PT - JOURNAL ARTICLE AU - James William Harrison Webbe AU - James M N Duffy AU - Elsa Afonso AU - Iyad Al-Muzaffar AU - Ginny Brunton AU - Anne Greenough AU - Nigel J Hall AU - Marian Knight AU - Jos M Latour AU - Caroline Lee-Davey AU - Neil Marlow AU - Laura Noakes AU - Julie Nycyk AU - Angela Richard-Löndt AU - Ben Wills-Eve AU - Neena Modi AU - Chris Gale TI - Core outcomes in neonatology: development of a core outcome set for neonatal research AID - 10.1136/archdischild-2019-317501 DP - 2020 Jul 01 TA - Archives of Disease in Childhood - Fetal and Neonatal Edition PG - 425--431 VI - 105 IP - 4 4099 - http://fn.bmj.com/content/105/4/425.short 4100 - http://fn.bmj.com/content/105/4/425.full SO - Arch Dis Child Fetal Neonatal Ed2020 Jul 01; 105 AB - Background Neonatal 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.Objective To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.Design Outcomes 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.Participants Four 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.Results The 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 relevance A 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.