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Development of a neonatal adverse event severity scale through a Delphi consensus approach

BACKGROUND: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety informati...

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Autores principales: Salaets, Thomas, Turner, Mark A, Short, Mary, Ward, Robert M, Hokuto, Isamu, Ariagno, Ronald L, Klein, Agnes, Beauman, Sandra, Wade, Kelly, Thomson, Merran, Roberts, Eve, Harrison, Judy, Quinn, Theresa, Baer, Gerri, Davis, Jonathan, Allegaert, Karel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943241/
https://www.ncbi.nlm.nih.gov/pubmed/31537552
http://dx.doi.org/10.1136/archdischild-2019-317399
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author Salaets, Thomas
Turner, Mark A
Short, Mary
Ward, Robert M
Hokuto, Isamu
Ariagno, Ronald L
Klein, Agnes
Beauman, Sandra
Wade, Kelly
Thomson, Merran
Roberts, Eve
Harrison, Judy
Quinn, Theresa
Baer, Gerri
Davis, Jonathan
Allegaert, Karel
author_facet Salaets, Thomas
Turner, Mark A
Short, Mary
Ward, Robert M
Hokuto, Isamu
Ariagno, Ronald L
Klein, Agnes
Beauman, Sandra
Wade, Kelly
Thomson, Merran
Roberts, Eve
Harrison, Judy
Quinn, Theresa
Baer, Gerri
Davis, Jonathan
Allegaert, Karel
author_sort Salaets, Thomas
collection PubMed
description BACKGROUND: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed. METHODS: A stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation. RESULTS: Neonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. DISCUSSION: The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.
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spelling pubmed-69432412020-01-21 Development of a neonatal adverse event severity scale through a Delphi consensus approach Salaets, Thomas Turner, Mark A Short, Mary Ward, Robert M Hokuto, Isamu Ariagno, Ronald L Klein, Agnes Beauman, Sandra Wade, Kelly Thomson, Merran Roberts, Eve Harrison, Judy Quinn, Theresa Baer, Gerri Davis, Jonathan Allegaert, Karel Arch Dis Child Original Article BACKGROUND: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed. METHODS: A stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation. RESULTS: Neonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. DISCUSSION: The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users. BMJ Publishing Group 2019-12 2019-09-19 /pmc/articles/PMC6943241/ /pubmed/31537552 http://dx.doi.org/10.1136/archdischild-2019-317399 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Article
Salaets, Thomas
Turner, Mark A
Short, Mary
Ward, Robert M
Hokuto, Isamu
Ariagno, Ronald L
Klein, Agnes
Beauman, Sandra
Wade, Kelly
Thomson, Merran
Roberts, Eve
Harrison, Judy
Quinn, Theresa
Baer, Gerri
Davis, Jonathan
Allegaert, Karel
Development of a neonatal adverse event severity scale through a Delphi consensus approach
title Development of a neonatal adverse event severity scale through a Delphi consensus approach
title_full Development of a neonatal adverse event severity scale through a Delphi consensus approach
title_fullStr Development of a neonatal adverse event severity scale through a Delphi consensus approach
title_full_unstemmed Development of a neonatal adverse event severity scale through a Delphi consensus approach
title_short Development of a neonatal adverse event severity scale through a Delphi consensus approach
title_sort development of a neonatal adverse event severity scale through a delphi consensus approach
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943241/
https://www.ncbi.nlm.nih.gov/pubmed/31537552
http://dx.doi.org/10.1136/archdischild-2019-317399
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