A National Audit of the Practice and
Outcomes of Implant Breast
Reconstruction
iBRA Study Group on behalf of the National Surgical
Research Collaborative
Study Protocol Version 7
20th March 2014
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Version 7, 20th March 2014
iBRA Study
A National Audit of the Practice and Outcomes of Implant Breast
Reconstruction
iBRA Study Contact:
E-mail: ibrastudy@gmail.com
iBRA Study Steering and Protocol Management Group
Ms Nicola Barnes
National Oncoplastic Fellow
Mersey
Trainee Representative
nicolabarnes@doctors.org
Ms Lisa Caldon
Clinical Lecturer
University of Sheffield
Trainee Representative
l.caldon@shefield.ac.uk
Miss Beth Conroy
University of Liverpool
Liverpool CTRC
Methodologist and Statistician
E.J.Conroy@liverpool.ac.uk
Mr Ramsay Cutress
Consultant Oncoplastic Breast Surgeon
Southampton University NHS Trust
ABS Academic Committee Representative
r.i.cutress@soton@ac.uk
Mr Jian Farhadi
Consultant Plastic Surgeon
Guys and St Thomas’ NHS Foundation Trust
BAPRAS Representative
Jian@farhadi.com
Ms Vicky Fung
Specialist Registrar in Plastic Surgery
Newcastle NHS Foundation Trust
Trainee Representative
vf@doctors.org.uk
Ms Anita Hazari
Consultant Plastic Surgeon
Queen Victoria Hospital NHS Foundation
Trust
BAPRAS Representative
anitahazari@btinternet.com
Professor Chris Holcombe
Professor of Breast Surgery
Royal Liverpool and Broadgreen NHS
University Trust
Chris.Holcombe@rlbuht.nhs.uk
Ms Shazia Khan
Specialist Registrar in Breast Surgery
Sheffield Teaching Hospitals NHS Trust
Trainee Representative
maukbs@hotmail.com
Ms Kat McEvoy
Specialist Registrar in Breast Surgery
Worcester Acute Hospitals NHS Trust
Trainee Representative
kat@guykat.com
Mr Seni Mylvaganam
National Oncoplastic Fellow
University of Birmingham
Mammary Fold Representative
Seni1@me.com
Miss Shelley Potter
Academic Clinical Lecturer in General
Surgery
Centre for Surgical Research, University of
Bristol
Shelley.Potter@bristol.ac.uk
Mr Joe O’Donoghue
Consultant Plastic Surgeon
Newcastle NHS Foundation Trust
BAPRAS Representative
Joe.O'Donoghue@nuth.nhs.uk
Professor Malcolm Reed
Professor of Surgical Oncology
University of Sheffield
ABS Academic Committee Chair
m.w.reed@sheffield.ac.uk
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Mr Gary Ross
Consultant Plastic Surgeon and Honorary
Senior Lecturer
Alexandra Hospital
BAPRAS Representative
glross@gmail.com
Ms Sunita Saha
Specialist Registrar in Breast Surgery
Barking and Havering NHS Trust
Trainee Representative
sahasunita@hotmail.com
Miss Jo Skillman
Consultant Plastic Surgeon
University Hospitals of Coventry and
Warwickshire NHS Trust
BAPRAS Representative
Joanna.skillman@uhcw.nhs.uk
Ms Elizabeth Teasdale
Patient Representative
teasdaleeem@hotmail.co.uk
Mr Steven Thrush
Consultant Oncoplastic Breast Surgeon
Worcester Acute Hospitals NHS Trust
Steven.thrush@worcsacute.nhs.uk
Ms Lisa Whisker
Consultant Oncoplastic Surgeon
Nottingham University Hospitals NHS Trust
l.whisker@doctors.org
Professor Paula Williamson
Professor of Medical Statistics
Liverpool CTRC
Methodologist and Statistician
P.R.Williamson@liverpool.ac.uk
Clinical Nurse Specialist Representative TBC
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Contents
1. Background...................................................................................................................
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1.1 Implant-based breast reconstruction.........................................................................
7
1.2 New techniques in implant-based breast reconstruction........................................
7
1.3 Trainee research collaboratives.............................................................................
8
2. Aims and objectives....................................................................................................
9
3. Definitions...................................................................................................................... 10
4. Audit standards
4.1 Phase 1 – National Practice Questionnaire.............................................................
11
4.2 Phase 2 – Prospective Audit....................................................................................
12
5. Methods.........................................................................................................................
13
5.1 Phase 1 – National Practice Questionnaire..............................................................
13
5.2 Phase 2 – Prospective Audit of the outcomes of implant-based breast
reconstruction.........................................................................................................
14
5.2.1 Logistical and clinical governance issues........................................................
14
5.2.2 Patient inclusion and exclusion criteria............................................................
14
5.2.3 Participant identification and recruitment.........................................................
15
5.3 Phase 3- On-going prospective audit of the outcomes of implant breast
reconstruction..........................................................................................................
16
6. Data collection............................................................................................................... 16
7. Data management and storage.................................................................................... 20
8. Data analysis.................................................................................................................
21
8.1 National practice questionnaire.................................................................................
21
8.2 Prospective audit......................................................................................................
21
8.2.1 Calculation of internal audit standards............................................................
21
8.2.2 Full analysis...................................................................................................... 21
9. Publication and authorship policy..............................................................................
21
9.1 Named authors.........................................................................................................
22
9.2 Citable collaborators.................................................................................................
23
9.3 Acknowledged collaborators.....................................................................................
23
10. Research governance...................................................................................................
24
11. Trial management.........................................................................................................
24
12. References.....................................................................................................................
25
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Abbreviations
ABS – Association of Breast Surgery
ABx - antibiotics
ADM – acellular dermal matrix
ASA – American Association of Anesthesiologists
BAPRAS – British Association of Plastic, Reconstructive and Aesthetic Surgery
BMI – body mass index
DVT – Deep vein thrombosis
GA – general anaesthetic
HES – Hospital episode statistics
IHD – ischaemic heart disease
MRSA – Methicillin resistant Staphlococcus aureus
MSSA - Methicillin sensitive Staphlococcus aureus
NAC – nipple areolar complex
NMBRA – National Mastectomy and Breast Reconstruction Audit
PE – pulmonary embolus
PIP - Poly Implant Prosthèse
PROMS – Patient-reported outcome measures
QC – Quality criteria (as specified in the Oncoplastic Breast Reconstruction Guidelines for
Best Practice)
RCT – randomised clinical trial
SNB – sentinel node biopsy
SPARCS – Severn and Peninsula Research Collaborative for Surgeons
SSM – skin sparing mastectomy
STROBE - Strengthening the Reporting of Observational Studies in Epidemiology
TBC – To be confirmed
TCPM - titanium coated polypropylene mesh
UK – United Kingdom
US – United States
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1. Background
1.1
Implant-based breast reconstruction
Implant-based breast reconstruction accounts for 30% of all breast reconstruction performed
in the UK1 and almost 75% of all reconstructions performed annually in the US2. Although a
good option for women with small to medium sized breasts with mild to moderate ptosis 3,
implant-based reconstruction is traditionally a two-stage procedure which typically involves
the initial placement of a tissue expander, often with total submuscular coverage in a subpectoral pocket. This is then expanded over time to accommodate a definitive implant. The
process can be time-consuming for patients and professionals and may be uncomfortable4
It also commits women to a second procedure and hospital admission with the associated
risks and financial implications.
1.2
New techniques in implant-based breast reconstruction
Over the last 10 years, a number of alternative techniques have been developed to provide
infero-lateral implant coverage, thus augmenting the subpectoral pocket to allow either
placement of larger expander, reducing pain and time to second stage or a definitive implant
facilitating a single-stage procedure5.
This technique may also offer improved cosmetic
outcome through better definition of the infra-mammary fold and reduce the need for contralateral surgery6-13. The subpectoral pocket may be augmented either with a mesh or a deepithelialised lower pole dermal sling5 14. Dermal slings are an excellent option in women
with larger, more ptotic breasts who desire a reduction at the time of mastectomy15-19, but for
those who lack extra tissue, a biological or synthetic mesh is to provide inferolateral implant
coverage20. The most commonly used biological products are acellular dermal matrices
(ADMs) of human (e.g. AlloDerm®, Flex-HD®, DermaMatrix®), porcine (e.g. Strattice®,
LifeCell, KCL) or bovine (e.g SurgiMend®, TEI Biosciences Inc) origin but other materials
such as bovine pericardium (e.g. Veritas®, Synovis Surgical Innovations), and silk (Serica®)
have also been used. More recently, the use of autologous abdominal dermal autografts21 22
has been reported. Synthetic materials include titanium coated polypropylene mesh (TCPM)
(TiLOOP
bra®)23-28
and
partially
absorbable
bi-component
polyglycolic
acid-
caprolacetone/polypropylene mesh (SERAGYN-BR®)29-31.
The use of these techniques is gaining in popularity and there has been a proliferation of
outcome literature, particularly relating to ADM32-56. The majority of this derives from North
America and relates to the outcomes of human products which are not licensed for use in
the UK. This is problematic as it cannot be assumed that the North American data can be
extrapolated to UK practice as there are important immunogenic differences between human
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and non-human products that may influence outcomes20.
Comparatively little published
outcome data exists for non-human ADM57-64 and less still for other biological65-67 and
synthetic meshes24-26 28.
There is therefore little high-quality evidence to support the benefits of these procedures and
concerns have been raised regarding excessive rates of complications when these products
are used68-70. There is therefore a need to document current practice relating to implantbased breast reconstruction and to robustly evaluate the outcomes of these novel
procedures to protect patients from adverse events, particularly in light of the issues
surrounding the Poly Implant Prosthèse (PIP) implant scandal71-74 and to provide evidence
for health commissioners to support the potentially increased costs of these techniques.
Assessment of outcomes is also important for individual surgeons for the purposes of
revalidation. Surgeons should be able to provide evidence of their outcomes to demonstrate
that they provide good clinical care – mapping to the Knowledge Skills and Performance and
Safety and Quality domains of the GMC’s Good Medical Practice framework for appraisal
and revalidation75. In addition, there is a drive for individual surgeons to publish their results
to allow patients to make informed decisions about who should perform their surgery76.
Participation in national audits may be an effective means of generating consistent and
comparable data, but the feasibility and practicalities of conducting these studies needs to
be explored.
1.3
Trainee research collaboratives
There are a number of established barriers to the conduct of large prospective multicentre
studies; they require significant organisation and collaboration between a large number of
centres; they may be expensive to run and can be prohibitively time-consuming for surgeons
working in busy breast and plastic surgery units.
Trainee research collaboratives have emerged over the last five years as a novel, but
effective model for delivery of high-quality multi-centre surgical research which effectively
overcomes these barriers77. Trainees work at the majority of hospitals across the UK, have
potentially more time to engage in research and audit activities than their consultant
colleagues and are highly-motivated to participate as collaborators are cited on all research
outputs including publications which are PubMed citable78-81. The trainee model therefore
facilitates the conduct of large, multi-centre projects that generate meaningful data which
may inform or change clinical practice. West Midlands were the first region to form a general
surgical trainee research collaborative, but now the research collaborative network has
almost universal coverage of the UK77. Specialised surgical trainee collaboratives have also
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emerged in neurosurgery, plastic, paediatric and cardiac surgery and a medical student
collaborative (STARSurgUK) has formed82 83. Trainee collaboratives have a key role in the
new UK surgical research infrastructure and have the support of both speciality and pan
speciality professional associations and the Royal College of Surgeons which has provided
academic, structural and logistical support to trainee research collaborative development77 84.
To date, the Trainee Research Collaborative network has an impressive track-record for the
design and delivery and high-quality, multicentre audits and randomised clinical trials; these
include;
i.
The National Appendicectomy Audit which recruited 3326 patients from 95
centres over 2 months, resulting in three high-quality publications to date78 80 81
ii.
The ROSSINI (Reduction in Surgical Site Infection using a Novel Intervention)
Trial which randomised 760 patients from 21 centres to a wound protection
device versus standard care. The trial recruited ahead of schedule and had
minimal loss to follow-up79.
iii.
The Sepsis Audit which has recruited patients from 125 centres in the UK and
internationally and plans to report soon.
iv.
The ROCSS (Reinforcement of Closure of Stoma Site Study) an ongoing RCT 85.
It is therefore anticipated that the trainee collaborative model can be utilised to deliver a
high-quality prospective multicentre audit in breast surgery.
2. Aims and objectives
The iBRA (Implant Breast Reconstruction Audit) Study aims to use the National Trainee
Research Collaborative Network to:
i.
Describe the current practice of immediate implant-based breast reconstruction in the
UK, variation in the provision of novel techniques and adherence to
ABS/BAPRAS Oncoplastic Breast Reconstruction: Guidelines for Best Practice3
and ADM guidelines86 relating to these.
ii. Evaluate the outcomes of different approaches to immediate implant-based
procedures against
a. National
ABS/BAPRAS
standards86
and
quality criteria
specified
in
ABS/BAPRAS ‘Oncoplastic Breast Reconstruction: Guidelines for Best
Practice’3 and the findings of the National Mastectomy and Breast
Reconstruction Audit (NMBRA)1 87 88.
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b. Standard subpectoral implant-based breast reconstructions conducted
contemporaneously
iii. Determine the feasibility of a long-term prospective audit of the outcomes of implantbased breast reconstruction.
iv. Generate data to inform future best practice guidelines
v. To inform a potential trial in implant-based breast surgery
3. Definitions
The following definitions of complications will be used for this audit. Patient reported
outcome measures (PROMs) will be assessed at 3 and 18 months as per the NMBRA to
generate comparable data.
Slight modifications will be made to the patient-reported
complication section to provide more accurate estimations of associated morbidity (e.g.
major vs minor infection; number of seromas drained).
Seroma - A symptomatic collection of fluid around the reconstructed breast following surgery
requiring aspiration. Number of aspirations will be evaluated using PROMs at 3 months
Haematoma - A collection of blood in the reconstructed breast

Minor – managed conservatively by aspiration in clinic or

Major – requiring surgical evacuation.
Infection - A hot, red swollen breast associated with one of the following; a temperature, pus
at the wound site, a raised white cell count; a positive wound culture within the first 3 months
following surgery. This will be further classified as:

Minor – requiring oral antibiotics only;

Major 1 – requiring admission for IV antibiotics and/or debridement;

Major 2 – requiring surgical drainage/debridement
Mastectomy skin flap necrosis - Any area of skin loss on the reconstructed breast

Minor – managed conservatively with dressings

Major – requiring surgical debridement under general anaesthesia (GA)
Nipple necrosis – Any area of necrosis of the nipple areolar complex (NAC) (if NAC
preserving mastectomy)

Minor – managed conservatively with dressings;

Major 1 – requiring surgical debridement under GA;

Major 2 – complete nipple loss
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Wound dehiscence – separation of the skin edges at the wound site.

Minor – treated conservatively;

Major – requiring return to theatre for re-suturing under GA
Implant loss - Unplanned and unexpected extirpation or loss of the implant including
removal as a result of infection within the first 3 months following surgery
Displaced implant requiring repositioning under GA – any implant displacement that
requires surgical correction to restore its position
In hospital complication – any complication that occurs during the patient’s initial hospital
stay at the time of their reconstructive surgery. This includes systematic complications such
as DVT/PE and procedure specific complications such as haematoma.
Readmission to hospital – any re-admission to hospital in the 30 days following surgery
directly related to the procedure (e.g with infection requiring antibiotics or systemic
complications including pulmonary embolus)
Return to theatre – Return to the operating theatre at any time during the first 30 days
following surgery to deal with any complication of the reconstruction.
Major complication - Any complication requiring readmission to hospital or return to theatre
Minor complication - Any other complication
4. Audit standards
4.1
i.
Phase 1 – National Practice Questionnaire
Patient selection criteria
Adherence to guidelines for patient selection for implant-based surgery and
ADM3 86
ii.
Use of strategies for reducing infection
Adherence to guidance for reducing the incidence of implant infection
Pre-operative- MRSA and MSSA screening for 100% of patients prior to
admission (QC7)3.
Intra-operative - use of laminar flow theatres; 2% chlorhexidine with 70%
isopropyl alcohol for pre-operative skin preparation; washing of implant cavity
and glove changing prior to implant handling3
Post-operative – type and duration of prophylactic antibiotics3
iii.
Local audit of the outcomes of implant-based reconstruction
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Medical photography (pre and post-operatively) is offered in 100% of patients
(QC4)3
Post-operative complications are audited (QC18)3
Patient reported outcomes (PROMS) are measured using standardised
assessment tools (QC19 and 20)3
iii.
Compliance with unit criteria specified in ADM guidelines
Presence of unit guidelines for post-operative management of patients with
agreed protocols of care (e.g. drains, post-operative antibiotics, follow-up)86
Presence of written information for patients on new techniques including ADM86
iv.
Compliance with organisational criteria specified in ADM guidelines
Local approvals from the New Procedures Policy/Clinical Governance boards in
each Trust86
Phase 2 - Prospective Audit
i.
Unplanned return to theatre for local complications
<5% of patients return to theatre for local complication (wound infection, skin flap
necrosis requiring debridement or haematoma requiring evacuation)(QC16)3
Assessed prospectively and by review of notes at 30 days and by patient selfreport at 3 months
ii. Unplanned readmission
<5% of patients require re-admission to hospital within 3 months (QC17)3
Assessed prospectively and by review of notes at 30 days and patient self-report
at 3 months
iii. Infection rates at 3 months
<10% of patients require antibiotics for suspected infection86
Assessed in hospital and by patient self-report at 3 months
iv. Implant loss at 3 months
Complications leading to implant loss occur in <5% of patients (QC15)3 86
Assessed in hospital and by patient self-report at 3 months
v. Information provision
Satisfaction with information provision is reported by 80% of patients at 3 months
(QC19)3
Assessed using by patient self-report using Satisfaction with Information module
of BREAST-Q questionnaire completed at 3 months
vi. Post-operative pain
<5% of patients report severe pain within the first 24 hours (QC13)3
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Assessed by patient self-report at 3 months
vii. Patient satisfaction with outcome of breast reconstruction using standardised
assessment tools
>90% of patients report satisfaction with their appearance clothed (QC20)3
Assessed using BREAST-Q questionnaire completed at 18 months.
5. Methods
This is a national trainee research collaborative led project with 3 phases:
1. A national practice survey
2. A prospective audit of the outcomes of implant breast reconstruction
3. An ongoing prospective audit of the outcomes of implant breast reconstruction
Progression to phase 3 will be dependent on the success of phase 2 and the support of local
collaborators and national professional associations.
Trainees will be invited to participate in the study through the Mammary Fold and the
National Research Collaborative network. A local Trainee Lead; ideally a higher surgical
trainee with a special interest in breast surgery will be identified at each centre. Trainee
leads will be responsible for identifying a supervising consultant and obtaining the support of
other consultants in the department.
Support will also be sort from the professional associations – the Association of Breast
Surgery (ABS) and the British Association of Plastic and Reconstructive Surgery (BAPRAS).
We will ask that they encourage all Consultant members who are carrying out implant based
reconstructive surgery to support their trainees in this audit and to enter all their patients
undergoing implant based reconstruction in to the study.
5.1
Phase 1 - National practice questionnaire
A questionnaire will be devised by members of the steering group to provide a
comprehensive summary the current practice of implant-based breast reconstruction in the
UK; types of surgery offered, variations service provision and adherence to national
guidelines for standards of care3 86. The questionnaire will also include items to determine
the feasibility different approaches to data collection in Phase 2 such as provision of WiFi in
participating Trusts and the availability of portable devices including iPads.
All breast and plastic surgical units offering care to women over the age of 16 will be
encouraged to participate, by direct contact and by the professional associations. Recent
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Hospital Episode Statistics (HES) data (2012-3) will be used to ensure that all centres
performing mastectomies are targeted for inclusion.
Local Trainee Leads will be responsible for completing the national practice questionnaire
with the support of their supervising consultants and returning them to Bristol University for
analysis. No formal approvals are required for Phase 1 of the study.
The questionnaire phase will be conducted during early 2014 and will used to identify
centres performing implant-based breast reconstruction eligible for progression to phase 2 of
the study. Data from the survey will also be used to determine the optimal duration of the
prospective audit period to ensure the inclusion of an adequate number of cases (n=1000).
5.2
Phase 2 - Prospective audit of the outcomes of implant-based breast
reconstruction
5.2.1
Logistical and clinical governance issues
Those centres identified as performing immediate implant-based breast reconstruction will
be eligible to progress to the audit phase of the study. The named supervising consultant
will act as the principal investigator for each unit (although trainees will be responsible for
data collection).
Patient recruitment and data collection will be completed by the local
trainee lead who will also be responsible for seeking local Clinical Audit Department
approval for the project prior to commencing data collection.
It is anticipated that each Trainee lead will identify a small team of 2-3 people to help
conduct the audit and will liaise with the wider surgical team including the breast care and
reconstructive nurses.
The study will be piloted in two to three centres (Liverpool, Bristol/Bath and Worcester) prior
to national roll-out of the audit to evaluate feasibility of using trainees to recruit patients to
the study, test the acceptability of data collection pro-formas and assess methods of data
management.
5.2.2
Patient inclusion and exclusion criteria
Inclusion criteria
All female patients over the age of 16 electing to undergo immediate implant-based breast
reconstruction for malignancy or risk-reduction under the care of the breast or plastic
surgeons will be eligible for inclusion in the study.
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Exclusion criteria
5.2.3
i.
Delayed implant-based reconstruction
ii.
Revisional surgery
iii.
Patients who do not give written consent (for PROMs part of the study)
Participation identification and recruitment
It is expected that participating centres will recruit consecutive patients into the audit.
Potential participants will be identified prospectively by the local audit team via clinics, local
MDTs, consultant surgeons and clinical nurse specialists. Simple demographic, procedure
and process data collected will be contemporaneously for each participant. Data will be
recorded in an anonymised format using a unique alphanumeric study identification number
on a secure web-based database designed by the Seven and Peninsula Research
Collaborative for Surgeons (SPARCS) team. Data regarding in hospital complications will be
collected prospectively and patients will be reviewed in clinic at 30 days to collect
complication and oncology data. Note review will be performed in patients who do not
attend for 30 day follow-up.
Trainees or a locally designated member of breast team will approach each patient either in
clinic (pre or post-operatively) or during their admission to obtain consent for patient-reported
outcome measure (PROMs) assessment. Individual centres will be free to determine the
optimal approach for recruiting patients to this part of the study depending on local
processes and staffing levels. PROMs assessment will be by post at 3 and 18 months
following surgery as per the NMBRA and will evaluate satisfaction with care, out of hospital
complications and health-related quality of life. If consent is obtained, address details will be
sent securely to the co-ordinating centre (Bristol University) and questionnaires distributed
centrally.
Phase 3 - On-going prospective audit of the outcomes of implant breast
reconstruction
A longer term audit project will be considered based in the feasibility of Phase 2.
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6. Data collection
The following data set will be collected
Section 1&2 – Pre-operative data
1. Co-morbidity data
1.1. Age (years)
1.2. Height (metres)
1.3. Weight (kg)
1.4. Bra size
1.5. Smoking
status
(current
smoker/non
smoker
–
stopped
>6/52
prior
to
surgery/nicotine replacement (patches or electric cigarettes)
1.6. Diabetes (Yes/No)
1.7. Medical co-morbidities (IHD, connective tissue disease, current steroid use)
2. Prior and neoadjuvant treatments
2.1. Previous radiotherapy to ipsilateral breast or chest wall (mantle radiotherapy)
(yes/no)
2.2. Neoadjuvant chemotherapy within 4-6 weeks of the mastectomy and reconstruction
(yes/no)
2.3. Neoadjuvant hormone therapy prior to mastectomy and reconstruction (yes/no)
2.4. Previous surgery to ipsilateral breast (none/wide local excision/sentinel
node/augmentation/reduction/other – please state) (date month/year)
2.5. Form completed by (name)
2.6. Date (dd/mm/yy)
2.7. Contact e-mail address
Section 3 Operative data
3. Operative data
3.1. Date of primary reconstruction
3.2. Grade of ptosis (I-IV, no ptosis)
3.3. ASA grade (I-IV)
3.4. Name of Consultant surgeon
3.5. Procedure performed in theatre with laminar flow system in situ (yes/no/don’t
know)
3.6. Type of skin prep used at time of surgery (iodine/Chlorhexidine/2%
cholorprep/other (please state)
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3.7. Antibiotic use (prophylactic only <24 hours/1-5 days/extended course 5 days or
more)
3.8. Duration of procedure (knife to skin to dressing on) in minutes
3.9. Procedure performed on right (none/implant reconstruction/other
reconstruction/reduction/augmentation/mastopexy/wide local excision)
3.10. Procedure performed on left (none/implant reconstruction/other
reconstruction/reduction/augmentation/mastopexy/wide local excision)
Following data will be collected for each reconstructed breast – if implant reconstruction
is selected for right/left or both; fields will self-populate or collapse as appropriate.
Right breast
3.11. Planned procedure (1 stage/2 stage)
3.12. Grade of operating surgeon (consultant/associate specialist/senior trainee/junior
trainee/other)
3.13. Indication for surgery (malignancy/risk reduction)
3.14. Type of mastectomy (skin-sparing/skin and nipple preserving/reduction
pattern/other)
3.15. Location of incision (peri-areolar/lateral/inframammary/elliptical removing
NAC/Wise-pattern/Other)
3.16. Mastectomy dry weight (grams)
3.17. Surgeon’s assessment of skin flap quality (good/average/poor)
3.18. Mode of lower pole coverage (none/complete submuscular/dermal sling/biological
mesh/synthetic mesh/other (please state))
3.19. Details of product used for lower pole coverage
(Strattice/Permacol/Veritas/Biodesign/SurgiMend/Protexa/Serica/Tiloop/other)
3.20. Breast prosthesis used (fixed volume – size/temporary expander (size operative
fill/combined implant (Becker) – volume of silicone, final saline volume, volume of
saline in situ at end of the procedure)
3.21. Cavity irrigation prior to insertion of implant (yes/no)
3.22. Surgeon glove change prior handling implant (yes/no)
3.23. Axillary surgery (None/SNB/Sample/Clearance/sample and completion clearance)
Left breast
3.24. Planned procedure (1 stage/2 stage)
3.25. Grade of operating surgeon (consultant/associate specialist/senior trainee/junior
trainee/other)
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3.26. Indication for surgery (malignancy/risk reduction)
3.27. Type of mastectomy (skin-sparing/skin and nipple preserving/reduction
pattern/other)
3.28. Location of incision (peri-areolar/lateral/inframammary/elliptical removing
NAC/Wise-pattern/Other)
3.29. Mastectomy dry weight (grams)
3.30. Surgeon’s assessment of skin flap quality (good/average/poor)
3.31. Mode of lower pole coverage (none/complete submuscular/dermal sling/biological
mesh/synthetic mesh/other (please state))
3.32. Details of product used for lower pole coverage
(Strattice/Permacol/Veritas/Biodesign/SurgiMend/Protexa/Serica/Tiloop/other)
3.33. Breast prosthesis used (fixed volume – size/temporary expander (size operative
fill/combined implant (Becker) – volume of silicone, final saline volume, volume of
saline in situ at end of the procedure)
3.34. Cavity irrigation prior to insertion of implant (yes/no)
3.35. Surgeon glove change prior handling implant (yes/no)
3.36. Axillary surgery (None/SNB/Sample/Clearance/sample and completion clearance)
3.37. Form completed by (name)
3.38. Date (dd/mm/yy)
3.39. Contact e-mail address
Section 4 Oncology data
4. Oncology data
4.1. Tumour laterality (left/right/not applicable – risk reducing surgery)
4.2. Invasive status (invasive/DCIS/)
4.3. Grade of DCIS/invasive carcinoma (1 (low grade DCIS)/2 (intermediate grade
DCIS)/ 3 (high grade DCIS)
4.4. Lymph node involvement
4.4.1. Number of involved nodes (macrometastases)
4.4.2. Total of nodes in pathology specimen)
4.5. Invasive lesion size (mm)
4.6. Planned adjuvant therapy
4.6.1. Radiotherapy (yes/no)
4.6.2. Chemotherapy (yes/no)
4.6.3. Endocrine therapy (yes/no)
4.6.4. Herceptin (yes/no)
4.7. Planned delayed completion clearance (yes/no)
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4.8. Form completed by (name)
4.9. Date (dd/mm/yy)
4.10. Contact e-mail
Section 5 - 30 day complication data
5. 30 day complication data
5.1. Seroma requiring aspiration (right/left/no)
5.2. Haematoma
5.2.1. major (surgical drainage) (right/left/no)
5.2.2. minor (conservative management) (right/left/no)
5.3. Wound infection
5.3.1. minor (oral Abx) (right/left/no)
5.3.2. major 1 (IV Abx) (right/left/no)
5.3.3. major 2 (surgical drainage +/- debridement) (right/left/no)
5.4. Mastectomy skin flap necrosis
5.4.1. minor (conservative management) (right/left/no)
5.4.2. major (surgical debridement) (right/left/no)
5.5. Nipple necrosis
5.5.1. minor (conservative management) (right/left/no)
5.5.2. major I (requiring debridement) (right/left/no)
5.5.3. major II (complete NAC loss) (right/left/no)
5.6. Wound dehiscence
5.6.1. minor (conservative management) (right/left/no)
5.6.2. major (resutured) (right/left/no)
5.7. Implant loss (right/left/no)
5.8. Displaced implant requiring repositioning under GA (right/left/no)
5.9. In-hospital complication including systemic complications e.g. DVT/PE at time of
initial surgery (yes/no with details)
5.10. Readmission to hospital within 30 days (yes/no with reason)
5.11. Re-operation within 30 days (yes/no with reason)
5.12. Initial length of stay (days)
5.13. Form completed by (name)
5.14. Date (dd/mm/yy)
5.15. Contact e-mail
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Patient reported outcomes at 3 months – modified version of the NMBRA 3 month
questionnaire
1. Length of stay
2. Patient satisfaction with information (BREAST-Q)
3. Management of pain (as per NMBRA)
4. Patient-reported complication data
5. Follow-up information (number of appointments in breast clinic for review)
6. Adjuvant treatment information
Patient reported outcomes at 18 months – using BREAST-Q as per NMBRA (omitting
TRAM and LD specific items)
1. Physical well-being
2. Psychosocial well-being
3. Cosmetic outcome
4. Sexual well-being
5. Breast and shoulder symptoms
6. Quality of life
7. Satisfaction with outcome of reconstruction
8. Adjuvant treatment information
9. Further surgery questions (planned and unplanned) including specific
question regarding implant loss
10. Overall satisfaction with care
7. Data management and storage
Data collection will occur in accordance with Caldicott II principles and no patient identifiable
data will be recorded for the purpose of the audit.
Data for each patient will be anonymised using a unique alphanumeric study identification
number and entered into a secure web-based database (RedCAP) developed by Vanderbilt
University and hosted on a secure server by the University of Edinburgh. RedCAP has
received approval from NHS Lothian’s information governance department and is currently
being used for other on-going research collaborative projects (e.g. CholeS). It is therefore
likely to be acceptable to participating Trusts for use in this audit.
Patient contact details will be stored securely in the School of Social and Community
Medicine in a locked filing cabinet and used only to distribute questionnaires at three and 18
months as per protocol.
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During the pilot phase of the study and the national practice survey, the feasibility of using
real-time data collection using electronic data collection systems (1. Starfish CL app for iPad
and 2. RedCAP web-based system) with central data storage will be explored. The Red
Starfish system has been used successfully in University Hospitals of South Manchester
NHS Trust with considerable cost savings89. The availability of the required technology will
be assessed and the costs and information governance issues evaluated.
If this is
considered acceptable by the Steering Group, use of the app for data collection will be
offered as an option to participating centres.
8. Data analysis
All data analysis will occur centrally and will be led by SPARCS with support from
statisticians and methodologists in the School of Social and Community Medicine, University
of Bristol and the University of Liverpool Clinical Trials Research Centre.
8.1
National Practice Questionnaire
Simple summary statistics will be calculated to describe the parameters identified in the
questionnaire and describe variations in the provision of care and practice of implant-based
reconstruction.
Anonymised data will be presented separately for each region to allow
geographical comparisons to be made. National data will be fed back to each participating
centre to allow local unit comparisons.
8.2
Prospective audit
8.2.1 Calculation of internal audit standards
At three month intervals, simple summary statistics will be calculated for each of the four
main clinical audit standards (unplanned return to theatre; unplanned readmission; infection
and implant loss) for

all implant-based procedures

individual procedure subtypes
These will be compared with targets from the National Oncoplastic Guidelines and those
reported in the NMBRA.
Measures of central tendency for the audit data will be calculated and acceptable ranges
(mean +/- three standard deviations, as per NMBRA) determined for each adverse outcome.
These ranges will be used for identifying outliers.
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Complication rates at individual units will be calculated and outlying units (both good and
bad) considered in more detail to explore factors influencing outcome using regression
analysis to control for potentially predictive variables such as BMI and smoking.
Information regarding performance will be fed back to units according to the clinical
governance policy.
Analyses will be repeated at three monthly intervals as the audit
progresses.
8.2.2 Full analysis
Simple summary statistics will be calculated for each outcome and regression analysis used
to control for predictive variables.
Data will be tested for distribution and differences
between groups using unpaired t-tests, Mann-Whitney U tests and Chi squared tests as
appropriate.
Exploratory analyses will be performed to generate hypotheses for future
studies.
Summary statistics will be calculated for each participating Trust and fed back to individual
units to allow comparison with national averages and ranges
9. Publication and authorship policy
All presentations and publications will be made on behalf of the Trainee Research
Collaborative and the iBRA Study Group.
Three levels of authorship are proposed based on degree of study participation:
9.1 Named authors
Named authors will be required to meet the International Committee of Medical Journal
Editors (ICMJE) criteria (www.icmje.org) for authorship based on the following four criteria:
1. Substantial contribution to the conception or design of the work; or the acquisition,
analysis or interpretation of the data for the work and
2. Drafting the work or revising it critically for important intellectual content and
3. Final approval of the version to be published and
4. Agreement to be accountable for all aspects of the work in ensuring that questions
related to the accuracy or integrity of any part of the work are appropriately
investigated and resolved.
The ICMJE states ‘when submitting a manuscript authored by a group, the
corresponding author should specify the group name if one exists and clearly identify the
group members who can take credit and responsibility for the work as authors. The
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byline of the article identifies who is directly responsible for the manuscript and
MEDLINE lists authors whichever names appear on the byline. If the byline includes a
group name, MEDLINE will list the names of individual group members who are authors
or who are collaborators, sometimes called non-author contributors, if there is a note
associated with the byline clearly stating that the individual names are elsewhere in the
paper and whether those names are authors or collaborators.’
It is anticipated that between six and eight individuals will be named on each publication
followed by the wording ‘on behalf of the Trainee Research Collaborative and the iBRA
Study Group’. All citable collaborators will be listed at the end of the paper and their roles
identified.
Collaborators will be invited to sit on the iBRA Writing Group which will be responsible for
drafting manuscripts and preparing them for publication.
9.2 Citable collaborators
Citable collaborators will have made a considerable contribution to the study, but will not
have met the ICMJE criteria for authorship (non-author contributors). These will include
trainee leads at each centre and other trainees or team members (including consultant
surgeons, clinical nurse specialists or research nurses) who have recruited at least 10
patients to the study. Recruitment in this context includes consenting patients for PROMS
and submission of at least 10 completed data sets. Judgement may be used to determine
participation according to local centre practice. Trainee leads will be asked to provide details
of their local team and whether individuals fulfil the criteria for citable or acknowledged
collaborator status.
9.3 Acknowledged collaborators
Acknowledged collaborators will include consultant surgeons who contributed patients to the
audit, but did not personally collect data or recruit patients to receive PROMS and trainees
who have made a lesser contribution to patient recruitment and data collection than that
required for citable collaborator status. Trainees who are acknowledged contributors will
also receive a certificate of participation for inclusion in their portfolios.
Local collaboratives and hospital Trusts will have ownership of their own data and will be
able to present it locally if they wish.
The final reports will be prepared in accordance with the STROBE90 (Strengthening the
Reporting of Observational Studies in Epidemiology) guidelines.
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10. Research Governance
The aim of the audit is to determine the safety of immediate implant-based breast
reconstruction.
Complication and implant loss rates for each individual centre and/or surgeon (depending on
number of patients recruited) will be calculated and compared with the national average.
Data will be analysed after three months data collection to determine mean complication
rates with particular reference to implant loss. These figures will be used for benchmarking
and to determine acceptable complication parameters for the audit (mean +/- 3 standard
deviations as per original NMBRA). Data will be analysed at three monthly intervals. Trusts
performing less than 3 implant based reconstructions (1 per month) in each 3 month period
will be excluded from the analysis.
Any centres or surgeons whose overall complication rate or implant loss rate is greater than
three standard deviations from the audit mean will be contacted by a member of the study
Executive Committee to inform them of this finding, check the validity of the results and
explore reasons for this finding (e.g learning curve; high-risk patients). Analyses will be
repeated at 3 monthly intervals. If a Unit is found to be an outlier in 2 consecutive analyses,
these results will be fed back to the Unit, the Clinical Director and local clinical governance
lead for that Trust.
Overall audit results and results from individual centres will be feedback to ABS and
BAPRAS and compared with NMBRA outcomes to complete the audit cycle and determine
whether standards of care are being achieved.
11. Trial Management
Oversight of the audit will be by the Audit Steering Group which will have wide
representation from reconstructing surgeons, trainees, the professional societies, patient
representative and those with experience of trial management and statistics. This group is
expected to meet twice per year, but may also meet more frequently if necessary.
There will in addition be a smaller executive group for day to day audit management. It is
expected that most of this work will be done as a ‘virtual group’ by e mail.
A writing and data analysis group will also be convened.
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