Abstract:
PURPOSE:A case-control study is the most powerful design to test the risk of specific congenital malformations associated with a specific drug. However, malformation registries often lack non-malformed controls. For the Dutch EUROCAT, we collected a non-malformed control group: the 'Healthy Pregnant'. The aim of this study was to evaluate the representativeness of this control group for the general pregnant population in the northern part of the Netherlands. METHODS:The Healthy Pregnant data set includes data from two midwife practices. The baseline characteristics of mother and child including smoking status, drinking status, body mass index, maternal age, educational level, exposures to several drugs for chronic diseases and pregnancy related symptoms were evaluated. RESULTS:Compared with the general population, mothers in Healthy Pregnant group (n = 556) were from either low or high education level, were more likely to have a body mass index > 25 kg/m² (26% versus 22%, p = 0.08) or to smoke (19% versus 10%, p < 0.01) but were less likely to consume alcohol (20% versus 29%, p < 0.01). The use of drugs for chronic conditions was lower in Healthy Pregnant group. Furthermore, drugs for occasional use were prescribed less frequently, and a significant underreporting of children with a low birth weight and a short duration of gestation was found. CONCLUSION:The Healthy Pregnant data set was not representative of the general pregnant population in the northern part of the Netherlands. Specifically, the exposure to (chronic) drugs was underestimated, possibly a result of second-line care on the basis of medical indication. Thus, continuous investigation of options for improvement of the Healthy Pregnant database is required.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Jentink J,Zetstra-van der Woude AP,Bos J,de Jong-van den Berg LTdoi
10.1002/pds.2254subject
Has Abstractpub_date
2011-11-01 00:00:00pages
1217-23issue
11eissn
1053-8569issn
1099-1557journal_volume
20pub_type
杂志文章abstract:PURPOSE:This paper aimed to systematically review algorithms to identify transfusion-related ABO incompatibility reactions in administrative data, with a focus on studies that have examined the validity of the algorithms. METHODS:A literature search was conducted using PubMed, Iowa Drug Information Service database, a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.2325
更新日期:2012-01-01 00:00:00
abstract:PURPOSE:Drug-induced liver injury (DILI) is one of the primary targets for pharmacovigilance using medical information databases (MIDs). Because of diagnostic complexity, a standardized method for identifying DILI using MIDs has not yet been established. We applied the Digestive Disease Week Japan 2004 (DDW-J) scale, a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3603
更新日期:2014-09-01 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:Multimorbidity (MM) (presence of more than one chronic condition within a same patient) imposes a heavy burden on patients and health care systems. In contrast to high-income countries, the epidemiology of this phenomenon is unclear in low- and middle-income countries, particularly among Iranian population. ME...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4925
更新日期:2020-01-01 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
abstract:PURPOSE:Ejection fraction (EF) is crucial information when studying the use and effectiveness of therapies in patients with heart failure (HF) and myocardial infarction (MI). We aimed to assess the validity of claims data-based definitions of systolic dysfunction (SD). METHODS:We identified 1072 patients with EF recor...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2146
更新日期:2011-07-01 00:00:00
abstract:OBJECTIVE:This study quantified the overall merit of adjunctive aripiprazole in major depressive disorder (MDD). METHODS:Global benefit-risk (GBR) analysis quantified the benefit and risk differences between adjunctive aripiprazole and antidepressant (ADT) monotherapy. Three hundred and fifty six patients receiving AD...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1805
更新日期:2009-10-01 00:00:00
abstract::In 1978, a systematic collection of adverse drug reactions (ADRs) was set up in a hospital including several departments and continued for more than 18 years. Quarterly meetings were organized gathering clinicians, students, nurses and pharmacologists to discuss the clinical cases collected each quarter. Approximately...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(sici)1099-1557(199808)7:1+
更新日期:1998-08-01 00:00:00
abstract:PURPOSE:To assess the effect of moderate alcohol consumption on Adverse Drug Reactions (ADRs) among older adults admitted to acute care hospitals and to examine the consistency of this effect across gender and age groups. METHODS:We used the GIFA (Italian Group of Pharmacoepidemiology in the Elderly) database, which i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.721
更新日期:2002-07-01 00:00:00
abstract:PURPOSES:(1) Measure the prevalence of herbal product (HP) use, alone, and concomitantly with prescribed medications during pregnancy, (2) identify the most frequently consumed HP during gestation and (3) determine predictors of HP use at the beginning of pregnancy, and during the third trimester. METHODS:A questionna...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1731
更新日期:2009-06-01 00:00:00
abstract:PURPOSE:To determine prescribing patterns by general physicians working in primary care (GPs) in Iran for the elderly and the prevalence of inappropriate prescribing. METHODS:We collected information about prescribed medicines for 10% of patients in primary care aged 65 years or above in six cities in one province dur...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2106
更新日期:2011-05-01 00:00:00
abstract:PURPOSE:Quantitative benefit-risk (B-R) assessments are used to characterize treatment by combining key benefits and risks into a single metric but have historically been done for the "average" patient. Our aim was to conduct an individualized assessment for the oral antiplatelet vorapaxar by combining trial and real-w...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4752
更新日期:2019-04-01 00:00:00
abstract:PURPOSES:The aim of the pharmacovigilance (PV) process is to bring together all the much-needed information about various aspects of product safety or, in particular, the safety and vigilance of drugs as pharmaceutical products. This study aimed to investigate and provide an overview on the current situation and activi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4991
更新日期:2020-09-01 00:00:00
abstract::Adverse drug reaction surveillance conducted by the US Federal Food and Drug Administration (FDA) is important for detecting new safety information about pharmaceuticals. FDA has sought to stimulate reporting of reactions by practitioners and manufacturers. Over the five years from 1989 to 1993, reporting more than do...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199611)5:6<393::AID-PDS235
更新日期:1996-11-01 00:00:00
abstract:BACKGROUND:Recent evidence suggested that oral form of domperidone may possess pro-arrhythmic effects and increase the risk of ventricular arrhythmia. The concomitant use of cytochrome P450 (CYP) 3A4 isoenzyme inhibitors may further potentiate this association. Nevertheless, empirical data supporting these associations...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3814
更新日期:2015-08-01 00:00:00
abstract:PURPOSE:Bayesian hierarchical models (BHMs) have been used to identify adverse drug reactions, allowing information sharing amongst adverse reactions and drugs expected to have similar properties. This study evaluated the use of BHMs in the routine signal detection analyses of potential first-trimester teratogens, wher...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4948
更新日期:2020-03-01 00:00:00
abstract:OBJECTIVE:To identify the relevant prescribing quality domains of type 2 diabetes mellitus care as a basis for the selection of a minimal set of prescribing quality indicators from a set of previously validated indicators. METHODS:We used the principal factor analysis to identify the underlying dimensions or domains o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2248
更新日期:2012-10-01 00:00:00
abstract::An information-theoretic definition of similarity proposed by Dekang Lin in 1998 appears to have attractive properties for identifying medically similar cases in a large database. Examination of similar cases that appear following vaccination may provide a way of detecting previously unexpected associations. A key ele...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1889
更新日期:2010-03-01 00:00:00
abstract:PURPOSE:To determine healthcare claim patterns associated using nonsteroidal anti-inflammatory drugs (NSAIDs) for rheumatoid arthritis (RA). METHODS:The CADEUS study randomly identified NSAID users within the French health insurance database. One-year claims data were extracted, and NSAID indication was obtained from ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
doi:10.1002/pds.3221
更新日期:2012-06-01 00:00:00
abstract:PURPOSE:Discontinuing low-dose acetylsalicylic acid (ASA) therapy after upper gastrointestinal bleeding (UGIB) may increase the risk of cardiovascular-related death. Our aim was to compare mortality in UK primary care patients who discontinue ASA after UGIB with that in patients who continue therapy. METHODS:ASA users...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4140
更新日期:2017-02-01 00:00:00
abstract:PURPOSE:To compare the frequency of adverse drug reactions (ADRs) recorded by doctors with perceived ADRs reported by patients during hospitalization and post-discharge and to compare both to formal reporting in Thailand. SETTING:Tertiary teaching hospital, North-East Thailand. METHODS:Over a 6-month period doctors w...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1708
更新日期:2009-03-01 00:00:00
abstract:PURPOSE:To describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency. METHODS:New users of cilostazol were identified in pop...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4167
更新日期:2017-06-01 00:00:00
abstract:BACKGROUND:Tramadol is a weak opioid analgesic, which is generally considered to be safe. However, conflicting data exist on the dependence potential of tramadol. OBJECTIVE:The aim of this study was to investigate occurrence of tramadol dependence and associated risk factors using spontaneously reported adverse drug r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1838
更新日期:2009-12-01 00:00:00
abstract:PURPOSE:There is an increasing number of children with in utero exposure to opioids. Knowledge about opioid safety in pregnancy, particularly for outcomes later in childhood is scarce. It has been suggested that opioids can modulate immune system and increase the risk of infections. Our goal was to study the impact of ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5088
更新日期:2020-12-01 00:00:00
abstract:PURPOSE:Innovative methods are needed to assess risks related to treatment for common medical conditions, where therapy is usually patient-directed or over-the-counter (OTC), and where tolerability, i.e. patient experienced events, may affect patterns of use. A large-scale, blinded, randomised trial was conducted to co...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1002/pds.1083
更新日期:2005-04-01 00:00:00
abstract::The UK Drug Utilization Research Group's (DURG) Regional Meeting 'New Horizons: Pharmacovigilance' was hosted by the Drug Safety Research Unit (DSRU) at Southampton on 19 May 2000. Opening the meeting, Dr Keith Beard, UK DURG chairman, welcomed delegates and speakers and thanked the DSRU team for hosting the meeting. ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/1099-1557(200009/10)9:5<429::AID-PDS528>3.
更新日期:2000-09-01 00:00:00
abstract:PURPOSE:To investigate the association between socioeconomic position and use of lipid-lowering drugs and ACE-inhibitors after an acute myocardial infarction (AMI) when simultaneously considering participation in the national quality register RIKS-HIA (Register of Information and Knowledge about Swedish Heart Intensive...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1917
更新日期:2010-04-01 00:00:00
abstract:PURPOSE:To determine the validity of pregnancy variables recorded in administrative databases of Quebec using patient medical charts as the gold standard among asthmatic pregnant women. METHODS:Three administrative databases were linked and provided information on maternal, pregnancy and infant characteristics for 726...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.1558
更新日期:2008-04-01 00:00:00
abstract:PURPOSE:Administration of pegylated interferon-alpha (IFN-alpha) and ribavirin in adults with chronic hepatitis C (CHC) is a recommended therapeutic standard. Nevertheless, this therapeutic regimen rises numerous controversies. The aim of this study was to analyze adverse effects during the treatment with pegylated IFN...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1458
更新日期:2007-10-01 00:00:00
abstract:OBJECTIVE:This study describes the use of psychotropic drugs in a sample of eight Italian psychiatric hospitals. METHODS:A cross-sectional approach was used to collect information about sociodemographic and clinical characteristics of the inpatient population, and about medications prescribed. Prescribing behaviour in...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199908/09)8:5<331::AID-PDS
更新日期:1999-08-01 00:00:00