ࡱ>  ;2bjbjqq ee#e&&iL8""""""8#-&L "sy0|6 7 7 7L_ld&"hyHxLhh 7 7n-2q2q2qhv  7" 72qh2q2q^|! 7"(i(hC0sLkR"~g0g"2qghgggdngggshhhhggggggggg& /:   Scottish Cancer Taskforce National Cancer Quality Steering Group Lung Cancer Clinical Quality Performance Indicators Engagement Document February 2020 Contents Page  TOC \o "1-3" \h \z \u  HYPERLINK \l "_Toc31370265" 1. National Cancer Quality Programme  PAGEREF _Toc31370265 \h 4  HYPERLINK \l "_Toc31370266" 1.1 Quality Assurance and Continuous Quality Improvement  PAGEREF _Toc31370266 \h 4  HYPERLINK \l "_Toc31370267" 2. Quality Performance Indicator Development Process  PAGEREF _Toc31370267 \h 4  HYPERLINK \l "_Toc31370268" 3. QPI Formal Review Process  PAGEREF _Toc31370268 \h 5  HYPERLINK \l "_Toc31370269" 4. Format of the Quality Performance Indicators  PAGEREF _Toc31370269 \h 5  HYPERLINK \l "_Toc31370270" 5. Supporting Documentation  PAGEREF _Toc31370270 \h 6  HYPERLINK \l "_Toc31370271" 6. Quality Performance Indicators for Lung Cancer  PAGEREF _Toc31370271 \h 7  HYPERLINK \l "_Toc31370272" QPI 1 Multi-Disciplinary Team (MDT) Meeting  PAGEREF _Toc31370272 \h 7  HYPERLINK \l "_Toc31370273" QPI 2 Pathological diagnosis  PAGEREF _Toc31370273 \h 8  HYPERLINK \l "_Toc31370274" QPI 4 PET CT in patients being treated with curative intent  PAGEREF _Toc31370274 \h 10  HYPERLINK \l "_Toc31370275" QPI 5 Investigation of Mediastinal Malignancy  PAGEREF _Toc31370275 \h 11  HYPERLINK \l "_Toc31370276" QPI 6 Surgical resection in non small cell lung cancer  PAGEREF _Toc31370276 \h 13  HYPERLINK \l "_Toc31370277" QPI 7 Lymph node assessment  PAGEREF _Toc31370277 \h 15  HYPERLINK \l "_Toc31370278" QPI 8 Radical Radiotherapy  PAGEREF _Toc31370278 \h 16  HYPERLINK \l "_Toc31370279" QPI 9 Chemoradiotherapy in locally advanced non small cell lung cancer  PAGEREF _Toc31370279 \h 17  HYPERLINK \l "_Toc31370280" QPI 10 Chemoradiotherapy in limited stage small cell lung cancer  PAGEREF _Toc31370280 \h 18  HYPERLINK \l "_Toc31370281" QPI 11 Systemic anti cancer therapy in non small cell lung cancer  PAGEREF _Toc31370281 \h 19  HYPERLINK \l "_Toc31370282" QPI 12 Chemotherapy in small cell lung cancer  PAGEREF _Toc31370282 \h 21  HYPERLINK \l "_Toc31370283" QPI 13 Mortality following treatment for lung cancer  PAGEREF _Toc31370283 \h 22  HYPERLINK \l "_Toc31370284" QPI 14 Stereotactic Ablative Radiotherapy (SABR) in inoperable stage I lung cancer  PAGEREF _Toc31370284 \h 24  HYPERLINK \l "_Toc31370285" QPI 15 Pre-treatment diagnosis  PAGEREF _Toc31370285 \h 25  HYPERLINK \l "_Toc31370286" QPI 16 Brain imaging  PAGEREF _Toc31370286 \h 26  HYPERLINK \l "_Toc31370287" QPI 17 Clinical Trial and Research Study Access  PAGEREF _Toc31370287 \h 27  HYPERLINK \l "_Toc31370288" QPI 18 - 30 Day Mortality following Systemic Anti-Cancer Therapy (SACT)  PAGEREF _Toc31370288 \h 28  HYPERLINK \l "_Toc31370289" 7. Survival  PAGEREF _Toc31370289 \h 29  HYPERLINK \l "_Toc31370290" 8. Areas for Future Consideration  PAGEREF _Toc31370290 \h 29  HYPERLINK \l "_Toc31370291" 9. Governance and Scrutiny  PAGEREF _Toc31370291 \h 29  HYPERLINK \l "_Toc31370292" 9.1 National  PAGEREF _Toc31370292 \h 29  HYPERLINK \l "_Toc31370293" 9.2 Regional Regional Cancer Networks  PAGEREF _Toc31370293 \h 30  HYPERLINK \l "_Toc31370294" 9.3 Local NHS Boards  PAGEREF _Toc31370294 \h 30  HYPERLINK \l "_Toc31370295" 10. How to participate in the engagement process  PAGEREF _Toc31370295 \h 30  HYPERLINK \l "_Toc31370296" 10.1 Submitting your comments  PAGEREF _Toc31370296 \h 30  HYPERLINK \l "_Toc31370297" 10.2 Engagement feedback  PAGEREF _Toc31370297 \h 31  HYPERLINK \l "_Toc31370298" 11. References  PAGEREF _Toc31370298 \h 32  HYPERLINK \l "_Toc31370299" 12. Appendices  PAGEREF _Toc31370299 \h 33  HYPERLINK \l "_Toc31370300" Appendix 1: QPI Development Process  PAGEREF _Toc31370300 \h 33  HYPERLINK \l "_Toc31370301" Appendix 2: Lung Cancer QPI Development Group Membership (2012)  PAGEREF _Toc31370301 \h 34  HYPERLINK \l "_Toc31370302" Appendix 3: Lung Cancer QPI Formal Review Group Membership (2016)  PAGEREF _Toc31370302 \h 36  HYPERLINK \l "_Toc31370303" Appendix 4: Lung Cancer QPI Formal Review Group Membership (2019)  PAGEREF _Toc31370303 \h 37  HYPERLINK \l "_Toc31370304" Appendix 5: 3 Yearly National Governance Process and Improvement Framework for Cancer Care  PAGEREF _Toc31370304 \h 38  HYPERLINK \l "_Toc31370305" Appendix 6: Regional Annual Governance Process and Improvement Framework for Cancer Care  PAGEREF _Toc31370305 \h 39  HYPERLINK \l "_Toc31370306" Appendix 7: Glossary of Terms  PAGEREF _Toc31370306 \h 40  1. National Cancer Quality Programme Beating Cancer: Ambition and Action (2016)1 details a commitment to delivering the national cancer quality programme across NHSScotland, with a recognised need for national cancer QPIs to support a culture of continuous quality improvement. Addressing variation in the quality of cancer services is pivotal to delivering improvements in quality of care. This is best achieved if there is consensus and clear indicators for what good cancer care looks like. Small sets of cancer specific outcome focussed, evidence based indicators are in place for 19 different tumour types. These are underpinned by patient experience QPIs that are applicable to all, irrespective of tumour type. These QPIs ensure that activity is focused on those areas that are most important in terms of improving survival and individual care experience whilst reducing variation and supporting the most effective and efficient delivery of care for people with cancer. QPIs are kept under regular review and are responsive to changes in clinical practice and emerging evidence. A programme to review and update the QPIs in line with evolving evidence is in place as well as a robust mechanism by which additional QPIs will be developed over the coming years. 1.1 Quality Assurance and Continuous Quality Improvement The ultimate aim of the programme is to develop a framework, and foster a culture of, continuous quality improvement, whereby real time data is reviewed regularly at an individual Multi Disciplinary Team (MDT)/Unit level and findings actioned to deliver continual improvements in the quality of cancer care. This is underpinned and supported by a programme of regional and national comparative reporting and review. NHS Boards will be required to report against QPIs as part of a mandatory, publicly reported programme at a national level. A rolling programme of reporting is in place, with approximately three national tumour specific reports published annually. National reports include comparative reporting of performance against QPIs at MDT/Unit level across NHSScotland, trend analysis and survival. This approach helps to overcome existing issues relating to the reporting of small volumes in any one year. In the intervening years tumour specific QPIs are monitored on an annual basis through established Regional Cancer Network and local governance processes, with analysed data submitted to Information Services Division (ISD) for inclusion in subsequent national reports. This approach ensures that timely action is taken in response to any issues that may be identified through comparative reporting and systematic review. 2. Quality Performance Indicator Development Process The QPI development process was designed to ensure that indicators are developed in an open, transparent and timely way. The development process can be found in appendix 1. The Lung Cancer QPI Development Group was convened in November 2011, chaired by Dr Hilary Dobson (Regional Lead Cancer Clinician, WoSCAN). Membership of this group included clinical representatives drawn from the three regional cancer networks, Healthcare Improvement Scotland, ISD and patient/carer representatives. Membership of the development group can be found in appendix 2. 3. QPI Formal Review Process As part of the National Cancer Quality Programme a systematic national review process has been developed, whereby all tumour specific QPIs published are subject to formal review following 3 years analysis of comparative QPI data. Formal review of the Lung Cancer QPIs was undertaken for the first time in February 2016. A Formal Review Group was convened, chaired by Dr Anne Parker, Consultant Haematologist, NHS Greater Glasgow and Clyde. Membership of this group included Clinical Leads from the three Regional Cancer Networks and can be found in appendix 3. The 2nd cycle of formal review commenced in November 2019 following reporting of 6 years of QPI data. This cycle of review is more selective and focussed on ensuring the ongoing clinical relevance of the QPIs. A Formal Review Group was convened, with Mr Iain Tait, Consultant HPB Surgeon and Clinical Director, North Cancer Alliance appointed as Clinical Advisor/Chair to the group. Membership of this group can be found in appendix 4. The formal review process is clinically driven with proposals for change sought from specialty specific representatives in each of the Regional Cancer Networks. Formal review meetings to further discuss proposals are arranged where deemed necessary. The review builds on existing evidence using expert clinical opinion to identify where new evidence is available, and a full public engagement exercise will take place where significant revisions have been made or new QPIs developed. During formal review QPIs may be archived and replaced with new QPIs. Triggers for doing so include significant change to clinical practice, targets being consistently met by all Boards, and publication of new evidence. Where QPIs have been archived, for those indicators which remain clinically relevant, data will continue to be collected to allow local / regional analysis of performance as required. Any new QPIs have been developed in line with the following criteria: Overall importance does the indicator address an area of clinical importance that would significantly impact on the quality and outcome of care delivered? Evidence based is the indicator based on high quality clinical evidence? Measurability is the indicator measurable i.e. are there explicit requirements for data measurement and are the required data items accessible and available for collection? 4. Format of the Quality Performance Indicators QPIs are designed to be clear and measurable, based on sound clinical evidence whilst also taking into account other recognised standards and guidelines. Each QPI has a short title which will be utilised in reports as well as a fuller description which explains exactly what the indicator is measuring. This is followed by a brief overview of the evidence base and rationale which explains why the development of this indicator was important. The measurability specifications are then detailed; these highlight how the indicator will actually be measured in practice to allow for comparison across NHSScotland. Finally a target is indicated, which dictates the level each unit should be aiming to achieve against each indicator. In order to ensure that the chosen target levels are the most appropriate and drive continuous quality improvement as intended they are kept under review and revised as necessary, if further evidence or data becomes available. Rather than utilising multiple exclusions, a tolerance level has been built into the QPIs. It is very difficult to accurately measure patient choice, co-morbidities and patient fitness therefore target levels have been set to account for these factors. Further detail is noted within QPIs where there are other factors which influenced the target level. Where less than (<) target levels have been set the rationale has been detailed within the relevant QPI. All other target levels should be interpreted as greater than (>) levels. 5. Supporting Documentation A national minimum core dataset and a measurability specification document have been developed in parallel with the indicators to support the monitoring and reporting of Lung Cancer QPIs. The updated document will be implemented for patients diagnosed with Lung Cancer on, or after, 1st January 2020. 6. Quality Performance Indicators for Lung Cancer QPI 1 Multi-Disciplinary Team (MDT) Meeting QPI Title: Patients with lung cancer should be discussed by a multidisciplinary team. Description: Proportion of patients with lung cancer who are discussed at the MDT meeting. 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 care2. Discussion prior to definitive treatment decisions being made provides reassurance that patients are being managed appropriately. There are a small number of patients where it may not be appropriate to discuss prior to definitive treatment therefore in order to ensure these are not excluded, the timing element has been removed. Specifications: Numerator: Number of patients with lung cancer discussed at the MDT meeting. Denominator: All patients with lung cancer. Exclusions: No exclusions.Target:95%  Revisions:Removed the requirement for discussion prior to definitive treatment in order to account for all patients being discussed including those who die before treatment or receive urgent treatment.  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 four distinct elements: Patients with lung cancer who have a pathological diagnosis; Patients with a pathological diagnosis of non small cell lung cancer (NSCLC) who have tumour subtype identified; Patients with a pathological diagnosis of non-squamous NSCLC who have tumour profiling* undertaken; and Patients with a pathological diagnosis of NSCLC who have PD-L1 testing 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 cancer3. Adequate tissue sampling should be undertaken, ensuring appropriate balance of risk to patients, to allow for pathological diagnosis including tumour sub-typing and molecular profiling4. 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) mutations4. 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 decline investigations or surgical resection. Target: 75% 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:90% The tolerance level within this target is designed to account for situations where there is insufficient tissue to perform additional testing.(Continued overleaf) QPI 2 Pathological diagnosis (cont..) Specification (iii):Numerator: Number of patients with a pathological diagnosis of stage III - IV non-squamous NSCLC who have tumour profiling undertaken. Denominator:All patients with a pathological diagnosis of stage III - IVa non-squamous NSCLC.Exclusions:Patients with performance status 4. Target:75% The tolerance level within this target is designed to account for situations where tumour profiling may not be appropriate if patients are not suitable for further treatment. Specification (iv):Numerator: Number of patients with a pathological diagnosis of stage III - IVa NSCLC who have PD-L1 testing undertaken. Denominator:All patients with a pathological diagnosis of stage III - IVa NSCLC.Exclusions:Patients with performance status 4.Target:75% The tolerance level within this target is designed to account for situations where PD-L1 testing may not be appropriate if patients are not suitable for further treatment.  * Please note - details of the tumour profiling tests that are currently measured within this QPI are outlined within the associated data definitions document. Revisions:Specification (i) target decreased from 80% to 75%. This will provide a larger scope for tolerance where patients may not be appropriate for testing. Specification (ii) no change. Specification (iii) clinical cohort changed from stage IIIB IV to stage III or IV and PD-L1 been removed from the measurement. Specification (iv) new specification added for PD-L1 testing in all stage III or IV patients with NSCLC. Target 75%.  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 with timely reports available. Description: Proportion of patients with non small cell lung cancer (NSCLC) who receive curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection) that undergo PET CT prior to start of treatment, where the report is available within 10 days of radiology request. Please note: This QPI measures two distinct elements: Patients with NSCLC who receive curative treatment that undergo PET CT prior to start of treatment; and Patients with NSCLC who receive curative treatment that undergo PET CT prior to treatment where the report is available within 10 days of radiology request. 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 before treatment3,4. Specification (i): Numerator: Number of patients with NSCLC who receive curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection) that undergo PET CT prior to start of treatment. Denominator: All patients with NSCLC who receive curative treatment (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 decline PET CT. In addition, in patients with subsolid tumours, PET CT may not always be clinically appropriate. Specification (ii): Numerator: Number of patients with NSCLC who receive curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection) that undergo PET CT prior to start of treatment where the report is available within 10 days of radiology request. Denominator: All patients with NSCLC who receive curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection) that undergo PET CT prior to start of treatment. Exclusions: No exclusions.Target: 95%  Revisions:Specification (ii) added to measure timeliness of PET CT investigation and reporting of results. 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 a NSCLC undergoing treatment with curative intent who have a PET CT scan that shows positive hilar / mediastinal / supraclavicular fossa (SCF) nodes, that have invasive nodal staging (assessment / sampling) performed and nodes sampled. Please note - This QPI measures two distinct elements: Patients with NSCLC undergoing treatment with curative intent who have a PET CT scan that shows positive hilar / mediastinal / supraclavicular fossa (SCF) nodes that: have invasive nodal staging (assessment / sampling) performed and nodes sampled and; have invasive nodal staging (assessment / sampling) performed and nodes sampled, with the sampled stations recorded. Rationale and Evidence: Mediastinal nodes which are PET CT positive should be further evaluated by mediastinal node sampling, unless patients have metastatic disease4. 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. Specification (i): Numerator: Number of patients with NSCLC undergoing treatment with curative intentb who have a PET CT scan that shows positive hilar (N1/N3), mediastinal (N2/N3) or SCF nodes (N3), that have invasive nodal staging (assessment / sampling) performedc and nodes sampled. Denominator: All patients with NSCLC undergoing treatment with curative intentb who have a PET CT scan that shows positive hilar (N1/N3), mediastinal (N2/N3) or SCF nodes (N3). Exclusions: Patients with stage IV (M1, M1a, M1b or M1c) disease. Patients who refuse investigation. Target: 80% 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 5 Investigation of Mediastinal Malignancy (cont) Specification (ii): Numerator: Number of patients with NSCLC undergoing treatment with curative intentb who have a PET CT scan that shows positive hilar (N1/N3), mediastinal (N2/N3) or SCF nodes (N3), that have invasive nodal staging (assessment / sampling) performedc and nodes sampled, with the sampled stations recorded. Denominator: All patients NSCLC undergoing treatment with curative intentb who have a PET CT scan that shows positive hilar (N1/N3), mediastinal (N2/N3) or SCF nodes (N3), that have invasive nodal staging (assessment / sampling) performedc and nodes sampled. Exclusions: Patients with stage IV (M1, M1a, M1b or M1c) disease. Target: 95%  Revisions:Re-instated a revised version of previously archived QPI 5 included positive hilar (N1/N3), mediastinal (N2/N3) or SCF nodes (N3). Also added specification (ii) to assess documentation of the stations that have been sampled.  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: Patients with NSCLC who undergo surgical resection; and 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 option4. Surgery is the treatment which offers best chance of cure to patients with localised NSCLC3. 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 die before surgery. Target: 20% 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. It also accounts for factors of patient choice. Specification (ii): Numerator: Number of patients with stage I - II NSCLCd who undergo surgical resection. Denominator: All patients with stage I - II NSCLCd. Exclusions: Patients who die before surgery. 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. It also accounts for factors of patient choice.  Revisions:Removed the following exclusion categories from both specifications: Patients who refuse surgery; and Patients who undergo stereotactic ablative radiotherapy (SABR) Tolerance been updated to include patient choice.  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 sampling should be performed for all patients undergoing surgery with curative intent5. At time of surgical resection a minimum of six lymph nodes or stations should be excised or sampled4,5. 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.  Revisions:No change to QPI.  QPI 8 Radical Radiotherapy QPI Title: Patients with lung cancer not undergoing surgery should receive radiotherapy chemotherapy, or stereotactic ablative 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 cancer3. For patients with stage I, II or III NSCLC, radical radiotherapy is the recommended treatment option if patients are not suitable for surgery4. SABR is now also a recognised treatment option for those patients with early stage medically inoperable lung cancer6. Specifications: Numerator: Number of patients with stage I - IIIA lung cancer not undergoing surgery who receive radical radiotherapy (> 54Gy) chemotherapy, or SABR. Denominator: All patients with stage I IIIAe lung cancer not undergoing surgery. Exclusions: Patients with Small Cell Lung Cancer (SCLC). Patients who decline radiotherapy. Patients who die prior to treatment. Patients with stage IV (M1, M1a, M1b or M1c) 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.  Revisions:Title been updated to refer to patients that do not undergo surgery rather than inoperable patients. Clinical cohort is now restricted to stage I - IIIA lung cancer who do not undergo surgery rather than all patients.  QPI 9 Chemoradiotherapy in locally advanced non small cell lung cancer QPI Title: Patients with locally advanced non small cell lung cancer (NSCLC) not undergoing surgery 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 cancer3. 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 treatment4. Specifications: Numerator: Number of patients with stage IIIA NSCLCf, 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, with performance status 0-1, not undergoing surgery who receive radical radiotherapy > 54Gy. Exclusions:Patients who decline radiotherapy 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.  Revisions:Title been updated to refer to patients that do not undergo surgery rather than inoperable patients.  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 IIIA) 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 survival4. 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 chemotherapy4. Specifications: Numerator: Number of patients with stage I - IIIA SCLC, performance status 0 or 1 who receive chemoradiotherapy (radiotherapy > 40Gy and concurrent or sequential platinum-based chemotherapy). Denominator: All patients with stage I IIIAh SCLC, performance status 0 or 1.Exclusions: Patients who decline radiotherapy and chemotherapy 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).  Revisions:Clinical cohort has been revised from stage I - IIIB to stage I IIIA  QPI 11 Systemic anti cancer therapy in non small cell lung cancer QPI Title: Patients with 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, targeted therapy, or immunotherapy where appropriate. Please note: This QPI measures three distinct elements: Patients with NSCLC who receive systemic anti cancer therapy (SACT); and Patients with stage IIIB - IV NSCLC that have an oncogenic driver mutation who receive targeted therapy; and Patients with stage IIIB IVi NSCLC with performance status 0-2 not undergoing surgery that are oncogene mutation negative who receive immunotherapy. 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 life4. Patients with EGFR mutations or ALK rearrangements in advanced stage lung cancer should be offered tyrosine kinase inhibitors (TKIs) which have been shown to increase progression-free survival7,8. Specification (i): Numerator: Number of patients with NSCLC not undergoing surgery who receive SACT.Denominator: All patients with NSCLC not undergoing surgery. Exclusions: Patients who decline SACT treatment. 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 SACT treatment.  (continued overleaf..) QPI 11 Systemic anti cancer therapy in non small cell lung cancer (cont.) Specification (ii): Numerator: Number of patients with stage IIIB IVi NSCLC, with performance status 0-2 not undergoing surgery that have an oncogenic driver mutation who receive targeted therapy. Denominator: All patients with stage IIIB IVi NSCLC, with performance status 0-2 not undergoing surgery that have an oncogenic driver mutation. Exclusions: Patients who decline 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 targeted therapy.Specification (iii): Numerator: Number of patients with stage IIIB IVi NSCLC, with performance status 0-2 not undergoing surgery that are oncogene mutation negative who receive immunotherapy. Denominator: All patients with stage IIIB IVi NSCLC, with performance status 0-2 not undergoing surgery that are oncogene mutation negative. Exclusions: Patients who decline SACT treatment. Patients who die before treatment. Patients who are participating in clinical trials. Target:35% The tolerance within this target accounts for the fact that due to co-morbidities not all patients will require or be suitable for immunotherapy. Revisions:Specification (i) no changes. Specification (ii) changed EGFR / ALK positive to patients who have an oncogenic driver mutation to account for ROS-1 and any further mutations that may be included in future (also added explanatory footnote). Changed biological therapy to targeted therapy. Specification (iii) added new specification for those patients who are oncogene mutation negative that receive immunotherapy. Target 35%.  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. Please note: This QPI measures two distinct elements: Patients with SCLC who receive chemotherapy radiotherapy; and Patients with SCLC not undergoing treatment with curative intent who receive palliative chemotherapy. 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 tumour3,4. Specification (i): Numerator: Number of patients with SCLC who receive chemotherapy radiotherapy. Denominator: All patients with SCLC.  Exclusions:  Patients who decline 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 decline 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.  Revisions:No change to QPI.  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 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. Please note 30 Day Mortality for Systemic Anti-Cancer Therapy (SACT) is measured separately within QPI 18 see page 28. Specification (i): Numerator: Number of patients with lung cancer who receive active treatmentk who die within 30 days of treatment. Denominator: All patients with lung cancer who receive active treatmentk. Exclusions: No exclusions. 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 as opposed to one single figure. Targets:  Surgery, Radical Radiotherapy, Radical Chemoradiotherapy <5%  Revisions:SACT element been removed from this QPI. This will be measured separately within a standardised 30 Day Mortality (SACT) QPI across all tumour types see QPI 18. The measurement will be revised to use data from Chemocare (electronic chemotherapy prescribing system) for reporting in order to utilise existing data and provide a more accurate picture of all patients with Lung Cancer undergoing Systemic Anti-Cancer Therapy.  QPI 14 Stereotactic Ablative Radiotherapy (SABR) in inoperable stage I lung cancer QPI Title: Patients with inoperable stage I lung cancer should receive stereotactic ablative radiotherapy (SABR). Description: Proportion of patients with stage I lung cancer 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 benefit6. Specifications: Numerator: Number of patients with stage Il lung cancer not undergoing surgery who receive SABR. Denominator: All patients with stage Il lung cancer not undergoing surgery. Exclusions: Patients with small cell lung cancer (SCLC) Patients who decline 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.  Revisions:No change to QPI.  QPI 15 Pre-treatment diagnosis QPI Title: Where possible patients should have a cytological / histological diagnosis prior to definitive treatment. Description: Proportion of patients who receive curative treatment (radical radiotherapy or surgical resection) that have a cytological / histological diagnosis prior to definitive 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 / histology3. Radical chemoradiotherapy has been archived as a treatment option within this QPI as all regions have achieved >95% compliance and this is considered to be standard practice. Specifications: Numerator: Number of patients who receive curative treatment (radical radiotherapy or surgical resection) that have a cytological / histological diagnosis prior to definitive treatment. Denominator: All patients with lung cancer who receive curative treatment (radical radiotherapy or surgical resection).Exclusions: Please note: Patients who decline investigations This indicator will be reported by treatment modality, i.e. surgery, radical radiotherapy 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-treatment diagnosis (small and / or peripheral lesions).  Revisions:Removed chemoradiotherapy as a treatment option within the QPI as all regions are achieving >95% compliance. Changed from first treatment to definitive treatment to ensure cytological / histological diagnosis prior to the correct treatment option.  QPI 16 Brain imaging QPI Title: Patients with N2 disease who are undergoing curative treatment should have brain imaging performed prior to commencing definitive treatment. Description: Proportion of patients with N2 disease who receive curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection) that undergo contrast enhanced CT or contrast enhanced MRI prior to start of definitive treatment. Rationale and Evidence: Brain metastases are an important prognostic factor in lung cancer patients and the detection of these can influence decisions on appropriate treatment9. Contrast enhanced CT is the most common imaging method used to detect brain metastases and has been shown to be as reliable as non-contrast enhanced MRI. Contrast enhanced MRI will detect more metastases than contrast enhanced CT but does not detect metastases in a greater number of patients10. All patients with N2 disease being considered for curative treatment should undergo contrast enhanced head CT or MRI10. Specifications: Numerator: Number of patients with N2 disease who receive curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection) that undergo contrast enhanced CT or contrast enhanced MRI prior to start of definitive treatment. Denominator: All patients with N2 disease who receive curative treatment (radical radiotherapy, radical chemoradiotherapy or surgical resection). Exclusions: Patients who decline brain imaging Patients with small cell lung cancer (SCLC) Target: 95% The tolerance within this target is designed to account for those patients with contraindications due to renal impairment, allergies to contrast media or deemed clinically unsuitable or unable to undergo MRI.  Revisions:Changed from first treatment to definitive treatment to ensure CT / MRI prior to the correct treatment option. Added exclusion category for patients with small cell lung cancer (SCLC).  QPI 17 Clinical Trial and Research Study Access Revision(s): The Clinical Trial and Research Study Access QPI which is applicable to all tumour sites will be included in the final Lung Cancer QPI document.  QPI 18 - 30 Day Mortality following Systemic Anti-Cancer Therapy (SACT) QPI Title:30 day mortality following Systemic Anti-Cancer Therapy (SACT) treatment for lung cancer. Description: Proportion of patients with lung cancer who die within 30 days of SACT treatment. 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)8. 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. This QPI is intended to ensure treatment is given appropriately, and the outcome reported on and reviewed. Specifications: Numerator: Number of patients with lung cancer who undergo SACT that die within 30 days of treatment.Denominator: All patients with lung cancer who undergo SACT. Exclusions: Please note: No exclusions This indicator will be reported separately for NSCLC and SCLC patients as opposed to one single figure. Target:Non palliative <5% Palliative <10%  Please note: Data from Chemocare (electronic chemotherapy prescribing system) will be utilisedto support reporting and monitoring of this QPIrather than clinical audit. This willmaximise the use of data which are already collected and provide a more accurate report of all patients with renal cancer undergoing chemotherapy. Standard reports will be specified to ensurenationally consistent analysis and reporting. Revision(s): This standard SACT 30 Day Mortality QPI is replacing the SACT mortality which was previously incorporated within QPI 13 above. Data from Chemocare (electronic chemotherapy prescribing system) will be used to maximise the use of data already collected and provide a more accurate picture of all patients with lung cancer undergoing Systemic Anti-Cancer Therapy. 7. Survival Improving survival forms an integral part of the national cancer quality improvement programme. Lung cancer survival analysis will be reported and analysed on a 3 yearly basis by Information Services Division (ISD). The specific issues which will be addressed will be identified by an expert group ahead of any analysis being undertaken, as per the agreed national cancer quality governance and improvement framework. The Lung Cancer QPI Group has identified, during the QPI development process, the following issues for survival analysis: Overall 6 month, 1 year and 3 year survival. To ensure consistent application of survival analysis, it has been agreed that a single analyst on behalf of all three regional cancer networks undertakes this work. Survival analysis will be scheduled as per the national survival analysis and reporting timetable, agreed with the National Cancer Quality Steering Group and Scottish Cancer Taskforce. This reflects the requirement for record linkage and the more technical requirements of survival analyses which would make it difficult for individual Boards to undertake routinely and in a nationally consistent manner. 8. Areas for Future Consideration The Lung Cancer QPI Groups have not been able to identify sufficient evidence, or determine appropriate measurability specifications, to address all areas felt to be of key importance in the treatment of lung cancer, and therefore in improving the quality of care for patients affected by lung cancer. The following areas for future consideration have been raised across the lifetime of the Lung Cancer QPIs. CT scan undertaken prior to first respiratory physician consultation. PET CT in patients with small cell lung cancer Symptom control and quality of life Management of oligometastatic disease 9. Governance and Scrutiny A national and regional governance framework to assure the quality of cancer services in NHSScotland has been developed; key roles and responsibilities within this are set out below. Appendices 5 and 6 provide an overview of these governance arrangements diagrammatically. The importance of ensuring robust local governance process are in place is recognised and it is essential that NHS Boards ensure that cancer clinical audit is fully embedded within established processes. 9.1 National Scottish Cancer Taskforce Accountable for overall national cancer quality programme and overseeing the quality of cancer care across NHSScotland. Healthcare Improvement Scotland Proportionate scrutiny of performance. Support performance improvement. Quality assurance: ensure robust action plans are in place and being progressed via regions/Boards to address any issues identified. Information Services Division (ISD) Publish national comparative report on tumour specific QPIs and survival for approximately three tumour types per annum as part of the rolling programme of reporting. 9.2 Regional Regional Cancer Networks Annual regional comparative analysis and reporting against tumour specific QPIs. Support national comparative reporting of specified generic QPIs. Identification of regional and local actions required and development of an action plan to address regional issues identified. Performance review and monitoring of progress against agreed actions. Provide assurance to NHS Board Chief Executive Officers that any issues identified have been adequately and timeously progressed. 9.3 Local NHS Boards Collect and submit data for regional comparative analysis and reporting in line with agreed measurability and reporting schedule (generic and tumour specific QPIs). Utilise local governance structures to review performance, develop local action plans and monitor delivery. Demonstrate continual improvements in quality of care through on-going review, analysis and feedback of clinical audit data at an individual multidisciplinary team (MDT) or unit level. 10. How to participate in the engagement process In order to ensure wide inclusiveness of clinical and management colleagues from across NHSScotland, patients affected by Lung Cancer and the wider public, draft documentation will be widely circulated for comment and feedback. This will include professional groups, health service staff, voluntary organisations and other relevant individuals. 10.1 Submitting your comments Forms for submission of comments on the Lung Cancer QPIs are available from the Scottish Government Consultation Hub (website details below):  HYPERLINK "https://consult.scotland.gov.uk/" https://consult.scotland.gov.uk/ All responses should be submitted by Friday 6th March 2020 to: Email:  HYPERLINK "mailto:LungQPIPublicEngagement@gov.scot" LungQPIPublicEngagement@gov.scot If you require any further information regarding the engagement process please use the email address above. 10.2 Engagement feedback At the end of the engagement period, all comments and responses will be collated for review by the Lung Cancer QPI Formal Review Group. Those who have participated in the engagement process will receive an overview of the changes made and a copy of the final Lung Cancer QPI document. 11. References Scottish Government (2016). Beating Cancer: Ambition and Action Available from: http://www.gov.scot/Resource/0049/00496709.pdf. NHS Quality Improvement Scotland (2008). Management of Core Cancer Services Standards  HYPERLINK "http://www.healthcareimprovementscotland.org/our_work/cancer_care_improvement/cancer_resources/standards_for_cancer_services.aspx" http://www.healthcareimprovementscotland.org/our_work/cancer_care_improvement/cancer_resources/standards_for_cancer_services.aspx (accessed August 2013) NHS Quality Improvement Scotland (2008). Management of Lung Cancer Services [online]. Available from:  HYPERLINK "http://www.healthcareimprovementscotland.org/his/idoc.ashx?docid=b3c9ed90-ad73-4ddf-b46c-c37da71deab4&version=-1" http://www.healthcareimprovementscotland.org/his/idoc.ashx?docid=b3c9ed90-ad73-4ddf-b46c-c37da71deab4&version=-1 (accessed 14th November 2012). NICE (2011). Lung Cancer: The diagnosis and treatment of lung cancer CG121 [online]. Available from:  HYPERLINK "http://www.nice.org.uk/nicemedia/live/13465/54202/54202.pdf" http://www.nice.org.uk/nicemedia/live/13465/54202/54202.pdf (accessed August 2013). Lim et al for the British Thoracic Surgery Society and the Society for Cardiothoracic Surgery in Great Britain & Ireland (2010). Guidelines on the Radical Management of Patients with Lung Cancer.Thorax.65 (Suppl III), iii1 - iii27. Murray L et al (2016). Stereotactic Ablative Radiotherapy (SABR) in Patients with Medically Inoperable Peripheral Early Stage Lung Cancer: Outcomes for the First UK SABR Cohort. Clinical Oncology 28 (1), 4-12. Lee C K et all (2013). Impact of EGFR inhibitor in non-small cell lung cancer on progression-free and overall survival: a meta analysis. Journal of the National Cancer Institute. 105: 595-605. Chan B, Hughes B (2015). Targeted therapy for non-small cell lung cancer: current standards and the promise of the future. Translational Lung Cancer Research 4: 36-54. Chi A, Komaki R (2010). Treatment of brain metastasis from lung cancer. Cancers (Basel) 2: 210037. SIGN (2014). SIGN 137: Management of Lung Cancer [online]. Available from:  HYPERLINK "http://www.sign.ac.uk/pdf/SIGN137.pdf" http://www.sign.ac.uk/pdf/SIGN137.pdf Downing a, et al (2016). High Hospital Research Participation and Improved Colorectal Cancer Survival Outcomes: A Population Based Study. Gut 0:18. doi:10.1136/gutjnl-2015-311308. Available from:  HYPERLINK "https://gut.bmj.com/content/66/1/89" https://gut.bmj.com/content/66/1/89 (accessed October 2017) 12. Appendices Appendix 1: QPI Development Process Preparatory Work and Scoping NHS Quality Improvement Scotland (QIS) Clinical Standards for Lung Cancer already existed, and were utilised nationally. It was therefore agreed that rather than undertake a lengthy QPI development process the extensive literature search and clinical discussion undertaken in the recent review of NHS QIS Lung Cancer standards (in 2008) was used as the basis for QPI development. The preparatory work involved the development group members independently reviewing and assessing the existing NHS QIS lung cancer standards against agreed criteria and identifying any potential gaps where they considered a need to develop new outcome focussed quality indicators. Responses were then collated and the output of this exercise used to inform development group discussions. Indicator Development The Lung Cancer QPI Development Group defined evidence based, measurable indicators with a clear focus on improving the quality and outcome of care provided. The Group developed QPIs using the clinical recommendations set out in the briefing paper as a base, ensuring all indicators met the following criteria: Overall importance does the indicator address an area of clinical importance that would significantly impact on the quality and outcome of care delivered? Evidence based is the indicator based on high quality clinical evidence? Measurability is the indicator measurable i.e. are there explicit requirements for data measurement and are the required data items accessible and available for collection? Engagement Process A wide clinical and public engagement exercise was undertaken as part of development in 2011 where the Lung Cancer QPIs, along with accompanying draft minimum core dataset and measurability specifications, were made available on the Scottish Government website. During the engagement period clinical and management colleagues from across NHSScotland, patients affected by lung cancer and the wider public were given the opportunity to influence the development of Lung Cancer QPIs. Draft documentation was circulated widely to professional groups, health service staff, voluntary organisations and individuals for comment and feedback. Following the engagement period all comments and responses received were reviewed by the Lung Cancer QPI Development Group and used to produce and refine the final indicators. Appendix 2: Lung Cancer QPI Development Group Membership (2012) Name DesignationCancer NetworkHilary Dobson (CHAIR)Regional Lead Cancer Clinician WoSCANDavid AtkinsonPatient RepresentativeFiona BarnettClinical Nurse SpecialistSCAN (Victoria Hospital, Kirkcaldy)Peter BrownConsultant Respiratory PhysicianNOSCAN (Ninewells Hospital, Tayside)Tracey Cole Project Manager (until May 2012)Ian ColquhounConsultant Thoracic SurgeonWoSCAN (Golden Jubilee Hospital, Clydebank) Kirsty DochertyClinical Nurse SpecialistWoSCAN (Inverclyde Royal Hospital, Inverclyde)Jane EdgecombeConsultant in Palliative Medicine WoSCAN (Beatson West of Scotland Cancer Centre)Carrie FeatherstoneConsultant Clinical OncologistWoSCAN (Beatson West of Scotland Cancer Centre)Mike GronskiConsultant RadiologistWoSCAN (Victoria Infirmary, Glasgow)Michele Hilton BoonProgramme ManagerHealthcare Improvement ScotlandJanet IronsideConsultant Clinical OncologistWoSCAN (Western General Hospital, Edinburgh)Robert JeffreyConsultant Thoracic SurgeonNOSCAN (Aberdeen Royal Infirmary, Grampian)Keith KerrConsultant PathologistNOSCAN (Aberdeen Royal Infirmary, Grampian)Carol MacGregorConsultant Clinical OncologistNOSCAN (Raigmore Hospital, Inverness)Liz MacMillanOncology Department ManagerWoSCAN (Forth Valley Royal Hospital, Falkirk)Lynn McAllisterMacmillan Lung Clinical Nurse Specialist NOSCAN (Ninewells Hospital, Dundee)Robert MilroyConsultant Respiratory Physician WoSCAN (Glasgow Royal Infirmary, Glasgow)John MurchisonConsultant Radiologist WoSCAN (Edinburgh Royal Infirmary, Edinburgh)Brian Murray Principle Information Development ManagerNHS National Services ScotlandMarianne Nicolson Consultant Medical Oncologist NOSCAN (Aberdeen Royal Infirmary, Grampian)Noelle ORourkeConsultant Clinical OncologistWoSCAN (Beatson West of Scotland Cancer Centre)Fiona RobertsConsultant PathologistWoSCAN (Western Infirmary, Glasgow)Donald Salter Consultant PathologistSCAN (Royal Infirmary of Edinburgh. Edinburgh)Iona Scott Project Manager (from May 2012)WoSCANColin SelbyConsultant Respiratory Physician SCAN (Queen Margaret Hospital, Dunfermline) Nicola SteeleConsultant Medical OncologistWoSCAN (Beatson West of Scotland Cancer Centre)Liz StevenMacmillan Lung Clinical Nurse SpecialistNOSCAN (Aberdeen Royal Infirmary, Grampian)Tom TaylorConsultant RadiologistNOSCAN (Ninewells Hospital, Dundee)Steven ThomasConsultant Respiratory Physician NOSCAN (Raigmore Hospital, Inverness)Evelyn ThomsonRegional Manager (Cancer)WoSCANJennifer WilsonClinical Nurse SpecialistWoSCAN (Forth Valley Royal Hospital, Falkirk)Stan WrightConsultant Respiratory PhysicianWoSCAN (Chair NHS QIS Lung Cancer Standards Development)Vipin ZamvarConsultant Cardiothoracic SurgeonSCAN (Royal Infirmary of Edinburgh, Edinburgh) NOSCAN - North of Scotland Cancer Network SCAN - South East Scotland Cancer Network WoSCAN - West of Scotland Cancer Network Appendix 3: Lung Cancer QPI Formal Review Group Membership (2016) Name DesignationCancer NetworkAnne Parker (CHAIR)Consultant HaematologistWoSCAN / NHS Greater Glasgow & ClydeIona Scott Quality and Service Improvement Manager WoSCANHardy RemmenClinical Lead Lung Cancer MCN NOSCANColin SelbyClinical Lead Lung Cancer MCN SCANJohn McPhelimClinical Lead Lung Cancer MCN WoSCANEvelyn ThomsonRegional Manager (Cancer)WoSCANCarrie FeatherstoneConsultant Clinical OncologistWoSCANCarol MacGregorConsultant Clinical OncologistNOSCANTamasin EvansConsultant Clinical OncologistSCANJen DohertyProject Co-ordinatorNational Cancer Quality Programme Formal review of the Lung Cancer QPIs has been undertaken in consultation with various other clinical specialties e.g. oncology and pathology. NOSCAN - North of Scotland Cancer Network SCAN - South East Scotland Cancer Network WoSCAN - West of Scotland Cancer Network Appendix 4: Lung Cancer QPI Formal Review Group Membership (2019) Name DesignationCancer NetworkIain Tait (Chair)Consultant HPB Surgeon and Clinical DirectorNCALorna BruceAudit ManagerSCANTamasin EvansConsultant Clinical OncologistSCANBrian ClarkConsultant Clinical OncologistWoSCANJen DohertyProject Co-ordinator National Cancer Quality ProgrammeCarol MacGregorConsultant Clinical Oncologist NCAMelanie MacKeanConsultant Oncologist and Lung Cancer MCN Clinical LeadSCANBryan McKellarProgramme CoordinatorNCAAilsa PatrizioAudit Facilitator SCANAlison RowellQuality and Service Improvement Manager WoSCANLorraine StirlingProject Officer National Cancer Quality ProgrammeRichard StrettonConsultant in Respiratory Medicine and Lung Cancer MCN Clinical LeadNCAEvelyn Thomson Regional Manager (Cancer)WoSCANJoris Van Der HorstConsultant in Respiratory Medicine and Lung Cancer MCN Clinical LeadWoSCAN Formal review of the Lung Cancer QPIs has been undertaken in consultation with various other clinical specialties e.g. pathology. NCA - North Cancer Alliance SCAN - South East Scotland Cancer Network WoSCAN - West of Scotland Cancer Network Appendix 5: 3 Yearly National Governance Process and Improvement Framework for Cancer Care This process is underpinned by the annual regional reporting and governance framework (see appendix 6).   1. National QPI Development Stage QPIs developed by QPI development groups, which include representation from Regional Cancer Networks, Healthcare Improvement Scotland, ISD, patient representatives and the Cancer Coalition.   2. Data Analysis Stage: NHS Boards and Regional Cancer Advisory Groups (RCAGs)* collect data and analyse on yearly basis using nationally agreed measurability criteria and produce action plans to address areas of variance, see appendix 6. Submit yearly reports to ISD for collation and publication every 3 years. National comparative report approved by NHS Boards and RCAGs. ISD produce comparative, publicly available, national report consisting of trend analysis of 3 years data and survival analysis.    3. Expert Review Group Stage (for 3 tumour types per year): Expert group, hosted by Healthcare Improvement Scotland, review comparative national results. Write to RCAGs highlighting areas of good practice and variances. Where required NHS Boards requested to submit improvement plans for any outstanding unresolved issues with timescales for improvement to expert group. Improvement plans ratified by expert group and Scottish Cancer Taskforce.   4. Improvement Support Stage: Where required Healthcare Improvement Scotland provide expertise on improvement methodologies and support.   5. Monitoring Stage: RCAGs work with Boards to progress outstanding actions, monitor improvement plans and submit progress report to Healthcare Improvement Scotland. Healthcare Improvement Scotland report to Scottish Cancer Taskforce as to whether progress is acceptable.  6. Escalation Stage: If progress not acceptable, Healthcare Improvement Scotland will visit the service concerned and work with the RCAG and Board to address issues. Report submitted to Scottish Cancer Taskforce and escalation with a proposal to take forward to Scottish Government Health Department. *The Regional Cancer Planning Group (South and East of Scotland) and the North Cancer Clinical Leadership Group (North Cancer Alliance) are equivalent to the Regional Cancer Advisory Group (RCAG) in the West of Scotland. Appendix 6: Regional Annual Governance Process and Improvement Framework for Cancer Care   1. Regional QPI Implementation Stage: National cancer QPIs and associated national minimum core dataset and measurability specifications, developed by QPI development groups. Regional implementation of nationally agreed dataset to enable reporting of QPIs.     2. Data Analysis Stage: NHS Boards collect data and data is analysed on a yearly basis using nationally agreed measurability criteria at local/ regional level. Data/results validated by Boards and annual regional comparative report produced by Regional Networks. Areas of best practice and variance across the region highlighted. Yearly regional reports submitted to ISD for collation and presentation in national report every 3 years.    3. Regional Performance Review Stage: RCAGs* review regional comparative report. Regional or local NHS Board action plans to address areas of variance developed. Appropriate leads identified to progress each action. Action plans ratified by RCAGs. 4. Monitoring Stage: Where required, NHS Boards monitor progress with action plans and submit progress reports to RCAGs. RCAGs review and monitor regional improvement.     5. Improvement Support Stage: Where required Healthcare Improvement Scotland maybe requested to provide expertise to NHS Boards/RCAGs on improvement methodologies and support.   6. Escalation Stage: If progress not acceptable, RCAGs will escalate any issues to relevant Board Chief Executives. If progress remains unacceptable RCAGs will escalate any relevant issues to Healthcare Improvement Scotland. *The Regional Cancer Planning Group (South and East of Scotland) and the North Cancer Clinical Leadership Group (North Cancer Alliance) are equivalent to the Regional Cancer Advisory Group (RCAG) in the West of Scotland. Appendix 7: Glossary of Terms Active treatmentTreatment which is intended to improve the cancer and/or alleviate symptoms, as opposed to supportive care.AdenocarcinomaCancer that begins in cells that line certain internal organs and that have gland-like (secretory) properties.Adjuvant ChemotherapyThe use of chemotherapy, after initial treatment by surgery to reduce the risk of recurrence of the cancer.BiopsyRemoval of a sample of tissue from the body to assist in diagnosis of a disease.CancerThe name given to a group of diseases that can occur in any organ of the body, and in blood, and which involve abnormal or uncontrolled growth of cells.ChemoradiotherapyTreatment that combines chemotherapy with radiotherapy.ChemotherapyThe use of drugs that kill cancer cells, or prevent or slow their growth.Clinical trialsA type of research study that tests how well new medical approaches or medicines work. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease.Co-morbidityThe condition of having two or more diseases at the same time.Combined modalityIntegrated use of two or more different treatments (surgery, chemotherapy, radiotherapy) to combat the cancer.Computerised Tomography (CT)An x-ray imaging technique, which allows detailed investigation of the internal organ of the body.Curative intent Treatment which is given with the aim of curing the cancer.CytologicalThe study of the structure and function of cells under the microscope, and of their abnormalities.DiagnosisThe process of identifying a disease, such as cancer, from its signs and symptoms.Extensive stage diseaseA term used to define the extent of small cell lung cancer. Broadly this includes all small cell lung cancers that have metastasised outside of the thorax.Gray (Gy)Unit of absorbed radiation dose.Histological/ histopathological The study of the structure, composition and function of tissues under the microscope, and their abnormalitiesHyperfractionated radiotherapyRadiotherapy treatment in which the total dose of radiation is divided into small doses and treatments are given more than once a day.Inoperable Describes a condition that cannot be treated by surgery. Limited stage SCLCA staging classification for small cell lung cancer developed by the Veterans Administration Lung Study Group. Using the 7th edition of the TNM staging system this broadly includes T1-4, N1-3, M0 disease.LobectomyA surgical procedure that is used to take out part of the lung (called a lobe). Lung Cancer There are two types of primary lung cancer: Small Cell Lung Cancer (SCLC) and Non Small Cell Lung Cancer (NSCLC) which behave and respond to treatment differently. Lymph nodes Small bean shaped organs located along the lymphatic system. Nodes filter bacteria or cancer cells that might travel through the lymphatic system.Malignancy Cancerous. Malignant cells can invade and destroy nearby tissue and spread to other parts of the body.Multi Disciplinary Team Meeting (MDT)A meeting which is held on a regular basis, which is made up of participants from various disciplines appropriate to the disease area, where diagnosis, management, and appropriate treatment of patients is discussed and decided.MediastinalThe thin membrane that lines the chest cavity in the area between the lungs.MetastaticSpread of cancer away from the primary site to somewhere else via the bloodstream or the lymphatic system.Molecular ProfilingA method of testing tumours for genetic characteristics and biomarkers. Based on this information, targeted therapies can then be recommended for treatment. MorbidityHow much ill health a particular condition causes.MortalityEither (1) the condition of being subject to death; or (2) the death rate, which reflects the number of deaths per unit of population in any specific region, age group, disease or other classification, usually expressed as deaths per 1000, 10,000 or 100,000.Non Small Cell Lung Cancer (NSCLC)The most common type of lung cancer, there are three types of NSCLC: Squamous Cell Carcinoma, Adenocarcinoma and Large Cell Carcinoma.Palliative treatmentAnything which serves to alleviate symptoms due to the underlying cancer but is not expected to cure it.PathologicalThe study of disease processes with the aim of understanding their nature and causes. This is achieved by observing samples of fluid and tissues obtained from the living patient by various methods, or at post mortem.Peripheral tumourAn abnormal mass of tissue situated in sub-segmental bronchi and is not usually visible on bronchoscopy.Performance statusA measure of how well a patient is able to perform ordinary tasks and carry out daily activities (e.g. WHO score of 0=asymptomatic, 4=bedridden).Platinum-based chemotherapyChemotherapy drugs that contain derivatives of the metal platinum.PneumonectomyAn operation to remove an entire lung.Positron emission tomography / Computed Tomography (PET CT)A specialised imaging technique which demonstrates uptake of tracer in areas of high cell metabolism and can help differentiate between benign and malignant masses. It is most frequently used to help stage lung cancer by demonstrating or excluding distant metastases.Primary TumourOriginal site of the cancer. The mass of tumour cells at the original site of abnormal tissue growth.PrognosisAn assessment of the expected future course and outcome of a persons disease.RadiotherapyThe use of radiation, usually X-rays or gamma rays, to kill tumour cells.Radical TreatmentTreatment which is given with the aim of destroying cancer cells to attain cure.Small Cell Lung Cancer (SCLC)A type of lung cancer in which the cells are small and round. SCLC is often fast growing and can spread quickly. Surgery/Surgical ResectionSurgical removal of the tumour/lesion.StagingProcess of describing to what degree cancer has spread from its original site to another part of the body. Staging involves clinical, surgical and pathology assessments. See TNM ClassificationStereotactic ablative radiotherapy (SABR)A type of radiotherapy that uses special equipment to position the patient and precisely deliver an intense dose of radiation to a tumour while limiting the dose to surrounding organs.Survival The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.Systemic Anti Cancer Therapy (SACT)Treatment of cancer using drugs which prevent the replication or growth of cancer cells. This encompasses biological therapies and cytotoxic chemotherapy.ThorascopicThoracoscopy is the insertion of an endoscope, a narrow diameter tube with a viewing mirror or camera attachment, through a very small incision (cut) in the chest wall.ToxicityThe extent to which something is poisonous or harmful.TissueA group or layer of cells that work together to perform a specific function.TNM classificationTNM classification provides a system for staging the extent of cancer. T refers to the size of the primary tumour. N refers to the involvement of the lymph nodes. M refers to the presence of metastases or distant spread of the disease.Tumour sizeThe size of a cancer measured by the amount of space taken up by the tumour.Well-differentiatedCancer in which the cells are mature and look like cells in the tissue from when it arose. Differentiated cancers tend to be decidedly less aggressive than undifferentiated cancers composed of immature cells.  Stage III - IV includes: T1 or T1a-c N2-T2b N3 M0; T3 N1N3 M0; T4, N0N3 M0; and T1 or T1a-T4 N0-3 M1 or M1a-c.  Treatment with curative intent includes: radical radiotherapy, radical chemoradiotherapy or surgical resection.  Methods of sampling include: Neck US guided or direct biopsy (core or FNA), EBUS, EUS-B, EUS, Mediastinoscopy or VATS  Stage I - II includes: T1 N0 T2b N1 M0; and T3 N0 M0.  Stage I IIIA includes: T1 N0T4 N1 M0; T1T2b N2 M0.  Stage IIIA NSCLC includes: T1a-T2b N2 M0; T3 N1 M0; T4 N0-N1 M0.  Patients with TxN0-2M0 disease will be included within the measurement of this QPI  Stage I IIIA includes: T1 N0 T4 N1 M0; T1 - T2b N2 M0.  Stage IIIB IV includes: T1 or T1a-T2b N3 M0; T3-T4 N2-N3 M0; and T1 or T1a-T4 N0-N3 M1 or M1a-c.  Details of the oncogenic driver mutations that are currently measured within this QPI are outlined within the associated measurability document.  Active treatment includes: Surgery Radical radiotherapy (> 54Gy) Chemoradiotherapy  Stage I includes: T1-T2a N0 M0.     PAGE 28 Lung Cancer QPI Formal Review Engagement Document v4.0 (4th February 2020) Development of nationally agreed QPIs, dataset and measurability Data collection, analysis, reporting and publication Satisfactory performance Expert Review Group convened to review results Where required, if significant variance identified Improvement Support If progress acceptable Monitoring If progress not acceptable Action if failure to progress improvement Regional implementation of nationally agreed QPIs Data collection, analysis, reporting and publication Satisfactory performance Results reviewed by RCAGs Monitoring If progress acceptable Improvement Support If progress not acceptable Action if failure to progress improvement !GHIQRW񻭢{m_TF@6h)CJ,^JaJ, h)^Jh hb5CJ,^JaJ,hb5CJ,^JaJ,hG=h\5CJ,^JaJ,hG=hG=5CJ,^JaJ,hChS5CJ4^JaJ4hS5CJ4^JaJ4hJhb5CJ,^JaJ,hGIX5CJ,^JaJ,hJhS5CJ,^JaJ,hS5CJ,^JaJ,hf5CJ,^JaJ,)jhf5CJ,U^JaJ,mHnHuhH5CJ,^JaJ,hJhGIX5CJ,^JaJ,!HIJKLMNOPQR_gd) x]gdS]gdSgdSgd[R9 h jhBh 0JUh hBh 0JjhBh 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