. 2020 Jul;105(4):425-431.

doi: 10.1136/archdischild-2019-317501. Epub 2019 Nov 15.

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

James William Harrison Webbe¹, James M N Duffy², Elsa Afonso³, Iyad Al-Muzaffar⁴, Ginny Brunton⁵, Anne Greenough⁶, Nigel J Hall⁷, Marian Knight⁸, Jos M Latour^{9

10}, Caroline Lee-Davey¹¹, Neil Marlow¹², Laura Noakes¹³, Julie Nycyk¹⁴, Angela Richard-Löndt¹³, Ben Wills-Eve¹⁵, Neena Modi¹⁶, Chris Gale¹⁷

Affiliations

¹ Academic Neonatal Medicine, Imperial College London, London, UK j.webbe@imperial.ac.uk.
² Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.
³ Neonatal Unit, Rosie Hospital, Cambridge, Cambridgeshire, UK.
⁴ The Neonatal Unit, Royal Glamorgan Hospital, Llantrisant, Rhondda Cynon Taf, UK.
⁵ UCL Institute of Education Centre for Longitudinal Studies, London, UK.
⁶ Department of Women and Children's Health, School of Life Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
⁷ Paediatric Surgery, Southampton General Hospital, Southampton, UK.
⁸ National Perinatal Epidemiology Unit, Oxford, UK.
⁹ School of Nursing and Midwifery, Faculty of Health, Education and Society, Plymouth University, Plymouth, Devon, UK.
¹⁰ School of Nursing and Midwifery, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
¹¹ Bliss, London, UK.
¹² Institute for Women's Health, University College London, London, UK.
¹³ Parent of Neonatal Patient, London, UK.
¹⁴ Neonatal Unit, Birmingham City Hospital, Birmingham, UK.
¹⁵ Former neonatal patient, London, UK.
¹⁶ Neonatal Medicine, Imperial College London, London, UK.
¹⁷ Academic Neonatal Medicine, Imperial College London, London, UK.

PMID: 31732683
PMCID: PMC7363790
DOI: 10.1136/archdischild-2019-317501

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

James William Harrison Webbe et al. Arch Dis Child Fetal Neonatal Ed. 2020 Jul.

. 2020 Jul;105(4):425-431.

doi: 10.1136/archdischild-2019-317501. Epub 2019 Nov 15.

Authors

Affiliations

¹ Academic Neonatal Medicine, Imperial College London, London, UK j.webbe@imperial.ac.uk.
² Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.
³ Neonatal Unit, Rosie Hospital, Cambridge, Cambridgeshire, UK.
⁴ The Neonatal Unit, Royal Glamorgan Hospital, Llantrisant, Rhondda Cynon Taf, UK.
⁵ UCL Institute of Education Centre for Longitudinal Studies, London, UK.
⁶ Department of Women and Children's Health, School of Life Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
⁷ Paediatric Surgery, Southampton General Hospital, Southampton, UK.
⁸ National Perinatal Epidemiology Unit, Oxford, UK.
⁹ School of Nursing and Midwifery, Faculty of Health, Education and Society, Plymouth University, Plymouth, Devon, UK.
¹⁰ School of Nursing and Midwifery, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
¹¹ Bliss, London, UK.
¹² Institute for Women's Health, University College London, London, UK.
¹³ Parent of Neonatal Patient, London, UK.
¹⁴ Neonatal Unit, Birmingham City Hospital, Birmingham, UK.
¹⁵ Former neonatal patient, London, UK.
¹⁶ Neonatal Medicine, Imperial College London, London, UK.
¹⁷ Academic Neonatal Medicine, Imperial College London, London, UK.

PMID: 31732683
PMCID: PMC7363790
DOI: 10.1136/archdischild-2019-317501

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.

Keywords: evidence based medicine; neonatology; outcomes research.

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Conflict of interest statement

Competing interests: JWHW has received support from Chiesi Pharmaceuticals to attend an educational conference and has received a research grant from Mason Medical Research Foundation. AG has held grants from various manufacturers (Abbott Laboratories, MedImmune) and ventilator manufacturers (SLE). AG has received honoraria for giving lectures and advising various manufacturers (Abbott Laboratories, MedImmune) and ventilator manufacturers (SLE). AG is currently receiving a non-conditional educational grant from SLE. NMa has received consultancy fees from Shire and Novartis and is Chair of the long-term outcomes group for the International Neonatal Consortium, Critical Path Institute. NMo is Director of the Neonatal Data Analysis Unit at Imperial College London. In the last 5 years NMo has served on the Board of Trustees of the Royal College of Paediatrics and Child Health, David Harvey Trust, Medical Women’s Federation and Medact; and is a member of the Nestle Scientific Advisory Board. NMo has received research grants from the British Heart Foundation, Medical Research Council, National Institute of Health Research, Westminster Research Fund, Collaboration for Leadership in Applied Health Research and Care Northwest London, Healthcare Quality Improvement Partnership, Bliss, Prolacta Life Sciences, Chiesi, Shire and HCA International; travel and accommodation expenses from Nutricia, Prolacta, Nestle and Chiesi; honoraria from Ferring Pharmaceuticals and Alexion Pharmaceuticals for contributions to expert advisory boards; and Chiesi for contributing to a lecture programme. CG is part of an international team developing reporting guidance (a CONSORT extension) for clinical trials using cohorts and routinely collected health data. He has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years he has been investigator on received research grants from Medical Research Council, National Institute of Health Research, Canadian Institutes of Health Research, Department of Health in England, Mason Medical Research Foundation, Westminster Medical School Research Trust and Chiesi Pharmaceuticals.

Figures

**Figure 1**
Example screenshot of eDelphi survey.

**Figure 2**
Flow chart of identification and selection of outcomes.

**Figure 3**
Scatterplots comparing round 1 mean scores (pairwise comparison between stakeholder groups).

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources