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


: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.


Am J Epidemiol


Jalbert JJ,Ritchey ME,Mi X,Chen CY,Hammill BG,Curtis LH,Setoguchi S




Has Abstract


2014-11-01 00:00:00














  • Correcting for Measurement Error in Time-Varying Covariates in Marginal Structural Models.

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    journal_title:American journal of epidemiology

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    authors: Kyle RP,Moodie EE,Klein MB,Abrahamowicz M

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  • Exploratory spatial analysis of pilot fatality rates in general aviation crashes using geographic information systems.

    abstract::Geographic information systems and exploratory spatial analysis were used to describe the geographic characteristics of pilot fatality rates in 1983-1998 general aviation crashes within the continental United States. The authors plotted crash sites on a digital map; rates were computed at regular grid intersections an...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Grabowski JG,Curriero FC,Baker SP,Li G

    更新日期:2002-03-01 00:00:00

  • Invited commentary: disclosure of gender-based violence in developing countries.

    abstract::The evolving concept of gender-based violence (GBV) is a multifaceted issue of public health significance. Until recently, most studies examining GBV have been conducted in North America. In this issue of the Journal, Palermo et al. (Am J Epidemiol. 2014;179(5):602-612) report their secondary analyses involving approx...

    journal_title:American journal of epidemiology

    pub_type: 评论,杂志文章


    authors: Beydoun HA,Beydoun MA

    更新日期:2014-03-01 00:00:00

  • Invited commentary: a sunbed epidemic?

    abstract::The Icelandic study of melanoma trends by Héry et al. in this issue of the Journal (Am J Epidemiol. 2010;172(7):762-767) is a fascinating analysis of an ecologic association. The authors noted a sharp increase in melanoma incidence that appeared to lag a few years behind the increased prevalence of sunbeds in Iceland....

    journal_title:American journal of epidemiology

    pub_type: 评论,杂志文章,评审


    authors: Berwick M

    更新日期:2010-10-01 00:00:00

  • The Tecumseh study of respiratory illness. X. Relation of acute infections to smoking, lung function and chronic symptoms.

    abstract::The relationship of acute respiratory illness and infection to chronic bronchitis was investigated in the community of Tecumseh, Michigan. Families were randomly selected for study from among all those in the community and they were followed for periods of one year. Occurrence of acute respiratory illnesses was identi...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Monto AS,Ross HW

    更新日期:1978-01-01 00:00:00

  • Conjugated estrogen use and risk of endometrial cancer.

    abstract::The relation between use of conjugated estrogens and the risk of uterine cancer was examined among 188 white women with newly diagnosed endometrial cancer and 428 controls hospitalized for nonmalignant conditions requiring surgery at the Boston Hospital for Women-Parkway Division, Boston, Massachusetts, in January 197...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Buring JE,Bain CJ,Ehrmann RL

    更新日期:1986-09-01 00:00:00

  • Protection against ischemic heart disease in the Belgian Physical Fitness Study: physical fitness rather than physical activity?

    abstract::Occupational and leisure time physical activity and conventional risk factors were determined in the Belgian Physical Fitness Study, a prospective study of 2,363 healthy male factory workers who were aged 40-55 years at entry in 1976-1978 and who were followed for five years. Physical fitness, defined as the interpola...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Sobolski J,Kornitzer M,De Backer G,Dramaix M,Abramowicz M,Degre S,Denolin H

    更新日期:1987-04-01 00:00:00

  • Association of Chlamydia trachomatis and Mycoplasma hominis with intrauterine growth retardation and preterm delivery. The John Hopkins Study of Cervicitis and Adverse Pregnancy Outcome.

    abstract::The authors conducted a prospective study of risk factors for intrauterine growth retardation (birth weight less than a standard (race- and sex-adjusted) 10th percentile for gestational age) and preterm birth (birth prior to 37 weeks gestation) in a high-risk, inner-city, obstetric population, with special interest in...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章



    更新日期:1989-06-01 00:00:00

  • A study of the effect of weight and dietary fat on breast cancer survival time.

    abstract::Female breast cancer patients who had participated in a case-control study conducted during 1973-1975 were followed up, using record linkage to the Statistics Canada mortality data base, to the end of 1980. A number of variables recorded for the case-control study, in particular body weight and daily intake of dietary...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Newman SC,Miller AB,Howe GR

    更新日期:1986-05-01 00:00:00

  • Menstrual cycle patterns and risk of breast cancer.

    abstract::Menstrual cycle characteristics may reflect underlying endocrine patterns that influence the risk of breast cancer. Most previous studies of menstrual function and breast cancer risk have used retrospective reports of menstrual bleeding, which may be unreliable. To examine this association, the authors conducted a mai...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Whelan EA,Sandler DP,Root JL,Smith KR,Weinberg CR

    更新日期:1994-12-15 00:00:00

  • Containing pandemic influenza with antiviral agents.

    abstract::For the first wave of pandemic influenza or a bioterrorist influenza attack, antiviral agents would be one of the few options to contain the epidemic in the United States until adequate supplies of vaccine were available. The authors use stochastic epidemic simulations to investigate the effectiveness of targeted anti...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Longini IM Jr,Halloran ME,Nizam A,Yang Y

    更新日期:2004-04-01 00:00:00

  • Oral contraceptive use in relation to nonfatal myocardial infarction.

    abstract::The relation of oral contraceptive (OC) use to the risk of hospitalization for myocardial infarction (MI) was evaluated among 121,964 US nurses who responded to a mail questionnaire. There were 156 women who reported having been hospitalized for MI before the menopause, and 23 (15%) were OC users at the time of the MI...

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    pub_type: 杂志文章


    authors: Rosenberg L,Hennekens CH,Rosner B,Belanger C,Rothman KJ,Speizer FE

    更新日期:1980-01-01 00:00:00

  • Neural tube defects among Mexican Americans living on the US-Mexico border: effects of folic acid and dietary folate.

    abstract::Populations of Mexican descent have high occurrences of neural tube defects (NTDs). A recent study suggested that folic acid supplements may not protect these populations from NTDs. In a case-control study, the authors investigated the role of folic acid and dietary folate intake in NTD risk among Mexican Americans li...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Suarez L,Hendricks KA,Cooper SP,Sweeney AM,Hardy RJ,Larsen RD

    更新日期:2000-12-01 00:00:00

  • Pesticides and lung cancer risk in the agricultural health study cohort.

    abstract::The authors examined the relation between 50 widely used agricultural pesticides and lung cancer incidence in the Agricultural Health Study, a prospective cohort study of 57,284 pesticide applicators and 32,333 spouses of farmer applicators with no prior history of lung cancer. Self-administered questionnaires were co...

    journal_title:American journal of epidemiology

    pub_type: 杂志文章


    authors: Alavanja MC,Dosemeci M,Samanic C,Lubin J,Lynch CF,Knott C,Barker J,Hoppin JA,Sandler DP,Coble J,Thomas K,Blair A

    更新日期:2004-11-01 00:00:00

  • Alcohol consumption with age: a cross-sectional and longitudinal study of the Atherosclerosis Risk in Communities (ARIC) study, 1987-1995.

    abstract::Previous cross-sectional and longitudinal studies assessing the association between age and drinking are inconsistent. Evaluating 15,425 Black and White men and women from four communities, this study sought to determine whether there was a consistent relation between age and drinking in cross-sectional and longitudin...

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    authors: Eigenbrodt ML,Mosley TH Jr,Hutchinson RG,Watson RL,Chambless LE,Szklo M

    更新日期:2001-06-01 00:00:00

  • Epidemiologic interactions, complexity, and the lonesome death of Max von Pettenkofer.

    abstract::In the mid-19th century, the German hygienist Max von Pettenkofer viewed cholera as resulting from the interaction between a postulated cholera germ and the characteristics of soils. In order to cause cholera, the cholera germ had to become a cholera miasma, but this transformation required prolonged contact of the ge...

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    authors: Morabia A

    更新日期:2007-12-01 00:00:00

  • Magnetic field exposure from electric appliances and childhood cancer.

    abstract::The effect on childhood cancer of prolonged exposure to 60-H magnetic fields from electric appliances was examined using interview data from a recently completed case-control study. Exposures of children aged 0-14 years whose incident cancers were diagnosed between 1976 and 1983 and who resided in the Denver, Colorado...

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    authors: Savitz DA,John EM,Kleckner RC

    更新日期:1990-05-01 00:00:00

  • Statistical modelling of lung cancer and laryngeal cancer incidence in Scotland, 1960-1979.

    abstract::The ratio of cancer occurrence among smokers compared to nonsmokers has been generally reported to be greatest for carcinomas arising in the lung and larynx. This report presents the results of an investigation into mechanisms underlying the temporal trends in the incidence of these two forms of cancer in Scotland ove...

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    authors: Boyle P,Robertson C

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  • Commentary: considerations for use of racial/ethnic classification in etiologic research.

    abstract::Numerous authors have critiqued the use of race as an etiologic quantity in medical research. Despite this criticism, the use of variables encoding racial/ethnic categorization has increased in epidemiology, and most researchers agree that important variation in disease risk is captured by this classification system. ...

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    authors: Kaufman JS,Cooper RS

    更新日期:2001-08-15 00:00:00

  • History-adjusted marginal structural models for estimating time-varying effect modification.

    abstract::Much of epidemiology and clinical medicine is focused on estimating the effects of treatments or interventions administered over time. In such settings of longitudinal treatment, time-dependent confounding is often an important source of bias. Marginal structural models (MSMs) are a powerful tool for estimating the ca...

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    authors: Petersen ML,Deeks SG,Martin JN,van der Laan MJ

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  • Performance of Disease Risk Score Matching in Nested Case-Control Studies: A Simulation Study.

    abstract::In a case-control study, matching on a disease risk score (DRS), which includes many confounders, should theoretically result in greater precision than matching on only a few confounders; however, this has not been investigated. We simulated 1,000 hypothetical cohorts with a binary exposure, a time-to-event outcome, a...

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    authors: Desai RJ,Glynn RJ,Wang S,Gagne JJ

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    abstract::More than a century of empirical evidence links marital status to mortality. However, the hazards of dying associated with long-term marital trajectories and contributing risk factors are largely unknown. The authors used 1992-2006 prospective data from a cohort of US adults to investigate the impact of current marita...

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    authors: Dupre ME,Beck AN,Meadows SO

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    abstract::Although the inverse association between hysterectomy and epithelial ovarian cancer (EOC) was considered well established, investigators in recent studies including women diagnosed after 2000 have observed modest increases in risk. Most studies have been conducted in white women with little representation of African-A...

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    authors: Peres LC,Alberg AJ,Bandera EV,Barnholtz-Sloan J,Bondy M,Cote ML,Funkhouser E,Moorman PG,Peters ES,Schwartz AG,Terry PD,Abbott SE,Camacho F,Wang F,Schildkraut JM

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    abstract::G-estimation is a flexible, semiparametric approach for estimating exposure effects in epidemiologic studies. It has several underappreciated advantages over other propensity score-based methods popular in epidemiology, which we review in this article. However, it is rarely used in practice, due to a lack of off-the-s...

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    authors: Dukes O,Vansteelandt S

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  • Hemostatic variables in Japanese and Caucasian men. Plasma fibrinogen, factor VIIc, factor VIIIc, and von Willebrand factor and their relations to cardiovascular disease risk factors.

    abstract::Mortality rates of coronary heart disease are much lower and hemorrhagic stroke rates are higher in Japanese than in Caucasians. To investigate whether population differences in plasma concentrations of coagulation factors are consistent with these mortality differences, the authors examined, in 1987, a total of 136 m...

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    authors: Iso H,Folsom AR,Wu KK,Finch A,Munger RG,Sato S,Shimamoto T,Terao A,Komachi Y

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    authors: Franco LJ,Stern MP,Rosenthal M,Haffner SM,Hazuda HP,Comeaux PJ

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    authors: Loewenstein MS

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