National Gastrointestinal Cancer Audit comprising National Bowel Cancer Audit and National Oesophago-Gastric Cancer Audit

The Gastrointestinal Cancer Audit Programme (GICAP) comprises the National Bowel Cancer Audit (NBOCA) and the National Oesophago-Gastric Cancer Audit (NOGCA). The aim of the NBOCA is to assess the quality of care received by patients with bowel cancer in England and Wales. Similarly, the aim of the NOGCA is to assess the quality of care received by patients with oesophago-gastric cancer or oesophageal high-grade dysplasia (a pre-cancerous condition) in England and Wales. The purpose of this application is to aid investigation into case ascertainment for bowel cancer and oesophago-gastric cancer. In addition, these data allow better understanding of the impact COVID-19 had and continues to have on the care and outcomes of those who fall within the inclusion criteria for GICAP.

The audit programme has previously been managed under a single data sharing Agreement, but to minimise the risk of data breaches the decision was made to split the overarching agreement into three separate and more specific agreements DARS-NIC-423859-V7S0R (for NBOCA and NOGCA unlinked quarterly data extracts), DARS-NIC-454669-H0H4X (linkage of NOGCA data), DARS-NIC-376603-K2J9R (linkage of NBOCA data) and DARS-NIC-656842-S5V7V (linkage of NDRS data for NBOCA and NOGCA).

The National GICAP is 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 the joint data controllers for the GICAP data, as together both organisations determine the purposes and means of processing. The Royal College of Surgeons of England (RCS) Clinical Effectiveness Unit (CEU) are the data processor. The CEU at the RCS will be processing the data under the direction of the data controllers, and only for the purposes described within this agreement.

NHS England is responsible for determining which projects/topics are included in the audits. HQIP, as commissioner of GICAP is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the GICAP, participates within 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 GICAP project through participation within specification development activities and may 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 are represented on the HQIP Data access request group which authorises data sharing applications from third parties.

The data requested is to be used for the assessment of performance of services under contract to HQIP.

To support the delivery of GICAP, the project team received and will continue to receive Hospital Episode Statistics – Admitted Patient Care (HES APC) and Civil Registration (Deaths) – Secondary Care Cut on a quarterly basis. The level of the data is pseudonymised.

The latest HES APC data with linked mortality data is required to feed back quarterly results to hospital trusts much quicker than is possible with the information gathered from annual HES records linked to GICAP data. More timely data from the audits is on one of the Programme's key deliverables and it is requested frequently at the Clinical Reference Groups of both audit streams. The contract for the GICAP states that development work will be carried out to provide more frequent and more timely reporting. These timely results on key care processes and outcomes will support hospital trusts in their quality improvement work.

Secondly, up to date HES APC data with linked mortality data is needed to continuously assess the impact of the COVID-19 pandemic on the care and outcomes of patients with oesophago-gastric cancer and bowel cancer and the recovery of health services post-pandemic.

To address the UK GDPR Principle of data minimisation this request is limited to a cohort of approximately 42,000 adult (aged 18 and over at the time of diagnosis) patients who have been diagnosed with or treated for colorectal or OG cancer in England and Wales.

Each quarterly extract is limited to a cohort of patients diagnosed within a 1 year period and includes no more than 3 years’ worth of their medical records.

Clinical Effectiveness Unit requires to retain data going back to 2010/11 (for NBOCA) and 2011/12 (for NOGCA), to enable longitudinal analyses of trends and patterns in cancer care, to plan further analyses, metrics and publications, but also to enable retrospective scrutiny of data, when required by care providers or commissioners such as CQC.

It is crucial that no geographical exclusions are made, otherwise such limitations would compromise the value of the audit itself. In addition, only fields that have been deemed necessary for the purpose of this work have been requested.

HQIP and NHS England request that a mortality indicator, created from data requested under this Agreement, can be onwardly shared with organisations who request it as part of HQIP’s data access request process.

Any data shared for this purpose must be subject to the conditions that the recipient organisation:

i. must not combine it with other datasets which could potentially increase the risk of reidentification for individuals in the dataset;

ii. must not attempt to re-identify individuals in the dataset;

iii. must not onwardly share the dataset;

iv. must use the dataset for a defined purpose;

v. must not publish the data.

Under the terms of this Agreement, HQIP and NHS England are responsible for ensuring compliance with the above conditions and for confirming destruction of the data by the recipient organisation once the data is no longer required for the purpose for which it was shared.

HQIP and NHS England both rely on Article 6 (1) (e) of the UK 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 quality of health care services.

HQIP rely on Article 9 (2) (i) as the legal basis for processing under UK 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 the conditions of Schedule 1 Part 1 paragraph 3 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons.

NHS England rely on Article 9 (2) (h) of the UK 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 are responsible for provision of health and social care, and management of systems and compliance. The processing meets conditions of Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons.

The outputs produced by GICAP are the deliverables contracted as part of the audit process commissioned by HQIP.

The GICAP programme measures the quality of care received by patients diagnosed with bowel and OG cancer within NHS services in England and Wales. It is designed to evaluate the care pathways followed by patients once they have been diagnosed with cancer and to assess outcomes. The GI audits also provide national and trust-level outcomes on end-of-life care.

The outputs are reported at National, Cancer Alliance and NHS Trust level. Examples of specific statistical outputs are:

- Percentage of patients with surgical intent

- Percentage of patients with complications

- Risk adjusted 90-day post-operative mortality

- Risk adjusted 2-year mortality

- Risk adjusted complication rate

- Percentage of adequate lymph node resections

- Percentage of positive resection margin

- Length of stay

- Percentage of unplanned readmissions

The results produced by the Audit teams are published in annual reports, short reports, scientific journal articles and presented at appropriate medical conferences. NHS trust-level outcomes are publicly available on audit web sites, which provides transparency and supports patient choice. In parallel, consultant- and trust-level outcome information are fed back to data providers to ensure the data quality and to reflect back on performance within each hospital. The intended audiences are people who deliver, receive, commission and regulate bowel and oesophago-gastric cancer care. This includes clinicians, healthcare professionals, hospital medical Directors and chief executives, audit managers, commissioners, Care Quality Commission, policy makers such as NHS England, patients and the public.

Trusts use the information in the annual reports to assess their care against national standards, clinical guidance and the performance of other trusts. For example, the Audit outputs show whether trusts are following national recommendations such as those published by the National Institute of Health and Care Excellence (NICE) and whether there is any variation in the provision of care. Risk-adjusted outcomes such as 90-day post-operative mortality enable the identification of potential outlier trusts, which are notified of their outlier status and will investigate the potential causes (these may be related to data quality issues or clinical practice). In cases where clinical practice is identified as contributing to poorer outcomes, trusts’ review and improvement of practices can have a direct impact on patient care.

Outliers at individual surgeon level and at trust level are identified through the analysis undertaken by the RCS CEU. Notifications are sent out for response from the individual surgeons and/or the trusts (as applicable). Their responses on the outlier measures are included in an appendix to the annual report. Clinical Outcomes Publication (COP) data is published on the professional bodies' websites.

Annual reports are presented at the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS), the British Society of Gastroenterology (BSG) and the Association of Coloproctology of Great Britain and Ireland (ACPGBI) annual meetings as a minimum and at other events, as appropriate.

All reports are written in plain language, to make them understandable to lay readers. However, to increase their accessibility, both audits also publish Patient Reports, which are patient-aimed, plain English and abbreviated versions of Annual Reports. The RCS takes the opportunity to disseminate their reports as widely as possible - as can be seen from the conferences attended to promote annual reports, social media messages and further sharing of audit publications by partnering organisations, such as charities, professional bodies, as well as patient and carer groups. Publications in peer-reviewed journals allow presentation of the audits methodology and results in more detail than in the Annual Reports.

All reports are published on the NBOCA and NOGCA web site (https://www.nboca.org.uk/reports-home/ and https://www.nogca.org.uk/reports/) and on the HQIP’s NCAPOP pages (https://www.hqip.org.uk/a-z-of-nca/national-bowel-cancer-audit/#.Y0-pqHbMKbg and https://www.hqip.org.uk/a-z-of-nca/national-oesophago-gastric-cancer-audit/#.Y0-us3bMKbg)

All outputs are aggregated with small numbers suppressed, except when assisting NHS Trusts in evaluating the reasons for their outlier status. Record-level data for the relevant trust is then provided back to the trust upon request to CARMS team. The appropriate section 251 approval is in place to allow the fact of death, in relation to the two mortality indicators, to be shared.

Quality assurance and improvement are among the key objectives of national clinical audits. The two audits within the Gastrointestinal Cancer Audit Programme (GICAP) - NBOCA and NOGCA - evaluate the performance of NHS hospitals using quality indicators based on good practice recommendations from national clinical guidelines. The audit results enable hospitals to benchmark themselves, and they also lead to evidence-based recommendations in the mandatory audit publications: the annual report (which has a state-of-the-Nation perspective), and short reports which focus on specific topics. The results of the audits also support health services, commissioners, as well as patients and their families by providing information on treatment outcomes and the various care pathways for patients with colorectal and oesophago-gastric cancers.

Each publication includes several recommendations for improving patient care. Therefore, the sections below are only a small sample of the impact and improvement to the healthcare system and to patients' outcomes provided by GICAP.

NBOCA

1.

The analysis of patient data collated and analysed by NBOCA over the last 12 years has resulted in a series of key recommendations for cancer service, commissioners and policymakers. These recommendations have been supported by the Association of Coloproctology of Great Britain and Ireland (ACGBI) and fed into updates to NICE guidance on bowel cancer. As an example, NBOCA developed a novel method for reporting on chemotherapy regimens using English SACT and English HES/ Welsh PEDW routine data. This allowed NBOCA to report rates of adjuvant chemotherapy (anti-cancer drug therapy that is used to increase the performance of other treatments being provided) in stage III colon cancer patients by NHS trust in both England and Wales, despite the lack of SACT data in Wales. This led to a recommendation that the NHS services review and ensure evidence-based local policies for offering adjuvant chemotherapy to people following major resection for pathological stage III colon cancer. NBOCA also established a quality improvement initiative to focus on improving cancer outcomes among patients with stage III colon cancer who received adjuvant chemotherapy because there was considerable variation in practice across England and Wales.

As a result of this work, the Audit was able to demonstrate improvement in this aspect of care in the previous NBOCA annual report (2021). Among patients diagnosed between April 2019 and March 2020, 61% of those undergoing major resection for stage III colon cancer received adjuvant chemotherapy. This is an increase from 54% for patients diagnosed in 2016/17. In addition, the variation between NHS trusts in the proportion of these patients receiving adjuvant chemotherapy has reduced, with the number of organisations with patterns of care outside the expected range falling from 27 in 2015/16 to 21 in 2019/20.

2.

On average, approximately 33,000 patients are diagnosed with colorectal cancer each year. Early detection significantly increases patients' chances of successfully going into remission after treatment. That is why the NBOCA reports evaluate the care pathway around the diagnosis and promote the findings that support early diagnosis and its benefits.

NBOCA findings have shown that patients presenting via screening programmes were more likely to have earlier stage disease, to undergo curative treatment and to have bowel cancer amenable to local resection rather than major surgery. This has led to NBOCA making recommendations of relevance to patients, bowel cancer charities, bowel cancer screening programmes in England and Wales, NHS England and all health professionals - in primary and secondary care settings. These recommendations emphasised:

- The need for campaigning, to raise awareness and educate patients about bowel cancer, particularly with regards to signs and symptoms of bowel cancer and

- The importance of the National Bowel Cancer Screening Programme given its association with more favourable outcomes.

Whilst the work around early detection still continues and changes to public awareness and culture (including breaking the taboo of talking about colorectal cancer symptoms) are far from being widely embedded, the results presented in the previous NBOCA annual report (2021) show small improving trends. The percentage of patients diagnosed after an emergency presentation has been slowly decreasing, from 20% in 2015/16 to 18% in 2019/20. A slowly improving trend has also shown for the diagnoses following national screening programmes - from 9% in 2015/16 to 12% in 2019/20.

NOGCA

1.

The NOGCA collects data on patients with high-grade dysplasia (HGD), a pre-cancerous condition about which information is not included in any other national collections or databases. Therefore, NOGCA provides a unique insight into the quality of care received by patients with this condition and patient outcomes. The data relating to HGD have been collected since 2012 and have used the British Society of Gastroenterology's guidelines on the diagnosis and management of HGD to formulate quality indicators and provide information for benchmarking and quality improvement by NHS services.

A State-of-the-Nation perspective is provided each year in the NOGCA Annual Report, and these reports have included recommendations for NHS services that focus on ensuring that:

- all patients with high-grade dysplasia are discussed by a specialist multi-disciplinary team (MDT),

- patients with suspected high-grade dysplasia have their diagnosis confirmed by a second pathologist,

- patients are considered for endoscopic treatment (recommended first-line therapy) and services with unusual patterns of care explore why patients are not being offered endoscopic treatment.

In the previous annual report (2021), NOGCA demonstrated that the proportion of patients with HGD who are discussed at a specialist MDT meeting has increased to 93% (compared to 86% two years earlier) and that 88% of patients had their diagnosis confirmed by a second pathologist (an increase from 84%) and 74% of patients had a plan for endoscopic therapy (an increase from 70%).

2.

In 2017, the audit first published information on surgical pathology indicators that were derived from recommendations in national guidance from the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS). This revealed overall rates of tumour-free resection margins that were above the recommended levels and variation in the number of lymph nodes examined as part of the tumour resection procedures. This led the audit to recommend that specialist surgical centres should:

- increase the proportion of patients who have the recommended minimum number of lymph nodes examined,

- review practice to decrease the proportion of patients who have positive surgical resection margins.

Since 2017, there have been improvements in lymph node yield and tumour-free circumferential margin rates among patients undergoing curative surgery for oesophageal cancer. The proportion of patients with 15 or more lymph nodes examined has increased from 81.9% among patients diagnosed in 2015/16 to 89.2% among those diagnosed in 2019/20. The proportion of patients with positive circumferential margins has decreased from 26.3% to 20.3%. Despite improvements nationally, NOGCA has found substantial variation in the way surgical specimens are prepared for histological assessment, which has prompted AUGIS and the Royal College of Pathologists to collaborate on developing recommendations for the standardisation of these methods.

The Gastrointestinal Cancer Audit Programme (GICAP) comprises the National Bowel Cancer Audit (NBOCA) and the National Oesophago-Gastric Cancer Audit (NOGCA). The aim of the NBOCA is to assess the quality of care received by patients with bowel cancer in England and Wales. Similarly, the aim of the NOGCA is to assess the quality of care received by patients with oesophago-gastric cancer or oesophageal high-grade dysplasia (a pre-cancerous condition) in England and Wales. The purpose of this application is to aid investigation into case ascertainment for bowel cancer and oesophago-gastric cancer. In addition, these data allow better understanding of the impact COVID-19 had and continues to have on the care and outcomes of those who fall within the inclusion criteria for GICAP.

The audit programme has previously been managed under a single data sharing Agreement, but to minimise the risk of data breaches the decision was made to split the overarching agreement into three separate and more specific agreements DARS-NIC-423859-V7S0R (for NBOCA and NOGCA unlinked quarterly data extracts), DARS-NIC-454669-H0H4X (linkage of NOGCA data) and DARS-NIC-376603-K2J9R (linkage of NBOCA data).

The National GICAP is 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 the joint data controllers for the GICAP data, as together both organisations determine the purposes and means of processing. The Royal College of Surgeons of England (RCS) Clinical Effectiveness Unit (CEU) are the data processor. The CEU at the RCS will be processing the data under the direction of the data controllers, and only for the purposes described within this agreement.

NHS England is responsible for determining which projects/topics are included in the audits. HQIP, as commissioner of GICAP is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the GICAP, participates within 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 GICAP project through participation within specification development activities and may 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 are represented on the HQIP Data access request group which authorises data sharing applications from third parties.

The data requested is to be used for the assessment of performance of services under contract to HQIP.

To support the delivery of GICAP, the project team received and will continue to receive Hospital Episode Statistics – Admitted Patient Care (HES APC) and Civil Registration (Deaths) – Secondary Care Cut on a quarterly basis. The level of the data is pseudonymised.

The latest HES APC data with linked mortality data is required to feed back quarterly results to hospital trusts much quicker than is possible with the information gathered from annual HES records linked to GICAP data. More timely data from the audits is on one of the Programme's key deliverables and it is requested frequently at the Clinical Reference Groups of both audit streams. The contract for the GICAP states that development work will be carried out to provide more frequent and more timely reporting. These timely results on key care processes and outcomes will support hospital trusts in their quality improvement work.

Secondly, up to date HES APC data with linked mortality data is needed to continuously assess the impact of the COVID-19 pandemic on the care and outcomes of patients with oesophago-gastric cancer and bowel cancer and the recovery of health services post-pandemic.

To address the UK GDPR Principle of data minimisation this request is limited to a cohort of approximately 42,000 adult (aged 18 and over at the time of diagnosis) patients who have been diagnosed with or treated for colorectal or OG cancer in England and Wales.

Each quarterly extract is limited to a cohort of patients diagnosed within a 1 year period and includes no more than 3 years’ worth of their medical records.

Clinical Effectiveness Unit requires to retain data going back to 2010/11 (for NBOCA) and 2011/12 (for NOGCA), to enable longitudinal analyses of trends and patterns in cancer care, to plan further analyses, metrics and publications, but also to enable retrospective scrutiny of data, when required by care providers or commissioners such as CQC.

It is crucial that no geographical exclusions are made, otherwise such limitations would compromise the value of the audit itself. In addition, only fields that have been deemed necessary for the purpose of this work have been requested.

HQIP and NHS England request that a mortality indicator, created from data requested under this Agreement, can be onwardly shared with organisations who request it as part of HQIP’s data access request process.

Any data shared for this purpose must be subject to the conditions that the recipient organisation:

i. must not combine it with other datasets which could potentially increase the risk of reidentification for individuals in the dataset;

ii. must not attempt to re-identify individuals in the dataset;

iii. must not onwardly share the dataset;

iv. must use the dataset for a defined purpose;

v. must not publish the data.

Under the terms of this Agreement, HQIP and NHS England are responsible for ensuring compliance with the above conditions and for confirming destruction of the data by the recipient organisation once the data is no longer required for the purpose for which it was shared.

HQIP and NHS England both rely on Article 6 (1) (e) of the UK 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 quality of health care services.

HQIP rely on Article 9 (2) (i) as the legal basis for processing under UK 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 the conditions of Schedule 1 Part 1 paragraph 3 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons.

NHS England rely on Article 9 (2) (h) of the UK 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 are responsible for provision of health and social care, and management of systems and compliance. The processing meets conditions of Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons.

The outputs produced by GICAP are the deliverables contracted as part of the audit process commissioned by HQIP.

The GICAP programme measures the quality of care received by patients diagnosed with bowel and OG cancer within NHS services in England and Wales. It is designed to evaluate the care pathways followed by patients once they have been diagnosed with cancer and to assess outcomes. The GI audits also provide national and trust-level outcomes on end-of-life care.

The outputs are reported at National, Cancer Alliance and NHS Trust level. Examples of specific statistical outputs are:

- Percentage of patients with surgical intent

- Percentage of patients with complications

- Risk adjusted 90-day post-operative mortality

- Risk adjusted 2-year mortality

- Risk adjusted complication rate

- Percentage of adequate lymph node resections

- Percentage of positive resection margin

- Length of stay

- Percentage of unplanned readmissions

The results produced by the Audit teams are published in annual reports, short reports, scientific journal articles and presented at appropriate medical conferences. NHS trust-level outcomes are publicly available on audit web sites, which provides transparency and supports patient choice. In parallel, consultant- and trust-level outcome information are fed back to data providers to ensure the data quality and to reflect back on performance within each hospital. The intended audiences are people who deliver, receive, commission and regulate bowel and oesophago-gastric cancer care. This includes clinicians, healthcare professionals, hospital medical Directors and chief executives, audit managers, commissioners, Care Quality Commission, policy makers such as NHS England, patients and the public.

Trusts use the information in the annual reports to assess their care against national standards, clinical guidance and the performance of other trusts. For example, the Audit outputs show whether trusts are following national recommendations such as those published by the National Institute of Health and Care Excellence (NICE) and whether there is any variation in the provision of care. Risk-adjusted outcomes such as 90-day post-operative mortality enable the identification of potential outlier trusts, which are notified of their outlier status and will investigate the potential causes (these may be related to data quality issues or clinical practice). In cases where clinical practice is identified as contributing to poorer outcomes, trusts’ review and improvement of practices can have a direct impact on patient care.

Outliers at individual surgeon level and at trust level are identified through the analysis undertaken by the RCS CEU. Notifications are sent out for response from the individual surgeons and/or the trusts (as applicable). Their responses on the outlier measures are included in an appendix to the annual report. Clinical Outcomes Publication (COP) data is published on the professional bodies' websites.

Annual reports are presented at the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS), the British Society of Gastroenterology (BSG) and the Association of Coloproctology of Great Britain and Ireland (ACPGBI) annual meetings as a minimum and at other events, as appropriate.

All reports are written in plain language, to make them understandable to lay readers. However, to increase their accessibility, both audits also publish Patient Reports, which are patient-aimed, plain English and abbreviated versions of Annual Reports. The RCS takes the opportunity to disseminate their reports as widely as possible - as can be seen from the conferences attended to promote annual reports, social media messages and further sharing of audit publications by partnering organisations, such as charities, professional bodies, as well as patient and carer groups. Publications in peer-reviewed journals allow presentation of the audits methodology and results in more detail than in the Annual Reports.

All reports are published on the NBOCA and NOGCA web site (https://www.nboca.org.uk/reports-home/ and https://www.nogca.org.uk/reports/) and on the HQIP’s NCAPOP pages (https://www.hqip.org.uk/a-z-of-nca/national-bowel-cancer-audit/#.Y0-pqHbMKbg and https://www.hqip.org.uk/a-z-of-nca/national-oesophago-gastric-cancer-audit/#.Y0-us3bMKbg)

All outputs are aggregated with small numbers suppressed, except when assisting NHS Trusts in evaluating the reasons for their outlier status. Record-level data for the relevant trust is then provided back to the trust upon request to CARMS team. The appropriate section 251 approval is in place to allow the fact of death, in relation to the two mortality indicators, to be shared.

Quality assurance and improvement are among the key objectives of national clinical audits. The two audits within the Gastrointestinal Cancer Audit Programme (GICAP) - NBOCA and NOGCA - evaluate the performance of NHS hospitals using quality indicators based on good practice recommendations from national clinical guidelines. The audit results enable hospitals to benchmark themselves, and they also lead to evidence-based recommendations in the mandatory audit publications: the annual report (which has a state-of-the-Nation perspective), and short reports which focus on specific topics. The results of the audits also support health services, commissioners, as well as patients and their families by providing information on treatment outcomes and the various care pathways for patients with colorectal and oesophago-gastric cancers.

Each publication includes several recommendations for improving patient care. Therefore, the sections below are only a small sample of the impact and improvement to the healthcare system and to patients' outcomes provided by GICAP.

NBOCA

1.

The analysis of patient data collated and analysed by NBOCA over the last 12 years has resulted in a series of key recommendations for cancer service, commissioners and policymakers. These recommendations have been supported by the Association of Coloproctology of Great Britain and Ireland (ACGBI) and fed into updates to NICE guidance on bowel cancer. As an example, NBOCA developed a novel method for reporting on chemotherapy regimens using English SACT and English HES/ Welsh PEDW routine data. This allowed NBOCA to report rates of adjuvant chemotherapy (anti-cancer drug therapy that is used to increase the performance of other treatments being provided) in stage III colon cancer patients by NHS trust in both England and Wales, despite the lack of SACT data in Wales. This led to a recommendation that the NHS services review and ensure evidence-based local policies for offering adjuvant chemotherapy to people following major resection for pathological stage III colon cancer. NBOCA also established a quality improvement initiative to focus on improving cancer outcomes among patients with stage III colon cancer who received adjuvant chemotherapy because there was considerable variation in practice across England and Wales.

As a result of this work, the Audit was able to demonstrate improvement in this aspect of care in the previous NBOCA annual report (2021). Among patients diagnosed between April 2019 and March 2020, 61% of those undergoing major resection for stage III colon cancer received adjuvant chemotherapy. This is an increase from 54% for patients diagnosed in 2016/17. In addition, the variation between NHS trusts in the proportion of these patients receiving adjuvant chemotherapy has reduced, with the number of organisations with patterns of care outside the expected range falling from 27 in 2015/16 to 21 in 2019/20.

2.

On average, approximately 33,000 patients are diagnosed with colorectal cancer each year. Early detection significantly increases patients' chances of successfully going into remission after treatment. That is why the NBOCA reports evaluate the care pathway around the diagnosis and promote the findings that support early diagnosis and its benefits.

NBOCA findings have shown that patients presenting via screening programmes were more likely to have earlier stage disease, to undergo curative treatment and to have bowel cancer amenable to local resection rather than major surgery. This has led to NBOCA making recommendations of relevance to patients, bowel cancer charities, bowel cancer screening programmes in England and Wales, NHS England and all health professionals - in primary and secondary care settings. These recommendations emphasised:

- The need for campaigning, to raise awareness and educate patients about bowel cancer, particularly with regards to signs and symptoms of bowel cancer and

- The importance of the National Bowel Cancer Screening Programme given its association with more favourable outcomes.

Whilst the work around early detection still continues and changes to public awareness and culture (including breaking the taboo of talking about colorectal cancer symptoms) are far from being widely embedded, the results presented in the previous NBOCA annual report (2021) show small improving trends. The percentage of patients diagnosed after an emergency presentation has been slowly decreasing, from 20% in 2015/16 to 18% in 2019/20. A slowly improving trend has also shown for the diagnoses following national screening programmes - from 9% in 2015/16 to 12% in 2019/20.

NOGCA

1.

The NOGCA collects data on patients with high-grade dysplasia (HGD), a pre-cancerous condition about which information is not included in any other national collections or databases. Therefore, NOGCA provides a unique insight into the quality of care received by patients with this condition and patient outcomes. The data relating to HGD have been collected since 2012 and have used the British Society of Gastroenterology's guidelines on the diagnosis and management of HGD to formulate quality indicators and provide information for benchmarking and quality improvement by NHS services.

A State-of-the-Nation perspective is provided each year in the NOGCA Annual Report, and these reports have included recommendations for NHS services that focus on ensuring that:

- all patients with high-grade dysplasia are discussed by a specialist multi-disciplinary team (MDT),

- patients with suspected high-grade dysplasia have their diagnosis confirmed by a second pathologist,

- patients are considered for endoscopic treatment (recommended first-line therapy) and services with unusual patterns of care explore why patients are not being offered endoscopic treatment.

In the previous annual report (2021), NOGCA demonstrated that the proportion of patients with HGD who are discussed at a specialist MDT meeting has increased to 93% (compared to 86% two years earlier) and that 88% of patients had their diagnosis confirmed by a second pathologist (an increase from 84%) and 74% of patients had a plan for endoscopic therapy (an increase from 70%).

2.

In 2017, the audit first published information on surgical pathology indicators that were derived from recommendations in national guidance from the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS). This revealed overall rates of tumour-free resection margins that were above the recommended levels and variation in the number of lymph nodes examined as part of the tumour resection procedures. This led the audit to recommend that specialist surgical centres should:

- increase the proportion of patients who have the recommended minimum number of lymph nodes examined,

- review practice to decrease the proportion of patients who have positive surgical resection margins.

Since 2017, there have been improvements in lymph node yield and tumour-free circumferential margin rates among patients undergoing curative surgery for oesophageal cancer. The proportion of patients with 15 or more lymph nodes examined has increased from 81.9% among patients diagnosed in 2015/16 to 89.2% among those diagnosed in 2019/20. The proportion of patients with positive circumferential margins has decreased from 26.3% to 20.3%. Despite improvements nationally, NOGCA has found substantial variation in the way surgical specimens are prepared for histological assessment, which has prompted AUGIS and the Royal College of Pathologists to collaborate on developing recommendations for the standardisation of these methods.

The Gastro-Intestinal Cancer Audit Programme (GICAP) comprises of the National Bowel Cancer Audit (NBOCA) and the National Oesophago-Gastric Cancer Audit (NOGCA).

A contract was awarded in early 2018 by Healthcare Quality Improvement Partnership (HQIP) to the Royal College of Surgeons and NHS Digital (the legal entity of the data processor is “HSCIC” who are trading as “NHS Digital”) to deliver the Gastro-Intestinal (GI) Cancer audit for 3 years, until 31st May 2021. This has now been extended to May 2023, which is when this Agreement is due to expire.

The National Gastro-Intestinal Cancer Audit Programme is 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).

The purposes for processing the data under this Agreement have joint Data Controllership consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. HQIP is commissioned by NHS England to commission and manage the Gastro-Intestinal Cancer Audit Programme (GICAP), NHS England is a controller of the GICAP jointly with HQIP as together both organisations determine the purposes and means of processing.

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

NHS England is involved with developing the scope and purpose of the GICAP project through participation within specification development activities and may 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 are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties

The data requested is to be used for the performance of services under contract to the Healthcare Quality Improvement Partnership (HQIP). All Intellectual Property Rights (IPR) in any guidance, specifications, instructions, toolkits, plans, data, drawings, databases, patents, patterns, models, design, or other material, furnished or made available to NHS Digital as part of this request remains vested solely in HQIP. This IPR is in turn vested to NHS England through HQIP’s headline contract with them.

The Clinical Audits and Registries Management Service (CARMS) at NHS Digital, and the Clinical Excellence Unit (CEU) at the Royal College of Surgeons (RCS) will be processing the data under the direction of the data controllers, and only for the purposes described within this Agreement.

The aim of the National Bowel Cancer Audit is to assess the quality of care received by patients with bowel cancer in England and Wales. Similarly, the aim of the Oesophago-gastric Cancer Audit is to assess the quality of care received by patients with oesophago-gastric cancer or oesophageal high-grade dysplasia (a pre-cancerous condition) in England and Wales. The purpose of this application is to aid investigation into case ascertainment for bowel cancer and oesophago-gastric cancer or oesophageal high-grade dysplasia, and to better understand the impact of COVID-19 on the care and outcomes of those who fall within the inclusion criteria for GICAP.

To support this work the Clinical Audits and Registries Management Service (CARMS) within NHS Digital have, and will continue to receive HES APC, HES A&E, ECDS, HES OP and Civil Registration Deaths (Secondary Care Cut). The cohort is identified by ICD10 Diagnosis Codes or OPCS Procedure codes in HES and should return information on those who fit the inclusion criteria but are not included in the Audit cohort to enable assessment of case ascertainment, and the outcomes of those patients who are not currently in the Audit cohort.

The latest HES Admitted Patient Care (APC) data with linked mortality data is required on a quarterly frequency. This will be used to feedback quarterly results to hospital trusts much more quickly than is possible with the HES data linked to GICAP data. More timely data from the audits is high on the agenda of all stakeholders and is requested frequently at the Clinical Reference Groups of both audit streams. The contract for the GICAP states that development work will be carried out to provide more frequent more timely reporting. These timely results on key care processes and outcomes will support hospital trusts in their quality improvement work. Secondly, up to date HES-APC data with linked mortality data is needed urgently to assess the impact of the ongoing COVID-19 pandemic on the care and outcomes of patients with oesophago-gastric cancer and bowel cancer. To allow comparisons over multiple years HES APC will also be disseminated annually, and will be inclusive of the most recent five-years of data.

HES Outpatients’ (OP) data will be received on all patients with ICD10 Diagnosis Codes or OPCS Procedure codes associated with Bowel Cancer only. This will provide information on care earlier and later in patient’s pathways in order to assess their diagnostic pathway, identify how many visits and what procedures patients have undergone prior to and after a diagnosis being made. Having outpatient data will allow the audit to evaluate whether patients are being diagnosed in a timely and appropriate manner, assess whether they are receiving the surveillance they should following treatment, and identify patterns of care which indicate that the cancer has recurred or progressed.

HES A&E/ ECDS: Under this Agreement GICAP will receive HES A&E and ECDS data for all patients with ICD10 Diagnosis Codes or OPCS Procedure codes associated with Bowel Cancer Only. Access to A&E and ECDS data will be invaluable with regards to widening how NBOCA assesses the care of patients with bowel cancer, in particular the burden on patients in terms of unplanned hospital attendances. As an example, there is a need to examine the impact of chemotherapy and radiotherapy on patients in terms of acute toxicity. As part of this NBOCA will look at how many times patients present to A&E with problems related to the side-effects of these treatments. None of this is possible with the data currently held by NBOCA.

Civil Registration (Deaths) data is requested to better understand patient outcomes.

Where available the Audit would like to receive provisional ('M13') data to support the timely delivery of the NBOCA and NOGCA annual reports.

To address the GDPR Principle of Data Minimisation only fields that have been deemed necessary for the purposes of this work have been requested.

HQIP and NHS England both rely on the Article 6 (1) (e) of the 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 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.

NHS England rely 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 are responsible for provision of health and social care, and management of systems and compliance.

Many of the outputs produced by NBOCA and NOGCA are contracted deliverables as part of an on-going part of the audit process commissioned by HQIP.

The Audit measures the quality of care received by patients diagnosed with bowel cancer and oesophago-gastric cancer or oesophageal high-grade dysplasia within NHS services in England and Wales. It is designed to evaluate the care pathways followed by patients once they have been diagnosed with these diseases and to assess outcomes. The findings of Audit are published in annual reports.

The National Bowel Cancer 2021 Annual report is targeted for publication in November 2021.

The National Bowel Cancer 2020 Annual report was published in December 2020.

The National Bowel Cancer 2019 Annual report was published in January 2020.

The National Bowel Cancer Audit published two short reports in July 2020 and will do the same in July 2021. It also released a prize-winning poster at a professional conference in 2019. Several papers and conference reports were published in 2020 using this data.

The National Oesophago-Gastric Cancer 2021 Annual report is targeted for publication in December 2021.

The National Oesophago-Gastric Cancer 2020 Annual report was published in December 2020.

The National Oesophago-Gastric Cancer 2019 Annual report was published in December 2019

This audit also published a short report in June 2019 and the summer of 2020. Several papers and conference reports were produced in the 2020 NHS Digital Data.

All reports are written in patient friendly language and can be understood by the lay reader, and The RCS takes the opportunity to disseminate their reports as widely as possible - as can be seen from the conferences attended to promote annual reports.

It is anticipated that the annual reports will be presented at the AUGIS, British Society of Gastroenterology (BSG) and ACPGBI annual meetings as a minimum and others as appropriate

Publication in peer-reviewed journals will allow presentation of the Audit methodology and results in more detail than in the Annual reports. For example, the findings of the 2016 Annual Report for NBOCA and NOGCA were published in several journals and presented at several conferences in 2017 including the annual meetings of each of the British Society of Gastroenterologists (BSG) the Association of Upper Gastro-intestinal Society (AUGIS) and the Association of Colo-proctologists in Great Britain and Ireland (ACPGBI). Presentations were also made at the PHE Cancer Data and Outcomes Conference.

The audit will provide national and trust level outcomes on end-of-life care.

The Audit will report on the feasibility of using information reported by patients themselves about the experience of their bowel cancer care and the feasibility of using information reported by patients themselves about the outcomes of their bowel cancer e.g., symptoms, functional status and quality of life.

The outputs are reported at National, Cancer Alliance and NHS Trust level. Examples of specific statistical outputs are:

NBOCA

• Percentage of patients with surgical intent

• Percentage of patients with complications

• Risk adjusted 90-day post-operative mortality

• Risk adjusted 2-year mortality

• Risk adjusted complication rate

• Percentage of adequate lymph node resections

• Percentage of positive resection margin

• Length of stay

• Percentage of unplanned readmissions

NOGCA

• Percentage of patients with curative treatment intent

• Risk adjusted 30- and 90-day post-operative mortality

• Percentage of adequate lymph node resections

• Percentage of positive resection margins

• Length of stay

Outputs on the management of patients with rectal cancer and advanced disease are also included in the NBOCA annual report.

Outliers at individual surgeon level and at trust level are identified through the analysis undertaken by the RCS CEU. Notifications are sent out for response from the individual surgeons and/or the trusts (as applicable). Their responses on the outlier measures are included in an appendix to the annual report. Clinical Outcomes Publication (COP) data is published on the professional bodies' websites (Advancing Knowledge and treatment of bowel disease (ACPGBI)/Association of Upper Gastrointestinal Surgeons (AUGIS) respectively) before being made available to the public via NHS Choices.

All outputs will be aggregated with small numbers suppressed except when assisting NHS Trusts in evaluating the reasons for their outlier status. Record level data for the relevant trust will be provided back to the trust upon request to NHS Digital, appropriate s251 is in place to allow the fact of death in relation to the two mortality indicators to be shared. Data files for these requests will be provided in a 256-bit encrypted zip file to a named individual via NHS.net; the password for the file will be sent to another named individual nominated by the trust, again using NHS.net email.

The OG cancer audit has shown the following outcomes:

1. A reduction in the percentage of patients diagnosed following emergency admissions, compared to 5 years ago

2. An increase in the proportion of patients receiving curative surgery

3. Postoperative mortality (both 30 & 90 days) has continued to fall over the last 6 years

4. Individual NHS trusts can download their own data for local use from the Audit IT system, thereby supporting local clinical audit and service evaluation. The IT system also provides hospitals with access to a series of online reports that describes their own performance relative to national benchmarks.

In addition to these clinical benefits, the CEU are able to report on national figures of treatment and outcomes of patients diagnosed with high-grade dysplasia. This is the only national source of data on these patients in the UK.

The OG Cancer Audit is now a repository of data on over 80,000 patients with OG cancer across England & Wales which represents a unique resource of clinical data. The data is available for secondary use by researchers through the HQIP Data Access Request Process (please note that this does not contain any NHS Digital data other than aggregated data with small numbers suppressed).

The OG Cancer audit project team is also working with CQC to implement improvements in data quality and completeness.

The NBOCA has shown the following impacts:

1. A reduction in diagnosis following emergency admissions, compared to 5 years ago and a lower risk of death after curative surgery

2. An increase in the proportion of patients receiving curative surgery

3. Postoperative mortality (both 30 & 90 days) has continued to fall over the last 6 years. And evidence of an acceleration in reduction in mortality coinciding with the start of clinical outcomes publication.

4. Providers and surgeons with outcomes that are outside the expected range are notified by the audit each year. They are asked to carry out a review and provide a response to be published, describing the actions they have taken and will continue to take. NBOCA maintains close connections with CQC and the Welsh Government regarding the outlier process.

5. Individual NHS trusts can download their own data for local use from the Audit IT system, thereby supporting local clinical audit and service evaluation. The IT system also provides hospitals with access to a series of online reports that describes their own performance relative to national benchmarks.

6. Results of NBOCA on advanced bowel cancer directly led to the Pelican’s Advanced Cancer Quality Improvement programme.

7. The 2020 Annual Report showed that approximately 4% of patients aged 65 and over who are diagnosed with colorectal cancer have an accompanying diagnosis of dementia. These patients are a high-risk group with poor prognostic features including older age, poor fitness, and emergency presentation. 25% of patients with dementia undergo major resection compared to 62% of those without dementia, and 2-year survival rates are markedly worse (31% vs 65%).

8. New NICE guidelines have suggested that hospitals should be performing a minimum of 10 rectal cancer resections per year, and surgeons should be performing a minimum of 5 resections a year. The median annual number of rectal resections reported per site was 25 (interquartile range 19 to 36) with 5% of sites not performing above this threshold. At surgeon level, the median annual number of cases was 5 (interquartile range 3 to 7) with 56% of surgeons performing in line with the new NICE guideline

The Gastro-Intestinal Cancer Audit Programme (GICAP) comprises of the National Bowel Cancer Audit (NBOCA) and the National Oesophago-Gastric Cancer Audit (NOGCA).

A contract was awarded in early 2018 by Healthcare Quality Improvement Partnership (HQIP) to the Royal College of Surgeons and NHS Digital (the legal entity of the data processor is “HSCIC” who are trading as “NHS Digital”) to deliver the Gastro-Intestinal (GI) Cancer audit for 3 years, until 31st May 2021. This has now been extended to May 2023, which is when this Agreement is due to expire.

The National Gastro-Intestinal Cancer Audit Programme is 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).

The purposes for processing the data under this Agreement have joint Data Controllership consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. HQIP is commissioned by NHS England to commission and manage the Gastro-Intestinal Cancer Audit Programme (GICAP), NHS England is a controller of the GICAP jointly with HQIP as together both organisations determine the purposes and means of processing.

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

NHS England is involved with developing the scope and purpose of the GICAP project through participation within specification development activities and may 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 are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties

The data requested is to be used for the performance of services under contract to the Healthcare Quality Improvement Partnership (HQIP). All Intellectual Property Rights (IPR) in any guidance, specifications, instructions, toolkits, plans, data, drawings, databases, patents, patterns, models, design, or other material, furnished or made available to NHS Digital as part of this request remains vested solely in HQIP. This IPR is in turn vested to NHS England through HQIP’s headline contract with them.

The Clinical Audits and Registries Management Service (CARMS) at NHS Digital, and the Clinical Excellence Unit (CEU) at the Royal College of Surgeons (RCS) will be processing the data under the direction of the data controllers, and only for the purposes described within this Agreement.

The aim of the National Bowel Cancer Audit is to assess the quality of care received by patients with bowel cancer in England and Wales. Similarly, the aim of the Oesophago-gastric Cancer Audit is to assess the quality of care received by patients with oesophago-gastric cancer or oesophageal high-grade dysplasia (a pre-cancerous condition) in England and Wales. The purpose of this application is to aid investigation into case ascertainment for bowel cancer and oesophago-gastric cancer or oesophageal high-grade dysplasia, and to better understand the impact of COVID-19 on the care and outcomes of those who fall within the inclusion criteria for GICAP.

To support this work the Clinical Audits and Registries Management Service (CARMS) within NHS Digital have, and will continue to receive HES APC, HES A&E, ECDS, HES OP and Civil Registration Deaths (Secondary Care Cut). The cohort is identified by ICD10 Diagnosis Codes or OPCS Procedure codes in HES and should return information on those who fit the inclusion criteria but are not included in the Audit cohort to enable assessment of case ascertainment, and the outcomes of those patients who are not currently in the Audit cohort.

The latest HES Admitted Patient Care (APC) data with linked mortality data is required on a quarterly frequency. This will be used to feedback quarterly results to hospital trusts much more quickly than is possible with the HES data linked to GICAP data. More timely data from the audits is high on the agenda of all stakeholders and is requested frequently at the Clinical Reference Groups of both audit streams. The contract for the GICAP states that development work will be carried out to provide more frequent more timely reporting. These timely results on key care processes and outcomes will support hospital trusts in their quality improvement work. Secondly, up to date HES-APC data with linked mortality data is needed urgently to assess the impact of the ongoing COVID-19 pandemic on the care and outcomes of patients with oesophago-gastric cancer and bowel cancer. To allow comparisons over multiple years HES APC will also be disseminated annually, and will be inclusive of the most recent five-years of data.

HES Outpatients’ (OP) data will be received on all patients with ICD10 Diagnosis Codes or OPCS Procedure codes associated with Bowel Cancer only. This will provide information on care earlier and later in patient’s pathways in order to assess their diagnostic pathway, identify how many visits and what procedures patients have undergone prior to and after a diagnosis being made. Having outpatient data will allow the audit to evaluate whether patients are being diagnosed in a timely and appropriate manner, assess whether they are receiving the surveillance they should following treatment, and identify patterns of care which indicate that the cancer has recurred or progressed.

HES A&E/ ECDS: Under this Agreement GICAP will receive HES A&E and ECDS data for all patients with ICD10 Diagnosis Codes or OPCS Procedure codes associated with Bowel Cancer Only. Access to A&E and ECDS data will be invaluable with regards to widening how NBOCA assesses the care of patients with bowel cancer, in particular the burden on patients in terms of unplanned hospital attendances. As an example, there is a need to examine the impact of chemotherapy and radiotherapy on patients in terms of acute toxicity. As part of this NBOCA will look at how many times patients present to A&E with problems related to the side-effects of these treatments. None of this is possible with the data currently held by NBOCA.

Civil Registration (Deaths) data is requested to better understand patient outcomes.

To address the GDPR Principle of Data Minimisation only fields that have been deemed necessary for the purposes of this work have been requested.

HQIP and NHS England both rely on the Article 6 (1) (e) of the 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 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.

NHS England rely 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 are responsible for provision of health and social care, and management of systems and compliance.

Many of the outputs produced by NBOCA and NOGCA are contracted deliverables as part of an on-going part of the audit process commissioned by HQIP.

The Audit measures the quality of care received by patients diagnosed with bowel cancer and oesophago-gastric cancer or oesophageal high-grade dysplasia within NHS services in England and Wales. It is designed to evaluate the care pathways followed by patients once they have been diagnosed with these diseases and to assess outcomes. The findings of Audit are published in annual reports.

The National Bowel Cancer 2021 Annual report is targeted for publication in November 2021.

The National Bowel Cancer 2020 Annual report was published in December 2020.

The National Bowel Cancer 2019 Annual report was published in January 2020.

The National Bowel Cancer Audit published two short reports in July 2020 and will do the same in July 2021. It also released a prize-winning poster at a professional conference in 2019. Several papers and conference reports were published in 2020 using this data.

The National Oesophago-Gastric Cancer 2021 Annual report is targeted for publication in December 2021.

The National Oesophago-Gastric Cancer 2020 Annual report was published in December 2020.

The National Oesophago-Gastric Cancer 2019 Annual report was published in December 2019

This audit also published a short report in June 2019 and the summer of 2020. Several papers and conference reports were produced in the 2020 NHS Digital Data.

All reports are written in patient friendly language and can be understood by the lay reader, and The RCS takes the opportunity to disseminate their reports as widely as possible - as can be seen from the conferences attended to promote annual reports.

It is anticipated that the annual reports will be presented at the AUGIS, British Society of Gastroenterology (BSG) and ACPGBI annual meetings as a minimum and others as appropriate

Publication in peer-reviewed journals will allow presentation of the Audit methodology and results in more detail than in the Annual reports. For example, the findings of the 2016 Annual Report for NBOCA and NOGCA were published in several journals and presented at several conferences in 2017 including the annual meetings of each of the British Society of Gastroenterologists (BSG) the Association of Upper Gastro-intestinal Society (AUGIS) and the Association of Colo-proctologists in Great Britain and Ireland (ACPGBI). Presentations were also made at the PHE Cancer Data and Outcomes Conference.

The audit will provide national and trust level outcomes on end-of-life care.

The Audit will report on the feasibility of using information reported by patients themselves about the experience of their bowel cancer care and the feasibility of using information reported by patients themselves about the outcomes of their bowel cancer e.g., symptoms, functional status and quality of life.

The outputs are reported at National, Cancer Alliance and NHS Trust level. Examples of specific statistical outputs are:

NBOCA

• Percentage of patients with surgical intent

• Percentage of patients with complications

• Risk adjusted 90-day post-operative mortality

• Risk adjusted 2-year mortality

• Risk adjusted complication rate

• Percentage of adequate lymph node resections

• Percentage of positive resection margin

• Length of stay

• Percentage of unplanned readmissions

NOGCA

• Percentage of patients with curative treatment intent

• Risk adjusted 30- and 90-day post-operative mortality

• Percentage of adequate lymph node resections

• Percentage of positive resection margins

• Length of stay

Outputs on the management of patients with rectal cancer and advanced disease are also included in the NBOCA annual report.

Outliers at individual surgeon level and at trust level are identified through the analysis undertaken by the RCS CEU. Notifications are sent out for response from the individual surgeons and/or the trusts (as applicable). Their responses on the outlier measures are included in an appendix to the annual report. Clinical Outcomes Publication (COP) data is published on the professional bodies' websites (Advancing Knowledge and treatment of bowel disease (ACPGBI)/Association of Upper Gastrointestinal Surgeons (AUGIS) respectively) before being made available to the public via NHS Choices.

All outputs will be aggregated with small numbers suppressed except when assisting NHS Trusts in evaluating the reasons for their outlier status. Record level data for the relevant trust will be provided back to the trust upon request to NHS Digital, appropriate s251 is in place to allow the fact of death in relation to the two mortality indicators to be shared. Data files for these requests will be provided in a 256-bit encrypted zip file to a named individual via NHS.net; the password for the file will be sent to another named individual nominated by the trust, again using NHS.net email.

The OG cancer audit has shown the following outcomes:

1. A reduction in the percentage of patients diagnosed following emergency admissions, compared to 5 years ago

2. An increase in the proportion of patients receiving curative surgery

3. Postoperative mortality (both 30 & 90 days) has continued to fall over the last 6 years

4. Individual NHS trusts can download their own data for local use from the Audit IT system, thereby supporting local clinical audit and service evaluation. The IT system also provides hospitals with access to a series of online reports that describes their own performance relative to national benchmarks.

In addition to these clinical benefits, the CEU are able to report on national figures of treatment and outcomes of patients diagnosed with high-grade dysplasia. This is the only national source of data on these patients in the UK.

The OG Cancer Audit is now a repository of data on over 80,000 patients with OG cancer across England & Wales which represents a unique resource of clinical data. The data is available for secondary use by researchers through the HQIP Data Access Request Process (please note that this does not contain any NHS Digital data other than aggregated data with small numbers suppressed).

The OG Cancer audit project team is also working with CQC to implement improvements in data quality and completeness.

The NBOCA has shown the following impacts:

1. A reduction in diagnosis following emergency admissions, compared to 5 years ago and a lower risk of death after curative surgery

2. An increase in the proportion of patients receiving curative surgery

3. Postoperative mortality (both 30 & 90 days) has continued to fall over the last 6 years. And evidence of an acceleration in reduction in mortality coinciding with the start of clinical outcomes publication.

4. Providers and surgeons with outcomes that are outside the expected range are notified by the audit each year. They are asked to carry out a review and provide a response to be published, describing the actions they have taken and will continue to take. NBOCA maintains close connections with CQC and the Welsh Government regarding the outlier process.

5. Individual NHS trusts can download their own data for local use from the Audit IT system, thereby supporting local clinical audit and service evaluation. The IT system also provides hospitals with access to a series of online reports that describes their own performance relative to national benchmarks.

6. Results of NBOCA on advanced bowel cancer directly led to the Pelican’s Advanced Cancer Quality Improvement programme.

7. The 2020 Annual Report showed that approximately 4% of patients aged 65 and over who are diagnosed with colorectal cancer have an accompanying diagnosis of dementia. These patients are a high-risk group with poor prognostic features including older age, poor fitness, and emergency presentation. 25% of patients with dementia undergo major resection compared to 62% of those without dementia, and 2-year survival rates are markedly worse (31% vs 65%).

8. New NICE guidelines have suggested that hospitals should be performing a minimum of 10 rectal cancer resections per year, and surgeons should be performing a minimum of 5 resections a year. The median annual number of rectal resections reported per site was 25 (interquartile range 19 to 36) with 5% of sites not performing above this threshold. At surgeon level, the median annual number of cases was 5 (interquartile range 3 to 7) with 56% of surgeons performing in line with the new NICE guideline