COHESION: core outcomes in neonatal encephalopathy (protocol)

dc.contributor.authorQuirke, Fiona A.
dc.contributor.authorHealy, Patricia
dc.contributor.authorNí Bhraonáin, Elaine
dc.contributor.authorDaly, Mandy
dc.contributor.authorBiesty, Linda
dc.contributor.authorHurley, Tim
dc.contributor.authorWalker, Karen
dc.contributor.authorMeher, Shireen
dc.contributor.authorHaas, David M.
dc.contributor.authorBloomfield, Frank H.
dc.contributor.authorKirkham, Jamie J.
dc.contributor.authorMolloy, Eleanor J.
dc.contributor.authorDevane, Declan
dc.contributor.departmentObstetrics and Gynecology, School of Medicineen_US
dc.date.accessioned2022-05-24T10:45:37Z
dc.date.available2022-05-24T10:45:37Z
dc.date.issued2021-02-08
dc.description.abstractBackground: 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.en_US
dc.eprint.versionFinal published versionen_US
dc.identifier.citationQuirke FA, Healy P, Bhraonáin EN, et al. COHESION: core outcomes in neonatal encephalopathy (protocol). Trials. 2021;22(1):125. Published 2021 Feb 8. doi:10.1186/s13063-021-05030-0en_US
dc.identifier.urihttps://hdl.handle.net/1805/29129
dc.language.isoen_USen_US
dc.publisherBMCen_US
dc.relation.isversionof10.1186/s13063-021-05030-0en_US
dc.relation.journalTrialsen_US
dc.rightsAttribution 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.sourcePMCen_US
dc.subjectCore outcome seten_US
dc.subjectDelphien_US
dc.subjectHigh-income countriesen_US
dc.subjectLow- to middle-income countriesen_US
dc.subjectNeonatal encephalopathyen_US
dc.titleCOHESION: core outcomes in neonatal encephalopathy (protocol)en_US
dc.typeArticleen_US
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