Abstract:
PURPOSE:Pre-licensure studies have limited ability to detect rare adverse events (AEs) to vaccines, requiring timely post-licensure studies. With the increasing availability of electronic health records (EHR) near real-time vaccine safety surveillance using these data has emerged as an option. We reviewed methods currently used to inform development of similar systems for countries considering their introduction. METHODS:Medline, EMBASE and Web of Science were searched, with additional searches of conference abstract books. Questionnaires were sent to organizations worldwide to ascertain unpublished studies. Eligible studies used EHR and regularly assessed pre-specified AE to vaccine(s). Key features of studies were compared descriptively. RESULTS:From 2779 studies, 31 were included from the USA (23), UK (6), and Taiwan and New Zealand (1 each). These were published/conducted between May 2005 and April 2015. Thirty-eight different vaccines were studied, focusing mainly on influenza (47.4%), especially 2009 H1N1 vaccines. Forty-six analytic approaches were used, reflecting frequency of EHR updates and the AE studied. Poisson-based maximized sequential probability ratio test was the most common (43.5%), followed by its binomial (23.9%) and conditional versions (10.9%). Thirty-seven of 49 analyses (75.5%) mentioned control for confounding, using an adjusted expected rate (51.4% of those adjusting), stratification (16.2%) or a combination of a self-controlled design and stratification (13.5%). Guillain-Barré syndrome (11.9%), meningitis/encephalitis/myelitis (11.9%) and seizures (10.8%) were studied most often. CONCLUSIONS:Near real-time vaccine safety surveillance using EHR has developed over the past decade but is not yet widely used. As more countries have access to EHR, it will be important that appropriate methods are selected, considering the data available and AE of interest.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Leite A,Andrews NJ,Thomas SLdoi
10.1002/pds.3966subject
Has Abstractpub_date
2016-03-01 00:00:00pages
225-37issue
3eissn
1053-8569issn
1099-1557journal_volume
25pub_type
杂志文章,评审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
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
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journal_title:Pharmacoepidemiology and drug safety
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更新日期:2017-10-01 00:00:00
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更新日期:2016-05-01 00:00:00
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更新日期:2017-06-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.841
更新日期:2003-12-01 00:00:00
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pub_type: 杂志文章
doi:10.1002/pds.3520
更新日期:2013-11-01 00:00:00
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pub_type: 杂志文章
doi:10.1002/pds.1095
更新日期:2005-06-01 00:00:00
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pub_type: 杂志文章
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更新日期:2015-01-01 00:00:00
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pub_type: 杂志文章
doi:10.1002/pds.1778
更新日期:2009-09-01 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2004-08-01 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:2020-09-01 00:00:00
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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
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pub_type: 杂志文章
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更新日期:2017-02-01 00:00:00
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pub_type: 杂志文章
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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
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更新日期:2019-06-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.596
更新日期:2001-08-01 00:00:00
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pub_type: 杂志文章,随机对照试验
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更新日期:2014-01-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199707)6:4<283::AID-PDS270
更新日期:1997-07-01 00:00:00