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.
journal_name
Am J Epidemioljournal_title
American journal of epidemiologyauthors
Jalbert JJ,Ritchey ME,Mi X,Chen CY,Hammill BG,Curtis LH,Setoguchi Sdoi
10.1093/aje/kwu206subject
Has Abstractpub_date
2014-11-01 00:00:00pages
949-58issue
9eissn
0002-9262issn
1476-6256pii
kwu206journal_volume
180pub_type
杂志文章abstract::Salmonella is a common cause of bacterial foodborne illness in the United States. The epidemiology and costs of nontyphoidal salmonellosis in California from 1990 through 1999 are described using surveillance, hospitalization, and death data. Trends in Salmonella rates and factors associated with prolonged hospitaliza...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwf155
更新日期:2003-01-01 00:00:00
abstract::An inverse association between socioeconomic status, as measured by years of education, and blood pressure has been reported in a number of studies. However, two secular trends may have changed the nature of this relation: a higher mean level of education in the population and intervention for high blood pressure in t...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a116245
更新日期:1992-06-15 00:00:00
abstract::This retrospective cohort study evaluated adverse birth outcomes in infants whose birth records indicated maternal residence in villages containing dumpsites potentially hazardous to health and environment. Birth records from 1997 to 2001 identified 10,073 eligible infants born to mothers in 197 Alaska Native villages...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwj241
更新日期:2006-09-15 00:00:00
abstract::A retrospective review of autopsy records was performed to evaluate a clustering of patients shown to have invasive pulmonary aspergillosis during the period July 1, 1978 through October 31, 1980 at Milwaukee County Medical Center, Milwaukee, Wisconsin. During this period, ten patients, all of whom were immunosuppress...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a113427
更新日期:1982-09-01 00:00:00
abstract::The authors examined the independent and combined associations of physical activity and obesity with incident type 2 diabetes among 675,496 Korean men from the database of the National Health Insurance Corporation. During an average follow-up of 7.5 years (1996-2005), 52,995 men developed type 2 diabetes. Men with ove...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwr471
更新日期:2012-07-01 00:00:00
abstract::Measurement and characterization of the human microbiome in large population-based human studies has recently become a reality secondary to technological advances in high-throughput DNA sequencing. These advances bring new challenges and knowledge gaps for study planning, data analysis, and interpretation that are nov...
journal_title:American journal of epidemiology
pub_type: 评论,杂志文章
doi:10.1093/aje/kwy063
更新日期:2018-06-01 00:00:00
abstract::Willingness of newly diagnosed lung cancer patients to volunteer names of friends as potential control subjects was assessed from August through December 1988 in a case-control study at the National Cancer Institute and Naval Hospital, Bethesda, Maryland. Friend controls appeared ideal to examine a genetically determi...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a115803
更新日期:1991-01-01 00:00:00
abstract::In a previous study, patients with spinal cord injuries were observed to have a high incidence of colonizaion of the perineum, rectum, and urethra with Pseudomonas. In the current report, 10 men and 10 women with spinal cord injury were studied prospectively during their stay in hospital between June-Dec. 1977 (men) a...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a113020
更新日期:1980-10-01 00:00:00
abstract::It is well established that women with a family history of breast cancer run a higher risk of breast cancer than do women without a family history. The evidence, however, is less clear regarding a possible association between a family history of breast cancer and risk of second primaries. The purpose of this prospecti...
journal_title:American journal of epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1093/oxfordjournals.aje.a116566
更新日期:1992-10-15 00:00:00
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. ...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/154.4.291
更新日期:2001-08-15 00:00:00
abstract::Increased lung cancer risks among hairdressers were observed in large registry-based cohort studies from Scandinavia, but these studies could not adjust for smoking. Our objective was to evaluate the lung cancer risk among hairdressers while adjusting for smoking and other confounders in a pooled database of 16 case-c...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwt119
更新日期:2013-11-01 00:00:00
abstract::This study evaluated 3 index-based dietary patterns-Healthy Eating Index (HEI)-2005, HEI-2010, and Alternate Healthy Eating Index (AHEI)-2010-in relation to ovarian cancer risk in African-American women. The study was conducted among 415 ovarian cancer cases and 629 age- and site-matched controls of African-American d...
journal_title:American journal of epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1093/aje/kwx022
更新日期:2017-06-15 00:00:00
abstract::Genetic epidemiology represents a hybrid of epidemiologic designs and statistical models that explicitly consider both genetic and environmental risk factors for disease. It is a relatively new field in public health; the term was first coined only 35 years ago. In this short time, the field has been through a major e...
journal_title:American journal of epidemiology
pub_type: 历史文章,杂志文章
doi:10.1093/aje/kww001
更新日期:2016-03-01 00:00:00
abstract::In a case-control study of childhood leukemia in relation to exposure to power-frequency electric and magnetic fields (EMF), 399 children resident in five Canadian provinces who were diagnosed at ages 0-14 years between 1990 and 1994 (June 1995 in British Columbia and Quebec) were enrolled, along with 399 controls. Ex...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a009899
更新日期:1999-05-01 00:00:00
abstract::For diseases of well-defined genetic etiology and with onset after birth, the age at onset corresponds to the incubation period of the disease. The lognormal model, as used by Sartwell to study the distribution of incubation periods in infectious diseases (Am J Hyg 1950;51:310-8), was applied in this study to the dist...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a113137
更新日期:1981-05-01 00:00:00
abstract::The objective of this study was to determine whether a less favorable risk factor pattern for cardiovascular disease among persons with impaired glucose tolerance could be explained by fasting insulin, obesity, and/or a central distribution of body fat. Between 1984 and 1988, cardiovascular risk factors were examined ...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a116575
更新日期:1992-11-01 00:00:00
abstract::Contradictory observations have accumulated regarding a secular trend and/or an epidemic pattern in the incidence of insulin-dependent diabetes mellitus. In this study, insulin-dependent diabetes mellitus incidence below age 15 years was examined in Allegheny County, Pennsylvania, and in Wielkopolska, Poland, two area...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a115169
更新日期:1989-03-01 00:00:00
abstract::The authors assessed the association between asthma prevalence and socioeconomic status at both the individual and center levels simultaneously.by using data from 32 centers in 15 countries. Included were 10,971 subjects aged 20-44 years selected from the general population and interviewed in 1991-1992. Socioeconomic ...
journal_title:American journal of epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1093/aje/kwh186
更新日期:2004-07-15 00:00:00
abstract::In the summer of 1991, four inmates from prison A in Upstate New York died of multi-drug-resistant tuberculosis. To determine the extent of resistant tuberculosis at prison A and transmission patterns, the authors interviewed staff and reviewed medical records and inmate movement histories. Contact investigation resul...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a117222
更新日期:1994-07-15 00:00:00
abstract::Epidemiologic research that uses administrative records (rather than registries or clinical surveys) to identify cases for study has been increasingly restricted because of concerns about privacy, making unbiased population-based research less practicable. In their article, Nattinger et al. (Am J Epidemiol. 2010;172(6...
journal_title:American journal of epidemiology
pub_type: 评论,杂志文章
doi:10.1093/aje/kwq219
更新日期:2010-09-15 00:00:00
abstract::Several studies have reported associations between airborne particles and/or ozone and hospital admissions for respiratory disease. This study examined whether such an association could be seen in Birmingham, Alabama, one of the few cities in the United States with daily monitoring of inhalable particles. Daily counts...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a117048
更新日期:1994-03-15 00:00:00
abstract::As the population ages, the burden of disease from cognitive decline and dementing illness is rising. In the absence of treatments to reverse cognitive decline, prevention is a public health priority. Physical fitness and physical activity have emerged as prevention targets based on evidence of "neuroprotective" benef...
journal_title:American journal of epidemiology
pub_type: 评论,杂志文章
doi:10.1093/aje/kww029
更新日期:2016-06-15 00:00:00
abstract::The objective was to study the association between birth weight and the insulin sensitivity index. Altogether, 331 unrelated Caucasian subjects aged 18-32 years with measures of the insulin sensitivity index and insulin secretion during a combined intravenous glucose and tolbutamide tolerance test were included in the...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a009188
更新日期:1997-07-01 00:00:00
abstract::The use of propensity scores to adjust for measured confounding factors has become increasingly popular in cohort studies. However, their use in case-control and case-cohort studies has received little attention. The authors present some theory on the estimation and use of propensity scores in case-control and case-co...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwm069
更新日期:2007-08-01 00:00:00
abstract::Childhood blood pressure (BP) is a strong predictor of later risk of cardiovascular disease. However, few studies have assessed dynamic BP trajectories throughout the early-life period. We investigated the relationship between early-life factors and systolic BP (SBP) from infancy to adolescence using linear spline mix...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwz181
更新日期:2019-11-01 00:00:00
abstract::Reasons for health disparities may include neighborhood-level factors, such as availability of health services, social norms, and environmental determinants, as well as individual-level factors. Investigating health inequalities using nationally or locally representative data often requires an approach that can accomm...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwu040
更新日期:2014-05-15 00:00:00
abstract::Flaws in the design of randomized trials may bias intervention effect estimates and increase between-trial heterogeneity. Empirical evidence suggests that these problems are greatest for subjectively assessed outcomes. For the Risk of Bias in Evidence Synthesis (ROBES) Study, we extracted risk-of-bias judgements (for ...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwx344
更新日期:2018-05-01 00:00:00
abstract::Some studies have suggested that diabetes mellitus may decrease the risk of prostate cancer because of lower insulin levels. To further investigate the relation between diabetes and prostate cancer, a nested case-control study was conducted within the US Physicians' Health Study. Cases (n = 1,110) had been diagnosed w...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwh139
更新日期:2004-05-15 00:00:00
abstract::A consistent framework has been developed for measuring health disparities and making comparisons across indicators with regard to the public health goals of Healthy People 2010. Disparities are measured as the percent difference from the best group rate, with all indicators being expressed in terms of adverse events....
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/aje/kwm044
更新日期:2007-07-01 00:00:00
abstract::In November 1984, a foodborne outbreak of Norwalk gastroenteritis occurred in a K-12 public school in northern Vermont. The outbreak offered an opportunity to systematically study in detail secondary transmission rates in households. Eating salad at Tuesday's school-sponsored Thanksgiving Banquet was associated with i...
journal_title:American journal of epidemiology
pub_type: 杂志文章
doi:10.1093/oxfordjournals.aje.a114756
更新日期:1987-12-01 00:00:00