Unmasking in an observational vaccine safety study: Using type 2 diabetes mellitus as an example
Highlights • Establishing the timing of adverse events is essential to vaccine safety studies. • Pre-existing conditions are usually excluded from safety analysis. • Exclusion of T2DM on or prior to Day 0 does not reliably exclude all pre-existing T2DM. • Work up performed at the time of vaccination...
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| Veröffentlicht in: | Vaccine 2015-11, Vol.33 (46), p.6224-6226 |
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| container_issue | 46 |
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| container_title | Vaccine |
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| creator | Ackerson, Bradley K Sy, Lina S Slezak, Jeff Chao, Chun R Hechter, Rulin C Takhar, Harpreet S Jacobsen, Steven J |
| description | Highlights • Establishing the timing of adverse events is essential to vaccine safety studies. • Pre-existing conditions are usually excluded from safety analysis. • Exclusion of T2DM on or prior to Day 0 does not reliably exclude all pre-existing T2DM. • Work up performed at the time of vaccination may unmask pre-existing conditions. • Chart review may be required to assess whether symptom onset preceded vaccination. |
| doi_str_mv | 10.1016/j.vaccine.2015.09.080 |
| format | Article |
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All rights reserved.</rights><rights>Copyright Elsevier Limited Nov 17, 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c481t-a4cd407f8904f9d9b959d3856ba7c38ce2020aad168e5e7d359dfb399da2f6983</citedby><cites>FETCH-LOGICAL-c481t-a4cd407f8904f9d9b959d3856ba7c38ce2020aad168e5e7d359dfb399da2f6983</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1732853274?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26440925$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ackerson, Bradley K</creatorcontrib><creatorcontrib>Sy, Lina S</creatorcontrib><creatorcontrib>Slezak, Jeff</creatorcontrib><creatorcontrib>Chao, Chun R</creatorcontrib><creatorcontrib>Hechter, Rulin C</creatorcontrib><creatorcontrib>Takhar, Harpreet S</creatorcontrib><creatorcontrib>Jacobsen, Steven J</creatorcontrib><title>Unmasking in an observational vaccine safety study: Using type 2 diabetes mellitus as an example</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Highlights • Establishing the timing of adverse events is essential to vaccine safety studies. • Pre-existing conditions are usually excluded from safety analysis. • Exclusion of T2DM on or prior to Day 0 does not reliably exclude all pre-existing T2DM. • Work up performed at the time of vaccination may unmask pre-existing conditions. • Chart review may be required to assess whether symptom onset preceded vaccination.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Adverse event</subject><subject>Allergy and Immunology</subject><subject>Automation</subject><subject>Bias</subject><subject>California</subject><subject>Child</subject><subject>Codes</subject><subject>Computerized physician order entry</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - 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Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ackerson, Bradley K</au><au>Sy, Lina S</au><au>Slezak, Jeff</au><au>Chao, Chun R</au><au>Hechter, Rulin C</au><au>Takhar, Harpreet S</au><au>Jacobsen, Steven J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Unmasking in an observational vaccine safety study: Using type 2 diabetes mellitus as an example</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2015-11-17</date><risdate>2015</risdate><volume>33</volume><issue>46</issue><spage>6224</spage><epage>6226</epage><pages>6224-6226</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>Highlights • Establishing the timing of adverse events is essential to vaccine safety studies. • Pre-existing conditions are usually excluded from safety analysis. • Exclusion of T2DM on or prior to Day 0 does not reliably exclude all pre-existing T2DM. • Work up performed at the time of vaccination may unmask pre-existing conditions. • Chart review may be required to assess whether symptom onset preceded vaccination.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>26440925</pmid><doi>10.1016/j.vaccine.2015.09.080</doi><tpages>3</tpages></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete; ProQuest Central |
| subjects | Adolescent Adult Adverse event Allergy and Immunology Automation Bias California Child Codes Computerized physician order entry Diabetes Diabetes Mellitus, Type 2 - chemically induced Diabetes Mellitus, Type 2 - epidemiology Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - pathology Emergency medical services Female Human papillomavirus Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 - administration & dosage Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 - adverse effects Humans Laboratories Licenses Medical records Methodology Papillomavirus Infections - prevention & control Product Surveillance, Postmarketing - methods Safety Studies Surveillance Vaccine safety Vaccines Young Adult Young adults |
| title | Unmasking in an observational vaccine safety study: Using type 2 diabetes mellitus as an example |
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