Review of Lung Cancer Quality Performance Indicators: consultation

A consultation on the revised Lung Cancer Quality Performance Indicators (QPIs), which were revised following a formal review.


6. Quality Performance Indicators for Lung Cancer

QPI 1 - Multi-Disciplinary Team ( MDT) Meeting

QPI Title:

Patients should be discussed by a multidisciplinary team prior to definitive treatment.

Description:

Proportion of patients with lung 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 lung cancer discussed at the MDT before definitive treatment.

Denominator:

All patients with lung 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 - Pathological diagnosis

QPI Title:

Where possible patients should have a pathological diagnosis of lung cancer.

Description:

Proportion of patients who have a pathological diagnosis of lung cancer.

Please note:

This QPI measures three distinct elements:

i. Patients with lung cancer who have a pathological diagnosis;

ii. Patients with a pathological diagnosis of non small cell lung cancer ( NSCLC) who have tumour subtype identified; and

iii. Patients with a pathological diagnosis of NSCLC who have molecular profiling undertaken.

Rationale and Evidence:

A definitive diagnosis is valuable in helping inform patients and carers about the nature of the disease, the likely prognosis and treatment choice.

Appropriate treatment of lung cancer depends on accurate diagnosis and distinction between histological types of lung cancer 3.

Adequate tissue sampling should be undertaken, ensuring appropriate balance of risk to patients, to allow for pathological diagnosis including tumour sub-typing and molecular profiling 4. Newer drug treatments for NSCLC work best if they are targeted on the basis of histological sub-type and/or molecular profiling. These molecular markers predict whether targeted treatments are likely to be effective and include, for example, epidermal growth factor receptor ( EGFR) mutations 4.

Specification (i):

Numerator:

Number of patients with lung cancer who have a pathological diagnosis (including following surgical resection).

Denominator:

All patients with lung cancer.

Exclusions:

  • Patients who refuse investigations or surgical resection.

Target:

70%

The tolerance level within 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 patients where pathological diagnosis is appropriate this should be achieved wherever possible.

Specification (ii):

Numerator:

Number of patients with a pathological diagnosis of NSCLC who have a tumour subtype identified.

Denominator:

All patients with a pathological diagnosis of NSCLC.

Exclusions:

  • No exclusions.

Target:

80%

The tolerance level within this target is designed to account for situations where there is insufficient tissue to perform additional testing.

Specification (iii):

Numerator:

Number of patients with a pathological diagnosis of stage IIIB or IV adenocarcinoma NSCLC who have molecular profiling undertaken.

Denominator:

All patients with a pathological diagnosis of stage IIIB or IV adenocarcinoma NSCLC.

Exclusions:

  • Patients with performance status 4.

Target:

75%

The tolerance level within this target is designed to account for situations where molecular profiling may not be appropriate if patients are not suitable for further treatment.

QPI 4 - PET CT in patients being treated with curative intent

QPI Title:

Patients with lung cancer who are being treated with curative intent should have a PET CT Scan (Positron Emission Tomography - Computed Tomography) prior to treatment.

Description:

Proportion of patients with non small cell lung cancer ( NSCLC) who are being treated with curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection) who undergo PET CT prior to start of treatment.

Rationale and Evidence:

Accurate staging is important to ensure appropriate treatment is delivered to patients with lung cancer.

All patients being considered for radical treatment with curative intent should have a PET CT scan completed and reported by the multidisciplinary team before treatment 3,4.

Specifications:

Numerator:

Number of patients with NSCLC who are treated with curative intent (radical radiotherapy, radical chemoradiotherapy or surgical resection) who undergo PET CT prior to start of treatment.

Denominator:

All patients with NSCLC who are treated with curative intent (radical radiotherapy, radical chemoradiotherapy or surgical resection).

Exclusions:

  • No exclusions.

Target:

95%

The tolerance level within this target accounts for the fact that some patients will refuse to undergo PET CT. In addition, in patients with small peripheral tumours (T1N0 disease) PET CT may not always be clinically appropriate.

QPI 5 - Investigation of mediastinal malignancy

QPI Title:

Patients with non small cell lung cancer ( NSCLC) with a possibility of mediastinal malignancy demonstrated on PET CT should undergo node sampling to confirm mediastinal malignancy.

Description:

Proportion of patients with NSCLC who have positive mediastinal/supraclavicular fossa ( SCF) nodes on PET CT scan who undergo node sampling.

Rationale and Evidence:

Mediastinal nodes which are PET CT positive should be further evaluated by mediastinal node sampling, unless patients have metastatic disease 4.

PET CT positive mediastinal nodes may be positive due to reactive changes rather than cancer. Sampling these nodes to determine if they are definitely positive for malignancy will ensure that patients suitable for radical treatment are treated appropriately.

Some patients with PET- CT positive mediastinal nodes may also have PET- CT positive SCF nodes where definite nodal staging could be effectively and safely achieved by SCF node fine needle aspiration or biopsy, and mediastinal nodal sampling would not be required.

Specifications:

Numerator:

Number of patients with NSCLC who have a PET CT scan that shows positive mediastinal/ SCF nodes (N2/N3) that have nodes sampled.

Denominator:

All patients with NSCLC who have a PET CT scan that shows positive mediastinal/ SCF nodes (N2/N3).

Exclusions:

  • Patients with stage IV (M1a or M1b) disease.
  • Patients who refuse investigation.

Target:

60%

The tolerance within this target accounts for incidences where mediastinal node sampling would be inappropriate to the management of the patient, specifically in patients in whom there is a high probability of metastatic disease (for example bulky disease).

QPI 6 - Surgical resection in non small cell lung cancer

QPI Title:

Patients with non small cell lung cancer ( NSCLC) should undergo surgical resection.

Description:

Proportion of patients who undergo surgical resection for NSCLC.

Please note:

This QPI measures two distinct elements:

i. Patients with NSCLC who undergo surgical resection; and

ii. Patients with stage I - II NSCLC who undergo surgical resection.

Rationale and Evidence:

All patients should be considered for surgical treatment appropriate to their stage of disease. For patients with NSCLC who are suitable for treatment with curative intent surgical resection by lobectomy is the superior treatment option 4. Surgery is the treatment which offers best chance of cure to patients with localised NSCLC 3.

Patients with stage I and II NSCLC are more likely to be suitable for surgical resection; therefore specification (ii) has been developed to ensure this indicator focuses on the patients most appropriate for surgical resection, whilst also providing an overall surgical resection rate for NSCLC.

Specification (i):

Numerator:

Number of patients with non small cell lung cancer ( NSCLC) who undergo surgical resection.

Denominator:

All patients with non small cell lung cancer ( NSCLC).

Exclusions:

  • Patients who refuse surgery.
  • Patients who die before surgery.
  • Patients who undergo stereotactic ablative body radiotherapy ( SABR).

Target:

17%

The tolerance within this target accounts for the fact that not all patients are suitable for surgical resection due to extent of disease, fitness levels and co morbidities.

Specification (ii):

Numerator:

Number of patients with stage I-II (T1aN0 - T2bN1, or T3N0) NSCLC who undergo surgical resection.

Denominator:

All patients with stage I-II (T1aN0 - T2bN1, or T3N0) NSCLC.

Exclusions:

  • Patients who refuse surgery.
  • Patients who die before surgery.
  • Patients who undergo stereotactic ablative body radiotherapy ( SABR).

Target:

60%

The tolerance within this target accounts for the fact that not all patients are suitable for surgical resection due to fitness levels and co-morbidities.

QPI 7 - Lymph node assessment

QPI Title:

In patients with non small cell lung cancer ( NSCLC) undergoing surgery adequate assessment of lymph nodes should be made.

Description:

Proportion of patients with NSCLC undergoing surgery who have adequate sampling of lymph nodes (at least 1 node from at least 3 N2 stations) performed at time of surgical resection or at previous mediastinoscopy.

Rationale and Evidence:

Adequate assessment of lymph nodes for accurate staging will help guide prognosis and further treatment management.

Nodal dissection should be performed for all patients undergoing surgery with curative intent 5. At time of surgical resection a minimum of six lymph nodes or stations should be excised or sampled 4,5.

Specifications:

Numerator:

Number of patients with NSCLC undergoing surgical resection by lobectomy or pneumonectomy that have at least 1 node from at least 3 N2 stations sampled at time of resection or at previous mediastinoscopy.

Denominator:

All patients with NSCLC undergoing surgical resection by lobectomy or pneumonectomy.

Exclusions:

  • No exclusions.

Target:

80%

The tolerance within this target accounts for situations where patients are not fit enough to undergo extensive lymphadenectomy.

QPI 8 - Radiotherapy in inoperable lung cancer

QPI Title:

Patients with inoperable lung cancer should receive radiotherapy ± chemotherapy, or stereotactic ablative body radiotherapy ( SABR).

Description:

Proportion of patients with lung cancer not undergoing surgery who receive radiotherapy with radical intent (54Gy or greater) ± chemotherapy, or SABR.

Rationale and Evidence:

Radiotherapy is an important treatment option for patients with lung cancer; it has a proven survival benefit for patients with lung cancer 3.

For patients with stage I, II or III NSCLC, radical radiotherapy is the recommended treatment option if patients are not suitable for surgery 4.

SABR is now also a recognised treatment option for those patients with early stage medically inoperable lung cancer 6.

Specifications:

Numerator:

Number of patients with lung cancer not undergoing surgery who receive radical radiotherapy (> 54Gy) ± chemotherapy, or SABR.

Denominator:

All patients with lung cancer not undergoing surgery.

Exclusions:

  • Patients with Small Cell Lung Cancer ( SCLC).
  • Patients who refuse radiotherapy.
  • Patients who die prior to treatment.
  • Patients with stage IV (M1a or M1b) disease.

Target:

35%

The tolerance within this target level accounts for the fact that due to co-morbidities not all patients will be suitable for radiotherapy. In addition, patients may not have disease that can be encompassed within a radical radiotherapy field without excess toxicity.

QPI 9 - Chemoradiotherapy in locally advanced non small cell lung cancer

QPI Title:

Patients with inoperable locally advanced non small cell lung cancer ( NSCLC) should receive potentially curative radiotherapy and concurrent or sequential chemotherapy.

Description:

Proportion of patients with NSCLC not undergoing surgery who receive radical radiotherapy, to 54Gy or greater, and concurrent or sequential chemotherapy.

Rationale and Evidence:

Chemoradiotherapy is an important treatment option for patients with lung cancer 3 .

Patients with stage III NSCLC who are not suitable for surgery should receive chemoradiotherapy, as this has a proven survival benefit. Potential benefit of survival does however have to be balanced with the risk of additional toxicities from this treatment 4.

Specifications:

Numerator:

Number of patients with stage IIIA NSCLC [a] , with performance status 0-1, not undergoing surgery who receive chemoradiotherapy (radiotherapy > 54Gy and concurrent or sequential chemotherapy).

Denominator:

All patients with stage IIIA NSCLC [a] , with performance status 0-1, not undergoing surgery who receive radical radiotherapy > 54Gy.

Exclusions:

  • Patients who refuse treatment.
  • Patients who die before treatment.
  • Patients receiving Continuous Hyperfractionated Radiotherapy.

Target:

50%

The tolerance within this target accounts for the fact that due to co-morbidities not all patients will be suitable for chemotherapy. In addition, patients may not have disease that can be encompassed within a radical radiotherapy field without excess toxicity.

QPI 10 - Chemoradiotherapy in limited stage small cell lung cancer

QPI Title:

Patients with limited stage small cell lung cancer ( SCLC) should receive platinum-based chemotherapy and (concurrent or sequential) radiotherapy.

Description:

Proportion of patients with limited stage (stage I - IIIB) [b] SCLC treated with radical intent who receive both platinum-based chemotherapy, and radiotherapy to 40Gy or greater.

Rationale and Evidence:

Patients with limited stage disease SCLC should receive concurrent chemoradiotherapy, as this is proven to improve survival 4.

Combination treatment is dependent on patient fitness levels and any potential survival benefit should be balanced with the risk of additional toxicities of this treatment.

Sequential radical thoracic radiotherapy should be considered where patients with limited-stage disease SCLC are unfit for concurrent chemoradiotherapy but respond to chemotherapy 4.

Specifications:

Numerator:

Number of patients with T1-4, N0-3, M0 (stage I to IIIB) [b] SCLC, performance status 0 or 1 who receive chemoradiotherapy (radiotherapy > 40Gy and concurrent or sequential platinum-based chemotherapy).

Denominator:

All patients with T1-4, N0-3, M0 (stage I to IIIB) [b] SCLC, performance status 0 or 1.

Exclusions:

  • Patients who refuse treatment.
  • Patients who die before treatment.
  • Patients who undergo surgical resection.

Target:

70%

The tolerance within this target accounts for the fact that due to co-morbidities not all patients will be suitable for chemotherapy. In addition, patients may not have disease that can be encompassed in a radical radiotherapy field with acceptable toxicity ( e.g. N3).

QPI 11 - Systemic anti cancer therapy in non small cell lung cancer

QPI Title:

Patients with advanced non small cell lung cancer ( NSCLC) should receive systemic anti cancer therapy, where appropriate.

Description:

Proportion of patients with NSCLC not undergoing surgery who receive chemotherapy, or biological therapy where appropriate.

Please note: This QPI measures two distinct elements:

i. Patients with NSCLC who receive systemic anti cancer therapy ( SACT); and

ii. Patients with stage IIIB and IV NSCLC that are EGFR / ALK positive who receive biological therapy.

Rationale and Evidence:

Systemic anti cancer therapy should be offered to all patients with NSCLC and good performance status, to improve survival, disease control and quality of life 4.

Patients with EGFR mutations / ALK rearrangements in advanced stage lung cancer should be offered tyrosine kinase inhibitors ( TKIs) which have been shown to increase progression-free survival 7,8.

Specification (i):

Numerator:

Number of patients with NSCLC not undergoing surgery who receive systemic anti cancer therapy.

Denominator:

All patients with NSCLC not undergoing surgery.

Exclusions:

  • Patients who refuse chemotherapy.
  • Patients who die before treatment.

Target:

35%

The tolerance within this target accounts for the fact that due to earlier stage disease, co-morbidities, and fitness not all patients will require or be suitable for chemotherapy.

Specification (ii):

Numerator:

Number of patients with stage IIIB or IV NSCLC, with performance status 0-2 not undergoing surgery that are EGFR / ALK positive who receive biological therapy.

Denominator:

All patients with stage IIIB or IV NSCLC, with performance status 0-2 not undergoing surgery that are EGFR / ALK positive.

Exclusions:

  • Patients who refuse SACT treatment.
  • Patients who die before treatment.
  • Patients who are participating in clinical trials.

Target:

60%

The tolerance within this target accounts for the fact that due to co-morbidities not all patients will require or be suitable for biological therapy.

QPI 12 - Chemotherapy in small cell lung cancer

QPI Title:

Patients with small cell lung cancer ( SCLC) should receive chemotherapy.

Description:

Proportion of patients with SCLC who receive first line chemotherapy ± radiotherapy.

Rationale and Evidence:

Patients with SCLC should receive combination chemotherapy, dependant on fitness levels, as this has a proven survival benefit and provides palliation for symptoms caused by primary or metastatic tumour 3,4.

Please note: This QPI measures two distinct elements:

i. Patients with SCLC who receive chemotherapy ± radiotherapy; and

ii. Patients with SCLC not undergoing treatment with curative intent who receive palliative chemotherapy.

Specification (i):

Numerator:

Number of patients with SCLC who are receive chemotherapy ± radiotherapy.

Denominator:

All patients with SCLC.

Exclusions:

  • Patients who refuse chemotherapy.
  • Patients who die prior to treatment.
  • Patients who are participating in clinical trials.

Specification (ii):

Numerator:

Number of patients with SCLC not undergoing treatment with curative intent who receive palliative chemotherapy.

Denominator:

All patients with SCLC not undergoing treatment with curative intent.

Exclusions:

  • Patients who refuse chemotherapy.
  • Patients who die prior to treatment.
  • Patients who are participating in clinical trials.

Target:

Specification (i): 70%

Specification (ii): 50%

The tolerance within this target accounts for the fact that due to co-morbidities, and fitness not all patients will require or be suitable for chemotherapy.

QPI 13 - Mortality following treatment for lung cancer

QPI Title:

30 and 90 day mortality following treatment for lung cancer.

Description:

Proportion of patients with lung cancer who die within 30 or 90 days of active treatment [c] for lung cancer.

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) 3.

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.

Specification (i):

Numerator:

Number of patients with lung cancer who receive active treatment [c] who die within 30 days of treatment.

Denominator:

All patients with lung cancer who receive active treatment [c] .

Exclusions:

Please note:

  • No exclusions.

This indicator will be split by diagnosis of NSCLC and SCLC for palliative chemotherapy and biological therapy.

Specification (ii):

Numerator:

Number of patients with lung cancer who receive treatment with curative intent (surgery, radical radiotherapy or chemoradiotherapy) who die within 90 days of treatment.

Denominator:

All patients with lung cancer who receive treatment with curative intent (surgery, radical radiotherapy or chemoradiotherapy).

Exclusions:

  • No exclusions

Please Note:

This indicator will be reported by treatment modality, i.e. surgery, radical radiotherapy, chemoradiotherapy etc. as opposed to one single figure.

Targets:

Surgery, Radical Radiotherapy, Adjuvant Chemotherapy and Radical Chemoradiotherapy
<5%

Palliative Chemotherapy/Biological Therapy
NSCLC <10%
SCLC <15%

QPI 14 - Stereotactic Ablative Body Radiotherapy ( SABR) in inoperable stage I non small cell lung cancer

QPI Title:

Patients with inoperable stage I non small cell lung cancer ( NSCLC) should receive Stereotactic Ablative Body Radiotherapy ( SABR).

Description:

Proportion of patients with stage I NSCLC not undergoing surgery who receive SABR.

Rationale and Evidence:

SABR is now a recognised treatment option for patients with medically inoperable early stage lung cancer. Patients with stage I lung cancer who are not suitable for surgery should receive SABR as this has a proven survival benefit 6.

Specifications:

Numerator:

Number of patients with stage I NSCLC not undergoing surgery who receive SABR.

Denominator:

All patients with stage I NSCLC not undergoing surgery.

Exclusions:

  • Patients who refuse SABR.
  • Patients who die prior to treatment.

Target:

35%

The tolerance within this target level accounts for the fact that due to co-morbidities, previous radiotherapy or excessive tumour motion not all patients will be suitable for SABR.

In addition, patients may not have disease that can be encompassed within a radical radiotherapy field without excess toxicity.

QPI 15 - Pre-treatment diagnosis

QPI Title:

Where possible patients should have a cytological / histological diagnosis prior to treatment.

Description:

Proportion of patients who are being treated with curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection) who have a cytological / histological diagnosis prior to treatment.

Rationale and Evidence:

A definitive diagnosis is valuable in helping inform patients and carers about the nature of the disease, the likely prognosis and treatment choice.

Appropriate treatment depends on accurate diagnosis which should be confirmed by cytology / histology 3.

Specification (i):

Numerator:

Number of patients who are treated with curative intent (radical radiotherapy, radical chemoradiotherapy or surgical resection) who have a cytological / histological diagnosis prior to treatment.

Denominator:

All patients with lung cancer who are treated with curative intent (radical radiotherapy, radical chemoradiotherapy or surgical resection).

Exclusions:

  • Patients who refuse investigations

Please note:

This indicator will be reported by treatment modality, i.e. surgery, radical radiotherapy, chemoradiotherapy etc. as opposed to one single figure.

Target:

75%

The tolerance level within this target takes account of the fact that not all lesions will be accessible for pre-operative diagnosis (small and / or peripheral lesions).

QPI 16 - Clinical Trial Access

QPI Title:

All patients should be considered for participation in available clinical trials, wherever eligible.

Description:

Proportion of patients with lung 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 3.

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 lung cancer enrolled in an interventional clinical trial or translational research.

Denominator:

All patients with lung 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

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