Abstract:
PURPOSE:To optimize the efficiency of signal detection by maximizing the proportion of true positive (TP) signals among signals detected by a disproportionality algorithm. METHODS:We compared 176 different combinations of stratification factors, sex (S), age (A), region (R) and year of report (Y), and cut-off values of a Multi-Item Gamma Poisson Schrinker (MGPS) algorithm. Spontaneous adverse event reports of eight vaccines from the GlaxoSmithKline Biologicals safety database were used. Defining events listed in the Product Information as proxy of true safety signals, we compared each algorithm performance in terms of positive predictive value (PPV). For each vaccine, each algorithm was ranked according to PPV. Median rank and overall PPV were computed across vaccines. RESULTS:For a standard cut-off of 2, the optimal stratification factors differed by vaccine and led to a set of algorithms with a median rank of 34.5 (PPV = 0.22; 34 TP). Keeping the original SARY stratification led to optimal cut-offs that differed by vaccine and a set of algorithms with a median rank of 1.75 (PPV = 0.20; 142 TP). The optimal combination of cut-off and stratification led to different algorithms by vaccine with a median rank of 1 (PPV = 0.19; 139 TP). The best unique algorithm parameterization across vaccines was 0.8-SARY (cut-off-stratification), with a median rank of 3 (PPV = 0.20; 195 TP). The original 2-SARY was one of the worst algorithms, with a median rank of 150.75 (PPV = 0.13; 8 TP). CONCLUSION:Within the scope of this study, a unique MGPS algorithm across vaccines with the original full stratification but a lowered cut-off provided major performance improvement.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Van Holle L,Bauchau Vdoi
10.1002/pds.3392subject
Has Abstractpub_date
2013-05-01 00:00:00pages
477-87issue
5eissn
1053-8569issn
1099-1557journal_volume
22pub_type
杂志文章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:To investigate suicide-related over-the-counter (OTC) analgesic medication exposures among individuals ≥6 years old reported to United States (US) poison control centers. METHODS:Data from the National Poison Data System for the years 2000-2018 were retrospectively analyzed. RESULTS:From 2000 to 2018, US pois...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4997
更新日期:2020-09-01 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 purpose of this paper is to describe the infrastructure of the total joint replacement registry of a large integrated healthcare system's and emphasize challenges associated with orthopedic device classification and evaluation. METHODS:Using a large integrated healthcare system innovative infrastructure in...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3228
更新日期:2012-05-01 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::The article is devoted to the establishment and development of the National Pharmacovigilance system in Ukraine. A drug safety centre of Ukraine started to form a pharmacovigilance system in 1996. It has been operating on a regular basis since 2000 and now provides the regulatory services that include data collection ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.886
更新日期:2004-03-01 00:00:00
abstract:PURPOSE:This study aimed to validate a predefined algorithm for osteonecrosis of the jaw (ONJ) among cancer patients in the Danish National Registry of Patients and to assess the nature of clinical information recorded in medical charts of ONJ patients. METHODS:We identified potential ONJ cases recorded in 2005-2010 a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3786
更新日期:2015-07-01 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: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:UK primary care databases are frequently used in observational studies with cancer outcomes. We aimed to systematically review methods used by such studies to identify and validate incident cancers of the breast, colorectum, and prostate. METHODS:Medline and Embase (1980-2013) were searched for UK primary care...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3729
更新日期:2015-01-01 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::Benzodiazepines belong to the most widely prescribed group of drugs and are involved in a large proportion of the acute poisonings seen in emergency departments. The aim of the study was to examine whether a relationship exists between the number of poisonings with different types of benzodiazepines and the number of ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199811/12)7:6<403::AID-PDS
更新日期:1998-11-01 00:00:00
abstract:PURPOSE:The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality. METHODS:A comprehensive analysis of data from three national surveillance systems estimated rates of acetaminophen-related events identified in different settings,...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3906
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:The Epidemiologic Registry of Cystic Fibrosis (ERCF) was a multicentre, longitudinal follow-up project of cystic fibrosis patients enrolled at some 200 centres in nine European countries between 1994 and 1999. PURPOSE:We aimed to assess and improve the quality of a subset of data from the ERCF relating to s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.804
更新日期:2003-09-01 00:00:00
abstract:PURPOSE:We developed a computerized system for signal detection in spontaneous reporting system (SRS) of Shanghai. Data acquisition, data mining could be carried out automatically and the process of data preprocessing and cleaning could be facilitated. This system was expected to detect signals from SRS after drug lice...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1695
更新日期:2009-02-01 00:00:00
abstract:UNLABELLED:Computerized hospital databases are used for clinical and economic research. In France, the hospital administrative database, Programme de médicalisation des systèmes d'information (PMSI), could be an interesting means for identifying cases of abuse and dependence in hospitals. PURPOSE:To assess the capabil...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3369
更新日期:2012-12-01 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:We developed an adverse events (AEs) reporting form for Korean folk medicine. METHODS:The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. RESULTS:We devel...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4077
更新日期:2017-05-01 00:00:00
abstract:PURPOSE:To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors. METHODS:We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of intere...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4285
更新日期:2017-10-01 00:00:00
abstract:PURPOSE:The study aimed to evaluate the comparative risk of oral ulcerations among antipsychotic medications. METHODS:We analyzed the National Health Insurance Research Database of Taiwan and included patients newly initiated with a single antipsychotic agent including haloperidol, sulpiride, olanzapine, quetiapine, r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3903
更新日期:2016-02-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to examine epidemiologic characteristics of Adverse Drug Events (ADEs) among children and adolescents presenting to an Emergency Department (ED) in Newfoundland and Labrador (NL), Canada. MATERIALS AND METHODS:This study was conducted in three phases and included an ED chart review...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1900
更新日期:2010-02-01 00:00:00
abstract:PURPOSE:Use of albumin (indications and quantities involved) has not been assessed in France since major changes occurred after the publication of Cochrane group meta-analysis. The objectives of this study were to measure the repartition of albumin indications in three French university hospitals in 2004 and to assess ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1328
更新日期:2007-01-01 00:00:00
abstract:AIM:The aim of the present study was to investigate to what extent patients using prescription antiobesity drugs (orlistat, sibutramine and rimonabant) concomitantly or concurrently used psychotropic drugs and analgesics and the association between this drug use and the patients' gender and age. An additional aim was t...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1896
更新日期:2010-03-01 00:00:00
abstract:PURPOSE:Research using healthcare databases often includes patients frequently excluded from clinical trials; yet it is not known whether commonly used data represents the overall population or specific sub-populations of interest. We aimed to examine population representativeness from data sources in recent research s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5087
更新日期:2020-11-01 00:00:00
abstract:PURPOSE:Three recent observational studies reported that the risk of fatal overdose is greater with venlafaxine than SSRI use. It is not clear whether patient factors could account for this finding. We evaluated whether risk factors for suicide are more prevalent among patients prescribed venlafaxine than patients pres...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1095
更新日期:2005-06-01 00:00:00
abstract:BACKGROUND:Studies demonstrate the potential for statins to prevent dementia and Alzheimer's disease (AD), but the evidence is inconclusive. OBJECTIVE:Conduct a meta-analysis to estimate any benefit of statins in preventing dementia and examine the potential effect of study design and confounding on the benefit of sta...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,meta分析
doi:10.1002/pds.3381
更新日期:2013-04-01 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:To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions and identify best practices for future evaluations. METHODS:We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empiri...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3480
更新日期:2013-09-01 00:00:00
abstract:PURPOSE:Gut microbiota has been postulated to serve as a significant promoter of CRC formation, and colonic dysbiosis was previously reported in CRC tissue. Our aim was to evaluate the association between the type and cumulative duration of antibiotic exposure and CRC risk. METHODS:We conducted a nested case-control s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3765
更新日期:2015-05-01 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