Is European Medicines Agency (EMA) sepsis criteria accurate for neonatal sepsis diagnosis or do we need new criteria?
Currently, there is a lack of clear definition for neonatal sepsis. The Pediatric Committee of the European Medicines Agency (EMA) developed consensus criteria to ensure a standardization for neonatal sepsis definition. However, there is no evidence supporting the accuracy of the EMA sepsis criteria...
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| Veröffentlicht in: | PloS one 2019-06, Vol.14 (6), p.e0218002-e0218002 |
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| creator | Tuzun, Funda Ozkan, Hasan Cetinkaya, Merih Yucesoy, Ebru Kurum, Ozge Cebeci, Burcu Cakmak, Ertan Ozkutuk, Aydan Keskinoglu, Pembe Baysal, Bora Kumral, Abdullah Duman, Nuray |
| description | Currently, there is a lack of clear definition for neonatal sepsis. The Pediatric Committee of the European Medicines Agency (EMA) developed consensus criteria to ensure a standardization for neonatal sepsis definition. However, there is no evidence supporting the accuracy of the EMA sepsis criteria in neonatal sepsis diagnosis. The main objective of this study was to evaluate the diagnostic accuracy of EMA sepsis criteria for proven neonatal sepsis.
A multicenter prospective cohort study was conducted from October 2015 to November 2018. Infants with a gestational age over 34th weeks, diagnosed with clinical sepsis and received antibiotics according to the EMA criteria or experienced neonatologists' opinion were included. Blood culture or multiplex real time-PCR or 16S-rRNA positive infants were accepted as "proven sepsis". The predictive performance of EMA criteria for proven sepsis was evaluated by sensitivity, specificity, accuracy, and area under the curve measures of receiver operator characteristic curves. Data-mining methods were used for further analysis.
Among the 245 included infants, the EMA criteria were positive in 97 infants (39.6%), while proven sepsis was diagnosed in 113 infants (46.1%). The sensitivity, specificity, and accuracy of the EMA criteria for proven sepsis were 44.2% (95%CI: 34.9-53.9), 64.4% (95%CI: 55.6-72.5), 55.1% (95%CI: 46.6-59.4) respectively. None of the clinical and laboratory parameters had sufficient performance individually in terms of sensitivity, specificity and accuracy measures. The diagnostic performance was similar when different clinical findings were added to the EMA sepsis criteria or assessment of the score was interpreted in different ways.
Results highlighted that clinician opinion and standard laboratory tests are limited in the neonatal sepsis diagnosis. The EMA criteria also did not efficiently meet the diagnostic accuracy measures for neonatal sepsis. A predictive sepsis definition and rapid bedside point-of care tests are urgently needed. |
| doi_str_mv | 10.1371/journal.pone.0218002 |
| format | Article |
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A multicenter prospective cohort study was conducted from October 2015 to November 2018. Infants with a gestational age over 34th weeks, diagnosed with clinical sepsis and received antibiotics according to the EMA criteria or experienced neonatologists' opinion were included. Blood culture or multiplex real time-PCR or 16S-rRNA positive infants were accepted as "proven sepsis". The predictive performance of EMA criteria for proven sepsis was evaluated by sensitivity, specificity, accuracy, and area under the curve measures of receiver operator characteristic curves. Data-mining methods were used for further analysis.
Among the 245 included infants, the EMA criteria were positive in 97 infants (39.6%), while proven sepsis was diagnosed in 113 infants (46.1%). The sensitivity, specificity, and accuracy of the EMA criteria for proven sepsis were 44.2% (95%CI: 34.9-53.9), 64.4% (95%CI: 55.6-72.5), 55.1% (95%CI: 46.6-59.4) respectively. None of the clinical and laboratory parameters had sufficient performance individually in terms of sensitivity, specificity and accuracy measures. The diagnostic performance was similar when different clinical findings were added to the EMA sepsis criteria or assessment of the score was interpreted in different ways.
Results highlighted that clinician opinion and standard laboratory tests are limited in the neonatal sepsis diagnosis. The EMA criteria also did not efficiently meet the diagnostic accuracy measures for neonatal sepsis. A predictive sepsis definition and rapid bedside point-of care tests are urgently needed.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0218002</identifier><identifier>PMID: 31170237</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Antibiotics ; Area Under Curve ; Biology and Life Sciences ; Blood ; Blood culture ; Blood tests ; Criteria ; Data mining ; Diagnosis ; Diagnostic systems ; Drugs ; Europe ; Gestational age ; Gram-positive bacteria ; Humans ; Infant, Newborn ; Infants ; Infection ; Infections ; Laboratories ; Laboratory tests ; Medical diagnosis ; Medical research ; Medicine ; Medicine and Health Sciences ; Mining industry ; Mortality ; Neonatal Sepsis - diagnosis ; Neonates ; Neonatology ; Newborn babies ; Newborn infants ; Parameter sensitivity ; Patient outcomes ; Pediatric research ; Pediatrics ; Performance prediction ; Polymerase chain reaction ; Research and Analysis Methods ; RNA ; rRNA 16S ; Sensitivity ; Sensitivity analysis ; Sepsis ; Societies, Medical ; Standardization ; Systematic review ; University faculty</subject><ispartof>PloS one, 2019-06, Vol.14 (6), p.e0218002-e0218002</ispartof><rights>COPYRIGHT 2019 Public Library of Science</rights><rights>2019 Tuzun et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2019 Tuzun et al 2019 Tuzun et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c593t-6a7d0b0b4f6abb8e30ea71d6427c04e0590ec848981eddb44db5ad531672dfd3</citedby><cites>FETCH-LOGICAL-c593t-6a7d0b0b4f6abb8e30ea71d6427c04e0590ec848981eddb44db5ad531672dfd3</cites><orcidid>0000-0003-4253-4222</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6553766/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6553766/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2101,2927,23865,27923,27924,53790,53792,79471,79472</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31170237$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Bhatt, Girish Chandra</contributor><creatorcontrib>Tuzun, Funda</creatorcontrib><creatorcontrib>Ozkan, Hasan</creatorcontrib><creatorcontrib>Cetinkaya, Merih</creatorcontrib><creatorcontrib>Yucesoy, Ebru</creatorcontrib><creatorcontrib>Kurum, Ozge</creatorcontrib><creatorcontrib>Cebeci, Burcu</creatorcontrib><creatorcontrib>Cakmak, Ertan</creatorcontrib><creatorcontrib>Ozkutuk, Aydan</creatorcontrib><creatorcontrib>Keskinoglu, Pembe</creatorcontrib><creatorcontrib>Baysal, Bora</creatorcontrib><creatorcontrib>Kumral, Abdullah</creatorcontrib><creatorcontrib>Duman, Nuray</creatorcontrib><title>Is European Medicines Agency (EMA) sepsis criteria accurate for neonatal sepsis diagnosis or do we need new criteria?</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Currently, there is a lack of clear definition for neonatal sepsis. The Pediatric Committee of the European Medicines Agency (EMA) developed consensus criteria to ensure a standardization for neonatal sepsis definition. However, there is no evidence supporting the accuracy of the EMA sepsis criteria in neonatal sepsis diagnosis. The main objective of this study was to evaluate the diagnostic accuracy of EMA sepsis criteria for proven neonatal sepsis.
A multicenter prospective cohort study was conducted from October 2015 to November 2018. Infants with a gestational age over 34th weeks, diagnosed with clinical sepsis and received antibiotics according to the EMA criteria or experienced neonatologists' opinion were included. Blood culture or multiplex real time-PCR or 16S-rRNA positive infants were accepted as "proven sepsis". The predictive performance of EMA criteria for proven sepsis was evaluated by sensitivity, specificity, accuracy, and area under the curve measures of receiver operator characteristic curves. Data-mining methods were used for further analysis.
Among the 245 included infants, the EMA criteria were positive in 97 infants (39.6%), while proven sepsis was diagnosed in 113 infants (46.1%). The sensitivity, specificity, and accuracy of the EMA criteria for proven sepsis were 44.2% (95%CI: 34.9-53.9), 64.4% (95%CI: 55.6-72.5), 55.1% (95%CI: 46.6-59.4) respectively. None of the clinical and laboratory parameters had sufficient performance individually in terms of sensitivity, specificity and accuracy measures. The diagnostic performance was similar when different clinical findings were added to the EMA sepsis criteria or assessment of the score was interpreted in different ways.
Results highlighted that clinician opinion and standard laboratory tests are limited in the neonatal sepsis diagnosis. The EMA criteria also did not efficiently meet the diagnostic accuracy measures for neonatal sepsis. A predictive sepsis definition and rapid bedside point-of care tests are urgently needed.</description><subject>Antibiotics</subject><subject>Area Under Curve</subject><subject>Biology and Life Sciences</subject><subject>Blood</subject><subject>Blood culture</subject><subject>Blood tests</subject><subject>Criteria</subject><subject>Data mining</subject><subject>Diagnosis</subject><subject>Diagnostic systems</subject><subject>Drugs</subject><subject>Europe</subject><subject>Gestational age</subject><subject>Gram-positive bacteria</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infants</subject><subject>Infection</subject><subject>Infections</subject><subject>Laboratories</subject><subject>Laboratory tests</subject><subject>Medical diagnosis</subject><subject>Medical research</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Mining industry</subject><subject>Mortality</subject><subject>Neonatal Sepsis - diagnosis</subject><subject>Neonates</subject><subject>Neonatology</subject><subject>Newborn babies</subject><subject>Newborn infants</subject><subject>Parameter sensitivity</subject><subject>Patient outcomes</subject><subject>Pediatric research</subject><subject>Pediatrics</subject><subject>Performance prediction</subject><subject>Polymerase chain reaction</subject><subject>Research and Analysis Methods</subject><subject>RNA</subject><subject>rRNA 16S</subject><subject>Sensitivity</subject><subject>Sensitivity analysis</subject><subject>Sepsis</subject><subject>Societies, Medical</subject><subject>Standardization</subject><subject>Systematic review</subject><subject>University 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European Medicines Agency (EMA) sepsis criteria accurate for neonatal sepsis diagnosis or do we need new criteria?</title><author>Tuzun, Funda ; Ozkan, Hasan ; Cetinkaya, Merih ; Yucesoy, Ebru ; Kurum, Ozge ; Cebeci, Burcu ; Cakmak, Ertan ; Ozkutuk, Aydan ; Keskinoglu, Pembe ; Baysal, Bora ; Kumral, Abdullah ; Duman, Nuray</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c593t-6a7d0b0b4f6abb8e30ea71d6427c04e0590ec848981eddb44db5ad531672dfd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Antibiotics</topic><topic>Area Under Curve</topic><topic>Biology and Life Sciences</topic><topic>Blood</topic><topic>Blood culture</topic><topic>Blood tests</topic><topic>Criteria</topic><topic>Data mining</topic><topic>Diagnosis</topic><topic>Diagnostic systems</topic><topic>Drugs</topic><topic>Europe</topic><topic>Gestational age</topic><topic>Gram-positive 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One</addtitle><date>2019-06-06</date><risdate>2019</risdate><volume>14</volume><issue>6</issue><spage>e0218002</spage><epage>e0218002</epage><pages>e0218002-e0218002</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Currently, there is a lack of clear definition for neonatal sepsis. The Pediatric Committee of the European Medicines Agency (EMA) developed consensus criteria to ensure a standardization for neonatal sepsis definition. However, there is no evidence supporting the accuracy of the EMA sepsis criteria in neonatal sepsis diagnosis. The main objective of this study was to evaluate the diagnostic accuracy of EMA sepsis criteria for proven neonatal sepsis.
A multicenter prospective cohort study was conducted from October 2015 to November 2018. Infants with a gestational age over 34th weeks, diagnosed with clinical sepsis and received antibiotics according to the EMA criteria or experienced neonatologists' opinion were included. Blood culture or multiplex real time-PCR or 16S-rRNA positive infants were accepted as "proven sepsis". The predictive performance of EMA criteria for proven sepsis was evaluated by sensitivity, specificity, accuracy, and area under the curve measures of receiver operator characteristic curves. Data-mining methods were used for further analysis.
Among the 245 included infants, the EMA criteria were positive in 97 infants (39.6%), while proven sepsis was diagnosed in 113 infants (46.1%). The sensitivity, specificity, and accuracy of the EMA criteria for proven sepsis were 44.2% (95%CI: 34.9-53.9), 64.4% (95%CI: 55.6-72.5), 55.1% (95%CI: 46.6-59.4) respectively. None of the clinical and laboratory parameters had sufficient performance individually in terms of sensitivity, specificity and accuracy measures. The diagnostic performance was similar when different clinical findings were added to the EMA sepsis criteria or assessment of the score was interpreted in different ways.
Results highlighted that clinician opinion and standard laboratory tests are limited in the neonatal sepsis diagnosis. The EMA criteria also did not efficiently meet the diagnostic accuracy measures for neonatal sepsis. A predictive sepsis definition and rapid bedside point-of care tests are urgently needed.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>31170237</pmid><doi>10.1371/journal.pone.0218002</doi><orcidid>https://orcid.org/0000-0003-4253-4222</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | PloS one, 2019-06, Vol.14 (6), p.e0218002-e0218002 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2236162690 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS); EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Antibiotics Area Under Curve Biology and Life Sciences Blood Blood culture Blood tests Criteria Data mining Diagnosis Diagnostic systems Drugs Europe Gestational age Gram-positive bacteria Humans Infant, Newborn Infants Infection Infections Laboratories Laboratory tests Medical diagnosis Medical research Medicine Medicine and Health Sciences Mining industry Mortality Neonatal Sepsis - diagnosis Neonates Neonatology Newborn babies Newborn infants Parameter sensitivity Patient outcomes Pediatric research Pediatrics Performance prediction Polymerase chain reaction Research and Analysis Methods RNA rRNA 16S Sensitivity Sensitivity analysis Sepsis Societies, Medical Standardization Systematic review University faculty |
| title | Is European Medicines Agency (EMA) sepsis criteria accurate for neonatal sepsis diagnosis or do we need new criteria? |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-09T07%3A22%3A06IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Is%20European%20Medicines%20Agency%20(EMA)%20sepsis%20criteria%20accurate%20for%20neonatal%20sepsis%20diagnosis%20or%20do%20we%20need%20new%20criteria?&rft.jtitle=PloS%20one&rft.au=Tuzun,%20Funda&rft.date=2019-06-06&rft.volume=14&rft.issue=6&rft.spage=e0218002&rft.epage=e0218002&rft.pages=e0218002-e0218002&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0218002&rft_dat=%3Cgale_plos_%3EA587945314%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2236162690&rft_id=info:pmid/31170237&rft_galeid=A587945314&rft_doaj_id=oai_doaj_org_article_4234e88ec42e451ca60d0a26b28e536a&rfr_iscdi=true |