National Lung Cancer Audit - NCRAS data request

NHS England and HQIP as joint data controllers and the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons of England (RCSEng) as data processors require access to National Disease Registration Service (NDRS) data for the purpose of delivering the National Lung Cancer Audit (NLCA)

Lung cancer is one of the most common and serious types of cancer with over 44,500 new cases diagnosed each year in the UK. Various studies have highlighted that UK patients with lung cancer had worse 5-year survival than comparable countries and have also identified considerable variation in practice between UK healthcare organisations.

The NLCA was developed after it was found that lung cancer patients in the UK had worse outcomes than comparable countries that spend a similar amount of money on healthcare. There was also considerable variation in practice between UK lung cancer units. The objectives of the NLCA are to evaluate the quality of care received by patients with lung cancer in England and Wales, and to identify areas for improvement and reduce this variation in practice. It aims to provide those who commission, deliver and use services for people with lung cancer with high-quality information on the process and outcomes of NHS care.

The National Lung Cancer Audit (NLCA) is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, as part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). NHS England and HQIP are joint data controllers for the NLCA.

The NLCA has used routinely collected cancer data on patients treated in England and Wales for a number of years. English data for this study was previously provided by Public Health England (PHE) when it controlled and managed the national cancer registration datasets. PHE facilitated the data release via its Office of Data Release service (ODR). The ODR was responsible for providing a common governance framework for responding to requests to access PHE datasets for secondary purposes, including service improvement, surveillance and ethically approved research. All requests to access data were reviewed by the ODR and were subject to strict confidentiality provisions. The responsibility for the management of the National Disease Registration Service of which the National Cancer Registration and Analysis Service is a part, transferred from PHE to NHS Digital on 1st October 2021. NHS Digital merged into NHS England on 1st February 2023.

NHS England is responsible for determining the scope and purpose of the NLCA. HQIP, as commissioner of NLCA is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England participates in specification development, procurement and project extension activities and authorises the publication of NLCA outputs. The scope and purpose of the NLCA was created after a specification development process involving key stakeholders was undertaken. NHS England (as chair of the specification development meetings) authorised the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect.

NHS England is a representative of the HQIP Data Access Request group which authorises data-sharing applications from third parties for data collected by national clinical audits. This Agreement does not permit the Data Processors to further disseminate data covered under this Agreement; any further dissemination would be subject to a separate DSA, with appropriate REC support (if required).

The data requested under this agreement is to be used to evaluate the performance of NHS lung cancer services against established standards of care, and to encourage NHS hospitals with unexplained variation in areas of clinical practice or patient outcomes to examine their lung cancer service and formulate action plans to improve their clinical performance. This work is carried out under contract with HQIP.

The NLCA will be delivered by the Clinical Effectiveness Unit for the current contract period 01.02.22 – 31.01.25. The CEU is a collaboration between RCSEng and the London School of Hygiene and Tropical Medicine (LSHTM), and has an excellent track record of producing high-quality national cancer audits in prostate, oesophago-gastric, bowel and breast cancers. Clinical leadership is provided by individuals substantively employed by Barts Health NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, and University College London Hospitals NHS Foundation Trust. These individuals act in an advisory capacity only; they do not process the data or determine why or how the data is processed.

The NLCA is a source of valuable information that supports various quality assurance and improvement activities, both at a local level (by NHS trusts, Cancer Alliances, Integrated Care Systems) and at national level (e.g. Care Quality Commission, service commissioning, health care policy). The NLCA activities will drive quality improvement across the country and help lung cancer services reach the highest standards possible.

The NLCA has specific healthcare improvement goals in the current contract period. These were developed in consultation with the medical professionals and patient representatives (e.g. individuals involved with the Lung Cancer Nursing UK and Roy Castle Lung Cancer Foundation). The goals focus on:

1. Increasing the proportion of patients who receive treatment with curative intent.

2. Increasing the proportion of patients who are assessed by a lung cancer nurse specialist.

3. Reducing the number of patients diagnosed after an emergency presentation. These patients usually have advanced stages and poor prognoses.

4. Improving compliance with the National Optimal Lung Cancer Pathway, which sets tight timeframes for each stage of the care pathway, ideally enabling treatment for patients to start within 49 days of lung cancer being suspected.

5. Reducing variation in quality and improving timeliness for patients undergoing diagnosis.

Patient representatives and clinical steering groups will play a major role in the evolution of the goals and indicators.

To support the Audit in achieving these goals pseudonymised subsets of the following datasets are requested:

• National Cancer Registry Dataset (NCDR)

• Cancer Outcomes and Services Dataset (COSD)

• National Radiotherapy Dataset (RTDS)

• Systemic Anti-Cancer Therapy Dataset (SACT)

• Admitted Patient Care Hospital Episodes Statistics (HES-APC)

In addition, the Audit requires pseudonymised subsets of the following data every quarter:

• Rapid Cancer Registration Dataset (RCRD) linked to HES-APC, RTDS and SACT (including the missing Sept 2023 extract)

To address the GDPR Principle of Data Minimisation, this request is limited to all patients aged ≥ 18 years, with a new diagnosis of lung cancer (ICD10 diagnosis code: C33-C34). The data request is limited to all patients diagnosed with lung cancer from 1st January 2017 to the latest available. National data is required to ensure that the Audit can review the performance of all NHS lung cancer units in England.

The data requested above provides the Audit with the necessary information on the disease characteristics of patients, their diagnostic pathways, and their combination of treatments (surgery, chemotherapy and/or radiotherapy). There are no alternative less intrusive means of achieving the purpose outlined within this Agreement.

HQIP and NHS England rely on Article 6 (1) (e) of the General Data Protection Regulation (GDPR) as the lawful basis of processing - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve the quality of health care services.

HQIP rely on Article 9 (2)(i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular, professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. The processing meets Schedule 1 Part 1 paragraph 3 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons of England on behalf of NHS England.

NHS England relies on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to a contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England is responsible for the provision of health and social care, and the management of systems and compliance. The processing meets Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons of England.

In line with the national data opt-out policy, opt-outs are not applied because the data is not Confidential Patient Information as defined in section 251(10) and section 251(11) of the National Health Service Act 2006.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out.

The outputs produced by the NLCA are specified as deliverables in the audit contract with HQIP.

Any statistical results contained within the outputs referenced within this section will be aggregated data, with small numbers suppressed unless otherwise specified.

The results produced by the NLCA team are published in annual ‘State of the Nation’ (SotN) reports, quarterly dashboards, and other documents such as peer-reviewed publications. Results will also be presented at appropriate medical conferences. The intended audiences for these outputs are patients and people who deliver, receive, commission and regulate lung cancer care.

The annual SotN reports describe how lung cancer care is delivered in the NHS and highlight where local providers should focus on quality improvement activities. In parallel with the publication of the SotN report, provider-level and regional-level results will be published on the publicly available NLCA website which provides transparency and supports patient choice. The results will be published alongside quality improvement tools and resources, and NHS trusts will use this information to assess their care against national standards, clinical guidance and the performance of other trusts.

Performance indicators for NHS provider (as well as national and regional results) will be reported in a dashboard available on the NLCA website. These dashboard results will be refreshed on a quarterly basis and will enable regular monitoring of NHS providers, essential for supporting local quality improvement. The NLCA website will include the facility to download activity summaries and outcomes in appropriate formats (such as short PDF documents).

The results from the SotN report will be presented at annual meetings of the British Thoracic Oncology Group (BTOG; scheduled for April 2024) and the Society for Thoracic Surgery (January 2024) as a minimum. The NLCA team will aim to disseminate their results and reports widely with the support of their stakeholders, including patient charities and professional organisations to ensure maximum engagement with scientific and policy-making communities.

Publications in peer-reviewed journals will broaden the dissemination of the NLCA findings and allow the presentation of the audit results and methodology in more detail than is possible in the SotN reports. In these outputs, the NLCA will use appropriate methods to derive a range of key process and outcome indicators, which enable the evaluation of NHS provider performance. The NLCA aims to publish in peer-reviewed journals within the next three years.

The NLCA will support other key national initiatives including the CQC’s inspection programme, HQIP’s National Clinical Audit Benchmarking (NCAB), and Model Hospital by providing them with provider-level results. To ensure that the Audit findings reach interested groups and civil society, the Audit will publish Newsletters (https://www.lungcanceraudit.org.uk/news/categories/enewsletters/) and social media messages to announce the publication of reports. The reports are written in plain language and use infographics to display key findings to make them accessible to lay readers.

The NLCA will also produce lay versions of the NLCA SotN reports for patients and the public, which will be available on the NLCA website. Patient representatives in the NLCA Patient Forum will guide the development of NLCA outputs. Members of the NLCA Patient Forum will also guide the development of the patient summaries and accompanying materials designed for patients including infographics, information leaflets and slide sets for patient support groups to ensure the findings, key messages and recommendations are accessible to a lay audience.

The NLCA has been commissioned as a national clinical audit since 2004, and has produced regular reports on clinical practice and patient outcomes in England and Wales. Using the findings and recommendations from the NLCA annual reports, NHS lung cancer services have been able to implement changes and quality improvement initiatives that have ultimately benefitted the provision of health and social care in England. The NLCA has helped to set standards and improve outcomes for patients year-on-year and it is a unique source of information about lung cancer patients in England and Wales.

Key messages outlined in the NLCA 2023 State of the Nation report were:

• The number of patients diagnosed in England in 2021 returned to pre-pandemic levels after a fall in 2020.

• The proportion of patients with NSCLC stage I/II (performance status 0-2) undergoing curative treatment in England increased from 73% in 2020 to 79% in 2021.

• The proportion of patients with NSCLC stage IIIB-IV (performance status 0-1) receiving systemic anti-cancer therapy in England increased from 55% in 2020 to 61% in 2021.

• Among patients with NSCLC undergoing treatment with curative intent in 2021 had not recovered to 2019 pre- pandemic levels.

Recommendations in the previous 2022 Annual Report highlighted these areas, and the toolkit (published with the NLCA 2021 report) was available to help NHS trusts review their processes for selecting patients. More generally, the NLCA reports revealed that initiatives, such as the National Optimum Lung Cancer Pathway (NOLCP) were helping to improve outcomes - with the one-year survival figure in England and Wales reaching at least 40.7% in 2019 – the highest ever achieved.

Over the last 10 years, the NLCA has enhanced its reporting of individual NHS trust reports. Since 2021, the NLCA has used the rapid cancer registration dataset for England to make its findings more up-to-date. In Summer 2023, it launched a quarterly report using the rapid cancer registration dataset, which will provide a more regular description of practice and how it is changing over time.

The audit is working with the Care Quality Commission and NHS England to help NHS trusts with local quality improvement.

NHS England and HQIP as joint data controllers and the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons of England (RCSEng) as data processors require access to National Disease Registration Service (NDRS) data for the purpose of delivering the National Lung Cancer Audit (NLCA)

Lung cancer is one of the most common and serious types of cancer with over 44,500 new cases diagnosed each year in the UK. Various studies have highlighted that UK patients with lung cancer had worse 5-year survival than comparable countries and have also identified considerable variation in practice between UK healthcare organisations.

The NLCA was developed after it was found that lung cancer patients in the UK had worse outcomes than comparable countries that spend a similar amount of money on healthcare. There was also considerable variation in practice between UK lung cancer units. The objectives of the NLCA are to evaluate the quality of care received by patients with lung cancer in England and Wales, and to identify areas for improvement and reduce this variation in practice. It aims to provide those who commission, deliver and use services for people with lung cancer with high-quality information on the process and outcomes of NHS care.

The National Lung Cancer Audit (NLCA) is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, as part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). NHS England and HQIP are joint data controllers for the NLCA.

The NLCA has used routinely collected cancer data on patients treated in England and Wales for a number of years. English data for this study was previously provided by Public Health England (PHE) when it controlled and managed the national cancer registration datasets. PHE facilitated the data release via its Office of Data Release service (ODR). The ODR was responsible for providing a common governance framework for responding to requests to access PHE datasets for secondary purposes, including service improvement, surveillance and ethically approved research. All requests to access data were reviewed by the ODR and were subject to strict confidentiality provisions. The responsibility for the management of the National Disease Registration Service of which the National Cancer Registration and Analysis Service is a part, transferred from PHE to NHS Digital on 1st October 2021. NHS Digital merged into NHS England on 1st February 2023.

NHS England is responsible for determining the scope and purpose of the NLCA. HQIP, as commissioner of NLCA is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England participates in specification development, procurement and project extension activities and authorises the publication of NLCA outputs. The scope and purpose of the NLCA was created after a specification development process involving key stakeholders was undertaken. NHS England (as chair of the specification development meetings) authorised the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect.

NHS England is a representative of the HQIP Data Access Request group which authorises data-sharing applications from third parties for data collected by national clinical audits. This Agreement does not permit the Data Processors to further disseminate data covered under this Agreement; any further dissemination would be subject to a separate DSA, with appropriate REC support (if required).

The data requested under this agreement is to be used to evaluate the performance of NHS lung cancer services against established standards of care, and to encourage NHS hospitals with unexplained variation in areas of clinical practice or patient outcomes to examine their lung cancer service and formulate action plans to improve their clinical performance. This work is carried out under contract with HQIP.

The NLCA will be delivered by the Clinical Effectiveness Unit for the current contract period 01.02.22 – 31.01.25. The CEU is a collaboration between RCSEng and the London School of Hygiene and Tropical Medicine (LSHTM), and has an excellent track record of producing high-quality national cancer audits in prostate, oesophago-gastric, bowel and breast cancers. Clinical leadership is provided by individuals substantively employed by Barts Health NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, and University College London Hospitals NHS Foundation Trust. These individuals act in an advisory capacity only; they do not process the data or determine why or how the data is processed.

The NLCA is a source of valuable information that supports various quality assurance and improvement activities, both at a local level (by NHS trusts, Cancer Alliances, Integrated Care Systems) and at national level (e.g. Care Quality Commission, service commissioning, health care policy). The NLCA activities will drive quality improvement across the country and help lung cancer services reach the highest standards possible.

The NLCA has specific healthcare improvement goals in the current contract period. These were developed in consultation with the medical professionals and patient representatives (e.g. individuals involved with the Lung Cancer Nursing UK and Roy Castle Lung Cancer Foundation). The goals focus on:

1. Increasing the proportion of patients who receive treatment with curative intent.

2. Increasing the proportion of patients who are assessed by a lung cancer nurse specialist.

3. Reducing the number of patients diagnosed after an emergency presentation. These patients usually have advanced stages and poor prognoses.

4. Improving compliance with the National Optimal Lung Cancer Pathway, which sets tight timeframes for each stage of the care pathway, ideally enabling treatment for patients to start within 49 days of lung cancer being suspected.

5. Reducing variation in quality and improving timeliness for patients undergoing diagnosis.

Patient representatives and clinical steering groups will play a major role in the evolution of the goals and indicators.

To support the Audit in achieving these goals pseudonymised subsets of the following datasets are requested:

• National Cancer Registry Dataset (NCDR)

• Cancer Outcomes and Services Dataset (COSD)

• National Radiotherapy Dataset (RTDS)

• Systemic Anti-Cancer Therapy Dataset (SACT)

• Admitted Patient Care Hospital Episodes Statistics (HES-APC)

In addition, the Audit requires pseudonymised subsets of the following data every quarter:

• Rapid Cancer Registration Dataset (RCRD) linked to HES-APC, RTDS and SACT (including the missing Sept 2023 extract)

To address the GDPR Principle of Data Minimisation, this request is limited to all patients aged ≥ 18 years, with a new diagnosis of lung cancer (ICD10 diagnosis code: C33-C34). The data request is limited to all patients diagnosed with lung cancer from 1st January 2017 to the latest available. National data is required to ensure that the Audit can review the performance of all NHS lung cancer units in England.

The data requested above provides the Audit with the necessary information on the disease characteristics of patients, their diagnostic pathways, and their combination of treatments (surgery, chemotherapy and/or radiotherapy). There are no alternative less intrusive means of achieving the purpose outlined within this Agreement.

HQIP and NHS England rely on Article 6 (1) (e) of the General Data Protection Regulation (GDPR) as the lawful basis of processing - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve the quality of health care services.

HQIP rely on Article 9 (2)(i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular, professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. The processing meets Schedule 1 Part 1 paragraph 3 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons of England on behalf of NHS England.

NHS England relies on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to a contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England is responsible for the provision of health and social care, and the management of systems and compliance. The processing meets Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons of England.

In line with the national data opt-out policy, opt-outs are not applied because the data is not Confidential Patient Information as defined in section 251(10) and section 251(11) of the National Health Service Act 2006.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out.

The outputs produced by the NLCA are specified as deliverables in the audit contract with HQIP.

Any statistical results contained within the outputs referenced within this section will be aggregated data, with small numbers suppressed unless otherwise specified.

The results produced by the NLCA team are published in annual ‘State of the Nation’ (SotN) reports, quarterly dashboards, and other documents such as peer-reviewed publications. Results will also be presented at appropriate medical conferences. The intended audiences for these outputs are patients and people who deliver, receive, commission and regulate lung cancer care.

The annual SotN reports describe how lung cancer care is delivered in the NHS and highlight where local providers should focus on quality improvement activities. In parallel with the publication of the SotN report, provider-level and regional-level results will be published on the publicly available NLCA website which provides transparency and supports patient choice. The results will be published alongside quality improvement tools and resources, and NHS trusts will use this information to assess their care against national standards, clinical guidance and the performance of other trusts.

Performance indicators for NHS provider (as well as national and regional results) will be reported in a dashboard available on the NLCA website. These dashboard results will be refreshed on a quarterly basis and will enable regular monitoring of NHS providers, essential for supporting local quality improvement. The NLCA website will include the facility to download activity summaries and outcomes in appropriate formats (such as short PDF documents).

The results from the SotN report will be presented at annual meetings of the British Thoracic Oncology Group (BTOG; scheduled for April 2024) and the Society for Thoracic Surgery (January 2024) as a minimum. The NLCA team will aim to disseminate their results and reports widely with the support of their stakeholders, including patient charities and professional organisations to ensure maximum engagement with scientific and policy-making communities.

Publications in peer-reviewed journals will broaden the dissemination of the NLCA findings and allow the presentation of the audit results and methodology in more detail than is possible in the SotN reports. In these outputs, the NLCA will use appropriate methods to derive a range of key process and outcome indicators, which enable the evaluation of NHS provider performance. The NLCA aims to publish in peer-reviewed journals within the next three years.

The NLCA will support other key national initiatives including the CQC’s inspection programme, HQIP’s National Clinical Audit Benchmarking (NCAB), and Model Hospital by providing them with provider-level results. To ensure that the Audit findings reach interested groups and civil society, the Audit will publish Newsletters (https://www.lungcanceraudit.org.uk/news/categories/enewsletters/) and social media messages to announce the publication of reports. The reports are written in plain language and use infographics to display key findings to make them accessible to lay readers.

The NLCA will also produce lay versions of the NLCA SotN reports for patients and the public, which will be available on the NLCA website. Patient representatives in the NLCA Patient Forum will guide the development of NLCA outputs. Members of the NLCA Patient Forum will also guide the development of the patient summaries and accompanying materials designed for patients including infographics, information leaflets and slide sets for patient support groups to ensure the findings, key messages and recommendations are accessible to a lay audience.

The NLCA has been commissioned as a national clinical audit since 2004, and has produced regular reports on clinical practice and patient outcomes in England and Wales. Using the findings and recommendations from the NLCA annual reports, NHS lung cancer services have been able to implement changes and quality improvement initiatives that have ultimately benefitted the provision of health and social care in England. The NLCA has helped to set standards and improve outcomes for patients year-on-year and it is a unique source of information about lung cancer patients in England and Wales.

Key messages outlined in the NLCA 2023 State of the Nation report were:

• The number of patients diagnosed in England in 2021 returned to pre-pandemic levels after a fall in 2020.

• The proportion of patients with NSCLC stage I/II (performance status 0-2) undergoing curative treatment in England increased from 73% in 2020 to 79% in 2021.

• The proportion of patients with NSCLC stage IIIB-IV (performance status 0-1) receiving systemic anti-cancer therapy in England increased from 55% in 2020 to 61% in 2021.

• Among patients with NSCLC undergoing treatment with curative intent in 2021 had not recovered to 2019 pre- pandemic levels.

Recommendations in the previous 2022 Annual Report highlighted these areas, and the toolkit (published with the NLCA 2021 report) was available to help NHS trusts review their processes for selecting patients. More generally, the NLCA reports revealed that initiatives, such as the National Optimum Lung Cancer Pathway (NOLCP) were helping to improve outcomes - with the one-year survival figure in England and Wales reaching at least 40.7% in 2019 – the highest ever achieved.

Over the last 10 years, the NLCA has enhanced its reporting of individual NHS trust reports. Since 2021, the NLCA has used the rapid cancer registration dataset for England to make its findings more up-to-date. In Summer 2023, it launched a quarterly report using the rapid cancer registration dataset, which will provide a more regular description of practice and how it is changing over time.

The audit is working with the Care Quality Commission and NHS England to help NHS trusts with local quality improvement.

NHS England and HQIP as joint data controllers and the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons of England (RCSEng) as data processors require access to National Disease Registration Service (NDRS) data for the purpose of delivering the National Lung Cancer Audit (NLCA)

Lung cancer is one of the most common and serious types of cancer with over 44,500 new cases diagnosed each year in the UK. Various studies have highlighted that UK patients with lung cancer had worse 5-year survival than comparable countries and have also identified considerable variation in practice between UK healthcare organisations.

The NLCA was developed after it was found that lung cancer patients in the UK had worse outcomes than comparable countries that spend a similar amount of money on healthcare. There was also considerable variation in practice between UK lung cancer units. The objectives of the NLCA are to evaluate the quality of care received by patients with lung cancer in England and Wales, and to identify areas for improvement and reduce this variation in practice. It aims to provide those who commission, deliver and use services for people with lung cancer with high-quality information on the process and outcomes of NHS care.

The National Lung Cancer Audit (NLCA) is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, as part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). NHS England and HQIP are joint data controllers for the NLCA.

The NLCA has used routinely collected cancer data on patients treated in England and Wales for a number of years. English data for this study was previously provided by Public Health England (PHE) when it controlled and managed the national cancer registration datasets. PHE facilitated the data release via its Office of Data Release service (ODR). The ODR was responsible for providing a common governance framework for responding to requests to access PHE datasets for secondary purposes, including service improvement, surveillance and ethically approved research. All requests to access data were reviewed by the ODR and were subject to strict confidentiality provisions. The responsibility for the management of the National Disease Registration Service of which the National Cancer Registration and Analysis Service is a part, transferred from PHE to NHS Digital on 1st October 2021. NHS Digital merged into NHS England on 1st February 2023.

NHS England is responsible for determining the scope and purpose of the NLCA. HQIP, as commissioner of NLCA is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England participates in specification development, procurement and project extension activities and authorises the publication of NLCA outputs. The scope and purpose of the NLCA was created after a specification development process involving key stakeholders was undertaken. NHS England (as chair of the specification development meetings) authorised the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect.

NHS England is a representative of the HQIP Data Access Request group which authorises data-sharing applications from third parties for data collected by national clinical audits. This Agreement does not permit the Data Processors to further disseminate data covered under this Agreement; any further dissemination would be subject to a separate DSA, with appropriate REC support (if required).

The data requested under this agreement is to be used to evaluate the performance of NHS lung cancer services against established standards of care, and to encourage NHS hospitals with unexplained variation in areas of clinical practice or patient outcomes to examine their lung cancer service and formulate action plans to improve their clinical performance. This work is carried out under contract with HQIP.

The NLCA will be delivered by the Clinical Effectiveness Unit for the current contract period 01.02.22 – 31.01.25. The CEU is a collaboration between RCSEng and the London School of Hygiene and Tropical Medicine (LSHTM), and has an excellent track record of producing high-quality national cancer audits in prostate, oesophago-gastric, bowel and breast cancers. Clinical leadership is provided by individuals substantively employed by Barts Health NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, and University College London Hospitals NHS Foundation Trust. These individuals act in an advisory capacity only; they do not process the data or determine why or how the data is processed.

The NLCA is a source of valuable information that supports various quality assurance and improvement activities, both at a local level (by NHS trusts, Cancer Alliances, Integrated Care Systems) and at national level (e.g. Care Quality Commission, service commissioning, health care policy). The NLCA activities will drive quality improvement across the country and help lung cancer services reach the highest standards possible.

The NLCA has specific healthcare improvement goals in the current contract period. These were developed in consultation with the medical professionals and patient representatives (e.g. individuals involved with the Lung Cancer Nursing UK and Roy Castle Lung Cancer Foundation). The goals focus on:

1. Increasing the proportion of patients who receive treatment with curative intent.

2. Increasing the proportion of patients who are assessed by a lung cancer nurse specialist.

3. Reducing the number of patients diagnosed after an emergency presentation. These patients usually have advanced stages and poor prognoses.

4. Improving compliance with the National Optimal Lung Cancer Pathway, which sets tight timeframes for each stage of the care pathway, ideally enabling treatment for patients to start within 49 days of lung cancer being suspected.

5. Reducing variation in quality and improving timeliness for patients undergoing diagnosis.

Patient representatives and clinical steering groups will play a major role in the evolution of the goals and indicators.

To support the Audit in achieving these goals pseudonymised subsets of the following datasets are requested:

• National Cancer Registry Dataset (NCDR)

• Cancer Outcomes and Services Dataset (COSD)

• National Radiotherapy Dataset (RTDS)

• Systemic Anti-Cancer Therapy Dataset (SACT)

• Admitted Patient Care Hospital Episodes Statistics (HES-APC)

In addition, the Audit requires pseudonymised subsets of the following data every quarter:

• Rapid Cancer Registration Dataset (RCRD) linked to HES-APC, RTDS and SACT

To address the GDPR Principle of Data Minimisation, this request is limited to all patients aged ≥ 18 years, with a new diagnosis of lung cancer (ICD10 diagnosis code: C33-C34). The data request is limited to all patients diagnosed with lung cancer from 1st January 2017 to the latest available. National data is required to ensure that the Audit can review the performance of all NHS lung cancer units in England.

The data requested above provides the Audit with the necessary information on the disease characteristics of patients, their diagnostic pathways, and their combination of treatments (surgery, chemotherapy and/or radiotherapy). There are no alternative less intrusive means of achieving the purpose outlined within this Agreement.

HQIP and NHS England rely on Article 6 (1) (e) of the General Data Protection Regulation (GDPR) as the lawful basis of processing - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve the quality of health care services.

HQIP rely on Article 9 (2)(i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular, professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. The processing meets Schedule 1 Part 1 paragraph 3 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons of England on behalf of NHS England.

NHS England relies on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to a contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England is responsible for the provision of health and social care, and the management of systems and compliance. The processing meets Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons of England.

The outputs produced by the NLCA are specified as deliverables in the audit contract with HQIP.

Any statistical results contained within the outputs referenced within this section will be aggregated data, with small numbers suppressed unless otherwise specified.

The results produced by the NLCA team are published in annual ‘State of the Nation’ (SotN) reports, quarterly dashboards, and other documents such as peer-reviewed publications. Results will also be presented at appropriate medical conferences. The intended audiences for these outputs are patients and people who deliver, receive, commission and regulate lung cancer care.

The annual SotN reports describe how lung cancer care is delivered in the NHS and highlight where local providers should focus on quality improvement activities. In parallel with the publication of the SotN report, provider-level and regional-level results will be published on the publicly available NLCA website which provides transparency and supports patient choice. The results will be published alongside quality improvement tools and resources, and NHS trusts will use this information to assess their care against national standards, clinical guidance and the performance of other trusts.

Performance indicators for NHS provider (as well as national and regional results) will be reported in a dashboard available on the NLCA website. These dashboard results will be refreshed on a quarterly basis and will enable regular monitoring of NHS providers, essential for supporting local quality improvement. The NLCA website will include the facility to download activity summaries and outcomes in appropriate formats (such as short PDF documents).

The results from the SotN report will be presented at annual meetings of the British Thoracic Oncology Group (BTOG; scheduled for April 2024) and the Society for Thoracic Surgery (January 2024) as a minimum. The NLCA team will aim to disseminate their results and reports widely with the support of their stakeholders, including patient charities and professional organisations to ensure maximum engagement with scientific and policy-making communities.

Publications in peer-reviewed journals will broaden the dissemination of the NLCA findings and allow the presentation of the audit results and methodology in more detail than is possible in the SotN reports. In these outputs, the NLCA will use appropriate methods to derive a range of key process and outcome indicators, which enable the evaluation of NHS provider performance. The NLCA aims to publish in peer-reviewed journals within the next three years.

The NLCA will support other key national initiatives including the CQC’s inspection programme, HQIP’s National Clinical Audit Benchmarking (NCAB), and Model Hospital by providing them with provider-level results. To ensure that the Audit findings reach interested groups and civil society, the Audit will publish Newsletters (https://www.lungcanceraudit.org.uk/news/categories/enewsletters/) and social media messages to announce the publication of reports. The reports are written in plain language and use infographics to display key findings to make them accessible to lay readers.

The NLCA will also produce lay versions of the NLCA SotN reports for patients and the public, which will be available on the NLCA website. Patient representatives in the NLCA Patient Forum will guide the development of NLCA outputs. Members of the NLCA Patient Forum will also guide the development of the patient summaries and accompanying materials designed for patients including infographics, information leaflets and slide sets for patient support groups to ensure the findings, key messages and recommendations are accessible to a lay audience.

The NLCA has been commissioned as a national clinical audit since 2004, and has produced regular reports on clinical practice and patient outcomes in England and Wales. Using the findings and recommendations from the NLCA annual reports, NHS lung cancer services have been able to implement changes and quality improvement initiatives that have ultimately benefitted the provision of health and social care in England. The NLCA has helped to set standards and improve outcomes for patients year-on-year and it is a unique source of information about lung cancer patients in England and Wales.

Key messages outlined in the NLCA 2023 State of the Nation report were:

• The number of patients diagnosed in England in 2021 returned to pre-pandemic levels after a fall in 2020.

• The proportion of patients with NSCLC stage I/II (performance status 0-2) undergoing curative treatment in England increased from 73% in 2020 to 79% in 2021.

• The proportion of patients with NSCLC stage IIIB-IV (performance status 0-1) receiving systemic anti-cancer therapy in England increased from 55% in 2020 to 61% in 2021.

• Among patients with NSCLC undergoing treatment with curative intent in 2021 had not recovered to 2019 pre- pandemic levels.

Recommendations in the previous 2022 Annual Report highlighted these areas, and the toolkit (published with the NLCA 2021 report) was available to help NHS trusts review their processes for selecting patients. More generally, the NLCA reports revealed that initiatives, such as the National Optimum Lung Cancer Pathway (NOLCP) were helping to improve outcomes - with the one-year survival figure in England and Wales reaching at least 40.7% in 2019 – the highest ever achieved.

Over the last 10 years, the NLCA has enhanced its reporting of individual NHS trust reports. Since 2021, the NLCA has used the rapid cancer registration dataset for England to make its findings more up-to-date. In Summer 2023, it launched a quarterly report using the rapid cancer registration dataset, which will provide a more regular description of practice and how it is changing over time.

The audit is working with the Care Quality Commission and NHS England to help NHS trusts with local quality improvement.

Lung cancer is one of the most common and serious types of cancer with over 44,500 new cases diagnosed each year in the UK. Various studies have highlighted that UK patients with lung cancer had worse 5-year survival than comparable countries and have also identified considerable variation in practice between UK healthcare organisations.

The NLCA was developed after it was found that lung cancer patients in the UK had worse outcomes than comparable countries that spend a similar amount of money on healthcare. There was also considerable variation between UK healthcare organisations. The NLCA began to collect data on patients with lung cancer in 2004, in order to review the quality of lung cancer care and to identify areas for improvement and reduce this variation in practice. The NLCA works with a number of specialists to collect hospital and healthcare information. The NLCA reports on how well people with lung cancer are being diagnosed and treated in hospitals across England, Wales, Jersey and Guernsey.

The National Lung Cancer Audit (NLCA) is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, as part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). NHS England and HQIP are joint data controllers for the NLCA, however, NHS England is not listed as a Controller on this Data Sharing Agreement as NHS England cannot enter into a contract with itself.

Data for this study has previously been shared when the data was controlled and managed by Public Health England (PHE). PHE facilitated data release via its Office of Data Release service (ODR). ODR was responsible for providing a common governance framework for responding to requests to access PHE data for secondary purposes, including service improvement, surveillance and ethically approved research. All requests to access data were reviewed by the ODR and were subject to strict confidentiality provisions. The responsibility for the management of the National Disease Registration Service of which the National Cancer Registration and Analysis Service is a part, transferred from PHE to NHS Digital on 1st October 2021, NHS Digital later merged into NHS England on 1st February 2023.

NHS England is responsible for determining which projects/topics are included in the NLCA. HQIP, as commissioner of NLCA is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England participates in specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is also involved with developing the scope and purpose of the NLCA through participation in specification development activities and will authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect.

NHS England is a representative of the HQIP Data access request group which authorises data-sharing applications for NLCA data from third parties. This Agreement does not permit the Data Controllers to further disseminate data covered under this Agreement, any further dissemination would be subject to a separate DSA, with appropriate REC support (if required).

The data requested under this agreement is to be used to evaluate the performance of NHS lung cancer services against established standards of care, and to encourage NHS hospitals with unexplained levels of variation in areas of clinical practice or patient outcomes to examine their lung cancer service and formulate action plans to improve their clinical performance. This work is carried out under contract with HQIP.

The NLCA will be delivered by the Clinical Effectiveness Unit (CEU) at the Royal College of Surgeons of England (RCSEng) for the current contract period 01.02.22 – 31.01.25. The CEU is a collaboration between RCSEng and the London School of Hygiene and Tropical Medicine (LSHTM), and has an excellent track record of producing high-quality national cancer audits in prostate, oesophago-gastric, bowel and breast cancers. Clinical leadership is provided by individuals substantively employed by Barts Health NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust and University College London Hospitals NHS Foundation Trust, these individuals act in an advisory capacity only, they do not process the data or determine why or how the data is processed.

The aim of the NLCA is to assess the process of care and its outcomes in patients diagnosed with lung cancer in England and support the NHS in England to improve the length and quality of life of people diagnosed with lung cancer. The NLCA will be a source of valuable information that supports various quality assurance and improvement activities, both at a local level (by NHS trusts, Cancer Alliances, Integrated Care Systems) and a national level (e.g. Care Quality Commission, service commissioning, health care policy). The NLCA activities will drive quality improvement across the country aiming to help lung cancer services reach the highest standards possible.

The NLCA has specific healthcare improvement goals in the current contract period, these have been developed in consultation with the patient and professional representatives (i.e. individuals involved with the Lung Cancer Nursing UK and Roy Castle Lung Cancer Foundation). The goals focus on:

1. Increasing the proportion of patients who receive treatment with curative intent.

2. Increasing the proportion of patients who are assessed by a lung cancer nurse specialist.

3. Reducing the number of patients diagnosed after an emergency presentation. These patients usually have advanced stages and poor prognoses.

4. Improving compliance with the National Optimal Lung Cancer Pathway, which sets tight timeframes for each stage of the care pathway, ideally enabling treatment for patients to start within 49 days of lung cancer being suspected.

5. Reducing variation in quality and improving timeliness for patients undergoing diagnosis.

Patient representatives and clinical steering groups will play a major role in the evolution of the goals and indicators.

To support the Audit in achieving these goals pseudonymised subsets of the following datasets are requested on an annual basis :

• National Cancer Registry Dataset (NCRD)

• National Radiotherapy Dataset (RTDS)

• Systemic Anti-Cancer Therapy Dataset (SACT)

• Admitted Patient Care Hospital Episodes Statistics (HES APC)

In addition, the Audit requires pseudonymised subsets of the following data every quarter:

• Rapid Cancer Registration Dataset (RCRD) linked to HES, RTDS and SACT.

To address the GDPR Principle of Data Minimisation, this request is limited to all patients ≥ 18 years of age with a new diagnosis of lung cancer (ICD10 diagnosis code: C33-C34). The data request is limited to all patients diagnosed with lung cancer from 1st January 2017 to the latest available. National data is required to ensure that the Audit can review the performance of all NHS lung cancer units in England.

The data requested above should provide the Audit with the necessary information on the disease characteristics of patients, their diagnostic pathways, and their combination of treatments (surgery, chemotherapy and/or radiotherapy). There are no alternative less intrusive means of achieving the purpose outlined within this Agreement.

HQIP rely on Article 6 (1) (e) of the General Data Protection Regulation (GDPR) as the lawful basis of processing - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve the quality of health care services.

HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular, professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. The processing meets Schedule 1 Part 1 paragraph 3 of the Data Protection Act 2018 as the processing is carried out by the RCSEng.

The outputs produced by the NLCA are the deliverables in the audit contract with HQIP.

Any data contained within the outputs referenced within this section will be aggregated with small numbers suppressed unless otherwise specified.

The results produced by the NLCA team are published in annual ‘State of the Nation’ (SotN) reports, quarterly dashboards and other documents such as peer-reviewed publications. Results will also be presented at appropriate medical conferences. The intended audience for these outputs is patients and people who deliver, receive, commission and regulate lung cancer care.

The annual SotN reports will highlight where local services should focus on quality improvement activities. In parallel with the publication of the SotN report, provider-level and regional-level results will be published on the publicly available NLCA website which provides transparency and supports patient choice. The results will be published alongside quality improvement tools and resources, and NHS trusts will use this information to assess their care against national standards, clinical guidance and the performance of other trusts.

NHS trust-level indicators (as well as national and regional results) will be reported in a dashboard on the NLCA website. These dashboard results will be refreshed on a quarterly basis and will enable continuous monitoring of NHS providers, essential for supporting local quality improvement. The NLCA website will include the facility to download activity summaries and outcomes as short PDF documents and presentations.

Publications in peer-reviewed journals will broaden the dissemination of the NLCA findings and allow the presentation of the audit results and methodology in more detail than in the SotN reports. In any such reports, the NLCA will use appropriate methods to measure a range of key process and outcome performance indicators, comparing and reporting the performance of NHS providers. The Audit aims to publish in peer-reviewed journals within the next three years.

The results from the SotN report will be presented at annual meetings of the British Thoracic Oncology Group (BTOG; scheduled for January 2023) and the Society for Thoracic Surgery (January 2023) as a minimum. The NLCA team will aim to disseminate their results and reports widely with the support of their stakeholders, including patient charities and professional organisations to ensure maximum engagement with scientific and policy-making communities.

The NLCA will support other key national initiatives including the CQC’s inspection programme, HQIP’s National Clinical Audit Benchmarking (NCAB), the Getting it right first time initiative (GIRFT) and Model Hospital by providing provider-level results.

To ensure that the Audit findings reach interested groups and civil society, the Audit will publish Newsletters (https://www.lungcanceraudit.org.uk/news/categories/enewsletters/) and social media messages to announce the publication of reports. The reports are written in plain language and use infographics to display key findings to make them accessible to lay readers.

The NLCA will also produce lay versions of the NLCA SotN reports for patients and the public, which will be available on the NLCA website. Patient representatives in the NLCA Patient Forum will guide the development of NLCA outputs. Members of the NLCA Patient Forum will also guide the development of the patient summaries and accompanying materials designed for patients including infographics, information leaflets and slide sets for patient support groups to ensure the findings, key messages and recommendations are accessible to a lay audience.

NHS England and HQIP have commissioned the NLCA since 2004. Data for this study has previously been shared when the data was controlled and managed by Public Health England (PHE). As such there are some yielded benefits to be observed from the access to the data for the study prior to NHS Digital (now NHS England) becoming data controller. Results of the findings and recommendations that the Audit has published in its annual reports, care providers have been able to implement changes and improvement work that have ultimately benefitted the provision of health and social care in England. The key benefits and yielded benefits outlined in the Audits 2022 report are as follows:

- For patients diagnosed with lung cancer in 2019, 1-year survival improved compared with 2018. This improvement may be linked to the recommendations and changes suggested in the 2021 Audit.

- In 2019 in England, curative treatment rates of NSCLC patients with stage I/II and good performance status from the RCRD were 81%, as a result, the Audit recommended that trusts with lower than expected performance in this area

use a toolkit (published with the Audits 2021 report) to review their processes for selection of patients for such treatment. Since this recommendation has been made this metric fell significantly to 73% in 2020 with a drop in surgical resection rate from 20% to 15%.

- Compared with 2019, lung cancer patients diagnosed in England in 2020 had worse performance status, were more likely to be diagnosed via emergency presentation and less likely to have a pathological diagnosis. The identification of reduction in performance has resulted in the Audit making several recommendations that would support an earlier diagnosis.

Lung cancer is one of the most common and serious types of cancer with over 44,500 new cases diagnosed each year in the UK. Various studies have highlighted that UK patients with lung cancer had worse 5-year survival than comparable countries and have also identified considerable variation in practice between UK healthcare organisations.

The NLCA was developed after it was found that lung cancer patients in the UK had worse outcomes than comparable countries that spend a similar amount of money on healthcare. There was also considerable variation between UK healthcare organisations. The NLCA began to collect data on patients with lung cancer in 2004, in order to review the quality of lung cancer care and to identify areas for improvement and reduce this variation in practice. The NLCA works with a number of specialists to collect hospital and healthcare information. The NLCA reports on how well people with lung cancer are being diagnosed and treated in hospitals across England, Wales, Jersey and Guernsey.

The National Lung Cancer Audit (NLCA) is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, as part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). NHS England and HQIP are joint data controllers for the NLCA. From 1 February 2022, the National Lung Cancer Audit will be run and managed by the Royal College of Surgeons.

Data for this study has previously been shared when the data was controlled and managed by Public Health England (PHE). PHE facilitated data release via its Office of Data Release service (ODR). ODR was responsible for providing a common governance framework for responding to requests to access PHE data for secondary purposes, including service improvement, surveillance and ethically approved research. All requests to access data were reviewed by the ODR and were subject to strict confidentiality provisions. The responsibility for the management of the National Disease Registration Service of which the National Cancer Registration and Analysis Service is a part, transferred from PHE to NHS Digital on 1st October 2021.

NHS England is responsible for determining which projects/topics are included in the NLCA. HQIP, as commissioner of NLCA is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England participates in specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is also involved with developing the scope and purpose of the NLCA through participation in specification development activities and will authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect.

NHS England is a representative of the HQIP Data access request group which authorises data sharing applications for NLCA data from third parties. This Agreement does not permit the Data Controllers to further disseminate NHS Digital data, any further dissemination would be subject to a separate DSA, with appropriate REC support (if required).

The data requested under this agreement is to be used to evaluate the performance of NHS lung cancer services against established standards of care, and to encourage NHS hospitals with unexplained levels of variation in areas of clinical practice or patient outcomes to examine their lung cancer service and formulate action plans to improve their clinical performance. This work is carried out under contract with HQIP.

The NLCA will be delivered by the Clinical Effectiveness Unit (CEU) at the Royal College of Surgeons of England (RCSEng) for the current contract period 01.02.22 – 31.01.25. The CEU is a collaboration between RCSEng and the London School of Hygiene and Tropical Medicine (LSHTM), and has an excellent track record of producing high-quality national cancer audits in prostate, oesophago-gastric, bowel and breast cancers. Clinical leadership is provided by individuals substantively employed by Barts Health NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust and University College London Hospitals NHS Foundation Trust, these individuals act in an advisory capacity only, they do not process the data or determine why or how the data is processed.

The aim of the NLCA is to assess the process of care and its outcomes in patients diagnosed with lung cancer in England and support the NHS in England to improve the length and quality of life of people diagnosed with lung cancer. The NLCA will be a source of valuable information that supports various quality assurance and improvement activities, both at a local level (by NHS trusts, Cancer Alliances, Integrated Care Systems) and a national level (e.g. Care Quality Commission, service commissioning, health care policy). The NLCA activities will drive quality improvement across the country aiming to help lung cancer services reach the highest standards possible.

The NLCA has specific healthcare improvement goals in the current contract period, these have been developed in consultation with the patient and professional representatives (i.e. individuals involved with the Lung Cancer Nursing UK and Roy Castle Lung Cancer Foundation). The goals focus on:

1. Increasing the proportion of patients who receive treatment with curative intent.

2. Increasing the proportion of patients who are assessed by a lung cancer nurse specialist.

3. Reducing the number of patients diagnosed after an emergency presentation. These patients usually have advanced stages and poor prognoses.

4. Improving compliance with the National Optimal Lung Cancer Pathway, which sets tight timeframes for each stage of the care pathway, ideally enabling treatment for patients to start within 49 days of lung cancer being suspected.

5. Reducing variation in quality and improving timeliness for patients undergoing diagnosis.

Patient representatives and clinical steering groups will play a major role in the evolution of the goals and indicators.

To support the Audit in achieving these goals pseudonymised subsets of the following datasets are requested on an annual basis :

• National Cancer Registry Dataset (NCRD)

• National Radiotherapy Dataset (RTDS)

• Systemic Anti-Cancer Therapy Dataset (SACT)

• Admitted Patient Care Hospital Episodes Statistics (HES APC)

In addition, the Audit requires pseudonymised subsets of the following data every quarter:

• Rapid Cancer Registration Dataset (RCRD) linked to HES, RTDS and SACT.

To address the GDPR Principle of Data Minimisation, this request is limited to all patients ≥ 18 years of age with a new diagnosis of lung cancer (ICD10 diagnosis code: C33-C34). The data request is limited to all patients diagnosed with lung cancer from 1st January 2017 to the latest available. National data is required to ensure that the Audit can review the performance of all NHS lung cancer units in England.

The data requested above should provide the Audit with the necessary information on the disease characteristics of patients, their diagnostic pathways, and their combination of treatments (surgery, chemotherapy and/or radiotherapy). There are no alternative less intrusive means of achieving the purpose outlined within this Agreement.

HQIP and NHS England both rely on Article 6 (1) (e) of the General Data Protection Regulation (GDPR) as the lawful basis of processing - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve the quality of health care services.

HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular, professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. The processing meets Schedule 1 Part 1 paragraph 3 of the Data Protection Act 2018 as the processing is carried out by the RCSEng.

NHS England relies on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England is responsible for the provision of health and social care, and management of systems and compliance. The processing meets Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons of England.

The outputs produced by the NLCA are the deliverables in the audit contract with HQIP.

Any data contained within the outputs referenced within this section will be aggregated with small numbers suppressed unless otherwise specified.

The results produced by the NLCA team are published in annual ‘State of the Nation’ (SotN) reports, quarterly dashboards and other documents such as peer-reviewed publications. Results will also be presented at appropriate medical conferences. The intended audience for these outputs is patients and people who deliver, receive, commission and regulate lung cancer care.

The annual SotN reports will highlight where local services should focus on quality improvement activities. In parallel with the publication of the SotN report, provider-level and regional-level results will be published on the publicly available NLCA website which provides transparency and supports patient choice. The results will be published alongside quality improvement tools and resources, and NHS trusts will use this information to assess their care against national standards, clinical guidance and the performance of other trusts.

NHS trust-level indicators (as well as national and regional results) will be reported in a dashboard on the NLCA website. These dashboard results will be refreshed on a quarterly basis and will enable continuous monitoring of NHS providers, essential for supporting local quality improvement. The NLCA website will include the facility to download activity summaries and outcomes as short PDF documents and presentations.

Publications in peer-reviewed journals will broaden the dissemination of the NLCA findings and allow the presentation of the audit results and methodology in more detail than in the SotN reports. In any such reports, the NLCA will use appropriate methods to measure a range of key process and outcome performance indicators, comparing and reporting the performance of NHS providers. The Audit aims to publish in peer-reviewed journals within the next three years.

The results from the SotN report will be presented at annual meetings of the British Thoracic Oncology Group (BTOG; scheduled for January 2023) and the Society for Thoracic Surgery (January 2023) as a minimum. The NLCA team will aim to disseminate their results and reports widely with the support of their stakeholders, including patient charities and professional organisations to ensure maximum engagement with scientific and policy-making communities.

The NLCA will support other key national initiatives including the CQC’s inspection programme, HQIP’s National Clinical Audit Benchmarking (NCAB), the Getting it right first time initiative (GIRFT) and Model Hospital by providing provider-level results.

To ensure that the Audit findings reach interested groups and civil society, the Audit will publish Newsletters (https://www.lungcanceraudit.org.uk/news/categories/enewsletters/) and social media messages to announce the publication of reports. The reports are written in plain language and use infographics to display key findings to make them accessible to lay readers.

The NLCA will also produce lay versions of the NLCA SotN reports for patients and the public, which will be available on the NLCA website. Patient representatives in the NLCA Patient Forum will guide the development of NLCA outputs. Members of the NLCA Patient Forum will also guide the development of the patient summaries and accompanying materials designed for patients including infographics, information leaflets and slide sets for patient support groups to ensure the findings, key messages and recommendations are accessible to a lay audience.

NHS England and HQIP have commissioned the NLCA since 2004. Data for this study has previously been shared when the data was controlled and managed by Public Health England (PHE). As such there are some yielded benefits to be observed from the access to the data for the study prior to NHS Digital becoming data controller. Results of the findings and recommendations that the Audit has published in its annual reports, care providers have been able to implement changes and improvement work that have ultimately benefitted the provision of health and social care in England. The key benefits and yielded benefits outlined in the Audits 2022 report are as follows:

- For patients diagnosed with lung cancer in 2019, 1-year survival improved compared with 2018. This improvement may be linked to the recommendations and changes suggested in the 2021 Audit.

- In 2019 in England, curative treatment rates of NSCLC patients with stage I/II and good performance status from the RCRD were 81%, as a result, the Audit recommended that trusts with lower than expected performance in this area

use a toolkit (published with the Audits 2021 report) to review their processes for selection of patients for such treatment. Since this recommendation has been made this metric fell significantly to 73% in 2020 with a drop in surgical resection rate from 20% to 15%.

- Compared with 2019, lung cancer patients diagnosed in England in 2020 had worse performance status, were more likely to be diagnosed via emergency presentation and less likely to have a pathological diagnosis. The identification of reduction in performance has resulted in the Audit making several recommendations that would support an earlier diagnosis.