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Core outcomes in neonatology: development of a core outcome set for neonatal research
James William Harrison Webbe1, James M N Duffy2, Elsa Afonso3
1Academic Neonatal Medicine, Imperial College London, London, UK j.webbe@imperial.ac.uk.
Insights
A core outcome set (COS) was defined for neonatal research, standardizing measures for infants in high-income settings. This ensures research outcomes are relevant to patients, parents, and professionals.
Area of Science:
- Neonatal research
- Clinical trials
- Health outcomes
Background:
- Neonatal research utilizes diverse outcome measures, hindering meta-analyses and relevance.
- Selected outcomes may not align with patient, parent, or professional priorities.
Purpose of the Study:
- To establish a standardized core outcome set (COS) for research involving infants in high-income neonatal care settings.
- To improve the relevance and comparability of neonatal research findings.
Main Methods:
- Systematic review of outcomes from neonatal trials and qualitative studies.
- International three-round Delphi survey involving 414 stakeholders (patients, parents, professionals, researchers).
- Consensus meeting with 16 stakeholders to finalize the COS based on survey results.
Main Results:
- Literature reviews identified 104 outcomes; 10 additional outcomes were proposed.
- 114 outcomes were scored, revealing differing stakeholder priorities.
- A final COS of 12 outcomes was established, including survival, sepsis, necrotising enterocolitis, brain injury, motor and cognitive abilities, quality of life, adverse events, and sensory/respiratory conditions.
Conclusions:
- A definitive COS for neonatal research in high-income settings has been identified.
- This COS will standardize outcome selection in clinical trials.
- Ensures research outcomes are relevant to key stakeholders, particularly those impacted by neonatal care.
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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