Webbe, JWH;
Duffy, JMN;
Afonso, E;
Al-Muzaffar, I;
Brunton, G;
Greenough, A;
Hall, NJ;
... Gale, C; + view all
(2019)
Core outcomes in neonatology: development of a core outcome set for neonatal research.
ADC Fetal & Neonatal
10.1136/archdischild-2019-317501.
(In press).
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Abstract
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.
Type: | Article |
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Title: | Core outcomes in neonatology: development of a core outcome set for neonatal research |
Location: | England |
Open access status: | An open access version is available from UCL Discovery |
DOI: | 10.1136/archdischild-2019-317501 |
Publisher version: | https://doi.org/10.1136/archdischild-2019-317501 |
Language: | English |
Additional information: | This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
Keywords: | evidence based medicine, neonatology, outcomes research |
UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Education UCL > Provost and Vice Provost Offices > School of Education > UCL Institute of Education UCL > Provost and Vice Provost Offices > School of Education > UCL Institute of Education > IOE - Social Research Institute UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health > Neonatology |
URI: | https://discovery.ucl.ac.uk/id/eprint/10087102 |
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