The ABS ASPIRE

(Breast Pain Pathway Rapid

Evaluation)
Project

Protocol for a National Breast Pain

Pathway Service Evaluation

On behalf of the
ABS ASPIRE Steering Group
Version 7.0
February 2023
 ABS ASPIRE Steering Group Members

Clinical Study Leads Association of Breast Surgery Lead

Mr Rajiv Dave Professor Chris Holcombe
Manchester University NHS Foundation ABS President
Trust
iBRA-NET Lead
Ms Jennifer Hu Miss Shelley Potter
Barts Health NHS Trust iBRA-NET Chair

ABS Clinical Practice and Standards
Committee Lead
Ms Karina Cox
Maidstone and Tunbridge Wells NHS Trust.
ABS Academic and Research Committee
Lead
Professor Ramsey Cutress
ABS ARC Chair
University of Southampton

ABS Nursing Leads Statistical Lead

Kathryn Ellis Dr Paul White
Manchester University NHS Foundation Associate Professor of Applied Statistics
Trust University of the West of England

Suzanne Halliday Communications Lead

Surrey and Sussex Healthcare NHS Trust
Joanne Fields
Hampshire Hospitals NHS Foundation Trust
Professor Cliona Kirwan
Professor of Surgical Trials
Manchester University NHS Foundation
Trust

Patient Representatives and Patient Lead for Breast Cancer Now

Advocates Madeline Webb
Ms Hilary Stobart Senior Policy Advisor

Mammary Fold Academic and Research Collaborative (MFAC) Leads

Ms Anna Isaac Mr Tom Hubbard

ABS Clinical Practice and Standards Committee Representative

Ms Carol-Ann Courtney
University Hospital of Derby and Burton NHS Foundation Trust

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Contents

1. Background 5

1.1 Breast pain and breast cancer 5

1.2 Current management of patients with breast pain 5

1.3 Development of breast pain pathways 6

1.4 iBRA-NET - No innovation without evaluation 8

2. Aims and objectives 9

2.1 Aim 9

2.2 Objective 9

2.3. Pathway Identification 10

2.4. Sample size and recruitment 11

3. Outcomes 11

3.1 Primary outcome 11

3.2 Secondary outcomes 12

4. Breast pain pathway quality indicators 12

5. Methods 13

5.1 Phase 1 - Pathway identification 13

5.2 Phase 2 – Prospective evaluation 14

5.2.1 Logistical and governance issues 14

5.2.2 Unit inclusion criteria 14

5.2.3 Patient inclusion criteria 15

5.2.4 Patient exclusion criteria 15

5.2.5 Patient identification and recruitment 15

6. Data collection

6.1 Clinical data collection 17

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 6.2 Patient reported outcomes 18

6.3 Data collection fields at index appointment 19

6.4 Patient satisfaction questionnaire 22

6.5 Dataset at 12 months following completion 25

7. Data management and storage 26

8. Data analysis 27

9. Patient and public involvement 28

10. Publication and authorship policy 28

11. Project management 29

12. Study timelines 32

13. Appendices 33

14. References 36

Abbreviations

2WW – 2 week wait; ABS – Association of Breast Surgery; A&R - Academic and Research

Committee; BCN – Breast Cancer Now; CPS - Clinical Practice and Standards Committee;

GP – general practice; OSC – one stop clinic; PAG – patient/p;ublic advisory group; PPI –

Patient and public involvement

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1. BACKGROUND

1.1 Breast pain and breast cancer

Breast pain is a common symptom that may cause anxiety and distress for patients but in

the absence of other symptoms, is highly unlikely to be associated with breast cancer1 2. The

incidence of breast cancer in these patients has been found to be around 0.4% in several

studies2, including a recent large prospective contemporary cohort from a large UK cancer

centre which is approximately half that expected in a healthy screening population3. A

systematic review has reported an incidence up of to 2% 4. However, the authors state that

the quality of the seven included studies was poor. A case-control study concluded that

However, the low likelihood of cancer for all the non-lump symptoms means that

investigations may not meet current NHS criteria for cost-benefit 5. There is currently no high

quality evidence that breast pain is associated with breast cancer.

1.2 Current management of patients with breast pain

Most patients with breast pain in England are currently referred for assessment via the 2

week wait (2WW) suspected cancer pathway. They are seen in resource intensive clinics

specifically designed to exclude a cancer diagnosis rather than to explore or address their

symptoms. This is unsatisfactory for patients who, whilst a diagnosis of breast cancer might

be confidently excluded, may not receive optimal management of their symptoms of breast

pain and presents a significant challenge to breast units that are increasingly struggling to

meet referral targets. Breast clinic referral have increased by 100% over that last decade 6

and now only 50% of breast units in the UK are currently meeting 2WW targets 7.

Assessment of patients with breast pain who are highly unlikely to have breast cancer

potentially diverts limited clinical resources from patients with red flag symptoms who may

have cancer, leading to longer waiting times, more anxiety and potentially delayed cancer

diagnoses.

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1.3 Development of breast pain pathways

There is a need to provide a better pathway of care for patients with breast pain to alleviate

pressure in the 2WW cancer pathway clinic for patients with ‘red flag’ cancer symptoms and

provide more appropriate, holistic care to women experiencing benign breast symptoms. The

need for change has been highlighted in both the 2022 Association of Breast Surgery

Position Statement on Breast Pain7 and the 2021 Getting it Right First Time (GIRFT) breast

surgery report6 that suggests that new breast referral and assessment pathways should be

‘timely and centred around the individual with the aim of providing the best outcomes

and experience.’6

Several breast units have already developed specific pathways for the management of

patients with isolated breast pain or mastalgia with different pathways at various stages of

development and evaluation. Pathways can differ significantly terms of i) organisation of care

and access and ii) components of the assessment. These differences include

i) Organisation of/access to care

a. Location of clinic (primary or secondary care)

b. Route of referral (direct access vs GP referral)

ii) Components of the assessment

a. Face to face or virtual/telephone assessment

b. Formal family history risk assessment

c. Clinical examination

d. Imaging

Two pathways have been developed and published results, namely by the East Midlands

and the Manchester groups. Key elements of published pathways are outlined below and

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other pathways submitted for evaluation and inclusion in the ASPIRE service evaluation are

summarised in the Appendix.

1.3.1 East Midlands Breast Pain Pathway

The East Midlands Breast Pain Pathway is the most developed and pilot evaluation data has

been published 2. This pathway has been developed in collaboration with primary care and

patients are managed in primary care for three months initially prior to referral to a

community-based breast pain clinic. The key elements of the East Midlands pathway are i)

reassurance that breast pain is not a symptom associated with breast cancer; ii) clinical

examination by an experienced clinician; iii) formal family history risk assessment. Patients

with abnormal clinical examination are referred to 2WW clinics and those with moderate/high

family history risk are referred to family history clinics and managed appropriately. Patients

with normal examination and population risk are reassured. Levels of patient satisfaction

with this pathway are high 2 and the pathway is currently being introduced in several UK

centres.

1.3.2 Manchester Pathway

The Manchester pathway is based in secondary care and includes a telephone assessment

and mammography in women over 40. There is no clinical examination or family history

assessment. Patient are provided with resources and safety-netting into the 2WW clinic

where needed. Patients can be referred directly into the breast pain clinic from primary care,

and these referrals are triaged for appropriateness. This pathway is in the process of being

introduced across Greater Manchester.

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1.4 iBRA-NET - No innovation without evaluation

While these pathways have the potential to improve outcomes for both patients with breast

pain and those with cancer, they are all very different in terms of organisation of care and

components of assessment. It is therefore vital that they are robustly evaluated to ensure

they are safe, effective and meet the needs of patients using the service.

iBRA-NET (www.ibra-net.com) is a multi-disciplinary group of breast and plastic surgeons,

allied professionals and patients from across the UK established to promote safe and

transparent innovation in breast surgery – the concept of “no innovation without evaluation”.

The iBRA-NET group has an established track-record in the design and delivery of large-

scale ‘real world’ evaluations8-12 that have rapidly and efficiently generated high quality data

to support the safety and effectiveness of surgical techniques including new localisation

devices11 12 and implant-based reconstruction13 14.

Specifically, the iBRA-NET localisation study11 12 used a multicentre platform design with a

core dataset to rapidly evaluate and compare new localisation technologies with standard

wire guided techniques. The pragmatic audit design allowed rapid recruitment from multiple

centres and the routine collection of a core dataset across all study arms allowed new

devices to be directly compared with standard practice. The platform study model has the

flexibility to add new evaluation arms as devices are introduced. This established and proven

methodology could be effectively used to allow pragmatic ‘real world’ evaluation of multiple

breast pain pathways in a timely and efficient way.

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2. AIMS AND OBJECTIVES

2.1 Aim

The aim of the ABS ASPIRE project is to rapidly and efficiently evaluate new breast pain

pathways using an established platform evaluation design

2.2 Objectives

To identify the different separate elements that have been used and are being used in the

pathways for diagnosing and treating breast pain, and to assess each of these to determine

if each individual element adds value. This will be judged using each of three parameters:

- Safety: evaluated according to number of cancers detected at 12 months

- Patient Satisfaction: evaluated by PROMS

- Effective use of resources: evaluated by staff time and grade, tests performed, return

to clinic within 12 months

With these objectives in mind, the aims of the ASPIRE project will be;

i. To design an electronic platform evaluation including a core data set to evaluate and

compare recently developed breast pain pathways in a robust, efficient and timely

manner

ii. To describe the uptake of different pathways, volumes of patients seen, and how this

varies by region and over time

iii. To describe and compare the safety of different pathways evaluated according to the

number of cancers detected at 12 months

iv. To determine and compare patient satisfaction with different models of care at the

time of assessment using a patient reported outcome assessment.

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 v. To describe resource use and determine whether new breast pain pathways

represent cost-savings and relieve pressure on the one stop clinic compared with

current standard of care (on a pathway level)

2.3 Pathway definition

The various pathways are defined based on seven core components, as defined in figure 1.

It is acknowledged that each pathway will be designed according to local policy, resource

and practicality. It is not the aim of this project to stipulate the minimum requirements of the

pathway being evaluated. Indeed, various pathways may have particularities which might be

unique that might not be included within these seven core components, but it would not be

within the scope of this project to evaluate these. It is, however, expected that the person

completing the breast pain consultation is competent to do so, and is appropriately trained

and supported via the usual governance pathways in the Unit.

Figure 1. The components of the breast pain pathway assessed in the APSIRE project

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2.4 SAMPLE SIZE AND RECRUITMENT

The primary outcome for the evaluation will be safety, defined as the number of cancers

diagnosed in patients managed in breast pain pathways in the 12 months following their

breast pain assessment.

There is no high quality evidence that breast pain is associated with breast cancer; it would

be anticipated that this group of patients will have an incidence of incidental breast cancer

consistent with an age-matched population. For the purposes of this study, we have defined

an Interval cancer as Presenting within 12 months of completion of initial assessment.

In order to estimate the incidence of interval cancers in patients presenting with breast pain,

we must consider the incidence of breast cancer in the screening population (0.89%) 15, and

the incidence of missed cancer diagnoses following initial symptomatic appointment which

ranges from 0.3% (0.06%following multidisciplinary review) 16 to 0.9% 17. Taking the upper

limit of this incidence at 0.9%, and based on a 1% equivalence limit, 1512 patients will be

needed in each group to provide 80% power to test this hypothesis. As 20% of the 500,000

2WW referrals/year are currently for breast pain, if 20% of eligible women are referred via

breast pain pathways by GPs and 40% UK breast units participate in the study, recruitment

should be completed within 12 months.

3 OUTCOMES

3.1 Primary outcome

The primary outcome for the evaluation will be safety at 12 months defined by the number

of invasive cancers diagnosed in the 12 months following completion of assessment. It is

accepted that pathways that provide imaging will detect a higher number of incidental

cancer, and therefore would be expected to have a lower interval cancer rate. This service

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evaluation is powered to detect an interval cancer rate of >1% (see power calculation,

section 2.4).

3.2. Secondary outcomes

Secondary outcomes will be

 Cancer detection rate of the pathway

 Patient satisfaction with care following assessment

 Time from referral to assessment

 Number of further clinic referrals/visits within 12 months for the same symptom

 Acceptability of pathway to GPs/surgeons (no. of patients referred/no. of units

adopting pathway)

 Resource use at 12 months (on a pathway level)

4 BREAST PAIN PATHWAY QUALITY INDICATORS

Five key quality standards for breast pain pathways have been agreed by steering group

consensus. These quality indicators will form the basis of the evaluation study and are:

 Safety – to ensure that the pathway does not lead to an interval cancer great greater

than 1%.

 Timeliness – allows patients to be seen in a timely manner

 Associated with high levels of patient satisfaction using a standardised dataset

across pathways

 Represents best use of resources – right patient, seen at right time, by the right

person, with only the right investigations performed and minimising further

presentation to clinic for the same symptom

 Any new pathway should be auditable – can be evaluated

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5 METHODS

The ABS ASPIRE project is a real-world pragmatic prospective multicentre evaluation of new

pathways introduced to manage patients presenting with breast pain only. It will have two

phases:

Phase 1: Identification of current pathways to include in the initial evaluation study

Phase 2: Prospective service evaluation

5.1 Phase 1 – Pathway identification

Existing breast pain pathways will be identified via the Association of Breast Surgery (ABS)

Clinical Practice and Standards (CPS) committee. Centres with established breast pain

pathways will be invited to submit details of their pathway (along with any evaluation/audit

that has already been undertaken) to the CPS committee via a standardised proforma.

Invitations to submit details of breast pain pathways will be sent via ABS newsletters and

individual emails and publicised widely via social media (Twitter, LinkedIn).

Details of each individual pathway and any supporting documentation will be reviewed by

ABS CPSC and a decision made whether to include the pathway in the Phase 2 evaluation.

There is ongoing recruitment into the study, to include all new pathways that will be

submitted to the CPS, and will be updated in the appendix. Several units that employ a

standard of care OSC for patient with breast pain, will provide ‘control’ data.

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5.2 Phase 2 – Prospective evaluation

5.2.1 Logistical and governance issues

This project will be undertaken as a service evaluation. Units wishing to participate in the

evaluation will be required to identify a local lead for the project and register it as per their

local clinical governance procedures. Confirmation of local approvals should be sent to the

steering committee prior to commencing participant recruitment.

The breast pain only patient cohort should be informed that an evaluation of breast pain

pathways is being undertaken and given the ABS ASPIRE information leaflet (provided in

the Appendix). Individual patient consent will not be required to collect anonymised clinical

outcome data as part of the evaluation. Patient-reported outcomes will also be collected

following assessment, via an email link.

Prior to the start of the participating unit’s involvement in the ASPIRE project, there will be an

‘on-boarding’ meeting with the clinical leads of the ASPIRE project. This will allow for

discussion of the individual unit’s processes, and how data collection could be adapted to

ensure feasibility and efficiency.

5.2.2 Unit inclusion criteria

This is a national, multicentre evaluation of new strategic approaches to managing referrals

from primary care to the breast service, with symptoms of breast pain only. All centres that

have adopted a breast pain pathway included in the evaluation will be encouraged to

participate via the Pathway Lead. Centres that have not yet adopted a specific breast pain

pathway (i.e. those assessing patients with breast pain in a 2WW/one-stop clinic [OSC]) will

be encouraged to participate in the ‘control’ arm of the evaluation. A 2WW/OSC pathway is

defined as one in which imaging is available on the same day as the clinical consultation.
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5.2.3 Patient Inclusion criteria

All patients referred for management of breast pain only in the absence of other breast

symptoms will be eligible for inclusion.

● In Units that have adopted a breast pain pathway, all patients referred to and

assessed via the dedicated breast pain pathway should be included.

● In Units where breast pain is managed in a 2WW/OSC setting, all patients referred

with breast pain only, irrespective of laterality, pattern or duration, in the absence of

additional breast symptoms will be eligible for inclusion in the standard of care arm.

This includes patients in whom the primary care referral criteria is breast pain only,

even if further symptoms/signs are identified during the assessment.

5.2.4 Patient Exclusion criteria

Patients referred with breast symptoms including lumps, thickening, nipple or skin changes

in addition to breast pain. How these patients will be identified is dependent on the novel

pathway design. They can either be identified at triage (to ‘pre-screen’ prior to the clinic

appointment) or when they attend the breast pain clinic, following which re-direction to the

OSC could occur if additional symptoms are established.

5.2.5 Patient identification and recruitment

It is expected that participating units will include consecutive patients being evaluated for

breast pain as a sole symptom to the evaluation.

Eligible participants will be identified directly from primary care and through review of

referrals and clinic lists by local teams. Local leads will be encouraged to work with

colleagues to develop unit specific processes that optimise participant identification and
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recruitment. The evaluation has been specifically designed to collect a core dataset to

minimise participation burden on already busy units.

All participants will be allocated a study ID number. A file linking study ID numbers to

NHS/hospital numbers should be created and stored locally to allow for 12 month follow up,

in a secure shared access folder named ‘ASPIRE BREAST PAIN’.

Anonymised clinical data will be collected at the end of the initial assessment and patients

will be invited to complete a patient satisfaction questionnaire, either on paper or

electronically (via e-mail or text link or QR code).

In pathways without imaging, or if in the standard of care 2WW/OSC arm, imaging is

not indicated, the end of the assessment will be defined as the end of the assessment

consultation.

In pathways in which imaging is performed, end of assessment will be defined as the time

at which the results of the requested investigations are available and have shared with the

patient. This may be at the same visit or a later date for pathways in which assessment and

imaging have been uncoupled.

Individual units, in collaboration with Pathway Leads will be free to determine the optimal

approach for data collection depending on local processes and staffing levels.

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6. DATA COLLECTION

6.1 Clinical data collection

Data collection is encouraged via the electronic platform, but paper documents could be

used, which are subsequently uploaded. Clinical data collection will occur at two time-

points:

i) Following completion of assessment (see 5.2.5 for definition)

 Clinical outcomes and cancer detection rate

 patient reported outcomes

ii) At 12 months following the assessment

 Clinical outcomes – interval cancer rate, re-presentation etc

All data will be anonymised and entered onto the REDCap database18. Individual logins will

be required for each collaborator. Each unit will have a bespoke data collection form

available on RedCap based on their pathway, which will be designed by the ASPIRE study

leads in consultation with the unit’s pathway lead. Logic functions and drop-down boxes will

be used to minimise the burden of data completion. It is anticipated that the data collection

will occur prospectively, ideally at the initial clinic appointment.

12-month clinical outcome data will be obtained by review of clinical notes, the electronic

patient record (EPR) and/or locally-available cancer databases (e.g. Somerset Cancer

Registry) to identify any subsequent cancer diagnoses in the 12 months following the

assessment and/or any additional presentations to secondary care breast services. It is

acknowledged that this will only identify patients who have re-presented to the same service

and that patients may present elsewhere, especially in areas where there are multiple breast

units or they are unhappy with the care received. This is a pragmatic approach that reflects a

real-world evaluation, and it is anticipated that the majority of patients who have problems

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will be identified in this way. Local teams will be encouraged to investigate the best ways of

completing 12 month follow up depending on local systems and resources.

6.2 Patient reported Outcome following completion of assessment

Patient satisfaction with the assessment experience will be evaluated at the end of the

assessment process (see section 5.3.4 for definition). Patients will have a hand-written

option for completing the satisfaction questionnaire, however, the preferred option is

electronic. An automated process will be built into RedCap; once the patient’s email has

been recorded, an email will be sent with the satisfaction questionnaire (triggered by the

completion of the ‘outcome’ section of the data collection). It is imperative that individual

units using a paper option ensure that the questionnaire is linked to the patient with the

ASPIRE Study ID.

As this is a service evaluation, patients will only be asked to complete the satisfaction

questionnaire once, and those individuals who chose not to provide feedback on the

experience that they have received, will not be followed up.

In the absence of a validated patient satisfaction questionnaire for use in patients with breast

pain, questionnaires already currently used by various services (East Midlands, Manchester,

Leeds) will be reviewed and adapted to ensure applicability across all potential breast pain

pathways. This work will be undertaken in collaboration with our patient and public

involvement (PPI) group so that the questions reflect areas that are important to patients

while minimising the burden of completion and ensuring ease of completion. The

questionnaire will be piloted and iteratively refined prior to use in the evaluation.

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6.3 Data collection fields at index assessment

Clinical dataset

Participant demographics

● Study ID - this is the APSIRE study ID, allocated by the individual unit, which is linked

to the patient’s NHS number in a secure file saved on the collaborator’s trust

computer

● Patient’s email and agreement to participate - this is for the satisfaction questionnaire

only, and only verbal consent for this service evaluation is required. This is outlined in

the patient information leaflet

● Date of referral (DD/MM/YY) - this is date the referral was sent, and is defined as the

‘clock start’

● Patient age (years) - this is the age when seen in clinic

Assessment details

● Date of 1st assessment (DD/MM/YY) - this is the date the patient was seen in clinic

● Pathway type

o Standard of care (2WW/OSC) or Registered Breast Pain pathway

● Modality of assessment

o Face to face/telephone/video/other – please give details

● Professional undertaking the assessment

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 o Advanced Nurse Practitioner or Consultant / Physician Associate / GP /

Trainee Breast Surgeon / Consultant Breast Surgeon / Breast Clinician /

Other

● Components of assessment completed

REDCap will use logic function to display the key elements of each pathway with an

option to add additional elements if needed. Options will only be displayed if ‘yes’ is

selected

o History of presenting complaint (in a table, by laterality)

▪ Breast pain only

▪ Other breast symptoms (Yes / No).

● If Yes, Lump / Nipple discharge / Other

o Objective family history assessment using recognised assessment tools

completed? (Yes / No)

● If Yes, outcome of assessment of risk – (Population risk /

Moderate risk / High risk)

o Clinical examination findings (in a table, by laterality)

▪ P1 / P2 / P3 / P4 / P5

o Imaging (Yes / No)

● If Yes, type of imaging performed/requested (in a table, by

laterality, tick all that apply); Mammogram / Tomosynthesis /

USS / MMG / Not requested as performed within 6 months

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 ● If Yes, date imaging performed (DD/MM/YY)

● If Yes, date imaging reported (DD/MM/YY)

● If Yes, results of imaging (in a table, by laterality)

o M1 / M2/ M3 / M4 / M5

o U1 / U2 / U3 / U4 / U5

● If Yes, Biopsy/FNA performed (Yes/no)

o If Yes, biopsy results (in a table, by laterality); B1 / B2 /

B3 / B4 / B5 / C1 / C2 / C3 / C4 / C5

o VAB / VAE also performed? If Yes, biopsy results (in a

table, by laterality); B1 / B2 / B3 / B4 / B5

Outcome of assessment consultation (In pathways that include imaging, this is the

outcome AFTER imaging complete)

o Reassure and discharge

▪ (If so, date: DD/MM/YY)

o Onward referral to OSC or 2WW clinic from the Breast Pain Pathway clinic

▪ If so, Date of 2WW/OSC assessment (DD/MM/YY)

▪ If so, Imaging performed (in a table, by laterality, tick all that apply);

Mammogram / tomosynthesis / USS / MMG / Not requested as

performed within 6 months

▪ If so, Biopsy/FNA performed? (Yes / No)

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 ● If Yes, biopsy results (in a table, by laterality); B1 / B2 / B3 / B4

/ B5 / C1 / C2 / C3 / C4 / C5

o Referral to Family History Clinic / Clinical Genetics (If so, date of referral:

DD/MM/YY)

o Other Follow up appointment (If so, date of referral: DD/MM/YY)

o Diagnosis of cancer (requires histological confirmation) following this

presentation with breast pain (If so, date of histology report; DD/MM/YY - this

refers to a cancer diagnosis at this presentation – it is appreciated that further

visits will be needed as part of the management process)

● If yes:

● Is this an incidental cancer? (see definition above)

● Laterality (Right / Left / Bilateral)

● IDC / ILC / Mixed / DCIS

● Size (mm) largest

● Grade (1-3)

● ER status

● Her2 status

● Nodal status (Positive / Negative)

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 ● Date of discharge from clinic (DD/MM/YY)

6.4 Patient Satisfaction Questionnaire

● Participant information

● Ethnicity

White

1. English/Welsh/Scottish/Northern Irish/British

2. Irish

3. Gypsy or Irish Traveller

4. Any other White background, please describe

Mixed/Multiple ethnic groups

5. White and Black Caribbean

6. White and Black African

7. White and Asian

8. Any other Mixed/Multiple ethnic background, please describe

Asian/Asian British

9. Indian

10. Pakistani

11. Bangladeshi

12. Chinese

13. Any other Asian background, please describe

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 Black/ African/Caribbean/Black British

14. African

15. Caribbean

16. Any other Black/African/Caribbean background, please describe

Other ethnic group

17. Arab

18. Any other ethnic group, please describe

● Before Your Appointment

● Did your GP/Practice Nurse advise you that breast pain is not a symptom of breast

cancer? Yes/No

● How many times have you seen your GP/ Practice Nurse for this episode of breast

pain prior to being referred to this clinic? 0/ 1 / 2 / 3 / 4 / 5 / 6+

● How did you feel before your breast pain appointment?

I was worried about the appointment Strongly agree/agree/neither/disagree/strongly

disagree

I felt anxious Strongly agree/agree/neither/disagree/strongly disagree

I wanted relief of my breast pain symptoms Strongly

agree/agree/neither/disagree/strongly disagree

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 I wanted reassurance that I did not have breast cancer Strongly

agree/agree/neither/disagree/strongly disagree

I was worried about my family history?

Strongly agree/agree/neither/disagree/strongly disagree

● Have you previously sought advice for your breast pain symptoms? Yes – GP only,

Yes – GP and onward referral to hospital / No

● How long after you saw your GP did you have the breast pain appointment? 0-1

week, 1-2, 2-3, 3-4 4weeks +

● After your appointment

● How did you feel after you had been assessed?

The advice I got was helpful Strongly agree/agree/neither/disagree/strongly disagree

The consultation reassured me Strongly agree/agree/neither/disagree/strongly

disagree

I felt listened to / not rushed Strongly agree/agree/neither/disagree/strongly disagree

I had the opportunity to have my left questions answered Strongly

agree/agree/neither/disagree/strongly disagree

● Did you receive advice on how to manage your breast pain during your appointment?

Yes/no

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  Were you given any information about breast pain? Yes / No

 If yes, Written / Video / Other

 If yes, did you find it useful?

Yes/No

If you didn’t receive written information, would you have liked some?

Yes/No

● How likely are you to recommend this service to friends and family? Extremely

likely/likely/neither likely or unlikely/unlikely/extremely unlikely/ don’t know

● Overall, how satisfied are you with the breast pain assessment that you have had?

● Very satisfied/slightly satisfied/neither satisfied or unsatisfied/slightly unsatisfied/very

unsatisfied

● Please tell us what could have been done differently to make your appointment

better? (nothing/free text)

6.5 Dataset at 12 months following assessment

Repeat consultation

● Has the patient re-presented to local secondary care breast services in the 12

months following their breast pain assessment (Yes / No)

o If yes, was this for;

▪ Breast pain only

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 ▪ Other breast symptoms

● If so, Lump / Nipple discharge / Other

o How many times has the patient been seen for breast symptoms in the

breast clinic since their breast pain assessment? (1/2/3/more than 3)

▪ Option for free-text comments

o Has the patient had further unplanned imaging since their assessment

(Mammogram / USS / Tomosynthesis / MRI / No imaging)

o Has the patient had a screening Mammogram? Yes / No / Unknown

o Has the patient had an unplanned biopsy since their assessment (Yes / No)

Subsequent cancer diagnosis

● Has the patient subsequently been diagnosed with a Cancer? (Yes/No)

○ If yes:

○ Date of diagnosis (DD/MM/YY) (use date diagnostic core biopsy performed)

○ Route of diagnosis (Screening / Symptomatic / Not known)

○ Laterality (Right / Left / Bilateral)

○ IDC / ILC / Mixed / DCIS

○ Size (mm) largest

○ Grade (1-3)

○ ER status

○ Her2 status

○ Nodal status (Positive / Negative)

○ Has an internal review been performed?

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7 DATA MANAGEMENT AND STORAGE

Data collection will occur in accordance with Caldicott II principles. Data for each patient will

be anonymised using a unique alphanumeric study identification number. No patient

identifiable data will be recorded for the purpose of the evaluation, but local sites will keep a

record of NHS numbers linked to study IDs to allow for 12 month follow up. All study data

will be collected and managed using REDCap electronic data capture tools13 and REDCap

survey options used to collect patient reported outcome data as per patient preference.

Logic functions will be used to minimise data collection burden and optimise data

completion. The REDCap forms will be developed and piloted to check for errors and check

for ease of use before rollout of the evaluation nationally.

8 DATA ANALYSIS

Simple summary statistics will be calculated to describe demographics and outcomes in the

cohort as a whole and by pathway type. Categorical data will be summarised by counts and

percentages. Continuous data will be summarised by mean, standard deviation and range if

the data is not skewed and median, interquartile-range (IQR) and range if the data is

skewed.

We will establish the proportion and 95% confidence intervals of patients diagnosed with

breast cancer in the 12 months following breast pain assessment overall and by pathway

type. Numbers of patients diagnosed with breast cancer in each pathway, numbers re-

presenting to secondary breast services and overall satisfaction scores will be compared

using a Chi-square test. Multivariable logistic regression will be used to examine the

relationship between key sociodemographic (age/ethnicity/geographical region) and

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assessment variables (including various components of the pathway as described in Figure

1) against cancer diagnoses/re-presentation/satisfaction.

Free text responses from the satisfaction questionnaire will be anonymised and a

combination of thematic and content analysis will be used to identify common themes 19 20.

Findings presented alongside the quantitative analysis to help contextualise and illuminate

them.

9 PATIENT AND PUBLIC INVOLVEMENT

Patient and public involvement is central to the successful completion of this evaluation and

is vital to ensure that the patient remains at the centre of the project. To this end, there is

patient advocate representation within the membership of the steering group together with

representatives from Breast Cancer Now. This will ensure that the patient voice is heard.

In addition, we will convene a patient/public advisory group (PAG). The PAG will input on the

design of the patient satisfaction questionnaire and patient facing materials and advise on

ways to optimise patient engagement and participation. We will share the findings of the

evaluation with our patient team and design patient friendly dissemination materials to share

the results.

10 PUBLICATION AND AUTHORSHIP POLICY

The results from the evaluation will be published in peer-reviewed journals and presented at

national and international meetings. All presentations and publications will be made on
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behalf of the ABS ASPIRE Evaluation Group, and all participating units will be

acknowledged.

Three levels of authorship are proposed based on degree of study participation:

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

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.’

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It is anticipated that between 10-12 individuals will be named on each publication followed by

the wording ‘on behalf of the ABS ASPIRE Evaluation Group’. All citable collaborators will

be listed at the end of the paper and their roles identified.

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

leads at each centre and other team members (including consultant surgeons, clinical nurse

specialists, trainees or research nurses) and those who have entered at least 50 records into

the evaluation. ‘Entered’ in this context includes entering participant data with submission of

at least 50 completed datasets. Judgement may be used to determine participation

according to local centre practice; for example, an individual who did not enter anyone into

the evaluation but who then completed the 12 month follow up data for all recruited

participants would be considered to have made a significant contribution to the project and

meet the citable collaborator criteria. Local leads will be asked to provide details of their

local team and whether individuals fulfil the criteria for citable or acknowledged collaborator

status.

Acknowledged collaborators

Acknowledged collaborators will include consultant surgeons who contributed patients to the

audit but did not personally collect data 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.

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The final reports will be prepared in accordance with the STROBE 21 (Strengthening the

Reporting of Observational Studies in Epidemiology) guidelines.

11 PROJECT MANAGEMENT

The ABS ASPIRE Delivery group will have overall oversight of the project and will include

representatives from ABS, including the President, Academic and Research Committee

chair, IBRA-net Chair, Clinical Practice and Standards Committee representative, the

nationally-appointed consultant, trainee and nursing leads, patient representative and a

communication lead. This group will meet monthly, and will work to promote engagement

and involvement with the wider breast surgical community to optimise the number of centres

participating in the evaluation. A writing and data analysis group will also be convened.

The ABS ASPIRE Advisory group will be invited to meet twice a year. The aim of this group

is engagement of the wider community, made up of everyone who has submitted a pathway

for evaluation and/or has an specific interest in a pathway under evaluation, a wider PPI

group (including representatives from Breast Cancer Now), wider trainee input, wider nursing

input, radiology input, general practice input, and methodologists/statisticians.

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 12 STUDY TIMELINES

S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N

Study Set

up

Data

collection

trial phase

Patient

recruitment

Patient

follow up

Data

Cleaning

and

analysis

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Disseminati

on

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Appendices

Patient information leaflet (designed to fit an A5 page)

The ABS ASPIRE project is a national project looking at best way to look after people with breast pain, across the UK. Breast pain is not

considered a symptom of breast cancer, and a woman with breast pain alone may not need the same investigations as a woman with a lump.

The purpose of this project is to look at all the different breast pain pathways in the UK over a period of 12 months and compare the results.

Data generated from this appointment will be entered into a national database. This does not include any personal data about you. This is to

primarily evaluate the service, and data collected will include details of the appointment such as waiting times, investigations performed, etc.

As part of this project it is really important that we have patient feedback. We need to know what patients like yourself, like or dislike about the

service they have had. You will be asked spend a few minutes completing a ‘patient satisfaction questionnaire.’

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Table 1 Comparison of breast pain pathways (to be added to)

appointm
governan
personne

ent letter
manages
approval
impleme

pathway

examina
Primary

upfront
written

patient
Patient
date of

history
clinical
details
Triage

if yes,
if yes
Trust
clinic

from

who

pre-

tion
age

ce

to
organisation

l
Royal 1 Y Y Breast Governance Y
Wolverhampton Sep 6 e e and Directorate N e N
NHS Trust -21 + s BCNS s Yes approval Cons BCNS Yes o Yes s o
East Sussex & North SOP approved by
Essex Foundation No 1 Y Clinical Delivery group y y
Trust (Ipswich & v- 8 n e and Divisional n e e
Colchester) 21 + o BCNS s Yes Governance board BCNS yes o yes s s
triage yes if 2y
Wessex Cancer Au 3 Y Y between 1 & care. No if Y
Alliance (Hampshire g- 0 e e 2 care BCNS. N telephone e N
Hospitals) 21 + s Consultant s Yes HHFT and Wessex RDS Consultant Yes o triage s o
yes
standard
SWBH Trust - City a Y Y no breast y y
Hospital Oct n e Breast e (application clinic N e e
Birmingham -21 y s Surgeon s in progress) surgeon info) o yes s s
yes. Audit
by East
De 1 Y Y Mids y y
UHDB FT/ East c- 6 e e Cancer e e
Midlands model 19 + s ANP s Alliance ANP Yes no s yes s
Sherwood Forest De 1 n Breast y yes breast Yes N yes y N
NHS Trust c- 6 o Surgeon e surgeon o e o
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 19 + s s
Consultant
a breast y clin gov team and y y
Sep n n surgeon e implemented as QI breast n e e
Yeovil -22 y o and ANP s yes project surgeon yes o yes s s
01/
Hereford County 06/ Y SAS approved at local Breast y
Hospital (Wye Valley 20 al e doctors & n breast clinical speciality n e n
trust) 22 l s BCN o yes governance meeting doctor no o yes s o
07/
07/ > y Consultant y Leeds Cancer Centre & Consultant y y
20 1 e Breast e WY+Harrogate Breast Breast n e e
Leeds 22 6 s surgeon s yes Cancer Alliance Surgeon yes o yes s s
Ma a Y y y
y- n n e governance team at n e e
Manchester 20 y o ANP s yes Trust ANP yes o no s s
1
01/ 6
10/ - y y y y
Prince Philip 20 6 n Doctor/ e submitted to audit speciality e n e e
Hospital (Wales) 22 5 o nurse led s yes department doctor yes s o yes s s

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