National Vascular Registry - patient level HES and Civil Registration Mortality data request.

Various types of vascular surgery are delivered in the NHS for arterial disease. The surgery is associated with significant morbidity and mortality, with some procedures having a postoperative 30-day mortality rate exceeding 30%.

The aim of the National Vascular Registry (NVR) is to improve the quality of care of patients having vascular surgery by providing high quality comparative information on clinical practice and outcomes and support quality improvement by NHS hospitals. The Registry was established in 2013 and collects data from NHS Trusts providing vascular surgery, in order to provide information on patient characteristics, pre-operative care, the range of surgery undertaken, and postoperative outcomes. Specific objectives of the NVR are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing vascular surgery

2. To provide comparative information on the process of care to NHS vascular units

3. To provide comparative information on patient outcomes following surgery.

4. To facilitate the development of effective change (quality improvement) initiatives and spread examples of best practice among NHS vascular services.

This Agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The Royal College of Surgeons (RCS) of England is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme (NCAPOP).

HQIP have commissioned the Royal College of Surgeons to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists.

The National Vascular Registry (NVR) is run by the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons.

NEC Software Solutions UK host the NVR IT system which is managed by the RCS. NEC Software Solutions UK will be sending in the patient identifiers to NHS England DARS they will not receive any data back from NHS England DARS.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP 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 NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, 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 NCAPOP projects 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.

As part of NCAPOP The NVR HQIP have commissioned the Royal College of Surgeons (RCS) to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists. The National Vascular Registry is run by the Clinical Effectiveness Unit of the Royal College of Surgeons. Some members of the NVR team are substantively employed by London School of Hygiene & Tropical Medicine but hold honorary contracts with RCS. There are no other organisations involved.

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

HQIP and NHS England are Data Controllers for the national clinical audit but do not have access to any data collected or analysed by the staff in the Clinical Effectiveness Unit at the RCS who are the Data Processors.

The National Vascular Registry is based on prospectively collected, patient-level data on patients who have had vascular surgery. The analysis undertaken by the NVR project team will only involve pseudonymised datasets that combine information submitted by NHS hospitals and data supplied by NHS England DARS on this specific cohort of patients listed on the NVR. The data are processed and stored at the RCS.

The NVR runs using a mixed patient consent model.

For patients having an elective procedure in England and Wales, patients are asked to consent for a number of personal identifiers to be submitted to the NVR by hospital staff - the identifiers are: NHS number, date of birth and full postcode.

For patients having surgery after an emergency admission in England and Wales, the NVR has Section 251 approval to collect these patient identifiers without consent because it is not typically feasible to ask for consent in these circumstances.

Where consent has been refused, no data will flow for those individuals, and they will therefore not form part of any cohort under this Data Sharing Agreement.

The RCS wish to link the patient records submitted to NVR, which make up the NVR cohort, with their Hospital Episode Statistics (HES) records. The NVR records relate only to an individual admission, and by linking to inpatient HES data, the Audit team will be able to provide more precise and relevant information to NHS hospitals by allowing the NVR to describe longer-term outcomes (e.g., readmission rates) and to improve risk-adjustment models by using the extensive information on comorbid conditions held within HES (e.g., to calculate the Charlson Comorbidity score). The audit questions are designed not to duplicate data that could be gathered by routinely gathered datasets which in turn necessitates the need for identifying data to flow and linkage to take place in order to complete the analysis.

The RCS also wish to link the patient records submitted to NVR with Civil Registration/Mortality data on an annual basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

The NVR began in 2013 and the historic data requested will provide important information when looking to improve key outcome measures such as mortality and length of stay. HQIP require the HES/Civil Registration/Mortality data for the whole of England in order to meet the aims of the NVR. Data for only specific hospitals or regions would not provide a full picture of what is occurring across the country. There are no alternative, less intrusive ways of achieving the aims of the NVR.

Patient level HES data is also being requested for all vascular procedures in 2011-2022 M13, to calculate cases identified through data held by NHS England DARS and for other long term outcomes for patients with vascular disease. This cohort will be identified by the relevant OPCS (Office of Population, Censuses and Surveys Classification of Surgical Operations and Procedures) codes, which are L16-L79 (Aortic repair, carotid endarterectomy, lower-limb revascularisation) and X09, X10, X11 – Lower limb amputation. This cohort is separate to the NVR cohort described above, and is required as the case ascertainment rates for the NVR are not 100% and without this data the audit would not be able to provide a robust picture of vascular care.

The RCS also require civil registration/ mortality data from the cohort of patients identified by OPCS procedure codes which will then be linked to the HES data for this cohort. This data was not previously provided for the cohort of patients identified by OPCS procedure codes. The main reason for this is to be able to determine the long-term mortality for all vascular patients in England, and not just those that have been able to be linked to the NVR cohort. Some hospitals have very low NVR consent rates, and so the existing mortality data held by the NVR team is insufficient to be able to ensure that the long-term outcomes of vascular patients at these hospitals are comparable to other hospitals.

The request is limited to patients undergoing vascular procedures in England.

Section 251 is in place for confidential patient information to flow to NHS England DARS for patients who underwent emergency vascular surgery.

Confidential patient information is flowed to NHS England DARS for patients who received elective surgery and consented to their details being entered into the NVR.

RCS will also send a list of OPCS codes to NHS England DARS to create a pseudonymised cohort for cases identified through data held by NHS England DARS. This will be comprised of the following OPCS codes:

(all relating to vascular events) L16-L79 (Aortic repair, carotid endarterectomy, lower-limb re-vascularisation)

X09, X10, X11 – Lower limb amputation. The data is used for case ascertainment calculations and other metrics, such as long-term outcomes of patients with vascular disease. The case ascertainment rates in the NVR are not 100% and without the data for those patients not in the NVR the data would not provide a robust picture of vascular care.

In summary, the purpose of this request is to support national clinical audit, quality improvement within NHS hospitals, and undertake research to enhance the methods used to monitor surgical outcomes.

Mortality occurring in the short-term following some vascular procedures (e.g., elective AAA repair and lower limb angioplasty) are very low and the more important measures are mortality at 2-5 years. The NVR has recently started collecting device information for AAA repairs and is planning to collect devices for lower limb angioplasty procedures in the near future. Monitoring the long-term outcomes of these devices are an important patient safety issue that is supported by NHS England.

Mortality occurring in the longer-term for all patients following vascular procedures is also an important measure during the COVID-19 pandemic. Vascular patients have multiple comorbidities and are therefore at a higher risk of morbidity and mortality if they contract COVID-19. The NVR team has heard evidence from a number of hospitals that patients undergoing vascular procedures in late 2019 and early 2020 died at home from COVID-19 in 2020. Without mortality data for all vascular patients, the NVR team would be unable to provide a complete picture on the effect of the COVID-19 pandemic on this high-risk patient group.

The audit cohort will be looked at in line with the review of the impact of adverse events in respect of COVID-19. It is hoped the findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19.

The Audit are treating the inclusion of looking at the impact of COVID-19 as part of the general review of the audit data and the impact of any adverse event to the cohort.

In April 2020, the NVR set to look at answering COVID-related questions as part of the audit using the data in response to a request from the Vascular Society of Great Britain and Ireland (VSGBI). The VSGBI are the professional organisation that represents vascular surgeons in UK and Ireland and provide the clinical expertise to the NVR team.

The main aims of the extra questions are to determine:

1. What proportion of patients who had a vascular procedure had COVID-19

2. What impact the COVID-19 epidemic had on the care of individual patients having vascular surgery

3. Whether respiratory-related complication rates after vascular surgery were affected by COVID-19

The specific objectives for Aim 1 are to determine:

a) What proportion of patients had a different operation due to COVID-19 epidemic than under normal circumstances

b) What proportion of patients had their operation delayed due to COVID-19 situation.

The audit cohort will therefore also be looked at in line with the review of the impact of adverse events in respect of COVID-19. The findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19. The inclusion of the COVID 19 questions are all aligned to the general purpose of the clinical audit. At the time that NVR set out their plan to address the above COVID-related questions, they had not yet requested data covering the COVID-19 affected period. Now that this data period is being requested, this COVID-related area of the audit can be investigated.

The linked dataset will be a product of this process and will enhance the quality of the comparative information produced by the NVR in subsequent years.

The NVR is commissioned to produce a "State of the Nation" annual report each year. These reports are typically published in November each year and are publicly available to view on the Vascular Services Quality Improvement Programme (VSQIP) website. Subsequent reports are scheduled to be published yearly. The reports contain information on patient characteristics, the types of surgery undertaken, and postoperative outcomes. Information about the quality of the NVR process is also presented, notably estimates of case-ascertainment. In this process, the HES records will provide a reference against which the number of patient records submitted to the NVR can be compared.

The NVR annual reports are published each November so that they are released for the annual conferences of the Vascular Society of Great Britain & Ireland. This means that any HES data used for case ascertainment purposes are required to be provided to the RCS , so that they can be used in the data analysis.

The NVR produces information at the level of an NHS organisation primarily. This information is used by NHS staff, other national bodies such as the Care Quality Commission and NHS Improvement. Information on consultant surgical outcomes is also produced for publication on MyNHS.

In order to disseminate the findings of the audit to the various stakeholders, various scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BJS (British Journal of Surgery), and EJVES (European Journal of Vascular and Endovascular Surgery) at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

The main benefit of this data for patients is that this will allow the RCS to provide longer term outcomes to help inform decisions about treatment and care. The datasets currently held only cover in-hospital and 30 day deaths. Some of the procedures (e.g. elective infra-renal AAAs and lower limb angioplasties) have a very low mortality rate at 30 days (<2%), but it is known that the long term outcomes for these patients is not as good.

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

As stated above, there will be no requirement nor attempt to re-identify individuals from the data.

Online reporting tables and graphs are available to NHS staff who have access to the NVR data collection system; these online tools are designed to assist NHS trusts and consultants benchmark themselves and promote local Quality Improvement work. The online reports will provide local units with aggregated information to compare their performance against a national average. Each individual user has their own login (username/password) to the NVR data collection system which gives them access to only their own hospital local data. No data supplied from NHS England DRAS is held or accessed here.

Information and outputs for the public can be accessed via https://www.vsqip.org.uk/public/

The case-ascertainment rates achieved by the Registry are a marker of its quality, and helps the individuals using the reports (clinicians, patients, commissioners, etc.) to have confidence in using them in their decision making. The outputs of the NVR have been used by surgeons for revalidation, by NHS trusts for local quality improvement initiatives and as part of the national NHS England CQUIN process, which links the performance of vascular units to income payments.

The HES data received under this Agreement has not yet been used to produce other planned outputs because the application of the NDO was removed, and the HES data was resupplied. Consequently, there are no yielded benefits to report from this planned work.

The application of National Data Opt-Outs (NDOs) have been removed from 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 NVR, this has been supported. The justification to not apply the NDOs is as below:

Application of the National Data Opt-Out is likely to result in around 5% of patient records being lost from the NVR every year. This estimate is based on data provided by NHS England DARS on current levels of opt-out. The NVR collects data for patients who undergo repair procedures for abdominal aortic aneurysm (AAA), patients who undergo lower limb angioplasty or stent, lower limb bypass surgery or lower limb amputation to treat peripheral arterial disease (PAD), and patients who undergo carotid endarterectomy or carotid stenting. Some of these conditions, particularly AAA, are relatively rare. The loss of data, even a small amount, relating to treatment of these conditions may adversely affect the ability to detect outliers. The registering of National Data Opt-Outs is not uniform across regions. The characteristics of those who register an opt-out are also not the same. This introduces the risk of selection bias.

Loss of patient data will adversely impact the ability to monitor patient safety and to evaluate the quality of care. The number of procedures undertaken each year within organisations may be small, therefore loss of data for a small number of patients may have a disproportionate impact on the ability to detect poor performance or may lead to the incorrect identification of poor performance. If patients who registered a National Data Opt-Out were excluded from the NVR, it would not be possible to know if any numbers or outcomes produced for hospitals are accurate. Therefore this agreement will be moving forward not apply the National Data Opt-outs for the data being disseminated in line with the section 251 support from CAG.

Various types of vascular surgery are delivered in the NHS for arterial disease. The surgery is associated with significant morbidity and mortality, with some procedures having a postoperative 30-day mortality rate exceeding 30%.

The aim of the National Vascular Registry (NVR) is to improve the quality of care of patients having vascular surgery by providing high quality comparative information on clinical practice and outcomes and support quality improvement by NHS hospitals. The Registry was established in 2013 and collects data from NHS Trusts providing vascular surgery, in order to provide information on patient characteristics, pre-operative care, the range of surgery undertaken, and postoperative outcomes. Specific objectives of the NVR are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing vascular surgery

2. To provide comparative information on the process of care to NHS vascular units

3. To provide comparative information on patient outcomes following surgery.

4. To facilitate the development of effective change (quality improvement) initiatives and spread examples of best practice among NHS vascular services.

This Agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The Royal College of Surgeons (RCS) of England is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme (NCAPOP).

HQIP have commissioned the Royal College of Surgeons to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists.

The National Vascular Registry (NVR) is run by the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons.

NEC Software Solutions UK host the NVR IT system which is managed by the RCS. NEC Software Solutions UK will be sending in the patient identifiers to NHS England DARS they will not receive any data back from NHS England DARS.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP 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 NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, 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 NCAPOP projects 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.

As part of NCAPOP The NVR HQIP have commissioned the Royal College of Surgeons (RCS) to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists. The National Vascular Registry is run by the Clinical Effectiveness Unit of the Royal College of Surgeons. Some members of the NVR team are substantively employed by London School of Hygiene & Tropical Medicine but hold honorary contracts with RCS. There are no other organisations involved.

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

HQIP and NHS England are Data Controllers for the national clinical audit but do not have access to any data collected or analysed by the staff in the Clinical Effectiveness Unit at the RCS who are the Data Processors.

The National Vascular Registry is based on prospectively collected, patient-level data on patients who have had vascular surgery. The analysis undertaken by the NVR project team will only involve pseudonymised datasets that combine information submitted by NHS hospitals and data supplied by NHS England DARS on this specific cohort of patients listed on the NVR. The data are processed and stored at the RCS.

The NVR runs using a mixed patient consent model.

For patients having an elective procedure in England and Wales, patients are asked to consent for a number of personal identifiers to be submitted to the NVR by hospital staff - the identifiers are: NHS number, date of birth and full postcode.

For patients having surgery after an emergency admission in England and Wales, the NVR has Section 251 approval to collect these patient identifiers without consent because it is not typically feasible to ask for consent in these circumstances.

Where consent has been refused, no data will flow for those individuals, and they will therefore not form part of any cohort under this Data Sharing Agreement.

The RCS wish to link the patient records submitted to NVR, which make up the NVR cohort, with their Hospital Episode Statistics (HES) records. The NVR records relate only to an individual admission, and by linking to inpatient HES data, the Audit team will be able to provide more precise and relevant information to NHS hospitals by allowing the NVR to describe longer-term outcomes (e.g., readmission rates) and to improve risk-adjustment models by using the extensive information on comorbid conditions held within HES (e.g., to calculate the Charlson Comorbidity score). The audit questions are designed not to duplicate data that could be gathered by routinely gathered datasets which in turn necessitates the need for identifying data to flow and linkage to take place in order to complete the analysis.

The RCS also wish to link the patient records submitted to NVR with Civil Registration/Mortality data on an annual basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

The NVR began in 2013 and the historic data requested will provide important information when looking to improve key outcome measures such as mortality and length of stay. HQIP require the HES/Civil Registration/Mortality data for the whole of England in order to meet the aims of the NVR. Data for only specific hospitals or regions would not provide a full picture of what is occurring across the country. There are no alternative, less intrusive ways of achieving the aims of the NVR.

Patient level HES data is also being requested for all vascular procedures in 2011-2022 M13, to calculate cases identified through data held by NHS England DARS and for other long term outcomes for patients with vascular disease. This cohort will be identified by the relevant OPCS (Office of Population, Censuses and Surveys Classification of Surgical Operations and Procedures) codes, which are L16-L79 (Aortic repair, carotid endarterectomy, lower-limb revascularisation) and X09, X10, X11 – Lower limb amputation. This cohort is separate to the NVR cohort described above, and is required as the case ascertainment rates for the NVR are not 100% and without this data the audit would not be able to provide a robust picture of vascular care.

The RCS also require civil registration/ mortality data from the cohort of patients identified by OPCS procedure codes which will then be linked to the HES data for this cohort. This data was not previously provided for the cohort of patients identified by OPCS procedure codes. The main reason for this is to be able to determine the long-term mortality for all vascular patients in England, and not just those that have been able to be linked to the NVR cohort. Some hospitals have very low NVR consent rates, and so the existing mortality data held by the NVR team is insufficient to be able to ensure that the long-term outcomes of vascular patients at these hospitals are comparable to other hospitals.

The request is limited to patients undergoing vascular procedures in England.

Section 251 is in place for confidential patient information to flow to NHS England DARS for patients who underwent emergency vascular surgery.

Confidential patient information is flowed to NHS England DARS for patients who received elective surgery and consented to their details being entered into the NVR.

RCS will also send a list of OPCS codes to NHS England DARS to create a pseudonymised cohort for cases identified through data held by NHS England DARS. This will be comprised of the following OPCS codes:

(all relating to vascular events) L16-L79 (Aortic repair, carotid endarterectomy, lower-limb re-vascularisation)

X09, X10, X11 – Lower limb amputation. The data is used for case ascertainment calculations and other metrics, such as long-term outcomes of patients with vascular disease. The case ascertainment rates in the NVR are not 100% and without the data for those patients not in the NVR the data would not provide a robust picture of vascular care.

In summary, the purpose of this request is to support national clinical audit, quality improvement within NHS hospitals, and undertake research to enhance the methods used to monitor surgical outcomes.

Mortality occurring in the short-term following some vascular procedures (e.g., elective AAA repair and lower limb angioplasty) are very low and the more important measures are mortality at 2-5 years. The NVR has recently started collecting device information for AAA repairs and is planning to collect devices for lower limb angioplasty procedures in the near future. Monitoring the long-term outcomes of these devices are an important patient safety issue that is supported by NHS England.

Mortality occurring in the longer-term for all patients following vascular procedures is also an important measure during the COVID-19 pandemic. Vascular patients have multiple comorbidities and are therefore at a higher risk of morbidity and mortality if they contract COVID-19. The NVR team has heard evidence from a number of hospitals that patients undergoing vascular procedures in late 2019 and early 2020 died at home from COVID-19 in 2020. Without mortality data for all vascular patients, the NVR team would be unable to provide a complete picture on the effect of the COVID-19 pandemic on this high-risk patient group.

The audit cohort will be looked at in line with the review of the impact of adverse events in respect of COVID-19. It is hoped the findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19.

The Audit are treating the inclusion of looking at the impact of COVID-19 as part of the general review of the audit data and the impact of any adverse event to the cohort.

In April 2020, the NVR set to look at answering COVID-related questions as part of the audit using the data in response to a request from the Vascular Society of Great Britain and Ireland (VSGBI). The VSGBI are the professional organisation that represents vascular surgeons in UK and Ireland and provide the clinical expertise to the NVR team.

The main aims of the extra questions are to determine:

1. What proportion of patients who had a vascular procedure had COVID-19

2. What impact the COVID-19 epidemic had on the care of individual patients having vascular surgery

3. Whether respiratory-related complication rates after vascular surgery were affected by COVID-19

The specific objectives for Aim 1 are to determine:

a) What proportion of patients had a different operation due to COVID-19 epidemic than under normal circumstances

b) What proportion of patients had their operation delayed due to COVID-19 situation.

The audit cohort will therefore also be looked at in line with the review of the impact of adverse events in respect of COVID-19. The findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19. The inclusion of the COVID 19 questions are all aligned to the general purpose of the clinical audit. At the time that NVR set out their plan to address the above COVID-related questions, they had not yet requested data covering the COVID-19 affected period. Now that this data period is being requested, this COVID-related area of the audit can be investigated.

The linked dataset will be a product of this process and will enhance the quality of the comparative information produced by the NVR in subsequent years.

The NVR is commissioned to produce a "State of the Nation" annual report each year. These reports are typically published in November each year and are publicly available to view on the Vascular Services Quality Improvement Programme (VSQIP) website. Subsequent reports are scheduled to be published yearly. The reports contain information on patient characteristics, the types of surgery undertaken, and postoperative outcomes. Information about the quality of the NVR process is also presented, notably estimates of case-ascertainment. In this process, the HES records will provide a reference against which the number of patient records submitted to the NVR can be compared.

The NVR annual reports are published each November so that they are released for the annual conferences of the Vascular Society of Great Britain & Ireland. This means that any HES data used for case ascertainment purposes are required to be provided to the RCS , so that they can be used in the data analysis.

The NVR produces information at the level of an NHS organisation primarily. This information is used by NHS staff, other national bodies such as the Care Quality Commission and NHS Improvement. Information on consultant surgical outcomes is also produced for publication on MyNHS.

In order to disseminate the findings of the audit to the various stakeholders, various scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BJS (British Journal of Surgery), and EJVES (European Journal of Vascular and Endovascular Surgery) at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

The main benefit of this data for patients is that this will allow the RCS to provide longer term outcomes to help inform decisions about treatment and care. The datasets currently held only cover in-hospital and 30 day deaths. Some of the procedures (e.g. elective infra-renal AAAs and lower limb angioplasties) have a very low mortality rate at 30 days (<2%), but it is known that the long term outcomes for these patients is not as good.

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

As stated above, there will be no requirement nor attempt to re-identify individuals from the data.

Online reporting tables and graphs are available to NHS staff who have access to the NVR data collection system; these online tools are designed to assist NHS trusts and consultants benchmark themselves and promote local Quality Improvement work. The online reports will provide local units with aggregated information to compare their performance against a national average. Each individual user has their own login (username/password) to the NVR data collection system which gives them access to only their own hospital local data. No data supplied from NHS England DRAS is held or accessed here.

Information and outputs for the public can be accessed via https://www.vsqip.org.uk/public/

The case-ascertainment rates achieved by the Registry are a marker of its quality, and helps the individuals using the reports (clinicians, patients, commissioners, etc.) to have confidence in using them in their decision making. The outputs of the NVR have been used by surgeons for revalidation, by NHS trusts for local quality improvement initiatives and as part of the national NHS England CQUIN process, which links the performance of vascular units to income payments.

The HES data received under this Agreement has not yet been used to produce other planned outputs because the application of the NDO was removed, and the HES data was resupplied. Consequently, there are no yielded benefits to report from this planned work.

This is an amendment to remove the application of National Data Opt-Outs (NDOs) which 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 NVR, this has been supported. The justification to not apply the NDOs is as below:

Application of the National Data Opt-Out is likely to result in around 5% of patient records being lost from the NVR every year. This estimate is based on data provided by NHS Digital on current levels of opt-out. The NVR collects data for patients who undergo repair procedures for abdominal aortic aneurysm (AAA), patients who undergo lower limb angioplasty or stent, lower limb bypass surgery or lower limb amputation to treat peripheral arterial disease (PAD), and patients who undergo carotid endarterectomy or carotid stenting. Some of these conditions, particularly AAA, are relatively rare. The loss of data, even a small amount, relating to treatment of these conditions may adversely affect the ability to detect outliers. The registering of National Data Opt-Outs is not uniform across regions. The characteristics of those who register an opt-out are also not the same. This introduces the risk of selection bias.

Loss of patient data will adversely impact the ability to monitor patient safety and to evaluate the quality of care. The number of procedures undertaken each year within organisations may be small, therefore loss of data for a small number of patients may have a disproportionate impact on the ability to detect poor performance or may lead to the incorrect identification of poor performance. If patients who registered a National Data Opt-Out were excluded from the NVR, it would not be possible to know if any numbers or outcomes produced for hospitals are accurate. Therefore this agreement will be moving forward not apply the National Data Opt-outs for the data being disseminated in line with the section 251 support from CAG.

Various types of vascular surgery are delivered in the NHS for arterial disease. The surgery is associated with significant morbidity and mortality, with some procedures having a postoperative 30-day mortality rate exceeding 30%.

The aim of the National Vascular Registry (NVR) is to improve the quality of care of patients having vascular surgery by providing high quality comparative information on clinical practice and outcomes and support quality improvement by NHS hospitals. The Registry was established in 2013 and collects data from NHS Trusts providing vascular surgery, in order to provide information on patient characteristics, pre-operative care, the range of surgery undertaken, and postoperative outcomes. Specific objectives of the NVR are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing vascular surgery

2. To provide comparative information on the process of care to NHS vascular units

3. To provide comparative information on patient outcomes following surgery.

4. To facilitate the development of effective change (quality improvement) initiatives and spread examples of best practice among NHS vascular services.

This Agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The Royal College of Surgeons (RCS) of England is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme (NCAPOP).

HQIP have commissioned the Royal College of Surgeons to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists.

The National Vascular Registry (NVR) is run by the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons.

NEC Software Solutions UK host the NVR IT system which is managed by the RCS. NEC Software Solutions UK will be sending in the patient identifiers to NHS Digital they will not receive any data back from NHS Digital.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP 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 NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, 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 NCAPOP projects 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.

As part of NCAPOP The NVR HQIP have commissioned the Royal College of Surgeons (RCS) to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists. The National Vascular Registry is run by the Clinical Effectiveness Unit of the Royal College of Surgeons. Some members of the NVR team are substantively employed by London School of Hygiene & Tropical Medicine but hold honorary contracts with RCS. There are no other organisations involved.

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

HQIP and NHS England are Data Controllers for the national clinical audit but do not have access to any data collected or analysed by the staff in the Clinical Effectiveness Unit at the RCS who are the Data Processors.

The National Vascular Registry is based on prospectively collected, patient-level data on patients who have had vascular surgery. The analysis undertaken by the NVR project team will only involve pseudonymised datasets that combine information submitted by NHS hospitals and data supplied by NHS Digital on this specific cohort of patients listed on the NVR. The data are processed and stored at the RCS.

The NVR runs using a mixed patient consent model.

For patients having an elective procedure in England and Wales, patients are asked to consent for a number of personal identifiers to be submitted to the NVR by hospital staff - the identifiers are: NHS number, date of birth and full postcode.

For patients having surgery after an emergency admission in England and Wales, the NVR has Section 251 approval to collect these patient identifiers without consent because it is not typically feasible to ask for consent in these circumstances.

Where consent has been refused, no data will flow for those individuals, and they will therefore not form part of any cohort under this Data Sharing Agreement.

The RCS wish to link the patient records submitted to NVR, which make up the NVR cohort, with their Hospital Episode Statistics (HES) records. The NVR records relate only to an individual admission, and by linking to inpatient HES data, the Audit team will be able to provide more precise and relevant information to NHS hospitals by allowing the NVR to describe longer-term outcomes (e.g., readmission rates) and to improve risk-adjustment models by using the extensive information on comorbid conditions held within HES (e.g., to calculate the Charlson Comorbidity score). The audit questions are designed not to duplicate data that could be gathered by routinely gathered datasets which in turn necessitates the need for identifying data to flow and linkage to take place in order to complete the analysis.

The RCS also wish to link the patient records submitted to NVR with Civil Registration/Mortality data on an annual basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

The NVR began in 2013 and the historic data requested will provide important information when looking to improve key outcome measures such as mortality and length of stay. HQIP require the HES/Civil Registration/Mortality data for the whole of England in order to meet the aims of the NVR. Data for only specific hospitals or regions would not provide a full picture of what is occurring across the country. There are no alternative, less intrusive ways of achieving the aims of the NVR.

Patient level HES data is also being requested for all vascular procedures in 2011-2022 M13, to calculate cases identified through data held by NHS Digital and for other long term outcomes for patients with vascular disease. This cohort will be identified by the relevant OPCS (Office of Population, Censuses and Surveys Classification of Surgical Operations and Procedures) codes, which are L16-L79 (Aortic repair, carotid endarterectomy, lower-limb revascularisation) and X09, X10, X11 – Lower limb amputation. This cohort is separate to the NVR cohort described above, and is required as the case ascertainment rates for the NVR are not 100% and without this data the audit would not be able to provide a robust picture of vascular care.

The RCS also require civil registration/ mortality data from the cohort of patients identified by OPCS procedure codes which will then be linked to the HES data for this cohort. This data was not previously provided for the cohort of patients identified by OPCS procedure codes. The main reason for this is to be able to determine the long-term mortality for all vascular patients in England, and not just those that have been able to be linked to the NVR cohort. Some hospitals have very low NVR consent rates, and so the existing mortality data held by the NVR team is insufficient to be able to ensure that the long-term outcomes of vascular patients at these hospitals are comparable to other hospitals.

The request is limited to patients undergoing vascular procedures in England.

Section 251 is in place for confidential patient information to flow to NHS Digital for patients who underwent emergency vascular surgery.

Confidential patient information is flowed to NHS Digital for patients who received elective surgery and consented to their details being entered into the NVR.

RCS will also send a list of OPCS codes to NHS Digital to create a pseudonymised cohort for cases identified through data held by NHS Digital. This will be comprised of the following OPCS codes:

(all relating to vascular events) L16-L79 (Aortic repair, carotid endarterectomy, lower-limb re-vascularisation)

X09, X10, X11 – Lower limb amputation. The data is used for case ascertainment calculations and other metrics, such as long-term outcomes of patients with vascular disease. The case ascertainment rates in the NVR are not 100% and without the data for those patients not in the NVR the data would not provide a robust picture of vascular care.

In summary, the purpose of this request is to support national clinical audit, quality improvement within NHS hospitals, and undertake research to enhance the methods used to monitor surgical outcomes.

Mortality occurring in the short-term following some vascular procedures (e.g., elective AAA repair and lower limb angioplasty) are very low and the more important measures are mortality at 2-5 years. The NVR has recently started collecting device information for AAA repairs and is planning to collect devices for lower limb angioplasty procedures in the near future. Monitoring the long-term outcomes of these devices are an important patient safety issue that is supported by NHS England.

Mortality occurring in the longer-term for all patients following vascular procedures is also an important measure during the COVID-19 pandemic. Vascular patients have multiple comorbidities and are therefore at a higher risk of morbidity and mortality if they contract COVID-19. The NVR team has heard evidence from a number of hospitals that patients undergoing vascular procedures in late 2019 and early 2020 died at home from COVID-19 in 2020. Without mortality data for all vascular patients, the NVR team would be unable to provide a complete picture on the effect of the COVID-19 pandemic on this high-risk patient group.

The audit cohort will be looked at in line with the review of the impact of adverse events in respect of COVID-19. It is hoped the findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19.

The Audit are treating the inclusion of looking at the impact of COVID-19 as part of the general review of the audit data and the impact of any adverse event to the cohort.

In April 2020, the NVR set to look at answering COVID-related questions as part of the audit using the data in response to a request from the Vascular Society of Great Britain and Ireland (VSGBI). The VSGBI are the professional organisation that represents vascular surgeons in UK and Ireland and provide the clinical expertise to the NVR team.

The main aims of the extra questions are to determine:

1. What proportion of patients who had a vascular procedure had COVID-19

2. What impact the COVID-19 epidemic had on the care of individual patients having vascular surgery

3. Whether respiratory-related complication rates after vascular surgery were affected by COVID-19

The specific objectives for Aim 1 are to determine:

a) What proportion of patients had a different operation due to COVID-19 epidemic than under normal circumstances

b) What proportion of patients had their operation delayed due to COVID-19 situation.

The audit cohort will therefore also be looked at in line with the review of the impact of adverse events in respect of COVID-19. The findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19. The inclusion of the COVID 19 questions are all aligned to the general purpose of the clinical audit. At the time that NVR set out their plan to address the above COVID-related questions, they had not yet requested data covering the COVID-19 affected period. Now that this data period is being requested, this COVID-related area of the audit can be investigated.

The linked dataset will be a product of this process and will enhance the quality of the comparative information produced by the NVR in subsequent years.

The NVR is commissioned to produce a "State of the Nation" annual report each year. These reports are typically published in November each year and are publicly available to view on the Vascular Services Quality Improvement Programme (VSQIP) website. Subsequent reports are scheduled to be published yearly. The reports contain information on patient characteristics, the types of surgery undertaken, and postoperative outcomes. Information about the quality of the NVR process is also presented, notably estimates of case-ascertainment. In this process, the HES records will provide a reference against which the number of patient records submitted to the NVR can be compared.

The NVR annual reports are published each November so that they are released for the annual conferences of the Vascular Society of Great Britain & Ireland. This means that any HES data used for case ascertainment purposes are required to be provided to the RCS , so that they can be used in the data analysis.

The NVR produces information at the level of an NHS organisation primarily. This information is used by NHS staff, other national bodies such as the Care Quality Commission and NHS Improvement. Information on consultant surgical outcomes is also produced for publication on MyNHS.

In order to disseminate the findings of the audit to the various stakeholders, various scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BJS (British Journal of Surgery), and EJVES (European Journal of Vascular and Endovascular Surgery) at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

The main benefit of this data for patients is that this will allow the RCS to provide longer term outcomes to help inform decisions about treatment and care. The datasets currently held only cover in-hospital and 30 day deaths. Some of the procedures (e.g. elective infra-renal AAAs and lower limb angioplasties) have a very low mortality rate at 30 days (<2%), but it is known that the long term outcomes for these patients is not as good.

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

As stated above, there will be no requirement nor attempt to re-identify individuals from the data.

Online reporting tables and graphs are available to NHS staff who have access to the NVR data collection system; these online tools are designed to assist NHS trusts and consultants benchmark themselves and promote local Quality Improvement work. The online reports will provide local units with aggregated information to compare their performance against a national average. Each individual user has their own login (username/password) to the NVR data collection system which gives them access to only their own hospital local data. No data supplied from NHS Digital is held or accessed here.

Information and outputs for the public can be accessed via https://www.vsqip.org.uk/public/

The case-ascertainment rates achieved by the Registry are a marker of its quality, and helps the individuals using the reports (clinicians, patients, commissioners, etc.) to have confidence in using them in their decision making. The outputs of the NVR have been used by surgeons for revalidation, by NHS trusts for local quality improvement initiatives and as part of the national NHS England CQUIN process, which links the performance of vascular units to income payments.

We not been able to use the extract of HES data to produce other planned outputs (due to the impact of the opt-outs) and, consequently, there are no yielded benefits to report from this planned work.

Various types of vascular surgery are delivered in the NHS for arterial disease. The surgery is associated with significant morbidity and mortality, with some procedures having a postoperative 30-day mortality rate exceeding 30%.

The aim of the National Vascular Registry (NVR) is to improve the quality of care of patients having vascular surgery by providing high quality comparative information on clinical practice and outcomes and support quality improvement by NHS hospitals. The Registry was established in 2013 and collects data from NHS Trusts providing vascular surgery, in order to provide information on patient characteristics, pre-operative care, the range of surgery undertaken, and postoperative outcomes. Specific objectives of the NVR are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing vascular surgery

2. To provide comparative information on the process of care to NHS vascular units

3. To provide comparative information on patient outcomes following surgery.

4. To facilitate the development of effective change (quality improvement) initiatives and spread examples of best practice among NHS vascular services.

This Agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The Royal College of Surgeons (RCS) of England is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme (NCAPOP).

HQIP have commissioned the Royal College of Surgeons to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists.

The National Vascular Registry (NVR) is run by the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons.

NEC Software Solutions UK host the NVR IT system which is managed by the RCS. NEC Software Solutions UK will be sending in the patient identifiers to NHS Digital they will not receive any data back from NHS Digital.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP 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 NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, 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 NCAPOP projects 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.

As part of NCAPOP The NVR HQIP have commissioned the Royal College of Surgeons (RCS) to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists. The National Vascular Registry is run by the Clinical Effectiveness Unit of the Royal College of Surgeons. Some members of the NVR team are substantively employed by London School of Hygiene & Tropical Medicine but hold honorary contracts with RCS. There are no other organisations involved.

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

HQIP and NHS England are Data Controllers for the national clinical audit but do not have access to any data collected or analysed by the staff in the Clinical Effectiveness Unit at the RCS who are the Data Processors.

The National Vascular Registry is based on prospectively collected, patient-level data on patients who have had vascular surgery. The analysis undertaken by the NVR project team will only involve pseudonymised datasets that combine information submitted by NHS hospitals and data supplied by NHS Digital on this specific cohort of patients listed on the NVR. The data are processed and stored at the RCS.

The NVR runs using a mixed patient consent model.

For patients having an elective procedure in England and Wales, patients are asked to consent for a number of personal identifiers to be submitted to the NVR by hospital staff - the identifiers are: NHS number, date of birth and full postcode.

For patients having surgery after an emergency admission in England and Wales, the NVR has Section 251 approval to collect these patient identifiers without consent because it is not typically feasible to ask for consent in these circumstances.

The RCS wish to link the patient records submitted to NVR, which make up the NVR cohort, with their Hospital Episode Statistics (HES) records. The NVR records relate only to an individual admission, and by linking to inpatient HES data, the Audit team will be able to provide more precise and relevant information to NHS hospitals by allowing the NVR to describe longer-term outcomes (e.g., readmission rates) and to improve risk-adjustment models by using the extensive information on comorbid conditions held within HES (e.g., to calculate the Charlson Comorbidity score). The audit questions are designed not to duplicate data that could be gathered by routinely gathered datasets which in turn necessitates the need for identifying data to flow and linkage to take place in order to complete the analysis.

The RCS also wish to link the patient records submitted to NVR with Civil Registration/Mortality data on an annual basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

The NVR began in 2013 and the historic data requested will provide important information when looking to improve key outcome measures such as mortality and length of stay. HQIP require the HES/Civil Registration/Mortality data for the whole of England in order to meet the aims of the NVR. Data for only specific hospitals or regions would not provide a full picture of what is occurring across the country. There are no alternative, less intrusive ways of achieving the aims of the NVR.

Patient level HES data is also being requested for all vascular procedures in 2011-2022 M13, to calculate cases identified through data held by NHS Digital and for other long term outcomes for patients with vascular disease. This cohort will be identified by the relevant OPCS (Office of Population, Censuses and Surveys Classification of Surgical Operations and Procedures) codes, which are L16-L79 (Aortic repair, carotid endarterectomy, lower-limb revascularisation) and X09, X10, X11 – Lower limb amputation. This cohort is separate to the NVR cohort described above, and is required as the case ascertainment rates for the NVR are not 100% and without this data the audit would not be able to provide a robust picture of vascular care.

The RCS also require civil registration/ mortality data from the cohort of patients identified by OPCS procedure codes which will then be linked to the HES data for this cohort. This data was not previously provided for the cohort of patients identified by OPCS procedure codes. The main reason for this is to be able to determine the long-term mortality for all vascular patients in England, and not just those that have been able to be linked to the NVR cohort. Some hospitals have very low NVR consent rates, and so the existing mortality data held by the NVR team is insufficient to be able to ensure that the long-term outcomes of vascular patients at these hospitals are comparable to other hospitals.

The request is limited to patients undergoing vascular procedures in England.

Section 251 is in place for confidential patient information to flow to NHS Digital for patients who underwent emergency vascular surgery.

Confidential patient information is flowed to NHS Digital for patients who received elective surgery and consented to their details being entered into the NVR.

RCS will also send a list of OPCS codes to NHS Digital to create a pseudonymised cohort for cases identified through data held by NHS Digital. This will be comprised of the following OPCS codes:

(all relating to vascular events) L16-L79 (Aortic repair, carotid endarterectomy, lower-limb re-vascularisation)

X09, X10, X11 – Lower limb amputation. The data is used for case ascertainment calculations and other metrics, such as long-term outcomes of patients with vascular disease. The case ascertainment rates in the NVR are not 100% and without the data for those patients not in the NVR the data would not provide a robust picture of vascular care.

For patients who have declined consent their data will flow to NHS Digital under Section 251, but their data will not be linked and will be destroyed after analysis.

In summary, the purpose of this request is to support national clinical audit, quality improvement within NHS hospitals, and undertake research to enhance the methods used to monitor surgical outcomes.

Mortality occurring in the short-term following some vascular procedures (e.g., elective AAA repair and lower limb angioplasty) are very low and the more important measures are mortality at 2-5 years. The NVR has recently started collecting device information for AAA repairs and is planning to collect devices for lower limb angioplasty procedures in the near future. Monitoring the long-term outcomes of these devices are an important patient safety issue that is supported by NHS England.

Mortality occurring in the longer-term for all patients following vascular procedures is also an important measure during the COVID-19 pandemic. Vascular patients have multiple comorbidities and are therefore at a higher risk of morbidity and mortality if they contract COVID-19. The NVR team has heard evidence from a number of hospitals that patients undergoing vascular procedures in late 2019 and early 2020 died at home from COVID-19 in 2020. Without mortality data for all vascular patients, the NVR team would be unable to provide a complete picture on the effect of the COVID-19 pandemic on this high-risk patient group.

The audit cohort will be looked at in line with the review of the impact of adverse events in respect of COVID-19. It is hoped the findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19.

The Audit are treating the inclusion of looking at the impact of COVID-19 as part of the general review of the audit data and the impact of any adverse event to the cohort.

In April 2020, the NVR set to look at answering COVID-related questions as part of the audit using the data in response to a request from the Vascular Society of Great Britain and Ireland (VSGBI). The VSGBI are the professional organisation that represents vascular surgeons in UK and Ireland and provide the clinical expertise to the NVR team.

The main aims of the extra questions are to determine:

1. What proportion of patients who had a vascular procedure had COVID-19

2. What impact the COVID-19 epidemic had on the care of individual patients having vascular surgery

3. Whether respiratory-related complication rates after vascular surgery were affected by COVID-19

The specific objectives for Aim 1 are to determine:

a) What proportion of patients had a different operation due to COVID-19 epidemic than under normal circumstances

b) What proportion of patients had their operation delayed due to COVID-19 situation.

The audit cohort will therefore also be looked at in line with the review of the impact of adverse events in respect of COVID-19. The findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19. The inclusion of the COVID 19 questions are all aligned to the general purpose of the clinical audit. At the time that NVR set out their plan to address the above COVID-related questions, they had not yet requested data covering the COVID-19 affected period. Now that this data period is being requested, this COVID-related area of the audit can be investigated.

The linked dataset will be a product of this process and will enhance the quality of the comparative information produced by the NVR in subsequent years.

The NVR is commissioned to produce a "State of the Nation" annual report each year. These reports are typically published in November each year and are publicly available to view on the Vascular Services Quality Improvement Programme (VSQIP) website. Subsequent reports are scheduled to be published yearly. The reports contain information on patient characteristics, the types of surgery undertaken, and postoperative outcomes. Information about the quality of the NVR process is also presented, notably estimates of case-ascertainment. In this process, the HES records will provide a reference against which the number of patient records submitted to the NVR can be compared.

The NVR annual reports are published each November so that they are released for the annual conferences of the Vascular Society of Great Britain & Ireland. This means that any HES data used for case ascertainment purposes are required to be provided to the RCS , so that they can be used in the data analysis.

The NVR produces information at the level of an NHS organisation primarily. This information is used by NHS staff, other national bodies such as the Care Quality Commission and NHS Improvement. Information on consultant surgical outcomes is also produced for publication on MyNHS.

In order to disseminate the findings of the audit to the various stakeholders, various scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BJS (British Journal of Surgery), and EJVES (European Journal of Vascular and Endovascular Surgery) at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

The main benefit of this data for patients is that this will allow The RCS to provide longer term outcomes for the patients entered on the NVR. The datasets currently held only cover in-hospital and 30 day deaths. Some of the procedures (e.g. elective infra-renal AAAs and lower limb angioplasties) have a very low mortality rate at 30 days (<2%), but it is known that the long term outcomes for these patients is not as good.

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

As stated above, there will be no requirement nor attempt to re-identify individuals from the data.

Online reporting tables and graphs are available to NHS staff who have access to the NVR data collection system; these online tools are designed to assist NHS trusts and consultants benchmark themselves and promote local Quality Improvement work. The online reports will provide local units with aggregated information to compare their performance against a national average. Each individual user has their own login (username/password) to the NVR data collection system which gives them access to only their own hospital local data. No data supplied from NHS Digital is held or accessed here.

Information and outputs for the public can be accessed via https://www.vsqip.org.uk/public/

As the previous data was incomplete, the work has not yet been started. Therefore, there have not been any achievable benefits to date.

Various types of vascular surgery are delivered in the NHS for arterial disease. The surgery is associated with significant morbidity and mortality, with some procedures having a postoperative 30-day mortality rate exceeding 30%.

The aim of the National Vascular Registry (NVR) is to improve the quality of care of patients having vascular surgery by providing high quality comparative information on clinical practice and outcomes and support quality improvement by NHS hospitals. The Registry was established in 2013 and collects data from NHS Trusts providing vascular surgery, in order to provide information on patient characteristics, pre-operative care, the range of surgery undertaken, and postoperative outcomes. Specific objectives of the NVR are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing vascular surgery

2. To provide comparative information on the process of care to NHS vascular units

3. To provide comparative information on patient outcomes following surgery.

4. To facilitate the development of effective change (quality improvement) initiatives and spread examples of best practice among NHS vascular services.

This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The Royal College of Surgeons (RCS) of England is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme (NCAPOP).

HQIP have commissioned the Royal College of Surgeons to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists.

The National Vascular Registry (NVR) is run by the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons.

Some members of the NVR team are substantively employed by London School of Hygiene & Tropical Medicine, but hold honorary contracts with RCS.

Northgate Public Services host the NVR IT system which is managed by the RCS. Northgate will be sending in the patient identifiers to NHS Digital they will not receive any data back from NHS Digital.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP 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 NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, 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 NCAPOP projects 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.

As part of NCAPOP The NVR HQIP have commissioned the Royal College of Surgeons (RCS) to deliver the audit, working in partnership with the Vascular Society for Great Britain and Ireland and the British Society of Interventional Radiologists. The National Vascular Registry is run by the Clinical Effectiveness Unit of the Royal College of Surgeons. Some members of the NVR team are substantively employed by London School of Hygiene & Tropical Medicine, but hold honorary contracts with RCS. There are no other organisations involved.

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

HQIP and NHS England act as data controllers for the national clinical audit but do not have access to any data collected or analysed by the staff in the Clinical Effectiveness Unit at the RCS who are the data processors.

The National Vascular Registry is based on prospectively collected, patient-level data on patients who have had vascular surgery. The analysis undertaken by the NVR project team will only involve pseudonymised (with exception to full Date of Death and Cause of Death) datasets that combine information submitted by NHS hospitals and data supplied by NHS Digital. The data are processed and stored at the RCS.

The NVR runs using a mixed patient consent model.

For patients having an elective procedure in England and Wales, patients are asked to consent for a number of personal identifiers to be submitted to the NVR by hospital staff - the identifiers are: NHS number, date of birth and full postcode.

For patients having surgery after an emergency admission in England and Wales, the NVR has Section 251 approval to collect these patient identifiers without consent because it is not typically feasible to ask for consent in these circumstances.

The RCS wish to link the patient records submitted to NVR with their Hospital Episode Statistics (HES) records. The NVR records relate only to an individual admission, and by linking to inpatient HES data, the Audit team will be able to provide more precise and relevant information to NHS hospitals by allowing the NVR to describe longer-term outcomes (e.g. readmission rates) and to improve risk-adjustment models by using the extensive information on comorbid conditions held within HES (eg, to calculate the Charlson Comorbidity score).

The RCS also wish to link the patient records submitted to NVR with Civil Registration/Mortality data on an annual basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

The NVR began in 2013 and the historic data requested will provide important information when looking to improve key outcome measures such as mortality and length of stay.

HQIP require the HES/Civil Registration/Mortality data for the whole of England in order to meet the aims of the NVR. Data for only specific hospitals or regions would not provide a full picture of what is occurring across the country. There are no alternative, less intrusive ways of achieving the aims of the NVR.

The request is limited to patients undergoing vascular procedures in England.

In summary, the purpose of this request is to support national clinical audit, quality improvement within NHS hospitals, and undertake research to enhance the methods used to monitor surgical outcomes.

The audit cohort will for future data dissemination be looked at in line with the review of the impact of adverse events in respect of COVID-19. The findings of the work will benefit clinicians and patients allowing them to better manage the reorganisation of their services and provide better counselling for the risks faced by patients during COVID-19. Data disseminated under this agreement however will not allow the audit to look at the impact of COVID - 19 due to the data years being requested

The linked dataset will be a product of this process and will enhance the quality of the comparative information produced by the NVR in subsequent years.

The NVR is commissioned to produce a "State of the Nation" annual report each year. These reports are typically published in November each year and are publicly available to view on the Vascular Services Quality Improvement Programme (VSQIP) website. Subsequent reports are scheduled to be published yearly. The reports contain information on patient characteristics, the types of surgery undertaken, and postoperative outcomes. Information about the quality of the NVR process is also presented, notably estimates of case-ascertainment. In this process, the HES records will provide a reference against which the number of patient records submitted to the NVR can be compared.

The NVR produces information at the level of an NHS organisation primarily. This information is used by NHS staff, other national bodies such as the Care Quality Commission and NHS Improvement. Information on consultant surgical outcomes is also produced for publication on MyNHS.

In order to disseminate the findings of the audit to the various stakeholders, various scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BJS (British Journal of Surgery), and EJVES (European Journal of Vascular and Endovascular Surgery) at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

The main benefit of this data for patients is that this will allow The RCS to provide longer term outcomes for the patients entered on the NVR. The datasets currently held only cover in-hospital and 30 day deaths. Some of the procedures (e.g. elective infra-renal AAAs and lower limb angioplasties) have a very low mortality rate at 30 days (<2%), but it is known that the long term outcomes for these patients is not as good.

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

As stated above, there will be no requirement nor attempt to re-identify individuals from the data.

Online reporting tables and graphs are available to NHS staff who have access to the NVR data collection system; these online tools are designed to assist NHS trusts and consultants benchmark themselves and promote local Quality Improvement work. The online reports will provide local units with aggregated information to compare their performance against a national average. Each individual user has their own login (username/password) to the NVR data collection system which gives them access to only their own hospital local data. No data supplied from NHS Digital is held or accessed here.

Information and outputs for the public can be accessed via https://www.vsqip.org.uk/public/

Yielded Benefits is not a requirement for new applications.