Protocol for the development of a meta-core outcome set for stillbirth prevention and bereavement care following stillbirth

Kushupika Dube, Elizabeth Ayebare, Danya Bakhbakhi, Carol Bedwell, Savitha Chandriah, Nasim Chaudhry, Ides Chilinda, Angela Chimwaza, Unice Goshomi, Rose Laisser, Tina Lavender, Tracey Mills, Sudhindrashayana Fattepur, Bellington Vwalika, Sabina Wakasiaka, Jamie Kirkham

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Abstract

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.
Original languageEnglish
Number of pages11
JournalmedRxiv
DOIs
Publication statusPublished - 13 Oct 2022

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