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.

Types, reporting and acceptability of community-based interventions for stillbirth prevention in sub-Saharan Africa (SSA): a systematic review

“…Recently, Kim et al., 82 reported a minimum set of key outcomes (core outcome set) agreed on by stakeholders that should be reported consistently in all efficacy and effectiveness trials for stillbirth prevention. While this appears to be a useful development for stillbirth prevention, Dube et al., 83 argue that the involvement of parents and families from high burden LMICs for the outcome set development appear ‘tokenistic’ and therefore may not reflect the needs of these parents or communities. The perspectives and experiences of women and their families can inform contextually appropriate strategies that address the unique challenges and cultural considerations of these settings, leading to improved outcomes for both women and babies.…”

Protocol for the development of a core outcome set for neonatal sepsis (NESCOS)

“…RTD has been used in healthcare studies that aim to develop a medication adherence technologies repository [ 50 ] and determine the negative impacts of substance use disorders among people with HIV in the United States [ 51 ]. Several researchers have incorporated an RTD approach into the COS development processes [ 52 , 53 ].…”