Discussion
Using a robust, reproducible consensus methodology, we have identified and prioritised 186 neonatal research questions suitable for definitive interventional clinical trials. Through involvement of a broad range of stakeholders, the results are generalisable to the wider neonatal community in the UK. These results should inform the design of practice-changing clinical trials to ensure such trials address clinically relevant research questions and avoid contributing to research waste.This neonatal research priority setting partnership builds on previous priority setting work by Duley A strength of this project is the large numbers of participants: over 200 people from several different high-income countries identified and ranked research questions. Additional strengths include ongoing parent representation with the use of specially designed training materials and question submission software supporting involvement in designing PICO questions. Finally, the use of a well-established, transparent eDelphi methodology ensures that this process was robust and reproducible for use in future initiatives. This approach could be used to identify and prioritise research questions suitable for other methodologies such as qualitative research.A limitation of this work was attrition during the eDelphi survey, which was most notable among parents and former patients. Ensuring ongoing parent, patient or public participation in Delphi surveys is well recognised to be challenging.We recognised at the outset that meaningful involvement in prioritisation required complex medical and technical knowledge of neonatal medicine, and that this knowledge may not be easily accessible to parents and ex-neonatal patients. We did however endeavour to include parents and ex-neonatal patients as they are key stakeholders in research designed to resolve uncertainties about the use of existing treatments. A different process would be needed to prioritise RCTs of emerging new therapies at earlier stages of translation. Following engagement with our parental representative and the organisation charity Bliss, we attempted specific and targeted parental prioritisation using plain English summaries of the most highly ranked questions. However, even this approach was considered inappropriate by our parent representative and charity partners who concluded that for parental involvement to be truly meaningful, it should be addressed by a more targeted qualitative approach focused on smaller numbers of research questions. Therefore, while robust health professional input was obtained from the full range of neonatal clinical and allied professions, this process should be considered less representative of parent and ex-neonatal patient views.Priority setting work is becoming more widespread, with a recent scoping review showing that health-related topics encompassed 93% of all priority setting projects completed by the end of 2020.Future steps include sharing these prioritised research questions with clinical trial funders through existing commissioning processes. Our study methods and training materials strove to support detailed PICO question formation; however, we recognise some questions will require further refinement prior to evaluation in perinatal and neonatal adaptive trial platforms. Utilisation of priority setting results by research funders is expanding rapidly and there is variation in the methods used.