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 countries (Denmark, Italy, Netherlands, the UK) were pooled using a distributed network approach by generation of common input data followed by local aggregation through custom-built software, Jerboa(©). Comparison of incidence rates of upper gastrointestinal bleeding (UGIB) and nonsteroidal anti-inflammatory drug (NSAID) utilization patterns were used to evaluate data harmonization and quality across databases. The known association of NSAIDs and UGIB was employed to demonstrate sensitivity of the system by comparing incidence rate ratios (IRRs) of UGIB during NSAID use to UGIB during all other person-time. RESULTS:The study population for this analysis comprised 19,647,445 individuals corresponding to 59,929,690 person-years of follow-up. 39,967 incident cases of UGIB were identified during the study period. Crude incidence rates varied between 38.8 and 109.5/100,000 person-years, depending on country and type of database, while age-standardized rates ranged from 25.1 to 65.4/100,000 person-years. NSAID use patterns were similar for databases within the same country but heterogeneous among different countries. A statistically significant age- and gender-adjusted association between use of any NSAID and increased risk for UGIB was confirmed in all databases, IRR from 2.0 (95%CI:1.7-2.2) to 4.3 (95%CI: 4.1-4.5). CONCLUSIONS:Combining data from EHR databases of different countries to identify drug-adverse event associations is feasible and can set the stage for changing and enlarging the scale for drug safety monitoring.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Coloma PM,Schuemie MJ,Trifirò G,Gini R,Herings R,Hippisley-Cox J,Mazzaglia G,Giaquinto C,Corrao G,Pedersen L,van der Lei J,Sturkenboom M,EU-ADR Consortium.doi
10.1002/pds.2053subject
Has Abstractpub_date
2011-01-01 00:00:00pages
1-11issue
1eissn
1053-8569issn
1099-1557journal_volume
20pub_type
杂志文章abstract:PURPOSE:To investigate a possible increased risk of esophageal obstruction among users of loratadine and pseudoephedrine (Claritin-D 24-Hour [C-D 24], the original, round, extended-release formulation) compared to two other tablet formulations of loratadine. METHODS:Pharmacy data of 12 managed care plans were screened...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.816
更新日期:2004-01-01 00:00:00
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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:vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggeste...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4247
更新日期:2017-08-01 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::The current medical care environment has created expectations that exceed its capabilities, one effect of which has been an increasing awareness of lapses in the quality of healthcare, including medical errors. As more new therapies reach clinical application, the expectations on the part of the public are unlikely to...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.699
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1764
更新日期:2009-08-01 00:00:00
abstract::Dr. Walker asserts that a hypothesis always can be tested using the same data source that generated the data if the test data are independent of the data generating the hypothesis. One way to do this is to use part of the totality of data to generate the hypothesis and the other to test the hypothesis. The validity of...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 评论,杂志文章
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更新日期:2010-05-01 00:00:00
abstract:PURPOSE:To validate the recorded diagnoses of colorectal cancer (CRC) and identify false negatives in The Health Improvement Network (THIN) primary care database. METHODS:We conducted a validation study of incident CRC cases in THIN among patients aged 40-89 years from 2000-2011. CRC Read code entries (N = 3805) were ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3877
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2011-12-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3996
更新日期:2016-08-01 00:00:00
abstract:INTRODUCTION:Cancer-related fatigue (CRF) has been suggested to be associated with the occurrence of chemotherapy-induced nausea and vomiting (CINV). This study aims to evaluate the potential of CRF in predicting the occurrence of CINV. METHOD:This is a prospective, observational study. Recruited patients received mod...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3516
更新日期:2013-12-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2169
更新日期:2012-02-01 00:00:00
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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
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4277
更新日期:2017-10-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4387
更新日期:2018-03-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4646
更新日期:2018-11-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4056
更新日期:2016-09-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4648
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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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
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4278
更新日期:2018-05-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
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更新日期:2019-07-01 00:00:00
abstract:PURPOSE:To estimate 1-year prevalence, 1-year incidence and indication of use of antidepressant (AD) drug treatment in general practice of Southern Italy during the years 2003-2004. METHODS:Among 142,346 individuals registered in the lists of 119 general practitioners of Southern Italy, we identified users of differen...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2007-05-01 00:00:00
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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
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2254
更新日期:2011-11-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.554
更新日期:2000-12-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2004-10-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3390
更新日期:2013-04-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:1997-11-01 00:00:00