NHS Digital Data Release Register - reformatted

University Of Newcastle Upon Tyne projects

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


🚩 University Of Newcastle Upon Tyne was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. University Of Newcastle Upon Tyne may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

Establishing evidence to inform culturally competent mental health services (EVOLVE) — DARS-NIC-613522-Q7Z8N

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2024-03-12 — 2027-03-11

Access method: One-Off

Data-controller type: UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. Community Services Data Set (CSDS)
  2. Emergency Care Data Set (ECDS)
  3. Hospital Episode Statistics Admitted Patient Care (HES APC)
  4. Hospital Episode Statistics Outpatients (HES OP)
  5. Improving Access to Psychological Therapies (IAPT) v1.5
  6. Improving Access to Psychological Therapies (IAPT) v2
  7. Mental Health Services Data Set (MHSDS)

Objectives:

The University of Newcastle Upon Tyne requires access to NHS England data for the purpose of the following research project - Establishing evidence to inform culturally competent mental health services (EVOLVE).

The following is a summary of the aims of the research project provided by University of Newcastle Upon Tyne:

"The aim of this project is to identify and quantify changes in engaging NHS mental health services (both primary and secondary care) for people who are ethnic minorities select areas within North East and North Cumbria (NENC) area, before and after the pandemic and the impact on their health-related outcomes.

A COVID-19 diagnosis has negative effects on mental health. About 1 in 5 positive COVID-19 cases have experienced a mental health problem within 90 days of diagnosis. COVID has also worsened and deepened the longstanding mental health inequalities for ethnic minorities. Research has reported higher levels of anxiety and depression in ethnic minorities across the pandemic, but less available support from mental health services. The COVID-19 Social Study by University College London (UCL) reported higher levels of anxiety and depression and worse mental health in ethnic minorities across the pandemic than in those of white ethnicity. This indicates a pressing need to understand what and how changes in using mental health services impact health outcomes of ethnic minorities, so practice will learn what and how services should be provided to satisfy people’s needs.

This study aims to examine the impact of the pandemic on patterns of engagement with mental health services for adult patients in North East and North Cumbria and determine whether these patterns were associated with health-related outcomes. The North East and North Cumbria was selected as the setting for the study, as there is a high prevalence of mental health referrals and higher percentage of ethnic minorities within the population.

The specific objectives of this study are:
• To investigate service utilisation, such as settings and pathways of care, where people experienced mental health difficulties in the year prior to periods of lockdown.
• To quantify changes in patients mental health service utilisation & patient outcomes between time periods of the COVID19 lockdown in England. This will be used to estimate the associations between mental health service utilisation and patient outcomes
• To compare the impact of changes in mental health in White British and ethnic minorities. Conduct comparative analyses using data from the least deprived areas.
• To quantify the contribution of individual, practical, and geographic factors to variation in mental health service utilisation.
• To explore the contributions of patients, providers, and geographic factors to these associations, establishing when, where and for whom mental health services may be effective."

The following NHS England Data will be accessed:
• Hospital Episode Statistics - Admitted Patient Care & Outpatient
• Emergency Care Data Set (ECDS)
– necessary to provide information on cohort member hospital admissions and associated treatments. This data will be used to assess health outcomes of cohort members that may be as a result or exaggerated because of their mental health. The data will also further add to the information collected on cohort member use of mental health services and the patient’s pathway through care to receiving specialist treatment.
• Community Services Dataset (CSDS) – necessary to provide information on cohort member use of community health services provided through NHS Trusts, health centres, schools, mental health trusts, and local authorities. The key variables from this dataset include personal and demographic information, social and personal circumstances, diagnoses including long-term conditions and disabilities, care events plus screening activities, and scored assessments.
• Mental Health Services Data Set (MHSDS) – necessary to provide information on cohort members contact with any type of secondary mental health services provided and/or funded by NHS England. This includes voluntary and involuntary inpatient treatment, outpatient attendance, community mental healthcare, and other episodes of secondary mental healthcare. The data will be uses to determine the type, clinical characteristics (such as diagnosis, care clusters & Health of the Nation Outcome Scales – a routine clinical outcome measure used by mental health services) and length of service use by cohort members.
• Improving Access to Psychological Therapies (IAPT) v1.5 & v2 – necessary to provide further information on cohort members use of mental health services. This data will provide information on the use of services such as cognitive behavioural therapy, counselling and self-help support through self or GP referral. This information will provide insight into cohort member use of these types of services, including waiting time before treatment, length of treatment, any gaps in treatment spells & patient outcomes.

The level of the Data will be identifiable – necessary to link the data with data collected from other sources. This linkage will be performed by a nominated individual within North of England Commissioning Support Unit. The data will be pseudonymised before processing is conducted for the purpose of the study.

The Data will be limited to a study cohort identified by NHS North of England Commissioning Support Unit. The cohort consists of approximately 11652 individuals who are:
• Adults over 18
• Registered with one of 6 GP practises within the Newcastle upon Tyne, Middlesbrough or Stockton-on-Tees local authority areas. These GP practises are:
- Elswick Family Practice
- West Road Medical Centre
- Elm Tree Surgery
- Riverside Medical Practice
- Park Surgery
- Prospect Surgery.
• Referred or self-referred to mental health services between 23 March 2019 and 22 March 2020.

University of Newcastle Upon Tyne is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e): processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller. The results of this study will provide information about potential disparities for those referred to mental health services within different ethnic populations in England & help to highlight the needs of the patient to be met by the care provided in order to improve the health outcomes and reduce these inequalities. University of Newcastle Upon Tyne is a public authority carrying out a research project.

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by National Institute for Health Research (NIHR). The funding is specifically for the study described. Funding is in place for the duration of the study. The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

NHS North of England Commissioning Support Unit is a processor acting under the instructions of University of Newcastle Upon Tyne. NECS have been commissioned to support the study within the areas listed below, utilising capability & expertise the research study team cannot fulfil entirely. NHS North of England Commissioning Support Unit role is limited to:
• Extracting the primary care data from the selected GP practises & processing of confidential data, including submitting this to NHS England for linkage to the datasets requested.
• Linking NHS England datasets to primary care data collected separately.
• Pseudonymisation of the linked data before transferring to University of Newcastle Upon Tyne for study analysis.
• Retention of the pseudonymisation key to be held separately from the research team at University of Newcastle Upon Tyne.

The study has engaged with multiple Public and Patient Involvement and Engagement (PPIE) groups to help refine the purpose of the research. Responses from the groups supported the collection of the data for the purposes described above.

People with lived experience and the Voluntary Community and Social Enterprise (VCSE) sectors, who closely link to their local ethnic minority communities, have been essential in developing the purpose of the study. The study has followed the UK Standards for Public Involvement in research in developing its PPIE strategy.

The study has consulted two PPIE partners, with lived experience or family carer for those with lived experience. These partners were members of the public recruited through Health equality for ethnically minoritised communities (Haref) and Ethnic Health Forum (EHF) charities. These partners provided the study with insight into their different and wide-ranging experiences of coping with and supporting mental health difficulties, helping to determine and measure study outcomes. The study also engaged representatives from the two third sector organisations (Haref & EHF).

PPIE partners were consulted on & advised on the methods, procedures, and analysis proposed within the study. PPIE partners agreed that mental health is an area of unmet needs with exacerbated inequalities due to the pandemic, especially for ethnic minorities, therefore requiring timely research input. All PPIE partners share a passion for improving mental health services/experiences and a commitment to promoting culturally competent services and disseminating study results for potential benefits for service users.

PPIE partners were supportive of the use of routinely collected health data for this purpose and were supportive of the potential benefits sought by the analysis. PPIE partners also commented on the use of routine data without consent and considered this to be appropriate because requesting consent would lead to a biased sample as the response rate would be extremely low in people experiencing mental health problems, who however would benefit the most from this study. In addition, given the expected low response rate, seeking consent from eligible patients would not meet the sample size required by this study.

The study has also expanded its PPIE strategy and are now linked to the Service User and Carer Reference Group for the Cumbria, Northumberland Tyne and Wear (CNTW) NHS Foundation Trust. This group is a service user and carer led forum that works towards continuous improvement of mental health services by utilising the group’s assets and expertise. A group member with little research experience has reviewed the study summary and design and expressed support & interest in being part of the PPIE group.

PPIE partners are consulted regularly with meetings taking place every 6 months. The group has advised on the methods, procedures, and analysis proposed in the study and will continue to advise on and co-deliver dissemination activities, to ensure that the concerns and needs of the public groups are addressed. University of Newcastle Upon Tyne are developing a long term relationship with the partners, with the view they will also support future projects.

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the data could:
• help the system to better understand the health and care needs of populations.
• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions associated with mental health.
• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

Immediate (Early 2024)
The study may have an immediate impact on the care of patients with mental health problems through increasing awareness of the impacts associated with service changes and factors enabling high-quality services, in both affected individuals and their service providers. This will be both through the conduct of the study and dissemination of findings regionally and nationally using our links via the 15 ARC network. Increased awareness in primary care may lead to proactive identification and improved care for these patients who are at risk.

Researchers anticipate that the overall project including the following literature reviews, stakeholder interviews and surveys will promptly impact the treatment of individuals with mental health issues in North East and North Cumbria (NENC). This impact will be achieved by raising awareness regarding the effects related to service alterations and the factors that facilitate the delivery of high-quality services. This increased awareness will be a result of both conducting the study and disseminating its findings on a regional and national scale. Leveraging our connections through NIHR infrastructure such as the Fuse International conference and SPCR Showcase, as well as collaborating with clinical partners like the NENC ICS Mental Health Workstream, Mental Health Clinical Network, and Greater Manchester Health and Social Care Partnership (HSCP) to amplify the dissemination of outputs.

Enhanced understanding of the factors influencing mental health service provision in primary care settings could lead to proactive identification and better care from health professionals for these patients who are at risk. Additionally, by mapping changes in mental health services across the region, the study aims to pinpoint immediate opportunities for improving care pathways that aren't reliant on commissioning. This endeavour aligns with the Policy Research Unit (PRU) Behavioural Sciences' focus on efficient and fair care, and our findings will be disseminated through PRU networks and closely connected with national policymakers.

Short term (2024 - Early 2025)
University of Newcastle Upon Tyne shares a footprint with the North East & North Cumbria ICB and this proposal complements their mental health workstreams. The recommendation on core service provision will aim to address ICS and regional needs. Evidence and practice recommendations will be produced for the above local health care providers and decision makers. This will include how services should be provided to meet the needs of ethnic minorities to reduce health inequalities and develop culturally competent services, and what should be provided, maintained or stopped in future emergencies. This will support NHS England and NHS Improvement’s (NHSEI) Restoration and Recovery Framework, which aims to address backlogs built up during the COVID pandemic and tackle long waits for care support in capacity for tests, checks and treatments. The study outcomes hope to add to the knowledge required to identify areas where improvements can be made to improve health care providers ability to treat patients and subsequently patient outcomes from these treatments by recognising current pressures and where changes can help address them.

Medium term (2025 - 2026)
Through examining patients’ pathways as well as lived experiences of participants, PPI partners and ethnic minority communities, the study hopes to identify areas where service of care is not fully meeting the needs of the patient, leading to the recognition of gaps in clinical management. Through sharing this information with healthcare providers, it is hoped that the study will provider decision makers with the necessary support to effectively plan arrangements to address current backlogs within the healthcare service as well as further recognise which will provide opportunities for service improvement.

The research also hopes to supplement subsequent research studies within the same area based on patient-centred evidence-based service development within mental health care services, evaluation and implementation.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, health care providers may recognise a significant change in how members of the population view and interact with mental health services as a result of regulations set during the pandemic and risks associated with the more vulnerable. Healthcare providers would then be able to investigate alternate methods of delivering treatment, potentially through existing pathways, to help meet the needs of these patients.

Outputs:

The expected outputs of the processing will be:
• A report of findings to NIHR (July 2024) and 2 further papers published including outcomes of the research (July 2024).
• Presentations to ethnic minority community members and community organisations. The outputs to and with ethnic minorities from two regions will be ongoing throughout the project and findings will be presented at our engaged communities and forums identified by participants as having a strong impact.

Haref (a Newcastle based charity) will help disseminate through presentations (Late 2024) at:
Haref Network meeting – community organisations
- Haref Allies events – health and wellbeing services
- The Community Forum – practitioners working with people with protected characterises
And will share information through
- Newcastle City Council and Gateshead Public Health teams
- Connected Voice bulletins, social media and quarterly magazine
EHF will disseminate through presentations and newsletters (Late 2024) at:
- The National Council for Voluntary Organisations
- Voluntary Sector North West
- Greater Manchester Centre for Voluntary Organisation
- Manchester’s local voluntary & community sector support organisation
- Manchester BME Network
- Manchester City Council Neighbourhood
Dissemination materials and summaries will be made available in multi-languages.
• Presentations at appropriate conferences such as Fuse International conference, Society for Academic Primary Care Annual Conference & School for Primary Care Research Showcase in 2024.

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

The outputs will be communicated to relevant recipients through the following dissemination channels:
• Social media
• Public reports
• Industry newsletters
• Public events & conferences
• Posters displayed at participant GP practises.
• Participant newsletters
• Reports aimed at participants, the public and study stakeholders.

Processing:

NHS North of England Commissioning Support Unit (NECS) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth & Name) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES, ECDS, CSDS, MHSDS & IAPT datasets to NECS. The Data will contain a unique study identifier which is required to link the Data at record level with primary care data already held by the recipient. NECS will also hold identifying details for the purposes of linking the Data.

NECS will link the Data with primary care data collected from GP practices included within the study at record level. NECS will then pseudonymised the linked data using a unique identifier. The pseudonymised & linked Data will then be securely transferred to University of Newcastle Upon Tyne for processing for the purposes of the study analysis.

The identifiable Data will be stored on servers at NECS. The pseudonymised subset of the data will be stored on servers at University of Newcastle Upon Tyne and accessed by University of Newcastle Upon Tyne substantial employees.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:
- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England. The data will not leave England at any time.

Access to the confidential patient identifiable Data is restricted to substantive employees of NECS. Access to the pseudonymised Data will be restricted to substantive employees of University of Newcastle Upon Tyne who have authorisation from the Chief Investigator. Employees of University of Newcastle Upon Tyne are permitted to access pseudonymised data only.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

There will be no requirement and no attempt to reidentify individuals when using the pseudonymised Data. The identifying details will be stored in a separate database held by NECS. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset. Researchers from University of Newcastle Upon Tyne will analyse the Data for the purposes described above.


Investigating the Routes to Diagnosis in Head and Neck Cancer in England: population-based analysis of secondary data ( ODR1718_151/A1 ) — DARS-NIC-659285-B3X8G

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: Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2023-11-13 — 2025-11-12

Access method: One-Off

Data-controller type: UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations

Objectives:

Please note this was a previous application under ODR (ODR1718_151) the information below pertains to the original application.

Project Aim and Objectives
To gain a greater understanding of the routes to diagnosis in patients with head and neck cancer.
Objectives:
1. To quantify the percentage of patients within head and neck cancer who present through each of the 8 possible “routes to diagnosis”;
2. To determine whether the percentage of patients presenting through each route has changed over time;
3. To compare the socio-demographic and clinical characteristics of those patients presenting through different routes (with a particular focus on comparing routes to diagnosis in potentially HPV-related and non-HPV related cancers);
4. To conduct a more detailed analysis of different healthcare professionals seen (with a particular interest in identifying who may patients present via dentists);
5. To compare stage at diagnosis for patients diagnosed through different routes;
6. To investigate whether there is any relationship between the route to diagnosis and survival, when other prognostic factors have been accounted for.

The lawful basis for processing personal data in this data request is covered under Article 6(1)e: processing necessary for the performance of a task carried out in the public interest or in the exercise of official authority in the controller.

The legal basis for processing special category data in this data request is covered under Article 9(2)j: processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The data held by NHS England enables assessment of Routes to Diagnosis in Head and Neck Cancers which was the aim of this data application.

This was a standalone project and this is a request to extend the time Newcastle University have the data to allow further analysis.

The primary focus of the project is exploring the routes to diagnosis in patients with a head and neck cancer diagnosis and Newcastle University report below outcomes to date in relation to this. Areas that will be investigated in the extension will be considering the routes to diagnosis for specific cancers and associations between diagnostic route and survival outcomes; these are therefore the topics Newcastle University expect future outputs will focus on.

This project is funded by Population Health Sciences Institute within Newcastle University as part of a student's PhD.

The base cohort will comprise all individuals in the National Cancer Registration database with a malignant (i.e. behaviour code /3) head and neck cancer ICD-10 codes (C01-C14, C32, grouped as follows: hypopharynx (C12, C13), larynx (C32), nasopharynx (C11), oral cavity (C02, C03, C04, C06), oropharynx (C01, C09, C10), palate (C05), salivary glands (C07, C08), other sites (C05, C07, C08, C11, C12, C13), and non-specific sites(C14, C31), diagnosed between 2006-2014. In the event that an individual has two primary head and neck cancers diagnosed in the relevant time period, only the first will be included in the dataset.

The level of data will be; pseudo anonymised - necessary to undertake analysis of population based data in this cohort.

Newcastle University already have data for years 2006-2014 and are not requesting any new data, rather Newcastle University are requesting a 2 year extension to allow time for further analysis as described above and to allow for publications and to allow for additional analysis which may be required after PhD examination.

Geographical spread reflects the diagnosis patterns across England, there are no alternative, less intrusive ways of achieving population based analysis of head and neck cancer routes to diagnosis at a population level.

Efforts have been taken to minimise the data required, we restricted the original request to only those ICD10 codes of interest.

Newcastle University is the only organisation involved, it is the data controller and data processor for the project.

The PhD funder had no role in the data application and analysis. There are no commissioners involved in the application.

Pulsant is where the Newcastle University servers are co-located. This means that the university rents secure rack space at this location where the university hosts its servers. Pulsant only provides a secure managed location and does not have access to any hardware.

Yielded Benefits:

The benefits yielded to date from the project so far have been as follows. The work has shed light on the scale of health inequalities still present in England despite considerable focus on improving earlier diagnosis of cancer. This is the first step towards starting to address this inequity. The results have highlighted that whilst there have been positive changes over time, for example the increase in cancers picked up through the urgent cancer referral route (2WW) there are significant socio-demographic inequalities. Older age, living in an area of greater deprivation and being from a non-white ethnic group increased the likelihood of being diagnosed through the emergency pathway. This is concerning as emergency cancer presentations may be considered a “failure” of the system and indicative of significant delays or barriers to presentation. This work provides a foundation for further work in this area, by highlighting those who are most vulnerable to further delays and providing clear areas to focus on. Indeed, on the basis of this work, the team have secured research funding to undertake a comprehensive investigation of inequalities across the head and neck cancer pathway, from route to diagnosis, through stage, treatment receipt and survival

Expected Benefits:

The initial ODR1718_151/A1 (now - ODR1718_151/A2) application was written prior to the “expected measurable benefits statement” question. This update therefore is an amendment of the implications section for the accompanying Protocol from the initial data request.

The primary impact of this project is expansion of knowledge regarding routes to diagnosis in cancer, and in particular the routes of those cancers under the umbrella term of “Head and Neck” cancers. This route has not been examined previously; in particular, evidence is lacking on whether there are socio-demographic inequalities in diagnostic routes. The main individuals considered to benefit from this work are members of the general public experiencing symptoms of a potential head and neck cancer. The project seeks primarily to understand the routes that patients take to a diagnosis of head and neck cancer and understand if there are any patterns in usage, or identify if there are any inequalities inherent within these routes. We intend that the findings will raise awareness of patterns and inequalities among health professionals involved in care of patients with suspected, or confirmed, head and neck cancer and of health service decision makers, benefiting them in the short-term. In the longer-term and ultimately, understanding if and where inequalities occur provides powerful evidence to support the development of strategies to improve equity, thus benefiting those patients who may have been more at risk of delay within their journey to diagnosis.

The secondary impact is promotion of further understanding of head and neck cancer. There has been an increase in incidence of head and neck cancers over recent years and it is important that there is understanding of the whole pathway so areas of further research and understanding are identified. This is thus a benefit to the research and clinical communities with an interest in head and neck cancer and, ultimately, to patients at risk of this condition.

The third impact and benefit relates to public health. Specifically, there is considerable concern about the adverse impacts of the health service disruption that resulted from the covid-19 pandemic on cancer diagnosis and outcomes. This data, and the previous and planned analyses, provides a pre-covid “baseline” against which any impacts on diagnostic routes in head and neck cancer may be assessed. This, in turn, will inform the need for remedial public health interventions and/or strategies to be put in place to prevent similar impacts in the event of future health service disruption.

Finally, with respect to the health and social care sector, cancer has a significantly detrimental impact on national economics and society as a whole, so studies (such as this one), which have the potential to lead a reduction in inequalities in cancer diagnosis can benefit the economy and society. Cancer diagnosed at a late stage and, for example, through emergency presentation, can often require more toxic and aggressive treatments, impacting a patient’s ability to work and increasing co-morbid conditions and the likelihood of earlier death. Cancer organisations, researchers, the NHS and governments all have an invested role in prioritising inequality reduction as a matter of social justice. The wider public will benefit from the expansion of knowledge regarding the scale of health inequalities in cancer care in England. Understanding these inequalities is the first step in starting to address them. Furthermore, the results will be important for ensuring that future policies and interventions do not exacerbate inequalities further.

The project’s outputs will achieve the stated purposes and thus the benefits of processing by:
i. Describing the routes used by head and neck cancer patients (as a group, and for specific sub-sites within the head and neck) to obtain a diagnosis of a cancer.
ii. Inequalities in different routes (Emergency, Primary Care or Urgent Cancer Referral (2WW)) will be explored by investigating variations in routes taken according to patients’ age, sex, ethnicity and socio-economic status .
iii. Exploring the primary care route further by considering referrals by dentists and general practitioners separately.
iv. Describing, where possible, the survival outcomes associated with being diagnosed with head and neck cancer through specific routes.
Dissemination of the results of this work (peer-reviewed publications, conference presentations, lay summaries) are particularly beneficial for raising the issues of inequalities in the pathway to wider clinical, academic and lay audiences. It is hoped that doing so will promote action for change.
The actions leading up to the benefit will be carried out in the first instance by the data controller. It is anticipated that the benefits will be measured by project outputs (e.g. publications) and longer term by further research into why these diagnosis inequalities exist along with any efforts to minimise their existence in the first instance. Some benefits are expected to be delivered by the extension end date 2025, others will occur beyond this date (given the sometimes, extended timeline for review, revision, and publication of scientific papers)

Outputs:

The level of data in outputs will be aggregate data with small number suppression that will not allow reidentification of individuals.

The anticipated outputs from this extension request are (i) further publications in peer-reviewed scientific journals and (ii) dissemination of results via conference presentations and associated abstracts. Outputs will cover topics relating to the routes to diagnosis for specific head and neck cancers, for example larynx patients.

The primary focus of the project is exploring the routes to diagnosis in patients with a head and neck cancer diagnosis and we report below outcomes to date in relation to this. Areas that will be investigated in the extension will be considering the routes to diagnosis for specific cancers and associations between diagnostic route and survival outcomes; these are therefore the topics we expect future outputs will focus on.

As this data request is for a project extension, there have already been a number of outputs from the initial data request. These are as follows:

Conference presentations:

Deane, J., Patterson, J., & Sharp, L. (2019) Socio-demographic variation in routes to diagnosis in Head and Neck Cancer: A population based analysis. Orally presented poster at NCRI Conference, Glasgow, UK

Deane, J., Patterson, J., & Sharp, L. (2020) Understanding who presents where: A population-based analysis of the socio-demographic variation in patients presenting as an emergency or urgent cancer referral. Poster presentation at British Association of Head and Neck Oncologists (BAHNO) annual conference, London, UK

Deane, J., Patterson, J., & Sharp, L. (April, 2023). Inequalities in the pathway to a diagnosis of head and neck cancer. Invited speaker at the Barts Centre for Squamous Cancer annual symposium 2023.

Peer-reviewed scientific publications:

Deane, J., Norris, R., O’Hara, J., Patterson, J. and Sharp, L., 2022. Who Presents Where? A Population-Based Analysis of Socio-Demographic Inequalities in Head and Neck Cancer Patients’ Referral Routes. International Journal of Environmental Research and Public Health, 19(24), p.16723.

Other:

Deane, J. Patterson, J., & Sharp, L., (May, 2023). Understanding the role of dentists within the route to diagnosis in Head and Neck Cancer. Invited speaker at the Newcastle University Dental Sciences Summer Seminar Series.

The data obtained in the initial request was used as part of a student’s PhD. The thesis is due to be submitted within the next few months.

It is also anticipated that there will be dissemination of the project’s outputs to a wider, lay audience. This is likely to take on the format of leaflets, podcasts and presentations. It is intended to disseminate the outputs to as wide an audience as possible (researchers, clinicians, patients and the public). Publication in open access journals is preferred in order to enable outputs to be free to users to access and there is funding available for publication by such means through the student’s PhD funding. The timescale of this includes completion of thesis within the next 3 months, publications will follow and be completed by 2025 (Target Journals; BMJ and target conferences: NCRI), and dissemination to lay audiences will be conducted within the next 12 months.

Data ownership belongs with NHS England (PHE) and data management is the responsibility of Newcastle University.

Processing:

The data in this application has already been received and at the time of the original application Newcastle University were not required to supply data flow or a data flow diagram.

The second data flow (2 - on data flow diagram) was from Public Health England to Newcastle University. This transfer of data referred to pseudo anonymised head and neck routes to diagnosis information.
The lawful basis of this flow was GDPR Article 6 1(E) and Article 9 2 (J).

Newcastle University then processed the data for analysis. Data linkage was completed by PHE, no data linkage was undertaken by Newcastle University. Public Health England took steps to mitigate the risk of reidentification should be set out for each stage/linkage.

There was no matching to publicly available data.

There was no attempt to re-identify individuals.

The Data will be accessed onsite at the premises of Newcastle University only.

Data processing is undertaken by a PhD student at Newcastle University under the direction of a substantive employee of Newcastle University, this was acceptable at the time of the initial application. Both the PhD student and substantive employee are trained in GDPR and have completed annual updates of GDPR training.

Data is stored on a secure university network only accessible to the PhD student and the substantive employee of Newcastle University. Policies and procedures are in place in the unlikely event that there is accidental loss, destruction or damage to data.

Only analysed data will be available in publications which may be transparent to the public, this has small number suppression and does not allow identification of individuals. Newcastle University will not share the received data with any other organisation.


Investigating inequalities in utilisation of targeted therapies (ODR1819_325) — DARS-NIC-656847-K4L8H

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: Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2023-02-03 — 2024-03-31

Access method: One-Off

Data-controller type: NEWCASTLE UNIVERSITY, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations
  2. NDRS Linked Cancer Waiting Times (Treatments only)
  3. NDRS Linked HES APC
  4. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objectives:

Newcastle University will access cancer registration data collected by the National Cancer Registration and Analysis Service (NCRAS; the national cancer registry in England) on patients with lung and breast cancer. They will access information about each patient, their tumour and the treatment that they have received. This will include information such as sex, ethnicity, cause of death and how they were diagnosed if they have other medical conditions, as well as their socio-economic background. This data will be analysed by Newcastle University to find out:
1. What percentage of patients received targeted therapy as part of their cancer treatment and how does this change by type of cancer, when the treatment is given and the geographical location of the patient.
2. If the use of targeted therapy is different depending upon a patient's social and economic background (based upon where they live)
3. If the use of targeted therapy is different depending upon a patient's age when they are diagnosed.
4. What percentage of breast cancer patients have hormone receptor testing ( a test to see how the cells in the body receive a hormone to change how often they divide) and if the types of people receiving these tests are different depending on their age and background
5. If the use of targeted therapies helps more people to survive from cancer, and if it does, whether this increased survival rate is the same for all ages and social or economic backgrounds.

Yielded Benefits:

The benefits yielded to date from the project so far have been as follows. The work sheds light on the scale of health inequalities present in England despite recent medical advances. This is the first step towards starting to address this inequity. It has found that women residing in the most deprived areas in England were 8% (95% CI 15%, 1%) less likely to utilise trastuzumab compared to women residing in the least deprived areas. In contrast, significant inequalities were found for NSCLC novel anti-cancer therapy, with patients resident in the most deprived areas being 46% less likely to utilise these therapies compared to those resident in the least deprived areas. It was also observed that deprivation associations were stronger with targeted therapies compared to immunotherapy utilisation. Overall, the work has concluded that there is a reduced likelihood of treatment utilisation with a lower socio-economic status (SES) regardless of the free at the point of care service provided in the English publicly funded healthcare system. As with conventional cancer treatments and despite advances in care, it appears that low SES is a potential barrier to fair treatment utilisation in the context of these novel treatments. These findings have furthered understanding of the real-world use of novel anti-cancer therapies in England. Current work on this project has therefore provided evidence of real world prescribing practice and has identified areas for further research (reasons for why there are these inequalities, if inequalities in biomarker testing is the barrier to work in this area and finally, what actions can be taken moving forward to minimise the impact of inequalities on cancer treatment moving forward). This provides the foundation for further work exploring whether or not inequalities in access to treatment have resulted in variations in survival. The data has also been used to successful enable the PhD student to produce novel work at the standard appropriate for awarding of a Doctor in Philosophy.

Expected Benefits:

The initial ODR1819_325 application was written prior to the “expected measurable benefits statement” question. This update therefore is an amendment of the lay summary section of the original ODR Data Request Form (April 2018 v4.0) question: “describe in plain English how PHE data will be used in the delivery of the project”.

From the initial ODR application:
The primary impact of this project is expansion of knowledge regarding the scale of present UK health inequalities in light of recent medical advancements. The main individuals considered to benefit from this work are patients, hence this project is in the public interest. If new novel anti-cancer therapies (targeted treatments, biologicals and immunotherapies) offer opportunity for increased tumour responses, reduced toxic side effects and improved survival (as it has been suggested for these therapies) then drug access should be equitable. This study is investigating – for the first time - whether there are inequalities in receipt of these treatments. If such inequalities are observed, this provides powerful evidence to support the development of strategies to improve equity, thus benefiting those patients who were less likely to have been treated previously.

The secondary impact is promotion of further research into underrepresented, vulnerable and disadvantaged groups. For example, clinical trials data currently lacks representation of elderly patients, despite cancer primarily being a disease of old age. Capturing evidence of real world prescribing practice for such populations is important for identifying where gaps exist and stimulating research or changes in practice to fill these gaps. This will, in turn, benefit patients.

Finally, with respect to the health and social care sector, cancer has a significantly detrimental impact on national economics and society as a whole, so studies (such as this one), which have the potential to lead a reduction in inequalities in cancer treatment can benefit the economy and society. Cancer organisations, researchers, the NHS and governments all have an invested role in prioritising inequality reduction as a matter of social justice. The wider public will benefit from the expansion of knowledge regarding the scale of health inequalities in cancer care in England. Understanding these inequalities is the first step in starting to address them. An understanding of local inequity will also be provided and will arm primary care trusts and policy makers with an appreciation of how best to serve the needs of their populations. Furthermore, the results will be important for ensuring that future policies and interventions do not exacerbate inequalities further.

Combined, the project addresses the priorities outlined in the All Party Parliamentary Group on Cancer’s Inquiry into Inequalities in Cancer (more data, further research promotion into inequality causes and improved cancer experiences). This is in addition to addressing innovative drug and molecular diagnostic access as presented in the Cancer Strategy for England documentation (2015 – 2020). Furthermore, the work considers the NHS’ Long Term Plan which aims to help patients age well (2019). Finally, this project is timely given the re-examination of the public health agenda in the updated Marmot Review recommendations (Health Equity in England: The Marmot Review 10 Years on; 2020).

The project’s outputs will achieve the stated purposes and thus the benefits of processing by:
(i) Describing the extent to which there are treatment inequalities based on patients’ socio-economic status.
(ii) Reporting whether inequalities in novel anti-cancer therapy access are associated with an impact on patient survival.
(iii) Exploring reasons for the treatment inequalities (e.g. by investigating the extent to which there are inequalities in determinants of treatment); this may help shed light on where interventions to address inequalities need to be targeted.
(iv) Highlighting further inequalities in lung and breast cancers across the diagnosis and treatment pathway.

Dissemination of the results of this work (peer-reviewed publications, conference presentations, lay summaries) are particularly beneficial for raising the issues of inequalities in disadvantaged groups to wider clinical and lay audiences. It is hoped that doing so will promote action for change. The magnitude of this impact is likely to be large. For example, from the work conducted to date on this dataset and the scope of inequalities reported by deprivation, it is possible to estimate crudely, that should inequalities be eradicated (i.e. the rate of treatment utilisation in the least deprived patients be applied to all other IMD quintiles) a further 41 patients would be anticipated to receive trastuzumab in HER2+ breast cancer out of a total population of 40,179 patients and a further 3,205 patients would utilise any novel anti-cancer therapy in a NSCLC context out of a population of 195,387.

The actions leading up to the benefit will be carried out in the first instance by the data controller. It is anticipated that the benefits will be measured by project outputs (e.g. publications) and longer term by further research into why these treatment inequalities exist along with any efforts to minimise their existence in the first instance. Some benefits are expected to be delivered by the extension end date (31st March 2025); others will occur beyond this date (given the sometimes, extended timeline for review, revision, and publication of scientific papers).

Outputs:

The anticipated outputs from this extension request are (i) further publications in peer-reviewed scientific journals and (ii) dissemination of results via conference presentations and associated abstracts. Outputs will cover topics relating to inequalities in lung and breast cancers across the diagnosis, treatment, and outcomes pathway. The primary focus of the project is treatment utilisation and we report below outcomes to date in relation to this. Areas that will be investigated in the extension will include inequalities in determinants of treatment (e.g. stage, route to diagnosis) and inequalities following treatment (e.g. net and cancer-specific survival); these are therefore the topics we expect future outputs will focus on.

As this data request is for a project extension, there have already been a number of outputs from the initial data request. These are as follows:

Conference presentations:
Norris. R.P. et al. (November 2021) Fair Treatment for All? Socio-economic inequalities in HER2+ breast cancer treatment utilisation, oral presentation and poster as the NCRI Virtual Festival.

Norris. R. P et al. (August 2022) Socio-economic inequalities in NSCLC treatment during the era of tumour biomarker guided therapy: a population-based study, oral presentation at IASLC 2022 World Conference on Lung Cancer, Vienna, Austria.

Peer-reviewed scientific publications:
Two papers are in preparation for publication which report the results of the breast and lung cancer analyses conducted on the dataset already provided. These papers explore socio-economic inequalities in the utilisation of novel anti-cancer therapies. The lung manuscript has been submitted to the Journal of Thoracic Oncology and is under review. The breast manuscript is intended for submission to either the Lancet Oncology, the British Journal of Cancer or the European Journal of Cancer. It is anticipated that both publications will be available to read in 2023.

Other:
The data obtained in the initial request was used as part of Ruth Norris’s PhD. The thesis has now been submitted to Newcastle University and the viva examination conducted. The thesis, titled “Socio-economic inequalities in the utilisation of novel anti-cancer therapies”, will be available in Newcastle University's dissertation repository following completion of minor corrections (likely timescale of 6 months – early 2023).

It is also anticipated that there will be dissemination of the project’s outputs to a wider, lay audience. This is likely to take on the format of blog posts (e.g. through the Centre for Translational Research in Public Health FUSE blog page). Early thesis doctoral work on the project already used this communication channel for increasing the readership of the systematic review’s findings (see: https://fuseopenscienceblog.blogspot.com/2020/10/can-your-education-income-or-even-your.html). The target date for such blog post outputs is 2023.

Outputs report only aggregate level data. For the breast cancer analysis, we report data on 40,179 women with HER2+ breast cancer of which 17,674 women utilised the novel anti-cancer therapy trastuzumab. The lung analysis reflects a NSCLC population (195,387 patients) of which 9,854 patients utilised a novel anti-cancer therapy (targeted treatment, biological and/or immunotherapy). Small numbers have been suppressed where necessary, for example by using wider age group bands. Finally, missing, and unknown detail was retained and levels of this are (and will be) reported in published analyses.

It is intended to disseminate the outputs to as wide an audience as possible (researchers, clinicians, patients and the public). Publication in open access journals is preferred in order to enable outputs to be free to users to access and there is funding available for publication by such means through Ruth Norris’s PhD funding. Any blog post outputs will also be free to access.


MR943 - SD89/SD21 - Cancer In Young People - North And North West Regions — DARS-NIC-291940-S3D6R

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable

Legal basis:

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2010-02-02 — 2020-02-01

Access method: One-Off

Data-controller type: NEWCASTLE UNIVERSITY, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. MRIS - Personal Demographics Service

Objectives:

To provide the Register with statistical analysis from the Birth Certificate and update and complete each Registration of young persons' with a malignant disease in the North and North West Regions of England


Impact of a community based social prescribing intervention in an ethnically diverse area of high socio-economic deprivation. Exploiting a natural experiment to evaluate effects on health and health care utilisation with economic assessment and ethnographic observation. — DARS-NIC-204646-B9G2N

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: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2019-02-01 — 2022-01-30

Access method: One-Off

Data-controller type: NEWCASTLE UNIVERSITY, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. SUS for Commissioners

Objectives:

The data will be used to evaluate a Social Prescribing (‘Ways to Wellness’) intervention in the West End of Newcastle upon Tyne. This is similar, although on a larger scale and more in-depth, to a recent review of a social prescribing scheme pilot in Rotherham in 2016. To-date, there is no robust evidence for the effectiveness of social prescribing and, therefore, there is considerable interest in collecting this evidence among the Department of Health, and NHS policy makers and practitioners.

The outcomes considered are secondary health care utilisation and the cost of utilisation. The data will exploit the fact that the intervention was only implemented in GP practices in the west end of Newcastle. The research team will use data from the whole of Newcastle to compare those individuals who are treated with those individuals who are not treated.

The use of SUS data is essential to investigate if, and in what ways, the ‘Ways to Wellness’ social prescribing scheme has affected the utilization and cost of secondary care for treated patients.

To conduct this study the SUS data provided to the North of England Commissioning Support Unit (NECS) will be linked, by NECS, to GP records (from Quality Outcomes Framework (QOF) extracts) and Ways to Wellness data (held by NECS). The SUS data will be pseudonymised by the DSCRO before being released to the Data Processor (NECS). All other identifiable data (specifically the WtW and GP data) will be pseudonymised by NECS in their role as a data processor for WtW and the GPs.

Why are Newcastle University requesting SUS data? This is because these data are used by NECS (who are the Data Processor) and they contain patient utilisation information and the associated tariffs. This will allow the research team to give accurate cost savings that may accrue to health care services in Newcastle/Gateshead CCG from the implementation of Social Prescribing.

Record level data is needed in order to undertake the necessary statistical and econometric analysis. However, all data would be pseudonymised (see below). Newcastle University require no patient level identifiers. The SUS data would be pseudonymised by the DSCRO and supplied to NECS. NECS will also undertake all data linkage as explained in Processing Activities. NECS provide the linked pseudonymised data to Newcastle University.

In summary:
• Estimate the impact of a Social Prescribing intervention on a range of secondary health care utilization outcomes (costs and use).
• The outcomes measured will include use and costs of: A&E, Day case, Elective, Non-elective, Outpatient first, Outpatient follow-up and totals.
• Newcastle University will use results from effectiveness to investigate the cost-effectiveness of a social prescribing intervention.

Outputs:

The research outputs will consist of peer reviewed papers published in academic journals, research reports for the study funder (the National Institute of Health Research) and Newcastle/Gateshead CCG, and conference presentations. All results will be reported at the aggregate level with small numbers suppressed in line with the applicable NHS Digital guidance, showing the effect of treatment on control groups compared to treatment groups. Statistical results will be presented in tables of aggregate statistics summarizing patient characteristics and will comply with the guidelines on disclosures of potentially identifiable patient data, i.e. no small numbered cells and figures will be reported.

In Summary:
• Journal paper on first set of data extracts estimating treatment effects on secondary care services and health outcomes: 1/12/2019 (Potential target: Health Economics Journal)
• Journal paper on second set of data extracts estimating treatment effects on secondary care services and health outcomes: 1/12/2020 (Potential target: Journal of Health Economics)
• Journal paper on economic review of SP intervention: 1/12/2020 (Potential target: Social Science and Medicine)
• Final report for funders - National Institute of Health Research: 1/12/2020

Targeted Conferences include:
International Social Prescribing Conference
The Gerontological Society of America conference
The Royal College of GPs conference (http://www.rcgp.org.uk/annualconference).
International Health Economics Association Conference

The results will be disseminated throughout the CCG. The study is fully supported by the Newcastle/Gateshead CCG and by North East Commissioning Support Unit (NECS); the current chair of the Newcastle-Gateshead CCG has written in support of this project and has been a keen advocate for the review of Social Prescribing. The CCG Clinical Director and Director of Public Health will be members of the grant's Study Steering Committee. The research team have support from the Health Improvement Directorate of Public Health England. The research results will be fed back to all of these groups.

The impact strategy proposed will use the research team’s existing networks which encompass health, the voluntary sector, local and national government. Specifically, these networks comprise: FUSE (UK CRC Centre for Translational Research in Public Health) a body with considerable expertise in knowledge translation including a knowledge exchange broker and a communications group to assist with the dissemination and pathways to impact of research; NIHR School for Public Health Research; NIHR School for Primary Care Research; Public Health England; NHS England, NHS Clinical Commissioners; Association of Directors of Public Health ; National Council for Voluntary Organisations (NCVO); Association of Chief Executives of Voluntary Organisations (ACEVO); Local Government Association Community Wellbeing Network; National Government via the Cabinet Office ; the Coalition for Collaborative Care; and National Voices - the leading coalition of health and social care charities aimed at strengthening the voice of patients and service users.

The research team are also providing a study website to allow interested parties to follow the progress of the research.

Processing:

SUS+ data will allow the research team to analyse the effectiveness and cost-effectiveness of a Social Prescribing (SP) intervention. The data will be used to undertake statistical, econometric and economic analysis relating to how SP affects a range of outcomes, including secondary-care utilisation, cost and health outcomes (derived from QOF data). The study team require pseudonymised data on both the treated (those individuals registered in practices in the West End of Newcastle) and untreated (those individuals registered in practices in the rest of Newcastle) in order to compare outcomes in the two groups. In order to estimate a treatment effect, the study team need data from three years before the start of the SP intervention (April 2015) and five years after (until April 2020). The analyses will control for age, gender, ethnicity and deprivation measures. The study team are focusing on patients with long-term health conditions, specifically type 2 diabetes (T2D), coronary heart disease (CHD) and Heart Failure, and will be controlling for co-morbidities and complexity. The study team will conduct sub-group analyses (e.g. by age-group and long-term condition severity) to investigate whether different groups benefit differently from SP.

Secondary/Community Care data

· NECS will download an extract pf SUS+ [SUS] from the DSCRO
· NECS receive a local provider flow from Ways to Wellness [WtW]. This contains information on age at referral, referral date, start date, assessment dates, wellbeing star (a WtW derived outcome measure), marital status, disability code, ethnicity, gender, number of contacts with link worker, provider.
· Both the SUS and WtW datasets will be pseudonymised with a project specific pseudo key [PSK1]
· North of England CSU [NECS] will receive a GP data extract from each practice. These GP extracts will include patients specific to the study. (Patients aged 40-74 at 1/4/2015 diagnosed with T2D, CHD or Heart Failure)
· Acting as a data processor on behalf of each practice NECS will utilise a bespoke pseudo key issued by the DSCRO to pseudonymise the GP data [PSK2].
· Once pseudonymised the NHS numbers in the GP data will be deleted and postcode is transformed into the less identifying Lower Layer Super Output Area (LSOA)
· This is undertaken by the NECS primary care support team.
· North of England CSU will receive a pseudonymised local provider flow from Ways to Wellness [WtW] – this will be pseudonymised at source using pseudo key [PSK3] issued by the DSCRO


Linking Data
· DSCRO North of England will pass the SUS+ data to the NECS data management service
· The NECS primary care support team will pass the pseudonymised GP data to the NECS data management service. Note these two sets of data are currently unlinkable due to different pseudo keys
· Upon receipt of the GP data the NECS data management service will request a bridging table from the DSCRO. This table will consist of a mapping between PSK1 and PSK2, there will be no NHS numbers or other identifiers present.
· The NECS data management service will also request a bridging table from the DSCRO for PSK1 to PSK3
· The NECS data management service will then swap the pseudonyms in the GP data and WtW data to use their respective mapped pseudo from the bridging table. The result of this process will produce GP and WtW datasets with consistent pseudonyms as used in the SUS+ data making them linkable. The bridging table will be destroyed once mapping is completed.


Data Provision
· The NECS data management service will provide the linked SUS, WtW and GP data to Newcastle University following the application of a data minimisation process. This will involve restricting the SUS data to only include records for patients (pseudonyms) present in the GP data.
· Neither NECS or Newcastle University have any means of re-identifying patients.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

By signing the data sharing agreement, the data controller confirms that the data processors listed within this agreement have each: confirmed that they understand their roles and responsibilities on behalf of the data controller as defined within the data sharing agreement.


MR563 - NEWCASTLE HEART PROJECT - SOUTH ASIAN FOLLOW UP — DARS-NIC-148150-D5TDH

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: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2018-10-01 — 2021-09-30

Access method: Ongoing, One-Off

Data-controller type: NEWCASTLE UNIVERSITY, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report

Objectives:

Under this agreement Newcastle University seeks to continue to retain mortality and flagging status data for use in the Newcastle Heart Project – South Asian follow-up study. No new data is requested under this agreement as the next follow-up analysis using new years of data is not due until 2021.

The Newcastle Heart Project (NHP) was initially a cross sectional study of a representative sample of White and South Asian individuals resident in Newcastle upon Tyne, which aimed to explore the relationship between risk factors for cardiovascular disease (CVD) and diabetes in these two populations and to examine if differences in the relationship between the risk factors and CVD and diabetes between the White and South Asian populations were apparent.

Subsequently NHP participants were mortality flagged with ONS to enable the study team to study the relationship between CVD and diabetes risk factors and mortality in these two populations. Newcastle University received mortality data from NHS Digital until 2014.

Newcastle University is the only organisation involved in the NHP. No other organisations have access to data supplied by NHS Digital.

The study team have been able to use their study data (survey and clinic data of participants) and the mortality data supplied by NHS Digital to explore the issue of the ‘healthy migrant effect’ – that immigrants are often found to have better health than locally born populations. All data held is pseudonymised. The study team examined the hypothesis that differences in established cardiometabolic, lifestyle and socio-economic risk factors account for differences in all-cause mortality rates between South Asians and White individuals living in the UK. At the time of conducting these analyses in 2014 they had relatively few deaths to include in the analysis (406 deaths). The study team wish to be able to retain the mortality registration data received to date, with a view to applying to receive data from 2014 onwards in the future, to allow them to extend their analyses with a larger number of cases that will allow them to make more robust estimates of the relationships between the variables of interest (new years of data are not requested as part of this agreement as new analysis is only undertaken at key intervals, with the next due in 2021).

Yielded Benefits:

The study has already furthered knowledge on the relationships between established cardiovascular risk factors and mortality risk, demonstrating that South Asians had lower all-cause mortality compared to European origin individuals living in the UK in a paper published in the Journal of Epidemiology and Community Health (Hayes et al. 2017 JECH:71:9:863-9) and demonstrated that further work is needed to better understand and measure the factors contributing to their survival advantage. A better understanding of the relationship between established cardiovascular risk factors and mortality, and how this differs between the two groups from different ethnic origins, could impact on healthcare by influencing decisions made by policy makers and commissioners (for example, guiding their choice of appropriate interventions to reduce cardiovascular disease and diabetes risk in specific populations).

Expected Benefits:

Future analyses will contribute to the understanding of the relationships between established cardiovascular risk factors and risk of mortality, how these vary by ethnic group and to what extent they support the theory of there being a 'healthy migrant effect'.

Planned future analyses, based on a larger number of events, will enable Newcastle University to make more confident and robust estimates of the association between risk factors and mortality and of how these differ between South Asian and White populations living in the UK. A better understanding of these relationships could inform targeted interventions to improve the cardiometabolic health and associated risk of mortality in both the White and South Asian population in the UK.

Outputs:

In 2017 the study researchers published an analysis of the mortality follow-up of this cohort, examining differences in the relationship between established cardiovascular disease risk factors and mortality between South Asian and White individuals and addressing the question of if differences in socio-economic, cardiometabolic and lifestyle factors explain the healthy migrant effect in the Journal of Epidemiology and Community Health (Hayes et al. 2017 JECH:71:9:863-9)

This analysis was based on data collected up until 2014. Newcastle University intend to repeat and update their analyses in 2021 to include additional data on mortality in the cohort. The research team anticipates this analysis will result in a publication in a peer reviewed journal and will be presented at an appropriate conference (e.g. Public Health England Annual Conference) to ensure the findings are disseminated to an appropriate audience so that they can impact on policy decisions about healthcare. In addition, all outputs from this study are made available on the Newcastle University website.

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

Processing:

All the data held by the study team is now pseudonymised and can be linked to NHS Digital only by a unique study number for each individual included in the study.

Previously Newcastle University provided identifiers (NHS number, name and date of birth) for the study cohort to NHS Digital's predecessor organisation for linkage, and received notifications of deaths in members of the cohort back from NHS Digital (MRIS at the time) via a secure portal in an Excel spreadsheet. In 2014 it was deemed that the consent material did not meet current standards, and so all identifiers were destroyed, and only pseudonymised data is now held by Newcastle University. All the data now held, therefore, is pseudonymised - the study data (questionnaire and clinic data), and the flagging/mortality data provided by NHS Digital.

The NHP data is stored on a secure server within Newcastle University and was updated as mortality notifications were received.

Data are only accessed by individuals within Newcastle University who have authorisation from the NHP study team to do so and are substantive employees of Newcastle University.

The mortality data is linked at record level to study data obtained from a questionnaire (consisting of health and lifestyle information such as physical activity) and a clinic visit (information such as weight, height, and glucose tolerance) but no other record level linkage will take place. Record level data linkage to study data is facilitated by the use of unique study identification numbers without personal identifying information being available i.e. all data is pseudonymised.

There will be no attempt to re-identify individuals from the data.

The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

At present the study team request that they are able to continue to hold the data they have already received from NHS Digital as they intend to build upon previous work in the future as additional years of data become available that will enable them to more robustly answer their research question.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).


MR420 - NEWCASTLE HEART PROJECT — DARS-NIC-148022-1MQBH

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c),

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2013-07-31 — 2020-05-24

Access method: Ongoing, One-Off

Data-controller type: NEWCASTLE UNIVERSITY, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report

Objectives:

Mortality and Cancer Data was supplied to Newcastle University by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR420 - NEWCASTLE HEART PROJECT"

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

The following information provides background information on the purpose of the original study. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated.

**

BACKGROUND:

The aim of this study is to measure the prevalence of coronary heart disease, diabetes mellitus and associated risk factors to a cross sectional study of men and women aged 25-64 within Newcastle city boundaries.

Individuals were recruited to the Newcastle Heart Project between 1993 and 1997 and provided written informed consent to participate in the study.

The following text has been drafted for publication online:

The Newcastle Heart Project was a study of 825 White and 709 South Asian men and women, drawn from a sampling frame of over 7000 individuals residing in Newcastle upon Tyne between 1993 and 1997. Individuals who were selected for inclusion and took part in the study completed questionnaires to provide information about their socio-economic circumstances, health and lifestyle and attended a clinical examination.

The data controller for this study is Newcastle University

Yielded Benefits:

Mortality and cancer registration data was supplied to Newcastle University by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR420 - NEWCASTLE HEART PROJECT" This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required. The following information provides background information on the benefits of the original dissemination. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated. Work carried out using this data has been published and has furthered knowledge on the relationships between established cardiovascular risk factors and mortality risk, demonstrating that South Asians have lower all-cause mortality compared to European origin individuals living in the UK (Hayes et al. 2017 JECH:71:9:863-9) demonstrating that further work is needed to better understand and measure the factors contributing to this survival advantage. A better understanding of the relationship between established cardiovascular risk factors and mortality, and how this differs between the two groups could have positive impacts on healthcare by influencing decisions made by policy makers and commissioners (for example, guiding their choice of appropriate interventions to reduce cardiovascular disease and diabetes risk in specific populations).

Expected Benefits:

Mortality and cancer registration data was supplied to Newcastle University by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR420 - NEWCASTLE HEART PROJECT"

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

The following information provides background information on the benefits of the original dissemination. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated.

**

Additional analysis of this dataset, with a larger number of events available to include in the analysis, will contribute to a better understanding of the relationships between established cardiovascular risk factors and risk of mortality and how these vary by ethnic group and to what extent they support the theory of a 'healthy migrant effect'.

Future analyses will allow confident and robust estimates of the association between risk factors and mortality and of how these differ between South Asian and White populations living in the UK. A better understanding of these relationships could inform targeted interventions to improve the cardiometabolic health and associated risk of mortality in both the White and South Asian population in the UK.

Outputs:

Mortality and cancer registration data was supplied to Newcastle University by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR420 - NEWCASTLE HEART PROJECT"

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

No further outputs of the data are permitted to be created under this version of the agreement. Outputs will only be permitted to be created once a new agreement that meets all of NHS Digital's legal, ethical and security requirements is in place.

The below provides background on to what has already been produced, and what will be produced once data flow and permission to process resumes.

**

In the longer term, the aim is to update work published in 2017. This was an analysis of the mortality follow-up of this cohort, examining differences in the relationship between established cardiovascular disease risk factors and mortality between South Asian and White individuals and addressing the question of if differences in socio-economic, cardiometabolic and lifestyle factors explain the healthy migrant effect in the Journal of Epidemiology and Community Health (Hayes et al. 2017 JECH:71:9:863-9).

The aim is to repeat and update the analyses in 2021 to include additional data on mortality in the cohort. It is anticipated this work will result in a publication in a peer reviewed journal and will be presented at an appropriate conference (e.g. Public Health England Annual Conference) to ensure the findings are disseminated to an appropriate audience for the best impact on policy decisions about healthcare.

The Newcastle Heart Project has allowed a better understanding of the prevalence of cardiovascular disease, diabetes and risk factors in White and South Asian men and women.

In addition, all outputs from this study are made available on the Newcastle University website.

Processing:

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

Mortality and cancer registration data was supplied to Newcastle University by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR420 - NEWCASTLE HEART PROJECT"

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

Below is information provided by the applicant (Newcastle University) on background to the study for details of previous disseminations, and also an insight into what is anticipated will happen once access to new data flows and permission to process data is granted in the future. As stated above - this version of the agreement permits retention of data only - permission is not granted to otherwise process the data at this stage until relevant documentation can be provided.

**

The purpose of processing this data is to further knowledge of the associations between risk factors for cardiovascular disease, diabetes and mortality in White and South Asian populations living in the UK. The intention is to inform the development of appropriate interventions to improve public health. It is intended that the data will be retained until 2037 to allow data on mortality to be collected for at least 40 years after individuals participated in the study.

Individuals who participated in the study along with all individuals in the
sampling frame were flagged with NHS Digital. This has enabled the study of the relationship between cardiovascular disease risk factors and risk of mortality in the two populations.

The Newcastle University have sent NHS Digital cohort data from Newcastle Heart Project and expect linkage between the cohort and MRIS data. The linkage will be anonymised. Once complete, the data will be stored in a secure university server.

NHS Digital data will not be shared with any other organisation.


Improving outcomeS for Women diagnosed with early breast cancer through adhErence to adjuvant Endocrine Therapy (SWEET) — DARS-NIC-680871-G5H4X

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2024-02-12 — 2026-02-11 2024.03 — 2024.03.

Access method: One-Off

Data-controller type: NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Medicines dispensed in Primary Care (NHSBSA data)

Outputs:

The SWEET study aims to produce a number of outputs as a result of data processing which hopes to target a wide audience (researchers, scientists, innovative technology-focused organisations, research participant audiences, patient groups, general population, and commissioners). Dissemination outputs will consider a number of mediums (journal publications, conference presentations, a website, public events, scientific writing, webinars, and newsletters).

In the first instance, a report from the findings of the SWEET feasibility study will be produced for submission to the NIHR. There will also be continuous reporting to the funder of further SWEET study findings throughout the short, medium, and long term of the programme.

Study outputs will be limited to aggregate data with small number data suppression as per the NHS BSA dataset suppression guidance.

Outputs will also take on the form of peer reviewed publications – most likely research in specialty journals in breast cancer survivorship (e.g. Journal of Cancer Survivorship, Supportive Care in Cancer) and psycho-oncology/behavioural science (e.g. Psycho-Oncology, Implementation Science, Patient Education and Counselling). Publication of the feasibility’s study’s findings in peer-reviewed scientific and clinical journals is anticipated as a medium-term goal of the SWEET programme (up to 2 year timescale).

Feasibility study publications will build on the number of abstracts already published from the early phases of the wider SWEET project work. There are currently two SWEET publication: (i) a paper exploring the theoretical-based, modifiable influences on non-adherence in breast cancer ; and (ii) a paper describing the HT&Me intervention development from an earlier phase of the SWEET programme. In addition to this, a systematic review of previous reviews of determinants of adherence and a further SWEET research programme protocol paper are both currently under review. These short-term outputs are anticipated soon (2023/24).

To assist with dissemination to the wider clinical team, patient groups, and commissioners the programme aims to utilise social media, lay communications, and briefings (paper, digital, and events). To reach patient and general populations, regular updates will be posted on the SWEET project website to assist with dissemination. Such postings are envisioned to include key project messages crafted with the assistance of the PPI panel. For the feasibility study, in the short term, the research team will report to the participants and the wider clinical team on the feasibility of obtaining prescription encashment data and using this information to generate a measure of adherence as well as the potential to scale up such data processing for the future SWEET RCT to follow. There are also plans to pursue a dissemination event for breast cancer survivors and healthcare professionals should there be sufficient interest in doing so. This event may also include a livestream to other locations (e.g. collaborating centres). Also, if of use to interested groups, parts of this livestream may also be recorded and posted on the SWEET website. Such an event is currently anticipated to fall towards the end of the research programme (January 2027).

In the longer term, the programme intends to have an impact on clinical policy, specifically through the integration of the SWEET intervention into clinical guidelines so that all women prescribed AET can benefit from the information provided by the HT&Me app. This will ensure that the project’s findings can reach all clinical and geographic communities – not just those with an interest in research driven clinical practice. Commercialisation of the HT&Me app has been explored so far for the initial work on this project but there are plans to expand on such discussion for roll out of the intervention across the whole National Health Service (NHS). Additionally, the RCT aims to consider recurrence risk in women over a longer time frame than that reported in the literature, as well as noting the findings of the intervention on recurrence over a longer time frame. Timescales for such longer-term outputs are 5 years plus.

Dissemination plans align with those for the intended research undertaken. Stakeholders in the project are currently updated quarterly with progress with the SWEET project. These meetings fluctuate between virtual and face to face communication to facilitate access to updates on the study’s progress. Following completion of the feasibility study and the later RCT, stakeholders will receive a report of the outcomes from the programme. There will be continuous reporting of findings throughout the short, medium, and long term of the programme to stakeholders.

Study outputs will be limited to aggregate data with small number data suppression as per the NHS BSA dataset suppression guidance.

Processing:

Newcastle-upon-Tyne Hospitals NHS Foundation Trust will securely transfer data to NHS England. The data will consist of identifying details (specifically NHS Number and Date of Birth for the cohort to be linked with NHS England Data). The Date of First Diagnosis of Breast Cancer and a unique study ID will also be provided by Newcastle-upon-Tyne Hospitals NHS Foundation Trust.

NHS England will provide the relevant records from the NHSBSA dataset to Newcastle University. The Data will contain no direct identifying data items but will contain the provided unique study ID which can be used to link the Data with other record level data already held by the study team.

Newcastle University will seek to examine the completeness of data, assess the suitability for computing different measures of adherence (e.g. MPR, PDC, CMA, CMG, CSA, CSG) and undertake a health economic evaluation. The deidentified dataset will be housed on a secure University network accessible only to named employees working for the Data Processor. The data will be worked on and saved to this secure drive. Policies and procedures are in place at Newcastle University which will be followed in the unlikely event that there is an accidental loss, destruction, or damage to the data during storage. There is no linkage in this application of data to a matched publicly available dataset.

The Data received under this Data Sharing Agreement and identifiable patient data received at the time of consent to sub-study II from clinical sites will be stored separately. The pseudonymised dataset will be processed in used in such a way to allow the study to address its key aims.

Pulsant is where the Newcastle University servers are co-located. This means that the University rents secure rack space at this location where the University hosts its servers. Pulsant only provides a secure managed location and does not have access to any hardware. Pulsant will have no access to the NHS England Data as described in this DSA.

Data processing will only be carried out by employees and agents of Newcastle University. These individuals will have been appropriately trained in data protection and confidentiality which will be reviewed on an annual basis. Annual General Data Protection Regulation (GDPR) training will be required for all employees using NHS England Data.

Access to NHS England record-level Data by authorised personnel will be either on-site at Newcastle University or via remote access. For remote access, the study team will comply with the following terms:

• Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
• Access controls granting users the minimum level of access required are in place;
• Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
• Multifactor authentication (MFA) is required for remote access;
• Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
• All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA.

The Data will not leave England at any time.

The Controller must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

There will be no student access to the data. Data from NHS England will not be used for any purpose other than that stated in this application.

Linked data will only remain available for 5 years following any publication after which retention will be reviewed. )


Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral). — DARS-NIC-361864-N8P1S

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Consent (Reasonable Expectation); Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2023-05-15 — 2026-05-14 2023.09 — 2023.11.

Access method: Ongoing

Data-controller type: NEWCASTLE UNIVERSITY, SOUTH TEES HOSPITALS NHS FOUNDATION TRUST, SOUTH TEES HOSPITALS NHS FOUNDATION TRUST, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death
  2. Emergency Care Data Set (ECDS)
  3. Hospital Episode Statistics Accident and Emergency (HES A and E)
  4. Hospital Episode Statistics Admitted Patient Care (HES APC)
  5. Hospital Episode Statistics Outpatients (HES OP)

Expected Benefits:

The UK Mini Mitral trial aims to answer the question of whether a minimally invasive surgical technique, is superior to conventional sternotomy when performing mitral valve repair surgery in relation to rate of recovery. The results hope to significantly impact patient care nationally and internationally. Indeed, the results are highly anticipated by the clinical community, and by NICE, who have already stated that its findings may influence the next set of clinical guidelines. Every year approximately 2000 patients undergo mitral valve repair surgery in the NHS and this number continues to increase. The UK Mini Mitral trial expects the information obtained from this processing to be used to update the NICE guideline: https://www.nice.org.uk/guidance/ng208 to support patients being offered a safe, effective intervention for their mitral valve disease with the shortest stay needed in hospital and shortest overall recovery time.

The minimally invasive approach has the potential to reduce post-operative complications, and thus hospital stay and overall recovery time to the benefit of patients and the NHS. However, there remains significant debate within the clinical community and uncertainty in the international literature about widespread adoption of minimally invasive surgery in the absence of definitive research evidence.

It is clear that findings may directly impact practice and policy in the UK, and internationally. In addition, the knowledge gained through this work could be used to design efficient and effective trials in the future that make appropriate use of routine data sets. The aim is to begin disseminating findings from the trial beginning in summer of 2023. Dissemination will continue beyond this date to ensure maximisation of the opportunity to change practice and policy once findings are known.

Outputs:

The research team are planning a comprehensive dissemination package that includes:

- Developing and submitting an NIHR Report that will be published.
- Aggregated findings will be widely publicised at national and international conferences (e.g. America College of Cardiology).
- Research findings will be published in high impact open access publications (New England Journal of Medicine [NEJM]/Lancet).
- To actively engage with policy makers and NICE to enable findings to be rapidly implemented in clinical practice.
- To continue to work with patients to develop patient facing materials that will convey the messages from the research that are important to patients - this may take the form of an animation. This will target both those who took part in the trial, and the wider patient groups as the study aims to create information accessible to all current and future patients requiring cardiac surgery. We have already forged close links with charities including Heart Valve Voice, to maximise the study's ability to reach patients with the findings.

Individual data will not be contained in outputs. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The target date for dissemination of findings is summer of 2023 onwards.

The University of Newcastle anticipate that the findings of this study may have international reach. The operations performed in this trial are also conducted globally and as such research findings will have international relevance.

Processing:

Newcastle University will provide NHS England with NHS number, Sex and Date of birth specific to participants of the study. This data has been collected from participants and stored in a Data Safe Haven within Newcastle University.

NHS England will flag participants within the HES, ECDS and Civil Registration data products requested by Newcastle University & South Tees Hospitals NHS Foundation Trust. Participant data will be linked to NHS England data and returned to Newcastle University for processing via Secure Electronic File Transfer (SEFT). Data will be downloaded by a named individual at Newcastle University and stored securely in the University’s Data Safe Haven. NHS England data will be linked to study data collected over the course of the trial directly from participants. The data will be processed within the Data Safe Haven.

- Hospital Episode Statistics will be processed to assist in identifying events within the participants health care records that could be attributed as related, contributing or and outcome of Mitral valve repair (MVr) surgery. Analysts will use the data to compare the treatments associated with MVr, validate how events associated with these treatments can be identified within the data and monitor the effectiveness & costs comparable between the treatments.

- Civil Registration - Deaths data will be utilised to identify instances of mortality of participants, linked to HES data to analyse and understand any relating factors.

The study will also NHS England data to National Institute for Cardiac Outcomes Research database (NICOR) data. This linkage will be to validate hospitals records and their outcomes and classify the relevant outcomes across mitral valve related events.

Data will be made available to Data Processors listed within this Data Sharing Agreement via remote access to Newcastle University’s Data Safe Haven secure environment. Data processors will be provided with secure access roles to the system. All access and processing of the data will be performed within the Newcastle University Data Safe Haven. Data processing is only carried out by substantive employees of the data processor(s) and or data controller(s) named within this agreement, and statisticians employed by Durham University and which hold honorary contracts with Newcastle University. Those accessing the data have been appropriately trained in data protection and confidentiality. Newcastle University will filter NHS England data, so that data processors and other partner organisations receive only the data required for their analyses.

- The project team employed by Newcastle University will have access to data received from NHS England and will be involved with analysis. This includes the Chief Investigator for the trial, trial managers, clinical trial administrator and Health Economist who will analyse the data to address the objectives outlined in this agreement.

- Data processing conducted by Oxford University Hospitals NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust and The Royal Wolverhampton NHS Trust will involve an independent panel of experts to review HES data at their local Trusts to help determine if events identified can be deemed mitral valve-related. The role of the independent panel of experts will be to review pseudonymised HES data to ensure there are no other clinical conditions (other than mitral valve disease) that may explain diagnoses.

Using a secure method of remote screen sharing from Newcastle University, pseudonymised data will be viewed by an independent panel of NHS-employed clinical adjudicators based at Oxford University Hospitals NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust and The Royal Wolverhampton NHS Trust.


Examining inequalities in the provision of elective surgical and diagnostic procedures — DARS-NIC-167794-K1P8H

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Academic)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2019-03-01 — 2022-02-28 2020.02 — 2020.02.

Access method: One-Off

Data-controller type: NEWCASTLE UNIVERSITY, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

Introduction
Newcastle University seek to examine the impact of patient choice in the NHS in both secondary care as choice of provider and in primary care as choice of GP. Following the NHS Plan in 2000, providers of health care services have expanded rapidly through the commercial contracting of NHS services. In 2003, privately owned independent sector treatment centres (ISTCs) were commissioned to treat NHS patients, focussing on high–volume elective surgical procedures and this was further expanded in 2005 and later repackaged as ‘free choice’ agenda, allowing any private provider of healthcare to provide elective care to any NHS patient provided they had registered with the relevant body. The 2012 Health and Social Care Act, has made commercial tendering of NHS contracts almost compulsory.

Also, as a result of the 2012 Act, the General Practice Choice Policy was introduced and since 05 January 2015 has allowed NHS patients to choose to register with a GP despite living outside the practice’s boundary area marking a change from the traditional place based method of organising GP practice lists. The aim of the scheme is to enhance convenience for patients who, for example, may choose to register with a GP near their work rather than their home and to improve the quality of access for patients to GP services. What is not known is the potential for destabilising of general practices with innovations, exploiting the new freedoms, as funding follows patients and local GPs are left with increasing proportions of older, sicker patients. The British Medical Association fear a widening of inequalities where the “choice” for many patients will be determined by their health, wealth and age leading to a destabilisation of practices through the loss of “commuter patients” disadvantaging the “frail, old or poor".

To examine the impact patient choice has had on inequality in access and NHS provision Newcastle University require data on NHS funded elective surgical and diagnostic procedures (specifically relating to cataracts, hip replacements, knee replacements, inguinal hernia, cholecystectomy and arthroscopy, plus all readmissions within 30 days of these procedures). Newcastle University researchers will analyse this pseudonymised data and report numbers, trends and rates of provision by both the NHS and private sector. The researchers will examine the impact increasing private provision of NHS care has had on inequality by gender, age and socio-economic deprivation. HES admitted care data is required for use in this “Examining inequalities in the provision of elective surgical and diagnostic procedures” study.

Organisations
The study is a research project carried out by researchers at Newcastle University. The work will follow on from previous work investigating service changes and effects on inequality of access for NHS funded treatment in Scotland and England. All data access will be through Newcastle University.

Why are Newcastle University undertaking this work?
The 2012 Health and Social Care Act established a duty on the Secretary of State for Health to “have regard to the need to reduce inequalities between the people of England with respect to the benefits that they can obtain from the health service.” The research proposed here will analyse whether this duty is being fulfilled in the context of UK government health policy driving NHS reform and patients’ ability to access NHS treatment equitably. This work follows on from previous work on investigating equality of access in the context of service changes and was instigated by the researchers themselves.

Aim
The research will address the following specific research questions:
1. Since the introduction of patient choice of general practitioner (GP) in the NHS in England, have there been changes in elective surgery rates for key procedures and has there been a change in waiting times, distance travelled for treatment and in treatment quality?
2. Since the introduction of patient choice of provider in the NHS in England, have there been changes in elective surgery rates for key procedures and has there been a change in waiting times, distance travelled for treatment and in treatment quality?
3. Have any changes in the measures in 1 and 2 above of treatment access and quality occurred equally with respect to age, sex and socio-economic deprivation and what is the effect of different provider types (acute NHS trusts; foundation NHS hospital trusts; Independent Sector treatment Centres (ISTCs); and other private providers) on equality by these measures?

Background to the work
This project carries on from previous work analysing these issues using data from both NHS Scotland and NHS England. The two Newcastle based researchers have been working on this topic since 2007. The objectives have developed particularly to include patient choice of GP as a focus of analysis.
To carry on with this work Newcastle University require admitted patient care data from NHS Digital.

The GDPR lawful basis for Newcastle University to process this data is Article 6(1)(e) 'task in the public interest' and Article 9(2)(j) 'scientific or historical research purposes or statistical purposes'.

Expected Benefits:

Through dissemination of the results of the project Newcastle University expect to raise awareness of the effects of government policy on patient choice with respect to health, particularly given the secretary of state’s duty with regard to the need to reduce inequalities. CCGs will find the results useful as they are currently unaware of the effects of different forms of service delivery on patient equality of access. GPs will also find the results useful as patient choice of GP is a steadily increasing phenomenon and the effects in terms of patient equality are unknown.

Newcastle University will disseminate the results in a report form to key stakeholders as soon as they have them available and prior to publication. These stakeholders will be able to use the knowledge the research will provide to adjust their strategies to health care delivery to ensure any increasing inequalities are addressed.

Other researchers (Cookson and colleagues) have found a 12% differential in favour of patients living in the least deprived areas of England in terms of waiting times attributable to patient choice, for urgent heart procedures. It isn’t known what the effects are for elective surgical procedures which is what Newcastle University researchers will analyse here. In addition the effects of patient choice of GP are unknown.

The study results will provide an evidence base for future decision making regarding the effects of patient choice in the provision of NHS funded care. It will examine causes of inequalities in access to effective treatments and can be used by patient advocacy groups, policy makers and commissioners to take measures to reduce inequalities and tackle barriers in access to treatments.

The study results will be important nationally in informing future NHS policy in countering any unintended consequences of patient choice such as increasing levels of inequality in access to treatment.

Outputs:

Newcastle University expect analysis to be completed within eighteen months.

As detailed above, the Secretary of State for Health has a duty to have due regard to reducing inequalities in a patient’s experience of using the NHS in England. This research will provide the government with evidence of the effects of health policy on patient choice of GP and provider on patient’s ability to access treatment equitably.

CCGs in England, planners and policy makers with responsibility for ensuring equity of access to health services need to understand the impact of service changes on differing patient groups especially the vulnerable and potentially disadvantaged. Knowledge is power and the purpose of this research is to provide CCGs, planners and policy makers an understanding of the possible effects of implemented service changes, in this case patient choice both in terms of GP and provider of health care. This should enable those organisations to instigate changes locally and nationally to ameliorate any unintended consequences of service changes which are often introduced untested and may be harming patient equity.

Prior to any publication of findings, these will be fed back to NHS England. The results will be made available to local authorities, UK and devolved government ministers and opposition political parties. As well as being of interest to planners and policy makers in local government, central government and the NHS with responsibilities in the areas of public health, health care and health inequalities, Newcastle University expect the research findings to be of interest to advocacy groups and charities working on behalf of potentially disadvantaged patients. Results from this project will also be compared to those from a separate analysis from Scotland and conclusions drawn will be used to inform policy and practice debates in Scotland and England.

Newcastle University will be flexible and tailor outputs depending on findings but these are likely to include a series of ‘policy briefings’ for politicians in the UK governments and CCGs, policy makers and planners at local and national level.
An impact strategy has been developed to influence policy and practice and has been designed to ensure robust translation and communication plans. The outputs will be of the greatest value to the study's intended beneficiaries (CCGs, planners and policy makers) and other key audiences. The study team will build on existing networks and in collaboration with their non-academic partners will influence key policy and practice arenas and ensure long-term use of the research findings.

Newcastle University researchers will analyse data and publish a research report, reporting:
- Annual numbers of elective procedures, by type of procedure and provider type (acute NHS trusts, foundation NHS trusts, Independent Sector Treatment Centres and other private providers).
- Crude annual rates of elective procedures, by type of procedure and provider type.
- Standardised rates of elective procedures, by type of procedure and provider type.
- Changes in inequalities between ages, sexes and deprivation categories by type of procedure and provider type through regression modelling.

Number and rates will be reported at national and Clinical Commissioning Group level. These outputs will be made available in an academic publication such as in the British Medical Journal, accessible by academics, clinicians and the public. Data will not be used for sales and marketing purposes.

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

Processing:

Newcastle University seek data going back to 1997/98 to have sufficient time before the implementation of patient choice (of provider) to allow a trend analysis, and also to allow a comparison with data at Newcastle University from NHS Scotland. The researchers need national data as patient choice is a national policy, additionally it will be important to identify regional variations in effects of the policy on treatment access equality. The lowest level of coding within the extract to allow consideration of regional variation will be at Clinical Commissioning Group level. GP Practice code will not be provided. Newcastle University have researched in detail to identify what they think are the key procedures in terms of them being high volume and likely to be informative on measures of equality. There is a requirement for sensitive data such as diagnostic information, these will only be used to measure levels of co-morbidity.

The data will be transferred to Newcastle University using Secure Electronic File Transfer. The data will be stored in the University’s Filestore, managed by the University’s IT Service, and located in the University’s restricted access data centre (mirrored between the on-site and off-site data centres using dedicated fibre connections). All hardware used to deliver the data centre infrastructure (on-site and off-site) is exclusively owned by Newcastle University.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

The data will not be linked with any record level data. There will be no requirement nor attempt to re-identify individuals from the data. The data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.


MR1103 - Long term sequelae of radiation exposure due to computed tomography in childhood — DARS-NIC-147852-RV70L

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N, Yes - patient objections upheld, Identifiable, Yes, No (Section 251, Section 251 NHS Act 2006, , )

Legal basis: Section 251 approval is in place for the flow of identifiable data, Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, 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'.; Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), , Health and Social Care Act 2012 – s261(7), National Health Service Act 2006 - s251 - 'Control of patient information'. ; Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

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

When:DSA runs 2010-02-01 — 2020-01-31 2016.05 — 2020.01.

Access method: Ongoing, One-Off

Data-controller type: NEWCASTLE UNIVERSITY, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Scottish NHS / Registration
  4. MRIS - Flagging Current Status Report
  5. MRIS - Members and Postings Report
  6. MRIS - Personal Demographics Service

Objectives:

Patients undergoing scanning by computed tomography (CT) are a subset of the population exposed to higher levels of radiation than background. In particular, children scanned using CT may have received high doses when compared to those from other diagnostic procedures involving radiation, such as X-rays. This is of concern as children are known to be at an increased susceptibility to the effects of radiation compared to adults.

As yet, no studies have investigated the potential long-term risk from CT radiation exposure. Extrapolations have been used from the Japanese Atomic Bomb Survivor Study but this study will be the first to use empirical data.

This study of medically irradiated patients is very relevant to a policy of understanding the health effects of ionising radiation. In particular, the Department of Health announced last year that COMARE should look at the benefits and risks of using CT scanning in preventative healthcare. They subsequently agreed to co-fund this study. Very little is currently known about the potential risks of CT in any population, other than from extrapolation studies. This study of a subset of the population, which is likely to show the greatest effect of radiation from CT, should there be one, will provide the information urgently required to allow guidelines to be developed for safe and more effective use of CT scans in children and young adults.

Yielded Benefits:


Survival and predictors of survival of children born with congenital heart disease-BINOCAR — DARS-NIC-31911-S3Y6M

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Anonymised - ICO Code Compliant (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(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (Academic)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2018-09-20 — 2021-09-19 2017.12 — 2018.09.

Access method: Ongoing, One-Off

Data-controller type: PUBLIC HEALTH ENGLAND (PHE)

Sublicensing allowed: No

Datasets:

  1. MRIS - Bespoke

Objectives:

What organisation instigated the work and why?
This project was instigated by researchers at Newcastle University to address the paucity of information on long-term survival of individuals born with congenital heart disease (CHD). This information can be used for counselling parents when a diagnosis of CHD is made either prenatally or postnatally. Additionally the information can be used to calculate estimates of the number of individuals living with CHD, which is important for health care commissioning.

How are other organisations involved? Why?
The data being requested is to be linked to death registrations is collected by congenital anomaly registries. Data will be sent from these registries to NHS Digital to be linked with death registrations. The data will then be sent to Public Health England Northern Office (which houses the congenital anomaly register covering the North of England), where it will be analysed by an employee of Newcastle University who has an honorary contract with PHE.

Which organisations will have access to the record level data supplied by NHS Digital?
Only the two listed ONS users will have access to the data when it is stored at the PHE Northern Office.

How was this work instigated?
This project was originally funded by British Heart Foundation as part of a PhD. However, due to the extreme delays in obtaining the data the PhD has been finished (Oct 2015) and the project is now being funded by a Newcastle University Faculty Fellowship.

Aim
The aim of this study is to produce robust survival estimates, up to 25 years, for children born with congenital heart disease (CHD) between 1985-2012 in England and Wales. A further objective is to identify predictors of long-term survival of children born with CHD. This application is to link together data on cases of CHD notified to six congenital anomaly registers to death registrations, using several patient identifiable variable. Using the death registrations, NHS Digital will add the following variables to the data sets: survival status (alive/ deceased), year of death, number of days survived. Public Health England (PHE) also request that NHS Digital add IMD score at delivery to the dataset so that we can examine socioeconomic inequalities in CHD survival.

What does the work aim to achieve
With advances in surgical and medical techniques, survival of individuals with CHD has increased dramatically over the last 20 to 30 years. However, there is a paucity of information on CHD survival. This information is useful for counselling parents when a diagnosis of CHD is made prenatally or postnatally. This information can also be used to estimate the number of individuals living with CHD in the UK, which can aid health service commissioning.

Background
PHE originally applied to complete this data linkage in 2013. However, we have not yet received any data. The objectives remain the same as in our original agreement.

The applicant requires NHS Digital to link in death registrations using the following patient identifiable variables: Name, Address, sex, maternal age. The applicant also requires NHS Digital to provide Index of Multiple Deprivation scores and ranks for each case (based on postcode).

Yielded Benefits:

PHE have only received the final data set in 2018 and so are still in the process of analysing it and writing up with results. Therefore there are not yet any benefits.

Expected Benefits:

Children with CHD require highly specialised healthcare, and it is important that health services are in place to address this. Robust estimates of prevalence and the long-term survival of CHD are required to accurately plan for the provision of health care and range of services required by these children in the future. However, very few studies have reported the long-term survival of children born with CHD.
This research will be of benefit not only to support planning and administration of the provision made for health and social care for pregnancies and infants affected by congenital anomalies, but the information on long-term survival is also important for health professionals who need these statistics to counsel parents when their child is diagnosed with CHD. This information is also important for parents, particularly when a diagnosis of CHD is made prenatally.

Outputs:

In order to inform parents and clinicians, the applicant intends to present the outputs to and liaise with the British Congenital Cardiac Association, which is affiliated with the British Cardiovascular Society.
The results will be presented at Epidemiology and perinatal medicine conferences (such as Society for Pediatric and Perinatal Epidemiologic Research and Society for Social Medicine). They will also be published in peer reviewed medical journals such as Circulation. A summary of the results will be put on the BINOCAR website http://www.binocar.org/. The results will be analysed within the first year after the data is received. The data will be kept for three years. All outputs stated here will be aggregated where there are less than five cases in order to ensure anonymity.
All outputs are aggregated with small number suppression in line with the HES Analysis Guide.

Processing:

Data from the 6 different Congenital anomaly registers (CARs) centres – Northern Congenital abnormality survey, East Midlands and South Yorkshire CAR, CAR and information service for Wales, CAR for Oxfordshire, Berkshire and Buckinghamshire, South West CAR, Wessex antenatal detected anomalies register- has been securely transferred to NHS Digital.

The data from each register contained information on all children born with a CHD in their region. Each case had data on the following variables: ID no, infant forename and surname, postcode at delivery, mothers age at delivery, sex, number of foetuses, date of birth, gestational age at delivery (weeks), birth weight, ethnicity, register, antenatal diagnosis (ICD codes and text), postnatal diagnosis (ICD codes and text).

Babies have been matched and NHS Digital has calculated the number of days the baby survived and recoded postcode into IMD. NHS Digital has removed infant forename, surname and postcode and recoded date of birth/death into year of birth/death only. The data is therefore pseudonymised. The pseudonymised data set will be securely sent to the Regional Maternity Survey Office, Public Health England (now known as the NCARDRS PHE Northern Office) where it will be stored on a password protected computer and analysed by the applicant. Of the three users who will have access to the data one is employed by PHE, while two are employed by Newcastle University but hold honorary contracts at PHE.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

PHE Northern Office stores the data on a server which can only be accessed at the PHE Northern Office. This data is stored in a separate location to the participant identifiers. The two datasets will not be re-linked and the data will remain pseudonymised. Data will only be accessed by individuals within the PHE Northern Office who have authorisation from CAG to access the data for the purpose described, all of whom are substantive employees or hold honorary contracts at PHE.

The ONS user at NCARDRS North will use Kaplan-Meier curves to estimate survival at age: one, five, ten and twenty of children born with any CHD. Similarly they will use Kaplan-Meier curves to estimate survival of CHD subtypes separately, as these vary in severity. Additionally, the NCARDRS North will use the demographic data collected by the BINOCAR (including maternal age, gestational age at delivery, birth weight, sex, index of multiple deprivation) to investigate predictors of survival. This will involve the use of Cox regression, and also use modelling to predict survival in the future.


MR1032 - The NEWCASTLE 85+ STUDY: BIOLOGICAL, CLINICAL & PSYCHOLOGICAL FACTORS ASSOCIATED WITH HEALTHY AGEING — DARS-NIC-148471-FR43L

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable (Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2019-10-01 — 2022-09-30 2017.09 — 2017.05.

Access method: Ongoing, One-Off

Data-controller type: NEWCASTLE UNIVERSITY, UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Members and Postings Report
  4. MRIS - Flagging Current Status Report

Objectives:

The data supplied by the NHSIC to Institute for Ageing & Health will be used only for the approved Medical Research project MR1032.

Yielded Benefits:

Over 60 original articles have been published from the Newcastle 85+ study in peer reviewed journals, covering a wide range of health and social care issues in, a full list is available on the website - https://research.ncl.ac.uk/85plus/ Results have also been disseminated at public events and national and international conferences, where symposia have been held based on the study. Members of the team have used results from the study to contribute to policy:- House of Lords Select Committee on Demography 'Ready for Ageing' (2012) Dilnot Commission on UK care provision (2011). Findings from the Newcastle 85+ Study on levels of capability and dependency provided important data to inform the Commission's work. (Jagger C, Collerton JC, Davies K, et al. Capability and dependency in the Newcastle 85+ cohort study. Projections of future care needs. BMC Geriatrics 2011; 11.) Swedish Social Council review on healthy ageing Government review 2010) Why We Age – (2010) A road map for future research in ageing in Europe was generated. This is now under active dissemination (e.g. FUTUREAGE and WHYWEAGE European conference Brussels December 2010). Social Care Green Paper – Government review (2009). Invited to give oral evidence on drivers of healthy life expectancy in the UK and the impact on long term care to the Health Committee in connection with the Green Paper on Social Care funding reforms.

Expected Benefits:

The Newcastle 85+ study cohort (born in 1921 and aged 85 at baseline) has been followed to age 97 years. One important finding has been uncovering how disability evolves between age 85 and 90. Understanding whether or how health trajectories change at advanced ages is paramount in the face of this growing population, and if researchers are to develop more effective and timely primary health and social care services; but few other studies include people aged 97. The study team hypothesise that demands on health and social care may increase in the tenth decade and levels of disability, cognitive impairment, multimorbidity, frailty and loneliness increase.

Specific research questions include: (i) Confirming trajectories of disability and estimating years spent with disability and frailty between age 85 and 97, with the aim to identify potentially modifiable risk factors (ii) Identifying predictors of “healthy” ageing to age 97, (iii) Establishing how the demand on health and social care resources change between the ninth and tenth decade, particularly regarding informal care. Profiling current health and social care use (including informal unpaid care) will inform policy makers on how to optimally manage this age group. (iv) Determine late life factors influencing frailty, in particular cognition? (v) Exploring the levels of participation and loneliness and its link to health and social care usage.
Addressing the above research questions will identify factors associated with declining health and increased usage of health and social care. The study team anticipate this information can contribute to the development of policies around optimising care in the very old age group to develop models of care that are both cost effective and efficient.

Outputs:

Those aged 85 and older are the fastest growing sector of the population. Some people age well, whereas others experience multiple health and social needs. Identifying why this heterogeneity exists and understanding which transitions from independence to dependence are malleable, is key to maintain wellbeing and reducing the burden on services; longitudinal observation is necessary. The Newcastle 85+ study was established in 2006 and is now nearing completion of the 10 year follow up, the participants now being 97 years of age. Few other studies include people aged 97. The study team hypothesise that demands on health and social care may increase in the tenth decade and levels of disability, cognitive impairment, multimorbidity, frailty and loneliness increase, therefore this data collection at aged 97 years is valuable. The study team specifically want to identify: (i) trajectories of disability and estimating years spent with disability and frailty between age 85 and 95, (ii) identify predictors of “healthy” ageing to age 97, (iii) Establish how health and social care resources change between the ninth and tenth decade, particularly regarding informal care, (iv) determine late life factors influencing frailty, in particular cognition, (v) Explore the levels of participation and loneliness.

Much of this analysis will involve survival analysis, and hence, the mortality data remains a vital piece of information on participants in this cohort. Once data collection is complete and prepared for analysis the study team aim to publish outputs over the next 3 years (2018-2021). The study team continue to collaborate with researchers who wish to use some of the study data set and are establishing new international collaborations. These collaborations will include sharing outputs derived from NHS Digital, which will be aggregated with small numbers suppressed in line with the HES Analysis Guide. The Newcastle 85+ study is part of an international collaboration called TULIPS. This is a collaborative partnership between countries who have cohort studies of the very old and includes Japan (TOOTH study), Netherlands (Leiden 85+ study), New Zealand (LILACS) and United Kingdom (Newcastle 85+ study). This collaboration will maximise the use of data and increase understanding of international comparisons. Dissemination of results will be in a wide field due to on-going analysis in the fields of musculoskeletal medicine, nutrition, frailty, disability, polypharmacy, participation and loneliness.

To date the study output dissemination strategy has been wide and includes the general public, academic researchers and those working in the NHS. Future dissemination will be undertaken in both the research and wider community to target older people and health and social care professionals. The study team will continue to involve the established public engagement group VOICE (Valuing Our Intellectual Capital Experience - https://www.voice-global.org/ ) and the lay representative on the study steering committee to help develop a dissemination strategy for a lay audience. Participant feedback will consist of an individual newsletter to all participants outlining the major findings of the study and the study team will highlight the work through newsletters and meetings in the voluntary sector. The study team has a track record of publishing in high quality peer reviewed journals and aims to publish in journals in the fields of ageing and primary care; subject-specific journals will be used where appropriate. The study team will identify those high ranking journals where their work will be of interest to the audience and have the most impact. Previously this has included the British Medical Journal (BMJ), Lancet, Age and Ageing, International Journal of Gerontology, Journal of the American Geriatrics Society, amongst others, and they will continue to target such journals. The study team will present at the major conferences in the field of primary care (Society of Academic Primary Care) and care of older people (British Geriatrics Society, International Association of Gerontology and Geriatrics) in order to disseminate the results to a wide audience. The study findings will be relevant to commissioners and policy makers who shape the future health and social care services for the very old and the study team will continue to aim to present to this audience.

Processing:

The University of Newcastle previously securely transferred files of identifiers for patients in the Newcastle 85+ Study (NHS Number, Date of birth, sex and postcode plus a unique study ID) to NHS Digital. NHS Digital returned linked Mortality data from 2008 data the unique study ID, Date of Death, Full Name, Date of Birth, Area, Occupation, Cause of death (words), Cause of Death(Code). NHS Digital have received the full study cohort and the study will not be adding any additional participants.

On receipt of cohort linked data the Newcastle 85+ study research team undertake the following processing activities:

The University of Newcastle stores the data obtained from NHS Digital on an encrypted secure area network and access is restricted to individuals working on the Newcastle 85+ study. Access to full death data obtained from NHS Digital is restricted to a Principal Investigator (PI) who receives the data and the research nurse who enters the data onto the database.

Date of death, cause of death (Words), Cause of Death(Code) are added to the Newcastle 85+ study database which is encrypted. The database is pseudo-anonymised by unique study ID. Full patient information is kept on the patient Consent forms and patient lists which are kept within the locked filing cabinets within the Newcastle 85+ study office, access to the cabinets is only by the PI and research nurse.

Upon completion of checks, an extract of identifiable data (Date of Death and Date of Birth) is taken from the Newcastle 85+ study database and linked to fields from the cohort linked data to calculate variables such as exact age at interview, survival time from first interview, length of survival from diagnosis, total length of follow-up if such variables are relevant to specific research questions. Specific date of death will not be shared with Newcastle University researchers; instead date of first interview (baseline recruitment to study) is shared, and month and year of death.

Researchers who are not substantively employed by Newcastle University may work in collaboration with the study team but would only have access to outputs, which would be aggregated with small numbers suppressed in line with the HES Analysis Guide. If a researcher from another organisation wishes to access record level NHS Digital Data then an amendment application will be submitted to update the data sharing agreement with NHS Digital to include any new collaborations prior to them receiving the data.

The Newcastle University study team access data via a secure server and they are granted access after they successfully complete training. They must work on the data in that location and any output must be saved back to that location. They are instructed that no copies of the data are to be taken and placed in any other locations.

Summaries of the results will be presented orally at conferences and are intended to be published in academic or medical journals. All outputs will be aggregated with small numbers suppressed and in line with the HES Analysis Guide.

The Newcastle 85+ study is one of the largest cohorts of the "very old" in the United Kingdom and is now in its 10th year of follow-up. Throughout the study data regarding mortality has been received from NHS Digital. Additionally, detailed information over a 10 year period regarding health and social care issues has been collected. The combination of this data will now allow the study to map in more detail mortality in this very old age group and identify what factors are associated with healthy ageing. Additionally, the mortality data will be used for further analyses of mortality, often in conjunction with other outcomes e.g. disability, frailty. Continued receipt of mortality data will be extremely helpful in order to profile this population further. Very few studies have information on people of this age, and the mortality data will become increasingly important for future analyses.


Project 14 — DARS-NIC-148021-GNMPC

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c)

Purposes: ()

Sensitive: Sensitive, and Non Sensitive

When:2017.06 — 2017.02.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report

Objectives:

The data supplied by the NHSIC to Newcastle University will be used only for the approved Medical Research project MR87.