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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
Main Authors: 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.
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container_end_page 1441
container_issue 5
container_start_page 1430
container_title Otolaryngology-head and neck surgery
container_volume 170
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
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H. ; Sood, Sunil ; Park, Albert H.</creator><creatorcontrib>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.</creatorcontrib><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><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. 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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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identifier ISSN: 0194-5998
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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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