Summary of iBRA study for launch event
Download
Report
Transcript Summary of iBRA study for launch event
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
1
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
08/04/2015
08/04/2015
Established track record
• National
appendicectomy
audit 2012
– 3326 patients
– 95 centres
– 3 papers (so far!)
08/04/2015
iBRA Study - 3 stage project
1) National practice questionnaire
2) Prospective study
3) Potential long-term audit
08/04/2015
National Practice Questionnaire
Aims
Describe current practice
Identify variations in
practice
Evaluate adherence to
national guidelines
Trainee to input data
with consultant advice
08/04/2015
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
08/04/2015
Prospective audit
08/04/2015
Audit approvals
Lead trainee to apply for
local clinical governance
approval
Named lead consultant to
‘oversee’
08/04/2015
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
08/04/2015
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
08/04/2015
08/04/2015
11
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
08/04/2015
08/04/2015
12
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
08/04/2015
08/04/2015
13
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
08/04/2015
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
08/04/2015
08/04/2015
15
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
08/04/2015
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)
08/04/2015
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
08/04/2015
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
Citable collaborators – recruit >10 patients
Acknowledged collaborators – provide support but do not collect
required amount of data
Certificates of participation for trainees
08/04/2015
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
08/04/2015
Progress so far
08/04/2015
National practice questionnaire
56 Trusts have entered data
35 have completed survey
More responses are
needed!
08/04/2015
Prospective audit
28 units recruiting
Another 20+ in set up
216 patients recruited to date
08/04/2015
Units recruiting to the iBRA study
08/04/2015
Patient recruitment to iBRA
08/04/2015
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)
08/04/2015
08/04/2015
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)
26
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)
08/04/2015
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)
08/04/2015
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
08/04/2015
08/04/2015
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
29
Think implant….think iBRA!
www.ibrastudy.com
Email: [email protected]
Twitter: @ibrastudy
08/04/2015