The iBRA Study
A National Multicentre
Audit of the Practice and
Outcomes of Immediate
Implant-Based Breast
Reconstruction
Nicola Barnes, on behalf of the iBRA
Steering Group
08/04/2015
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iBRA Aims
1. Describe current national practice of immediate implant-
based breast reconstruction
2. Prospectively evaluate the outcomes against ABS/BAPRAS
guidelines for Oncoplastic Breast Surgery and ADM
3. Determine feasibility of long-term prospective audit
4. To inform future research
Using the national trainee research collaborative network
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Established track record
• National
appendicectomy
audit 2012
– 3326 patients
– 95 centres
– 3 papers (so far!)
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iBRA Study - 3 stage project
1) National practice questionnaire
2) Prospective study
3) Potential long-term audit
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National Practice Questionnaire
 Aims
 Describe current practice
 Identify variations in
practice
 Evaluate adherence to
national guidelines
 Trainee to input data
with consultant advice
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What does the questionnaire collect?
 What type of reconstructions are offered
 Who’s doing it
 Which mesh(s) are used
 For which patients
 Standard intra and post op protocols
 How many patients a year
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Prospective audit
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Audit approvals
 Lead trainee to apply for
local clinical governance
approval
 Named lead consultant to
‘oversee’
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Prospective audit
Identification patients undergoing immediate implant based BR
Clinics/MDTs/Operating lists
Patient consent for PROMS
Allocated local study ID number
Pre-operative data collection
Patient admitted for surgery
(Pre and) Operative data collection
Patient discharged
30 day data collection
PROMS sent out centrally at 3 and 18 months to consenting patients
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Data collection
 Via a secure password-protected
on-line database.
 Run by the Surgical Outcomes
Research Group.
(Edinburgh University)
 Study ID only – no patient
identifiers entered
 Local secure storage of patient
Study ID and identifiable details
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What data is collected?
Pre op
Intra op
 Demographics
 Type of op
 Co-morbidities
 Length of procedure
 Previous surgery / XRT /
 Grade of surgeon
chemo
 Smoking
 Type of mesh used
 Type and vol of implant
 Antibiotic use
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What data is collected?
30 day Post op
Oncology data
 Complications
 Risk reducing
 Return to theatre
 DCIS/invasive
 Seroma drainage
 Grade/ size
 Wound infection
 Node positivity
 Wound breakdown
 Further surgery
 Implant loss
 Adjuvant Rx
 DVT/PE/MI
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Practicalities of process
 Ideally trainee led patient
identification, data collection
and recruitment for PROMS
 BUT individual centres can
refine process according to
local processes/resources
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Patient Reported Outcomes
 Team (ideally trainees) to
 Discuss audit with patients
 Provide information sheet
 Obtain consent for PROMS
to be used in study
 PROMS forms get sent from
Bristol
 Retain one copy of consent;
return a copy to Bristol
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Patient Reported Outcomes
 3 month questionnaire
 Satisfaction with information (BREAST-Q)
 3 month patient-reported complication data
 Adjuvant treatment data
 18 month questionnaire
 Psychosocial well-being (BREAST-Q)
 Physical well-being – chest and upper body (BREAST-Q)
 Sexual well-being (BREAST-Q)
 Satisfaction with breasts (BREAST-Q)
 Satisfaction with outcome (BREAST-Q)
 Late complications
 Additional surgery
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Quality standards
 Implant loss (<10% at 3/12)
 Unplanned return to theatre (<5% at 3/12)
 Unplanned readmission (<5% at 3/12)
 Infection (<10% at 3/12)
 Satisfaction with information provision (>80% at 3/12)
 Post-operative pain (<5% report severe pain in 1st 24 hours)
 Satisfaction with outcome (>90% satisfaction when clothed
at 18 months)
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Data Analysis
 Undertaken centrally – Bristol
and Liverpool
 Simple summary statistics
 Mean +/- 3 SD for complications
 Comparative analysis between
procedure types
 Regression modelling to explore
risk factors for primary outcomes
and inform future research
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FAQs
 Who has ownership of the data?
 Individual units – will be made available to individual centres
 Publication policy?
 All participants (Consultants and trainees) will be acknowledged
in all study outputs
 2 levels of participation
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Citable collaborators – recruit >10 patients
Acknowledged collaborators – provide support but do not collect
required amount of data
Certificates of participation for trainees
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FAQs
 What happens if our unit has a high complication rate?
 Data will be analysed at 3 monthly intervals
 If complication rates > 3 standard deviations from mean,
this will be fed back to the unit by iBRA team
 If outlier for 2 consecutive analyses, results will be fed back
to governance leads
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Progress so far
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National practice questionnaire
 56 Trusts have entered data
 35 have completed survey
 More responses are
needed!
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Prospective audit
 28 units recruiting
 Another 20+ in set up
 216 patients recruited to date
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Units recruiting to the iBRA study
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Patient recruitment to iBRA
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Recruiting Centres (n=28)
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Liverpool (n=45)
Belfast (n=15)
West Herts (n=14)
Brighton & Sussex (n=12)
Exeter (n=12)
UH Coventry (n=12)
UH North Stafford (n=10)
GWH Swindon (n=10)
Royal Surrey (n=8)
St Barts (n=7)
North Lincs (n=7)
Frimley (n=7)
Royal Marsden (n=7)
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Taunton (n=6)
Bradford (n=6)
Dorset (n=5)
QE Birmingham (n=4)
Lancaster (n=4)
Peterborough (n=3)
East Lancs (n=3)
Worcester (n=2)
UH London (n=2)
Bolton (n=2)
Yeovil (n=1)
Neville Hall (n=1)
Milton Keynes (n=1)
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Patient demographics (n=210)
N = 210 (%)
Age
<45
45-60
>60
Median (range)
43 (20.5)
101 (48.1)
41 (19.5)
49 (26-74)
Laterality
Unilateral
Bilateral
Missing
142 (67.6)
48 (22.9)
20 (9.5)
BMI
Underweight (<18.5)
Healthy (18.5-25)
Overweight (25-30)
Obese (>30)
Missing
1 (0.5)
90 (42.9)
55 (26.2)
39 (18.6)
25 (11.9)
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Types of implant reconstruction (n=242)
N 242 (%)
Median mastectomy weight
(range) (g)
454 (65-1580)
Types of reconstruction
Subpectoral
Dermal slings
Biological mesh
Synthetic mesh
Other
30 (12.4)
63 (26.0)
121 (50.0)
23 (9.5)
5 (2.1)
Products used
Strattice
SurgiMend
BioDesign
TiLOOP
Seri
TIGR
XCM
91 (75.2)
16 (13.2)
13 (10.7)
11 (9.1)
8 (6.6)
7 (5.8)
1 (0.8)
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iBRA Steering Group
 Principal Investigators
 Miss Shelley Potter
 Prof Chris Holcombe
 Bristol Surgical Trials Centre
 Prof Jane Blazeby
 Clinical Trials Research Centre
 Prof Paula Williamson
 Miss Beth Conroy
 Specialist nurses
 Mrs Ruth Harcourt
 Patient Representative
 Mrs Liz Teasdale
 Trainees
 Miss Lisa Caldon
 Miss Kat McEvoy
 Miss Vicky Fung
 Miss Shazia Khan
 Miss Sunita Saha
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 ABS
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Prof Malcolm Reed
Mr Ramsey Cutress
Mr Steven Thrush
Miss Lisa Whisker
Miss Nicola Barnes
Mr Seni Mylvaganam
 BAPRAS
 Miss Jo Skillman
 Mr Joe O’Donaghue
 Mr Jian Farhadi
 Mr Gary Ross
 Miss Anita Hazari
 RSTN
 Mr Abhi Jain
 Mr Matthew Gardiner
 Mr Olivier Branford
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Think implant….think iBRA!
www.ibrastudy.com
Email: ibrastudy@gmail.com
Twitter: @ibrastudy
08/04/2015