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18/04/23 1
The iBRA StudyA National Multicentre
Audit of the Practice and Outcomes of Immediate
Implant-Based Breast Reconstruction
Nicola Barnes, on behalf of the iBRA Steering Group
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iBRA Aims1. 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 QuestionnaireAims
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
Allocated local study ID number
Pre-operative data collection
Identification patients undergoing immediate implant based BRClinics/MDTs/Operating lists
(Pre and) Operative data collection
30 day data collection
PROMS sent out centrally at 3 and 18 months to consenting patients
Patient admitted for surgery
Patient discharged
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Data collectionVia 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
DemographicsCo-morbiditiesPrevious surgery / XRT /
chemoSmoking
Intra op
Type of opLength of procedureGrade of surgeonType of mesh usedType and vol of implantAntibiotic use
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What data is collected?30 day Post op
ComplicationsReturn to theatreSeroma drainageWound infectionWound breakdownImplant lossDVT/PE/MI
Oncology data
Risk reducingDCIS/invasiveGrade/ size Node positivityFurther surgeryAdjuvant Rx
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Practicalities of processIdeally 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 OutcomesTeam (ideally trainees) to
Discuss audit with patientsProvide information sheetObtain consent for PROMS
to be used in studyPROMS 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 AnalysisUndertaken centrally – Bristol
and Liverpool
Simple summary statisticsMean +/- 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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FAQsWho 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 outputs2 levels of participation
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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FAQsWhat 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 questionnaire56 Trusts have entered data
35 have completed survey
More responses are needed!
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Prospective audit28 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)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)
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 <4545-60>60Median (range)
43 (20.5)101 (48.1)41 (19.5)
49 (26-74)
LateralityUnilateralBilateralMissing
142 (67.6)48 (22.9)20 (9.5)
BMIUnderweight (<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 reconstructionSubpectoral Dermal slingsBiological meshSynthetic meshOther
30 (12.4)63 (26.0)121 (50.0)23 (9.5)5 (2.1)
Products usedStratticeSurgiMendBioDesignTiLOOPSeriTIGRXCM
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
ABS 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.comEmail: [email protected]
Twitter: @ibrastudy