The iBRA study is a collaborative project led by practising breast and plastic surgeons in the UK and ROI.
Partners include the Association of Breast Surgery, The Mammary Fold, RSTN, BAPRAS and SPARCS.
Spring 2016 Newsletter

The main iBRA manuscript has been accepted for publication in Lancet Oncology. Full text to follow . . .

The main iBRA manuscript will soon be submitted for publication.

The third part of the iBRA Study is now underway. This is a randomisation acceptability survey. Click the link for the invitation to take part: 61501 – iBRA randomisation invitation e-mail_v2 6th Feb 2018_bold and the survey link is here: https://is.gd/ibrasurvey.

Shelley Potter presented an update at the 3rd iBRA Study Day.

78 units recruited over 2000 patients. Largest prospective study of implant based breast reconstruction.

Less than 10% smokers, 25% bilateral, 10% neoadjuvant chemotherapy, 1/3 risk reducing. 50% have biological mesh but synthetic mesh increasing. Mainly Strattice and Surgimend.

Next is a randomisation acceptability survey and patient and clinician interviews. This is to build the protocol for an RCT.

1. Define current practice of implant-based breast reconstruction in the UK

2. Evaluate clinical and patient reported outcomes of implant-based breast reconstruction

3. Determine the feasibility of future evaluation in a clinical trial or registry

4. Generate new guidelines for implant-based breast reconstruction

Olivier Branford is leading the RSTN involvement in the study. To get involved please contact him at olivier.branford@totalise.co.uk.

Follow @OlivierBranford

The latest protocol is available for download here: iBRA protocol version 7 and an extract below.

Aims and objectives
The iBRA Study aims to work with the National Trainee Research Collaborative Network to:

Describe the current practice of immediate implant-based breast reconstruction in the UK, variation in the provision of novel techniques and adherence to ABS/BAPRAS Oncoplastic Breast Reconstruction: Guidelines for Best Practice3 and ADM guidelines86 relating to these.
Evaluate the outcomes of different approaches to immediate implant-based procedures against
National ABS/BAPRAS standards86 and quality criteria specified in ABS/BAPRAS ‘Oncoplastic Breast Reconstruction: Guidelines for Best Practice’3 and the findings of the National Mastectomy and Breast Reconstruction Audit (NMBRA)18788.
Standard subpectoral implant-based breast reconstructions conducted contemporaneously
Determine the feasibility of a long-term prospective audit of the outcomes of implant-based breast reconstruction.
Generate data to inform future best practice guidelines
To inform a potential trial in implant-based breast surgery
Research plan
The study will have 3 phases. Phases 1 and 2 are part of this application and Phase 3 will involve the design of a RCT, but the trial itself will be the focus of a separate funding application.

Phase 1 will evaluate current practice of BR surgery with a national practice questionnaire (NPQ)
Phase 2 will prospectively examine clinical and PROs of implant-based breast reconstruction (IBBR)
Phase 3 will be the design of a pragmatic randomised clinical trial (RCT) with an internal pilot phase evaluating two approaches to IBBR
Phase 1 – National practice questionnaire
The overall aim of Phase 1 is to understand current practice of IBBR in the UK to inform the design of the Phase 3 RCT. This will be achieved with these objectives:

To describe current practice of IBBR in the UK and establish details of the frequency of different types of IBBR procedures performed in routine practice and the number of units performing each procedure subtype
To describe current views and practice of patient selection for type of IBBR subtype
To gather information about how centres vary in surgical technique especially in selection of materials used for lower pole coverage and frequency with which each material is used to inform trail design
To gather information about the components of pre, peri and post-operative care for IBBR in each centre and how women are followed-up (frequency and methods of follow-up)
The NPQ

The questionnaire will be developed by members of the steering group. It will ask each centre for information on current BR practice (what operations and approaches are performed), the multi-disciplinary team in the unit (the type of staff and numbers), the use of novel techniques (dermal slings, biological and synthetic meshes and products used), how patients are selected for procedure types (e.g the role of neoadjuvant treatments, diabetes, smoking and body habitus). Information about the care pathway in each centre will also be collected.

Inclusion criteria for the NPQ

All breast and plastic surgical units performing mastectomy with or without breast reconstruction in women in the UK over the age of 16 will be eligible for inclusion and encouraged to participate. Recent Hospital Episode Statistics (HES) data (2012-3) will be used to ensure that all centres performing mastectomies are targeted for inclusion.

Data collection in each participating centre

Trainees will be invited to participate in the study through the Mammary Fold (MF) (the Breast Trainees Association), the National Trainee Research Collaborative (NTRC) and the Reconstructive Surgery Trials Network (RSTN). A local Trainee Lead with a special interest in breast surgery will be identified at each centre via SP. Trainee leads will be responsible for identifying a supervising consultant and obtaining the support of other consultants in the department. Consultant surgeons will be made aware of the study through communications from the professional associations (Association of Breast Surgery, ABS and British Association of Plastic, Reconstructive and Aesthetic Surgeons, BAPRAS). ABS and BAPRAS will encourage Units to participate in the study and support their trainees in recruiting patients and collect data. This approach is widely-used for trainee collaborative projects and is acceptable to surgeons and trainees and highly-effective. The national appendicectomy study recruited 3326 patients from 95 centres over a 2 month period and the Sepsis study recruited patients from 125 centres in the UK and internationally.

Local Trainee Leads will be responsible for completing the NPQ with the support of their supervising consultants. Both paper and electronic versions will be made available.

Sample size
The 2007 National Mastectomy and Breast Reconstruction Audit (NMBRA) collected data from 156 acute Trusts performing mastectomy and breast reconstruction surgery. Based on a 60% participation rate, it is anticipated that 100 units may contribute to the study. It is important that the study includes centres that are representative of UK practice in terms of both size and surgical speciality (breast and plastics) and purposive sampling will be used to supplement recruitment to ensure this is achieved.

Questionnaire data analysis.
Questionnaire data will be summarised and summary statistics reported to describe provision of care and practice of IBBR overall. [In addition, individual participating Units will receive an anonymised feedback in the form of a St. Elsewhere report to illustrate variation between local practice and the national standard.

Categorical data will be summarised by counts and percentages. Continuous data will be summarised by mean, SD and range if data is normally distributed. Median, IQR and range will be reported if the data is skewed. No formal statistical testing will be undertaken. Standard statistical software [Statistical Analysis Software (SAS®) 9.1.3; SAS Institute Inc., Cary, NC, USA] will be used for all analyses.

Where respondents’ free text responses to open-ended items have been collected these will be anonymised. Data will be grouped according to overall themes within the responses and presented alongside the quantitative analysis to help contextualise and illuminate them.