National priority setting partnership using a Delphi consensus process to develop neonatal research questions suitable for practice-changing randomised trials in the United Kingdom.

Methodologically robust clinical trials are required to improve neonatal care and reduce unwanted variations in practice. Previous neonatal research prioritisation processes have identified important research themes rather than specific research questions amenable to clinical trials. Practice-changing trials require well-defined research questions, commonly organised using the Population, Intervention, Comparison, Outcome (PICO) structure. By narrowing the scope of research priorities to those which can be answered in clinical trials and by involving a wide range of different stakeholders, we aim to provide a robust and transparent process to identify and prioritise research questions answerable within the National Healthcare System to inform future practice-changing clinical trials. A steering group comprising parents, doctors, nurses, allied health professionals, researchers and representatives from key organisations (Neonatal Society, British Association of Perinatal Medicine, Neonatal Nurses Association and Royal College of Paediatrics and Child Health) was identified to oversee this project. We will invite submissions of research questions formatted using the PICO structure from the following stakeholder groups using an online questionnaire: parents, patients, healthcare professionals and academic researchers. Unanswered, non-duplicate research questions will be entered into a three-round eDelphi survey of all stakeholder groups. Research questions will be ranked by mean aggregate scores. The final list of prioritised research questions will be disseminated through traditional academic channels, directly to key stakeholder groups through representative organisations and on social media. The outcome of the project will be shared with key research organisations such as the National Institute for Health Research. Research ethics committee approval is not required.

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Déclaration de conflit d'intérêts

Competing interests: CG is vice chair of the NIHR Research for Patient Benefit London Regional Advisory Panel and a member of the Glasgow Children’s Hospital Charity External Panel; he holds a Medical Research Council Transition Support Award. JPB is a member of the Wellcome Trust's Career Development Award Panel and the Great Ormond Street Hospital Charity Research Assessment Panel. CB is the NIHR deputy chair of HTA prioritisation committee for hospitals. JD is a member of the NIHR HTA CET Funding Committee. CM is funded by HEE-NIHR Integrated Clinical Academic Programme and holds a NIHR ICA CSRF Fellowship.