NHS Digital Data Release Register - reformatted

University Of Newcastle Upon Tyne projects

287 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.

Investigating and explaining contemporary patterns and trends in inequalities across the head and neck cancer pathway: understanding the roles of deprivation and region — DARS-NIC-726177-R0H8V

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: Non-Sensitive

When:DSA runs 2024-09-29 — 2025-09-28 2024.11 — 2024.11.

Access method: System Access
(System access exclusively means data was not disseminated, but was accessed under supervision on NHS Digital's systems)

Data-controller type: UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care (HES APC)
  2. Hospital Episode Statistics Outpatients (HES OP)
  3. NDRS Cancer Consolidated Data Set

Objectives:

Newcastle University requires access to NHS England data for the purpose of the following research project:
Investigating and explaining contemporary patterns and trends in inequalities across the head and neck cancer pathway: understanding the roles of deprivation and region.

The following is a summary of the aims of the research project as provided by Newcastle University:
Head and neck cancer (HNC) includes cancers of the mouth, throat, and voice box. These cancers are common in people who smoke and drink excessive alcohol. They particularly affect people living in more deprived areas and the North, including North West England (NWE) and North Wales (NW). These differences are called inequalities.
In 2020, during the COVID-19 pandemic, 20% fewer HNC were diagnosed in North England. This drop was not seen in other areas. This may mean that inequalities in HNC are now even bigger than they were before the pandemic. Even before the pandemic, we didn’t really understand the extent of reasons for inequalities in HNC: researchers have not looked thoroughly at national and regional data since around 2014. Our research will do this by bringing together up-to-date information from national databases to help work out the size of the problem and how to reduce inequalities in HNC.

The specific research questions are as follows:
(1) Determine how early HNCs were when diagnosed and how they were treated, including whether where patients lived (both region and deprivation status of area or residence) affected this. The main analysis will look at England as a whole. Sub-group analyses will focus on the NWE and NW.
(2) Compare the numbers of deprived and affluent patients alive 1-year after HNC diagnosis (survival).
(3) Compare HNC diagnosis, treatment and survival with data from before and during the pandemic.
(4) Use advanced statistical methods (mediation models) to find out the reasons for inequalities in survival.
(5) Work with patients, charities, and health professionals to come up with suggestions for what needs to happen to reduced HNC inequalities.

For aims (1)-(3), the main analysis will include all of England. Sub-group analyses will be conducted for NWE and NW (this is a particular interest of the funder).

This research project will build on a background of previous work in HNC which has found inequalities and poorer survival in patients living in the most deprived areas of the UK. This is thought to be related to: i) late stage at diagnosis; ii) diagnosis as an emergency and; iii) delayed treatment receipt. It is also known that in other cancers, patients living in deprived areas do not always receive the most appropriate treatment, even after considering other factors which could influence this such as the number of other health conditions (comorbidities) they have.

Studies in HNC in Scotland have previously found different findings. For example, a study using Scottish audit data found that inequalities in HNC survival disappear when stage is accounted for. In comparison, a study using Scottish cancer registry and Head and Neck 5000 data did find survival differences by deprivation and income when stage was considered. Limitations with the methods used in these studies may explain these differences. It seems likely that the real situation is more complex i.e. instead of treating all potential factors on survival as having a direct influence, that instead, indirect effects are also considered. For example deprivation could influence treatment and then survival (indirect) as well having direct effects on survival too. New work using more up to date methods (e.g. using causal inference) is needed.

Previous work has also shown that living in a deprived community in the North is associated with worse health outcomes than living in a deprived community in London. Yet HNC outcomes by region have not been investigated since the early 2000s even though it is known that age-standardised incidence rates are highest in the North East and North West. Finally, Cancer Alliance data from during the pandemic suggests that HNC diagnoses fell by 20% in some parts of Northern England but not elsewhere. The impact of the pandemic on HNC outcomes still remains unknown.

This data request is for a standalone project which commenced start 2024 and has three phases:
1) Developing a database of HNC incidence and survival estimates.
2) Understanding how deprivation is related to survival (Mediation model analyses).
3) Development of recommendations for HNC policy, intervention development, and research.

The scope of the data use will be across all three phases of this research project.


The following NHS England Data will be accessed:
• Cancer Registration – used as the ‘spine’ dataset. It is necessary to determine who was diagnosed with pathologically-confirmed head and neck cancer in the population of interest during the time period of interest. We will obtain from this dataset demographic (e.g. sex, age, ethnicity, region) and clinical information (e.g. tumour grade, size, number of tumours, comorbidities (Charlson Comorbidity Index), route to diagnosis and treatments) on HNC. These data will enable examination of HNC incidence and survival, determining if inequalities are explained by variations observed by deprivation and region (or other confounding factors).
• Hospital Episode Statistics
o Admitted Patient Care – necessary to provide additional information on persons diagnosed with HNC including surgical procedures received and other conditions. These data will enable examination of variations in incidence and survival in HNC and whether factors such as comorbidities (considered individually and as total number) and surgical treatments received explain variations by deprivation and region. This data will also be used to augment, if possible, information on ethnicity recorded on the NCRD.
o Outpatients – necessary to provide additional information on persons diagnosed with HNC including clinical diagnoses, specialist service provision, and consultant details. These data will be used to determine if variations in incidence and survival in HNC are explained by patient comorbidities (individual and number of), specialism referred to and/or, consultant workload. This data will also be used to augment, if possible, information on ethnicity recorded on the NCRD.


The Data is required for the above aims because the information will provide details on: i) all HNC registrations in the time frame of interest and; ii) demographic and clinical variables of interest. Combined, this data enables analyses to be undertaken exploring associations in HNC diagnosis, treatment, and survival by both region and deprivation, allowing for control of important covariates.

The level of the Data will be:
• Pseudonymised

The Data in Cancer Consolidated Dataset will be minimised as follows and the output will be limited to include;
• The conditions relevant to the study identified by specific ICD-10 codes (C00, C01, C02, C03, C04, C05, C06, C07, C08, C09, C10, C11, C12, C13, C14, C30, C31, C32, and C76).
• The data between patients with a date of diagnosis from 01/01/2016 and to the latest date available at the time of data request. This will enable the analysis of HNC inequalities both pre- and during the pandemic.

Newcastle University is the sponsor and will be the sole Controller for the released dataset.

The Oracle Cancer Trust and North West Cancer Research are joint research funders. Neither the Oracle Cancer Trust and North West Cancer Research will carry out any data controllership or processing activities. Once the data has been processed, anonymised, aggregated findings will be shared in the public domain via a range of dissemination means e.g. publications and conference presentations.

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 carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data 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, services users, and the public, and aims to produce generalisable and publicly available information to inform future decisions over the priorities for reducing HNC inequalities in England.

The funding comes from a joint call on cancer inequalities from Oracle Cancer Trust and North West Cancer Research.

Funding to continue the work described will be sought on an ongoing basis if required.

The funders will have no ability to suppress or otherwise limit the publication of findings.

An individual from the University of Naples, Italy and an individual from the London School of Hygiene and Topical Medicine, UK will act in an advisory capacity for the project but neither of these individuals nor anyone from their organisations will have access to the Data.

Data will be accessed by members of the research project team based at Newcastle University. It may also be accessed by undergraduate, Masters or PhD students affiliated with Newcastle University. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to Newcastle University’s policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of Newcastle University. Newcastle University would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this DSA.

A convenor of CHANGES HNC PPI group has helped refine the purpose of the research. They strongly support the use of the Data for the purposes described above. The PPI lead and the CHANGES group will provide PPI input throughout the project.

Expected Benefits:

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

The use of the Data could:
• Generate contemporary understanding of inequalities in HNC nationally and regionally (previous analyses use data from up to 2006 in England and 2008 for Scotland only).
• Help the system better understand the health and care needs of HNC populations and to not exacerbate any present inequalities further. In particular this research could illuminate the mechanisms which link deprivation, region, and HNC outcomes.
• Advance the understanding of regional and national trends in HNC care needs.
• Explore what happened during the peri-pandemic period to HNC incidence and survival. This would provide the first robust assessment of the impact of the COVID-19 pandemic on inequalities across the HNC pathway which in turn would highlight any learning points for future pandemic planning and the implication of such an event for HNC care.
• Increase awareness of inequalities in the HNC pathways among health professionals involved in HNC diagnosis and treatment.
• Create an easily accessible and free resource which others (healthcare professionals, service providers, policy-makers, patients, general population) can access to obtain information on inequalities in HNC, regionally and nationally.
• Provide an exemplar of how to maximise the value and information that can be gained from NHS datasets, by using rigorous methods of analysis and imaginative ways to summarise, display and communicate results.
• Build capacity: project staff will gain knowledge around health inequalities and develop experience in using “Big Data” and advanced SEM-based approaches for analysis.
• Generate a comprehensive database of patient-level data which can be used to answer further research questions relating to HNC.
• Lead to identification or improvement of healthcare system design for patients in deprived regions with HNC.
• Inform planning health services and programmes (e.g. those improving equity of access, experience, and outcomes for HNC patients). In particular, highlighting points where effective interventions could have the most impact. This could help benefit the provision of health care for the HNC patient population.
• Inform decisions on effective allocation of funding for HNC according to health needs e.g. by areas of higher HNC incidence and/or where deprivation is most pronounced; project findings will provide a baseline against which any such changes can be evaluated.
• Provide a mechanism for checking the quality of care - for example, by identifying regional areas of good practice to learn from, or regional areas with poorer practice which need to be addressed.
• Provide aggregated data to health professionals, service providers, and policy-makers to inform local (and national) strategies to address inequalities.
• Support post-graduate research study within the Population Health Sciences Institute at Newcastle University aligned to the inequalities theme and NIHR Patient Safety Research Collaboration seeking to research inequalities in areas of disadvantage.
• Stimulate follow-on research around the development and testing of strategies, policies, and interventions to ameliorate HNC inequalities.
• Long-term help contribute to cost savings for the NHS relating to early cancer detection, reduced need for challenging treatments and/or extensive follow up care and support from a range of other clinical specialities e.g. speech and language therapy (HNC can cause changes to everyday functioning of speech, voice, and swallowing ability) and mental health services (HNC cancer patients have higher rates of pre-existing mental health conditions such as anxiety and depression; experience trauma, have restricted access to good support, higher risk of suicide, and less successful application of cognitive and behavioural therapy relative to survivors in other cancers).
• Potential reduction in the number of HNC survivors unable to work for long periods and/or permanently if cancers can be caught and treated earlier.

Dissemination of the findings has no direct benefit to those patients already diagnosed with HNC. Benefits will instead relate to future HNC diagnoses. This is because long term initiatives as a result of this work could: reduce inequalities in HNC incidence and survival by understanding the underlying causes of these differentials. This may involve one or more of; increasing HNC diagnoses at an earlier stage, increase the proportion of patients receiving optimal HNC directed cancer treatment, increasing HNC symptom awareness. Given that HNC is the 8th most common cancer in the UK (4th most common in males) and annually there are around 4,100 deaths per annum in the UK, the magnitude of the benefits listed above for this patient population is large. These changes will thus be welcomed by all HNC patients (not just those residing in areas of disadvantage) as opportunities to reduce the trauma associated with diagnosis, treatment, and living with and beyond HNC.

Depending on where HNC inequalities are found to be most pronounced, specific benefits to certain patient groups (e.g., those resident in areas of higher deprivation, those with comorbid conditions) are likely to be observed if targeted provision is deemed an appropriate research outcome. Such benefits are feasible as this project’s focus will serve to promote research into underrepresented, vulnerable, and disadvantaged HNC patient populations (which can otherwise be missed using clinical trial methodologies).

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 practitioner charged with making policy decisions in relation to HNC patients.

Recipients of the outputs will need to take action based on the information provided to them in order to realise the potential improvement opportunities. To assist with this process, HNC stakeholders (e.g. health professionals, Cancer Alliances, Integrated Care Boards, charity, government and PPI representative, researchers) will be invited to two consecutive online workshops reporting the study’s findings and more importantly to help discuss/prepare the next step recommendations (including for policy, practice, and intervention development and research).

Listed benefits (see earlier) will be achieved through collaboration of the research team with health professionals, service providers, and policy makers. The funder will not directly be involved with the research but will assist with publicising the outputs of the work. Whilst benefits of this research are not directly measurable, engagement, interest in the findings, and education as a result of this work will raise awareness of HNC disparities.

Finally, all the project outputs (See Section ‘Objective for Processing’) achieve the stated purposes and thus justify the benefits of processing.

Several actions will be taken to optimise any potential public benefits of this data’s use. Efforts will be made to advertise the findings to a wider audience. This will include engaging with the project’s website and Twitter feed, as well as utilising Newcastle University’s media team to publicise the study’s findings.

The funding charities (Oracle Cancer Trust and North West Cancer Research) will also be updated with the research findings. Links that Consultant James O’Hara and Professor Linda Sharp have with the HNC community will also be utilised to assist with further publicity and dissemination of findings from this research study.

Outputs:

’The expected outputs of the processing will be:
• Submission to peer reviewed journals specialising in head and neck cancer and/or epidemiology. Papers will be on (i) Incidence patterns; (ii) Survival patterns, and (iii) Mediation analyses. The Data Controller anticipates publishing the incidence paper (i) within 8 months of data receipt, whilst (ii) and (iii) will be completed within 6 months of the end of the project registration period.
• Presentations of the findings to Newcastle University colleagues at internal University events, as the opportunity arises.
• Presentations at appropriate conferences such as the British Association of Head and Neck Oncologists over the 12-24 month period following project registration end.
• Provide an update to deprivation and region-specific life tables for England and Wales at an earlier time period than is currently available. The Data Controller anticipates this will be available within 6 months of the start of the project period.
• Create a database of incidence and survival estimates which will be freely available online, alongside summary tables, funnel plots, interactive graphics, and maps to illustrate variability between different population groups across regions and how these have changed over time. These outputs will be timed with the end of the project registration period.
• Convene a group of HNC stakeholders (e.g. health professionals; Cancer Alliance; Charity; Government; and PPI representatives; researchers) in two consecutive online workshops to develop recommendations for next steps for research, policy, and practice to be disseminated e.g. via publications. These outputs are planned within the project registration period.
• Develop recommendations for next steps in terms of practice, policy, intervention development and research for dissemination e.g. via publications after the end of the project registration period.

The outputs listed above will only contain aggregated information with small numbers supressed as appropriate in line with the relevant disclosure rules for the datasets from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:
PPI:
• PPI involvement provided by a HNC survivor and CHANGES (HNC PPI group established in a deprived area of North East England) to have a focus on dissemination (to whom and how, as well as assisting with developing key messages) and identifying priorities for follow-on research.
• Lay summaries of findings (support provided by the HNC survivor and CHANGES) circulated via publications, the project website, and charities.
• Other routes of lay engagement as suggested by the PPI group.

Communications will be timed to correspond with their relevant output:
• Briefing document provided to the Cancer Alliances.
• Project website communicating progress and findings, including lay summaries.
• Social media (Twitter account) to communicate progress and findings e.g. publicising journal articles and conference presentations.
• Infographics (including interactive graphics and maps) on project website.
• High impact journals (e.g. Cancer, Oral Oncology) with open access (taking advantage of Newcastle University’s arrangements with publishers)
• Submit abstracts to conferences e.g. British Association of Head and Neck Oncologists, Society for Social Medicine
• Webinars open to healthcare professionals (including medical, nursing and allied health educators), GPs, and the Cancer Alliances to discuss findings and promote professional HNC CPD.
• Charities e.g. dissemination of lay summaries and published papers (if permissible).

Dissemination of outputs will follow the following steps: 1) Short term: HNC incidence; 2) medium term: HNC survival; and 3) long term: HNC mediation modelling.

Processing:

No data will flow into NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide access to the relevant records from Hospital Episode Statistics (Admitted Patient Care and Outpatients) and the pseudonymised NDRS Cancer consolidated datasets - Packages 10, 12 and 14) to Newcastle University.

• Contain special categories of personal data but with no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

NHS England will grant access to the Data via the Secure Data Environment (SDE). The SDE is a secure data and research analysis platform. It allows approved researchers with approved projects access to pseudonymised data and industry leading analytics tools.

The Data will not be transferred to any other location.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this DSA. The access and use of the system is fully auditable and all users must comply with the use of the Data as specified in this DSA.

Users will be authorised to access the data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.


Remote processing will be from secure locations within England.

The Data will not leave England at any time.

Access will be restricted to employees and students of Newcastle University who have authorisation from the Principal Investigators. All employees and students accessing the data will comply with the requirements of the Data Protection Act 2018.

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

The data provided by NHS England derives from several datasets which have been linked by NHS England. The pseudonymised dataset will be merged with geographical codes only (for example, LSOA merged with Urban/Rural indicator and other deprivation measures). The pseudonymised dataset will not be individually linked to any other data.

There will be no requirement and no attempt to reidentify individuals when using the Data..

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.

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.

Emerging eviDence on the impact of COVID-19 on mental hEalth sErvices and health inequalities in highly dePrived communities (DEEP) — DARS-NIC-641622-S4C1Q

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2024-05-24 — 2027-05-23 2024.08 — 2024.10.

Access method: One-Off

Data-controller type: UNIVERSITY OF NEWCASTLE UPON TYNE

Sublicensing allowed: No

Datasets:

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

Objectives:

University of Newcastle Upon Tyne requires access to NHS England data for the purpose of the following research project:

Emerging eviDence on the impact of COVID-19 on mental hEalth sErvices and health inequalities in highly dePrivedcommunities (DEEP)

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

“This study aims to examine the impact of the COVID-19 pandemic and lockdown periods on patterns of engagement with mental health services for people from the most deprived communities in North East and North Cumbria, and determine whether these patterns were associated with health-related outcomes.

Evidence suggests that the impacts of the COVID-19 pandemic and periods of lockdown have increased the risk of mental health problems within England. It is estimated that the pandemic will lead to new or additional mental health support need for up to 10 million people in England (around 20% of the population). Evidence from previous studies illustrated that the impacts of the virus and the lockdown deteriorated population mental health and disproportionately worsened the mental health burden for more deprived populations. This can have a significant negative impact on the heath of individuals living within these areas, on their partners & wider families. The unequal impact of the pandemic is at risk of entrenching and exacerbating the existing structural inequalities in mental health among the most deprived communities.

However, there is an incomplete picture of the use of mental health services by more deprived populations, and the impact of the COVID-19 pandemic on their mental health service utilisation. Such information is essential to inform current policies looking at expansion of specialist mental health as part of national initiatives aimed at improving mental health services in England. The pandemic could provide an opportunity to rethink conventional approaches to mental health services planning to meet patients’ needs. Similarly, the threshold for hospital admission for mental illness varies between individuals and requires continuous adaptation over time. Therefore, learning from service utilisation changes due to the COVID-19 pandemic, and their consequences for people’s physical and mental health is vital to inform policy solutions for integrated service recovery and effectively plan services that reach those with the greatest needs.

The specific objectives of the study are:
• To investigate NHS service utilisation (such as care settings and pathways of care) where people were in contact with mental health services in the year prior to the lockdown across the deprived population and in specific groups such as the elderly or ethnic minorities.
• To quantify changes in their mental health service utilisation between multiple time periods across pre-, during- and post-lockdown including out of lockdown in England.
• To quantify the contribution of individual and general practitioner (GP) practical-level factors to variation in mental health service utilisation, measuring their impact on association between mental health service utilisation and health outcomes. The aim is to identify where mental health services are most effective for different population groups.
• To quantify patients’ health outcomes among the cohort between the multiple time periods, examining any associations between mental health service utilisation and patients’ health outcomes.

The study will explore advanced statistical methods to examine the effects of national lockdowns on mental health service use and its subsequent consequences while accounting for both observed and unobserved confounders. Various methodological approaches will be employed to assess any uncertainty surrounding the results. For example, one method the study will utilise is propensity score matching, which allows the creation of comparable control groups by matching individuals with similar social-demographic and clinical characteristics who did not experience the same exposure to services."

The following NHS England Data will be accessed:
• Hospital Episode Statistics
o Admitted Patient Care
o Accident & Emergency
o Outpatients
• Emergency Care Data Set (ECDS)
- Necessary to provide information on secondary care utilisation of individuals, including any associated treatments, in order to measure variations in health outcomes of those with higher usage of mental health services.
• Civil Registrations of Death - Secondary Care Cut - Necessary to provide an indication of instances of death in cohort members.
• 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 used 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.
• Community Services Data Set (CSDS) - Necessary to provide information on individuals 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. Pseudonymised occupation data will also be accessed from this dataset. Occupation data will be used to assess the evidence linking health outcomes to income or lifestyle, it acts as a substitute for evaluating income level or lifestyle to address potential confounding factors in regression analyses. In addition, it would be used as a categorical variable, thereby minimising the risk of identifying individuals compared to income data.
• 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 pseudonymised.

The Data will be limited to a study cohort created by the Data Services for Commissioners Regional Office (DSCRO). The study cohort will consist of individuals who are:
• Adults over the age of 18
• Have been referred or self-referred to NHS-funded secondary mental health services or Improving Access to Psychological Therapies (IAPT) services between 23/03/2019 to 22/03/2020.
• Registered at one of 20 GP practices identified within North East and North Cumbria. The 20 practices identified for the study fall within the 10% most deprived GP practices in England.
• Data requested will be limited to the periods 2019/20 – 2021/22 in order to analyse data covering pandemic and lockdown periods.

An estimated 5,390 patients will be included in this cohort.

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 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 results of this study will provide information about potential disparities for those referred to mental health services within the most deprived areas & 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.

Creation of the cohort & extraction of the data will be conducted by NHS England only, including NHS England's Data Services for Commissioners Regional Office (DSCRO). Identification of the cohort and extraction of the data will be conducted under NHS England's powers for dissemination under Section 261 of the Health and Social Care Act 2012.

The funding is provided by the National Institute for Health Research (NIHR). The funding is specifically for the study described. Funding remains in place for the duration of this study.

A Public and Patient Involvement (PPI) and Engagement group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above. The group provided guidance to the study to maximise its relevance and impact. The group consists of mental health service users and professionals. Group members consist of a diverse range of individuals of varying age, gender, and ethnicity. Members of the group were recruited from the Clinical Research Network, the Deep End network for the North East and North Cumbria and the Harrogate District Service User and Carer Involvement Group. The reference group was consulted on aspects to ensure that analyses and dissemination are relevant to the needs of stakeholders.

Group members were consulted, revealing dissatisfaction with current primary care mental health support. Clinicians expressed discomfort with available options, citing long waiting lists for Talking Therapies services (9-18 months) and concerns about the adequacy of therapies for complex patient histories. The consensus from patients, professionals, and support organisations supports the necessity of this study, with their active involvement in shaping the study design. Collaboration with two well-connected members linked to local service users' groups through the PPI group led to significant enhancements in study design, plain summaries, and components in the routine data analysis work package. The group agreed with the benefits outlined by the proposed study processing and agreed that the use of data would support this. A study summary has been shared widely through the groups connections, including the Harrogate District Service User and Carer Involvement Group.

The study will actively engage with the PPI group across the entire analysis cycle to facilitate the creation of easily comprehensible and widely accessible findings. Regular meetings are scheduled every three months to facilitate co-production, encompassing a thorough review of context/ethics, troubleshooting, interpretation of outcomes, decision-making, as well as planning and executing implementation/dissemination activities. Additionally, researchers have plans to sustain a long-term working relationship with PPI members, extending into the development of subsequent funding bids.

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.
• advance understanding of regional and national trends in health and social care needs.
• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions focused around mental health.
• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
• inform decisions on how to effectively allocate and evaluate funding according to health needs.

Benefits for those living with mental health problems:
It is likely that the pandemic will be responsible for both short and longer-term increased demand for mental health services. This study will involve acknowledging the linkages and dependencies between different levels in the NHS mental healthcare pathway. This will identify where problems might be occurring and what well-managed flow that is more likely to reduce the risk of people reaching severe or crisis mental health symptoms before they can access appropriate help, as well as reducing the number of people needing inpatient admission.

Causal inference methods will be used to investigate the impact of pathways on subsequent outcomes (such as health/wellbeing & cost). This study will also provide practice recommendations on how an appropriate service should be provided in a timely manner and what would be a minimum acceptable service for times of emergency or lockdown. Stakeholders could use the recommendations to plan prospectively to react quickly and meet the needs of patients.

Benefits for underserved communities:
This study focuses on people living in areas of high deprivation to understand their complex needs and identify barriers to provision for underserved groups. Participants are often affected by the wider determinants of health, such as ethnicity, Indices of Multiple Deprivation (IMD), unemployment, and housing. This study will explore segmented patient data in relation to social and demographic elements that can affect patient vulnerability and barriers to access. National longitudinal data (i.e. Understanding Society) will be used to map out some of the main dimensions of life events and social circumstances, such as reduction in social network or support, issues with finances or employment, likely to become more common in response to COVID-19. An image of nuanced needs and demands in different contexts combined with local knowledge will be an important part of a more meaningful and bespoke service planning ensuring that demand is met in an adequate and timely fashion in underserved communities.

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.

Stakeholders will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, 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.

Outputs:

The expected outputs of the processing will be:
• A report of findings to NIHR funders (October 2024)
• Submissions to peer reviewed journals:
o Journal paper on the impact of the pandemic on NHS primary and secondary care services (mid-2024), potential target journal: the British Medical Journal.
o Journal paper on the impact of the pandemic on health outcome (late 2024), potential target journal: Value of Health
• Presentations at appropriate conferences. Target conferences include:
o NIHR Applied Research Collaborations (ARCs) Inequalities and Prevention National Symposium
o The Royal College of GPs conference
o European Conference on Mental Health
o International Health Economics Association Conference

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:
• Journals
• Public reports
• Reports aimed at community members, practitioners and commissioners
The research outputs will be shared with communities members, practitioners and commissioners across the country. Findings and events will be shared via the NIHR Three Schools and NIHR Applied Research Collaboration (ARC) websites.

An impact strategy has been developed to influence policy and practice and has been designed to ensure robust translation and communication plans. 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; NIHR ARC Mental Health Special Interest Group (mSIG); Public Health England; NHS England, NHS Clinical Commissioners; and Local Government Association Community Wellbeing Network.

Processing:

No cohort data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). NHS England's DSCRO will create a cohort of individuals using the data minimisation parameters set out by University of Newcastle Upon Tyne, which include:

• Adults over the age of 18
• Have been referred or self-referred to NHS-funded secondary mental health services or Improving Access to Psychological Therapies (IAPT) services between 23/03/2019 to 22/03/2020.
• Registered at one of 20 GP practices identified within North East and North Cumbria. The 20 practices identified for the study fall within the 10% most deprived GP practices in England.
• Data requested will be limited to the periods 2019/20 – 2021/22 in order to analyse data covering pandemic and lockdown periods.

NHS England's DSCRO will create a cohort of individuals using Personal Demographic Service (PDS) data and, securely transfer the relevant cohort identifiers to NHS England's Data Provisioning Team for linkage to and extraction of relevant pseudonymised data from the datasets mentioned within this DSA. No PDS data will be accessible by University of Newcastle Upon Tyne. Data will be pseudonymised before being disseminated to University of Newcastle Upon Tyne. No cohort identifiers will be accessed by University of Newcastle Upon Tyne.

NHS England will provide the relevant records from the datasets to the University of Newcastle Upon Tyne. The Data will contain no direct identifying data items.

The Data will be stored on servers at University of Newcastle Upon Tyne.

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

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.

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 pseudonymised Data will be restricted to employees or agents of University of Newcastle Upon Tyne who have authorisation from the Chief Investigator.

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.

Researchers from University of Newcastle Upon Tyne will analyse the Data for the purposes described above.

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, No (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 2024.10 — 2024.10.

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)
  5. NDRS Linked HES Outpatient
  6. NDRS National Lung Cancer Audit (NLCA)
  7. NDRS Somatic Molecular Dataset

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.

Processing:

No data will flow into NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from Cancer Registration, Hospital Episode Statistics (Admitted Care - Inpatients), HES (Outpatients), Systemic Anti-Cancer Therapy Dataset (SACT), Cancer Waiting Times (Treatment Only), the Somatic and Molecular Dataset, and National Lung Cancer Audit (NLCA) to Newcastle University.

The Data will:
- contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at Newcastle University.

Newcastle University uses offsite back-up services provided by Pulsant.

The Data will be accessed on site at the premises of Newcastle University.

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

Newcastle University confirms and will provide evidence upon audit by NHS England that access via remote devices 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;
- Personnel are both prohibited and technically prevented from downloading or copying NHSE data to local devices;
- 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 agreement) 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 only. The data will not leave England at any time.

Access is restricted to employees or agents of Newcastle University who have authorisation from the Principal Investigator.

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

The Data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Researchers from the Population Health Sciences Institute, Newcastle University will analyse the Data for the purposes described above.

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 — 2024.10.

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.

Recovery, Renewal and Reset of Services to Disabled Children — DARS-NIC-594012-C9R9H

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012 - s261(5)(d)

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2024-05-07 — 2027-05-06 2024.09 — 2024.09.

Access method: One-Off

Data-controller type: CUMBRIA, NORTHUMBERLAND, TYNE AND WEAR 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)
  6. Mental Health Services Data Set (MHSDS)

Objectives:

The University of Newcastle Upon Tyne and NHS North of England Commissioning Support Unit (NECS) require access to NHS England data for the purpose of the following research project:
The Resetting Services to Disabled Children study

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

Eight percent of UK children are disabled. Many have complex physical and mental health needs that require care from paediatricians, specialist medical services, psychologists, nurses, and allied health professionals. Disabled children receive care in hospital, community health settings, school and in their homes. In response to COVID-19, disabled children who were at increased risk due to poor respiratory function were advised to shield and the duty to deliver care plans was relaxed during the initial phases of the pandemic. Most community services for children were de-prioritised as efforts centred on those most at risk from the virus. Services stopped and reorganised; some restarted via video link, others face-to-face, but practice varied and has continued to flex and change in response to policy changes. Service managers have described having to respond as ‘daily to changes in planning’. Many parents have reported children’s deteriorating mental health and their own isolation and stress. Impacts on physical health are currently unclear but tele-practice may not suit examination, diagnosis or interventions requiring touch/instrumentation. There is emerging evidence of delays to diagnosis and appropriate treatment for children, increases in abuse, and regional inequity in the health impact of coronavirus. Learning from changes and consequences for children’s physical and mental health and their families’ wellbeing was vital to inform practical policy solutions for integrated service recovery during the recent pandemic, and going forward, is vital to plan for future emergencies.

The Resetting Services to Disabled Children study was commissioned by National Institute for Health and Care Research (NIHR) Policy Research Programme (June 2021 – May 2024) to establish which reconfigurations of services, practices and strategies for disabled children arising from COVID-19 work well and should inform policy on system recovery and planning for future emergencies.

Objectives of the Resetting Services to Disabled Children study include to:

1. Identify service changes and their impacts.
2. Quantify change in disabled children’s contacts with services between five time points: Pre-lockdown (1st April 2019- 22nd March 2020); first full lockdown (Lockdown 1 23rd March 2020- 14th June 2020); post first lockdown (Social Distancing 1 15th June 2020 – 4th November 2020); second and third full lockdowns combined due to the short period between them (Lockdown 2 5 November 2020 – 11th April 2021); and post second lockdown (12th April 2021 – 30th September 2021).
3. Identify factors (child, family, intervention type, provider, organisation) that enabled sustained provision of high-quality services during the pandemic.
4. Ratify agreement across families and professionals on resetting care.
5. Identify benefits and risks of individual changes within and across services.

The study comprises six Work Packages (WP1-6) to address the five objectives (1-5) which, together, aim to establish which reconfigurations of services, practices and strategies for disabled children arising from COVID-19 work well and to inform policy on system recovery and planning for future emergencies.

NHS England Data will only be used in relation to WP2 to address Objectives 1 and 2 of the Resetting Services to Disabled Children study - Quantifying changes in disabled children’s contacts with NHS services between five time points from April 2019 to September 2021, when the English government enforced different social distancing measures, and their impacts. Analysis of the NHS England data will allow the investigation of the change in care during the COVID-19 pandemic and their impacts for children with different conditions, at different ages, and at the stage of diagnosis and management of chronic needs. The data will also allow the investigation of the effect of ethnicity and social deprivation on care and its outcomes during the pandemic. Both factors have been associated with risk of COVID. The findings will form guidance to health, social care, education and third sector services on how services should be organised and delivered to disabled infants and children.

The following NHS England Data will be accessed:
> Hospital Episode Statistics Admitted Patient Care (HES APC), HES Accident & Emergency (A&E) HES Outpatients (OP) and Emergency Care Data Set (ECDS) – necessary to investigate change in children’s contacts with medical services for both planned and unplanned care, and to investigate the impact of changes in services on children’s morbidity. Data on all emergency care assessments and treatments are required to investigate the impact of changes to NHS and care on children's health, as an indicator of severe unplanned care need.
> Mental Health data - necessary to investigate the impact of changes in children's health care during the COVID-19 pandemic on their health outcomes. Mental health care data is requested for inpatient care of children with all diagnoses to investigate if the types and numbers of in-patient mental health episodes of care varied in the year before the COVID pandemic to during the pandemic according to children's health condition, age, ethnicity, sex and deprivation level.
> Civil Registration Mortality – necessary to investigate the impact of changes in services on children’s mortality.

The level of the Data will be:
> Identifiable – NHS number is required to enable the DSCRO to pseudonymise the data into the correct pseudonymisation key. The pseudonymisation key allows the linkage to the NHS England Datasets and is also used on the datasets being received directly from the Trust. The key is bespoke to this project.

Some sensitive fields have been requested. Data on ethnicity is required because in the UK general population, people from BAME (Black, Asian and minority ethnic) backgrounds were at greater risk of COVID-19. It is unclear if this risk extends to disabled children; this research will estimate risk for disabled children from different ethnic groups. Full date of death is required to enable the comparison of outcomes at different time periods before, during and after the COVID-19 pandemic, with time periods occurring at different points within a month. Month and year of death will not allow accurate analysis.

The Data will be minimised as follows:
> Limited to a study cohort identified by NECS – cohort is comprised of disabled children aged 0-19 years who have a diagnosis that usually requires multi-disciplinary care: cerebral palsy, attention deficit hyperactivity disorder, autism spectrum disorder, acquired brain injury, and syndromes associated with intellectual disability (Down Syndrome, Di George, neurofibromatosis, foetal alcohol, tuberous sclerosis).
> Limited to data between April 2019 and September 2021; The data period requested is minimised to one year prior to the COVID-19 pandemic and the period during the pandemic.
> Limited to the following geographic areas: cohort minimised to include five NHS Foundation Trust boundaries that differ in region, demography of the population served and organisation of services.

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust as the research sponsor, and the University of Newcastle Upon Tyne as the main collaborator, are joint controllers as the organisations responsible for ensuring that the Data will only be processed for the purpose described above.

The Department of Health and Social Care (DHSC) has commissioned the University of Newcastle Upon Tyne to undertake the work. DHSC does not specify what data are required to deliver the work nor how the data shall be processed to achieve that purpose. Such decisions are taken by the University of Newcastle Upon Tyne.

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 carried out in the public interest or in the exercise of official authority vested in the controller;

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. Scientific research will be undertaken to investigate which contacts with NHS services changed during the COVID-19 pandemic and the association between change in care and health outcomes. Services to disabled children continue to be challenged by workforce reductions and increasing waiting lists. There is still a need to understand the impact of changes in healthcare to disabled children during COVID-19 to inform service redesign and remodelling and future emergencies. This research is therefore in the public interest as, to the University of Newcastle Upon Tyne’s knowledge, no other research has conducted a similar analysis.

The funding is provided by NIHR Central Commissioning Facility (CCF). The funding is specifically for the study described. Funding is in place until the end of May 2024.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

NECS is a processor acting under the instructions of the University of Newcastle Upon Tyne. NECS’s role is limited to linking data supplied by NHS England and local services. NECS will apply a second pseudonymisation to the data prior to their provision to the University of Newcastle Upon Tyne. NECS are acting as processors to maintain confidentiality.

Microsoft Limited provides IT hosting services to NECS and will store the Data as contracted by NECS.

Two Public and Patient Involvement and Engagement advisory groups (4-6 parent-carers; 4-6 disabled young people) have been set up. These groups will advise on study conduct and dissemination. The PPI Lead will be the primary contact for the Parent Advisory Group. The research team have consulted with chairs of local Parent Carer Networks in the National Network of Parent Carer Forums, a voluntary organisation of parent carer who have come together to support the development of statutory services for children with special educational needs and disabilities. The parent carers and support organisations have strongly supported the need for the research and have been involved in the design of the study. In total, up 80 parent-carers across eight local authorities considered the study design. These parent-carers are of both sexes, are diverse in age (30’s – 60’s), are both working and not working, and are from ethnic backgrounds, reflecting the populations they serve. Some of the group have additional needs/disabilities. The children of the parent carers consulted range in age from preschool to early twenties and have a wide range of needs. They are educated in a range of settings: mainstream, day and residential special schools, and at home. The use of routine data without consent was judged by the parent-carers consulted to be appropriate because it would give the study access to data without more intrusively involving families, and it was felt that consent was gained at source (with the opt out of NHS England data).

The Co-Investigator and member of the leadership team is the Director of the Council for Disabled Children, the umbrella body for the disabled children's sector which has a membership of over 300 voluntary and community organisations and an active network of practitioners that spans education, health and social care. They have consulted widely with parents and professionals and voluntary organisations supporting them about the research aims and objectives. Throughout the pandemic, the Council for Disabled Children’s Friendship, Learning, Achieve, Reach and Empower (FLARE) group of disabled young people have continued to meet and provide advice to government on their experience of the pandemic. They have been vocal about the way in which young people’s needs have been marginalised and have talked about social isolation and loss of friendships, falling behind at school and exam stress fears. Some are worried about adapting back to face-to-face learning and the consequences of school refusal. About half of the FLARE members have lost or seen changes to their social care that has impacted their emotional wellbeing and/or mental health. They are clear that research which identifies how best services for children and young people can be protected would be welcome.

Expected Benefits:

The study is expected to:
1. Create an agreed set of recommendations and strategies to ensure renewed health and social care services for disabled children are equitable and effective in reducing children’s mortality and increasing health and wellbeing of the children and their families.
2. Identify the factors that enable or threaten renewed and reset services delivery.
3. Produce an agreed minimum service for rapid deployment in future emergencies and risks associated with a lack of minimum service provision.

The study is expected to lead to the creation of policy guidance that can be adopted by the United Kingdom and other countries to address what provision should be given to disabled children and families during national emergencies. This will include practice recommendations on how services should be provided to meet the needs of disabled children and their families now as we reset the NHS and social care, and what would be a minimum acceptable service for times of emergency and lockdown.

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 regional and national trends in health and social care needs.
> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
> inform decisions on how to effectively allocate and evaluate funding according to health needs.
> provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.
> support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

Across the project, the University of Newcastle Upon Tyne will disseminate information to key stakeholder groups who use, provide and commission services to inform practical policy solutions to service resetting. This includes parent carers; disabled young people; allied health practitioners; community paediatricians; education staff; neurodisability paediatricians; psychologists; SEND leads from education; social workers; commissioners of services; national policy leads. The key policy makers at a local level are DMOs, DCOs, SEND leads, commissioners and Parent Carer Forum chairs. The University of Newcastle Upon Tyne will meet with each of these stakeholder groups in regular national meetings to ensure timely impact of the findings.

The findings and guidance produced are expected to support those responsible for setting policy; enabling them to ensure that in any future emergency high quality health, education and care services for disabled children would be maintained. The guidance should enable planning that will reduce child physical and mental health morbidity and mortality that has been associated with the COVID-19 emergency and inequalities in impact of COVID-19. Countries, regions and localities will use the guidance to plan prospectively, enabling them to react quickly in emergencies with short or longer preparation periods. This agreed minimal service is expected to avoid the deterioration in health during an emergency. For professionals, the guidance should create clarity about what their role should be in supporting children and families, reducing uncertainty and professionals stopping provision. For example, it should allow NHS managers and commissioners, governors and head teachers at schools, and social care directors to create plans that are relevant to their local population (such as accounting for deprivation or families for whom English is a second language), ensuring inequality in provision is reduced through local solutions. Given service managers’ concerns about continual changes to policy and practice, guidance is also expected to reduce workforce stress by providing a clear blueprint for managing future emergencies and enable disaster planning.

University of Newcastle Upon Tyne will be engaging with the National Network of Parent Carer Forums across England, who will use the findings in their work with local authorities and health services to plan local service provision for disabled children.

Outputs:

The expected outputs of the processing will be:
> Regular briefing papers reporting findings will be sent to local policy makers (local authority Special Educational Needs and Disabilities (SEND) Leads, Designated Medical Officers (DMOs), Designated Clinical Officers (DCOs), and commissioners) and national policy leads (NHS England and NHS Improvement Learning Disability and Complex Needs leads; Association of Directors of Children’s Services).
> Submissions to peer reviewed journals; two submissions expected. Target journals are the British Medical Journal (BMJ) and the Developmental Medicine and Child Neurology journal.
> Plain language summaries to be shared with families, the Council for Disabled Children other support organisations, such as Contact, Cerebra, Scope, National Autistic Society, Autistica, and Mencap, via social media such as X and Facebook.
> Presentations at British Academy of Childhood Disability and the European Academy of Childhood Disability annual meetings, which focus on neurological disability conditions.

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:
> Journals
> Information about the study, its aims, design and status will be made available on the study website
> Meetings (online) and webinars will be held with local policy makers (local authority SEND Leads, DMOs, DCOs, and commissioners) and national policy leads (NHS England and NHS Improvement (NHSE/I) Learning Disability and Complex Needs leads; Association of Directors of Children’s Services).
> Social media
> Conference presentations

Publication in peer reviewed journals is expected to be complete by 2025.

Processing:

The North of England Data Services for Commissioners Regional Offices (DSCRO) will 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.

Prior to this a pseudonymisation process will be applied:

a) North of England DSCRO will generate an external pseudo key and share this with the five NHS Foundation Trusts who will be supplying data to North of England Commissioning Support Unit (NECS). NECS will not receive a copy of the external key.
b) North of England DSCRO will generate a mapping table that can be used for re-identification, using the external pseudo key
c) The organisations supplying the patient lists, will pseudonymise the list using a pseudonymisation@source tool and supply the patient list and the patient's month and year of birth to NECS
d) NECS will collate the pseudonymised patient lists
e) NECS will share the pseudonymised patient list and the patient's month and year of birth with North of England DSCRO
f) North of England DSCRO will use the mapping table to re-identify the NHS Numbers on the patient list
g) North of England DSCRO will validate the NHS Number by using the patient's month and year of birth against the Patient Demographic Service (PDS) data the DSCRO holds and retrieve the patient's full date of birth
h) North of England DSCRO will share the clear patient list (NHS number) and the patient's date of birth with NHS England

NHS England will provide the relevant records from the HES, ECDS, deaths and mental health datasets to North of England DSCRO. The Data will
> contain directly identifying data items including NHS Number which are required to enable the DSCRO to pseudonymise the data into the correct pseudonymisation key.

A further pseudonymisation process will then be applied:

a) North of England DSCRO will pseudonymise the data using the external pseudo key (generated by the pseudonymisation@source tool)
b) North of England DSCRO will send the pseudonymised data extracts to NECS
c) NECS will apply a second pseudonym to the pseudonymised data, using an internal pseudonym, which no other organisations hold
d) NECS will transfer the twice pseudonymised data to the University of Newcastle Upon Tyne

The Data will not be transferred to any other location.

The Data will be stored on servers at the University of Newcastle Upon Tyne and NECS.

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

The Data will also 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).

The Data will not leave England at any time.

Access is restricted to employees or agents of the University of Newcastle Upon Tyne and North of England CSU. All such individuals are substantive employees of the University of Newcastle Upon Tyne or North of England CSU.

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

Death data will be linked to the other NHS England datasets to investigate if disabled children were more likely to die during the COVID-19 pandemic, and if mortality was associated with child (age, diagnosis, sex, ethnicity, IMD) and care factors (type of procedure, speciality, frequency of hospital inpatient, outpatient and A&E care).

The Data will be linked at person record level with data obtained from local services on children’s contacts with community medical and non-medical NHS practitioners.

For each child in the cohort, local services will provide the following data for each contact between 1 April 2019 and 30 September 2021:
•date of contact
•purpose of contact: diagnostic assessment / review or management or treatment
•method of contact: face-to-face / phone / video conferencing
•contact with: professional group or specified team if multidisciplinary team
•service: e.g. autism diagnostic team / complex needs / child protection or safeguarding etc
•setting in which contact took place: school/education, hospital, community clinic, home, other
•attendance of child at contact: attended / did not attend

Children will be identified by their pseudonymised NHS number. Data will be sourced from electronic patient records held by each participating site.

Together, the data from NHS England and data provided by local services is expected to show disabled children’s contacts with NHS services provided by multidisciplinary teams across settings before and during the pandemic.

The Data will not be linked with any other data, other than what has already been described above.

The identifying details will be stored in a separate database at the North of England DSCRO to the linked dataset at the University of Newcastle Upon Tyne used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers at the University of Newcastle Upon Tyne will not receive data on which NHS trusts treated the children, minimising risk of making identification. Diagnosis words and operation words (with pseudo child ID) will be copied into an Excel file. Clinicians in the research team will check the file and replace any diagnosis or operation word with a higher order word if this information could identify a child (e.g. Sturge Weber syndrome will be recoded as genetic disorder; Deep Brain Stimulation will be recoded as neurosurgery). Diagnoses and operations in the linked data file will be recoded using the clinicians’ higher order codes. North of England CSU will reveal the area supplying data once the recoding has occurred and children cannot be identified.

Researchers from the University of Newcastle Upon Tyne and NECS will process the Data for the purposes described above.

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, Yes (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 2024.06 — 2024.09.

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.

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. )

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, Yes (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, Yes

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
  7. Cancer Registration Data
  8. Civil Registrations of Death

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 17 — 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.