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

TY - JOUR

T1 - Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS)—an international multi-stakeholder Delphi study

T2 - study protocol

AU - Walker, Shawn

AU - Dasgupta, Tisha

AU - Shennan, Andrew

AU - Sandall, Jane

AU - Bunce, Catey

AU - Roberts, Phoebe

N1 - Funding Information: The Project Steering Committee (PSC) Professor Melania Amorim, Brazil (obstetrician) Professor Yifru Berhan, Ethiopia (obstetrician) Dr Andrew Bisits, Australia (obstetrician) Dr Floortje Vlemmix, Netherlands (obstetrician) Dr Anke Reitter, Germany (obstetrician) Sarah Hunter, London (service user) The members of the PSC were consulted to provide feedback during the study design and protocol development. This project has been registered with KDPR, Project ID 14460. Respondents who agree to take part will be assigned a unique identification number. All data will be stored against the unique identifier only; participants will be blinded to the other respondents in the study. Only the chief investigator (SW) and research assistant will have access to the complete list of Delphi survey panellists. Sponsor Reference: MRA-18/19-13879 Name of Sponsoring Organisation: King?s College London Name of Sponsor Representative: Professor Reza Razavi Address: Vice President & Vice Principal (Research) Room 5.31, James Clerk Maxwell Building, 57 Waterloo Road, London SE1 8WA Telephone: +44 (0)207 848 3224 Neither the study sponsor (King?s College London) nor the funder (National Institute for Health Research) has played any role in the design of the study, nor will they be in a position to influence the data collection, management, analysis, interpretation of data, writing of the report and/or authority over the decision to submit the report for publication. Funding Information: This study is funded by a National Institute of Health Research (NIHR) Advanced Fellowship: NIHR300582. It is part of a feasibility study for a pragmatic trial of OptiBreech Care. The COS Delphi was registered with the King’s College London Research Ethics Office (MRA-18/19-13879). Publisher Copyright: © 2022, The Author(s).

PY - 2022/12

Y1 - 2022/12

N2 - Background: Women pregnant with a breech-presenting foetus 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) for studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth. Methods: 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, to enable service user perspectives on the results of the literature review to influence the design of the Delphi survey instrument. Second, an international Delphi survey will be conducted to prioritise outcomes for inclusion in the Breech-COS from the point of view of key stakeholders, including perinatal care providers and 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. Discussion: The expectation is that the Breech-COS will always be collected in all clinical trials, audits of practice and other forms of observation research that concern breech birth at term, along with other outcomes of interest. This will facilitate comparing, contrasting and combining studies with the ultimate goal of improved maternal and neonatal outcomes. Trial registration: Core Outcome Measures in Effectiveness Trials (COMET) #1749.

AB - Background: Women pregnant with a breech-presenting foetus 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) for studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth. Methods: 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, to enable service user perspectives on the results of the literature review to influence the design of the Delphi survey instrument. Second, an international Delphi survey will be conducted to prioritise outcomes for inclusion in the Breech-COS from the point of view of key stakeholders, including perinatal care providers and 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. Discussion: The expectation is that the Breech-COS will always be collected in all clinical trials, audits of practice and other forms of observation research that concern breech birth at term, along with other outcomes of interest. This will facilitate comparing, contrasting and combining studies with the ultimate goal of improved maternal and neonatal outcomes. Trial registration: Core Outcome Measures in Effectiveness Trials (COMET) #1749.

KW - Breech presentation

KW - Clinical trial

KW - Consensus

KW - Core outcome set

KW - Delphi

UR - http://www.scopus.com/inward/record.url?scp=85127495910&partnerID=8YFLogxK

U2 - 10.1186/s13063-022-06136-9

DO - 10.1186/s13063-022-06136-9

M3 - Article

C2 - 35379305

AN - SCOPUS:85127495910

SN - 1745-6215

VL - 23

JO - Trials

JF - Trials

IS - 1

M1 - 249

ER -