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Congenital Cytomegalovirus Testing Outcomes From the ValEAR Trial
Objective To determine the positivity rate of congenital cytomegalovirus (cCMV) testing among universal, hearing‐targeted CMV testing (HT‐cCMV) and delayed targeted dried blood spot (DBS) testing newborn screening programs, and to examine the characteristics of successful HT‐cCMV testing programs. S...
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Published in: | Otolaryngology-head and neck surgery 2024-05, Vol.170 (5), p.1430-1441 |
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creator | Orb, Quinn T. Pesch, Megan Allen, Chelsea M. Wilkes, Ashlea Ahmad, Iram Alfonso, Kristan Antonio, Stephanie Moody Mithal, Leena Bhattacharya Brinkmeier, Jennifer V. Carvalho, Daniela Chan, Dylan Cheng, Alan G. Chi, David Cohen, Michael Discolo, Christopher Michael Duran, Carlos Germiller, John Gibson, Laura Grunstein, Eli Harrison, Gail Lee, Kenneth Hawley, Karen Kohlhoff, Stephan Melvin, Ann MacArthur, Carol Nassar, Michel Neff, Laura Pecha, Phayvanh Salvatore, Christine Schoem, Scott Virgin, Frank Saunders, James Schleiss, Mark Smith, Richard J. H. Sood, Sunil Park, Albert H. |
description | Objective
To determine the positivity rate of congenital cytomegalovirus (cCMV) testing among universal, hearing‐targeted CMV testing (HT‐cCMV) and delayed targeted dried blood spot (DBS) testing newborn screening programs, and to examine the characteristics of successful HT‐cCMV testing programs.
Study Design
Prospective survey of birth hospitals performing early CMV testing.
Setting
Multiple institutions.
Methods
Birth hospitals participating in the National Institutes of Health ValEAR clinical trial were surveyed to determine the rates of cCMV positivity associated with 3 different testing approaches: universal testing, HT‐cCMV, and DBS testing. A mixed methods model was created to determine associations between successful HT‐cCMV screening and specific screening protocols.
Results
Eighty‐two birth hospitals were surveyed from February 2019 to December 2021. Seven thousand six hundred seventy infants underwent universal screening, 9017 infants HT‐cCMV and 535 infants delayed DBS testing. The rates of cCMV positivity were 0.5%, 1.5%, and 7.3%, respectively. The positivity rate for universal CMV screening was less during the COVID‐19 pandemic than that reported prior to the pandemic. There were no statistically significant drops in positivity for any approach during the pandemic. For HT‐cCMV testing, unique order sets and rigorous posttesting protocols were associated with successful screening programs.
Conclusion
Rates of cCMV positivity differed among the 3 approaches. The rates are comparable to cohort studies reported in the literature. Universal CMV prevalence decreased during the pandemic but not significantly. Institutions with specific order set for CMV testing where the primary care physician orders the test and the nurse facilitates the testing process exhibited higher rates of HT‐cCMV testing. |
doi_str_mv | 10.1002/ohn.670 |
format | article |
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To determine the positivity rate of congenital cytomegalovirus (cCMV) testing among universal, hearing‐targeted CMV testing (HT‐cCMV) and delayed targeted dried blood spot (DBS) testing newborn screening programs, and to examine the characteristics of successful HT‐cCMV testing programs.
Study Design
Prospective survey of birth hospitals performing early CMV testing.
Setting
Multiple institutions.
Methods
Birth hospitals participating in the National Institutes of Health ValEAR clinical trial were surveyed to determine the rates of cCMV positivity associated with 3 different testing approaches: universal testing, HT‐cCMV, and DBS testing. A mixed methods model was created to determine associations between successful HT‐cCMV screening and specific screening protocols.
Results
Eighty‐two birth hospitals were surveyed from February 2019 to December 2021. Seven thousand six hundred seventy infants underwent universal screening, 9017 infants HT‐cCMV and 535 infants delayed DBS testing. The rates of cCMV positivity were 0.5%, 1.5%, and 7.3%, respectively. The positivity rate for universal CMV screening was less during the COVID‐19 pandemic than that reported prior to the pandemic. There were no statistically significant drops in positivity for any approach during the pandemic. For HT‐cCMV testing, unique order sets and rigorous posttesting protocols were associated with successful screening programs.
Conclusion
Rates of cCMV positivity differed among the 3 approaches. The rates are comparable to cohort studies reported in the literature. Universal CMV prevalence decreased during the pandemic but not significantly. Institutions with specific order set for CMV testing where the primary care physician orders the test and the nurse facilitates the testing process exhibited higher rates of HT‐cCMV testing.</description><identifier>ISSN: 0194-5998</identifier><identifier>EISSN: 1097-6817</identifier><identifier>DOI: 10.1002/ohn.670</identifier><identifier>PMID: 38415855</identifier><language>eng</language><publisher>England</publisher><subject>congenital cytomegalovirus ; COVID-19 - diagnosis ; COVID-19 - epidemiology ; Cytomegalovirus Infections - congenital ; Cytomegalovirus Infections - diagnosis ; Cytomegalovirus Infections - epidemiology ; Dried Blood Spot Testing ; Female ; hearing‐targeted cytomegalovirus testing ; Humans ; Infant, Newborn ; Male ; Neonatal Screening - methods ; pediatric hearing loss ; Prospective Studies ; United States - epidemiology ; universal cytomegalovirus testing</subject><ispartof>Otolaryngology-head and neck surgery, 2024-05, Vol.170 (5), p.1430-1441</ispartof><rights>2024 American Academy of Otolaryngology–Head and Neck Surgery Foundation.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3120-40f5916e1978a47d62742508646945a5c3d4913158fb62d11006b1cbfbb6eb723</cites><orcidid>0000-0003-4672-674X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38415855$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Orb, Quinn T.</creatorcontrib><creatorcontrib>Pesch, Megan</creatorcontrib><creatorcontrib>Allen, Chelsea M.</creatorcontrib><creatorcontrib>Wilkes, Ashlea</creatorcontrib><creatorcontrib>Ahmad, Iram</creatorcontrib><creatorcontrib>Alfonso, Kristan</creatorcontrib><creatorcontrib>Antonio, Stephanie Moody</creatorcontrib><creatorcontrib>Mithal, Leena Bhattacharya</creatorcontrib><creatorcontrib>Brinkmeier, Jennifer V.</creatorcontrib><creatorcontrib>Carvalho, Daniela</creatorcontrib><creatorcontrib>Chan, Dylan</creatorcontrib><creatorcontrib>Cheng, Alan G.</creatorcontrib><creatorcontrib>Chi, David</creatorcontrib><creatorcontrib>Cohen, Michael</creatorcontrib><creatorcontrib>Discolo, Christopher Michael</creatorcontrib><creatorcontrib>Duran, Carlos</creatorcontrib><creatorcontrib>Germiller, John</creatorcontrib><creatorcontrib>Gibson, Laura</creatorcontrib><creatorcontrib>Grunstein, Eli</creatorcontrib><creatorcontrib>Harrison, Gail</creatorcontrib><creatorcontrib>Lee, Kenneth</creatorcontrib><creatorcontrib>Hawley, Karen</creatorcontrib><creatorcontrib>Kohlhoff, Stephan</creatorcontrib><creatorcontrib>Melvin, Ann</creatorcontrib><creatorcontrib>MacArthur, Carol</creatorcontrib><creatorcontrib>Nassar, Michel</creatorcontrib><creatorcontrib>Neff, Laura</creatorcontrib><creatorcontrib>Pecha, Phayvanh</creatorcontrib><creatorcontrib>Salvatore, Christine</creatorcontrib><creatorcontrib>Schoem, Scott</creatorcontrib><creatorcontrib>Virgin, Frank</creatorcontrib><creatorcontrib>Saunders, James</creatorcontrib><creatorcontrib>Schleiss, Mark</creatorcontrib><creatorcontrib>Smith, Richard J. H.</creatorcontrib><creatorcontrib>Sood, Sunil</creatorcontrib><creatorcontrib>Park, Albert H.</creatorcontrib><title>Congenital Cytomegalovirus Testing Outcomes From the ValEAR Trial</title><title>Otolaryngology-head and neck surgery</title><addtitle>Otolaryngol Head Neck Surg</addtitle><description>Objective
To determine the positivity rate of congenital cytomegalovirus (cCMV) testing among universal, hearing‐targeted CMV testing (HT‐cCMV) and delayed targeted dried blood spot (DBS) testing newborn screening programs, and to examine the characteristics of successful HT‐cCMV testing programs.
Study Design
Prospective survey of birth hospitals performing early CMV testing.
Setting
Multiple institutions.
Methods
Birth hospitals participating in the National Institutes of Health ValEAR clinical trial were surveyed to determine the rates of cCMV positivity associated with 3 different testing approaches: universal testing, HT‐cCMV, and DBS testing. A mixed methods model was created to determine associations between successful HT‐cCMV screening and specific screening protocols.
Results
Eighty‐two birth hospitals were surveyed from February 2019 to December 2021. Seven thousand six hundred seventy infants underwent universal screening, 9017 infants HT‐cCMV and 535 infants delayed DBS testing. The rates of cCMV positivity were 0.5%, 1.5%, and 7.3%, respectively. The positivity rate for universal CMV screening was less during the COVID‐19 pandemic than that reported prior to the pandemic. There were no statistically significant drops in positivity for any approach during the pandemic. For HT‐cCMV testing, unique order sets and rigorous posttesting protocols were associated with successful screening programs.
Conclusion
Rates of cCMV positivity differed among the 3 approaches. The rates are comparable to cohort studies reported in the literature. Universal CMV prevalence decreased during the pandemic but not significantly. Institutions with specific order set for CMV testing where the primary care physician orders the test and the nurse facilitates the testing process exhibited higher rates of HT‐cCMV testing.</description><subject>congenital cytomegalovirus</subject><subject>COVID-19 - diagnosis</subject><subject>COVID-19 - epidemiology</subject><subject>Cytomegalovirus Infections - congenital</subject><subject>Cytomegalovirus Infections - diagnosis</subject><subject>Cytomegalovirus Infections - epidemiology</subject><subject>Dried Blood Spot Testing</subject><subject>Female</subject><subject>hearing‐targeted cytomegalovirus testing</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Male</subject><subject>Neonatal Screening - methods</subject><subject>pediatric hearing loss</subject><subject>Prospective Studies</subject><subject>United States - epidemiology</subject><subject>universal cytomegalovirus testing</subject><issn>0194-5998</issn><issn>1097-6817</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp1kF1LwzAUQIMobk7xH0jfFKQzSfPRPI6yOWE4kOlrSNt0q6TNTFrH_r0Zm775dB_u4XDvAeAWwTGCED_ZTTtmHJ6BIYKCxyxF_BwMIRIkpkKkA3Dl_SeEkDHOL8EgSQmiKaVDMMlsu9Zt3SkTZfvONnqtjP2uXe-jlfZd3a6jZd8VYeGjmbNN1G109KHMdPIWrVytzDW4qJTx-uY0R-B9Nl1l83ixfH7JJou4SBCGMYEVFYhpJHiqCC8Z5gRTmDLCBKGKFklJBErCWVXOcInCWyxHRV7lOdM5x8kIPBy9W2e_-nCabGpfaGNUq23vJRYJFgRiyAJ6f0QLZ713upJbVzfK7SWC8tBLhl4y9Ark3Una540u_7jfQAF4PAK72uj9fx65nL8edD-5CXFq</recordid><startdate>202405</startdate><enddate>202405</enddate><creator>Orb, Quinn T.</creator><creator>Pesch, Megan</creator><creator>Allen, Chelsea M.</creator><creator>Wilkes, Ashlea</creator><creator>Ahmad, Iram</creator><creator>Alfonso, Kristan</creator><creator>Antonio, Stephanie Moody</creator><creator>Mithal, Leena Bhattacharya</creator><creator>Brinkmeier, Jennifer V.</creator><creator>Carvalho, Daniela</creator><creator>Chan, Dylan</creator><creator>Cheng, Alan G.</creator><creator>Chi, David</creator><creator>Cohen, Michael</creator><creator>Discolo, Christopher Michael</creator><creator>Duran, Carlos</creator><creator>Germiller, John</creator><creator>Gibson, Laura</creator><creator>Grunstein, Eli</creator><creator>Harrison, Gail</creator><creator>Lee, Kenneth</creator><creator>Hawley, Karen</creator><creator>Kohlhoff, Stephan</creator><creator>Melvin, Ann</creator><creator>MacArthur, Carol</creator><creator>Nassar, Michel</creator><creator>Neff, Laura</creator><creator>Pecha, Phayvanh</creator><creator>Salvatore, Christine</creator><creator>Schoem, Scott</creator><creator>Virgin, Frank</creator><creator>Saunders, James</creator><creator>Schleiss, Mark</creator><creator>Smith, Richard J. H.</creator><creator>Sood, Sunil</creator><creator>Park, Albert H.</creator><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><orcidid>https://orcid.org/0000-0003-4672-674X</orcidid></search><sort><creationdate>202405</creationdate><title>Congenital Cytomegalovirus Testing Outcomes From the ValEAR Trial</title><author>Orb, Quinn T. ; Pesch, Megan ; Allen, Chelsea M. ; Wilkes, Ashlea ; Ahmad, Iram ; Alfonso, Kristan ; Antonio, Stephanie Moody ; Mithal, Leena Bhattacharya ; Brinkmeier, Jennifer V. ; Carvalho, Daniela ; Chan, Dylan ; Cheng, Alan G. ; Chi, David ; Cohen, Michael ; Discolo, Christopher Michael ; Duran, Carlos ; Germiller, John ; Gibson, Laura ; Grunstein, Eli ; Harrison, Gail ; Lee, Kenneth ; Hawley, Karen ; Kohlhoff, Stephan ; Melvin, Ann ; MacArthur, Carol ; Nassar, Michel ; Neff, Laura ; Pecha, Phayvanh ; Salvatore, Christine ; Schoem, Scott ; Virgin, Frank ; Saunders, James ; Schleiss, Mark ; Smith, Richard J. H. ; Sood, Sunil ; Park, Albert H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3120-40f5916e1978a47d62742508646945a5c3d4913158fb62d11006b1cbfbb6eb723</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>congenital cytomegalovirus</topic><topic>COVID-19 - diagnosis</topic><topic>COVID-19 - epidemiology</topic><topic>Cytomegalovirus Infections - congenital</topic><topic>Cytomegalovirus Infections - diagnosis</topic><topic>Cytomegalovirus Infections - epidemiology</topic><topic>Dried Blood Spot Testing</topic><topic>Female</topic><topic>hearing‐targeted cytomegalovirus testing</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Male</topic><topic>Neonatal Screening - methods</topic><topic>pediatric hearing loss</topic><topic>Prospective Studies</topic><topic>United States - epidemiology</topic><topic>universal cytomegalovirus testing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Orb, Quinn T.</creatorcontrib><creatorcontrib>Pesch, Megan</creatorcontrib><creatorcontrib>Allen, Chelsea M.</creatorcontrib><creatorcontrib>Wilkes, Ashlea</creatorcontrib><creatorcontrib>Ahmad, Iram</creatorcontrib><creatorcontrib>Alfonso, Kristan</creatorcontrib><creatorcontrib>Antonio, Stephanie Moody</creatorcontrib><creatorcontrib>Mithal, Leena Bhattacharya</creatorcontrib><creatorcontrib>Brinkmeier, Jennifer V.</creatorcontrib><creatorcontrib>Carvalho, Daniela</creatorcontrib><creatorcontrib>Chan, Dylan</creatorcontrib><creatorcontrib>Cheng, Alan G.</creatorcontrib><creatorcontrib>Chi, David</creatorcontrib><creatorcontrib>Cohen, Michael</creatorcontrib><creatorcontrib>Discolo, Christopher Michael</creatorcontrib><creatorcontrib>Duran, Carlos</creatorcontrib><creatorcontrib>Germiller, John</creatorcontrib><creatorcontrib>Gibson, Laura</creatorcontrib><creatorcontrib>Grunstein, Eli</creatorcontrib><creatorcontrib>Harrison, Gail</creatorcontrib><creatorcontrib>Lee, Kenneth</creatorcontrib><creatorcontrib>Hawley, Karen</creatorcontrib><creatorcontrib>Kohlhoff, Stephan</creatorcontrib><creatorcontrib>Melvin, Ann</creatorcontrib><creatorcontrib>MacArthur, Carol</creatorcontrib><creatorcontrib>Nassar, Michel</creatorcontrib><creatorcontrib>Neff, Laura</creatorcontrib><creatorcontrib>Pecha, Phayvanh</creatorcontrib><creatorcontrib>Salvatore, Christine</creatorcontrib><creatorcontrib>Schoem, Scott</creatorcontrib><creatorcontrib>Virgin, Frank</creatorcontrib><creatorcontrib>Saunders, James</creatorcontrib><creatorcontrib>Schleiss, Mark</creatorcontrib><creatorcontrib>Smith, Richard J. H.</creatorcontrib><creatorcontrib>Sood, Sunil</creatorcontrib><creatorcontrib>Park, Albert H.</creatorcontrib><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>Otolaryngology-head and neck surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Orb, Quinn T.</au><au>Pesch, Megan</au><au>Allen, Chelsea M.</au><au>Wilkes, Ashlea</au><au>Ahmad, Iram</au><au>Alfonso, Kristan</au><au>Antonio, Stephanie Moody</au><au>Mithal, Leena Bhattacharya</au><au>Brinkmeier, Jennifer V.</au><au>Carvalho, Daniela</au><au>Chan, Dylan</au><au>Cheng, Alan G.</au><au>Chi, David</au><au>Cohen, Michael</au><au>Discolo, Christopher Michael</au><au>Duran, Carlos</au><au>Germiller, John</au><au>Gibson, Laura</au><au>Grunstein, Eli</au><au>Harrison, Gail</au><au>Lee, Kenneth</au><au>Hawley, Karen</au><au>Kohlhoff, Stephan</au><au>Melvin, Ann</au><au>MacArthur, Carol</au><au>Nassar, Michel</au><au>Neff, Laura</au><au>Pecha, Phayvanh</au><au>Salvatore, Christine</au><au>Schoem, Scott</au><au>Virgin, Frank</au><au>Saunders, James</au><au>Schleiss, Mark</au><au>Smith, Richard J. H.</au><au>Sood, Sunil</au><au>Park, Albert H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Congenital Cytomegalovirus Testing Outcomes From the ValEAR Trial</atitle><jtitle>Otolaryngology-head and neck surgery</jtitle><addtitle>Otolaryngol Head Neck Surg</addtitle><date>2024-05</date><risdate>2024</risdate><volume>170</volume><issue>5</issue><spage>1430</spage><epage>1441</epage><pages>1430-1441</pages><issn>0194-5998</issn><eissn>1097-6817</eissn><abstract>Objective
To determine the positivity rate of congenital cytomegalovirus (cCMV) testing among universal, hearing‐targeted CMV testing (HT‐cCMV) and delayed targeted dried blood spot (DBS) testing newborn screening programs, and to examine the characteristics of successful HT‐cCMV testing programs.
Study Design
Prospective survey of birth hospitals performing early CMV testing.
Setting
Multiple institutions.
Methods
Birth hospitals participating in the National Institutes of Health ValEAR clinical trial were surveyed to determine the rates of cCMV positivity associated with 3 different testing approaches: universal testing, HT‐cCMV, and DBS testing. A mixed methods model was created to determine associations between successful HT‐cCMV screening and specific screening protocols.
Results
Eighty‐two birth hospitals were surveyed from February 2019 to December 2021. Seven thousand six hundred seventy infants underwent universal screening, 9017 infants HT‐cCMV and 535 infants delayed DBS testing. The rates of cCMV positivity were 0.5%, 1.5%, and 7.3%, respectively. The positivity rate for universal CMV screening was less during the COVID‐19 pandemic than that reported prior to the pandemic. There were no statistically significant drops in positivity for any approach during the pandemic. For HT‐cCMV testing, unique order sets and rigorous posttesting protocols were associated with successful screening programs.
Conclusion
Rates of cCMV positivity differed among the 3 approaches. The rates are comparable to cohort studies reported in the literature. Universal CMV prevalence decreased during the pandemic but not significantly. Institutions with specific order set for CMV testing where the primary care physician orders the test and the nurse facilitates the testing process exhibited higher rates of HT‐cCMV testing.</abstract><cop>England</cop><pmid>38415855</pmid><doi>10.1002/ohn.670</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0003-4672-674X</orcidid><oa>free_for_read</oa></addata></record> |
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ispartof | Otolaryngology-head and neck surgery, 2024-05, Vol.170 (5), p.1430-1441 |
issn | 0194-5998 1097-6817 |
language | eng |
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source | Wiley-Blackwell Read & Publish Collection |
subjects | congenital cytomegalovirus COVID-19 - diagnosis COVID-19 - epidemiology Cytomegalovirus Infections - congenital Cytomegalovirus Infections - diagnosis Cytomegalovirus Infections - epidemiology Dried Blood Spot Testing Female hearing‐targeted cytomegalovirus testing Humans Infant, Newborn Male Neonatal Screening - methods pediatric hearing loss Prospective Studies United States - epidemiology universal cytomegalovirus testing |
title | Congenital Cytomegalovirus Testing Outcomes From the ValEAR Trial |
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