Introduction: A stillbirth is the death of a baby before or during birth and accounts for about 14 in every 1,000 births globally with the highest rates seen in Sub-Saharan Africa and South Asia. Stillbirth prevention and bereavement care following stillbirth remains a challenge, particularly in Low-Middle Income Countries (LMiC). One approach to improvement is the prioritisation of women/family-centred care. However, there are a large variety of outcomes measured in stillbirth studies and consensus on the outcomes that matter most to women and families is often lacking, which can impact on the ability to make informed decisions about improved care practices. To help mitigate this problem, a core outcome set (COS) has been developed for stillbirth prevention and another COS has recently been finalised for care after stillbirth. Despite the majority of stillbirths occurring in LMiC involvement in these studies is ‘tokenistic’ and therefore the outcomes may not reflect the needs of parents or communities in these settings. The aim is to develop standard sets of outcomes for use in all interventional studies for stillbirth prevention and bereavement care using participants from predominantly Sub-Saharan Africa and South Asia, where the burden of stillbirth is highest.
Methods/Design: This study will involve three stages in the development of the COS: (1) a list of outcomes will be identified from multiple sources, specifically existing reviews of outcomes and a targeted qualitative literature review of studies that have interviewed parents who have experienced stillbirth and healthcare professionals working in this field across Sub-Saharan Africa and South Asia. (2) The list of outcomes will first be reviewed by in-country leads and scored by multiple stakeholder groups in a real-time online Delphi survey. (3) The results of the Delphi will be summarised and discussed at a face-to-face or virtual consensus meeting with representation from all stakeholder groups.
Discussion: As well as improving the consistency of outcomes for future research in an LMiC setting, these COS will harmonise with the existing COS in this field developed in a high income setting. The final output will be a global ‘meta-COS’, a recommended set of outcomes that can be used in stillbirth research worldwide.
The aim of this study is to contribute to the rapid development of a COS exclusively to an LMiC setting, relevant to all interventions and care options for use in studies for preventing stillbirth and improving bereavement care following stillbirth
ContributorsKushupika Dube, Elizabeth Ayebare, Danya Bakhbakhi, Carol Bedwell, Savitha Chandriah, Nasim Chaudhry, Ides Chilinda, Angela Chimwaza, Unice Goshomi, Rose Laisser, Tina Lavender, Tracey A Mills, Sudhindrashayana Fattepur, Bellington Vwalika, Sabina Wakasiaka, View ORCID Profile, Jamie J Kirkham
Disease Category: Pregnancy & childbirth
Disease Name: Stillbirth
Age Range: Unknown
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Systematic review
Step 1: identification of the long list of outcomes. The list of outcomes for use in the real-time Delphi survey will be generated from the
following sources:
1) The 56 outcomes entered into the Delphi study from the COSTIL study and the 108
outcomes entered into the Delphi for the iCHOOSE study.
2) Outcomes will also be extracted from a narrative synthesis of the qualitative literature.
Step 2: outcome prioritisation through a Delphi survey.
Step 3: consensus meeting and final core outcome set development