COHESION: core outcomes in neonatal encephalopathy (protocol)

Fiona Quirke, Patricia Healy, Elaine Bhraonáin, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David Hass, Frank Bloomfield, Jamie Kirkham, Eleanor Molly, Declan Devane

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Abstract

Abstract

Background: Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other
organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in
mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for
neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging.
However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in
outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to
standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy.

Methods: We will systematically review the literature to identify outcomes reported previously in randomised trials and
systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants
diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in
person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income
countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and
researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round
Delphi survey or a “Real-Time” Delphi survey to which stakeholders will be allocated at random. Consensus meetings
will take place by video conference to allow for an international group of stakeholder representatives to discuss and
vote on the outcomes to include in the final core outcome set (COS).

Discussion: More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured
and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will
improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall,
this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall
patient care to be enhanced.

Trial registration: This study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://
www.comet-initiative.org/Studies/Details/1270.
Original languageEnglish
Article number125
Number of pages11
JournalTrials
Volume22
DOIs
Publication statusPublished - 8 Feb 2021

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