Background
Neonatal encephalopathy (NE) is a multi-organ condition potentially leading to death or long-term neurodisability. Therapeutic hypothermia is the standard treatment for NE; however, long-term impairments remain common. Studies of new treatments for NE often measure and report different outcomes. Core outcome sets (COSs), a minimum set of outcomes to be measured and reported in all studies for a condition, address this problem. This paper aimed to identify outcomes reported (primary, secondary, adverse events and other reported outcomes) in (1) randomised trials and (2) systematic reviews of randomised trials of interventions for the treatment of NE in the process of developing a COS for interventions for the treatment of NE.
Methods
We completed a systematic search for outcomes used to evaluate treatments for NE using MEDLINE, Embase, Cochrane CENTRAL, the Cochrane Database of Systematic Reviews and the WHO International Clinical Trials Registry Platform. Two reviewers screened all included articles independently. Outcomes were extracted verbatim, similar outcomes were grouped and outcome domains were developed.
Results
386 outcomes were reported in 116 papers, from 85 studies. Outcomes were categorised into 18 domains. No outcome was reported by all studies, a single study reported 11 outcomes and it was not explicitly stated that outcomes had input from parents.
Discussion
Heterogeneity in reported outcomes means that synthesis of studies evaluating new treatments for NE remains difficult. A COS, that includes parental/family input, is needed to ensure consistency in measuring and reporting outcomes, and to enable comparison of randomised trials.
Fiona Quirke, Linda Biesty, Malcolm Battin, Frank Harry Bloomfield, Mandy Daly, Elaine Finucane, Patricia Healy, Tim Hurley, Jamie J Kirkham, Eleanor Molloy, David M Haas, Shireen Meher, Elaine Ní Bhraonáin, Karen Walker, James Webbe, Declan Devane
Disease Category: Neonatal care
Disease Name: Neonatal Encephalopathy
Age Range: 0 - 0
Sex:
Nature of Intervention: Any
- Systematic review of outcomes measured in trials
- Systematic review