Pharmacoepidemiology and Drug Safety
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Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk
Pharmacoepidemiology and Drug Safety - Tập 22 Số 9 - Trang 1013-1018 - 2013
ABSTRACTPurposeTo determine which medications are most commonly used by women in
the first trimester of pregnancy and identify the critical gaps in information
about fetal risk for those medications.MethodsSelf‐reported first‐trimester
medication use was assessed among women delivering liveborn infants without
birth defects and serving as control mothers in two large case–control studies
of major ...
Network analysis of drug prescriptions
Pharmacoepidemiology and Drug Safety - Tập 22 Số 2 - Trang 130-137 - 2013
ABSTRACTPurposeNetworks exist in many different aspects of the world, at social,
economical, biological, and molecular levels. Network science studies their
parameters, or quantitative indicators; its instruments make it possible to draw
and analyze networks from a mathematical perspective.The present study is an
attempt to apply network science techniques to the drug prescription process, a
typic...
Association rule mining in the US Vaccine Adverse Event Reporting System (VAERS )
Pharmacoepidemiology and Drug Safety - Tập 24 Số 9 - Trang 922-933 - 2015
AbstractPurposeSpontaneous adverse event reporting systems are critical tools
for monitoring the safety of licensed medical products. Commonly used signal
detection algorithms identify disproportionate product–adverse event pairs and
may not be sensitive to more complex potential signals. We sought to develop a
computationally tractable multivariate data‐mining approach to identify
product–multipl...
Assessing general side effects in clinical trials: reference data from the general population
Pharmacoepidemiology and Drug Safety - Tập 20 Số 4 - Trang 405-415 - 2011
AbstractPurposeSide effects in clinical trials are frequently assessed in an
unstructured fashion, using ascertainment strategies with unclear quality
criteria. To improve the assessment and interpretation of general side effects,
a structured approach is presented and validated (General Assessment of Side
Effects, GASE). Base rates and reference data of the general population as well
as quality c...
Validation of claims‐based diagnostic and procedure codes for cardiovascular and gastrointestinal serious adverse events in a commercially‐insured population
Pharmacoepidemiology and Drug Safety - Tập 19 Số 6 - Trang 596-603 - 2010
AbstractPurposeTo validate administrative claims codes with medical chart review
for myocardial infarction (MI), ischemic stroke, and severe upper
gastrointestinal (UGI) bleed events in a large, commercially‐insured US
population.MethodsThese validation studies were part of a larger study examining
the risk of MI, ischemic stroke, and severe UGI bleeds in patients receiving a
new prescription of s...
A systematic review of validated methods for identifying venous thromboembolism using administrative and claims data
Pharmacoepidemiology and Drug Safety - Tập 21 Số S1 - Trang 154-162 - 2012
ABSTRACTBackgroundVenous thromboembolism (VTE) is a serious complication. Large
claims databases can potentially identify the effects that medications have on
VTE. The purpose of this study is to evaluate the evidence supporting the
validity of VTE codes.MethodsA search of MEDLINE database is supplemented by
manual searches of bibliographies of key relevant articles. We selected all
studies in whi...
A survey of adult awareness and use of medicine containing acetaminophen
Pharmacoepidemiology and Drug Safety - Tập 22 Số 3 - Trang 229-240 - 2013
ABSTRACTPurposeTo compare awareness, use of acetaminophen, and preferences for
receiving information aimed at reducing acetaminophen overdose.MethodsA survey
of health plan enrollees identified from automated pharmacy data who were
long‐term and acute users of opioids with acetaminophen (n = 720 each cohort),
and a general population cohort (n = 360) during the 2010–2011 cold/flu season.
A 74% res...
A model for the future conduct of pharmacovigilance
Pharmacoepidemiology and Drug Safety - Tập 12 Số 1 - Trang 17-29 - 2003
AbstractA scientific model to support excellence in pharmacovigilance has been
developed from first principles by brainstorming sessions and discussions with
experts in the field. The model represents a long‐term vision of how
pharmacovigilance could be conducted in the future. So far it has been developed
without any consideration of constraints such as resources or the need for
legislative chang...
Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database
Pharmacoepidemiology and Drug Safety - Tập 13 Số 6 - Trang 355-363 - 2004
AbstractPurposeAn important role for the WHO Programme for International Drug
Monitoring is to identify signals of international drug safety problems as early
as possible. The signal detection strategy, operated at the Uppsala Monitoring
Centre (UMC), gave too many drug–adverse drug reaction (ADR) combinations for
individual review. Therefore additional selection strategies were needed to
improve ...
Quantitative signal detection using spontaneous ADR reporting
Pharmacoepidemiology and Drug Safety - Tập 18 Số 6 - Trang 427-436 - 2009
AbstractQuantitative methods are increasingly used to analyse spontaneous
reports. We describe the core concepts behind the most common methods, the
proportional reporting ratio (PRR), reporting odds ratio (ROR), information
component (IC) and empirical Bayes geometric mean (EBGM). We discuss the role of
Bayesian shrinkage in screening spontaneous reports, the importance of changes
over time in sc...
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