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, where these models have not previously been applied. METHODS:Data on 15 058 malformed foetuses exposed to first trimester medications (1995-2011) from 13 European congenital anomaly (CA) registries were analysed. The proportion of each CA in women taking a specific medication was compared with the proportion of that CA in all other women in the dataset (55 CAs × 523 medications). BHMs were grouped by either medications or CAs or by both simultaneously, and the results compared with analysing each medication-CA combination separately and adjusting for multiplicity using a double false discovery rate (FDR) procedure. The proportions of "high-risk" medications (medications which have been shown to carry a moderate to high risk of foetal malformations) identified as potential signals were compared, as well as the total number of potential signals requiring follow up (the effective workload). RESULTS:BHMs identified more high-risk medications than the double FDR method, but the effective workload was larger. A BHM grouping both medications and CAs, for example, identified 23% of high-risk medications compared with 14% by the double FDR; however, there was an increase from 16 to 71 potential signals requiring follow up. CONCLUSION:For comparable effective workloads, BHMs did not outperform the double FDR, which is comparatively straightforward to implement and is therefore recommended for continued use in teratogenic signal detection analyses.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Cavadino A,Prieto-Merino D,Morris JKdoi
10.1002/pds.4948subject
Has Abstractpub_date
2020-03-01 00:00:00pages
337-346issue
3eissn
1053-8569issn
1099-1557journal_volume
29pub_type
杂志文章abstract:PURPOSE:This study aimed to examine the effect of antidepressant use on persistence with newly initiated oral antidiabetic medicines in older people. METHODS:A retrospective study of administrative claims data from the Australian Government Department of Veterans' Affairs, from 1 July 2000 to 30 June 2008 of new users...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3424
更新日期:2013-06-01 00:00:00
abstract:INTRODUCTION:Since the introduction of therapeutic risk management regulatory guidance, an increase in the number of risk minimization interventions (RMIs) published in the literature has been observed. Methods used to evaluate their effectiveness remain, however, poorly examined. OBJECTIVE:This paper aimed to conduct...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3596
更新日期:2014-06-01 00:00:00
abstract::The General Practice Research Database (GPRD) is the world's largest computerized database of anonymized longitudinal patient records from general practice and is a unique public health research tool. Several issues have threatened the viability of the database in recent years; in April 1999 responsibility for its man...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.608
更新日期:2001-08-01 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
abstract:PURPOSE:To evaluate the outcomes of patients participating in a program of integrated care for osteoporosis in terms of medication supply, fracture incidence and expenses. METHODS:Outcomes were assessed from secondary data provided by the AOK PLUS health insurance for 2455 participants of the program and the same numb...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3399
更新日期:2013-03-01 00:00:00
abstract:PURPOSE:The thorough analysis of special drug characteristics requires information on the specific brand of a drug. This information is often not sought in pharmacoepidemiologic surveys although in many countries packages are labelled with an unequivocal code (in Germany called Pharmazentralnummer (PZN)). We aimed to a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1406
更新日期:2007-09-01 00:00:00
abstract:PURPOSE:Meta-analysis is a quantitative approach to summarize the findings from several studies and has been applied with increasing frequency to clinical trials. Because of their sample size and duration limitations, experimental studies (ESs) could not be able to detect late or rare adverse events (AEs), which may be...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.2260
更新日期:2012-01-01 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:To identify and quantify risk factors associated with preterm birth, stratified by gestational age at birth. METHODS:Three case-control analyses were done. Controls were pregnancies of > or =37 weeks of gestational age at birth. Cases were defined as: <28, 28-32, 33- <37 weeks of gestational age at birth respe...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1575
更新日期:2008-06-01 00:00:00
abstract:PURPOSE:To demonstrate how the Intensive Medicines Monitoring Programme (IMMP) can be used to monitor adverse events associated with an intrauterine device, using the levonorgestrel-releasing intrauterine device (Mirena) as an example. METHODS:A long-term prospective observational cohort study using Prescription Event...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.875
更新日期:2003-07-01 00:00:00
abstract:PURPOSE:Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP) is a population based database administered by the AEMPS (Spanish Agency for Medicines) of longitudinal electronic medical records (EMR) of patients attended in primary care. Its main purpose is to serve as source of informat...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5006
更新日期:2020-10-01 00:00:00
abstract:PURPOSE:We aim to derive an internationally applicable data set to improve prescription safety of psychiatric drugs. METHODS:We performed an in-depth analysis of the concordance of prescribing information of 10 key psychiatric drugs across four major drug markets with regard to indications, warnings and precautions, a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3389
更新日期:2013-03-01 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 use of healthcare databases in research provides advantages such as increased speed, lower costs and limitation of some biases. However, database research has its own challenges as studies must be performed within the limitations of resources, which often are the product of complex healthcare systems. The primary ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2229
更新日期:2012-01-01 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
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.2317
更新日期:2012-01-01 00:00:00
abstract:PURPOSE:This study aimed to assess the trends in antipsychotic prescriptions for outpatients in Japan, where a community-based approach to mental healthcare is emphasized. METHODS:This descriptive epidemiological study used claims data from 1038 community pharmacies across Japan. Outpatients who were ≥18 years old and...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4187
更新日期:2017-06-01 00:00:00
abstract:BACKGROUND:Previous reports have suggested that new evidence of the comparative effectiveness of different medication classes from randomized controlled trials (RCTs) does not always alter treatment decisions for first-line anti-hypertensive therapy. OBJECTIVES:To evaluate the association of RCT evidence in December 2...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1788
更新日期:2009-09-01 00:00:00
abstract:PURPOSE:To determine the prevalence of purchase of prescribed antihypertensive and/or serum lipid-reducing pharmaceutical preparations among different age groups, from the age of 45, in the Swedish population. Further, to calculate the percentage of the population, from the age of 60, who purchased these pharmaceutical...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1515
更新日期:2008-01-01 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:De-implementation of low-value services among patients with limited life expectancy is challenging. Robust mortality prediction models using routinely collected health care data can enhance health care stakeholders' ability to identify populations with limited life expectancy. We developed and validated a claim...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4769
更新日期:2019-05-01 00:00:00
abstract::It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regardi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.650
更新日期:2002-01-01 00:00:00
abstract:PURPOSE:Determining the nature of the relationship between cumulative duration of exposure to an agent and the hazard of an adverse outcome is an important issue in environmental and occupational epidemiology, public health and clinical medicine. The Cox proportional hazards regression model can incorporate time-depend...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3607
更新日期:2014-08-01 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:BACKGROUND:Laboratory technicians, laboratory supervisors, decontamination/remediation workers, and environmental investigators are at increased risk for repeated occupational exposure to Bacillus anthracis. In 2002, the Advisory Committee on Immunization Practices (ACIP) recommended pre-exposure vaccination for these ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1302
更新日期:2006-12-01 00:00:00
abstract:PURPOSE:Drug treatment of idiopathic Parkinson's disease (IPD) is a difficult task, and comorbidity and comedication add to its complexity. Since in IPD there is little information about drug use, this study investigated drug prescribing and indications in IPD patients. METHODS:From June 1997 to April 1998, a cross-se...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.682
更新日期:2002-03-01 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:OBJECTIVE:We sought to describe the epidemiology of viral respiratory-tract infections and patterns in prescriptions of cough and cold medications among young children who were suffering from viral respiratory tract infections (vRTIs). METHODS:We conducted a cross-sectional study to examine vRTI-episode occurrence and...
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:OBJECTIVE:To learn the evolution of antidepressant and lithium use in Castilla y León (Central Spain) and its relationship with suicide rates. METHODS:A search in the ECOM (Especialidades Consumo de Medicamentos) database of the Spanish Ministry of Health for antidepressants and lithium was carried out for the period ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1944
更新日期:2010-09-01 00:00:00
abstract:PURPOSE:Adverse drug events (ADEs) are an important cause of preventable hospitalizations among elderly individuals taking high-risk medications. The objective of the study was to identify health care system factors that affect the risk of digoxin toxicity for older adults on digoxin. METHODS:We conducted a prospectiv...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1680
更新日期:2009-01-01 00:00:00