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

James Webbe · James MN Duffy · Elsa Afonso · Iyad Al-Muzaffar · Ginny Brunton · Anne Greenough +11 more

235 citations0/0 files storedArchives of Disease in Childhood Fetal & Neonatal

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Delphi Technique in Research Infant Development and Preterm Care Ethics and Legal Issues in Pediatric Healthcare

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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1963An Experimental Application of the DELPHI Method to the Use of Experts 2008Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1. The Cochrane Collaboration 2018Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017 2017The COMET Handbook: version 1.0 2012Developing core outcome sets for clinical trials: issues to consider 2009Methods to increase response to postal and electronic questionnaires 2011Using the Delphi Technique to Determine Which Outcomes to Measure in Clinical Trials: Recommendations for the Future Based on a Systematic Review of Existing Studies 2014Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0

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