Evaluating outcomes of Implant-based breast reconstruction
The iBRA Study
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If you would like to be involved please contact us.
   
  
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Implant-based breast reconstruction is the commonest form of immediate breast reconstruction performed in the UK.
  
Over recent years, practice has changed significantly with the introduction of biological and synthetic meshes and the use of dermal slings.
  
There is currently a lack of high-quality evidence to support the safety or effectiveness of these new techniques and concerns have been raised regarding high complication rates, particularly when ADMs are used.
  
A well-designed, multi-centre, prospective study is required to address these issues.
  
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The iBRA (Implant Breast Reconstruction EvAluation) study aims to use the National Trainee Research Collaborative, an established network of motivated trainees with an excellent track-record in delivering high-quality prospective audits and research to:
  
1. Describe the current practice of immediate implant breast reconstruction in the UK
  
2. Evaluate the outcomes of different approaches to immediate implant-based procedures against
  
a) National ABS/BAPRAS standards and quality criteria specified in ABS/BAPRAS ‘Oncoplastic Breast Reconstruction: Guidelines for Best Practice’.
  
b) Standard subpectoral implant-based breast reconstructions
  
3. Determine the feasibility of a long-term prospective study
  
4. Generate data to inform future best practice guidelines
  
5. Evaluate the feasibility of a randomised clinical trial comparing different approaches to implant-based breast reconstruction
  
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The iBRA study will consist of three phases
1.A National Practice Questionnaire
  
2. A prospective study  of consecutive patients receiving immediate implant based breast reconstruction using the National Mastectomy and Breast Reconstruction Audit methodology and including clinical and patient-reported outcome data at 3 and 18 months following surgery
  
3. A long-term prospective study phase
  
We plan to recruit approximately 1000 patients into the project making this the largest prospective cohort study in the world.
  
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A Trainee Lead (ideally a senior breast trainee) will be identified at each centre who will be responsible for:
  • Obtaining the support of the local team including consultants and clinical nurse specialists
  • Identifying a nominal consultant ‘audit lead’
  • Securing local audit approvals prior to recruiting patients to the audit 
  • Identifying a small team of trainees to help with the audit
  • Completing the National Practice Survey with the support of the nominated lead consultant in each Unit.
  • The National Practice Survey can also be completed online.
  • To commence as soon as audit approvals obtained
  • Trainees will identify all potentially eligible participants from clinics, MDTs and surgeons’ operating diaries and recruit them to the audit.
  • It is expected that consecutive patients receiving immediate implant-breast reconstruction after mastectomy for malignancy or risk reduction at each unit should be included in the study.
  • Trainees will collect pre-operative, operative, oncological and 30 day complication data for each patient.
  • All data will be anonymised with a unique study ID number and entered prospectively on a secure, password-protected electronic database (REDCap) – No patient identifiable data will be collected in the audit. Paper forms can also be used.
  • Trainees will also be responsible for discussing the study with patients, giving them the patient information sheet and obtaining consent for PROMs questionnaires to be sent out centrally at 3 and 18 months by post or e-mail, depending on patient preference by the iBRA study team.
  • Individual units may decide on the best logistical process for their centres
For a quick reference guide flow chart of how to get started click here.   
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  • Data will be analysed every three months and rates of implant loss, infection, readmission to hospital and re-operation calculated +/- three standard deviations.
  • If units fall outside this range, they will be contacted by the iBRA team and reasons for this explored.
  •  If a unit falls outside the range for two consecutive analysis periods, the Clinical Director and Clinical Governance teams at that Unit will be contacted.
  
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Data belongs to each individual unit 
  
What is the authorship policy for the project? 
  
All participants will be acknowledged in all resulting outputs from iBRA.  There will be two levels of participation:
  
Citable contributors – participants who recruit at least 10 patients (with complete datasets) to the audit will be citable via PubMed.
  
Acknowledged contributors – participants who contribute patients to the audit, but do not collect data and participants who collect less than the required amount of data will be acknowledged. 
  
Junior staff will also be given a certificate of participation for their portfolios.
  
Are you being funded by any of the implant or matrix mesh companies?
  
No.
We are not funded by any commercial companies.
  
What happens if our unit has a high complication rate?
 
Data will be analysed at 3 monthly intervals
 
If complication rates are >3 standard deviations above the mean this will be fed back to the unit by the iBRA team.
 
If a unit is an outlier for 2 consecutive analyses, results will be fed back to governance leads.
 
 
REDCap is a secure web-based application for building and designing online surveys and data collection tools. It is run out of the University of Edinburgh, under licence of the Vanderbilt University. Security information can be seen on the REDCap website. To get a user name please contact us once you have audit department approval to begin the project, and we can arrange online data collection access. If you do not have online access you can still use the paper copies of the forms. Both collect the same information.
 
The iBRA Study 
Office Room 3.12
Canynge Hall 
The University of Bristol 
39 Whatley Road 
Bristol
BS28 2PS 


If you have entered data into the iBRA study, or if you are a Consultant who has entered patients, click this link to a summary of all the presentations that you can put on your CV.


We have had great response to the iBRA study and have already exceeded our initial target of 1000 ladies participating. However, there appears to be both a lower than predicted complication rate and also the emergence of new types of mesh, including pre-pectoral techniques. We would really like to be able to make a meaningful comment on the newer techniques especially. We have therefore made the decision to extend recruitment until Summer 2016.
 

 
If you would like to be involved, or would like more information, please contact: ibrastudy@gmail.com
This study is made possible by the collaboration of reconstructive breast and plastic surgeons across the UK.
  
For details of the Steering Group please click here.
For a quick guide flow chart of how to get started click here
For copies of the data collection forms please click here.
For a copy of the protocol please click here.
For REDCap data entry click here (log in details required)
The largest prospective study of implant-based breast reconstruction.
                

Ensuring quality through collaborative research. The iBRA Study. 2014-2017.