National Prostate Cancer Audit (ODR1920_024)

The Health Quality Improvement Partnership (HQIP) and NHS England (NHSE) requires access to NHS England National Disease Registration Service (NDRS) data in support of the following National Audit:

The National Prostate Cancer Audit (NPCA) which The Royal College of Surgeons of England (RCS) Clinical Effectiveness Unit (CEU) are running as Data Processors on behalf of the controllers.

The following is a summary of the aims of the audit:

The NPCA aims to assess the care process and its outcomes in men diagnosed with prostate cancer in England and Wales (this Agreement covers patients who are residents of England only). By auditing the care delivered by cancer services, we can highlight areas where hospitals are doing well and areas where the quality of care can be improved. The Audit produces performance indicators for all NHS providers, it allows cancer services to compare themselves with others in England and Wales, and share examples of good practice.

The following NHS England NDRS datasets have already been accessed in support of the Audit:

• NDRS Cancer Registrations- including Cancer Outcomes and Services Dataset (COSD) items

• NDRS Rapid Cancer Registrations

• NDRS Linked Hospital Episode Statistics (HES) Accident & Emergency

• NDRS Linked HES Admitted Patient Care (APC)

• NDRS Linked HES Outpatients (OP)

• NDRS National Radiotherapy Dataset (RTDS)

• NDRS Systemic Anti-Cancer Therapy (SACT) Dataset

The Audit now wishes to request a refresh of the data to support the continuation of the work that the Audit undertakes.

This DSA will support the following releases of data

1) The ongoing quarterly releases of linked Rapid Cancer Registrations over the term of the DSA. Including August 2023 (Feb – April 2023 linked to the most recently available RTDS, SACT and HES APC/OP/A&E data), Nov 2023 (May – July 2023 linked to the most recently available RTDS, SACT and HES APC/OP/A&E data - due), Feb 2024, May 2024

Rapid cancer registration dataset – list of data items provided to the NPCA each quarter

• Data will be provided for patients diagnosed 1 January 2018 to the most recent data available. The tumour section of the rapid cancer registration dataset (RCRD) will be extracted to determine the diagnosis cohort, and then linked to treatment data from HES, RTDS and SACT.

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2) NDRS cancer registry data for patients diagnosed up until end of 2021 (latest available) linked to HES APC/OP/A&E, SACT and RTDS.

NPCA fully processed data cohort specification for NDRS Cancer Registrations:

The prostate cohort is defined as all men with a finalised case of malignant prostate (ICD10-O2 C61) diagnosed between 1 January 2008– 31 December 2021 in English residents, excluding those diagnosed by death certificate only (Basis of Diagnosis = 0). Also excluding any cases where the prostate cancer diagnosis is 1 week before or 6 months after a Bladder cancer diagnosis (ICD10-O2 C67). Where there are 2 tumours (very unusual) the earliest diagnosed tumour has been selected so we only have one tumour record per patient.

The CR (Cancer registry) trust of diagnosis and diagnosis date for provided for each patient (from the selected tumour as these are tumour level fields). Data from the cancer registry and event tables are tumour level data, the data from the other databases are patient level data. Tumours diagnosed from 01/01/18 onwards are coded in TNM8.

A pseudonymised patient id has been created for each patient; this is a stable id across snapshots and data releases whenever the code is run so from this data release onwards the patient data can be compared if necessary.

CR, ONS, HES, RTDS and SACT data will be provided for patients diagnosed between 1 January 2008– latest available (SACT available from April 2012 onwards); COSD data will be provided for patients diagnosed between 1 April 2014 – latest available, with the exception of any items only listed as available from 1 April 2019 in the DSC (noted below).

Due to the size of files and the previous need to link cases from April 2014 onwards to the COSD NPCA dataset the cohort is spilt into two diagnosis periods and data extracted separately, these are the ARYYYY cohort (1 April 2014 - 31 December 2021) and the historic cohort (1 January 2008– 31 March 2014).

Cohort definition: CR, COSD, NPCA, HES, RTDS and SACT data have been taken from the December 2023 snapshot (CAS2309).

RTDS, HES and SACT will be provided to the latest available.

……………….

The level of the data will be:

• Pseudonymised

The data will be minimised as follows:

• Limited to a cohort, used for long-term follow-up, identified by NHS England as meeting the following criteria: Men with a finalised case of malignant prostate cancer in the NDRS cancer Registry, and received a diagnosis between 01/01/2008 and 31/12/2021

• Limited to a cohort, used for the NPCA Prospective Audit, identified by NHS England as meeting the following criteria: Men diagnosed with a case of malignant prostate cancer in the NDRS Rapid Cancer Registry between 01/01/18 – to the most recent available (disseminated quarterly)

• Limited specific ICD or OPCS codes that relate to Prostate Cancer

• Exclusion Criteria: Patients whose diagnosis has only been included on their death certificate, any cases where there is a prostate diagnosis 1 week before or 6 months after a Bladder Cancer diagnosis.

The NPCA is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, and is part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). NHS England and HQIP are the joint controllers for the data being held and disseminated under this Agreement, as together both organisations determine the purposes and means of processing.

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

HQIP rely on Article 9 (2) (i) as the legal basis for processing under the UK GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular, professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. The processing meets 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 relies on Article 9(2)(h) of the UK GDPR as the legal basis for processing. "Processing is necessary for preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England is responsible for the provision of health and social care, and the management of systems and compliance. The processing meets Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons.

The funding is provided by NHS England via the intermediary of HQIP. The funding is specifically for the audit described.

The RCS is a processor acting under the instructions of NHS England and HQIP.

The RCS collaborate with the British Association of Urological Surgeons (BAUS) and the British Uro-Oncology Group (BUG), neither organisation processes the data being provisioned under this Agreement. The BAUS and BUG serve in an advisory capacity only.

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

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

The expected outputs of the processing will be:

• The publication of an Annual ‘State of the Nation’ (SotN) report, including a patient summary of such reports.

• The production of dashboards to aid continuous monitoring of NHS Providers. The dashboards will be updated on a quarterly basis and will be made available on the Audit webpages.

• Submissions to appropriate peer-reviewed journals on an ongoing basis

• Shorter reports on various relevant topics- including a comparison of the ‘Gold Standard’ NDRS Cancer Registration and the Rapid Cancer Registrations data.

• Presentations at appropriate conferences- including the respective annual meetings of BAUS and BUG

• The use of appropriate methods to measure a range of key process and outcome performance indicators, comparing and reporting the performance of NHS providers

The Audit also supports other key national initiatives including the Care Quality Commission (CQC) inspection programme, HQIP’s National Clinical Audit Benchmarking (NCAB), and the Getting It Right First Time (GIRFT) initiative by providing provider-level results.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Reports published on the Audit webpages

• Social media

• Public reports

• Newsletters (https://www.npca.org.uk/news/)

• Reports aimed at patients (lay summaries)

Outputs will be produced on an ongoing basis until the end of the contract with HQIP.

More specifically, benefits of the Audit can already be seen in the decreasing number of patients considered to be ‘under-treated’ (defined as patients diagnosed with high-risk disease not offered radical therapy) and the decreasing number of patients being ‘over-treated’ (defined as patients diagnosed with low-risk disease undergoing radical treatment).

The Audit highlights the proportion of patients diagnosed at the metastatic stage, and further research showed a difference in the population characteristics of these patients, which in turn enables targeted initiatives at these groups, in order to decrease the number of patients diagnosed with late-stage disease and therefore improve their outcomes.

The Audit has organised two very well-attended (100+ clinicians, commissioners, patients) Quality Improvement Workshops in 2021 and 2023, for which slides and recordings of the presentation are available on the NPCA website (https://www.npca.org.uk/quality-improvement/). Both workshops stimulated discussions around Audit outputs and research, as well as providing data for local and regional quality improvement activities.

Findings from the Audit’s 2022 organisational audit (94% response rate) showed areas where supportive services are available in the majority of trusts (Specialist nurses, continence services and sexual function services) and others where there is variation (genetic counselling and onco-geriatric services). Using this data enables Trusts to assess their service provision and if necessary, to improve it, ultimately benefitting patient care.

The Health Quality Improvement Partnership (HQIP) and NHE England (NHSE) requires access to NHS England National Disease Registration Service (NDRS) data in support of the following National Audit:

The National Prostate Cancer Audit (NPCA) which The Royal College of Surgeons of England (RCS) Clinical Effectiveness Unit (CEU) are running as Data Processors on behalf of the controllers.

The following is a summary of the aims of the audit:

The NPCA aims to assess the care process and its outcomes in men diagnosed with prostate cancer in England and Wales (this Agreement covers patients who are residents of England only). By auditing the care delivered by cancer services, we can highlight areas where hospitals are doing well and areas where the quality of care can be improved. The Audit produces performance indicators for all NHS providers, it allows cancer services to compare themselves with others in England and Wales, and share examples of good practice.

The following NHS England NDRS datasets have already been accessed in support of the Audit:

• NDRS Cancer Registrations- including Cancer Outcomes and Services Dataset (COSD) items

• NDRS Rapid Cancer Registrations

• NDRS Linked Hospital Episode Statistics (HES) Accident & Emergency

• NDRS Linked HES Admitted Patient Care (APC)

• NDRS Linked HES Outpatients (OP)

• NDRS National Radiotherapy Dataset (RTDS)

• NDRS Systemic Anti-Cancer Therapy (SACT) Dataset

The Audit now wishes to request a refresh of the data to support the continuation of the work that the Audit undertakes.

The level of the data will be:

• Pseudonymised

The data will be minimised as follows:

• Limited to a cohort, used for long-term follow-up, identified by NHS England as meeting the following criteria: Men with a finalised case of malignant prostate cancer, and received a diagnosis between 01/01/2008 and 31/12/2021

• Limited to a cohort, used for the NPCA Prospective Audit, identified by NHS England as meeting the following criteria: Men with a finalised case of malignant prostate cancer, and received a diagnosis between 01/04/2014 to 31/12/2021

• Limited specific ICD or OPCS codes that relate to Prostate Cancer

• Exclusion Criteria: Patients whose diagnosis has only been included on their death certificate, any cases where there is a prostate diagnosis 1 week before or 6 months after a Bladder Cancer diagnosis.

The NPCA is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, and is part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). NHS England and HQIP are the joint controllers for the data being held and disseminated under this Agreement, as together both organisations determine the purposes and means of processing.

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

HQIP rely on Article 9 (2) (i) as the legal basis for processing under the UK GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular, professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. The processing meets 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 relies on Article 9(2)(h) of the UK GDPR as the legal basis for processing. "Processing is necessary for preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England is responsible for the provision of health and social care, and the management of systems and compliance. The processing meets Schedule 1 Part 1 paragraph 2 of the Data Protection Act 2018 as the processing is carried out by the Royal College of Surgeons.

The funding is provided by NHS England via the intermediary of HQIP. The funding is specifically for the audit described.

The RCS is a processor acting under the instructions of NHS England and HQIP.

The RCS collaborate with the British Association of Urological Surgeons (BAUS) and the British Uro-Oncology Group (BUG), neither organisation processes the data being provisioned under this Agreement. The BAUS and BUG serve in an advisory capacity only.

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

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

The expected outputs of the processing will be:

• The publication of an Annual ‘State of the Nation’ (SotN) report, including a patient summary of such reports.

• The production of dashboards to aid continuous monitoring of NHS Providers. The dashboards will be updated on a quarterly basis and will be made available on the Audit webpages.

• Submissions to appropriate peer-reviewed journals on an ongoing basis

• Shorter reports on various relevant topics- including a comparison of the ‘Gold Standard’ NDRS Cancer Registration and the Rapid Cancer Registrations data.

• Presentations at appropriate conferences- including the respective annual meetings of BAUS and BUG

• The use of appropriate methods to measure a range of key process and outcome performance indicators, comparing and reporting the performance of NHS providers

The Audit also supports other key national initiatives including the Care Quality Commission (CQC) inspection programme, HQIP’s National Clinical Audit Benchmarking (NCAB), and the Getting It Right First Time (GIRFT) initiative by providing provider-level results.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Reports published on the Audit webpages

• Social media

• Public reports

• Newsletters (https://www.npca.org.uk/news/)

• Reports aimed at patients (lay summaries)

Outputs will be produced on an ongoing basis until the end of the contract with HQIP.

More specifically, benefits of the Audit can already be seen in the decreasing number of patients considered to be ‘under-treated’ (defined as patients diagnosed with high-risk disease not offered radical therapy) and the decreasing number of patients being ‘over-treated’ (defined as patients diagnosed with low-risk disease undergoing radical treatment).

The Audit highlights the proportion of patients diagnosed at the metastatic stage, and further research showed a difference in the population characteristics of these patients, which in turn enables targeted initiatives at these groups, in order to decrease the number of patients diagnosed with late-stage disease and therefore improve their outcomes.

The Audit has organised two very well-attended (100+ clinicians, commissioners, patients) Quality Improvement Workshops in 2021 and 2023, for which slides and recordings of the presentation are available on the NPCA website (https://www.npca.org.uk/quality-improvement/). Both workshops stimulated discussions around Audit outputs and research, as well as providing data for local and regional quality improvement activities.

Findings from the Audit’s 2022 organisational audit (94% response rate) showed areas where supportive services are available in the majority of trusts (Specialist nurses, continence services and sexual function services) and others where there is variation (genetic counselling and onco-geriatric services). Using this data enables Trusts to assess their service provision and if necessary, to improve it, ultimately benefitting patient care.

The NPCA aims to contribute to changes in clinical practice in England and Wales that will save lives and improve quality of life. Five specific healthcare improvement goals were established in the first term of the audit (1st April 2013 – 30 June 2018):

• Increased use of active surveillance to treat men with low-risk prostate cancer, thus avoiding potential over-treatment.

• Increased use of multimodality therapy (external beam radiotherapy and hormones; combined treatments with surgery and radiotherapy) for men with high risk or locally advanced prostate cancer and thus avoiding potential under-treatment.

• Improved safety and toxicity profile of prostate cancer therapy.

• Reduced variation in prostate cancer management among NHS providers.

• Improved experience of care among men with prostate cancer.

The NPCA determines whether the care received by men diagnosed with prostate cancer in England and Wales is consistent with current recommendations and practice, such as those outlined in the NICE Quality Standards (see below) and provides information to support healthcare providers, commissioners and regulators in helping to improve care for patients.

In the new audit term (from 01.07.19 onwards), the scope of the NPCA will include the development of longer-term outcomes measures including cancer recurrence, progression, and metastatic disease development.

The aim of the NPCA is to assess the process of care and its outcomes in men diagnosed with prostate cancer in England and Wales.

The NPCA aims to contribute to changes in clinical practice in England and Wales that will save lives and improve quality of life. Five specific healthcare improvement goals were established in the first term of the audit (1st April 2013 – 30 June 2018):

• Increased use of active surveillance to treat men with low-risk prostate cancer, thus avoiding potential over-treatment.

• Increased use of multimodality therapy (external beam radiotherapy and hormones; combined treatments with surgery and radiotherapy) for men with high risk or locally advanced prostate cancer and thus avoiding potential under-treatment.

• Improved safety and toxicity profile of prostate cancer therapy.

• Reduced variation in prostate cancer management among NHS providers.

• Improved experience of care among men with prostate cancer.

The NPCA determines whether the care received by men diagnosed with prostate cancer in England and Wales is consistent with current recommendations and practice, such as those outlined in the NICE Quality Standards (see below) and provides information to support healthcare providers, commissioners and regulators in helping to improve care for patients.

In the new audit term (from 01.07.19 onwards), the scope of the NPCA will include the development of longer-term outcomes measures including cancer recurrence, progression, and metastatic disease development.