Breast Cancer Clinical Quality Performance Indicators Engagement Document.

6. Quality Performance Indicators for Breast Cancer

QPI 1: Multidisciplinary Team Meeting ( MDT)

QPI Title:	Patients with newly diagnosed breast cancer should be discussed by a multidisciplinary team prior to definitive treatment.
Description:	Proportion of patients with breast cancer who are discussed at MDT meeting before definitive treatment.
Rationale and Evidence:	Evidence suggests that patients with cancer managed by a multidisciplinary team have a better outcome. There is also evidence that the multidisciplinary management of patients increases their overall satisfaction with their care 3 . Discussion prior to definitive treatment decisions being made provides reassurance that patients are being managed appropriately.
Specifications:	Numerator: Number of patients with breast cancer discussed at the MDT before definitive treatment.
	Denominator: All patients with breast cancer.
	Exclusions: Patients who died before first treatment.
Target:	95% The tolerance within this target is designed to account for situations where cancer is not suspected pre-operatively or where patients receive endocrine treatment prior to MDT meeting.

QPI 2: Non-Operative Diagnosis

QPI Title:	Patients with breast cancer should have a non-operative histological diagnosis.
Description:	Proportion of patients with invasive or in-situ breast cancer who have a non-operative diagnosis (core biopsy / large volume biopsy).
Rationale and Evidence:	Diagnosis of patients non-operatively allows them to have only one definitive procedure, where possible. A lesion considered malignant should have histopathological confirmation of malignancy before any definitive surgical procedure takes place 4 .
Specifications:	Numerator: Number of patients with a non-operative diagnosis of breast cancer (core biopsy / large volume biopsy).
	Denominator: All patients with invasive or in-situ breast cancer.
	Exclusions: All breast cancer patients with lobular carcinoma in situ ( LCIS).
Target:	95% The tolerance within this target accounts for the fact that it may not always be technically possible to undertake a biopsy and factors of patient choice.

QPI 3: Pre-Operative Assessment of Axilla

QPI Title:	Patients with breast cancer should have pre-operative assessment of the axilla.
Description:	Proportion of patients with invasive breast cancer who undergo assessment of the axilla: (i) ultrasound (ii) +/- FNA/core biopsy if suspicious morphology is reported on ultrasound, before surgery. Please note: This QPI measures 2 distinct elements: (i) All patients with invasive breast cancer should undergo ultrasound assessment of the axilla; and (ii) If findings of ultrasound are suspicious of cancer spread to nodes all patients should undergo FNA/core biopsy. The specifications are therefore separated to ensure clear measurement of both these factors.
Rationale and Evidence:	"A preoperative diagnosis of nodal disease enables definitive treatment of the axilla at the time of initial breast surgery 5 . Patients with invasive breast cancer should undergo pre-treatment ultrasound assessment of the axilla. If morphologically suspicious nodes are identified these should be sampled, using FNA or core biopsy 5 6 .
Specifications (i) :	Numerator: Number of patients with invasive breast cancer who undergo assessment of the axilla by ultrasound before surgery.
	Denominator: All patients with invasive breast cancer undergoing surgery.
	Exclusions: No exclusions.
Target:	95% The tolerance within this target accounts for the fact that some patients may refuse investigation and/or treatment.
Specifications (ii):	Numerator: Number of patients with invasive breast cancer with suspicious morphology reported on ultrasounds who undergo a FNA/core biopsy of the axilla before surgery.
	Denominator: All patients with invasive breast cancer undergoing surgery with suspicious morphology reported on ultrasound.
	Exclusions: No exclusions.
Target:	85% The tolerance within this target accounts for the fact that FNA/core biopsy of the axilla it is not always technically possible.

QPI 4: Conservation Rate

QPI Title:	Patients with small breast cancers should undergo breast conservation whenever appropriate*.
Description:	Proportion of surgically treated patients with breast cancer less than 20mm whole tumour size on histology who achieve breast conservation.
Rationale and Evidence:	Breast conservation is appropriate for small breast cancers. Randomised trials have shown no difference in survival for tumours treated by conservation surgery followed by radiotherapy to mastectomy 4 . *Breast conservation may not be appropriate for all patients for a variety of reasons including patient choice, genetic risk and small breast size 7 .
Specifications:	Numerator: Number of surgically treated patients with breast cancer less than 20mm whole tumour size on histology (invasive plus in situ disease) treated by breast conservation surgery.
	Denominator: All surgically treated patients with breast cancer less than 20mm whole tumour size on histology (invasive plus in situ disease).
	Exclusions: Patients with multifocal breast cancer. Patients with breast cancer who have received neoadjuvant systemic therapy for ≥6 weeks (hormonal therapy or chemotherapy). High risk patients. Patients who have had previous ipsilateral breast cancer. Male patients.
Target:	90% The tolerance within this target accounts for the fact that breast conservation may not always be an appropriate treatment option for a variety of reasons, primarily patient choice.

QPI 5: Surgical Margins

QPI Title:	Breast cancers which are surgically treated should be adequately excised.
Description:	Proportion of surgically treated patients with breast cancer (invasive or ductal carcinoma in situ) with final radial excision margins of less than 1mm.
Rationale and Evidence:	There is an increased risk of local recurrence if radial surgical excision margins are less than 1mm after breast cancer surgery 4 .
Specifications:	Numerator: Number of patients with breast cancer (invasive or ductal carcinoma in situ) having breast conservation surgery with final radial ( i.e. superior, inferior, medial or lateral) excision margins less than 1mm (on pathology report).
	Denominator: All patients with breast (invasive or ductal carcinoma in situ) cancer having breast conservation surgery.
	Exclusions: LCIS alone
Target:	<5% This QPI is measuring the proportion of patients who undergo surgery where the tumour has not been completely excised, a 'less than' target level has therefore been set.

QPI 6: Re-excision Rates

QPI Title:	Patients undergoing surgery for breast cancer should only undergo one definitive operation where possible.
Description:	Proportion of surgically treated patients with breast cancer (invasive or in situ) who undergo re-excision or mastectomy following their initial surgery.
Rationale and Evidence:	It is important to minimise treatment related morbidity. Patients undergoing additional surgical procedures can be subject to unnecessary stress, as well as potential complications and delays in recovery 8 . Re-operation is also a factor related to poorer cosmetic outcomes for patients 9 .
Specifications:	Numerator: Number of patients with breast cancer (invasive or in situ) having breast conservation surgery who undergo re-excision or mastectomy following initial surgery.
	Denominator: All patients with breast (invasive or in situ) cancer having breast conservation surgery.
	Exclusions: LCIS alone
Target:	<20% This QPI is measuring the proportion of patients who undergo more than one surgical procedure to achieve clear margins, a 'less than' target level has therefore been set.

QPI 7: Immediate Reconstruction Rate

QPI Title:	Patients undergoing mastectomy for breast cancer should have access to immediate breast reconstruction.
Description:	Proportion of patients who undergo immediate breast reconstruction at the time of mastectomy for breast cancer.
Rationale and Evidence:	Evidence suggests that breast reconstruction is not associated with an increase in the rate of local recurrence, nor does it affect the ability to detect recurrence, and it can yield psychological benefit. There may be good reasons for individual patients not to undergo immediate breast reconstruction but this indicator is intended to demonstrate that mastectomy patients have access to a reconstructive service 4 7 . Access to immediate breast reconstruction is very difficult to measure accurately therefore uptake is utilised within this QPI as a proxy for access. Although it will not provide an absolute measure of patient access to this procedure it will give an indication of access across NHS Boards and highlight any areas of variance which can then be further examined.
Specifications:	Numerator: Number of patients with breast cancer undergoing immediate breast reconstruction at the time of mastectomy.
	Denominator: All patients with breast cancer undergoing mastectomy.
	Exclusions: All patients with M1 disease [a] . All male patients.
Target:	25% The tolerance within this target accounts for patient choice and fitness for treatment. Patient choice is a key factor in the number of patients who undergo immediate breast reconstruction at the time of mastectomy.

Please note:
Additional information on the time from diagnosis to reconstructive surgery will be reported across NHS Boards. This information should be reviewed to ensure there is no impact on quality of care for patients undergoing this treatment option.

QPI 8: Referral for Genetics Testing

QPI Title:	Patients with breast cancer should be offered referral to a specialist genetics clinic within 6 months of diagnosis where appropriate
Description:	Proportion of patients with breast cancer who meet the following criteria for gene testing and are referred to a specialist genetics clinic: (i) Patients who are <30 years of age diagnosed with breast cancer (ii) Patients who are <40 years of age diagnosed with triple negative [b] breast cancer Please note: The specifications of this QPI are separated to ensure clear measurement of both.
Rationale and Evidence:	Where patients have breast cancer, genetic testing should be offered if their combined BRCA1 and BRCA2 mutation carrier probability is ≥10% 10 . Various predictions models exist to assess the likelihood of a BRCA1 or BRCA2 mutation in a family. All patients with TNBC <40 would be predicted to have ≥10% of a BRCA1 or BRCA2 mutation. Breast cancer <30 also increases the likelihood of a BRCA1/ BRCA2 or p53 mutation. It is difficult to accurately capture data for all eligibility criteria for gene testing within current systems, therefore measurement of this QPI will focus on patients <30 years of age and patients <40 years of age with triple negative breast cancer in the first instance. This will be kept under review and revised as necessary when further data becomes available.
Specification (i):	Numerator: Number of patients <30 years of age with breast cancer referred to a specialist clinic for genetic testing within 6 months of diagnosis
	Denominator: All patients <30 years of age with breast cancer
	Exclusions: None
Specification (ii):	Numerator: Number of patients <40 years of age with triple negative breast cancer* referred to a specialist clinic for genetics testing within 6 months of diagnosis
	Denominator: All patients <40 years of age with triple negative breast cancer*
	Exclusions: None
Target:	90% The target tolerance level accounts for factors of patient choice. Please note: varying evidence exists regarding the most appropriate target level therefore this may need redefined in the future, to take account of new evidence or as further data becomes available.

QPI 9: Minimising Hospital Stay -"23 Hour" Surgery

QPI Title:	Patients should have the opportunity for "23 hour" surgery (no overnight stay) wherever appropriate.
Description:	Proportion of patients undergoing wide excision and/or an axillary sampling procedure for breast cancer with no overnight stay following their procedure.
Rationale and Evidence:	It is safe to perform wide excision and axillary staging as a short stay procedure in the majority of patients and clinical quality has been shown to be improved utilising this model, resulting in better patient outcomes. Benefits of short stay following surgery include: reduction in re-admissions, reduction in complications, improved patient mobility and enhanced recovery 11 .
Specifications:	Numerator: Number of patients with breast cancer undergoing wide excision and/or axillary sampling procedure (sentinel node biopsy or node sample (≥4 nodes) with no overnight stay following their procedure.
	Denominator: All patients with breast cancer undergoing wide excision and/or axillary sampling procedure (sentinel node biopsy or node sample (≥4 nodes).
	Exclusions: All patients with breast cancer undergoing partial breast reconstruction.
Target:	20% The tolerance within this target takes account of the fact that "23 hour" surgery may not be appropriate for all patients due to social circumstances, co-morbidities and/or the geographical area in which they live. It may not always be safe or practical for patients to go home immediately after surgery; this may therefore affect short-stay surgery rates across NHS Scotland.

Please note:
SMR01 data will be utilised to support reporting and monitoring of this QPI rather than clinical audit. This will maximise the use of data which are already collected and remove the need for any duplication of data collection. Standard reports are currently being specified and direct access for each Board to run these reports is being investigated to ensure nationally consistent analysis and reporting.

QPI 10: HER2 Status for Decision Making

QPI Title:	HER2 status should be available to inform treatment decision making.
Description:	Proportion of patients with HER2 positive cancer, as defined by ImmunoHistoChemistry ( IHC), where HER2 result is available prior to commencing treatment.
Rationale and Evidence:	HER2 status has a significant impact on survival and so has a significant influence on decisions on neoadjuvant and adjuvant treatment 5 . Delay in the availability of a HER2 result may lead to a delay in appropriate neoadjuvant or adjuvant therapy and make communication of a clear plan to the patient more difficult. At present HER2 testing is undertaken in all relevant cases; however the point of the patient pathway at which this takes place varies across NHS Scotland. The purpose of this indicator is to synchronise practice across Scotland by ensuring the availability of HER2 status to inform treatment decision making.
Specifications:	Numerator: Number of patients with HER2 positive (by 3+ on IHC &/or FISH +ve) breast cancer for whom the HER2 result is available prior to definitive treatment.
	Denominator: All patients with HER2 positive (by 3+ on IHC &/or FISH +ve) breast cancer.
	Exclusions: No exclusions.
Target:	90% The tolerance within this target is designed to account for situations where patients require treatment urgently.

QPI 11: Radiotherapy for Breast Conservation

QPI Title:	After wide local excision patients with breast cancer should receive radiotherapy.
Description:	Proportion of patients with breast cancer who receive radiotherapy to the breast after conservation for invasive cancer.
Rationale and Evidence:	Trials have demonstrated a significant reduction in local recurrence with the use of radiotherapy after breast conservation 12 . Clinical trials of radiotherapy have shown it can produce a reduction in local recurrence would produce an absolute increase in 20-year survival of about 2-4% 13 14 15 .
Specifications:	Numerator: Number of patients with invasive breast cancer having conservation surgery receiving radiotherapy to the breast.
	Denominator: All patients with invasive breast cancer having conservation surgery.
	Exclusions: All patients with breast cancer taking part in clinical trials of radiotherapy treatment. All patients with M1 disease.
Target:	95% The tolerance within this target accounts for factors of patient choice and fitness for treatment.

QPI 12: Adjuvant Chemotherapy

QPI Title:	Patients with higher risk breast cancer should receive chemotherapy post operatively where it will provide a survival benefit for patients.
Description:	Proportion of patients with surgically proven node positive (or at least G3 >20mm breast cancer) and a ≥5% benefit predicted* who receive adjuvant chemotherapy.
Rationale and Evidence:	Large randomised trials have confirmed that adjuvant systemic therapy improves relapse-free survival and overall survival 12 . Clinical trials have demonstrated that adjuvant drug treatments substantially reduce 5-year recurrence rates and 15-year mortality rates 16 . Success of treatment is based on a number of different factors including tumour size, grade and involvement of lymph nodes. Prognostic tools such as PREDICT assist clinicians and patients to make informed decisions on appropriate treatment by predicting survival and determining those patients likely to benefit from adjuvant treatment. 17, 18
Specifications:	Numerator: Number of patients with surgically proven node positive (or at least G3 >20mm breast cancer), with a ≥5% benefit predicted who receive adjuvant chemotherapy.
	Denominator: All patients with surgically proven node positive (or at least G3 >20mm breast cancer), with a ≥5% benefit predicted.
	Exclusions: All patients with breast cancer taking part in trials of chemotherapy treatment. All patients with breast cancer who have had neo-adjuvant chemotherapy. All patients with M1 disease.
Target:	85% The tolerance within this target accounts for factors of patient choice, co-morbidities and fitness for treatment.

*The validated tool PREDICT should be used to calculate predicted benefit

QPI 13: 30 Day Mortality following Chemotherapy

QPI Title:	30 day mortality following chemotherapy treatment with curative intent for breast cancer.
Description:	Proportion of patients with breast cancer who die within 30 days of chemotherapy with curative intent. .
Rationale and Evidence:	Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team ( MDT) 12 . Outcomes of treatment, including treatment related morbidity and mortality should be regularly assessed. Treatment should only be undertaken in individuals that may benefit from that treatment, that is, treatments should not be undertaken in futile situations. This QPI is intended to ensure treatment is given appropriately, and the outcome reported on and reviewed.
Specifications:	Numerator: Number of patients with breast cancer who undergo neoadjuvant or adjuvant chemotherapy with curative intent that die within 30 days of treatment.
	Denominator: All patients with breast cancer who undergo neoadjuvant or adjuvant chemotherapy with curative intent.
	Exclusions: No exclusions Please note: This indicator will be reported separately for neoadjuvant and adjuvant chemotherapy, as opposed to one single figure.
Target:	<2%