Protocol for development of a meta-core outcome set for stillbirth prevention and bereavement care following stillbirth, version 1.0

Kirkham, Jamie; Chimwaza, Angela

Protocol for development of a meta-core outcome set for stillbirth prevention and bereavement care following stillbirth, version 1.0

Date

2022-06-15

Authors

Kirkham, Jamie

Chimwaza, Angela

Abstract

Type of research study: Delphi survey for the development of a meta-core outcome set for stillbirth prevention and bereavement care following stillbirth. Problem statement A stillbirth 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 a stillbirth remains a challenge, particularly in Low and Middle Income Countries (LMiC). One approach to improvement is the prioritization of women/family-centered care. There is a large variety of outcomes measured in stillbirth studies but 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. Objectives The broad objective of this study is to develop standard sets of outcomes for use in interventional studies for stillbirth prevention and improving bereavement care following stillbirths in LMiC settings. The specific objectives are to: identify outcomes used in current stillbirth research including outcomes reported in qualitative literature in LMiC settings relevant to stillbirth; to prioritize outcomes from health care professionals, researchers and parents’ perspectives; and to integrate the outcomes important to all stakeholders in order to ratify a core outcome set (COS). Methodology 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, a search of trial registry data, 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 be 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 15-Jun-2022 Protocol for development of a meta-core outcome sets for stillbirth prevention and bereavement care following stillbirth Version 1.0 1/05/2022 8 virtual consensus meeting with representation from all stakeholder groups. Expected findings and their dissemination It is expected that two COS for use in a LMiC setting will be developed, one for stillbirth prevention and one for bereavement care following stillbirth. Both COS will be developed for research and clinical practice and will consider all interventions and care options for stillbirth care within this scope. The development of these COS will be reported according to the COS-STAR (Core Outcome Set-STAndards for Reporting) guidelines [16]. We will register the COS with CROWN (Core Outcomes in Women’s & Newborn Health) [17] and share our findings across the GHRU Network, College of Medicine Research Ethics committee (COMREC), the LAMRN (Lugina Africa Midwives Research Network) [18] and other relevant international societies and organisations for wider dissemination.