NHS Digital Data Release Register - reformatted

NHS England - X26 projects

59 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).


tabulation request — DARS-NIC-79417-X0D8T

Type of data: information not disclosed for TRE projects

Opt outs honoured:

Legal basis:

Purposes: The growing prevalence and costs of diabetes and its complications make diabetes care improvement a priority for the whole healthcare system. In particular, a large proportion of the hospital inpatient population are admitted to hospital with diabetes, often as a result of conditions that are not directly related to their diabetes.

The National Diabetes Inpatient Audit (NaDIA) allows hospitals to benchmark hospital diabetes care and to prioritise improvements in service provision that will make a real difference to patients’ experiences and outcomes. NaDIA results have also stimulated the development of a number of tools to support service improvements in hospitals.

The audit will ultimately allow us to measure whether outcomes have improved for diabetes patients over time and whether diabetes patients are at a greater risk of complications compared to the general population. Two publications are released, one at hospital level allowing for local comparisons, and another which is a national report looking at trends across the years since NaDIA began in 2010.

The HES data is specifically required to support the analysis and to facilitate comparisons between audit participants and the wider hospital population. (internal NHS transfer)

Sensitive:

When:DSA runs 2017-01-05 — No

Access method:

Data-controller type: NHS ENGLAND - X26

Sublicensing allowed: No

Datasets:

Objectives:

National Diabetes Inpatient Audit 2016 National Report – to be published March 2017.

HES data is only used in a table and chart in the 2015 report (table 4 and chart 6), and also in the Supporting Data for 2015. We would need this data by early February 2017 at the latest to be able to include it in the report.


DigiTrials Feasibility Self-Service — DARS-NIC-652726-K9S4D

Type of data: Aggregated

Opt outs honoured: (Internal flow of aggregate tables only)

Legal basis: Internal flow of aggregate tables only

Purposes: The objective of using the DigiTrials Feasibility Self-Service tool is for clinical research bodies find out whether there are enough potential individuals meeting their search criteria to take part in potential future clinical trials.

DigiTrials Feasibility Self-Service tool interrogates a number of NHS England datasets using pre-defined lists of inclusion and exclusion criteria in order to provide a high level aggregated tabulation of potential candidates from the population of England, and - where applicable – a map displaying areas of required population densities. (internal NHS transfer)

Sensitive:

When:DSA runs 2023-03-24 — No

Access method:

Data-controller type: NHS ENGLAND (X26), NHS ENGLAND - X26

Sublicensing allowed: Yes

Datasets:

  1. Demographics
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)
  3. Hospital Episode Statistics Outpatients (HES OP)
  4. Medicines dispensed in Primary Care (NHSBSA data)


TEST — DARS-NIC-401994-D5Q7S

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant (Does not include the flow of confidential data)

Legal basis:

Purposes: No (Agency/Public Body)

Sensitive: Non-Sensitive

When:DSA runs 2023-06-17 — 2026-06-16

Access method: Ongoing

Data-controller type: NHS, TEST

Sublicensing allowed: Yes

Datasets:

  1. COVID-19 SGSS First Positives (Second Generation Surveillance System)
  2. Demographics
  3. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

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Yielded Benefits:

benefits 2

Expected Benefits:

benefits

Outputs:

outputs

Processing:

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Gastro-Intestinal Cancer Audit Programme (GICAP) (ODR1819_260) — DARS-NIC-656842-S5V7V

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Yes, No (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(2)(a); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2022-07-28 — 2023-07-27 2022.11 — 2024.04.

Access method: One-Off

Data-controller type: HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), NHS ENGLAND (QUARRY HOUSE)

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registry
  2. NDRS National Radiotherapy Dataset (RTDS)
  3. NDRS Rapid Cancer Registrations
  4. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)
  5. NDRS Cancer Registrations
  6. NDRS Linked Cancer Waiting Times (Treatments only)
  7. NDRS Linked DIDs
  8. NDRS Linked HES APC
  9. NDRS National Cancer Patient Experience Survey (CPES)
  10. NDRS Somatic Molecular Dataset

Objectives:

The Gastrointestinal Cancer Audit Programme (GICAP) comprises the National Bowel Cancer Audit (NBOCA) and the National Oesophago-Gastric Cancer Audit (NOGCA). This application relates to both GICAP workstreams.

This application is to request the renewal of data previously provided under the agreement with the Public Health England (PHE) Office for Data Release (ODR)(ref. ODR1819_260).

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

In early 2018 a contract was awarded by HQIP to the Royal College of Surgeons of England (RCS), who in turn sub-contracted NHS Digital (the Health and Social Care Information Centre (HSCIC)) to deliver the Gastrointestinal (GI) Cancer audit - initially for 3 years - until 31st May 2021, then the contract has been extended to May 2023. The RCS is the data processor contracted by HQIP to undertake the analysis of the data requested under this Agreement to support the Audit.

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

NHS England is also involved in developing the scope and purpose of the GICAP project through participation in 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 is represented on the HQIP Data access request group which authorises data sharing applications from third parties. This Agreement does not permit the Data Controllers to further disseminate NHS Digital data, any further dissemination would be subject to a separate DSA, with appropriate REC support (if required).

The Clinical Effectiveness Unit (CEU) at the RCS will be processing the data under the direction of the data controllers, and only for the purposes described within this Agreement.

Bowel cancer is the third most common malignancy in the UK with approximately 33,000 people diagnosed with the disease each year. Oesophago-gastric cancer is the fifth most common malignancy and affects approximately 13,500 people each year.

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

The Oesophago-Gastric Cancer Audit aims to assess the quality of care received by patients with oesophago-gastric cancer or oesophageal high-grade dysplasia (a pre-cancerous condition) in England and Wales.

Both audits respectively undertake case ascertainment work for bowel cancer and oesophago-gastric cancer or oesophageal high-grade dysplasia.

The audits are based on prospectively collected, patient-level data and collectively cover patients diagnosed with colorectal cancer and patients diagnosed with invasive epithelial oesophago-gastric cancer or oesophageal high-grade dysplasia, in England and Wales. Each audit combines these patient records with records from other available national datasets to provide information to NHS trusts, patients, commissioners and other stakeholders on the patterns of care from diagnosis to the end of the primary treatment pathway (both curative and palliative treatments) and patient outcomes. Apart from supplying a rich description of the care process, audits aim to minimise the burden of data collection on clinical staff.

To support the delivery of NBOCA and NOGCA, the Clinical Audits and Registries Management Service (CARMS) within NHS Digital requests National Cancer Registrations and Analysis Service (NCRAS) data on behalf of NHS England and HQIP. There are no other reasonable means for the data processors to achieve their purpose that is less intrusive to the data subjects.

The following data sets, from the NCRAS portfolio, are processed by GI audits. This DSA permits the GICAP Audits to receive a refresh of the below-listed datasets:
- Pseudonymised NDRS Cancer Registry - Provision of this data set allows the Audit to identify patients omitted in the data submitted by hospitals directly to the CARMS team at NHS Digital. This allows reporting on the complete set of patients diagnosed with GI cancers. This will help to further assess the representativeness of patients captured in NBOCA and NOGCA. Such cross-referencing is also intended not only to assess the extent of possible missing data but to identify any patterns relating to this, e.g., particular geographical areas under-reporting cases or any potential linkage to under-presentation related to social deprivation.

- Pseudonymised NDRS Rapid Cancer Registrations - This data set, although known for its data quality issues, is used as a more up-to-date and more frequent substitute for Cancer Registry, where more timely data is necessary. Rapid Cancer Registrations data, which is routinely linked with RTDS and SACT data sets, provide up-to-date diagnostic, surgical, radiotherapy and systemic treatment data for the cohort of GICAP patients that complements the annual Cancer Registry data.

- Pseudonymised NDRS Radiotherapy Data Set (RTDS) and NDRS Systemic Anti-Cancer Therapy (SACT) - These data sets, holding information on patients treated with radio- or chemotherapy, allow the audit build the full picture of the treatment provided to cancer patients, in-depth analysis of specific regimens and changes to prescribed treatments. It allows the exploration of whether the radiotherapy and chemotherapy data items, collected by the Audits from hospitals, are appropriate and necessary. Should particular data be available in existing, national data sets, these data items could be removed from the data collection, to ease the burden on data providers (hospital staff).

To address the GPDR Principle of Data Minimisation the NHS Digital CARMS Team and the RCS have had lengthy discussions with the NHS Digital Data Production Team to develop the data specification. This exercise has ensured that only the minimum amount of data necessary for achieving the purposes described within this DSA is being requested.

The cohort is limited to ~300,000 individuals who have been diagnosed with bowel cancer or oesophago-gastric cancer that the Audit is aware of, as well as any patients that have a diagnosis based on a selection of ICD-10 codes that the Audit was not already aware of. National data is required to ensure that national and local trends can be identified. This request is deemed to be compliant with the NHS Digital Standard for Data Minimisation.

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

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

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

Yielded Benefits:

Quality assurance and improvement are among the key objectives of national clinical audits. The two audits within GICAP – NBOCA and NOGCA – evaluate the performance of NHS hospitals using quality indicators based on good practice recommendations from national clinical guidelines. The audit results enable hospitals to benchmark themselves, and they also lead to evidence-based recommendations in the mandatory audit publications: the annual report (which has a state-of-the-Nation perspective), and short reports which focus on specific topics. The results of the audits also support health services, commissioners, as well as patients and their families by providing information on treatment outcomes and the various care pathways for patients with colorectal and oesophago-gastric cancers. Each publication includes several recommendations for improving patient care. Therefore, the sections below are only a small sample of the impact and improvement to the healthcare system and to patients’ outcomes provided by GICAP. NBOCA 1.The analysis of patient data collated and analysed by NBOCA over the last 12 years has resulted in a series of key recommendations for cancer service, commissioners and policymakers. These recommendations have been supported by the Association of Coloproctology of Great Britain and Ireland (ACGBI) and fed into updates to NICE guidance on bowel cancer. As an example, NBOCA developed a novel method for reporting on chemotherapy regimens using English SACT and English HES/ Welsh PEDW routine data. This allowed NBOCA to report rates of adjuvant chemotherapy in stage III colon cancer patients by NHS trust in both England and Wales, despite the lack of SACT data in Wales. This led to a recommendation that the NHS services review and ensure evidence-based local policies for offering adjuvant chemotherapy to people following major resection for pathological stage III colon cancer. NBOCA also established a quality improvement initiative to focus on improving cancer outcomes among patients with stage III colon cancer who received adjuvant chemotherapy because there was considerable variation in practice across England and Wales. As a result of this work, the Audit was able to demonstrate improvement in this aspect of care in the latest NBOCA annual report (2021). Among patients diagnosed between April 2019 and March 2020, 61% of those undergoing major resection for stage III colon cancer receiving adjuvant chemotherapy. This is an increase from 54% for patients diagnosed in 2016/17. In addition, the variation between NHS trusts in the proportion of these patients receiving adjuvant chemotherapy has reduced, with the number of organisations with patterns of care outside the expected range falling from 27 in 2015/16 to 21 in 2019/20. 2.On average, approximately 33,000 patients are diagnosed with colorectal cancer each year. Early detection significantly increases patients’ chances of successfully going into remission after treatment. That is why the NBOCA reports evaluate the care pathway around the diagnosis and promote the findings that support early diagnosis and its benefits. NBOCA findings have shown that patients presenting via screening programmes were more likely to have earlier stage disease, to undergo curative treatment and to have bowel cancer amenable to local resection rather than major surgery. This has led to NBOCA making recommendations of relevance to patients, bowel cancer charities, bowel cancer screening programmes in England and Wales, NHS England and all health professionals – in primary and secondary care settings. These recommendations emphasised: • The need for campaigning, to raise awareness and educate patients about bowel cancer, particularly with regards to signs and symptoms of bowel cancer and • The importance of the National Bowel Cancer Screening Programme given its association with more favourable outcomes. Whilst the work around early detection still continues and changes to public awareness and culture (including breaking the taboo of talking about colorectal cancer symptoms) are far from being widely embedded, the results presented in the latest NBOCA annual report (2021) show small improving trends. The percentage of patients diagnosed after an emergency presentation has been slowly decreasing, from 20% in 2015/16 to 18% in 2019/20. A slowly improving trend has also shown for the diagnoses following national screening programmes – from 9% in 2015/16 to 12% in 2019/20. NOGCA 1. The NOGCA collects data on patients with high-grade dysplasia (HGD), a pre-cancerous condition about which information is not included in any other national collections or databases. Therefore, NOGCA provides a unique insight into the quality of care received by patients with this condition and patient outcomes. The data relating to HGD have been collected since 2012 and have used the British Society of Gastroenterology’s guidelines on the diagnosis and management of HGD to formulate quality indicators and provide information for benchmarking and quality improvement by NHS services. A State-of-the-Nation perspective is provided each year in the NOGCA Annual Report, and these reports have included recommendations for NHS services that focus on ensuring that: • all patients with high-grade dysplasia are discussed by a specialist multi-disciplinary team (MDT), • patients with suspected high-grade dysplasia have their diagnosis confirmed by a second pathologist, • patients are considered for endoscopic treatment (recommended first-line therapy) and services with unusual patterns of care explore why patients are not being offered endoscopic treatment In the latest annual report (2021), NOGCA demonstrated that the proportion of patients with HGD who are discussed at a specialist MDT meeting has increased to 93% (compared to 86% two years earlier) and that 88% of patients had their diagnosis confirmed by a second pathologist (an increase from 84%) and 74% of patients had a plan for endoscopic therapy (an increase from 70%). 2. In 2017, the audit first published information on surgical pathology indicators that were derived from recommendations in national guidance from AUGIS. This revealed overall rates of tumour-free resection margins that were above the recommended levels and variation in the number of lymph nodes examined as part of the tumour resection procedures. This led the audit to recommend that specialist surgical centres should: • increase the proportion of patients who have the recommended minimum number of lymph nodes examined, • review practice to decrease the proportion of patients who have positive surgical resection margins. Since 2017, there have been improvements in lymph node yield and tumour-free circumferential margin rates among patients undergoing curative surgery for oesophageal cancer. The proportion of patients with 15 or more lymph nodes examined has increased from 81.9% among patients diagnosed in 2015/16 to 89.2% among those diagnosed in 2019/20. The proportion of patients with positive circumferential margins has decreased from 26.3% to 20.3%. Despite improvements nationally, NOGCA has found substantial variation in the way surgical specimens are prepared for histological assessment, which has prompted AUGIS and the Royal College of Pathologists to collaborate on developing recommendations for the standardisation of these methods.

Expected Benefits:

By auditing the care delivered by cancer services, GICAP can highlight areas where hospitals are doing well, and areas in which the quality of care can be improved. By producing information for all NHS services, it allows cancer services to compare themselves with others in England and Wales and share examples of good practice.

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

The GICAP audit can identify and report on such improvements in the following year's annual report. This provides commissioners and clinicians with a national-wide picture of how patients are being treated, with the aim of reducing variation and driving up standards of care. Practice in trusts and local health boards across England and Wales will be compared against evidence-based standards from the Royal College of Radiologists to identify where current practice does not meet these standards.

The trust-level Clinical Outcomes Programme measures are publicly available, providing transparency and supporting patient choice. Note that consultant-level reporting in a public domain has been suspended due to the impact of the Covid-19 pandemic on NHS services.

The analyses provided in the Audit allow NBOCA and NOGCA to provide evidence-based recommendations with the aim to improve the quality of patient care.

More specifically, the linkage of audit data to national cancer data sets enables the assessment of the completeness of data submitted to the audit, both in terms of case ascertainment (what proportion of all cancer cases are covered by the audits) and in terms of the completeness of data on particular treatments, such as chemotherapy and radiotherapy. Secondly, it enables the richer description of treatment pathways because the national cancer datasets provide more granular details on specific therapies (e.g. drug combinations used in chemotherapy and fraction / dose in radiotherapy).

The linkage of the NBOCA and NOGCA datasets to national cancer data sets represents also an evolution of the audit methodology. The data items on patient and tumour characteristics and treatment planning collected by NBOCA and NOGCA are closely aligned to the NCRAS data sets. That allows reducing the number of data items collected by each audit and in turn, supports reducing the burden of data submission on front-line staff.

Outputs:

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

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

The outputs are reported at National, Cancer Alliance and NHS Trust level. Examples of specific statistical outputs are:
- Percentage of patients with surgical intent
- Percentage of patients with complications
- Risk adjusted 90-day post-operative mortality
- Risk adjusted 2-year mortality
- Risk adjusted complication rate
- Percentage of adequate lymph node resections
- Percentage of positive resection margin
- Length of stay
- Percentage of unplanned readmissions

The audits also look into the feasibility of using information reported by patients themselves about the experience of their cancer care e.g., symptoms, functional status and quality of life.

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

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

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

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

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

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

Processing:

This application is to request the renewal of data previously provided under the agreement with the Office for Data Release (ref. ODR1819_260).

The data flow will be as follows:
1. CARMS team (NHS Digital) to send the cohort of patient identifiers (listed below) to the NHS Digital production team
2. The NHS Digital data production team to link patient identifiers to Cancer Registrations, Rapid Cancer Registrations, RTDS and SACT data
3. The NHS Digital production team to remove patient identifiers from the linked data
4. The NHS Digital production team to send the de-identified linked data, now including a pseudonymised identifier (Audit ID) to the data recipient at the RCS. Data files for these requests are provided securely via Secure Electronic File Transfer (SEFT). The use of file encryption and passwords also ensures the appropriate data security standards. Access to the data is role-based and it is granted only to those who are necessary to perform specific tasks

To facilitate the linkage of the GICAP cohorts to NCRAS data, the CARMS team will securely transfer the following identifiers to the NHS Digital data production team:
- Audit ID
- NHS Number
- Date of Birth (DOB)
- Sex
- Postcode

The Audit ID is a pseudo-identifier which is unique to each patient in the cohort. This primary key is used to reduce the flow of patient identifiers where data is requested from other data sets and where Audit data collected from Hospitals is sent from the NHS Digital CARMS team to the Clinical Effectiveness Unit (CEU). The key is held by the NHS Digital CARMS team, who are acting as Data Processor for HQIP.

The data extract to be provided by the NHS Digital data production team is to include all the Cancer Registrations, Rapid Cancer Registrations, RTDS and SACT records, corresponding to the cohort provided.

In addition, to support the case ascertainment, the NHS Digital data production team is requested to provide records of patients meeting the following inclusion criteria, but not included in the cohort from CARMS:
- any patients aged 18 and over
- diagnosed between 01/04/2014 and the latest available record
- who have records of cancer diagnosis based on ICD-10 codes: C15, C16 (for OG cancer), C18, C19, and C20 (for bowel cancer)

The data requested is for patients diagnosed with the mentioned cancers between the dates of 01/04/2014 and the latest available data (at the time of production). For these patients, their records are required from 01/04/2013 until the latest available date.

The above criteria are the same for all datasets requested.

All data disseminated under this Agreement is subject to both the NDRS Opt-Out and the National Data Opt-Out. If an individual has indicated that they wish to be excluded from the national cancer registry, their data will be permanently removed from all NCRAS datasets and will no longer be released by NHS Digital. If an individual has evoked their right to opt-out from the use of their data for research or planning purposes (the National Data Opt-Out) their data will not be released under this Agreement.

In parallel, the CARMS team enables other data linkage activities, not covered by this agreement, to allow GICAP to fulfil its contracted objectives and deliverables. Those data linkages are as follows:
- CARMS team send patient identifiers and Audit ID to NHS Digital’s DARS Data Production team for linkage of cohort data to English hospital data (Hospital Episode Statistics, HES), demographics and mortality data; the linked data is then pseudonymised and forwarded to the CEU
- CARMS team send patient identifiers and Audit ID to Digital Health and Care Wales (DHCW) for linkage of cohort data to Welsh hospital data (Patient Episode Database for Wales, PEDW); the linked data is then pseudonymised, returned to CARMS and then forwarded to the CEU
- CARMS team send patient identifiers and Audit ID to the Intensive Care National Audit & Research Centre (ICNARC) for linkage of cohort data (NBOCA only) to the Case Mix Programme data; the linked data is then pseudonymised and forwarded to the CEU
- CARMS team send patient identifiers and Audit ID to NHS England for linkage of cohort data (NBOCA only) to the Cancer Patient Experience Survey data; the linked data is then pseudonymised and forwarded to the CEU
- The National Emergency Laparotomy Audit (NELA) team send patient identifiers and pseudo-identifiers (NELA ID) to CARMS to facilitate linkage to audit patients; the “linkage spine” containing two pseudo-identifiers – NELA ID and Audit ID is then forwarded to CEU (NBOCA only)
These linkages help build a better picture of the treatment and outcomes of Bowel and Oesophago-Gastric cancer patients

-FUTURE LINKAGES: CARMS team to send patient identifiers and Audit ID to The Christie NHS Foundation Trust for linkage of cohort data (NBOCA only) to the Rectal Cancer Complete Oncological Response Data (OnCoRe); the linked data will be then pseudonymised and forwarded to the CEU. This would be subject to a future amendment to this DSA.

Upon receipt of all the linked, pseudonymised data, the CEU at the RCS then analyses the audit and other data sets to produce statistical tables for inclusion in the outputs listed in the next section. The CEU does not make record-level information available to any other party. The CEU only use the data for the stated purposes.

While the RCS can re-identify individuals from the pseudonymised data, this DSA prohibits the re-identification of the data released under this Agreement.

At the RCS, the GICAP data is stored in a secure IT environment and access to the data is only available for approved individuals and security is maintained through the use of passwords and encryption.

All flows of record-level identifiable data are covered by the section 251 approval continuously supported by the Confidentiality Advisory Group (CAG). CAG application reference numbers are: ECC 1-06(c)/2011 (for NOGCA) and ECC 1-03(d)/2012 (for NBOCA).

The audits use role-based access to the data, which means that only staff involved in the audit work can be granted access to the strictly necessary information.


National Gastro Intestinal Cancer Audit Programme (GICAP)- National Bowel Cancer Audit (NBOCA) — DARS-NIC-376603-K2J9R

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Anonymised - ICO Code Compliant, Yes, No (Section 251, Section 251 NHS Act 2006)

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(7), National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Agency/Public Body)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2021-05-07 — 2023-05-06 2018.06 — 2023.04.

Access method: One-Off, Ongoing

Data-controller type: HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), NHS ENGLAND (QUARRY HOUSE), HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP)

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. MRIS - Cause of Death Report
  3. MRIS - Flagging Current Status Report
  4. Hospital Episode Statistics Accident and Emergency
  5. Hospital Episode Statistics Outpatients
  6. Civil Registration - Deaths
  7. Demographics
  8. Emergency Care Data Set (ECDS)
  9. HES:Civil Registration (Deaths) bridge
  10. HES-ID to MPS-ID HES Accident and Emergency
  11. HES-ID to MPS-ID HES Admitted Patient Care
  12. HES-ID to MPS-ID HES Outpatients
  13. Civil Registrations of Death
  14. Hospital Episode Statistics Accident and Emergency (HES A and E)
  15. Hospital Episode Statistics Admitted Patient Care (HES APC)
  16. Hospital Episode Statistics Outpatients (HES OP)
  17. Civil Registrations of Death - Secondary Care Cut

Objectives:

Update March 2018 *******
The contract to run the bowel cancer audit as part of the Upper GI Cancer audit is still to be awarded by HQIP. This was expected to have taken place by the end of February 2018, giving 3 months notice to the end of the contract. As it has not yet happened there is the need to continue to hold, collect and process the data until it is known whether the RCS and NHS Digital will be awarded the contract to continue the audit or whether it will need to be arranged for transfer of the data to a new audit provider. The request to extend the deadline is to allow time for this contract situation to be resolved.

An additional request for 2017/18 HES APC data has been added, this was inadvertently missed off the previous application by the customer.

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The National Bowel Cancer Audit is based on prospectively-collected, patient-level data on patients diagnosed with colorectal cancer. This information is combined with other available datasets to provide a rich description of the care process and to minimise the burden of data collection on clinical staff.

The aim of the National Bowel Cancer Audit is to assess the quality of care received by patients with bowel cancer in England and Wales. Survival depends on early diagnosis through appropriate investigations, use of complicated surgical techniques and input from a range of professionals. The management of patients with this type of cancer is complex and requires multidisciplinary working. By collecting data from NHS Trusts providing care to bowel cancer patients the audit is able to provide outcomes on patient characteristics, treatment planning, postoperative outcomes and palliative treatment.

Bowel cancer is the third most common malignancy in the UK and affects approximately 33,000 people each year. Incidence is increasing and the prognosis for most patients diagnosed with bowel cancer remains poor.
HES data required for:
• Analysing patient follow up, such as emergency readmissions and stoma reversals.
• Audit-HES linked dataset used to investigate hospital utilisation and readmissions among patients with palliative treatment intent.
• Addressing the completion of chemotherapy among patients with palliative treatment intent.
• These outcomes are published in the Audit’s annual reports, which are used by trusts to assess whether they are meeting national guidance and benchmark their performance. If they are not then trusts will address and make improvements and this will then result in benefits to patients.

The National Bowel Cancer Audit is run by the Royal College of Surgeons (RCS) Clinical Effectiveness Unit (CEU) with data provision, management and publication provided by NHS Digital Clinical Audit and Registries Management Service (CARMS).

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

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

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

Death Data required for:
Date of Death will be linked to the Audit data to provide short-term and long-term survival outcomes so we can publish short-term and long-term mortality outcomes which evidence that patient survival is improving.

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

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

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

An on-going part of the audit process commissioned by HQIP is the Clinical Outcomes Programme. The information from the audit is used to measure the performance of trusts and surgeons on the following 4 measures
• 90 day emergency readmission after major resection;
• 18 month stoma rate after major resection for rectal cancer;
• 90 day mortality after major resection;
• 24 month mortality after major resection.

Outliers at individual surgeon level and at trust level are identified through the analysis undertaken by the RCS CEU. Notifications are sent out for response by the individual surgeons and/ or the trusts (as applicable) and their responses are included in the annual report. To assist the trusts in evaluating the reasons for their outlier status, record level data for the relevant trust will be provided back to the trust upon request to NHS Digital. Data files for these requests will be provided in a 256 bit encrypted zip file to a named individual via NHS.net; the password for the file will be sent to another named individual nominated by the trust, again using NHS.net.

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

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

Linkage will initially allow assessing the completeness of submissions of oncology records to the audit and explore whether the chemotherapy data items in the Audit could be dropped to ease the burden of data collection.
The request is also for SACT data to be returned for patients who fit the inclusion criteria but are not included in Audit cohort.

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

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

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

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

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

National Emergency Laparotomy Audit (NELA) Dataset required for:
The NELA collects data on patients undergoing emergency laparotomy and is a Healthcare Quality Improvement Partnership funded Audit.
Linkage will initially allow the assessing of the patients submitted to the National Bowel Cancer Audit that have an emergency laparotomy.
The request is also for NELA data to be returned for patients who fit the inclusion criteria but are not included in the Audit cohort.

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


NHS England’s Cancer Patient Experience Survey Dataset required for:
The National Cancer Patient Experience collects information reported by patients themselves about the experience of their bowel cancer care.

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

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

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

The collection of PREMS data as part of this agreement is limited to prospective data from 2017 onwards, this follows a successful amendment request to CAG to address issues of notifying patients of the use of the data. This approval (outcome letter included in Evidence) supercedes the previous 2015 approval relating to use of retrospective PREMS data. The legal basis for the PROMS and PREMS linkage is the National Health Service Act 2006 - s251 - 'Control of patient information'. 2015 following a successful amendment request

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

Linkage would allow the assessing of the feasibility of using information reported by patients themselves about the outcomes of their bowel cancer.

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

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

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

Welsh hospital episode data

The Patient Episode Database for Wales (PEDW) records all episodes of inpatient and day case activity in NHS Wales hospitals. This includes planned and emergency admissions, minor and major operations, and hospital stays for giving birth. Hospital activity for Welsh residents treated in hospitals in England is also included.
The data are collected and coded at each hospital. The records are then electronically transferred to the NHS Wales Informatics Service (NWIS), where they are validated and merged into the main database.

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

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

Additional evidence has been added to this agreement in response to questions from IGARD (11.05.2017) about continued CAG support for the s251 approval relating to flow of PEDW data.


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

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

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

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

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

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

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

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

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

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

Yielded Benefits:

At national level the audit is able to report the following outcomes: - Overall 90-day mortality after major surgery has steadily reduced over five years from 5.4 per cent in 2010-11 to 3.8 per cent in 2014-15. - Two-year survival in patients having major surgery has improved from 80% in 2009-10 to 82% in 2012-13 - Rates of laparoscopic surgery have increased from 42% in 2010-11 to 61% in 2014-2015. There has been no rebound increase in rates of conversion from laparoscopic to open surgery over this time (9.0% to 8.5%) - The proportion of patients being seen by a clinical nurse specialist has increased from 87% in 2010-11 to 92% in 2014-15. - The rate of rectal cancer patients having a local excision to remove their cancer has increased from 5.3% in 2010-11 to 6.8% in 2014-15. Supporting local trust level improvement: - Since 2013, the audit has provided individual trust reports comparing results to the local and region and nationally. - In 2016, the audit started to provide MDTs with individualised slide packs of the trust results. 50% of MDTs reported using these. - Potentially outlying trusts report that they have carried out local quality improvement including case note review. - Clinical leads have reported taking their individual trust reports to their CEO to justify increased resources. Providing information to patients and the public - The 2016 patient friendly version of the annual report has had 474 downloads since the publication date in December 2016. - The Clinical Outcomes Publication data is published on NHS Choices. - The audit and the data in the reports are promoted to the public via bowel cancer charities.

Expected Benefits:

The Audit outcomes are published in annual reports, scientific journals and the consultant outcomes publications. The intended audience are clinicians, healthcare professionals, Medical Directors, CEs, audit managers, commissioners, NHS England, public and patients.

Trusts will use the outcomes in the annual reports to assess their care against national standards and benchmark against other trusts, make improvements which in turn will benefit patients. The Audit is able to identify and report the following year whether improvements have been made. The outputs will show whether the trusts are meeting national guidance such as NICE and whether there is any variation in the provision of care. The Audit outcomes such as 90-day post-operative mortality are risk-adjusted and any potential outlying trusts are identified as part of the Audit outlier policy. Trusts are notified that they are showing as an alarm and will investigate the cause; this can either be down to data quality issues or clinical practice. The trust will address the cause and either review the data submitted to the Audit or their clinical practice. Improvements in clinical practice have a direct impact on improvements in patient care.

The trust profiles are publically available, providing transparency and enabling patient choice.
Publishing 90-day post-operative mortality outcomes at individual consultant level provides transparency and enables patient choice.

Publishing in peer-reviewed journals will allow greater discussion of the strengths and weaknesses of the results, and will provide the benefit of peer-review of the work from third parties. The work is highly relevant to current clinical practice and publication will allow us to disseminate the findings widely amongst health professionals.

The SACT dataset would be linked to the audit dataset and would be used to assess completeness of submissions of oncology records to the audit and to explore whether the burden of data collection could be reduced by substituting audit items for items from the national chemotherapy dataset.

The RTDS dataset would be linked to the audit dataset and would be used to assess completeness of submissions of radiotherapy records to the audit and to explore whether the burden of data collection could be reduced by submitting audit items for items from the national radiotherapy dataset.

The NELA data will be linked to the National Bowel Cancer Audit data to provide further findings on emergency laparotomy patients and their treatments and outcomes.

Linkage to the Intensive Care data allows the Audit to report patterns of care and outcomes while patients were admitted to critical care. The Audit is able to examine the characteristics of the patients admitted to critical care.
The PROMs and PREMs data will be linked to the National Bowel Cancer Audit data to provide further findings on the feasibility of using information reported by patients themselves on the experience of their treatment and care the outcomes of their bowel cancer, and whether this can be incorporated into the National Audit.

The information from patients on how they rate their quality of life and treatment following their diagnosis for cancer will help the Health Service measure and improve the quality of future services and understand how the experience has affected patients’ longer term.

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Linkage to the COSD and Cancer Registration data will identify whether the Audit are missing cases and whether there is the potential for the NBCA to drop data items which could be collected via the COSD and potentially reduce the burden of data collection for trusts.

Linkage to the COSD will enable the NBCA to further explore and report on the management and outcomes of patients with rectal cancer and advanced disease.

Outputs:

Annual report
The National Bowel Cancer 2018 Annual report is targeted for publication in Autumn 2018. With publications in peer-reviewed journals in 2018.

Publication in peer-reviewed journals will allow presentation of the Audit methodology and results in more detail than in the Annual reports.

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

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

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

The outputs are reported at National, Cancer Alliance and NHS Trust level. Examples of specific outputs are:
• Percentage of patients with surgical intent
• Percentage of patients with complications
• Risk adjusted 90-day post-operative mortality
• Risk adjusted 2 year mortality
• Risk adjusted complication rate
• Percentage of adequate lymph node resections
• Percentage of positive resection margin
• Length of stay
• Percentage of unplanned readmissions

The linked HES/Audit/death data dataset is also used to report the individual Consultant Outcomes as required by NHS England under Everyone Counts. The outcomes are 90-day post-operative mortality. The Consultant Outcomes are published on the Professional Body website and NHS Choices. The target date for delivery is Autumn 2018.
http://www.nhs.uk/Service-Search/Hospital/LocationSearch/7/Procedures?procedure=Gastrectomy
http://www.acpgbi.org.uk/surgeon-outcomes/

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

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

Outputs from linkage to COSD and Cancer Registration data will relate to assessment of completeness of NBOCA data, assessment of missing cases and the potential to reduce the burden of collection in future years by using data from COSD and Cancer Registration and removing any duplication between these collections and the NBOCA dataset. This will be progressed during 2017/18 once the data request has been progressed with PHE Office of Data Requests and analysis will be included in outputs such as topic specific short reports or sections included in the next Annual Report.

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

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

Processing:


Audit Tumour ID:

The Audit Tumour ID is a pseudonym, which is unique to each patient in the cohort. This primary key is used to reduce the flow of patient identifiers where data is requested from other data sets and where data is sent from CASU to CEU. The key is held by the NHS Digital CARMS team. The Audit Tumour ID is used for linkage to the HES, ONS, SACT, RTDS, NELA, PEDW, ICNARC, PROMs and PREMs data.

The Royal College of Surgeons Clinical Effectiveness Unit Audit Tumour ID which they use as a pseudonym. The CEU also receive Date of Death.

Processing activities:
1. All eligible NHS trusts submit data on their patients with bowel cancer to a system hosted by NHS Digital. This system holds data on patient characteristics, pre-treatment tumour stage, the staging process and the management plan of all patients and if appropriate data on process and outcomes of surgery, chemotherapy and radiotherapy. In keeping with minimum datasets and easing the burden on NHS staff, date of death, place of death and cause of death is not collected in the audit as it is recognised that this could be sought through the ONS. Date of death and place of death will be linked to the audit data to provide survival outcomes. Place of death will be in the form of a code from ONS known as Communal Establishment Code and will remove the potential of the address being identifiable to the patient.
2. Audit Patient Identifiers (NHS number, Date of Birth, Sex and Postcode ) are sent securely by the CARMS team to the data linkage team with an Audit Tumour ID (a pseudonym which is unique to each patient in the cohort) for linking to the HES data and also the DARS team for the death data.
3. HES data is returned to CARMS with only the Audit Tumour ID, none of the other patient identifiers are returned.
4. HES data is also returned for patients who fit the inclusion criteria but are not included in the Audit cohort.
5. Death data is returned to CARMS with only the Audit Tumour ID, none of the other patient identifiers are returned.
6. The HES data with the Audit Tumour ID and the Death data with the Audit Tumour ID are sent by the CARMS team to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.
7. The CEU then analyse the linked Audit/HES/death data dataset to produce statistical tables for inclusion in the outputs listed in the next section. The CEU will not make record level information available to any other party. The CEU will only use the data for the stated purposes.


Linkage to the SACT dataset:
1. Audit Patient Identifiers (NHS number, Date of Birth, Sex and Postcode) are sent by the CARMS team to the Chemotherapy Intelligence Unit within Public Health England. An Audit Tumour ID (a pseudonym which is unique to each patient in the cohort) is also sent to the Chemotherapy Intelligence Unit.
2. SACT data is returned to the CARMS team with only the Audit Tumour ID, none of the other patient identifiers are returned.
3. SACT data is also returned for patients who fit the inclusion criteria but are not included in the Audit cohort.
4. The SACT data with the Audit Tumour ID are sent by the CARMS team to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.
The CEU then analyse the linked Audit/SACT dataset to produce statistical tables for inclusion in the outputs listed in the next section. The CEU will not make record level information available to any other party. The CEU will only use the data for the stated purposes.


Linkage to the RTDS dataset:
1. Audit Patient Identifiers (NHS number, Date of Birth, Sex and Postcode) are sent by the CARMS team to the Office for Data Release (ODR), Public Health England
2. An Audit Tumour ID (a pseudonym which is unique to each patient in the cohort) is also sent to the Office for Data Release (ODR), Public Health England
3. RTDS data is returned to CARMS with only the Audit Tumour ID, none of the other patient identifiers are returned.
4. RTDS data is also returned for patients who fit the inclusion criteria but are not included in the Audit cohort.
5. The RTDS data with the Audit Tumour ID are sent by CARMS to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.
The CEU then analyse the linked Audit/RTDS dataset to produce statistical tables for inclusion in the outputs listed in the next section. The CEU will not make record level information available to any other party. The CEU will only use the data for the stated purposes.


Linkage to the NELA dataset:
1. Audit Patient Identifiers (NHS number, Date of Birth, Sex and Postcode ) are sent by the CARMS team to the National Institute of Academic Anaesthesia's Health Services Research Centre
2. An Audit Tumour ID (a pseudonym which is unique to each patient in the cohort) is also sent to the National Institute of Academic Anaesthesia's Health Services Research Centre.
3. NELA data is returned to the CARMS team with only the Audit Tumour ID, none of the other patient identifiers are returned.
4. NELA data is also returned for patients who fit the inclusion criteria but are not included in the Audit cohort.
5. The NELA data with the Audit Tumour ID are sent by CARMS to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.
The CEU then analyse the linked Audit/NELA dataset to produce statistical tables for inclusion in the outputs listed in the next section. The CEU will not make record level information available to any other party. The CEU will only use the data for the stated purposes.


Linkage to the NHS England’s Cancer Patient Experience Surveys
1. Audit Patient Identifiers (NHS number) are sent by the CARMS team to Public Health England.
2. An Audit Tumour ID (a pseudonym which is unique to each patient in the cohort) is also sent to PHE.
3. PREMs data is returned to the CARMS team with only the Audit Tumour ID, none of the other patient identifiers are returned.
4. PREMS data is also returned for patients who fit the inclusion criteria but are not included in the Audit cohort.
5. The PREMs data with the Audit Tumour ID are sent by the Clinical Audit Support Unit to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.


Linkage to NHS England’s National Cancer PROMs Programme of the National Survivorship Initiative.
1. Audit Patient Identifiers (NHS number) are sent by the CARMS team to the National Cancer Registration and Analysis Service (NCRAS), hosted by PHE.
2. An Audit Tumour ID (a pseudonym which is unique to each patient in the cohort) is also sent to NCRAS.
3. PROMs data is returned to CARMS with only the Audit Tumour ID, none of the other patient identifiers are returned.
4. PROMS data is also returned for patients who fit the inclusion criteria but are not included in the Audit cohort.
The PROMs data with the Audit Tumour ID are sent by CARMS to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.

Linkage to the Patient Episode Database for Wales (PEDW) dataset (from NHS Wales Informatics Service NWIS)

The audit will use the Hospital Site code where the patient was diagnosed; this tells the audit where the patient were diagnosed. If that is in Wales the audit will then pull the NHS number, Date of Birth, Sex and Postcode to send the relevant cohort to NWIS. There is a risk that the patients are diagnosed in Wales but are resident in England and go on to receive treatment elsewhere. In which case the audit won't get any further information on those patients from PEDW.

1. Audit Patient Identifiers (NHS number, Date of Birth, Sex and Postcode ) are sent by CARMS to NWIS only for patients identified as being diagnosed in Wales. The full audit cohort will not be sent to NWIS at any time. An Audit Tumour ID (a pseudonym which is unique to each patient in the cohort) is also sent to the NWIS
2. PEDW data is returned to CARMS with only the Audit Tumour ID, none of the other patient identifiers are returned.
3. PEDW data is also returned for patients who fit the inclusion criteria but are not included in the Audit cohort.
4. The PEDW data with the Audit Tumour ID are sent by CARMS to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.

The CEU then analyse the linked Audit/PEDW dataset to produce statistical tables for inclusion in the outputs listed in the next section. The CEU will not make record level information available to any other party. The CEU will only use the data for the stated purposes.

Additional evidence has been added to this agreement in response to questions from IGARD (11.05.2017) about continued CAG support for the s251 approval relating to flow of PEDW data.

Intensive Care National Audit and Research Centre data:
Linkage to Intensive Care National Audit and Research Centre (ICNARC) dataset:
1. Audit Patient Identifiers (NHS number, Date of Birth, Sex and Postcode ) are sent by CARMS to ICNARC. An Audit Tumour ID (a pseudonym which is unique to each patient in the cohort) is also sent to INCARC
2. ICNARC data is returned to CARMS with only the Audit Tumour ID, none of the other patient identifiers are returned.
3. The ICNARC data with the Audit Tumour ID are sent by NHS Digital CARMS to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.
The CEU then analyse the linked Audit/ICNARC dataset to produce statistical tables for inclusion in the outputs listed in the next section. The CEU will not make record level information available to any other party. The CEU will only use the data for the stated purposes.


Cancer Outcomes and Services Dataset
Linkage to Cancer Outcomes and Services Dataset
1. Audit Patient Identifiers (NHS number, Date of Birth, Sex and Postcode) are sent by NHS Digital CARMS team to the Office for Data Release (ODR), Public Health England. An Audit Tumour ID is also sent to the Office for Data Release (ODR), Public Health England
2. COSD data is returned to NHS Digital CARMS Team with only the Audit Tumour ID, none of the other patient identifiers are returned.
3. The COSD data with the Audit Tumour ID are sent by CARMS to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.
The CEU then analyse the linked Audit/COSD dataset to produce statistical tables for inclusion in the outputs listed in the next section. The CEU will not make record level information available to any other party. The CEU will only use the data for the stated purposes.

Cancer Registration data
Linkage to Cancer Registration data
1. Audit Patient Identifiers (NHS number, Date of Birth, Sex and Postcode) are sent by the CARMS team to the Office for Data Release (ODR), Public Health England. An Audit Tumour ID is also sent to the Office for Data Release (ODR), Public Health England.
2. Cancer Registration data is returned to CARMS with only the Audit Tumour ID, none of the other patient identifiers are returned.
3. Cancer Registration data is also returned for patients who fit the inclusion criteria but are not included in the Audit cohort.
4. The Cancer Registration data with the Audit Tumour ID are sent by CARMS to the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons for linking to the Audit data that they already hold having previously been sent from CARMS to the CEU. The Audit Tumour ID is used as a pseudonym to allow linkage of the datasets.
The CEU then analyse the linked Audit/ Cancer Registration dataset to produce statistical tables for inclusion in the outputs listed in the next section. The CEU will not make record level information available to any other party. The CEU will only use the data for the stated purposes.


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

ONS terms and conditions relating to the data being shared under this agreement will be adhered to.

The Bowel Cancer Audit has been continuous since 2002 and data is retained from that time up to the present. The data is retained so that any queries about previously published reports can be queried.

The audit reports on patients over the most recent 5 years. A refresh of data is required for the most recent 10 years. This is to provide the most up-to-date information on patients diagnosed during this 5-year reporting period, with 5 years’ preceding HES data to ensure that patients with a historic diagnosis of bowel cancer are not included as primary bowel cancer diagnoses. Data will be retained for 5 years after the end of the contract to allow queries about previously published results to be answered, and to ensure consistency checks can be carried out over multiple data extracts. This is In line with DH data retention requirements. The previous 5 years would only be used in the event of queries relating to previous audit years and the published annual reports from these years.




Mass evaluation of lateral flow immunoassays for the detection of SARS-CoV-2 antibody responses in immunosuppressed people (MELODY) — DARS-NIC-609903-V6Q7S

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Yes (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Agency/Public Body)

Sensitive: Non-Sensitive

When:DSA runs 2021-12-17 — 2024-12-16 2022.02 — 2022.02.

Access method: One-Off

Data-controller type: IMPERIAL COLLEGE LONDON

Sublicensing allowed: No

Datasets:

  1. Demographics

Expected Benefits:

It is anticipated that the data may help the study to:
1) Quantification of the proportion of immunosuppressed patients who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses). It is hoped that this will inform patients, clinicians and those who devise health policy of the numbers of immunosuppressed people in the UK who have not responded to the SARS-CoV-2 by developing antibodies. It is hoped that this will pave the way to protect them in other ways, for example by additional targeted protection with prophylactic monoclonal antibody treatments – target date February 2022.
2) Description of and the demographic, disease, and treatment characteristics that influence antibody status. It is hoped that this will allow stratification of the whole group of people who are immunosuppressed into groups at different risks of having no detectable antibodies to SARS-CoV-2 following their 3rd primary vaccination. It is hoped that this will inform which groups may benefit from targeted strategies such as prophylactic monoclonal antibodies. Target date March 2022.
3) Understanding if the detection of antibodies inversely correlates with subsequent risk of SARS-CoV2 infection and/or severity of disease in immunosuppressed individuals. It is hoped that this will further inform the potential need for additional measures targeted towards these individuals. Target date – July 2022.

Outputs:

The outputs will be a report for the Department of Health and Social Care (DHSC) to inform health policy, and papers in the peer-reviewed medical literature to make the results available for the benefit of all. Target date for report of antibody prevalence in people who are immunosuppressed - Jan/Feb 2022; target date for full study results publication in the medical literature - up to and including Oct 2022.

Processing:

The data will be requested in one drop: NHS Digital to provide the identifiable data extract (approx. 80,000), including demographic and contact details, to Ipsos MORI. Imperial have a Data Processing Agreement with Ipsos Mori, that has the provisions for sharing data outside of the UK for example standard contractual clauses within their Data Processing Agreement.

The contact details will be used to contact up to 80,000 people to ask them to register and consent to complete the test - stopping when 24,000 have consented to do this. In order to do this each person will be sent a letter by an approved print supplier (Formara Ltd). If they agree they will register online which will then trigger a test being sent to their address by Formara Limited. The test is then self-administered and the participant is asked to take part in a short online or telephone survey including information on demographic variables, household composition and their medical condition.

Tivian GmbH is responsible for the technical implementation of the online registration/ survey and data collection platform. While Ipsos Germany programme the questionnaires using the Tivian GmbH platform and therefore have access to sample data, Tivian GmbH actually hold the sample data on their servers.

Name and address information is held securely and separately from the survey data, for example, there is controlled and restricted access to the computer system where this information is stored at Ipsos MORI.

The personal data is only used for the purpose of inviting people to take part in the research, and confirming the identities of people who register for the study or contact the helpline. No identifiable data is shared outside the research team (unless they consent to data linkage) and it is not possible to identify individuals in the published results.

No linkage will be done without consent from patients. If participants do not consent to data linkage they will be withdrawn from the second part of the study (aim 2: If the detection of antibodies inversely correlates with subsequent risk of SARS-CoV-2 infection and/or severity of disease in immunosuppressed people) as outcome measures for the second part require linkage to other datasets within NDRS at NHS Digital.

The identifiable patient level data is used to invite patients to register to take part in the research.

Data resulting from the study will be incorporated into patients’ records per Section 3.4 of the Requirements Specification for the National Disease Registries Directions 2021: National Congenital Anomaly and Rare Disease Registration Service.

All employees involved in the processing are appropriately trained in data protection and confidentiality. Ipsos MORI is certified to ISO 27001 the international standard for Information Security and ISO 20252 the international standard for market research, as well as an MRS Company partner. All employees sign contracts that include appropriate confidentiality clauses, requiring them to comply with relevant data protection policies and procedures. Information Security and acceptable use policies and procedures include clauses that clearly define unauthorised use and/or deliberate misuse, disclosure, loss or destruction as misconduct, with appropriate links to disciplinary procedures. Policies and procedures also include clear warnings that such actions may also lead to legal action against those involved.

All suppliers (for printing and online survey delivery) are approved suppliers (also certified to ISO 9001 and ISO 27001) and Article 28 compliant agreements are in place.

All personal data held in delivering this survey will be subject to appropriate security measures to ensure it is kept secure from accidental or deliberate loss, destruction or disclosure. All organisations handling personal data are accredited to the international standard for information security (ISO 27001), which requires an information security policy documenting their approach.

In terms of technical measures, all users have their own login and password, and access controls are based on user accounts with rights automatically controlled by ‘Active Directory’ group security policy objects.

Access to patient identifiable data will be restricted to the minimum number of personnel; all of whom have undergone training in data protection law, their duty of confidentiality under contract and in the care and handling of personal data. Any locations containing patient identifiable information would have restricted access to a limited number of project team members, with access rights regularly reviewed.

The NHS Digital data will not be used for any other purposes or combined with any other datasets other than those detailed in this Agreement.