Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data

The Brighton Collaboration Neonatal Infections Working Group

doi:10.1016/j.vaccine.2016.03.046

Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data

The Brighton Collaboration Neonatal Infections Working Group

Medicine

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49 Citas (Scopus)

Resumen

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting.

Idioma original	English
Páginas (desde-hasta)	6038-6046
Número de páginas	9
Publicación	Vaccine
Volumen	34
N.º	49
DOI	https://doi.org/10.1016/j.vaccine.2016.03.046
Estado	Published - dic. 1 2016

Nota bibliográfica

Funding Information:
The authors are grateful for the support and helpful comments provided by the Brighton Collaboration (Jan Bonhoeffer, Jorgen Bauwens) and the reference group (see https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/groups.html for reviewers), as well as other experts consulted as part of the process. The authors are also grateful to the Brighton Collaboration Secretariat and to the members of the ISPE Special Interest Group in Vaccines (VAX SIG) for their review and constructive comments on this document. Finally, we would like to acknowledge the Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) project, funded by the Bill and Melinda Gates Foundation .

Publisher Copyright:
© 2016

ASJC Scopus Subject Areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

ODS de las Naciones Unidas

Este resultado contribuye a los siguientes Objetivos de Desarrollo Sostenible

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@article{a0b0172a59ae44f3a4fe6a7233712c3b,

title = "Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data",

abstract = "Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting.",

author = "{The Brighton Collaboration Neonatal Infections Working Group} and Stefania Vergnano and Jim Buttery and Ben Cailes and Ravichandran Chandrasekaran and Elena Chiappini and Ebiere Clark and Clare Cutland and {de Andrade}, {Solange Dourado} and Alejandra Esteves-Jaramillo and Guinazu, {Javier Ruiz} and Chrissie Jones and Beate Kampmann and Jay King and Sonali Kochhar and Noni Macdonald and Alexandra Mangili and {de Menezes Martins}, Reinaldo and {Velasco Mu{\~n}oz}, C{\'e}sar and Michael Padula and Mu{\~n}oz, {Flor M.} and James Oleske and Melvin Sanicas and Elizabeth Schlaudecker and Hans Spiegel and Maja Subelj and Lakshmi Sukumaran and Tagbo, {Beckie N.} and Top, {Karina A.} and Dat Tran and Heath, {Paul T.}",

note = "Funding Information: The authors are grateful for the support and helpful comments provided by the Brighton Collaboration (Jan Bonhoeffer, Jorgen Bauwens) and the reference group (see https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/groups.html for reviewers), as well as other experts consulted as part of the process. The authors are also grateful to the Brighton Collaboration Secretariat and to the members of the ISPE Special Interest Group in Vaccines (VAX SIG) for their review and constructive comments on this document. Finally, we would like to acknowledge the Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) project, funded by the Bill and Melinda Gates Foundation . Publisher Copyright: {\textcopyright} 2016",

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doi = "10.1016/j.vaccine.2016.03.046",

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AU - The Brighton Collaboration Neonatal Infections Working Group

AU - Vergnano, Stefania

AU - Buttery, Jim

AU - Cailes, Ben

AU - Chandrasekaran, Ravichandran

AU - Chiappini, Elena

AU - Clark, Ebiere

AU - Cutland, Clare

AU - de Andrade, Solange Dourado

AU - Esteves-Jaramillo, Alejandra

AU - Guinazu, Javier Ruiz

AU - Jones, Chrissie

AU - Kampmann, Beate

AU - King, Jay

AU - Kochhar, Sonali

AU - Macdonald, Noni

AU - Mangili, Alexandra

AU - de Menezes Martins, Reinaldo

AU - Velasco Muñoz, César

AU - Padula, Michael

AU - Muñoz, Flor M.

AU - Oleske, James

AU - Sanicas, Melvin

AU - Schlaudecker, Elizabeth

AU - Spiegel, Hans

AU - Subelj, Maja

AU - Sukumaran, Lakshmi

AU - Tagbo, Beckie N.

AU - Top, Karina A.

AU - Tran, Dat

AU - Heath, Paul T.

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N2 - Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting.

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Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data

Resumen

Nota bibliográfica

ASJC Scopus Subject Areas

ODS de las Naciones Unidas

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