Abstract:
PURPOSE:Administrative claim databases are increasingly being used to study the safety of medication exposures during pregnancy. These studies are restricted to live births due to a reliance on algorithms for estimating gestational age that are based on codes associated with live delivery. Conditioning on live birth may induce selection bias when studying the effect of a drug on a pregnancy complication if fetal death is a competing risk for the complication or is caused by the complication. METHODS:We simulated a population of 100,000 pregnancies and estimated the impact of selection bias on relative estimates for the effect of antidepressant exposure on the outcome of preeclampsia. We assumed that the exposure, outcome, and covariates increased the risk of fetal loss. RESULTS:A downward bias in the risk ratio was consistently observed when conditioning on live births. When an unmeasured covariate was assumed to be a common cause of fetal death, antidepressant use, and preeclampsia, the direction of bias varied depending on the strength of the confounding relationship coupled with the selection bias. Despite the very low prevalence of stillbirth, the strength of the relationship between antidepressant use and stillbirth had a substantial impact on bias. CONCLUSIONS:Conditioning on live birth can be problematic when studying pregnancy complications. Simple quantitative selection bias analysis in populations restricted to live births may not fully account for selection bias.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Suarez EA,Landi SN,Conover MM,Jonsson Funk Mdoi
10.1002/pds.4387subject
Has Abstractpub_date
2018-03-01 00:00:00pages
307-314issue
3eissn
1053-8569issn
1099-1557journal_volume
27pub_type
杂志文章abstract:PURPOSE:To examine and compare the quality of drug prescribing for older patients in nursing homes and home nursing services. METHODS:Cross-sectional study comprising 11,254 patients aged ≥ 65 years in nursing homes (n = 2986) and home nursing services (n = 8268). Potentially inappropriate medications were identified ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2232
更新日期:2012-09-01 00:00:00
abstract:PURPOSE:Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. METHODS:Data were obtained ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2155
更新日期:2011-07-01 00:00:00
abstract:PURPOSE:To assess the pattern of in-hospital changes in drug use in older patients from 2010 to 2016. METHODS:People aged 65 years or more acutely hospitalized in those internal medicine and geriatric wards that did continuously participate to the REgistro POliterapie Società Italiana di Medicina Interna register from...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4330
更新日期:2017-12-01 00:00:00
abstract:PURPOSE:We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveil...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2336
更新日期:2012-01-01 00:00:00
abstract:PURPOSE:To examine and compare risks of serious hypoglycemia among antidiabetic monotherapy-treated adults receiving metformin, a sulfonylurea, a meglitinide, or a thiazolidinedione. METHODS:We performed a retrospective cohort study of apparently new users of monotherapy with metformin, glimepiride, glipizide, glyburi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4337
更新日期:2018-01-01 00:00:00
abstract:PURPOSE:To explore associations between preterm birth and use of medications in young adulthood as a proxy for different diseases. METHODS:We linked data on birth characteristics from the Medical Birth Registry of Norway (1967-1999) and the Norwegian Prescription Database (2004-2015). Individuals born as singletons du...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4174
更新日期:2017-07-01 00:00:00
abstract:PURPOSE:Our aim was to describe and assess the medicinal products and doses used for euthanasia in a series of cases, identified within an epidemiological death certificate study in Belgium, where euthanasia was until recently legally forbidden and where guidelines for euthanasia are not available. METHODS:In a random...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.863
更新日期:2004-02-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4394
更新日期:2018-04-01 00:00:00
abstract:PURPOSE:The aim of this study was to estimate the prevalence of first-generation antipsychotics (FGA) prescribed for treatment of psychiatric and neurological conditions and use of benztropine to reduce extrapyramidal side effects (EPS) by patient race/ethnicity in a nationally representative sample of adult outpatient...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3819
更新日期:2015-11-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1356
更新日期:2007-05-01 00:00:00
abstract:PURPOSE:Some studies have reported reduced risks of advanced, but not early, prostate cancer among statin users, and one study found a reduced risk only among statin users who had also used non-steroidal anti-inflammatory drugs (NSAIDs). We have previously reported no association between statin use and prostate cancer ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1970
更新日期:2010-07-01 00:00:00
abstract::There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in commun...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4004
更新日期:2016-07-01 00:00:00
abstract:PURPOSE:Type 2 diabetes is associated with increased cardiovascular risk. The comparative effectiveness of statin plus fibrate combination therapy and statin monotherapy in reducing risk of cardiovascular disease in real-world settings is unknown. METHODS:A retrospective database analysis was performed using a large m...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3261
更新日期:2012-05-01 00:00:00
abstract:PURPOSE:Many patients use complementary/alternative medicine (CAM) for their health problems especially where long-term treatment is required. Epilepsy is the most prevalent neurological disorder requiring long-term treatment and compliance. The purpose of the study was to establish the pattern of use of CAM in epilept...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.731
更新日期:2002-09-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1144
更新日期:2005-10-01 00:00:00
abstract::Denmark has one of the worlds most comprehensive registration of its citizens' use of medical and social services. Most databases are population-based and of very high quality. Virtually all employ a mutual person identifier, which renders it technically possible to link any of them with others. There are two prescrip...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.638
更新日期:2001-12-01 00:00:00
abstract:PURPOSE:To examine the utility of electronic health records from a routine care setting in assessing comparative effectiveness of fourth-line anti-hypertensive drugs to treat resistant hypertension. METHODS:We conducted a cohort study using the Clinical Practice Research Datalink: a repository of electronic health rec...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4808
更新日期:2019-09-01 00:00:00
abstract:PURPOSE:This paper introduces an improved tool for designing matched-pairs randomized trials. The tool allows the incorporation of clinical and other knowledge regarding the relative importance of variables used in matching and allows for multiple types of missing data. The method is illustrated in the context of a clu...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3260
更新日期:2012-05-01 00:00:00
abstract:PURPOSE:Most epidemiologic studies have detected no association between prior use of antidepressant medications and breast cancer risk. Despite the uniform conclusion, there is a continuous rise in the proportion of women using antidepressants, lending support to further monitoring of disease effects. METHODS:We condu...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1719
更新日期:2009-04-01 00:00:00
abstract::A series of case reports to the varicella vaccine Pregnancy Registry described inadvertent administrations during pregnancy of this live virus product instead of the intended Varicella zoster immune globulin. Cases continued to accrue despite an early publication about the pattern. The persistent problem warrants spec...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.749
更新日期:2002-12-01 00:00:00
abstract:PURPOSE:We aimed to quantify the extent of over-the-counter (OTC) low-dose aspirin use among patients in The Health Improvement Network (THIN) in the UK. METHODS:In September 2013, a random sample of low-dose aspirin users (75 past users and 75 never users) was identified based on prescriptions recorded in THIN. Prima...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3926
更新日期:2016-04-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
doi:10.1002/pds.3460
更新日期:2014-01-01 00:00:00
abstract:PURPOSE:To examine the effects of analgesics on bone mineral density (BMD), which have not been examined in a longitudinal study with multiple measurements. METHODS:We investigated changes in BMD associated with new use of analgesics in a prospective longitudinal cohort of mid-life women. BMD and medication use were m...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4362
更新日期:2018-02-01 00:00:00
abstract:PURPOSE:Drug induced Torsades de Pointes (TdP) is a major concern for new drugs seeking regulatory approval. Prolongation of QT intervals greater than 60 millisecond or to longer than 500 millisecond in an individual patient has been considered to be associated with a higher risk. The purpose of this study is to identi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1707
更新日期:2009-03-01 00:00:00
abstract:BACKGROUND:Following approval in the EU in 2002 and the USA in 2003, an Intensive Safety Surveillance Scheme (IS(3) ) was initiated to educate prescribers on the appropriate use of miglustat for the treatment of type I Gaucher disease (GD1), and to actively solicit safety-relevant information. This report summarises da...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.3760
更新日期:2015-03-01 00:00:00
abstract:PURPOSE:In this proof-of-concept paper we describe the framework, process, and preliminary results of combining data from European electronic healthcare record (EHR) databases for large-scale monitoring of drug safety. METHODS:Aggregated demographic, clinical, and prescription data from eight databases in four countri...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2053
更新日期:2011-01-01 00:00:00
abstract:PURPOSE:Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequen...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4859
更新日期:2019-09-01 00:00:00
abstract:PURPOSE:To determine the risk factors and rate of medication administration error (MAE) alerts by analyzing large-scale medication administration data and related error logs automatically recorded in a closed-loop medication administration system using radio-frequency identification and barcodes. METHODS:The subject h...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4068
更新日期:2016-12-01 00:00:00
abstract:PURPOSE:This study evaluated the safety of oseltamivir during the 2009 influenza pandemic. METHODS:Case reports were obtained from the Roche safety database. The incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 2009) was compared with that beforehand (during previous influenza seasons) ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2136
更新日期:2011-05-01 00:00:00
abstract:PURPOSE:The objective of this study was to evaluate the level of use and therapy profile of antibacterial agents in hospitals. Further to explore whether type, size or geographical situation influenced antibacterial agents used. METHODS:Antibacterial use during 1998-1999, in 13 hospitals, including emergency, referral...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1080
更新日期:2005-09-01 00:00:00