Core outcomes in neonatology: development of a core outcome set for neonatal research

Abstract

BackgroundNeonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

A core outcome set for pre‐eclampsia research: an international consensus development study

“…43 It is intended that these consensus outcome measures will be used for core outcomes included in other core outcome sets relevant to the health of women and newborn infants. [44][45][46][47][48][49][50]…”

Early assessment of lung aeration using an ultrasound score as a biomarker of developing bronchopulmonary dysplasia: a prospective observational study

“…Bronchopulmonary dysplasia (BPD) is a major preterm morbidity and is strongly associated with poor neurodevelopmental outcomes [1]. Despite significant advances in neonatal care, the incidence of BPD has not decreased over the past decade [2,3]. Disrupted lung and pulmonary vascular development, infection and inflammation, postnatal insults (positive pressure ventilation, undernutrition, hyperoxia, etc.)…”

Improving the Efficiency and Impact of Clinical Research: A Game Changer for 21st Century Neonatology

“…The international alliance, StaR Child Health, is developing standards for improving the design, conduct, and reporting of paediatric trials [2]. The incorporation of core outcome measures in trials [3, 4] and standard case definitions in studies [5] facilitate research syntheses. A core outcome set is a small number of important outcomes that are recorded in a standardised manner in all relevant studies.…”