Background In high resource settings, 1 in 10 newborn babies require admission to a neonatal unit. Research evaluating neonatal care involves recording and reporting many different outcomes and outcome measures. Such variation limits the usefulness of research as studies cannot be compared or combined. To address these limitations, we aim to develop, disseminate and implement a core outcome set for neonatal medicine.
Methods A steering group that includes parents and former patients, healthcare professionals and researchers has been formed to guide the development of the core outcome set. We will review neonatal trials systematically to identify previously reported outcomes. Additionally, we will specifically identify outcomes of importance to parents, former patients and healthcare professionals through a systematic review of qualitative studies. Outcomes identified will be entered into an international, multi-perspective eDelphi survey. All key stakeholders will be invited to participate. The Delphi method will encourage individual and group stakeholder consensus to identify a core outcome set. The core outcome set will be mapped to existing, routinely recorded data where these exist.
Discussion Use of a core set will ensure outcomes of importance to key stakeholders, including former patients and parents, are recorded and reported in a standard fashion in future research. Embedding the core outcome set within future clinical studies will extend the usefulness of research to inform practice, enhance patient care and ultimately improve outcomes. Using routinely recorded electronic data will facilitate implementation with minimal addition burden.
Trial registration number Core Outcome Measures in Effectiveness Trials (COMET) database: 842 (www.comet-initiative.org/studies/details/842).
- core outcome set
- modified delphi method
- neonatal medicine
- systematic review
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Contributors CG conceived of this project. JW, CG and SA planned the systematic review of outcomes reported in clinical trials. JW, CG and GB planned the systematic review of outcomes identified by patients, parents and other stakeholders. The first draft of the manuscript was written by JW, CG, GB and JMND; NM edited and reviewed the manuscript. It was approved by JW, CG, GB, SA, JMND, NM and the Core Outcomes in Neonatology (COIN) Project Steering Group.
Funding This study was funded as part of a Medical Research Council (MRC) Clinician Scientist Fellowship awarded to CG (MR/N008405/1). The MRC were not involved in the design of the study, collection, analysis and interpretation of data or in writing the manuscript.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Steering Group Chair: Marian Knight, Professor of Maternal and Child Population Health, National Perinatal Epidemiology Unit, Oxford. Project Management Team: Chris Gale, Clinical Senior Lecturer in Neonatal Medicine, Imperial College, London. James Webbe, Clinical Research Fellow, Imperial College, London. Steering Group: Elsa Afonso, Neonatal Staff Nurse, Cambridge University Hospitals NHS Foundation Trust, Cambridge. Iyad Al-Muzaffar, Consultant Neonatologist and Parent of preterm baby, Cwm Taf University Health Board, Wales. Ginny Brunton, Midwife and qualitative methodologist, UCL Institute of Education, London. James Duffy, Doctoral Research Fellow in Obstetrics and Gynaecology, Nuffield Department of Primary Health Sciences, Oxford. Anne Greenough, Professor of Neonatology and Clinical Respiratory Physiology, King's College, London. Nigel Hall, Associate Professor of Paediatric Surgery, University of Southampton. Jos Latour, Professor of Clinical Nursing, Plymouth University, Plymouth. Neil Marlow, Professor of Neonatal Medicine, University College, London. Neena Modi, Professor of Neonatal Medicine, Imperial College, London. Laura Noakes, Parent of neonatal patient. Julie Nycyk, Consultant Neonatologist, Sandwell and West Birmingham Hospitals NHS Trust. Mehali Patel, Research Engagement Officer, Bliss, London. Angela Richard-Londt, Parent of neonatal patients. Ben Wills-Eve, Ex-neonatal patient.
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