Development of a core outcome set for stillbirth care research

The impact of stillbirth is profound, yet there is a paucity of evidence on the effectiveness of care for bereaved families due to the heterogeneity of outcomes reported. To address this issue a minimum set of outcomes to be measured and reported for stillbirth care research was developed in the form of a core outcome set. A systematic review was undertaken to identify potentially important outcomes for inclusion in a core outcome set. The review indicated a wide variation in outcomes, outcome definitions and outcome measurement tools in use. It highlighted considerable research gaps on specific intervention types in stillbirth care. A qualitative study of the lived experience of stillbirth identified additional meaningful outcomes that are under-measured within the stillbirth care research field, indicating researchers are not focusing on outcomes important to bereaved families. International think-aloud interviews were conducted to robustly pilot and develop an outcomes long-list to prioritise outcomes of importance. Five hundred and forty-two families with lived experience of stillbirth, stillbirth researchers, healthcare professionals and stillbirth advocates from 29 different countries participated in a Delphi survey and consensus meetings to agree on a core outcome set for stillbirth care research. Mandatory outcomes in all circumstances: life-threatening complications and death, parents' experience of respectful and supportive care, grief, mental health and emotional wellbeing, isolation, stigma, impact on work, impact on relationship with immediate family. Mandatory outcomes in specific circumstances: cause of death identified and parents' understanding of cause of death. Mandatory subsequent pregnancy care outcomes: antenatal complications for mother, antenatal complications for baby, survival of baby, neonatal outcomes and attachment to baby. The findings of this thesis directly contribute to the advancement of stillbirth care research. The core outcome set will improve outcome selection, collection and reporting, and ultimately evidence and clinical decision making on what care is best for families following stillbirth.