012042:Registries; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
keywords: United States Food and Drug Administration; comparative effectiveness; epidemiologic methods; medical device epidemiology; pharmacoepidemiology; prostheses and implants