Core outcomes in neonatology: Development of a core outcome set for neonatal research

James William Harrison Webbe; James M.N. Duffy; Elsa Afonso; Iyad Al-Muzaffar; Ginny Brunton; Anne Greenough; Nigel J. Hall; Marian Knight; Jos M. Latour; Caroline Lee-Davey; Neil Marlow; Laura Noakes; Julie Nycyk; Angela Richard-Löndt; Ben Wills-Eve; Neena Modi; Chris Gale

doi:10.1136/archdischild-2019-317501

Core outcomes in neonatology: Development of a core outcome set for neonatal research

James William Harrison Webbe^*, James M.N. Duffy, Elsa Afonso, Iyad Al-Muzaffar, Ginny Brunton, Anne Greenough, Nigel J. Hall, Marian Knight, Jos M. Latour, Caroline Lee-Davey, Neil Marlow, Laura Noakes, Julie Nycyk, Angela Richard-Löndt, Ben Wills-Eve, Neena Modi, Chris Gale

^*Corresponding author for this work

King's College London

Research output: Contribution to journal › Article › peer-review

157 Citations (Scopus)

Abstract

Background: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals. Objective: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting. Design: Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results. Participants: Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting. Results: The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia. Conclusions and relevance: A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

Original language	English
Journal	Archives of Disease in Childhood: Fetal and Neonatal Edition
DOIs	https://doi.org/10.1136/archdischild-2019-317501
Publication status	Published - 1 Jan 2019

Keywords

evidence based medicine
neonatology
outcomes research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/archdischild-2019-317501

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Webbe, J. W. H., Duffy, J. M. N., Afonso, E., Al-Muzaffar, I., Brunton, G., Greenough, A., Hall, N. J., Knight, M., Latour, J. M., Lee-Davey, C., Marlow, N., Noakes, L., Nycyk, J., Richard-Löndt, A., Wills-Eve, B., Modi, N., & Gale, C. (2019). Core outcomes in neonatology: Development of a core outcome set for neonatal research. Archives of Disease in Childhood: Fetal and Neonatal Edition. https://doi.org/10.1136/archdischild-2019-317501

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title = "Core outcomes in neonatology: Development of a core outcome set for neonatal research",

abstract = "Background: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals. Objective: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting. Design: Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results. Participants: Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting. Results: The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia. Conclusions and relevance: A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.",

keywords = "evidence based medicine, neonatology, outcomes research",

author = "Webbe, {James William Harrison} and Duffy, {James M.N.} and Elsa Afonso and Iyad Al-Muzaffar and Ginny Brunton and Anne Greenough and Hall, {Nigel J.} and Marian Knight and Latour, {Jos M.} and Caroline Lee-Davey and Neil Marlow and Laura Noakes and Julie Nycyk and Angela Richard-L{\"o}ndt and Ben Wills-Eve and Neena Modi and Chris Gale",

year = "2019",

month = jan,

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doi = "10.1136/archdischild-2019-317501",

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Webbe, JWH, Duffy, JMN, Afonso, E, Al-Muzaffar, I, Brunton, G, Greenough, A, Hall, NJ, Knight, M, Latour, JM, Lee-Davey, C, Marlow, N, Noakes, L, Nycyk, J, Richard-Löndt, A, Wills-Eve, B, Modi, N & Gale, C 2019, 'Core outcomes in neonatology: Development of a core outcome set for neonatal research', Archives of Disease in Childhood: Fetal and Neonatal Edition. https://doi.org/10.1136/archdischild-2019-317501

TY - JOUR

T1 - Core outcomes in neonatology

T2 - Development of a core outcome set for neonatal research

AU - Webbe, James William Harrison

AU - Duffy, James M.N.

AU - Afonso, Elsa

AU - Al-Muzaffar, Iyad

AU - Brunton, Ginny

AU - Greenough, Anne

AU - Hall, Nigel J.

AU - Knight, Marian

AU - Latour, Jos M.

AU - Lee-Davey, Caroline

AU - Marlow, Neil

AU - Noakes, Laura

AU - Nycyk, Julie

AU - Richard-Löndt, Angela

AU - Wills-Eve, Ben

AU - Modi, Neena

AU - Gale, Chris

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals. Objective: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting. Design: Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results. Participants: Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting. Results: The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia. Conclusions and relevance: A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

AB - Background: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals. Objective: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting. Design: Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results. Participants: Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting. Results: The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia. Conclusions and relevance: A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

KW - evidence based medicine

KW - neonatology

KW - outcomes research

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SN - 1359-2998

JO - Archives of Disease in Childhood: Fetal and Neonatal Edition

JF - Archives of Disease in Childhood: Fetal and Neonatal Edition

ER -

Core outcomes in neonatology: Development of a core outcome set for neonatal research

Abstract

Keywords

UN SDGs

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