Fiona A Quirke1,2,3, Patricia Healy4,5, Elaine Ní Bhraonáin6, Mandy Daly7, Linda Biesty4,5,8, Tim Hurley9,10, Karen Walker11, Shireen Meher12, David M Haas13, Frank H Bloomfield14, Jamie J Kirkham15, Eleanor J Molloy10,16, Declan Devane17,4,5,18,19. 1. Health Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Galway, Ireland. f.quirke1@nuigalway.ie. 2. Health Research Board - Trials Methodology Research Network (HRB-TMRN), Galway, Ireland. f.quirke1@nuigalway.ie. 3. College of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland. f.quirke1@nuigalway.ie. 4. College of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland. 5. School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland. 6. Family Support Liaison, Irish Neonatal Health Alliance, Wicklow, Ireland. 7. Advocacy and Policymaking, Irish Neonatal Health Alliance, Wicklow, Ireland. 8. Qualitative Research in Trials Centre (QUESTS), National University of Ireland Galway, Galway, Ireland. 9. Health Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Galway, Ireland. 10. Paediatrics and Child Health, Trinity College Dublin, Dublin, Ireland. 11. RPA Newborn Care, Sydney Local Health District, Sydney, Australia. 12. Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK. 13. Department of Obstetrics and Gynaecology, Indiana University School of Medicine, Indianapolis, USA. 14. Liggins Institute, University of Auckland, Auckland, New Zealand. 15. Centre for Biostatistics, University of Manchester, Manchester, UK. 16. Department of Neonatology, Children's Hospital Ireland at Crumlin and Tallaght, Coombe Women and Infants University Hospital, Dublin, Ireland. 17. Health Research Board - Trials Methodology Research Network (HRB-TMRN), Galway, Ireland. 18. Evidence Synthesis Ireland, National University of Ireland Galway, Galway, Ireland. 19. Cochrane Ireland, National University of Ireland Galway, Galway, Ireland.
Abstract
BACKGROUND: Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy. METHODS: We will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a "Real-Time" Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS). DISCUSSION: More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall, this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall patient care to be enhanced. TRIAL REGISTRATION: This study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://www.comet-initiative.org/Studies/Details/1270 .
BACKGROUND:Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy. METHODS: We will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a "Real-Time" Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS). DISCUSSION: More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall, this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall patient care to be enhanced. TRIAL REGISTRATION: This study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://www.comet-initiative.org/Studies/Details/1270 .
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