National Gastrointestinal Cancer Audit Programme (GICAP) - National Bowel Cancer Audit (NBOCA)

The Gastrointestinal Cancer Audit Programme (GICAP) comprises the National Bowel Cancer Audit (NBOCA) and the National Oesophago-Gastric Cancer Audit (NOGCA). This application relates solely to the NBOCA workstream. The aim of NBOCA is to assess the quality of care received by patients with bowel cancer in England and Wales, providing those who commission, deliver and use services for people with colorectal cancer with high quality data on the process and outcomes of NHS care.

The audit programme has previously been managed under a single data sharing Agreement, but to minimise the risk of data breaches and to utilise the automated Civil Registrations (Deaths) and Demographics products the decision was made to split the overarching agreement into three separate and more specific agreements DARS-NIC-376603-K2J9R (linkage of NBOCA data), DARS-NIC-454669-H0H4X (linkage of NOGCA data), DARS-NIC-423859-V7S0R (unlinked NBOCA and NOGCA quarterly data reports) 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 being retained is to be used for the assessment of performance of services under contract to HQIP.

The audit is based on prospectively collected, patient-level data and collectively cover adult patients (aged 18 or over) diagnosed with colorectal cancer in England and Wales. It combines these patient records with records from other available national datasets to provide information to NHS trusts, patients, commissioners and other stakeholders on the patterns of care from diagnosis to the end of the primary treatment pathway (both curative and palliative treatments) and patient outcomes. Apart from supplying a rich description of the care process, audits such as NBOCA aim to minimise the burden of data collection on clinical staff.

To support the delivery of NBOCA, the project team have already received the below datasets from NHS England's Data Access Request Service (DARS). There is no other reasonable means to achieve the purpose that is less intrusive to the data subjects. The level of the data is pseudonymised.

- Hospital Episodes Statistics – Outpatients (HES OP) - Outpatients’ data provide information on care earlier and later in patients’ pathways 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 allows 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.

- Hospital Episode Statistics Accident & Emergency (HES A&) and Emergency Care Data Set (ECDS) - Access to A&E and ECDS data is 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 looks 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 other data currently held by NBOCA.

- Hospital Episode Statistics Admitted Patient Care (HES APC) - allows the investigation of hospital utilisations and readmissions among patients with palliative treatment intent.

- Demographics and Civil Registrations (Deaths) - are required to better understand patient outcomes and track overall mortality, which is one of the audit’s key indicators, dictated by NHS England and the Care Quality Commission (CQC). Demographics product is needed to cross-reference the mortality records (numbers) and to trace records of patients exiting the NHS.

The data provided also allows the audit to assess the impact of COVID-19 on the outcomes of the NBOCA cohort and how NHS services are recovering post pandemic.

To address the UK GDPR Principle of data minimisation this request is limited to a cohort of ~300,000 individuals that have been registered in the NBOCA within the last 9 years, in England and Wales. It is crucial that no geographical exclusions are made, otherwise such limitations would compromise the value of the audit itself. In addition, the cohort is limited to adult patients only (aged 18 and over). Also, only fields that have been deemed necessary for the purpose of this work have been requested.

The request also encompasses the data for patients who were identified in HES as having colorectal cancer diagnosis or treatment but who were not registered with the audit. This cross-checking, feeding into the audit’s case ascertainment work, helps with assessing further the representativeness of NBOCA, the extent of possible missing data and any patterns relating to this, e.g., particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation.

National Data Opt-Outs (NDOs) have been historically applied to the data disseminated under this agreement following support from the Confidentiality Advisory Group (CAG).

The National Data Opt-Out (NDO) enables patients to opt-out from the use of their confidential patient information for research and planning purposes where the data flows rely upon Regulation 5 of the Health Service COPI (Control of Patient Information) Regulations 2002. It is a standard condition of support under Regulation 5 of the COPI Regulations 2002 that patient wishes are respected. In line with the National Data Opt-Out Operational Policy the Confidentiality Advisory Group (CAG) may exceptionally advise the decision-maker that the NDO should not apply to a specific data flow supported under Regulation 5 of the COPI Regulations 2002. In the case of the GICAP, this has been supported. The justification to not apply the NDOs is as below:

The GICAP’s work in detecting statistical outliers for key outcome indicators enables the identification of potential patient safety issues, leading to local improvement activities where necessary. There are many examples – which were submitted to the CAG for their consideration - from across both audits of the impact of outlier reporting on patient safety.

The pseudonymised data received under this Agreement is linked to the pseudonymised NBOCA audit data held by the CEU. This in turn is linked to pseudonymised data assets provided by the National Disease Registration Service (NDRS) under DARS-NIC-656842-S5V7V this includes: NDRS Cancer Registration (inc. data items from the Cancer Outcomes and Services Dataset (COSD)), NDRS Rapid Cancer Registrations, NDRS Linked Cancer Waiting Times, NDRS Linked Diagnostic Imaging Dataset, NDRS Linked Hospital Episode Statistics (HES) Admitted Patient Care (APC), NDRS Systemic Anti Cancer Therapy Dataset (SACT), NDRS National Radiotherapy Dataset (RTDS), NDRS Somatic Molecular Dataset, NDRS National Cancer Patient Experience Survey (CPES), Patient Reported Outcome Measures (PROMs) for Cancer. The requested data is also linked to data provided by other organisations including National Emergency Laparotomy Audit (NELA), Patient Reported Experience Measure (PREMs),, Patient Episode Database for Wales (PEDW), the Case Mix Programme (CMP).

HQIP and NHS England request that a mortality indicator, created from NHS England data, 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 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. 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.

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. The processing meets Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by and the Royal College of Surgeons.

Many of the outputs produced by NBOCA 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 within NHS services in England and Wales. It is designed to evaluate the care pathways followed by patients once they have been diagnosed with bowel cancer and to assess outcomes. The findings of Audit are published in annual reports.

- The National Bowel Cancer 2023 State of the Nation report is targeted for publication in February 2024.

- The National Bowel Cancer 2022 Annual report was published in January 2023.

- The National Bowel Cancer 2021 Annual report was published in January 2022.

- The National Bowel Cancer Audit also published two short reports each year between 2019 and 2022.

NBOCA published its Quality Improvement Plan in 2021. The aim is to involve all members of the multidisciplinary clinical team managing patients with colorectal cancer, covering all areas of the patient pathway, from diagnosis and perioperative care to adjuvant and neoadjuvant oncological management, stage IV disease and end of life care. NBOCA is responsible for providing trusts/hospitals/MDTs with relevant metrics across the patient pathway. For each metric a national and a mirrored local MDT QI target is set. All trusts/hospitals/MDTs are expected to adopt local QI strategies in two to three areas where they have poor performance. Trusts/hospitals/MDTs excelling in all areas are expected to adopt local QI strategies in two areas where they believe improvement may still be made.

Several papers and conference reports are published each year using this 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 Association of Coloproctologists in Great Britain and Ireland (ACPGBI) annual meetings as a minimum and others as appropriate.

Publication in peer-reviewed journals allows presentation of the Audit methodology and results in more detail than in the Annual reports. For example, the findings of the 2022 Annual Report for the Bowel cancer audit were published in several journals and presented at several conferences in 2023 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 Coloproctologists 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 has reported 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:

- 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

- Percentage of patients receiving adjuvant chemotherapy

- Percentage of patients with acute severe toxicity after adjuvant chemotherapy

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

Outliers 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.

All outputs are aggregated with small numbers suppressed except when assisting NHS Trusts in evaluating the reasons for their outlier status.

Quality assurance and improvement are among the key objectives of national clinical audits. The NBOCA evaluates 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 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 the Gastrointestinal Cancer Audit Programme (GICAP).

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 ʹin 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.

The Gastrointestinal Cancer Audit Programme (GICAP) comprises the National Bowel Cancer Audit (NBOCA) and the National Oesophago-Gastric Cancer Audit (NOGCA). This application relates solely to the NBOCA workstream. The aim of NBOCA is to assess the quality of care received by patients with bowel cancer in England and Wales, providing those who commission, deliver and use services for people with colorectal cancer with high quality data on the process and outcomes of NHS care.

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

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.

The audit is based on prospectively collected, patient-level data and collectively cover adult patients (aged 18 or over) diagnosed with colorectal cancer in England and Wales. It combines these patient records with records from other available national datasets to provide information to NHS trusts, patients, commissioners and other stakeholders on the patterns of care from diagnosis to the end of the primary treatment pathway (both curative and palliative treatments) and patient outcomes. Apart from supplying a rich description of the care process, audits such as NBOCA aim to minimise the burden of data collection on clinical staff.

To support the delivery of NBOCA, the project team receive the below datasets from NHS England's Data Access Request Service (DARS). There is no other reasonable means to achieve the purpose that is less intrusive to the data subjects. The level of the data is pseudonymised.

- Hospital Episodes Statistics – Outpatients (HES OP) - Outpatients’ data provide information on care earlier and later in patients’ pathways 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 allows 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.

- Hospital Episode Statistics Accident & Emergency (HES A&) and Emergency Care Data Set (ECDS) - Access to A&E and ECDS data is 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 looks 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 other data currently held by NBOCA.

- Hospital Episode Statistics Admitted Patient Care (HES APC) - allows the investigation of hospital utilisations and readmissions among patients with palliative treatment intent.

- Demographics and Civil Registrations (Deaths) - are required to better understand patient outcomes and track overall mortality, which is one of the audit’s key indicators, dictated by NHS England and the Care Quality Commission (CQC). Demographics product is needed to cross-reference the mortality records (numbers) and to trace records of patients exiting the NHS.

The data provided also allows the audit to assess the impact of COVID-19 on the outcomes of the NBOCA cohort and how NHS services are recovering post pandemic.

To address the UK GDPR Principle of data minimisation this request is limited to a cohort of ~300,000 individuals that have been registered in the NBOCA within the last 9 years, in England and Wales. It is crucial that no geographical exclusions are made, otherwise such limitations would compromise the value of the audit itself. In addition, the cohort is limited to adult patients only (aged 18 and over). Also, only fields that have been deemed necessary for the purpose of this work have been requested.

The request also encompasses the data for patients who were identified in HES as having colorectal cancer diagnosis or treatment but who were not registered with the audit. This cross-checking, feeding into the audit’s case ascertainment work, helps with assessing further the representativeness of NBOCA, the extent of possible missing data and any patterns relating to this, e.g., particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation.

National Data Opt-Outs (NDOs) have been historically applied to the data disseminated under this agreement following support from the Confidentiality Advisory Group (CAG).

The National Data Opt-Out (NDO) enables patients to opt-out from the use of their confidential patient information for research and planning purposes where the data flows rely upon Regulation 5 of the Health Service COPI (Control of Patient Information) Regulations 2002. It is a standard condition of support under Regulation 5 of the COPI Regulations 2002 that patient wishes are respected. In line with the National Data Opt-Out Operational Policy the Confidentiality Advisory Group (CAG) may exceptionally advise the decision-maker that the NDO should not apply to a specific data flow supported under Regulation 5 of the COPI Regulations 2002. In the case of the GICAP, this has been supported. The justification to not apply the NDOs is as below:

The GICAP’s work in detecting statistical outliers for key outcome indicators enables the identification of potential patient safety issues, leading to local improvement activities where necessary. There are many examples – which were submitted to the CAG for their consideration - from across both audits of the impact of outlier reporting on patient safety.

The pseudonymised data received from the Data Access Request Service (DARS) is sent to CEU and it is then linked to pseudonymised NBOCA audit data held by CEU. This is in turn linked to other pseudonymised assets (provided by other organisations), such as the Systemic Anti-Cancer Therapy (SACT) Dataset, Radiotherapy Dataset (RTDS), National Emergency Laparotomy Audit (NELA), Patient Reported Experience Measure (PREMs), Patient Reported Outcome Measures (PROMs) for Cancer, Patient Episode Database for Wales (PEDW), the Case Mix Programme (CMP), Cancer Outcomes and Services Dataset (COSD) and Cancer Registration Data.

HQIP and NHS England request that a mortality indicator, created from NHS Digital data, 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 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. 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.

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. The processing meets Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by and the Royal College of Surgeons.

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

The audit measures the quality of care received by patients diagnosed with bowel 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 bowel cancer and to assess their care outcomes. The audit also provides national and trust level outcomes on end-of-life care.

The findings of the audit 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 audience for these outputs are people who deliver, receive, commission and regulate colorectal 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.

Whilst all reports are written in a patient-friendly language and can be understood by a lay reader, the RCS also release Patient Reports, specifically aimed at non-medical audience. The CEU 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.

It is anticipated that the annual reports will be presented at the Association of Coloproctology of Great Britain and Ireland (ACPGBI) annual meetings as a minimum and at other events as appropriate.

The audit reports 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.

All reports are published on the NBOCA web site (https://www.nboca.org.uk/reports-home/) and on the HQIP’s NCAPOP pages (https://www.hqip.org.uk/a-z-of-nca/national-bowel-cancer-audit/#.Y06ffHbMJPY).

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

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. Some of the Clinical Outcomes Publication (COP) data is published on the professional bodies' websites.

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.

Data files for these requests are provided in a secure manner to named individuals holding NHS.net accounts. Use of file encryption and passwords also ensures the appropriate data security standards. Access to the data is role-based and it is granted only to those who are necessary to perform specific tasks.

Quality assurance and improvement are among the key objectives of national clinical audits. The NBOCA evaluates 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 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 the Gastrointestinal Cancer Audit Programme (GICAP).

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 ʹin 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 ʹfrom 9% in 2015/16 to 12% in 2019/20.

The Gastro-Intestinal Cancer Audit Programme (GICAP) comprises of the National Bowel Cancer Audit (NBOCA) and the National Oesophago-Gastric Cancer Audit (NOGCA). This application relates solely to NBOCA. The audit programme has previously been managed under a single DARS application, but to utilise the automated reporting of deaths the decision was made to split the audit into three separate Agreements.

A contract was awarded in early 2018 by Healthcare Quality Improvement Partnership (HQIP) to the Royal College of Surgeons and 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.

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 NBOCA is to assess the quality of care received by patients with bowel cancer in England and Wales, providing those who commission, deliver and use services for people with colorectal cancer with high quality data on the process and outcomes of NHS care.

To support the delivery of NBOCA, the Clinical Audits and Registries Management Service (CARMS) within NHS Digital have received, and will continue to receive HES OP, HES A&E, ECDS, HES APC, Civil Registration (Deaths) and Demographics data. The applicant is satisfied that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects.

• Outpatients’ will provide information on care earlier and later in patient’s pathways 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.

• 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

• HES APC will allow the investigation of hospital utilisations and readmissions among patients with palliative treatment intent.

• Demographics and Civil Registrations are requested to better understand patient outcomes, and mortality.

• The data requested will also allow the Audit to assess the impact of COVID-19 on the outcomes of the NBOCA cohort.

• The Audit request to receive the Provisional ('M13') data where available to help support the timely delivery of the NBOCA yearly reports.

To address the GDPR Principle of Data Minimisation this request is limited to a cohort of ~150,000 individuals that currently make up the NBOCA cohort. In addition, only fields that have been deemed necessary for the purpose of this work have been requested.

Historic access to data from 2003 onwards will link to the NBOCA data that HQIP currently have and allow more robust analysis over a longer period. Data received under this Agreement is retained to allow the audit to address any queries, although the audit only uses the five most recent years of data for reporting.

The data received from the Data Access Request Service (DARS, NHS Digital) is sent to CEU via CARMS to be linked to NBOCA audit data held by CEU. This is in turn linked to the Systemic Anti-Cancer Therapy (SACT) Dataset, Radiotherapy Dataset (RTDS), National Emergency Laparotomy Audit (NELA), Patient Reported Experience Measure (PREMs), Patient Reported Outcome Measures (PROMs), Patient Episode Database for Wales (PEDW), the Case Mix Programme (CMP), Cancer Outcomes and Services Dataset (COSD) and Cancer Registration Data.

• SACT: The SACT data covers patients receiving cancer chemotherapy in, or funded by, the NHS in England. This data is collected by the National Cancer Registration and Analysis Service (NCRAS) within Public Health England (PHE) and can be requested via the Office for Data Release (ODR). Linkage will allow a more in-depth analysis of specific chemotherapy regimens and changes to prescribed treatments.

• RTDS: The RTDS hold information on every patient treated with Radiotherapy in the National Health Service in the UK. This data is collected by the NCRAS within Public Health England (PHE) and can be requested via the ODR. The linkage will allow the audit to explore whether the radiotherapy data items in the Audit could be dropped to ease the burden of data collection.

• NELA: NELA collect data on patients undergoing emergency laparotomy as part of a HQIP funded audit. Linkage allows the assessment of the patients submitted to the NBOCA that have an emergency laparotomy.

• PREMS: The National Cancer Patient Experience collects information reported by patients themselves about the experience of the bowel cancer audit. This information is collected by PHE and is requested via ODR. Linkage will allow the assessment of how representative the PREMs survey is of all groups of patients, including those not having a major resection, and those receiving palliative and supportive care. The collection of PREMs data is limited to prospective data from 2017 onwards. This follows successful amendment request to CAG to address issues of notifying patients of the use of data. This approval supersedes the 2015 approval relating to the use of retrospective PREMs data.

• PROMS: NHS England’s National Cancer PROMS Programme of the National Survivorship Initiative collects information reported by the patients themselves about the outcomes of their bowel cancer e.g., symptoms, functional status, and quality of life. Linkage has allowed the assessment of the feasibility of using information reported by the patients themselves about the outcomes of their bowel cancer. The collection of PROMS data is limited to retrospective data only.

• PEDW: PEDW records all episodes of inpatient and day case activity in NHS Wales Hospitals. This is inclusive of planned and emergency admissions and minor and major operations. Hospital activity for Welsh residents treated in English Hospitals is also included. This data is collected by NHS Wales Informatics Service (NWIS), from whom this data can be requested.

• CMP: The CMP is hosted by the Intensive Care National Audit and Research Centre (ICNARC), from whom the CMP data can be requested. CMP is an audit of patient’s outcomes from adult, general critical care units (intensive care and combined intensive care/high dependency units) covering England, Wales and Northern Ireland. Linkage will allow reporting patterns of care and outcomes while patients were admitted to critical care and the characteristics of the patients admitted to critical care.

• COSD: When linked to NBOCA data, the COSD will be used to describe in further detail those patients with more advanced disease and rectal cancer, as well as to assess the representativeness of the patients captured in NBOCA. This data is collected by NCRAS within PHE and can be requested via ODR.

• Cancer Registration: This linkage will supplement the cases that are recorded in COSD, as Cancer Registration services undertake active case finding and will pick up cases of bowel cancer that have not been entered into the audits. For the Audit to be able to report on the complete set of patients diagnosed with bowel cancer, records will be examined for patients who were identified in Cancer Registration data but who are not in GICAP. This will help to further assess the representativeness of patients captured in NBOCA It is intended to use the data to assess the extent of possible missing data and any patterns relating to this, e.g., particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation.

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 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 within NHS services in England and Wales. It is designed to evaluate the care pathways followed by patients once they have been diagnosed with bowel cancer 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 January 2022.

• 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.

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 the Bowel cancer audit 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:

• 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

Outputs on the management of patients with rectal cancer and advanced disease are also included in the NBCOA 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 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). This application relates solely to NBOCA. The audit programme has previously been managed under a single DARS application, but to utilise the automated reporting of deaths the decision was made to split the audit into three separate Agreements.

A contract was awarded in early 2018 by Healthcare Quality Improvement Partnership (HQIP) to the Royal College of Surgeons and 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.

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 NBOCA is to assess the quality of care received by patients with bowel cancer in England and Wales, providing those who commission, deliver and use services for people with colorectal cancer with high quality data on the process and outcomes of NHS care.

To support the delivery of NBOCA, the Clinical Audits and Registries Management Service (CARMS) within NHS Digital have received, and will continue to receive HES OP, HES A&E, ECDS, HES APC, Civil Registration (Deaths) and Demographics data. The applicant is satisfied that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects.

• Outpatients’ will provide information on care earlier and later in patient’s pathways 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.

• 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

• HES APC will allow the investigation of hospital utilisations and readmissions among patients with palliative treatment intent.

• Demographics and Civil Registrations are requested to better understand patient outcomes, and mortality.

• The data requested will also allow the Audit to assess the impact of COVID-19 on the outcomes of the NBOCA cohort.

To address the GDPR Principle of Data Minimisation this request is limited to a cohort of ~150,000 individuals that currently make up the NBOCA cohort. In addition, only fields that have been deemed necessary for the purpose of this work have been requested.

Historic access to data from 2003 onwards will link to the NBOCA data that HQIP currently have and allow more robust analysis over a longer period. Data received under this Agreement is retained to allow the audit to address any queries, although the audit only uses the five most recent years of data for reporting.

The data received from the Data Access Request Service (DARS, NHS Digital) is sent to CEU via CARMS to be linked to NBOCA audit data held by CEU. This is in turn linked to the Systemic Anti-Cancer Therapy (SACT) Dataset, Radiotherapy Dataset (RTDS), National Emergency Laparotomy Audit (NELA), Patient Reported Experience Measure (PREMs), Patient Reported Outcome Measures (PROMs), Patient Episode Database for Wales (PEDW), the Case Mix Programme (CMP), Cancer Outcomes and Services Dataset (COSD) and Cancer Registration Data.

• SACT: The SACT data covers patients receiving cancer chemotherapy in, or funded by, the NHS in England. This data is collected by the National Cancer Registration and Analysis Service (NCRAS) within Public Health England (PHE) and can be requested via the Office for Data Release (ODR). Linkage will allow a more in-depth analysis of specific chemotherapy regimens and changes to prescribed treatments.

• RTDS: The RTDS hold information on every patient treated with Radiotherapy in the National Health Service in the UK. This data is collected by the NCRAS within Public Health England (PHE) and can be requested via the ODR. The linkage will allow the audit to explore whether the radiotherapy data items in the Audit could be dropped to ease the burden of data collection.

• NELA: NELA collect data on patients undergoing emergency laparotomy as part of a HQIP funded audit. Linkage allows the assessment of the patients submitted to the NBOCA that have an emergency laparotomy.

• PREMS: The National Cancer Patient Experience collects information reported by patients themselves about the experience of the bowel cancer audit. This information is collected by PHE and is requested via ODR. Linkage will allow the assessment of how representative the PREMs survey is of all groups of patients, including those not having a major resection, and those receiving palliative and supportive care. The collection of PREMs data is limited to prospective data from 2017 onwards. This follows successful amendment request to CAG to address issues of notifying patients of the use of data. This approval supersedes the 2015 approval relating to the use of retrospective PREMs data.

• PROMS: NHS England’s National Cancer PROMS Programme of the National Survivorship Initiative collects information reported by the patients themselves about the outcomes of their bowel cancer e.g., symptoms, functional status, and quality of life. Linkage has allowed the assessment of the feasibility of using information reported by the patients themselves about the outcomes of their bowel cancer. The collection of PROMS data is limited to retrospective data only.

• PEDW: PEDW records all episodes of inpatient and day case activity in NHS Wales Hospitals. This is inclusive of planned and emergency admissions and minor and major operations. Hospital activity for Welsh residents treated in English Hospitals is also included. This data is collected by NHS Wales Informatics Service (NWIS), from whom this data can be requested.

• CMP: The CMP is hosted by the Intensive Care National Audit and Research Centre (ICNARC), from whom the CMP data can be requested. CMP is an audit of patient’s outcomes from adult, general critical care units (intensive care and combined intensive care/high dependency units) covering England, Wales and Northern Ireland. Linkage will allow reporting patterns of care and outcomes while patients were admitted to critical care and the characteristics of the patients admitted to critical care.

• COSD: When linked to NBOCA data, the COSD will be used to describe in further detail those patients with more advanced disease and rectal cancer, as well as to assess the representativeness of the patients captured in NBOCA. This data is collected by NCRAS within PHE and can be requested via ODR.

• Cancer Registration: This linkage will supplement the cases that are recorded in COSD, as Cancer Registration services undertake active case finding and will pick up cases of bowel cancer that have not been entered into the audits. For the Audit to be able to report on the complete set of patients diagnosed with bowel cancer, records will be examined for patients who were identified in Cancer Registration data but who are not in GICAP. This will help to further assess the representativeness of patients captured in NBOCA It is intended to use the data to assess the extent of possible missing data and any patterns relating to this, e.g., particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation.

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 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 within NHS services in England and Wales. It is designed to evaluate the care pathways followed by patients once they have been diagnosed with bowel cancer 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 January 2022.

• 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.

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 the Bowel cancer audit 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:

• 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

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

This application covers two separate audits which have now been amalgamated into a single programme for cost-saving purposes. The National Gastro-Intestinal Cancer Audit Programme (“the GI Cancer audit”) comprises both the National Bowel Cancer Audit and the National Oesophago-Gastric Cancer Audit which were previously managed as two separate audits. The two audits have been amalgamated into the same Programme in order to save costs: both audits need to deliver a cost saving of 15%.

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 GI Cancer audit for 3 years, until 31st May 2021. There is one programme for governance purposes to oversee the two audits relating to the bowel and OG care pathways; for avoidance of doubt, the two audits are conducted separately, and no data is shared between them. The National GI Project Board manages the two audits and aims to deliver the necessary 15% cost reduction across both Audits.

The audits are based on prospectively-collected, patient- level data on patients diagnosed with colorectal cancer or invasive epithelial oesophago-gastric cancer or oesophageal high-grade dysplasia. This information in each audit is combined with other available datasets – as described below – to provide a rich description of the care process, to minimise the burden of data collection on clinical staff, and to satisfy patient needs in the least intrusive way possible (the applicant is satisfied that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects).

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. For both types of cancer, survival depends on early diagnosis through appropriate investigations, use of complicated surgical techniques and input from a range of professionals. The management of patients is complex and requires multidisciplinary working. By collecting data from NHS Trusts providing care to bowel and oesophago-gastric cancer patients the audits are able to provide information on patient characteristics, treatment planning, postoperative outcomes and palliative treatment.

Bowel cancer is the third most common malignancy in the UK and affects approximately 33,000 people each year, while oesophago-gastric cancer is the fifth most common malignancy and affects approximately 13,500 people each year. Incidence of both cancers is increasing and the prognosis for most patients diagnosed with GI cancer remains poor.

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 Clinical Audit and Patient Outcomes Programme. The audit aims to provide those who commission, deliver and use services for people with colorectal cancer or invasive epithelial oesophago-gastric cancer or oesophageal high-grade dysplasia with high quality data on the process and outcomes of NHS care.

This agreement has 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 NBOCA. NHS England is a controller of the NBOCA 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 the NBOCA, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NBOCA, 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 NBOCA 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.

Legal Basis Justification:

HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "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.

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This request for HES A&E and OP data is required for:

• Analysing patient follow up and outcomes of surgery, such as emergency readmissions and stoma reversals.

• Investigating hospital utilisation and readmissions among patients with palliative treatment intent.

• Addressing the completion of chemotherapy among patients with palliative treatment intent.

• Providing national results on patterns of patient referral and time to diagnosis such as investigating what proportion of patients had an endoscopic examination prior to diagnosis in order to assess cancers that are potentially missed.

• Examining patterns of palliative and oncological care across hospitals and illustrating the full patient journey from point of entry to hospital: either A&E or Out Patients.

Outpatients data will be linked to the National Bowel Cancer Audit (NBOCA). 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. Currently NBOCA only has access to admitted care data over time (HES Admitted Patient Care data), with more detailed clinical data around the short window of time at diagnosis and primary treatment of their cancer (NBOCA dataset). 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. None of this is possible with the data currently held by NBOCA.

Access to A&E 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. Currently NBOCA is only able to look at unplanned hospital attendances for patients who are admitted to hospital (using HES Admitted Patient Care data), and misses those who attend A&E without being admitted. 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

This amendment will be required indefinitely to accumulate data to facilitate robust analyses. If this amendment does not go ahead, the audit will be unable to expand the work as aforementioned and will therefore not be able to develop important performance indicators which will help to improve and standardise the care of patients with bowel cancer. Historic access to data from 2011 onwards will link to the NBOCA data that HQIP currently have and allow more robust analysis over a longer period of time.

These outcomes are published in the Audit’s annual reports, which are used by trusts to assess whether they are meeting national guidance and benchmark their performance. If they are not meeting national standards, trusts will address these areas and make improvements and this will then result in benefits to patients.

The request is also for HES data to be returned for patients who fit the inclusion criteria but are not included in the Audit cohort to enable assessment of case ascertainment; there is no linkage to the case ascertainment cohort.

Consultant code is required to provide individual consultant level 30-day and 90-day post-operative mortality outcomes as part of Everyone Counts, NHS England’s strategic plan.

The HES data with the Audit Tumour id is shared with the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. The Audit Tumour ID key is held by NHS Digital Clinical Audits and Management Service (CARMS).

Access to HES allows the Audit to substantially reduce the number of items in the bowel and OG cancer datasets by retrieving relevant information on follow up and outcomes from Hospital Episode Statistics (N.B. the bowel cancer dataset reduced from 130 plus data items to 43 data items since the audit has been linking to HES).

An on-going part of the audit process commissioned by HQIP is the Clinical Outcomes Programme. The information from the audit is used to measure the performance of trusts and surgeons on the following measures

Bowel cancer:

• 90 day emergency readmission after major resection;

• 18 month stoma rate after major resection for rectal cancer;

• 90 day mortality after major resection;

• 24 month mortality after major resection.

OG Cancer

• 30 day post operative mortality

• 90 day post operative mortality

• Volume of care – number of procedures by individual

• Length of stay

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. To assist the 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. 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.

Whilst the provision of data back to trusts as part of the Clinical Outcomes Programme is not new, the ability to provide fact of death in relation to the 2 mortality indicators is a new element, which is supported by the Confidentiality Advisory Group (CAG) amendment approval letter.

Onward Dissemination: the following linkages are subsequently carried out by Intensive Care National and Audit Research Centre (ICNARC), National Health Service England, Public Health England (PHE) and Clinical Audit and Registeries Management Service (CARMS) for HQIP (the Data Controller):

~ Systemic Anti-Cancer Therapy (SACT) dataset required for:

The SACT data collection covers patients receiving cancer chemotherapy in or funded by the NHS in England. It relates to all cancer patients, both adult and paediatric, in acute inpatient, daycase, outpatient settings and delivery in the community. It covers chemotherapy treatment for all solid tumour and haematological malignancies and those in clinical trials.

Linkage will allow assessment of the completeness of submissions of oncology records to the audit and explore whether the chemotherapy data items in the Audit could be dropped to ease the burden of data collection. SACT data also enable more in-depth analysis of specific chemotherapy regimens and changes to prescribed treatment.

The request is also for SACT data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The SACT data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. SACT linkage is carried out for each of the Bowel and OG cancer audits.

~ The Radiotherapy Dataset (RTDS) required for:

The RTDS holds information on every patient treated with radiotherapy funded by the National Health Service (NHS) in the UK.

Linkage will allow assessment of the completeness of submissions of radiotherapy records to the audit and explore whether the radiotherapy data items in the Audit could be dropped to ease the burden of data collection.

The request is also for RTDS data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The RTDS data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. RTDS linkage is carried out for each of the Bowel and OG cancer audits.

~ NBOCA (National Bowel Cancer Audit) uses the National Emergency Laparotomy Audit (NELA) Dataset for:

The NELA collects data on patients undergoing emergency laparotomy and is a Healthcare Quality Improvement Partnership funded Audit.

Linkage allows the assessment of the patients submitted to the National Bowel Cancer Audit that have an emergency laparotomy.

The request is also for NELA data to be returned for patients who fit the inclusion criteria but are not included in the Audit cohort. Note that NELA data only applies to the Bowel cancer audit.

The NELA data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. NELA linkage is carried out for the Bowel cancer audit only.

Note that only the Bowel Cancer audit is linked to NELA.

~ NBOCA uses NHS England’s Cancer Patient Experience Survey Dataset for:

The National Cancer Patient Experience collects information reported by patients themselves about the experience of their bowel cancer care.

Linkage will allow the assessment of how representative the Patient Reported Experience Measure (PREMs) survey is of all groups of patients, including those not having a major resection and those receiving palliative and supportive care.

The request is for all the colorectal PREMs data to be sent to NHS Digital. The NHS number from the PREMs patients would be linked to the Audit data within NHS Digital.

The PREMs data with the Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. PREMs linkage is carried out for the Bowel cancer audit only

The collection of PREMS data as part of this agreement is limited to prospective data from 2017 onwards. This follows a successful amendment request to CAG to address issues of notifying patients of the use of the data. This approval supersedes the previous 2015 approval relating to use of retrospective PREMS data. The legal basis for the PROMS and PREMS linkage is the NHS Act 2006 - s251 - 'Control of patient information'.

NBOCA uses NHS England’s National Cancer PROMs Programme of the National Survivorship Initiative Dataset for:

NHS England’s National Cancer PROMs Programme of the National Survivorship Initiative collects information reported by patients themselves about the outcomes of their bowel cancer e.g. symptoms, functional status and quality of life.

Linkage has allowed the assessment of the feasibility of using information reported by patients themselves about the outcomes of their bowel cancer.

The request is for all the colorectal PROMs data to be sent to NHS Digital. The NHS number from the PROMs patients would be linked to the Audit data within NHS Digital.

The PROMs data with the Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. PROMs linkage is carried out for the Bowel cancer audit only.

The collection of PROMS data as part of this agreement is limited to retrospective data only.

Welsh hospital episode data

The Patient Episode Database for Wales (PEDW) records all episodes of inpatient and day case activity in NHS Wales hospitals. This includes planned and emergency admissions, minor and major operations, and hospital stays for giving birth. Hospital activity for Welsh residents treated in hospitals in England is also included.

The data are collected and coded at each hospital. The records are then electronically transferred to the NHS Wales Informatics Service (NWIS), where they are validated and merged into the main database.

The request is also for PEDW data to be returned for patients diagnosed in Wales only who fit the inclusion criteria but are not included in Audit cohort.

The PEDW data with the Audit Tumour ID is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour ID only is used for linkage purposes.

~ Intensive Care National Audit and Research Centre data:

The Intensive Care National Audit and Research Centre (ICNARC) hosts the case mix programme (CMP) from where NHS Digital will collect the data. The Case Mix Programme is an audit of patient outcomes from adult, general critical care units (intensive care and combined intensive care/high dependency units) covering England, Wales and Northern Ireland.

The CMP is listed in the Department of Health’s ‘Quality Accounts’ as a recognised national audit by the National Advisory Group on Clinical Audit & Enquiries (NAGCAE) for ‘Acute’ care.

Currently 100% of adult, general critical care units participate in the CMP. Other specialist units, including neurosciences, cardiac and high dependency units, also participate.

The CMP is open to both NHS (publicly funded) and independent sector critical care units.

Critical care units collect data on all the patients they admit to their unit. They securely submit this data and the CMP team run over 600 validation checks, identifying errors and missing information. Units then have a chance to correct and complete the data before analyses.

ICNARC compare the data from these patients with the outcomes from other similar patients, other similar units and all the units in the CMP. The unit receives a Data Analysis Report which identifies trends over time showing how the unit compares with others and helps the unit understand more about the care they deliver. It aims to assist them in decision-making, resource allocation and local quality improvement.

Linkage will allow reporting patterns of care and outcomes while patients were admitted to critical care and the characteristics of the patients admitted to critical care.

The request is also for ICNARC data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The ICNARC data with the Audit Tumour ID is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour ID is used for linkage purposes.

~ NBOCA uses the Cancer Outcomes and Services Dataset (COSD)

COSD data when linked to National Bowel Cancer Audit (NBCA) data will be used to describe in further detail those patients with more advanced disease and rectal cancer and to assess the representativeness of patients captured in NBCA. This linkage will allow further investigation of the quality of the audit data and the opportunity to address concerns that there are cases of bowel cancer which are not being recorded in the audit. It is intended to use the data to assess the extent of possible missing data and any patterns relating to this, e.g. particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation. Linkage with COSD will enable the NBCA to further determine the pathway of care for patients with advanced disease and to describe in further detail the management and outcomes of patients with rectal cancer.

NBOCA uses the Cancer Registration Data

The Cancer Registration data will supplement the cases that are recorded in COSD as Cancer Registration services undertake active case finding and will pick up cases of bowel cancer that have not been entered in to the NBOCA. In order for the Audit to be able to report on the complete set of patients diagnosed with bowel cancer, records will be examined for patients who were identified in Cancer Registration data but who are not in NBOCA. This will help to further assess the representativeness of patients captured in NBOCA It is intended to use the data to assess the extent of possible missing data and any patterns relating to this, e.g. particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation.

Linkage to both COSD and Cancer Registration data will enhance the existing data collection to ensure that a full picture of the patient journey is collected for reporting purposes. The audit team will also look at the completeness of the collection of data items within COSD to assess whether any data items collected in the NBOCA collection could be obtained from COSD in future years, thereby reducing the burden of collection on trusts going forwards. Linkage to the Cancer Registration data may also provide some options to reduce the collection burden in addition to providing information on the number of cases of bowel cancer which may be registered but are not included in the audit.

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In addition this amendment requests data to address for the following:

The COVID-19 pandemic has serious implications for patients with oesophago-gastric cancer and bowel cancer, and will lead to many patients not having the optimal treatment pathways. First, hospital-based care will increase their chance of contracting COVID-19, not least because treatments can lead to patients to become immunosuppressed.

Second, fewer patients will undergo elective surgery during the pandemic due to restricted access to operating theatres and critical care provision.

Third, many patients will no longer receive neoadjuvant or palliative chemotherapy due to the risk of increased mortality during treatment. Radiotherapy plans are also likely to be adapted to reduce hospital visits.

Up-to-date HES-APC data is needed urgently to assess the extent to which these issues are already affecting the care of patients with oesophago-gastric cancer and bowel cancer The findings of the work will have immediate benefit for cancer services adapting to the COVID-19 pandemic, allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by cancer patients during COVID-19.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Annual reports: Separate reports will continue to be produced for each of the two audits.

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

The National Bowel Cancer 2020 Annual report is targeted for publication in January 2021.

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

The National Oesophago-Gastric Cancer 2018 Annual report was published in September 2018: https://www.nogca.org.uk/reports/2018-annual-report/

The National Oesophago-Gastric Cancer 2020 Annual report is targeted for publication 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 will do so again in the summer of 2020. Several papers and conference reports are planned for 2020 using this data.

The annual reports are written in patient-friendly language and can be understood by the lay reader.

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 Reports for both Bowel and OG cancer audits were published in a number of journals and presented at a number of 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 Royal College of Surgeons 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.

Linking Date of Death to the Audit data will provide short-term and long-term survival outcomes.

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

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

~ NOGCA

• Percentage of patients with surgical intent

• Percentage of patients with complications

• Risk adjusted 90-day post-operative mortality

• Risk adjusted complication rate

• Percentage of adequate lymph node resections

• Percentage of positive resection margin

• Length of stay

• Place of death

The Audit will provide national and trust level outcomes on end of life care. Linking Date of Death to the Audit data will provide short-term and long-term survival outcomes.

The linked HES/Audit/death data dataset is also used to report the individual Consultant Outcomes as required by NHS England under Everyone Counts. For Bowel the outcomes are 90-day post-operative mortality. For OG the outcomes include 30-day and 90-day post-operative mortality and length of stay.

The Consultant Outcomes are published on the respective Professional Body website (ACPGBI or AUGIS).

http://www.acpgbi.org.uk/surgeon-outcomes/

http://www.augis.org/outcomes-data-2019/

Linkage to ICNARC data will enable assessment of outcomes for patients that are cared for in intensive care following surgery to see if there are any differences in outcomes between different patient pathways. This will be progressed during 2020/21 with feasibility work once the data has been received from ICNARC.

Outputs from linkage to COSD and Cancer Registration data will relate to assessment of completeness of NBOCA data, assessment of missing cases and the potential to reduce the burden of collection in future years by using data from COSD and Cancer Registration and removing any duplication between these collections and the NBOCA dataset.

If the linkage to COSD and Cancer Registration data identify data completeness and data quality issues then the NBCA will work with the Audit's Clinical Advisory Group and lead clinicians to encourage trusts to improve their data quality.

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

Any additional findings related to the affect COVID 19 may have had on the cohort will be contained in the annual reports.

The National Oesophago-Gastric Cancer 2018 Annual report and the National Bowel Cancer 2018 Annual report were both published in late 2018 following sign off by NHS England.

At national level the Bowel cancer audit is able to report the following outcomes:

- Overall 90-day mortality after major surgery has steadily reduced over five years from 5.4 per cent in 2010-11 to 3.8 per cent in 2014-15.

- Two-year survival in patients having major surgery has improved from 80% in 2009-10 to 82% in 2012-13

- Rates of laparoscopic surgery have increased from 42% in 2010-11 to 61% in 2014-2015. There has been no rebound increase in rates of conversion from laparoscopic to open surgery over this time (9.0% to 8.5%)

- The proportion of patients being seen by a clinical nurse specialist has increased from 87% in 2010-11 to 92% in 2014-15.

- The rate of rectal cancer patients having a local excision to remove their cancer has increased from 5.3% in 2010-11 to 6.8% in 2014-15.

Supporting local trust level improvement:

- Since 2013, the audit has provided individual trust reports comparing results to the local and region and nationally.

- In 2016, the audit started to provide MDTs with individualised slide packs of the trust results. 50% of MDTs reported using these.

- Potentially outlying trusts report that they have carried out local quality improvement including case note review.

- Clinical leads have reported taking their individual trust reports to their CEO to justify increased resources.

Providing information to patients and the public

- The 2016 patient friendly version of the annual report has had 474 downloads since the publication date in December 2016.

- The Clinical Outcomes Publication data is published on NHS Choices.

- The audit and the data in the reports are promoted to the public via bowel cancer charities.

The 2017 NBOCA Annual Report was published in December 2017.

2 short reports were also published in 2017 -

- Validity of cancer-specific mortality as a performance indicator

- Optimal timing between radiotherapy and surgery in rectal cancer patients

All the reports are available on https://www.nboca.org.uk/reports/

There will also be 2 short reports on the following topics -

- End of Life – looking at how many patients are dying at home and how many in hospital; just under a third of colorectal patients are dying at home.

- The use of adjuvant chemotherapy in stage III colon and rectal cancer.

The audit is working with the CQC and the NHS Improvement Getting it Right First Time (GIRFT) teams on improvements in data quality and completeness. It is also supporting the IMPACT programme which is an ACPGBI initiative focused on improving the management of patients with advanced colorectal tumours.

The OG Cancer audit has shown the following outcomes:

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

4. Re-assurance that no surgeon or NHS trust has outcomes that are outside the expected range in the Clinical Outcomes Publication (i.e. there were no outliers).

5. Individual NHS trusts are able to 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 70,000 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.

This application covers two separate audits which have now been amalgamated into a single programme for cost-saving purposes.

The National Gastro-Intestinal Cancer Audit Programme (“the GI Cancer audit”) comprises both the National Bowel Cancer Audit and the National Oesophago-Gastric Cancer Audit which were previously managed as two separate audits. The two audits have been amalgamated into the same Programme in order to save costs: both audits need to deliver a cost saving of 15%.

A contract was awarded in early 2018 by HQIP to the Royal College of Surgeons and NHS Digital to deliver the GI Cancer audit for 3 years, until 31st May 2021. There is one programme for governance purposes to oversee the two audits relating to the bowel and OG care pathways; for avoidance of doubt, the two audits are conducted separately and no data is shared between them. The National GI Project Board manages the two audits, and aims to deliver the necessary 15% cost reduction across both Audits.

The audits are based on prospectively-collected, patient-level data on patients diagnosed with colorectal cancer or invasive epithelial oesophago-gastric cancer or oesophageal high-grade dysplasia. This information in each audit is combined with other available datasets – as described below – to provide a rich description of the care process, to minimise the burden of data collection on clinical staff, and to satisfy patient needs in the least intrusive way possible (the applicant is satisfied that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects).

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. For both types of cancer, survival depends on early diagnosis through appropriate investigations, use of complicated surgical techniques and input from a range of professionals. The management of patients is complex and requires multidisciplinary working. By collecting data from NHS Trusts providing care to bowel and oesophago-gastric cancer patients the audits are able to provide information on patient characteristics, treatment planning, postoperative outcomes and palliative treatment.

Bowel cancer is the third most common malignancy in the UK and affects approximately 33,000 people each year, while oesophago-gastric cancer is the fifth most common malignancy and affects approximately 13,500 people each year. Incidence of both cancers is increasing and the prognosis for most patients diagnosed with GI cancer remains poor.

HES data required for:

• Analysing patient follow up and outcomes of surgery, such as emergency readmissions and stoma reversals.

• Investigating hospital utilisation and readmissions among patients with palliative treatment intent.

• Addressing the completion of chemotherapy among patients with palliative treatment intent.

• Providing national results on patterns of patient referral and time to diagnosis such as investigating what proportion of patients had an endoscopic examination prior to diagnosis in order to assess cancers that are potentially missed.

• Examining patterns of palliative and oncological care across hospitals.

These outcomes are published in the Audit’s annual reports, which are used by trusts to assess whether they are meeting national guidance and benchmark their performance. If they are not meeting national standards, trusts will address these areas and make improvements and this will then result in benefits to patients.

The request is also for HES data to be returned for patients who fit the inclusion criteria but are not included in the Audit cohort to enable assessment of case ascertainment; there is no linkage to the case ascertainment cohort.

Consultant code is required to provide individual consultant level 30-day and 90-day post-operative mortality outcomes as part of Everyone Counts, NHS England’s strategic plan.

The HES data with the Audit Tumour id is shared with the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. The Audit Tumour ID key is held by NHS Digital Clinical Audits and Management Service (CARMS).

Access to HES allows the Audit to substantially reduce the number of items in the bowel and OG cancer datasets by retrieving relevant information on follow up and outcomes from Hospital Episode Statistics (N.B. the bowel cancer dataset reduced from 130 plus data items to 43 data items since the audit has been linking to HES).

An on-going part of the audit process commissioned by HQIP is the Clinical Outcomes Programme. The information from the audit is used to measure the performance of trusts and surgeons on the following measures

Bowel cancer:

• 90 day emergency readmission after major resection;

• 18 month stoma rate after major resection for rectal cancer;

• 90 day mortality after major resection;

• 24 month mortality after major resection.

OG Cancer

• 30 day post operative mortality

• 90 day post operative mortality

• Volume of care – number of procedures by individual

• Length of stay

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. To assist the 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. 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.

Whilst the provision of data back to trusts as part of the Clinical Outcomes Programme is not new, the ability to provide fact of death in relation to the 2 mortality indicators is a new element, which is supported by the CAG amendment approval letter.

Onward Dissemination: the following linkages are subsequently carried out by ICNARC, NHS England, PHE and CARMS for HQIP (the Data Controller):

~ Systemic Anti-Cancer Therapy (SACT) dataset required for:

The SACT data collection covers patients receiving cancer chemotherapy in or funded by the NHS in England. It relates to all cancer patients, both adult and paediatric, in acute inpatient, daycase, outpatient settings and delivery in the community. It covers chemotherapy treatment for all solid tumour and haematological malignancies and those in clinical trials.

Linkage will allow assessment of the completeness of submissions of oncology records to the audit and explore whether the chemotherapy data items in the Audit could be dropped to ease the burden of data collection. SACT data also enable more in-depth analysis of specific chemotherapy regimens and changes to prescribed treatment.

The request is also for SACT data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The SACT data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. SACT linkage is carried out for each of the Bowel and OG cancer audits.

~ The Radiotherapy Dataset (RTDS) required for:

The RTDS holds information on every patient treated with radiotherapy funded by the National Health Service (NHS) in the UK.

Linkage will allow assessment of the completeness of submissions of radiotherapy records to the audit and explore whether the radiotherapy data items in the Audit could be dropped to ease the burden of data collection.

The request is also for RTDS data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The RTDS data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. RTDS linkage is carried out for each of the Bowel and OG cancer audits.

~ NBOCA (National Bowel Cancer Audit) uses the National Emergency Laparotomy Audit (NELA) Dataset for:

The NELA collects data on patients undergoing emergency laparotomy and is a Healthcare Quality Improvement Partnership funded Audit.

Linkage allows the assessment of the patients submitted to the National Bowel Cancer Audit that have an emergency laparotomy.

The request is also for NELA data to be returned for patients who fit the inclusion criteria but are not included in the Audit cohort. Note that NELA data only applies to the Bowel cancer audit.

The NELA data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. NELA linkage is carried out for the Bowel cancer audit only.

Note that only the Bowel Cancer audit is linked to NELA.

~ NBOCA uses NHS England’s Cancer Patient Experience Survey Dataset for:

The National Cancer Patient Experience collects information reported by patients themselves about the experience of their bowel cancer care.

Linkage will allow the assessment of how representative the Patient Reported Experience Measure (PREMs) survey is of all groups of patients, including those not having a major resection and those receiving palliative and supportive care.

The request is for all the colorectal PREMs data to be sent to NHS Digital. The NHS number from the PREMs patients would be linked to the Audit data within NHS Digital.

The PREMs data with the Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. PREMs linkage is carried out for the Bowel cancer audit only

The collection of PREMS data as part of this agreement is limited to prospective data from 2017 onwards. This follows a successful amendment request to CAG to address issues of notifying patients of the use of the data. This approval supersedes the previous 2015 approval relating to use of retrospective PREMS data. The legal basis for the PROMS and PREMS linkage is the NHS Act 2006 - s251 - 'Control of patient information'.

NBOCA uses NHS England’s National Cancer PROMs Programme of the National Survivorship Initiative Dataset for:

NHS England’s National Cancer PROMs Programme of the National Survivorship Initiative collects information reported by patients themselves about the outcomes of their bowel cancer e.g. symptoms, functional status and quality of life.

Linkage has allowed the assessment of the feasibility of using information reported by patients themselves about the outcomes of their bowel cancer.

The request is for all the colorectal PROMs data to be sent to NHS Digital. The NHS number from the PROMs patients would be linked to the Audit data within NHS Digital.

The PROMs data with the Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. PROMs linkage is carried out for the Bowel cancer audit only.

The collection of PROMS data as part of this agreement is limited to retrospective data only.

Welsh hospital episode data

The Patient Episode Database for Wales (PEDW) records all episodes of inpatient and day case activity in NHS Wales hospitals. This includes planned and emergency admissions, minor and major operations, and hospital stays for giving birth. Hospital activity for Welsh residents treated in hospitals in England is also included.

The data are collected and coded at each hospital. The records are then electronically transferred to the NHS Wales Informatics Service (NWIS), where they are validated and merged into the main database.

The request is also for PEDW data to be returned for patients diagnosed in Wales only who fit the inclusion criteria but are not included in Audit cohort.

The PEDW data with the Audit Tumour ID is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour ID only is used for linkage purposes.

~ Intensive Care National Audit and Research Centre data:

The Intensive Care National Audit and Research Centre (ICNARC) hosts the case mix programme (CMP) from where NHS Digital will collect the data. The Case Mix Programme is an audit of patient outcomes from adult, general critical care units (intensive care and combined intensive care/high dependency units) covering England, Wales and Northern Ireland.

The CMP is listed in the Department of Health’s ‘Quality Accounts’ as a recognised national audit by the National Advisory Group on Clinical Audit & Enquiries (NAGCAE) for ‘Acute’ care.

Currently 100% of adult, general critical care units participate in the CMP. Other specialist units, including neurosciences, cardiac and high dependency units, also participate.

The CMP is open to both NHS (publicly funded) and independent sector critical care units.

Critical care units collect data on all the patients they admit to their unit. They securely submit this data and the CMP team run over 600 validation checks, identifying errors and missing information. Units then have a chance to correct and complete the data before analyses.

ICNARC compare the data from these patients with the outcomes from other similar patients, other similar units and all the units in the CMP. The unit receives a Data Analysis Report which identifies trends over time showing how the unit compares with others and helps the unit understand more about the care they deliver. It aims to assist them in decision-making, resource allocation and local quality improvement.

Linkage will allow reporting patterns of care and outcomes while patients were admitted to critical care and the characteristics of the patients admitted to critical care.

The request is also for ICNARC data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The ICNARC data with the Audit Tumour ID is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour ID is used for linkage purposes.

~ NBOCA uses the Cancer Outcomes and Services Dataset (COSD)

COSD data when linked to National Bowel Cancer Audit (NBCA) data will be used to describe in further detail those patients with more advanced disease and rectal cancer and to assess the representativeness of patients captured in NBCA. This linkage will allow further investigation of the quality of the audit data and the opportunity to address concerns that there are cases of bowel cancer which are not being recorded in the audit. It is intended to use the data to assess the extent of possible missing data and any patterns relating to this, e.g. particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation. Linkage with COSD will enable the NBCA to further determine the pathway of care for patients with advanced disease and to describe in further detail the management and outcomes of patients with rectal cancer.

NBOCA uses the Cancer Registration Data

The Cancer Registration data will supplement the cases that are recorded in COSD as Cancer Registration services undertake active case finding and will pick up cases of bowel cancer that have not been entered in to the NBOCA. In order for the Audit to be able to report on the complete set of patients diagnosed with bowel cancer, records will be examined for patients who were identified in Cancer Registration data but who are not in NBOCA. This will help to further assess the representativeness of patients captured in NBOCA It is intended to use the data to assess the extent of possible missing data and any patterns relating to this, e.g. particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation.

Linkage to both COSD and Cancer Registration data will enhance the existing data collection to ensure that a full picture of the patient journey is collected for reporting purposes. The audit team will also look at the completeness of the collection of data items within COSD to assess whether any data items collected in the NBOCA collection could be obtained from COSD in future years, thereby reducing the burden of collection on trusts going forwards. Linkage to the Cancer Registration data may also provide some options to reduce the collection burden in addition to providing information on the number of cases of bowel cancer which may be registered but are not included in the audit.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Annual reports:

Separate reports will continue to be produced for each of the two audits.

The National Bowel Cancer 2018 Annual report was published in December 2018. https://www.nboca.org.uk/reports/annual-report-2018/

The National Bowel Cancer 2019 Annual report is targeted for publication in Autumn 2019.

The National Oesophago-Gastric Cancer 2018 Annual report was published in September 2018: https://www.nogca.org.uk/reports/2018-annual-report/

The National Oesophago-Gastric Cancer 2019 Annual report is targeted for publication in Autumn 2019.

The annual reports are written in patient-friendly language and can be understood by the lay reader.

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 Reports for both Bowel and OG cancer audits were published in a number of journals and presented at a number of 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 Royal College of Surgeons takes the opportunity to disseminate their reports as widely as possible - as can be seen from the conferences attended to promote the 2016 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.

Linking Date of Death to the Audit data will provide short-term and long-term survival outcomes.

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

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

~ NOGCA

• Percentage of patients with surgical intent

• Percentage of patients with complications

• Risk adjusted 90-day post-operative mortality

• Risk adjusted complication rate

• Percentage of adequate lymph node resections

• Percentage of positive resection margin

• Length of stay

• Place of death

The Audit will provide national and trust level outcomes on end of life care. Linking Date of Death to the Audit data will provide short-term and long-term survival outcomes.

The linked HES/Audit/death data dataset is also used to report the individual Consultant Outcomes as required by NHS England under Everyone Counts. For Bowel the outcomes are 90-day post-operative mortality. For OG the outcomes include 30-day and 90-day post-operative mortality and length of stay.

The Consultant Outcomes are published on the respective Professional Body website (ACPGBI or AUGIS) and NHS Choices. The target date for delivery is Autumn 2018.

http://www.nhs.uk/Service-Search/Hospital/LocationSearch/7/Procedures?procedure=Gastrectomy

http://www.acpgbi.org.uk/surgeon-outcomes/

http://www.augis.org/surgical-outcomesdata-2018

All outputs will contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

Linkage to ICNARC data will enable assessment of outcomes for patients that are cared for in intensive care following surgery to see if there are any differences in outcomes between different patient pathways. This will be progressed during 2017/18 with feasibility work once the data has been received from ICNARC.

Outputs from linkage to COSD and Cancer Registration data will relate to assessment of completeness of NBOCA data, assessment of missing cases and the potential to reduce the burden of collection in future years by using data from COSD and Cancer Registration and removing any duplication between these collections and the NBOCA dataset. This will be progressed during 2018 once the data request has been progressed with PHE Office of Data Requests and analysis will be included in outputs such as topic specific short reports or sections included in the next Annual Report.

If the linkage to COSD and Cancer Registration data identify data completeness and data quality issues then the NBCA will work with the Audit's Clinical Advisory Group and lead clinicians to encourage trusts to improve their data quality.

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

The National Oesophago-Gastric Cancer 2018 Annual report and the National Bowel Cancer 2018 Annual report were both published in late 2018 following sign off by NHS England.

At national level the Bowel cancer audit is able to report the following outcomes:

- Overall 90-day mortality after major surgery has steadily reduced over five years from 5.4 per cent in 2010-11 to 3.8 per cent in 2014-15.

- Two-year survival in patients having major surgery has improved from 80% in 2009-10 to 82% in 2012-13

- Rates of laparoscopic surgery have increased from 42% in 2010-11 to 61% in 2014-2015. There has been no rebound increase in rates of conversion from laparoscopic to open surgery over this time (9.0% to 8.5%)

- The proportion of patients being seen by a clinical nurse specialist has increased from 87% in 2010-11 to 92% in 2014-15.

- The rate of rectal cancer patients having a local excision to remove their cancer has increased from 5.3% in 2010-11 to 6.8% in 2014-15.

Supporting local trust level improvement:

- Since 2013, the audit has provided individual trust reports comparing results to the local and region and nationally.

- In 2016, the audit started to provide MDTs with individualised slide packs of the trust results. 50% of MDTs reported using these.

- Potentially outlying trusts report that they have carried out local quality improvement including case note review.

- Clinical leads have reported taking their individual trust reports to their CEO to justify increased resources.

Providing information to patients and the public

- The 2016 patient friendly version of the annual report has had 474 downloads since the publication date in December 2016.

- The Clinical Outcomes Publication data is published on NHS Choices.

- The audit and the data in the reports are promoted to the public via bowel cancer charities.

The 2017 OG Annual Report was published in December 2017.

2 short reports were also published in 2017 -

- Validity of cancer-specific mortality as a performance indicator

- Optimal timing between radiotherapy and surgery in rectal cancer patients

All the reports are available on https://www.nboca.org.uk/reports/

There will also be 2 short reports on the following topics -

- End of Life – looking at how many patients are dying at home and how many in hospital; just under a third of colorectal patients are dying at home.

- The use of adjuvant chemotherapy in stage III colon and rectal cancer.

The audit is working with the CQC and the NHS Improvement Getting it Right First Time (GIRFT) teams on improvements in data quality and completeness. It is also supporting the IMPACT programme which is an ACPGBI initiative focused on improving the management of patients with advanced colorectal tumours.

The OG audit has shown the following outcomes:

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

4. Re-assurance that no surgeon or NHS trust has outcomes that are outside the expected range in the Clinical Outcomes Publication (i.e. there were no outliers).

5. Individual NHS trusts are able to 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 Audit is now a repository of data on over 70,000 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 audit project team is also working with CQC to implement improvements in data quality and completeness.

This application covers two separate audits which have now been amalgamated into a single programme for cost-saving purposes.

The National Gastro-Intestinal Cancer Audit Programme (“the GI Cancer audit”) comprises both the National Bowel Cancer Audit and the National Oesophago-Gastric Cancer Audit which were previously managed as two separate audits. The two audits have been amalgamated into the same Programme in order to save costs: both audits need to deliver a cost saving of 15%.

A contract was awarded in early 2018 by HQIP to the Royal College of Surgeons and NHS Digital to deliver the GI Cancer audit for 3 years, until 31st May 2021. There is one programme for governance purposes to oversee the two audits relating to the bowel and OG care pathways; for avoidance of doubt, the two audits are conducted separately and no data is shared between them. The National GI Project Board manages the two audits, and aims to deliver the necessary 15% cost reduction across both Audits.

The audits are based on prospectively-collected, patient-level data on patients diagnosed with colorectal cancer or invasive epithelial oesophago-gastric cancer or oesophageal high-grade dysplasia. This information in each audit is combined with other available datasets – as described below – to provide a rich description of the care process, to minimise the burden of data collection on clinical staff, and to satisfy patient needs in the least intrusive way possible (the applicant is satisfied that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects).

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. For both types of cancer, survival depends on early diagnosis through appropriate investigations, use of complicated surgical techniques and input from a range of professionals. The management of patients is complex and requires multidisciplinary working. By collecting data from NHS Trusts providing care to bowel and oesophago-gastric cancer patients the audits are able to provide information on patient characteristics, treatment planning, postoperative outcomes and palliative treatment.

Bowel cancer is the third most common malignancy in the UK and affects approximately 33,000 people each year, while oesophago-gastric cancer is the fifth most common malignancy and affects approximately 13,500 people each year. Incidence of both cancers is increasing and the prognosis for most patients diagnosed with GI cancer remains poor.

HES data required for:

• Analysing patient follow up and outcomes of surgery, such as emergency readmissions and stoma reversals.

• Investigating hospital utilisation and readmissions among patients with palliative treatment intent.

• Addressing the completion of chemotherapy among patients with palliative treatment intent.

• Providing national results on patterns of patient referral and time to diagnosis such as investigating what proportion of patients had an endoscopic examination prior to diagnosis in order to assess cancers that are potentially missed.

• Examining patterns of palliative and oncological care across hospitals.

These outcomes are published in the Audit’s annual reports, which are used by trusts to assess whether they are meeting national guidance and benchmark their performance. If they are not meeting national standards, trusts will address these areas and make improvements and this will then result in benefits to patients.

The request is also for HES data to be returned for patients who fit the inclusion criteria but are not included in the Audit cohort to enable assessment of case ascertainment; there is no linkage to the case ascertainment cohort.

Consultant code is required to provide individual consultant level 30-day and 90-day post-operative mortality outcomes as part of Everyone Counts, NHS England’s strategic plan.

The HES data with the Audit Tumour id is shared with the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. The Audit Tumour ID key is held by NHS Digital Clinical Audits and Management Service (CARMS).

Access to HES allows the Audit to substantially reduce the number of items in the bowel and OG cancer datasets by retrieving relevant information on follow up and outcomes from Hospital Episode Statistics (N.B. the bowel cancer dataset reduced from 130 plus data items to 43 data items since the audit has been linking to HES).

Civil Registration Death Data required for:

Date of Death will be linked to the Audit data to provide short-term and long-term survival outcomes to publish short-term and long-term mortality outcomes which evidence that patient survival is improving. RCS CEU therefore receive the Date of Death linked to the Tumour ID, with no other identifiers.

Place of Death (with NHS indicator code) will be used in analysis of the palliative care pathway, particularly whether patients die at home, the usual residence (if not home), in the hospital, or in another institutional setting. This will allow the Audit to provide national and trust level outcomes on end of life care.

Place of death will be in the form of a code known as Communal Establishment Code and will remove the potential of the address being identifiable to the patient.

Cause of Death will be used in analysis of whether patients are dying from their cancer or other causes.

An on-going part of the audit process commissioned by HQIP is the Clinical Outcomes Programme. The information from the audit is used to measure the performance of trusts and surgeons on the following measures

Bowel cancer:

• 90 day emergency readmission after major resection;

• 18 month stoma rate after major resection for rectal cancer;

• 90 day mortality after major resection;

• 24 month mortality after major resection.

OG Cancer

• 30 day post operative mortality

• 90 day post operative mortality

• Volume of care – number of procedures by individual

• Length of stay

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. To assist the 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. 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.

Whilst the provision of data back to trusts as part of the Clinical Outcomes Programme is not new, the ability to provide fact of death in relation to the 2 mortality indicators is a new element, which is supported by the CAG amendment approval letter.

Onward Dissemination: the following linkages are subsequently carried out by ICNARC, NHS England, PHE and CARMS for HQIP (the Data Controller):

~ Systemic Anti-Cancer Therapy (SACT) dataset required for:

The SACT data collection covers patients receiving cancer chemotherapy in or funded by the NHS in England. It relates to all cancer patients, both adult and paediatric, in acute inpatient, daycase, outpatient settings and delivery in the community. It covers chemotherapy treatment for all solid tumour and haematological malignancies and those in clinical trials.

Linkage will allow assessment of the completeness of submissions of oncology records to the audit and explore whether the chemotherapy data items in the Audit could be dropped to ease the burden of data collection. SACT data also enable more in-depth analysis of specific chemotherapy regimens and changes to prescribed treatment.

The request is also for SACT data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The SACT data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. SACT linkage is carried out for each of the Bowel and OG cancer audits.

~ The Radiotherapy Dataset (RTDS) required for:

The RTDS holds information on every patient treated with radiotherapy funded by the National Health Service (NHS) in the UK.

Linkage will allow assessment of the completeness of submissions of radiotherapy records to the audit and explore whether the radiotherapy data items in the Audit could be dropped to ease the burden of data collection.

The request is also for RTDS data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The RTDS data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. RTDS linkage is carried out for each of the Bowel and OG cancer audits.

~ NBOCA (National Bowel Cancer Audit) uses the National Emergency Laparotomy Audit (NELA) Dataset for:

The NELA collects data on patients undergoing emergency laparotomy and is a Healthcare Quality Improvement Partnership funded Audit.

Linkage allows the assessment of the patients submitted to the National Bowel Cancer Audit that have an emergency laparotomy.

The request is also for NELA data to be returned for patients who fit the inclusion criteria but are not included in the Audit cohort. Note that NELA data only applies to the Bowel cancer audit.

The NELA data with the Audit Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. NELA linkage is carried out for the Bowel cancer audit only.

Note that only the Bowel Cancer audit is linked to NELA.

~ NBOCA uses NHS England’s Cancer Patient Experience Survey Dataset for:

The National Cancer Patient Experience collects information reported by patients themselves about the experience of their bowel cancer care.

Linkage will allow the assessment of how representative the Patient Reported Experience Measure (PREMs) survey is of all groups of patients, including those not having a major resection and those receiving palliative and supportive care.

The request is for all the colorectal PREMs data to be sent to NHS Digital. The NHS number from the PREMs patients would be linked to the Audit data within NHS Digital.

The PREMs data with the Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. PREMs linkage is carried out for the Bowel cancer audit only

The collection of PREMS data as part of this agreement is limited to prospective data from 2017 onwards. This follows a successful amendment request to CAG to address issues of notifying patients of the use of the data. This approval supersedes the previous 2015 approval relating to use of retrospective PREMS data. The legal basis for the PROMS and PREMS linkage is the NHS Act 2006 - s251 - 'Control of patient information'.

NBOCA uses NHS England’s National Cancer PROMs Programme of the National Survivorship Initiative Dataset for:

NHS England’s National Cancer PROMs Programme of the National Survivorship Initiative collects information reported by patients themselves about the outcomes of their bowel cancer e.g. symptoms, functional status and quality of life.

Linkage has allowed the assessment of the feasibility of using information reported by patients themselves about the outcomes of their bowel cancer.

The request is for all the colorectal PROMs data to be sent to NHS Digital. The NHS number from the PROMs patients would be linked to the Audit data within NHS Digital.

The PROMs data with the Tumour id is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour id is used for linkage purposes. PROMs linkage is carried out for the Bowel cancer audit only.

The collection of PROMS data as part of this agreement is limited to retrospective data only.

Welsh hospital episode data

The Patient Episode Database for Wales (PEDW) records all episodes of inpatient and day case activity in NHS Wales hospitals. This includes planned and emergency admissions, minor and major operations, and hospital stays for giving birth. Hospital activity for Welsh residents treated in hospitals in England is also included.

The data are collected and coded at each hospital. The records are then electronically transferred to the NHS Wales Informatics Service (NWIS), where they are validated and merged into the main database.

The request is also for PEDW data to be returned for patients diagnosed in Wales only who fit the inclusion criteria but are not included in Audit cohort.

The PEDW data with the Audit Tumour ID is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour ID only is used for linkage purposes.

~ Intensive Care National Audit and Research Centre data:

The Intensive Care National Audit and Research Centre (ICNARC) hosts the case mix programme (CMP) from where NHS Digital will collect the data. The Case Mix Programme is an audit of patient outcomes from adult, general critical care units (intensive care and combined intensive care/high dependency units) covering England, Wales and Northern Ireland.

The CMP is listed in the Department of Health’s ‘Quality Accounts’ as a recognised national audit by the National Advisory Group on Clinical Audit & Enquiries (NAGCAE) for ‘Acute’ care.

Currently 100% of adult, general critical care units participate in the CMP. Other specialist units, including neurosciences, cardiac and high dependency units, also participate.

The CMP is open to both NHS (publicly funded) and independent sector critical care units.

Critical care units collect data on all the patients they admit to their unit. They securely submit this data and the CMP team run over 600 validation checks, identifying errors and missing information. Units then have a chance to correct and complete the data before analyses.

ICNARC compare the data from these patients with the outcomes from other similar patients, other similar units and all the units in the CMP. The unit receives a Data Analysis Report which identifies trends over time showing how the unit compares with others and helps the unit understand more about the care they deliver. It aims to assist them in decision-making, resource allocation and local quality improvement.

Linkage will allow reporting patterns of care and outcomes while patients were admitted to critical care and the characteristics of the patients admitted to critical care.

The request is also for ICNARC data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

The ICNARC data with the Audit Tumour ID is shared with the Clinical Effectiveness Unit of the Royal College of Surgeons for linking to the Audit data that they already hold. The Audit Tumour ID is used for linkage purposes.

~ NBOCA uses the Cancer Outcomes and Services Dataset (COSD)

COSD data when linked to National Bowel Cancer Audit (NBCA) data will be used to describe in further detail those patients with more advanced disease and rectal cancer and to assess the representativeness of patients captured in NBCA. This linkage will allow further investigation of the quality of the audit data and the opportunity to address concerns that there are cases of bowel cancer which are not being recorded in the audit. It is intended to use the data to assess the extent of possible missing data and any patterns relating to this, e.g. particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation. Linkage with COSD will enable the NBCA to further determine the pathway of care for patients with advanced disease and to describe in further detail the management and outcomes of patients with rectal cancer.

NBOCA uses the Cancer Registration Data

The Cancer Registration data will supplement the cases that are recorded in COSD as Cancer Registration services undertake active case finding and will pick up cases of bowel cancer that have not been entered in to the NBOCA. In order for the Audit to be able to report on the complete set of patients diagnosed with bowel cancer, records will be examined for patients who were identified in Cancer Registration data but who are not in NBOCA. This will help to further assess the representativeness of patients captured in NBOCA It is intended to use the data to assess the extent of possible missing data and any patterns relating to this, e.g. particular geographical areas under-reporting cases or any potential linkage to under presentation related to social deprivation.

Linkage to both COSD and Cancer Registration data will enhance the existing data collection to ensure that a full picture of the patient journey is collected for reporting purposes. The audit team will also look at the completeness of the collection of data items within COSD to assess whether any data items collected in the NBOCA collection could be obtained from COSD in future years, thereby reducing the burden of collection on trusts going forwards. Linkage to the Cancer Registration data may also provide some options to reduce the collection burden in addition to providing information on the number of cases of bowel cancer which may be registered but are not included in the audit.

Annual reports:

Separate reports will continue to be produced for each of the two audits.

The National Bowel Cancer 2018 Annual report is due to be published in Autumn 2018 (this has not yet been published, is awaiting sign-off by NHS England).

The National Bowel Cancer 2019 Annual report is targeted for publication in Autumn 2019.

The National Oesophago-Gastric Cancer 2018 Annual report was published in September: https://www.nogca.org.uk/reports/2018-annual-report/

The National Oesophago-Gastric Cancer 2019 Annual report is targeted for publication in Autumn 2019.

The annual reports are written in patient-friendly language and can be understood by the lay reader.

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 Reports for both Bowel and OG cancer audits were published in a number of journals and presented at a number of 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 Royal College of Surgeons takes the opportunity to disseminate their reports as widely as possible - as can be seen from the conferences attended to promote the 2016 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.

Linking Date of Death to the Audit data will provide short-term and long-term survival outcomes.

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

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

~ NOGCA

• Percentage of patients with surgical intent

• Percentage of patients with complications

• Risk adjusted 90-day post-operative mortality

• Risk adjusted complication rate

• Percentage of adequate lymph node resections

• Percentage of positive resection margin

• Length of stay

• Place of death

The Audit will provide national and trust level outcomes on end of life care. Linking Date of Death to the Audit data will provide short-term and long-term survival outcomes.

The linked HES/Audit/death data dataset is also used to report the individual Consultant Outcomes as required by NHS England under Everyone Counts. For Bowel the outcomes are 90-day post-operative mortality. For OG the outcomes include 30-day and 90-day post-operative mortality and length of stay.

The Consultant Outcomes are published on the respective Professional Body website (ACPGBI or AUGIS) and NHS Choices. The target date for delivery is Autumn 2018.

http://www.nhs.uk/Service-Search/Hospital/LocationSearch/7/Procedures?procedure=Gastrectomy

http://www.acpgbi.org.uk/surgeon-outcomes/

http://www.augis.org/surgical-outcomesdata-2018

All outputs will contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

Linkage to ICNARC data will enable assessment of outcomes for patients that are cared for in intensive care following surgery to see if there are any differences in outcomes between different patient pathways. This will be progressed during 2017/18 with feasibility work once the data has been received from ICNARC.

Outputs from linkage to COSD and Cancer Registration data will relate to assessment of completeness of NBOCA data, assessment of missing cases and the potential to reduce the burden of collection in future years by using data from COSD and Cancer Registration and removing any duplication between these collections and the NBOCA dataset. This will be progressed during 2018 once the data request has been progressed with PHE Office of Data Requests and analysis will be included in outputs such as topic specific short reports or sections included in the next Annual Report.

If the linkage to COSD and Cancer Registration data identify data completeness and data quality issues then the NBCA will work with the Audit's Clinical Advisory Group and lead clinicians to encourage trusts to improve their data quality.

Outputs on the management of patients with rectal cancer and advanced disease will be included in the NBCA's annual report.

The National Oesophago-Gastric Cancer 2018 Annual report has recently been published.

(the National Bowel Cancer 2018 Annual report is currently is awaiting sign-off by NHS England).

At national level the Bowel cancer audit is able to report the following outcomes:

- Overall 90-day mortality after major surgery has steadily reduced over five years from 5.4 per cent in 2010-11 to 3.8 per cent in 2014-15.

- Two-year survival in patients having major surgery has improved from 80% in 2009-10 to 82% in 2012-13

- Rates of laparoscopic surgery have increased from 42% in 2010-11 to 61% in 2014-2015. There has been no rebound increase in rates of conversion from laparoscopic to open surgery over this time (9.0% to 8.5%)

- The proportion of patients being seen by a clinical nurse specialist has increased from 87% in 2010-11 to 92% in 2014-15.

- The rate of rectal cancer patients having a local excision to remove their cancer has increased from 5.3% in 2010-11 to 6.8% in 2014-15.

Supporting local trust level improvement:

- Since 2013, the audit has provided individual trust reports comparing results to the local and region and nationally.

- In 2016, the audit started to provide MDTs with individualised slide packs of the trust results. 50% of MDTs reported using these.

- Potentially outlying trusts report that they have carried out local quality improvement including case note review.

- Clinical leads have reported taking their individual trust reports to their CEO to justify increased resources.

Providing information to patients and the public

- The 2016 patient friendly version of the annual report has had 474 downloads since the publication date in December 2016.

- The Clinical Outcomes Publication data is published on NHS Choices.

- The audit and the data in the reports are promoted to the public via bowel cancer charities.

The 2017 OG Annual Report was published in December 2017.

2 short reports were also published in 2017 -

- Validity of cancer-specific mortality as a performance indicator

- Optimal timing between radiotherapy and surgery in rectal cancer patients

All the reports are available on https://www.nboca.org.uk/reports/

There will also be 2 short reports on the following topics -

- End of Life – looking at how many patients are dying at home and how many in hospital; just under a third of colorectal patients are dying at home.

- The use of adjuvant chemotherapy in stage III colon and rectal cancer.

The audit is working with the CQC and the NHS Improvement Getting it Right First Time (GIRFT) teams on improvements in data quality and completeness. It is also supporting the IMPACT programme which is an ACPGBI initiative focused on improving the management of patients with advanced colorectal tumours.

The OG audit has shown the following outcomes:

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

4. Re-assurance that no surgeon or NHS trust has outcomes that are outside the expected range in the Clinical Outcomes Publication (i.e. there were no outliers).

5. Individual NHS trusts are able to 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 Audit is now a repository of data on over 70,000 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 audit project team is also working with CQC to implement improvements in data quality and completeness.