Hepatobiliary and pancreatic cancer quality performance indicators: consultation review

6. Quality Performance Indicators for HPB Cancer

QPI 1 - Multi-Disciplinary Team ( MDT) Meeting

QPI Title:	Patients with HepatoPancreatoBiliary ( HPB) Cancer should be discussed by a multidisciplinary team prior to definitive treatment.
Description:	Proportion of patients with HPB cancer who are discussed at MDT meeting before definitive treatment.
Rationale and Evidence:	Evidence suggests that patients with cancer managed by a multi-disciplinary team have a better outcome. There is also evidence that the multidisciplinary management of patients increases their overall satisfaction with their care [2] . Discussion prior to definitive treatment decisions being made provides reassurance that patients are being managed appropriately.
Specifications:	Numerator:	Number of patients with HPB cancer discussed at the MDT before definitive treatment.
	Denominator:	All patients with HPB cancer.
	Exclusions:	Patients who died before first treatment.
Target:	95% The tolerance within this target is designed to account for situations where patients require treatment urgently.

QPI 2 - Diagnosis and Staging of HCC

QPI Title:	Patients with Hepatocellular Carcinoma ( HCC) should be appropriately diagnosed and staged.
Description:	Proportion of patients with HCC who have undergone computerised tomography ( CT) or Magnetic Resonance Imaging ( MRI) and with full information recorded*. Please note: The specifications of this QPI are separated to ensure clear measurement of patients undergoing: (i) CT or MRI; and (ii) CT or MRI with full information recorded
Rationale and Evidence:	Management of HCC is determined by both the stage of HCC and presence/severity of underlying chronic liver disease. Complete information is required to enable correct management decisions to be made by the Multi-Disciplinary Team ( MDT). Treatment options for patients with liver cancer are dependant on numerous factors, including the location, number and size of tumour(s) [3] . CT or MRI is the recommended imaging technique for the diagnosis of hepatocellular carcinoma [4] .
Specification (i):	Numerator:	Number of patients with HCC undergoing either CT or MRI.
	Denominator:	All patients with HCC.
	Exclusions:	No exclusions.
Target:	90% This target accounts for the fact that some patients may have significant co-morbidities or may not be fit for investigation and/or treatment.
Specification (ii):	Numerator:	Number of patients with HCC undergoing either CT or MRI, and with full information recorded*.
	Denominator:	All patients with HCC.
	Exclusions:	No exclusions.
Target:	90% This target accounts for the fact that some patients may have significant co-morbidities or may not be fit for investigation and/or treatment.

* Full information requires the following to be recorded:

• No. of liver lesions
• Size of largest liver lesion
• Presence or absence of vascular invasion
• Presence or absence of chronic liver disease
• Cause of chronic liver disease
• Childs Pugh severity of chronic liver disease
• Alpha-Fetoprotein Quantification ( AFP)

QPI 3 - Referral to Scottish Liver Transplant Unit

QPI Title:	Patients with early Hepatocellular Carcinoma ( HCC) should be referred for consideration of liver transplantation.
Description:	Proportion of patients with HCC who meet the current UK listing criteria for orthotopic liver transplantation referred to the Scottish Liver Transplant Unit ( SLTU) for consideration of liver transplantation.
Rationale and Evidence:	Liver transplantation is associated with good long term outcome in selected patients with HCC [5,6] . All patients with early HCC should be considered for liver transplantation and there should be equity of access to liver transplantation across Scotland. Current UK listing criteria, as defined by NHS Blood and Transplant ( NHSBT), are based on the "Milan criteria" which are well validated selection criteria for liver transplantation in patients with HCC. Liver transplantation should be considered for all patients with HCC meeting the criteria. Failure to consider liver transplantation where appropriate may result in inequity of access to a successful therapeutic option [4,6] .
Specifications:	Numerator:	Number of patients with HCC meeting UK listing criteria that are referred to SLTU.
	Denominator:	All patients with HCC meeting UK listing criteria (as defined by NHSBT).
	Exclusions:	Patients who refuse treatment. Patients with evidence of vascular invasion. Patients with extrahepatic disease.
Target:	90% This target accounts for the fact that for some patients it may not be appropriate for referral to the SLTU, due to factors of patient fitness.

* Current UK listing criteria are:

• Single tumour ≤5cms diameter
• Up to 5 tumours all ≤3cms
• Single tumour 5-7cms which shows no significant progression over 6 months

QPI 4 - Palliative Treatment for HCC

QPI Title:	Patients with Hepatocellular Carcinoma ( HCC) who are not suitable for curative treatment should receive palliative treatment.
Description:	Proportion of patients with HCC not suitable for treatment with curative intent (liver transplantation, resection or ablative therapies) that undergo specific treatment with palliative intent (Trans-arterial chemoembolisation ( TACE) or Systemic Anti Cancer Therapy ( SACT)).
Rationale and Evidence:	TACE and SACT have been demonstrated to improve survival in patients with HCC and well compensated chronic liver disease that are not suitable for treatments with curative intent [5] . TACE is recommended as treatment for patients with inoperable advanced HCC, with chronic liver disease of Child's-Pugh grade A and B [4,5] .
Specifications:	Numerator:	Number of patients with HCC not undergoing treatment with curative intent who receive TACE or SACT.
	Denominator:	All patients with HCC not undergoing treatment with curative intent (liver transplantation, resection or ablative therapies).
	Exclusions:	Patients with decompensated chronic liver disease (Child's Pugh Grade C). Patients who refuse treatment.
Target:	40% This target accounts for the fact that some patients may have significant co-morbidities or fitness level which means that TACE or SACT is not appropriate. Additionally, this tolerance accounts for patients where synthetic function is not adequate to receive treatment. Please note: In order to ensure that the chosen target level is the most appropriate and drives continuous quality improvement as intended it will be kept under review and revised as necessary, once baseline data or further evidence becomes available.

QPI 5 - 30 and 90 Day Mortality After Curative or Palliative Treatment

QPI Title:	30 and 90 day mortality following treatment for Hepatocellular Carcinoma ( HCC) with either curative or palliative intent.
Description:	Proportion of patients with HCC undergoing disease specific treatment, either curative (liver transplantation, resection or ablation) or palliative (Trans-arterial chemoembolisation ( TACE) or Systemic Anti Cancer Therapy ( SACT)) who die within 30 or 90 days of definitive treatment. Please note: The specifications of this QPI are separated to ensure clear measurement of both: (i) Patients who die within 30 days of definitive treatment (with curative or palliative intent); and (ii) Patients who die within 90 days of treatment with curative intent
Rationale and Evidence:	Disease specific interventions for HCC are delivered with either curative (liver transplantation, resection or ablation) or palliative ( TACE or SACT) intent. In either case treatments should be performed safely with low rates of mortality. Similarly, disease specific treatment should only be undertaken in individuals that may benefit from treatment, that is, disease specific treatments should not be undertaken in futile situations. Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team ( MDT) [7] .
Specification (i):	Numerator:	Number of patients with HCC undergoing disease specific treatment (liver transplant, resection, ablation, TACE or SACT) that die within 30 days of definitive treatment.
	Denominator:	All patients with HCC undergoing disease specific treatment (liver transplant, resection, ablation, TACE or SACT).
	Exclusions:	No exclusions.
Specification (ii):	Numerator:	Number of patients with HCC undergoing disease specific treatment with curative intent (liver transplant, resection, or ablation) that die within 90 days of definitive treatment.
	Denominator:	All patients with HCC undergoing disease specific treatment with curative intent (liver transplant, resection, or ablation).
	Exclusions	No exclusions.
Please Note:	This indicator will be reported by principal treatment modality, in the following hierarchy: liver transplant, resection, ablation, TACE, SACT. Mortality following SACT will be measured from date of commencement of therapy, as this particular treatment is taken over a prolonged period of time.
Target:	<10%

QPI 6 - Radiological Diagnosis of Pancreatic, Duodenal or Biliary Tract Cancer

QPI Title:	Patients with pancreatic, duodenal or biliary tract cancers should undergo computerised tomography ( CT) of the chest, abdomen and pelvis to evaluate the extent of disease.
Description:	Proportion of patients with pancreatic, duodenal or biliary tract cancer who undergo CT of the chest, abdomen and pelvis.
Rationale and Evidence:	Accurate staging is important to ensure appropriate treatment is delivered and futile interventions avoided. The primary tumour and its local extent should be defined and the presence or absence of metastatic disease assessed. CT is recommended for the diagnosis of pancreatic cancer as it will accurately delineate tumour size, infiltration, and the presence of metastatic disease [8] .
Specifications:	Numerator:	Number of patients with pancreatic, duodenal or biliary tract cancer who undergo CT of the chest, abdomen and pelvis.
	Denominator:	All patients with pancreatic, duodenal or biliary tract cancer.
	Exclusions:	Patients receiving supportive care only.
Target:	80% This target accounts for factors of patient choice.

QPI 7 - Pathological Diagnosis of Pancreatic, Duodenal or Biliary Tract Cancer

QPI Title:	Patients with pancreatic, duodenal or distal biliary tract cancers having non-surgical treatment should have a cytological or histological diagnosis.
Description:	Proportion of patients with pancreatic, duodenal or distal biliary tract cancer undergoing non-surgical treatment who have a cytological or histological diagnosis.
Rationale and Evidence:	In patients who are being considered for anti-cancer therapy, definitive cytological or histological diagnosis is essential before chemotherapy to ensure full benefit of any treatment offered [8] . Even when no active treatment is being considered, a definitive diagnosis is valuable in helping to inform patients and carers about the nature of the disease and the likely prognosis.
Specifications:	Numerator:	Number of patients with pancreatic, duodenal or distal biliary tract cancer undergoing non-surgical treatment who have a histological or cytological diagnosis (e.g. brush cytology, endoscopic or image guided biopsy).
	Denominator:	All patients with pancreatic, duodenal or distal biliary tract cancer undergoing non-surgical treatment.
	Exclusions:	No exclusions.
Target:	75% This target takes account of the fact that it is not always appropriate, safe or possible to obtain a histological or cytological diagnosis due to the performance status of the patient or advanced nature of the disease. In addition it is intended to reflect factors relating to patient choice.

QPI 8 - Systemic Therapy for Pancreatic Cancer

QPI Title:	Patients undergoing resection for pancreatic cancer should receive adjuvant chemotherapy, where appropriate.
Description:	Proportion of patients undergoing resection for pancreatic cancer receiving adjuvant chemotherapy.
Rationale and Evidence:	Adjuvant chemotherapy is the accepted standard of care for patients with pancreatic cancer following surgical resection and is proven to have a survival benefit [9] . It is difficult to accurately and consistently measure whether patients have been considered for adjuvant chemotherapy. The number of patients who actually receive this treatment is therefore being utilised as a proxy measure of consideration for treatment. If available, clinical trials should be considered the preferred option for eligible patients.
Specifications:	Numerator:	Number of patients undergoing pancreatic cancer resection who receive adjuvant chemotherapy.
	Denominator:	All patients undergoing resection for pancreatic cancer.
	Exclusions:	Patients who die post-operatively (within 60 days of surgery). Patients who refuse chemotherapy.
Target:	50% This target accounts for the fact that patients may have post-operative complications that preclude consideration of adjuvant therapy. Please note: In order to ensure that the chosen target level is the most appropriate and drives continuous quality improvement as intended it will be kept under review and revised as necessary, once baseline data or further evidence becomes available.

QPI 9 - Resection Rate for Pancreatic, Duodenal or Biliary Tract Cancers

QPI Title:	Patients with localised pancreatic, distal biliary tract or duodenal cancer should have surgical resection.
Description:	Proportion of patients who undergo resection for pancreatic, distal biliary tract or duodenal cancer.
Rationale and Evidence:	Surgical resection is the only potentially curative treatment for pancreatic cancer [8,10] . Where surgical resection is not carried out the reason(s) should be clearly documented by the MDT.
Specifications:	Numerator:	Number of patients with pancreatic, duodenal or distal biliary tract cancer who undergo resection.
	Denominator:	All patients with pancreatic, duodenal or distal biliary tract cancer.
	Exclusions:	No exclusions
Target:	15% This target takes into consideration patient choice as well as patients who may develop pancreatitis or other complications during the pre-operative phase. It is intended as a composite measure of the entire diagnostic and staging pathway, but recognises that the majority of patients will have advanced disease at presentation.

QPI 10 - Lymph Node Yield

QPI Title:	In patients undergoing surgery for pancreatic, duodenal or distal biliary tract cancer the number of lymph nodes examined should be maximised.
Description:	Average number of lymph nodes resected and pathologically examined for patients with pancreatic, duodenal or distal biliary tract cancer who undergo pancreatoduodenectomy performed by a specialist centre, over a 1 year period.
Rationale and Evidence:	Adequate lymph node yield is important for accurate staging and is a surrogate marker of adequacy of en-bloc cancer resection and diligence of the pathologist. Evidence suggests that pancreatoduodenectomy should yield a mean of at least 15 lymph nodes examined from the principal specimen [11] . Within the measurement of this QPI, pancreatoduodenectomy is being utilised as a proxy measurement for all surgical resection, to ensure consistent and comparable measurement across NHS Scotland.
Specifications:	Average number of lymph nodes resected and pathologically examined for patients with pancreatic, duodenal or distal biliary tract cancer who undergo pancreatoduodenectomy by each centre in a given year.
	Exclusions:	No exclusions.
	Target:	Average of 15 lymph nodes per centre. An average number is used rather than a minimum within this target as it is recognised that there may be cases where the surgery produces a smaller bulk of tissue and therefore less lymph nodes as a result.

QPI 11 - 30 and 90 Day Mortality After Treatment with Curative Intent

QPI Title:	Mortality after surgery with curative intent † for pancreatic, duodenal or distal biliary tract cancer.
Description:	Proportion of patients undergoing surgical resection with curative intent for pancreatic, duodenal or distal biliary tract cancer who die within 30/90 days.
Rationale and Evidence:	Mortality following resection for HPB cancer has fallen over the past 30 years and in specialist units should be less than 5% [12] . Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team ( MDT) [7] .
Specifications:	Numerator:	Number of patients with pancreatic, duodenal or distal biliary tract cancer undergoing surgical resection who die within 30/90 days of surgery.
	Denominator:	All patients with pancreatic, duodenal or distal biliary tract cancer undergoing surgical resection.
	Exclusions:	No exclusions.
	Please Note:	This indicator will be reported separately as 30 day mortality and 90 day mortality, as opposed to a single figure.
Target:	<5%

^† Surgical resection with palliative intent may be undertaken in unique circumstances. For the purposes of this QPI, surgical resection with palliative intent has not been removed from the measurement due to the rare occurrence of these cases.

QPI 12 - Volume of Cases per Centre/Surgeon

QPI Title:	HPB resectional surgery should be performed in hospitals where there is an appropriate annual volume of such cases.
Description:	Number of surgical resections for pancreatic, duodenal or distal biliary tract cancer performed by a specialist centre, and surgeon, over a 1 year period.
Rationale and Evidence:	Pancreatic resectional surgery should be performed by surgeons who work in a specialist Multi Disciplinary Team ( MDT) in a specialist centre, with outcomes audited regularly and benchmarked nationally [12] . Surgical resection should be confined to specialist centres to increase resection rates and reduce hospital morbidity and mortality [8] . The literature demonstrates that there is a relationship between increasing surgical volumes for major hepatopancreatobiliary resections and improved patients outcomes (mortality) [13] .
Specifications:	Number of surgical resections for pancreatic, duodenal or distal biliary tract cancer performed by each surgeon/centre in a given year.
	Exclusions:	No exclusions
Target:	Minimum 11 procedures per centre, with a minimum of 4 procedures per surgeon, in a 1 year period. This is a minimum target level and is designed to ensure that all surgeons performing pancreatic resection perform a minimum of 4 procedures per year. Please Note: Varying evidence exists regarding the most appropriate target level for surgical case volume. In order to ensure that the target level takes account of level 1 evidence and will drive continuous quality improvement as intended this performance indicator must be kept under regular review. It is recognised that multiple factors affect overall performance and that the end point focus must be clinical outcomes in what is a team delivered goal. It is recommended that where two consultants share an operation each should count the case in his/her numbers as this best reflects the partnership accountability of such shared procedures.

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 in place with direct access for each Board to run these reports to ensure nationally consistent analysis and reporting.

QPI 13 - Clinical Trial Access

QPI Title:	All patients should be considered for participation in available clinical trials, wherever eligible.
Description:	Proportion of patients with HPB cancer who are enrolled in an interventional clinical trial or translational research.
Rationale and Evidence:	Clinical trials are necessary to demonstrate the efficacy of new therapies and other interventions. Furthermore evidence suggests improved patient outcomes from participation in clinical trials [2] . Clinicians are therefore encouraged to enter patients into well-designed trials and to collect longer-term follow-up data. High accrual activity into clinical trials is used as a goal of an exemplary clinical research site.
Specifications:	Numerator:	Number of patients with HPB cancer enrolled in an interventional clinical trial or translational research.
	Denominator:	All patients with HPB cancer.
	Exclusions:	No exclusions.
Target:	Interventional clinical trials - 7.5% Translational research - 15%

The clinical trials QPI will be measured utilising SCRN data and ISD incidence data, as is the methodology currently utilised by the Chief Scientist Office ( CSO) and NCRI. The principal benefit of this approach is that this data is already collected utilising a robust mechanism. At present a 'clinical trial' data item is contained within all tumour specific datasets, however in order to avoid any duplication of effort, and focus resources appropriately, SCRN data is the preferred option.

Utilising SCRN data allows for comparison with CSO published data and ensures capture of all clinical trials recruitment, not solely first line treatment trials, as contained in the clinical audit data. Given that a significant proportion of clinical trials are for relapsed disease this is felt to be particularly important in driving quality improvement. This methodology utilises incidence as a proxy for all patients with cancer. This may slightly over, or underestimate, performance levels, however this is an established approach currently utilised by NHSScotland. For clinical trials definitions please see appendix 4.

The full Clinical Trials QPI document can be found at:

Healthcare Improvement Scotland - Cancer Quality Performance Indicators