COHESION: a core outcome set for the treatment of neonatal encephalopathy

Fiona A. Quirke; Shabina Ariff; Malcolm R. Battin; Caitlin Bernard; Linda Biesty; Frank H. Bloomfield; Mandy Daly; Elaine Finucane; Patricia Healy; David M. Haas; Jamie J. Kirkham; Vincent Kibet; Sarah Koskei; Shireen Meher; Eleanor J. Molloy; Maira Niaz; Elaine Ní Bhraonáin; Christabell Omukagah Okaronon; Matthew J. Parkes; Farhana Tabassum; Karen Walker; James W.H. Webbe; Declan Devane

doi:10.1038/s41390-023-02938-y

COHESION: a core outcome set for the treatment of neonatal encephalopathy

Fiona A. Quirke, Shabina Ariff, Malcolm R. Battin, Caitlin Bernard, Linda Biesty, Frank H. Bloomfield, Mandy Daly, Elaine Finucane, Patricia Healy, David M. Haas, Jamie J. Kirkham, Vincent Kibet, Sarah Koskei, Shireen Meher, Eleanor J. Molloy, Maira Niaz, Elaine Ní Bhraonáin, Christabell Omukagah Okaronon, Matthew J. Parkes, Farhana TabassumKaren Walker, James W.H. Webbe, Declan Devane

Department of Paediatrics and Child Health, Division of Woman and Child Health, Medical College, Pakistan

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

5 Citations (Scopus)

Abstract

Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE. Methods: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. Results: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. Conclusion: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. Impact: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy.Previously, a core outcome set for neonatal encephalopathy treatments did not exist.This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.

Original language	English
Journal	Pediatric Research
DOIs	https://doi.org/10.1038/s41390-023-02938-y
Publication status	Accepted/In press - 2023

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Quirke, F. A., Ariff, S., Battin, M. R., Bernard, C., Biesty, L., Bloomfield, F. H., Daly, M., Finucane, E., Healy, P., Haas, D. M., Kirkham, J. J., Kibet, V., Koskei, S., Meher, S., Molloy, E. J., Niaz, M., Bhraonáin, E. N., Okaronon, C. O., Parkes, M. J., ... Devane, D. (Accepted/In press). COHESION: a core outcome set for the treatment of neonatal encephalopathy. Pediatric Research. https://doi.org/10.1038/s41390-023-02938-y

@article{85d08b3d37b0451c9a77b6b3aa5a81f1,

title = "COHESION: a core outcome set for the treatment of neonatal encephalopathy",

abstract = "Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE. Methods: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. Results: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. Conclusion: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. Impact: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy.Previously, a core outcome set for neonatal encephalopathy treatments did not exist.This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.",

author = "Quirke, {Fiona A.} and Shabina Ariff and Battin, {Malcolm R.} and Caitlin Bernard and Linda Biesty and Bloomfield, {Frank H.} and Mandy Daly and Elaine Finucane and Patricia Healy and Haas, {David M.} and Kirkham, {Jamie J.} and Vincent Kibet and Sarah Koskei and Shireen Meher and Molloy, {Eleanor J.} and Maira Niaz and Bhraon{\'a}in, {Elaine N{\'i}} and Okaronon, {Christabell Omukagah} and Parkes, {Matthew J.} and Farhana Tabassum and Karen Walker and Webbe, {James W.H.} and Declan Devane",

note = "Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

doi = "10.1038/s41390-023-02938-y",

language = "English",

journal = "Pediatric Research",

issn = "0031-3998",

publisher = "Lippincott Williams and Wilkins Ltd.",

}

Quirke, FA, Ariff, S, Battin, MR, Bernard, C, Biesty, L, Bloomfield, FH, Daly, M, Finucane, E, Healy, P, Haas, DM, Kirkham, JJ, Kibet, V, Koskei, S, Meher, S, Molloy, EJ, Niaz, M, Bhraonáin, EN, Okaronon, CO, Parkes, MJ, Tabassum, F, Walker, K, Webbe, JWH & Devane, D 2023, 'COHESION: a core outcome set for the treatment of neonatal encephalopathy', Pediatric Research. https://doi.org/10.1038/s41390-023-02938-y

TY - JOUR

T1 - COHESION

T2 - a core outcome set for the treatment of neonatal encephalopathy

AU - Quirke, Fiona A.

AU - Ariff, Shabina

AU - Battin, Malcolm R.

AU - Bernard, Caitlin

AU - Biesty, Linda

AU - Bloomfield, Frank H.

AU - Daly, Mandy

AU - Finucane, Elaine

AU - Healy, Patricia

AU - Haas, David M.

AU - Kirkham, Jamie J.

AU - Kibet, Vincent

AU - Koskei, Sarah

AU - Meher, Shireen

AU - Molloy, Eleanor J.

AU - Niaz, Maira

AU - Bhraonáin, Elaine Ní

AU - Okaronon, Christabell Omukagah

AU - Parkes, Matthew J.

AU - Tabassum, Farhana

AU - Walker, Karen

AU - Webbe, James W.H.

AU - Devane, Declan

PY - 2023

Y1 - 2023

N2 - Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE. Methods: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. Results: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. Conclusion: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. Impact: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy.Previously, a core outcome set for neonatal encephalopathy treatments did not exist.This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.

AB - Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE. Methods: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. Results: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. Conclusion: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. Impact: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy.Previously, a core outcome set for neonatal encephalopathy treatments did not exist.This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.

UR - http://www.scopus.com/inward/record.url?scp=85180433677&partnerID=8YFLogxK

U2 - 10.1038/s41390-023-02938-y

DO - 10.1038/s41390-023-02938-y

M3 - Article

AN - SCOPUS:85180433677

SN - 0031-3998

JO - Pediatric Research

JF - Pediatric Research

ER -

COHESION: a core outcome set for the treatment of neonatal encephalopathy

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