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Cited by 235Delphi Technique in ResearchInfant Development and Preterm CareEthics and Legal Issues in Pediatric Healthcare

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

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Webbe, James William Harrison, Duffy, James M N, Afonso, Elsa, Al-Muzaffar, Iyad, Brunton, Ginny, Greenough, Anne, Hall, Nigel J, Knight, Marian +9 more·2020·Archives of Disease in Childhood - Fetal and Neonatal Edition
DOI 10.1136/archdischild-2019-317501PMC PMC7363790
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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.

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  • If a family member is present in an emergency, it may not be feasible for the researcher to explain to them the research protocol, or even the concept of informed consent.

    “For instance, if a family member is present in an emergency, it may not be feasible for the researcher to explain to them the research protocol, or even the concept of informed consent. 348”

    From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [348]

    The Methods (Participants and Consensus meeting; page unavailable) describe recruiting parents and discussing which outcomes trials could feasibly record. The Discussion (page unavailable) addresses parents’ involvement in outcome selection. Searches for emergency research, family members, research protocols, and informed consent found no passage addressing whether a researcher could explain a protocol or consent during an emergency. (LLM, conf=0.76)

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Authors
Webbe, J. W. H., Duffy, J. M. N., Afonso, E., Al-Muzaffar, I., Brunton, G., Greenough, A., Hall, N. J., Knight, M., Latour, J. M., Lee-Davey, C., Marlow, N., Noakes, L., Nycyk, J., Richard-Löndt, A., Wills-Eve, B., Modi, N., & Gale, C.
Affiliations
  • Imperial College London (GB)
  • University of Oxford (GB)
  • Rosie Hospital (GB)
  • Royal Glamorgan Hospital (GB)
  • University College London (GB)
  • King's College London (GB)
  • Southampton General Hospital (GB)
  • Curtin University (AU)
  • Bliss (GB)
  • Parent of Neonatal Patient, London, UK
  • Birmingham City Hospital (GB)
  • Former neonatal patient, London, UK
Corresponding author
Webbe, James William Harrison
ORCID
Venue
Archives of Disease in Childhood - Fetal and Neonatal Edition
Publisher
BMJ
Published
2019-11-15
Volume
105
Issue
4
Pages
425-431
ISSN
  • 1359-2998 (ISSN-L)
  • 1468-2052
DOI
10.1136/archdischild-2019-317501
PMC
PMC7363790
OpenAlex
W2988264143
Cited by
235
References
6
Citations by year
2026: 33 · 2025: 34 · 2024: 50 · 2023: 39 · 2022: 26 · 2021: 32 · 2020: 20 · 2019: 1
FWCI
5.07
Type
journal article
Language
en
Open access
Licence
Locations
  • Archives of Disease in Childhood Fetal & Neonatal (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • ePrints Soton (University of Southampton) (acceptedVersion)
  • PEARL (University of Plymouth) (submittedVersion)
  • UCL Discovery (University College London) (submittedVersion)
  • Research Portal (King's College London) (submittedVersion, other-oa)
  • HighWire Press Open Archive (submittedVersion)
  • Spiral (Imperial College London) (submittedVersion, other-oa)
Funders
  • Mason Medical Research Foundation
  • The Portland Hospital
  • Medical Research Council (MR/N008405/1)
Topics
  • Social Sciences › Sociology and Political Science › Delphi Technique in Research
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Ethics and Legal Issues in Pediatric Healthcare
Keywords
core outcome set, neonatal care, neonatal clinical trials, outcome standardization, stakeholder prioritization, neonatal survival, neonatal sepsis, necrotizing enterocolitis, brain injury, gross motor development, cognitive development, quality of life, visual impairment, hearing loss, retinopathy of prematurity, bronchopulmonary dysplasia, adverse events
MeSH terms
Humans, Infant, Neonatology, Outcome Assessment, Health Care, Biomedical Research

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