Protocol for development of a meta-core outcome set for stillbirth prevention and bereavement care following stillbirth, version 1.0
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Date
2022-07-11
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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.
Broad Objective
The broad objective of this study is to develop standard sets of outcomes for
stillbirth prevention and bereavement care in LMiC settings.
Specific Objectives
The specific objectives are 1. to identify outcomes used in current stillbirth
research in LMiC settings relevant to stillbirth; 2. to solicit the importance of
stillbirth outcomes from health care professionals, researchers and parents’
perspectives; and 3. to determine 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
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Protocol for development of a meta-core outcome sets for stillbirth
prevention and bereavement care following stillbirth Version 2 16/06/2022
8
virtual consensus meeting with representation from all stakeholder groups.
In Malawi, the study will be conducted at Bwaila, Ethel Mutharika and
Mitundu Hospitals.
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.11-Jul-2022
Protocol for development of a meta-core outcome sets for stillbirth
prevention and bereavement care following stillbirth Version 2 16/06/2022