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The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction

The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction
The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction

BACKGROUND: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the procedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these techniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are challenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design and conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR.

METHODS/DESIGN: The iBRA study is a trainee-led research collaborative project with four phases:Phase 1 - a national practice questionnaire (NPQ) to survey current practicePhase 2 - a multi-centre prospective cohort study of patients undergoing IBBR to evaluate the clinical and patient-reported outcomesPhase 3- an IBBR-RCT acceptability survey and qualitative work to explore patients' and surgeons' views of proposed trial designs and candidate outcomes.Phase 4 - phases 1 to 3 will inform the design and conduct of the future RCT All centres offering IBBR will be encouraged to participate by the breast and plastic surgical professional associations (Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons). Data collected will inform the feasibility of undertaking an RCT by defining current practice and exploring issues surrounding recruitment, selection of comparator arms, choice of primary outcome, sample size, selection criteria, trial conduct, methods of data collection and feasibility of using the trainee collaborative model to recruit patients and collect data.

DISCUSSION: The preliminary work undertaken within the iBRA study will determine the feasibility, design and conduct of a definitive RCT in IBBR. It will work with the trainee collaborative to build capacity by creating an infrastructure of research-active breast and plastic surgeons which will facilitate future high-quality research that will ultimately improve outcomes for all women seeking reconstructive surgery.

TRIAL REGISTRATION: ISRCTN37664281.

Journal Article
1-11
Potter, Shelley
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Conroy, Elizabeth J.
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Williamson, Paula R.
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Thrush, Steven
54ed886c-690c-41e8-a7d6-6bc05d4b7dd6
Whisker, Lisa J.
6cae5575-e545-407f-9b9d-7a6db1f2cd42
Skillman, Joanna M.
9dcb124c-14c3-4f88-be59-5c802c573aad
Barnes, Nicola L.P.
4ec5f15a-362a-459c-8b50-f6b15aa94081
Cutress, Ramsey I.
68ae4f86-e8cf-411f-a335-cdba51797406
Teasdale, Elizabeth M.
e2b691a0-b8f3-4ef3-a6d9-4722771bb7ec
Mills, Nicola
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Mylvaganam, Senthurun
69d44b29-5c5f-4dd6-976a-8cee876196c8
Branford, Olivier A.
27bce544-8583-4c4f-a99d-803360d4a9e3
McEvoy, Katherina
4f7a2f24-ea6b-4f7b-8bc4-a750e7acd612
Jain, Abhilash
c68ef4be-e2dd-4317-9d2e-f146a2ee9e4c
Gardiner, Matthew D.
eea0ad25-65ea-4867-a60c-311aac543eab
Blazeby, Jane M.
689d490e-fca3-4430-88de-f19ec6cebf58
Holcombe, Christopher
e10e54d6-3370-45be-a43f-59a381f4391c
Breast Reconstruction Research Collaborative
Potter, Shelley
77970724-8e7c-47cb-973c-d5a7c6bd783c
Conroy, Elizabeth J.
d050f25a-4835-4a7b-a7a9-1c3a01abe2a7
Williamson, Paula R.
cef0b386-84e6-4f2e-8e9b-516c58a14e44
Thrush, Steven
54ed886c-690c-41e8-a7d6-6bc05d4b7dd6
Whisker, Lisa J.
6cae5575-e545-407f-9b9d-7a6db1f2cd42
Skillman, Joanna M.
9dcb124c-14c3-4f88-be59-5c802c573aad
Barnes, Nicola L.P.
4ec5f15a-362a-459c-8b50-f6b15aa94081
Cutress, Ramsey I.
68ae4f86-e8cf-411f-a335-cdba51797406
Teasdale, Elizabeth M.
e2b691a0-b8f3-4ef3-a6d9-4722771bb7ec
Mills, Nicola
d43e1677-c156-4fc6-a09c-6519798682cc
Mylvaganam, Senthurun
69d44b29-5c5f-4dd6-976a-8cee876196c8
Branford, Olivier A.
27bce544-8583-4c4f-a99d-803360d4a9e3
McEvoy, Katherina
4f7a2f24-ea6b-4f7b-8bc4-a750e7acd612
Jain, Abhilash
c68ef4be-e2dd-4317-9d2e-f146a2ee9e4c
Gardiner, Matthew D.
eea0ad25-65ea-4867-a60c-311aac543eab
Blazeby, Jane M.
689d490e-fca3-4430-88de-f19ec6cebf58
Holcombe, Christopher
e10e54d6-3370-45be-a43f-59a381f4391c

Potter, Shelley, Conroy, Elizabeth J., Williamson, Paula R., Thrush, Steven, Whisker, Lisa J., Skillman, Joanna M., Barnes, Nicola L.P., Cutress, Ramsey I., Teasdale, Elizabeth M., Mills, Nicola, Mylvaganam, Senthurun, Branford, Olivier A., McEvoy, Katherina, Jain, Abhilash, Gardiner, Matthew D., Blazeby, Jane M. and Holcombe, Christopher , Breast Reconstruction Research Collaborative (2016) The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction. Pilot and Feasibility Studies, 2 (41), 1-11. (doi:10.1186/s40814-016-0085-8).

Record type: Article

Abstract

BACKGROUND: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the procedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these techniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are challenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design and conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR.

METHODS/DESIGN: The iBRA study is a trainee-led research collaborative project with four phases:Phase 1 - a national practice questionnaire (NPQ) to survey current practicePhase 2 - a multi-centre prospective cohort study of patients undergoing IBBR to evaluate the clinical and patient-reported outcomesPhase 3- an IBBR-RCT acceptability survey and qualitative work to explore patients' and surgeons' views of proposed trial designs and candidate outcomes.Phase 4 - phases 1 to 3 will inform the design and conduct of the future RCT All centres offering IBBR will be encouraged to participate by the breast and plastic surgical professional associations (Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons). Data collected will inform the feasibility of undertaking an RCT by defining current practice and exploring issues surrounding recruitment, selection of comparator arms, choice of primary outcome, sample size, selection criteria, trial conduct, methods of data collection and feasibility of using the trainee collaborative model to recruit patients and collect data.

DISCUSSION: The preliminary work undertaken within the iBRA study will determine the feasibility, design and conduct of a definitive RCT in IBBR. It will work with the trainee collaborative to build capacity by creating an infrastructure of research-active breast and plastic surgeons which will facilitate future high-quality research that will ultimately improve outcomes for all women seeking reconstructive surgery.

TRIAL REGISTRATION: ISRCTN37664281.

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Accepted/In Press date: 10 June 2016
e-pub ahead of print date: 4 August 2016
Keywords: Journal Article

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Local EPrints ID: 413489
URI: http://eprints.soton.ac.uk/id/eprint/413489
PURE UUID: 64b0d5b0-41dc-46b7-b3db-f57215d146ab

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Date deposited: 24 Aug 2017 16:31
Last modified: 16 Dec 2019 19:04

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Contributors

Author: Shelley Potter
Author: Elizabeth J. Conroy
Author: Paula R. Williamson
Author: Steven Thrush
Author: Lisa J. Whisker
Author: Joanna M. Skillman
Author: Nicola L.P. Barnes
Author: Elizabeth M. Teasdale
Author: Nicola Mills
Author: Senthurun Mylvaganam
Author: Olivier A. Branford
Author: Katherina McEvoy
Author: Abhilash Jain
Author: Matthew D. Gardiner
Author: Jane M. Blazeby
Author: Christopher Holcombe

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