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

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.

Competing Interest Statement

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years. DB was the lead author on the iCHOOSE core outcome set development study.

Funding Statement

This research was funded by the National Institute for Health Research (NIHR) (NIHR132027), a major funder of global health research and training, using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK Department of Health and Social Care.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics approval has been granted from the study sponsor Liverpool School of Tropical Medicine UK In country ethics from each of the eight participating countries also gave ethical approval for this work Bangalore Medical College & Research Institute India University of Nairobi Kenya Kamuzu University of Health Sciences Malawi Health Research Institute National Bioethics Committee Pakistan Catholic University of Health and Allied Sciences Bugando Tanzania Makerere University Uguanda University of Zambia Zambia Womens University in Africa Zimbabwe

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Yes

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Data Availability

This is a study protocol - no data to date have been collected.

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