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

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

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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.
Original languageEnglish
Article number95
Pages (from-to)922–930
Number of pages9
JournalPediatr Res
Early online date22 Dec 2023
DOIs
Publication statusPublished - 1 Mar 2024

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