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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!

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