Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS): an international multi-stakeholder Delphi study

Women pregnant with a breech-presenting fetus at term are at increased risk of adverse pregnancy outcomes. The most common intervention used to improve neonatal outcomes is planned delivery by caesarean section. But this is not always possible, and some women prefer to plan a vaginal birth. A number of providers have proposed alternative interventions, such as delivery protocols or specialist teams, but heterogeneity in reported outcomes and their measurements prevents meaningful comparisons. The aim of this paper is to present a protocol for a study to develop a Breech Core Outcome Set (Breech-COS) studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth. The development of a Breech-COS will include three phases: (1) a systematic review to identify outcomes previously used in effectiveness studies and a focus group discussion with the study’s PPI group; (2) an international Delphi survey to prioritise outcomes for inclusion in the Breech-COS from the point of view of key stakeholders; (3) a consensus meeting with stakeholders to ratify the Breech-COS and disseminate findings for application in future effectiveness studies.

Contributors

Dr Shawn Walker, King's College London (Chief Investigator)
Tisha Dasgupta, King's College London (Research Assistant)
Professor Andrew Shennan, King's College London
Professor Jane Sandall, King's College London
Dr Catey Bunce, King's College London
Project Steering Committee

Further Study Information

Current Stage: Ongoing
Date: June 2020 - June 2021
Funding source(s): This study is funded by a National Institute of Health Research Advanced Fellowship (NIHR300582). It is part of a feasibility study for a pragmatic trial of physiological breech birth team care.

Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Breech presentation

Target Population

Age Range: 15 - 45

Sex:

Nature of Intervention: Management of care

Stakeholders Involved

- Clinical experts
- Economists
- Patient/ support group representatives
- Researchers
- Service commissioners
- Service users
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Survey
- Systematic review

The development of a Breech-COS includes three phases. First, a systematic literature review will be conducted to identify outcomes previously used in effectiveness studies of breech birth at term. A focus group discussion will be conducted with the study’s pre-established Patient and Public Involvement (PPI) group. This will aim to identify whether the outcomes reported include those that are important to women and pregnant people. Second, an international Delphi survey of four rounds will be conducted to prioritise outcomes and agree on definitions for inclusion in the Breech-COS from the point of view of key stakeholders, including families who have experienced a term breech pregnancy. Finally, a consensus meeting will be held with stakeholders to ratify the Breech-COS and disseminate findings for application in future effectiveness studies.

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