WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization

Standardized case definitions strengthen post-marketing safety surveillance of new vaccines by improving generated data, interpretation and comparability across surveillance systems. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project developed standardized case defini...

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Autores principales:	Anke L. Stuurman, Apoorva Sharan, Shubhashri Jahagirdar, Varalakshmi Elango, Margarita Riera-Montes, Neeraj Kashyap, Jorne Biccler, Ramesh Poluru, Narendra Arora, Matthews Mathai, Punam Mangtani, Hugo DeVlieger, Steven Anderson, Barbee Whitaker, Hui-Lee Wong, Clare Cutland, Christine Guillard Maure
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Vaccination Pregnancy Maternal immunization Vaccine safety Brighton Collaboration Standardized case definitions Immunologic diseases. Allergy RC581-607
Acceso en línea:	https://doaj.org/article/f1434c23587e4b0c8174a3ddb603af60
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spelling	oai:doaj.org-article:f1434c23587e4b0c8174a3ddb603af602021-11-14T04:35:21ZWHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization2590-136210.1016/j.jvacx.2021.100123https://doaj.org/article/f1434c23587e4b0c8174a3ddb603af602021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2590136221000401https://doaj.org/toc/2590-1362Standardized case definitions strengthen post-marketing safety surveillance of new vaccines by improving generated data, interpretation and comparability across surveillance systems. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project developed standardized case definitions for 21 key obstetric and neonatal terms following the Brighton Collaboration (BC) methodology.In this prospective cohort study, we assessed the applicability of GAIA definitions for maternal immunization exposure and for low birth weight (LBW), preterm birth, small for gestational age (SGA), stillbirth, neonatal death, neonatal infection, and congenital microcephaly. We identified the missing data elements that prevented identified cases and exposures from meeting the case definition (level 1–3 of BC diagnostic certainty). Over a one-year period (2019–2020), all births occurring in 21 sites (mostly secondary and tertiary hospitals) in 6 Low Middle Income Countries and 1 High Income Country were recorded and the 7 perinatal and neonatal outcome cases were identified from routine medical records. Up to 100 cases per outcome were recruited sequentially from each site.Most cases recruited for LBW, preterm birth and neonatal death met the GAIA case definitions. Birth weight, a key parameter for all three outcomes, was routinely recorded at all sites. The definitions for SGA, stillbirth, neonatal infection (particularly meningitis and respiratory infection) and congenital microcephaly were found to be less applicable. The main barrier to obtaining higher levels of diagnostic certainty was the lack of sonographic documentation of gestational age in first or second trimester. The definition for maternal immunization exposure was applicable, however, the highest level of diagnostic certainty was only reached at two sites. Improved documentation of maternal immunization will be important for vaccine safety studies. Following the field-testing of these 8 GAIA definitions, several improvements are suggested that may lead to their easier implementation, increased standardization and hence comparison across studies.Anke L. StuurmanApoorva SharanShubhashri JahagirdarVaralakshmi ElangoMargarita Riera-MontesNeeraj KashyapJorne BicclerRamesh PoluruNarendra AroraMatthews MathaiPunam MangtaniHugo DeVliegerSteven AndersonBarbee WhitakerHui-Lee WongClare CutlandChristine Guillard MaureElsevierarticleVaccinationPregnancyMaternal immunizationVaccine safetyBrighton CollaborationStandardized case definitionsImmunologic diseases. AllergyRC581-607ENVaccine: X, Vol 9, Iss , Pp 100123- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Vaccination Pregnancy Maternal immunization Vaccine safety Brighton Collaboration Standardized case definitions Immunologic diseases. Allergy RC581-607
spellingShingle	Vaccination Pregnancy Maternal immunization Vaccine safety Brighton Collaboration Standardized case definitions Immunologic diseases. Allergy RC581-607 Anke L. Stuurman Apoorva Sharan Shubhashri Jahagirdar Varalakshmi Elango Margarita Riera-Montes Neeraj Kashyap Jorne Biccler Ramesh Poluru Narendra Arora Matthews Mathai Punam Mangtani Hugo DeVlieger Steven Anderson Barbee Whitaker Hui-Lee Wong Clare Cutland Christine Guillard Maure WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization
description	Standardized case definitions strengthen post-marketing safety surveillance of new vaccines by improving generated data, interpretation and comparability across surveillance systems. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project developed standardized case definitions for 21 key obstetric and neonatal terms following the Brighton Collaboration (BC) methodology.In this prospective cohort study, we assessed the applicability of GAIA definitions for maternal immunization exposure and for low birth weight (LBW), preterm birth, small for gestational age (SGA), stillbirth, neonatal death, neonatal infection, and congenital microcephaly. We identified the missing data elements that prevented identified cases and exposures from meeting the case definition (level 1–3 of BC diagnostic certainty). Over a one-year period (2019–2020), all births occurring in 21 sites (mostly secondary and tertiary hospitals) in 6 Low Middle Income Countries and 1 High Income Country were recorded and the 7 perinatal and neonatal outcome cases were identified from routine medical records. Up to 100 cases per outcome were recruited sequentially from each site.Most cases recruited for LBW, preterm birth and neonatal death met the GAIA case definitions. Birth weight, a key parameter for all three outcomes, was routinely recorded at all sites. The definitions for SGA, stillbirth, neonatal infection (particularly meningitis and respiratory infection) and congenital microcephaly were found to be less applicable. The main barrier to obtaining higher levels of diagnostic certainty was the lack of sonographic documentation of gestational age in first or second trimester. The definition for maternal immunization exposure was applicable, however, the highest level of diagnostic certainty was only reached at two sites. Improved documentation of maternal immunization will be important for vaccine safety studies. Following the field-testing of these 8 GAIA definitions, several improvements are suggested that may lead to their easier implementation, increased standardization and hence comparison across studies.
format	article
author	Anke L. Stuurman Apoorva Sharan Shubhashri Jahagirdar Varalakshmi Elango Margarita Riera-Montes Neeraj Kashyap Jorne Biccler Ramesh Poluru Narendra Arora Matthews Mathai Punam Mangtani Hugo DeVlieger Steven Anderson Barbee Whitaker Hui-Lee Wong Clare Cutland Christine Guillard Maure
author_facet	Anke L. Stuurman Apoorva Sharan Shubhashri Jahagirdar Varalakshmi Elango Margarita Riera-Montes Neeraj Kashyap Jorne Biccler Ramesh Poluru Narendra Arora Matthews Mathai Punam Mangtani Hugo DeVlieger Steven Anderson Barbee Whitaker Hui-Lee Wong Clare Cutland Christine Guillard Maure
author_sort	Anke L. Stuurman
title	WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization
title_short	WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization
title_full	WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization
title_fullStr	WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization
title_full_unstemmed	WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization
title_sort	who global vaccine safety multi-country collaboration project on safety in pregnancy: assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/f1434c23587e4b0c8174a3ddb603af60
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WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization

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