Title: Development of a core outcome set and associated measurement tools for neonatal palliative and end-of-life care
Funder: Health Education England

Abstract: BackgroundNeonatal death is the leading cause of death in children under 5yrs in the UK; annually 1200 babies die in the first 28 days after birth. Many deaths occur following a decision between parents and clinicians to redirect treatment from active to palliative, however the evidence base supporting neonatal palliative and end-of-life care is sparse. Study comparison is difficult as researchers report different approaches towards, and outcomes of, palliative care in their work. Evidence synthesis is required to develop standardised outcomes and measurements which define safe and effective approaches to practice, taking into account the needs of families involved. This is particularly relevant for families from Black, Asian and Ethnic Minority populations where the risk of neonatal death is 73% higher compared to white babies.Aims & ObjectivesThe aim of this research is to develop a core outcome set and associated measurement tools for a neonatal palliative and end-of-life care, incorporating the views key stakeholders including bereaved parents from diverse communities, healthcare professionals and researchers. MethodsCore outcome set development methodology will be used to determine outcomes and measurements. A steering group will be identified to determine the scope of the core outcome set. A systematic review of the literature will identify previously reported outcomes for interventions in neonatal palliative or end-of-life care. Qualitative interviews with bereaved parents from diverse communities, healthcare professionals and researchers will be undertaken to identify outcomes not reported in the literature.All outcomes identified will be refined for evaluation by relevant stakeholders in a national Delphi study. Results will be presented at a consensus meeting to finalise the core outcomes for inclusion. All outcomes will then be subject to systematic review to determine reliable measurement methods in clinical practice. Timelines: Year 1Steering group agree on core outcome set scope and stakeholders for involvementProtocol prepared and accepted for publicationSystematic review completedEthical approval granted for key stakeholder interviews First short animation complete (for Delphi participation) Year 2Systematic review results manuscript accepted for publicationStakeholder interviews and analysis complete and results manuscript accepted for publicationKey stakeholders for Delphi study identified and invited to register with Delphi studyDelphi survey launchedDissemination tools under development (website) Year 3Delphi survey and consensus meeting to finalise core outcome set completeCore Outcome Set accepted for publicationSystematic review of outcome measurement tools complete and accepted for publicationDissemination on-going (website and second short animation of results complete)Anticipated impact and disseminationThe core outcome set for neonatal palliative and end-of-life care will determine minimum standards for reporting and measurement when conducting research or quality improvements. Standardised reporting outcomes will improve consistency of the evidence-base, supporting clinicians to improve practice. Ultimately this will improve experiences of babies, families, and healthcare providers. Dissemination will be supported by a dedicated website hosting publications, a short, animated film of the results and on-going research and discussion. This will be shared widely with study participants, on relevant social media pages and through relevant professional groups.

Lay abstract: Background Death in the first 28 days of life, or 'neonatal death', represents the highest number of deaths in children under 5 in the UK. Each year 1,200 babies die during this period, with most neonatal deaths happening on neonatal units where babies receive treatment from specialist doctors and nurses. For many families, conversations will have occurred with professionals around whether or not to continue with lifesaving treatment for their babies. If it is agreed continuing treatment is not in babies' best interests, palliative, or 'end-of-life care', will be provided to babies and families. What constitutes end-of-life care, however, is unclear and professionals often provide different treatment to different families, reporting different outcomes in their research. This means we cannot compare whether one approach to neonatal end-of-life care is better than another. Creating a common, or 'core' set of outcomes from which to measure neonatal end-of-life care would allow us to develop measures of good practice and improve our care of families. These outcomes must reflect the needs of families involved; these are currently unknown. This is particularly relevant for Black, Asian and Ethnic Minority families whose infants are at significantly higher risk of death than other populations.AimThe study aims to develop ways in which to measure end-of-life treatment provided in neonatal end-of-life care.Design and methods usedDetermining the core outcomes for neonatal end-of-life care requires careful consideration of the needs of families, healthcare professionals and researchers. This study will explore these needs to determine what treatment should be measured, and how, when undertaking research into neonatal end-of-life care. Interviews will be undertaken with bereaved parents from diverse communities, with full support, to explore what they feel is important for families receiving neonatal end-of-life care. All outcomes previously discussed in the literature will be gathered. These outcomes will be combined and sent through an online survey to a large group of relevant parents, health professionals and researchers. Participants will be asked to rate the importance of each outcome, with the highest-scoring items recommended as 'core outcomes'. Ways in which professionals can measure these in practice will be identified. Patient/service user, carer and public involvementI have worked with many families in both research and practice whose experiences highlight the inequity of neonatal end-of-life care provision; this study originates from these experiences. A number of these bereaved parents and representatives from bereaved parent charity groups have agreed to be part of the study steering group. We will work together on all aspects of the study including recruitment, participant support and the development of two short films to facilitate participation and results dissemination. To ensure the core outcomes reflect the needs of diverse populations, the study will include bereaved families from a wide range of backgrounds. Work currently being undertaken will help to identify how to reach these potential participants and support their engagement in the research process. The use of translators is included in the study to support interviews in different languages and translation of study materials to facilitate participation and sharing of results. DisseminationA dedicated website, shared with study participants and through social media and professional networks, will disseminate results. Here, a short, animated film will highlight findings using lay language and subtitles. Specific pages will share resources for families and practitioners and resulting publications to encourage nurses, doctors and researchers to use the core outcomes in practice and research to measure and improve neonatal end-of-life care. The dedicated specialist website will provide a platform for the outcomes developed to be considered for adaptation to national and international settings, facilitating best practice in neonatal end-of-life care.

Research activity codes: 7.2 END OF LIFE CARE
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH