Assessment of anthrax vaccination data in the Defense Medical Surveillance System, 1998-2004

Purpose Understanding the completeness and accuracy of U.S. military anthrax vaccination data is important to the design and interpretation of studies to assess the safety of anthrax vaccine. We estimated the agreement between electronically recorded anthrax vaccination data in the Defense Medical S...

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Veröffentlicht in:Pharmacoepidemiology and drug safety 2007-06, Vol.16 (6), p.605-611
Hauptverfasser: Payne, Daniel C., Rose Jr, Charles E., Aranas, Aaron, Zhang, Yujia, Tolentino, Herman, Weston, Emily, McNeil, Michael M., Ruscio, Bruce
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container_end_page 611
container_issue 6
container_start_page 605
container_title Pharmacoepidemiology and drug safety
container_volume 16
creator Payne, Daniel C.
Rose Jr, Charles E.
Aranas, Aaron
Zhang, Yujia
Tolentino, Herman
Weston, Emily
McNeil, Michael M.
Ruscio, Bruce
description Purpose Understanding the completeness and accuracy of U.S. military anthrax vaccination data is important to the design and interpretation of studies to assess the safety of anthrax vaccine. We estimated the agreement between electronically recorded anthrax vaccination data in the Defense Medical Surveillance System (DMSS) versus anthrax vaccination data ed from hardcopy medical charts in a representative sample of the U.S. military from 1998 to 2004. Methods Medical chart ions were conducted at 28 military treatment facilities for 4201 personnel. ed anthrax vaccination data for 1817 personnel, representing 7400 anthrax vaccine doses, were compared with electronically captured data in the DMSS from 1998 to 2004. Sensitivity, positive predictive value (PPV), specificity and negative predictive value (NPV) were calculated using weighted analyses. Results Weighted person‐level analysis revealed DMSS sensitivity = 93.8% (95%CI = 91.1, 95.8), specificity = 87.0% (79.0, 92.3), PPV = 85.6% (77.2, 91.3) and NPV = 94.5% (91.7, 96.4). Report of anthrax vaccination within a ±7 days window in both medical chart and DMSS electronic data had a sensitivity of 88.3% (85.4, 90.7) and a PPV of 86.6% (84.9, 88.2) in the vaccine dose‐level analysis. Conclusions These results support that anthrax vaccination data captured by the DMSS are adequate for post‐marketing surveillance investigations in the U.S. military and are of comparable quality to data captured by other vaccine safety databases. Copyright © 2007 John Wiley & Sons, Ltd.
doi_str_mv 10.1002/pds.1395
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We estimated the agreement between electronically recorded anthrax vaccination data in the Defense Medical Surveillance System (DMSS) versus anthrax vaccination data ed from hardcopy medical charts in a representative sample of the U.S. military from 1998 to 2004. Methods Medical chart ions were conducted at 28 military treatment facilities for 4201 personnel. ed anthrax vaccination data for 1817 personnel, representing 7400 anthrax vaccine doses, were compared with electronically captured data in the DMSS from 1998 to 2004. Sensitivity, positive predictive value (PPV), specificity and negative predictive value (NPV) were calculated using weighted analyses. Results Weighted person‐level analysis revealed DMSS sensitivity = 93.8% (95%CI = 91.1, 95.8), specificity = 87.0% (79.0, 92.3), PPV = 85.6% (77.2, 91.3) and NPV = 94.5% (91.7, 96.4). Report of anthrax vaccination within a ±7 days window in both medical chart and DMSS electronic data had a sensitivity of 88.3% (85.4, 90.7) and a PPV of 86.6% (84.9, 88.2) in the vaccine dose‐level analysis. Conclusions These results support that anthrax vaccination data captured by the DMSS are adequate for post‐marketing surveillance investigations in the U.S. military and are of comparable quality to data captured by other vaccine safety databases. Copyright © 2007 John Wiley &amp; Sons, Ltd.</description><identifier>ISSN: 1053-8569</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.1395</identifier><identifier>PMID: 17437247</identifier><language>eng</language><publisher>Chichester, UK: John Wiley &amp; Sons, Ltd</publisher><subject>Adolescent ; Adult ; Aged ; anthrax vaccine ; anthrax vaccine adsorbed (AVA) ; Anthrax Vaccines - adverse effects ; Defense Medical Surveillance System (DMSS) ; Female ; Humans ; Male ; Medical Records ; Middle Aged ; Military Personnel ; military vaccination records ; post-marketing surveillance ; Product Surveillance, Postmarketing ; Time Factors ; Vaccination - adverse effects ; vaccine safety</subject><ispartof>Pharmacoepidemiology and drug safety, 2007-06, Vol.16 (6), p.605-611</ispartof><rights>Copyright © 2007 John Wiley &amp; Sons, Ltd.</rights><rights>Copyright (c) 2007 John Wiley &amp; Sons, Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3575-ea9f7de254204180c0444491164980170365146f1eeb56dedaffa5d02662aee23</citedby><cites>FETCH-LOGICAL-c3575-ea9f7de254204180c0444491164980170365146f1eeb56dedaffa5d02662aee23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fpds.1395$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fpds.1395$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17437247$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Payne, Daniel C.</creatorcontrib><creatorcontrib>Rose Jr, Charles E.</creatorcontrib><creatorcontrib>Aranas, Aaron</creatorcontrib><creatorcontrib>Zhang, Yujia</creatorcontrib><creatorcontrib>Tolentino, Herman</creatorcontrib><creatorcontrib>Weston, Emily</creatorcontrib><creatorcontrib>McNeil, Michael M.</creatorcontrib><creatorcontrib>Ruscio, Bruce</creatorcontrib><title>Assessment of anthrax vaccination data in the Defense Medical Surveillance System, 1998-2004</title><title>Pharmacoepidemiology and drug safety</title><addtitle>Pharmacoepidem. Drug Safe</addtitle><description>Purpose Understanding the completeness and accuracy of U.S. military anthrax vaccination data is important to the design and interpretation of studies to assess the safety of anthrax vaccine. We estimated the agreement between electronically recorded anthrax vaccination data in the Defense Medical Surveillance System (DMSS) versus anthrax vaccination data ed from hardcopy medical charts in a representative sample of the U.S. military from 1998 to 2004. Methods Medical chart ions were conducted at 28 military treatment facilities for 4201 personnel. ed anthrax vaccination data for 1817 personnel, representing 7400 anthrax vaccine doses, were compared with electronically captured data in the DMSS from 1998 to 2004. Sensitivity, positive predictive value (PPV), specificity and negative predictive value (NPV) were calculated using weighted analyses. Results Weighted person‐level analysis revealed DMSS sensitivity = 93.8% (95%CI = 91.1, 95.8), specificity = 87.0% (79.0, 92.3), PPV = 85.6% (77.2, 91.3) and NPV = 94.5% (91.7, 96.4). Report of anthrax vaccination within a ±7 days window in both medical chart and DMSS electronic data had a sensitivity of 88.3% (85.4, 90.7) and a PPV of 86.6% (84.9, 88.2) in the vaccine dose‐level analysis. Conclusions These results support that anthrax vaccination data captured by the DMSS are adequate for post‐marketing surveillance investigations in the U.S. military and are of comparable quality to data captured by other vaccine safety databases. Copyright © 2007 John Wiley &amp; Sons, Ltd.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>anthrax vaccine</subject><subject>anthrax vaccine adsorbed (AVA)</subject><subject>Anthrax Vaccines - adverse effects</subject><subject>Defense Medical Surveillance System (DMSS)</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medical Records</subject><subject>Middle Aged</subject><subject>Military Personnel</subject><subject>military vaccination records</subject><subject>post-marketing surveillance</subject><subject>Product Surveillance, Postmarketing</subject><subject>Time Factors</subject><subject>Vaccination - adverse effects</subject><subject>vaccine safety</subject><issn>1053-8569</issn><issn>1099-1557</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kMtKw0AUQAdRfINfILMSF6beSeaRWUqrVmhVqI-NMEyTGxzNo2YStX9vSoOunM0duIfD5RByxGDAAMLzReoHLNJig-wy0DpgQqjN1V9EQSyk3iF73r8BdDvNt8kOUzxSIVe75OXCe_S-wLKhVUZt2bzW9pt-2iRxpW1cVdLUNpa6kjavSEeYYemRTjF1ic3prK0_0eW5LROks6VvsDijTOs4CAH4AdnKbO7xsJ_75PHq8mE4DiZ31zfDi0mQREKJAK3OVIqh4CFwFkMCvHuaMcl1DExBJAXjMmOIcyFTTG2WWZFCKGVoEcNon5ysvYu6-mjRN6ZwPsHVWVi13iiQwDSPO_B0DSZ15X2NmVnUrrD10jAwq5KmK2lWJTv0uHe28wLTP7BP1wHBGvhyOS7_FZn70awX9rzrKn3_8rZ-N1JFSpjn22sjxnE8EdMncxv9AJT6icU</recordid><startdate>200706</startdate><enddate>200706</enddate><creator>Payne, Daniel C.</creator><creator>Rose Jr, Charles E.</creator><creator>Aranas, Aaron</creator><creator>Zhang, Yujia</creator><creator>Tolentino, Herman</creator><creator>Weston, Emily</creator><creator>McNeil, Michael M.</creator><creator>Ruscio, Bruce</creator><general>John Wiley &amp; Sons, Ltd</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200706</creationdate><title>Assessment of anthrax vaccination data in the Defense Medical Surveillance System, 1998-2004</title><author>Payne, Daniel C. ; Rose Jr, Charles E. ; Aranas, Aaron ; Zhang, Yujia ; Tolentino, Herman ; Weston, Emily ; McNeil, Michael M. ; Ruscio, Bruce</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3575-ea9f7de254204180c0444491164980170365146f1eeb56dedaffa5d02662aee23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>anthrax vaccine</topic><topic>anthrax vaccine adsorbed (AVA)</topic><topic>Anthrax Vaccines - adverse effects</topic><topic>Defense Medical Surveillance System (DMSS)</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical Records</topic><topic>Middle Aged</topic><topic>Military Personnel</topic><topic>military vaccination records</topic><topic>post-marketing surveillance</topic><topic>Product Surveillance, Postmarketing</topic><topic>Time Factors</topic><topic>Vaccination - adverse effects</topic><topic>vaccine safety</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Payne, Daniel C.</creatorcontrib><creatorcontrib>Rose Jr, Charles E.</creatorcontrib><creatorcontrib>Aranas, Aaron</creatorcontrib><creatorcontrib>Zhang, Yujia</creatorcontrib><creatorcontrib>Tolentino, Herman</creatorcontrib><creatorcontrib>Weston, Emily</creatorcontrib><creatorcontrib>McNeil, Michael M.</creatorcontrib><creatorcontrib>Ruscio, Bruce</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmacoepidemiology and drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Payne, Daniel C.</au><au>Rose Jr, Charles E.</au><au>Aranas, Aaron</au><au>Zhang, Yujia</au><au>Tolentino, Herman</au><au>Weston, Emily</au><au>McNeil, Michael M.</au><au>Ruscio, Bruce</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessment of anthrax vaccination data in the Defense Medical Surveillance System, 1998-2004</atitle><jtitle>Pharmacoepidemiology and drug safety</jtitle><addtitle>Pharmacoepidem. Drug Safe</addtitle><date>2007-06</date><risdate>2007</risdate><volume>16</volume><issue>6</issue><spage>605</spage><epage>611</epage><pages>605-611</pages><issn>1053-8569</issn><eissn>1099-1557</eissn><abstract>Purpose Understanding the completeness and accuracy of U.S. military anthrax vaccination data is important to the design and interpretation of studies to assess the safety of anthrax vaccine. We estimated the agreement between electronically recorded anthrax vaccination data in the Defense Medical Surveillance System (DMSS) versus anthrax vaccination data ed from hardcopy medical charts in a representative sample of the U.S. military from 1998 to 2004. Methods Medical chart ions were conducted at 28 military treatment facilities for 4201 personnel. ed anthrax vaccination data for 1817 personnel, representing 7400 anthrax vaccine doses, were compared with electronically captured data in the DMSS from 1998 to 2004. Sensitivity, positive predictive value (PPV), specificity and negative predictive value (NPV) were calculated using weighted analyses. Results Weighted person‐level analysis revealed DMSS sensitivity = 93.8% (95%CI = 91.1, 95.8), specificity = 87.0% (79.0, 92.3), PPV = 85.6% (77.2, 91.3) and NPV = 94.5% (91.7, 96.4). Report of anthrax vaccination within a ±7 days window in both medical chart and DMSS electronic data had a sensitivity of 88.3% (85.4, 90.7) and a PPV of 86.6% (84.9, 88.2) in the vaccine dose‐level analysis. Conclusions These results support that anthrax vaccination data captured by the DMSS are adequate for post‐marketing surveillance investigations in the U.S. military and are of comparable quality to data captured by other vaccine safety databases. Copyright © 2007 John Wiley &amp; Sons, Ltd.</abstract><cop>Chichester, UK</cop><pub>John Wiley &amp; Sons, Ltd</pub><pmid>17437247</pmid><doi>10.1002/pds.1395</doi><tpages>7</tpages></addata></record>
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subjects Adolescent
Adult
Aged
anthrax vaccine
anthrax vaccine adsorbed (AVA)
Anthrax Vaccines - adverse effects
Defense Medical Surveillance System (DMSS)
Female
Humans
Male
Medical Records
Middle Aged
Military Personnel
military vaccination records
post-marketing surveillance
Product Surveillance, Postmarketing
Time Factors
Vaccination - adverse effects
vaccine safety
title Assessment of anthrax vaccination data in the Defense Medical Surveillance System, 1998-2004
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