NHS Digital Data Release Register - reformatted

University Of Bristol projects

2084 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 University Of Bristol was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. University Of Bristol 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.

Older men's mental health and emotional wellbeing: Exploring factors associated with the use of community support groups using a UK-based population survey. — DARS-NIC-604129-X4D1K

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 - 'Other dissemination of information'

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2022-02-25 — 2025-02-24 breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Adult Psychiatric Morbidity Survey
  2. Adult Psychiatric Morbidity Survey (APMS)

Objectives:

The University of Bristol requires the Adult Psychiatric Morbidity Survey (APMS) 2014 data to investigate the use of community support group services by older men living in the UK.

Mental health in older people is a social care area that requires more attention as there is an existing long-held assumption that mental ill-health is an inevitable consequence of ‘old age’. The APMS (2014) found that prevalence rates of common mental disorders (CMDs) (comprising of depression and different anxiety disorders) in those aged 75+ was half the rate of that of working age adults. Yet given the increasing social isolation and poorer physical health that ageing may bring this seems surprising. One British study has shown that only a quarter of community-based older people with depression consult their GP and only a sixth receive treatment. Another study further noted that older people with CMDs had the lowest rates of psychological therapy and unmet treatment requests. This could suggest that older people may find it difficult to ask for what they need or may not even be aware of what mental health support is available to them.

In addition, older men with common mental disorders (such as anxiety and depression) are less likely than women to be using treatment. This is in part due to the longstanding stigma or reluctance to talk about mental health or to seek mental health help.

To explore older men’s psychiatric distress, help seeking and use of community services, the University of Bristol requires the APMS 2014 to examine the question: Under what circumstances do older men use community support groups for mental health difficulties? The aim is to investigate associations between different social and demographic factors and older men’s use of support group services.

The APMS is a representative sample of the whole population and is the primary source of information on treated and untreated psychiatric problems and their associations, as well as the level and nature of treatment and support service use, among adults in England. The research project at the University of Bristol, requiring access to APMS data, is particularly interested in the use of community support services by older men who may or may not have been diagnosed with a common mental health problem.

Defined in the APMS, “CMDs, also known as neurotic disorders, cause marked emotional stress and interfere with daily function, although they do not usually affect insight and cognition”. CMDs cover different types of depression and anxiety, for example, low mood and loss of interest and enjoyment in things, generalised anxiety disorder, panic disorder, phobias and obsessive-compulsive disorder. The survey also included information on the extent of use of health care services for a mental health reason (GP, inpatient and outpatient health care) as well as day and community service use.

In addition, the APMS includes responses from older adults. Importantly, the two most recent APMS’ (2007 and 2014) had no upper age limit for participation. Using the APMS data, the University of Bristol will assess the social contexts that are significantly associated with older men’s use of community support group services. If the numbers of older men in the 2014 dataset are low, then the dataset will be combined with the 2007 dataset which this project group already has access to.

Participants have freely participated in the APMS and were aware that their data would be used for research purposes.

This research will be undertaken as part of an Academic National Institute for Health Research (NIHR) School for Social Care (SSCR) early career, post-doctoral social care fellowship. Older men’s use of community support groups will be focused on and considered in relation to other forms of formal and informal support that older men might access for help with mental health difficulties. This secondary analysis is one phase of a mixed-methods study that will assess trends and patterns of older men’s use of community services for mental health difficulties. The second phase of the study will be a qualitative, cross-sectional element that uses in-depth, semi-structured interviews with older men. Data from the APMS will not be linked in any way to the data collected in the qualitative phase of the study.

The data subjects for this study are UK (male residents) residents aged over 55 years living in private households who have completed the APMS. The level of data required is pseudonymised and there will be no further data linkage and no attempt to identify individuals. When the UK Data Service (UKDS) supply the dataset, they provide the whole dataset as there is no facility to select individual variables. The UKDS holds the data on behalf of NHS Digital and, once a Data Sharing Agreement is active with NHS Digital, access to the data will be provided by the UKDS. No data will be shared with third parties. The data is requested for 3 years to allow time for submission to academic journals and revision of data at the request of peer reviewers.

The University of Bristol is the sole Data Controller will also process the data.

NIHR SSCR are funding the early career, post-doctoral fellowship for which this project is being conducted. The University of Bristol have provided NHS Digital with evidence of this funding award. NIHR will only get notified of a publication output and do not request or require any data before that. NIHR does not control the scope or conduct of the research. They are therefore not listed as a data controller or data processor in this Agreement.

The data will be processed in line with GDPR Article 6(1)(e) “for the performance of a task carried out in the public interest” and GDPR Article 9(2)(j) “Processing is necessary for archiving purposes in the public interest, or scientific and historical research purposes or statistical purposes in accordance with Article 89 (1)”.

Article 6(1)(e) can be relied upon because the University of Bristol is a public authority as described under Schedule 1 of the Freedom of Information Act 2000. University of Bristol is also founded and regulated by its Charter of Incorporation which states that “the University shall have all the powers of a natural person to do anything within the law which promotes or helps to promote the Objects including, but not limited to, power…to promote or carry out research and disseminate knowledge”.

Article 9(2)(j) can be relied upon as research into the mental health and emotional wellbeing of older men is in the public interest. Mental health in older people is a neglected area of research as there is an assumption that mental ill-health is an inevitable consequence of ‘old age’.

Expected Benefits:

The outputs hope to identify socio-demographics and social contexts (including if they have clinical diagnosis of CMD) which are associated with older men being likely to attend a community support group service. The data may be able to support health and social care providers and the voluntary, community and social enterprise (VCSE) sector working with people, specifically older men, experiencing mental health difficulties.

1) Findings from this project aim to highlight the social demographics and contexts that might influence an older man’s use of community support services. The findings could be used by support services to target support interventions and community groups at specific (social) groups of older men.
2) Outcomes of this project hope to demonstrate the need for support groups targeted at specific groups or men, or men who have experienced certain social contexts and situations.
3) The associations found between social factors and older men’s community support group use may identify areas where new research focusing specifically on men’s or older people’s mental health should be explored further.
4) Using the APMS data as part of a post-doctoral fellowship plans to highlight the benefits of using large datasets in adult social care research. Specifically, this research wishes to demonstrate ways in which APMS can be used within social care and indicate its uses to other social care researchers.

In a recent NIHR SSCR Review, it was indicated that older people are a group potentially facing more disadvantage and in need of more research about their use of social care. Furthermore, older people’s mental health is a social care area that deserves more focus. This project hopes to address this gap in research by focusing specifically on older men’s mental health, a subgroup of the population that might have distinct gendered experiences, needs and/or disadvantages. The Community Mental Health Framework for Adults and Older Adults (2019) (https://www.england.nhs.uk/publication/the-community-mental-health-framework-for-adults-and-older-adults/), set out as part of the NHS Long Term Plan, points to the need for effective links with community assets to support and enable people to become more embedded in their community and to use these assets, such as specific support groups (e.g. older adult groups, depression groups), to support their mental health. Specifically, this Framework locates community mental health services in the centre of the community, allowing all other services in the mental health care system to function more effectively (p.4). This project aims to advance this priority in highlighting how community support groups can support older men to manage and maintain good mental health.

Outputs:

The research hopes to provide outputs to support secondary community support group services and to older men’s mental health awareness, and guidance for working with older men experiencing distress. The outputs may provide support for both community mental health and adult social care professionals as well as people working in the voluntary, community and social enterprise (VCSE) sector in the context of mental health distress to facilitate support service use.

The output reports will only include figures based on aggregated data. In line with the minimum requirements of the NIHR SSCR contract, an end-of-project report will be produced comprising:
- A short academic and administrative report.
- The pre-submission manuscript form of a peer reviewed paper that communicates the main findings of the project.
- A brief, accessible ‘findings’ document indicating key messages from the project to be placed on the NIHR SSCR website. The University of Bristol will ensure that this document is aimed at a variety of audiences, especially those who can help to improve practice.

A research paper will be produced and submitted to an academic peer-reviewed journal, specialising in health and social care and community services, for example the journal, Ageing & Mental Health. The aim of this paper will be to highlight the value of using large scale datasets for secondary analysis in social research and specifically the relevance of the APMS to UK adult social care practice. As Hussien’s (2011) SSCR methods review highlights, using existing large datasets relating to the social care sector can offer a great deal of potential value to users, practitioners, commissioners, providers and policy makers.

Results will also be broadcast through Twitter (https://twitter.com/ayvickery). If outputs are of public health interest, information hopes to also be made available for local community mental health teams to advise regarding the importance of community support groups for older men experiencing mental health difficulties.

Outputs to be included in the peer-review journal are expected to be submitted by April 2023. Findings will be presented at the NIHR SSCR conference, which will likely be April 2023.

Any paper or poster submitted for publication or review will involve acknowledgement of and review by the original authors of APMS 2014. Where possible, research outputs hope to be published to open access journals, for example, Health & Social Care in the Community and Ageing & Mental Health. The University of Bristol has an open access team to allow open access for a publication to, where possible, increase dissemination of research outputs.

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 i.e. employees, agents and contractors of the Data Recipient who may have access to that data).

In order to protect patient confidentiality in publications resulting from analysis of APMS data users must:
- guarantee that any outputs made available to anyone other than those with whom this agreement is made, will meet required standards, including the guarantee, methods and standards contained in the Code of Practice for Official Statistics and the ONS Statistical Disclosure Control for tables produced from surveys;
- apply methods and standards specified in the Microdata Handling and Security Guide to Good Practice for disclosure control for statistical outputs.

The request is for the APMS 2014 dataset. The APMS is carried out by NatCen, in collaboration with the University of Leicester, on behalf of NHS Digital. Once this agreement is active the actual flow of data will be from the UK Data Service (UKDS) (www.ukdataservice.ac.uk) who are the data processors on behalf of NHS Digital. UKDS will grant system access to pseudonymised APMS 2014 data to the research team at the University of Bristol. There will be no subsequent flows of data and there will be no to attempt to re-identify individuals or link the dataset to any other healthcare data. It is not possible to obtain individual variables from this dataset.

The University of Bristol will be able to download the dataset from UKDS for the period specific within the data sharing agreement (DSA). The University of Bristol must securely destroy all local copies of the dataset upon expiration of the DSA and notify the Data Access Request Service (DARS) in line with standard procedures.

Data will be stored and upheld in line with the University of Bristol’s Data Security and Protection Policy. It will be marked as highly confidential and will only be accessed by the principal research team through the University of Bristol Safe Haven source. The Safe Haven source is encrypted at rest on the server, accessed only by a controlled username, has access logs kept for audit reports and is not backed up, to comply with data destruction notices. The principal research team consists of an academic NIHR SSCR Research Fellow, a senior lecturer and an associate professor from the School of Policy Studies at the University of Bristol. The NIHR SSCR Research Fellow is substantively employed by the University of Bristol as a Senior Research Associate. They are identified as an NIHR SSCR Research Fellow as this research project comprises part of a post-doctoral fellowship which the NIHR SSCR is funding. All members of the principal research team are therefore substantive employees of the University of Bristol. All members of the research team have undergone data protection training with the University of Bristol.

Women and respondents under 55 years of age will be excluded from the sample before analyses take place. There are two potential variables in APMS 2014 that can be used to measure support service use in the proposed analysis, and these could be used as the dependent variable (DV) in chi-square tests and the binary logistic regression model. A chi-square test is used to explore the relationship between two categorical variables e.g. is there an association between a man's marital status and their attendance at a support service. Binary logistic regression is used to determine the relationship between features and the probability of a particular outcome, e.g. what factors predict the likelihood that respondents would report that they had used a community support service?

Survey participants were asked to report use of community and day-care services in the past year. Community care services included use of the following in the past year: a psychiatrist, psychologist, community psychiatric nurse, community learning difficulty nurse, other nursing services, social worker, self-help/support group, home help/homecare worker or outreach worker. Day care service use included use of a community mental health centre, day activity centre, sheltered workshop and other nursing services in the past year. ‘Self-help/support group’ and ‘Used a day activity centre’ within the last year are two potential dependent variables to be used in the analysis.

Descriptive statistics and chi-square tests will initially be carried to investigate associations between socio-demographics (e.g. ethnicity, sexuality, socio-economic status), other contextual factors and community support use. Descriptive statistics are used to describe the characteristics of the sample and to check the variables will be appropriate for the chosen statistical techniques that will be used. Most current research in the social care field has applied logistic regression models in analysis of large datasets, in particular to rank the relative importance of independents on predicting the dependent variable. The University of Bristol will use binary logistic regression to examine what social factors (independents) predict older men’s community service use in the past year. The University of Bristol are interested in exploring factors that appear to influence community support service use by older men with and without a common mental disorder (CMD) present.

The selection of predictor (independent) variables will be informed by previous research and what is known about older men’s service use and mental health experiences. Examples of variables from APMS 2014 that could be explored in models as potential predictors are: socio-economic status; age; sexual orientation; ethnicity; religion; marital status; physical health conditions; previous mental health service use; alcohol or drug dependence; financial and housing circumstances; social functioning; stressful life events experienced; social support and social capital and participation. Only variables that show an association with support group service use will be used in the binary logistic regression analysis.

MR593 - Mortality and Cancer in Christs Hospital School Cohort — DARS-NIC-147837-RJMRN

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: Yes, No (Academic)

Sensitive: Sensitive

When:DSA runs 2019-05-01 — 2020-04-30 breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

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 were supplied to the University of Bristol by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research project referred to as ’Christ’s Hospital School (CHS) study'.

This data was linked to growth records from school records, subjects’ self-completed questionnaires and blood samples, all held by the University of Bristol.

The following provides background information on the purpose of the original study:

The CHS study is a retrospective cohort study that comprises former male students of Christ’s Hospital (CH) born between 1927 and 1956. During this period, students had regular measures of height and weight conducted by the School Medical Officer. Growth record cards with height and weight measures were found in the School archive and was the basis of testing the developmental origins hypothesis that growth patterns around puberty and young adulthood may have a long term effect on chronic diseases such as cancer and heart disease.

With the help of the School alumni office, former pupils for whom there was contact information were asked to complete a postal questionnaire to obtain data on life styles and chronic diseases and if willing, attend their local general practice to measure weight, blood pressure and have a blood sample taken.

The data collected for the CHS study enabled the study to look at whether growth and development during childhood and adolescence may be associated with risk factors for chronic diseases such as heart disease and diabetes.

The University of Bristol currently holds identifying record level data on the cohort on a secure auditable server. The data was received from November 1998 to September 2012. The purpose of retaining these data is to enable the empirical testing of the hypotheses stated above.

No new data will be supplied to the University of Bristol under this Agreement.

This Agreement permits the retention of data previously supplied by NHS Digital and ONS but no other processing is permitted.

The University of Bristol has plans to reuse the data in the future for biomedical research subject to the necessary approvals. Before using the data in future biomedical research, the University of Bristol must successfully apply to NHS Digital to amend this Agreement to permit processing for that purpose. That application must be supported with evidence of favourable REC approval and support for the processing under section 251 of the NHS Act 2006.

Researchers at the University of Bristol are currently exploring the possibility of using stored DNA to undertake genome wide analysis that can then be related to both the growth parameters and the health outcomes (with appropriate ethical approval). In addition, the existing number of events that have already been provided are relatively few, so there is little statistical power to look at the existing growth data with cause specific mortality. The University of Bristol may therefore make a future application to NHS Digital to receive new events occurring since 2012 to enable a more rigorous analysis.

The University of Bristol process these data in the public interest under Articles 6(1)(e) and 9(2)(j) as the data has previously been used and is being retained with the intention of future use to contribute to a greater understanding of health related risks, how secular changes in growth may impact on future disease patterns and how these may be tackled in terms of public health prevention and as such serve as public interest. Such research can identify new risk factors with the potential for developing new interventions to prevent disease or look at potential interactions between different risk factors. There are also stored biosamples that could be used to identify new biomarkers, including genetic markers, that may have value in risk prediction, earlier diagnosis and prognosis. In some cases, these findings may lead to the reuse of existing therapeutics or the development of new drug targets or diagnostics. There are very few cohorts with such detailed growth measurements during puberty so it is vital that where possible one replicates findings across cohorts. If this is the case then this adds to the generalisability of any findings on potential prevention strategies.

The University of Bristol is the sole data controller and also processes the data for this study. No other organisations process the data for this purpose.

Currently individuals are directly identifiable from the data held by the study as their personal details are held on the main study database and there are stored signed questionnaires from those who completed them. Personal details are held on the main study database and there are stored signed questionnaires from those who completed them. There are no moral or ethical reasons why the data cannot be retained or processed. However, in the future, under a subsequent Agreement, the University of Bristol intends to provide a new study member identifier to NHS Digital and request a second members and posting list including the new study member ID, as well as the original member ID, to ensure that linkage has been successful with the new identifier. Once this is in place, the University of Bristol intend to proceed to an amendment whereby they will move to a pseudononymised dataset where all personal identifying data are removed, other than a new unique identifier which will replace the old identifier so data cannot be linked to existing paper records. A link file (old and new study identifier) will be stored by third parties who have do not access to any of the data. This is essential as there are blood samples stored in -80C freezers, that may be of great scientific value in the future and are labelled with the original identifier. In this way any future anonymised blood results could be sent to the third party who would add the new identifier and remove the original thereby allowing these new data to be added to the revised database. There would be no attempt to re identify the individuals.

The data is stored on a special secure audited server with access limited to the data processor. Individuals in this study could be located anywhere in the United Kingdom and some will have emigrated. At this stage it is uncertain whether there will be any further follow-up with the participants who completed the past questionnaire. If the University of Bristol decides to undertake further follow-up, it will take advice from NHS Digital as to the appropriate explanation for the PIS and consent form to get permission for future follow-up of their health status.

There is no alternative way of obtaining outcome data on the full cohort other than through linkage to NHS Digital data due to difficulties in contacting participants either because of death or relocation. Merely following up survivors will introduce bias and under ascertain events.

The study was originally undertaken by a research grant from Cancer research UK though this has now ended. It does not currently receive any grant funding but is supported by the Population Health Sciences department, University of Bristol through staff time and support and infra-structure.

Yielded Benefits:

Several publications have already resulted from this work to date. For example, the study has shown the impact of childhood obesity in the CHS cohort in terms of both timing of puberty, attainment of adult height and adult obesity. This is of particular relevance given the marked increase in childhood obesity seen in all high income countries over the last 20 years. This is the first study to document an association between timing of puberty and adult IGF-I levels. A better understanding of life course determinants of the IGF system may provide new insights into disease etiology and primary or secondary prevention.

Expected Benefits:

The University of Bristol believes that the knowledge gained from the analyses of this dataset will add to epidemiological understanding on life course influences on adult chronic diseases in relation to growth and development in childhood and adolescence. This is one of a few such cohorts in the world that have detailed data on childhood growth between the ages of 9 to 20. This has allowed the researchers to derive valuable measures such as peak height velocity and age at peak height velocity and relate this to risk markers of chronic disease risk such as IGF1 a growth hormone associated with cancer risk. Only the Copenhagen study has a better dataset to look at this question.

Subject to a future amendment to this Agreement, the University of Bristol hopes to undertake and complete further analyses in the next 2-3 years but this is partially dependent on how many new events have accrued over time, which in turn is dependent on the age and health of the cohort. It is possible that for some events, there will still be too few events to enable valid analysis in which case further event updates would be requested over a longer period

Outputs:

There will be no new outputs under this Agreement.

Under a future Agreement, the University of Bristol intend to undertake exploratory analyses looking at whether timing of puberty is or is not associated with specific outcomes e.g. colorectal, prostate cancer. Because of the limited number of events, it has not been decided whether to publish or not publish these findings at this stage due to lack of statistical power. However with future updated event data the University of Bristol would aim to disseminate findings through a variety of methods such as peer reviewed journals, reports, scientific presentations and conferences. All outputs will only contain summary data such as effect estimates but cell counts < 7 will be suppressed to minimise any potential for re-identification. It is likely there would be other research outputs using the non-NHS Digital data for example around statistical methods.

Beyond the research community, the University of Bristol will try to engage with policy makers and civil society more generally through websites and other social media channels to highlight what has been found. The University of Bristol has its own news website where it highlights research undertaken by staff that is thought to be of general interest. Given the historical nature of the data from over 50 years ago, the results may have some interest to populations in low middle income settings who are undergoing the epidemiological transition. In addition, findings may have some relevance to the health care providers and the National Health Service if it allows one to have a better estimate of future health needs using data on secular trends. For example, if earlier onset of puberty is associated with a greater risk of cancer then one could use data on the secular trends for pubertal timing to make predictions about future disease burden and hence related costs.

The stored blood samples may also identify genetic, epigenetic or other biomarkers that may predict growth patterns health-related outcomes. These findings may or may not have commercial value through the development of diagnostic or therapeutic agents that may help risk stratify individuals thereby enabling targeting of secondary or tertiary prevention interventions. The University of Bristol RED department would be actively involved in any opportunities for commercial exploitation.

Processing:

Identifying data was shared with ONS to carry out the linkage between the study data and civil registration data. Participants records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at University of Bristol of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in September 2012.

The University of Bristol will securely retain the existing data that is held but will undertake no further processing of the data under this Agreement. No new data will be supplied under this Agreement.

It is anticipated that a future request to NHS Digital will be made requesting new data to enhance the number of events and enable more statistically powerful analyses relating pubertal growth with later life disease end-points such as CHD, stroke and specific cancers.

Existing data on mortality and cancers has been linked to the school growth data and analysed to test whether there are any associations between growth patterns and health outcomes.

Under a future Agreement, the University of Bristol aim to permanently pseudonymise the dataset by adding a new unique study ID to replace the existing study ID and deleting the personal identifying data such as name and address.

No data or any information derived from the data will be shared with external third parties. In the event that the University of Bristol was asked to collaborate with external parties to share data, for example in a meta-analysis of multiple studies, advice would be sought from NHS Digital on the use of “derived” variables such as age at death rather than date of death to further mitigate any risk of re-identification. An amendment to this Agreement would be required before any data could be shared.

There is no data linkage other than to research data collected by the University of Bristol as specified above. There is no matching to publicly available data.
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).

MR159 - Speedwell Study - Longitudinal Study of Ischaemic Heart Disease — DARS-NIC-147814-86GS4

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2019-09-01 — 2021-03-31 breached contract — audit report.

Access method: Ongoing

Data-controller type: UNIVERSITY OF BRISTOL, UNIVERSITY OF CAMBRIDGE

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:

The following provides background information on the purpose of the original study and how the data are managed: The Speedwell study was set up by the University of Bristol as a prospective cohort study in the late 1970s to look at the determinants of cardiovascular disease, though over time other phenotypes of interest have been added. The study was set up to examine risk factors for cardiovascular disease such as elevated cholesterol and obesity amongst around 2500 middle aged men living in Bristol. It recruited men aged 45-59 years of age from 16 General Practitioners based at two health centres in Bristol. Men were invited to research clinics where they completed questionnaires, had clinical measures such as blood pressure and blood samples taken. Over time men were seen over an additional 4 clinics (known as phase 2, 3, 4, and 5) so that new data on non-fatal cardiovascular events could be collected as well as repeating the collection of data on risk factors such as blood pressure, body mass index etc. At phase 5, as the men were older, cognitive function and retinal photographs were added to look at age-related cognitive decline and eye diseases such as macular degeneration. The storage and processing of these data are in line with the GDPR principles for the following reasons. The primary aim of the data collection and follow-up of these participants is to understand the underlying risk factors behind a number of common chronic diseases and their potential consequences on health and mortality. The processing of these data are in the public interest (GDPR Article 6(1)(e)) as they contribute to a greater understanding of health related risks and how these may be tackled in terms of public health prevention and as such serve as public interest. Such research can identify new risk factors, be they environmental or genetic that may lead to new causes of disease with the potential for developing new interventions to prevent disease. Storage and archiving of these data is of value as external researchers may contact the principal investigator for the possibility of new analyses and this fulfills GDPR Article 9(2)(j) which states “is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes…”. The researchers carrying out this study believe that the potential benefit of using these data far outweigh any potential harm. Steps are taken to reduce and mitigate any risk of individual identification and hence there is minimal risk of potential harm to the public by dissemination. Sadly most of the participants will have died by now as the study was started in 1979. The aim of collecting the data can only be achieved if it is actively used for medical research. With further follow-up and given the age of the cohort, there are a large number of further clinical events (cause specific deaths and cancer registrations) which can only be obtained from NHS Digital MRIS reports, as the study are no longer contacting the men in this cohort due to their age, frailty and the fact most will have died. The additional data provided by NHS Digital is very valuable as it will increase the statistical power to look at outcomes such as heart disease and rarer outcomes. At this stage the University of Bristol and the University of Cambridge are asking for permission to continue processing the data they already hold from 1982 to March 2016. The University of Cambridge co-ordinates the Emerging Risk Factors Collaboration (https://www.phpc.cam.ac.uk/ceu/erfc/) funded by the British Heart Foundation and Medical Research Council. This group host a consortium of >130 prospective studies from >30 countries that has collated and harmonised individual-participant data (IPD) from a total of ~2.5 million participants to study risk factors for cardiovascular diseases and cause-specific mortality in greater detail by IPD meta-analysis. They have previously published work in all the major medical journals and have contributed to new guidance with the World Health Organisation on how to operate the risk of diabetes mellitus. They are currently working on 6 distinct research projects as part of their programme. Current analyses being undertaken by the ERFC collaboration and how they use the data provided by NHS Digital are described below: 1. Determining the reductions in life expectancy according to different ages at diagnosis of diabetes mellitus. This research will use NHS Digital data on date and cause of death to calculate the negative impact on life expectancy for diabetics versus non-diabetics. 2. Development and validation of updated CVD risk prediction models for Europe (in collaboration with European Society of Cardiology (ESC) 2021 guideline committee). This looks at an existing risk prediction model and examines its ability to predict both fatal and non-fatal CVD events and thus necessitates the use of NHS Digital data.. 3. Estimating the association between renal function and CVD incidence in the general population. Baseline renal function from blood tests will be used to predict future fatal and non-fatal CVD events and thus requires NHS Digital data. 4. Use of lifetime risk for cardiovascular disease risk assessment. Current risk calculators such as QRISK look at 10 year CVD risk. This research will expand the time window to look at life time risk so each member of the cohort is followed up until death or end of the follow-up period. Data on vital status and age at death comes from NHS Digital. 5. Risk prediction for composite cardiovascular outcomes. This will expand the usual outcomes of heart attack and stroke to other fatal or non-fatal events such as heart failure and pulmonary embolus and thus requires NHS Digital data. 6. Sequential strategies for CVD screening, including health-economic evaluation. This work compares two different screening strategies, population-based versus high risk and compare the cost-effectiveness in relation to the prevention of future events (fatal or non-fatal) and requires NHS Digital data. The objectives of the ERFC are consistent with the aims and purpose behind the establishment and maintenance of the Speedwell study i.e. to look at risk factors for a wide range of chronic diseases especially cardiometabolic disease. ERFC works collaboratively with the Speedwell team who are involved in the drafting, interpretation and approval of any academic outputs through co-authorship of publications. If the Speedwell team have any concerns as to how the Speedwell data has been used they would request for this to be amended or in the worst case that the data form the cohort was withdrawn, thereby maintaining final control as to how the Speedwell data re used. Researchers have access to individual level data from the baseline and subsequent assessments with outcome data from either participant self-report or hospital data and mortality from NHS Digital. NHS Digital data covers all follow-up events to enhance statistical power and the geographical spread is limited to the cohort, hence the Bristol area (though some participants will have moved away over the years). Individual level data are required to enable sophisticated statistical models that can harmonise data coding and adjust for confounding factors through some sort of regression technique as appropriate. Cause of death data are essential as it is standard epidemiological practice to look at risk factors with specific causes that are thought to be caused by those risk factors. In some cases, researchers may wish to aggregate up specific causes e.g. all types of stroke but often need the more detailed sub-groups e.g. ischaemic versus haemorrhagic stroke as, for example high cholesterol level is associated with the former but not the latter. To maximise the scientific and public health value of the data, researchers need to have the flexibility to examine future research hypotheses and this can be best achieved by having cause of death data which maintains maximum flexibility. The data held and shared with researchers is the minimum required for the respective analysis and in addition, several additional steps are taken to mitigate the possibility of re-identification (NHS Digital data dictionaries have been provided to enable researchers to assess for themselves any potential risk). The University of Bristol and the University of Cambridge are joint data controllers and both organisations process the data for this study. No other organisations process the data for the purposes described. The University of Bristol has shared data with a research group at the University of Oxford which is examining how the body responds to allergens in terms of an immune response may contribute to the risk of cardiovascular disease. There are few cohort studies that have measures of immunoglobulins and long term follow-up such as the Speedwell study. Data shared by the University of Bristol for this purpose has been assessed by NHS Digital as derived data. NHS Digital has determined that data has been shared with the University of Oxford in a controlled way, bound by Data Sharing Agreements that confer the same level of adherence to protecting the rights of individuals involved in research and specifically covered by informed consent of subjects. All such data shared is either aggregate (as in publication), anonymous, or pseudonymised containing no NHS Digital data (such that additional data provided by the collaboration can be added to the sum of knowledge about subjects within the University of Bristol, but not allowing others to link data and risk re-identification – this includes measures to suppress rare events). Any data shared with the University of Oxford must be subject to the conditions that the University of Oxford: i. must not combine it with other datasets which could potentially increase the risk of reidentification for individuals in the dataset; ii. must not attempt to re-identify individuals in the dataset; iii. must not onwardly share the dataset; iv. must use the dataset for a defined purpose in support of the LLP’s aims defined within this Agreement, and v. must not publish the data. Under the terms of this Agreement, the University of Bristol and the University of Cambridge are responsible for ensuring compliance with the above conditions and for confirming destruction of the data by the University of Oxford once the data is no longer required for the purpose for which it was shared.

Yielded Benefits:

The Speedwell study has contributed to several studies looking at different biochemical biomarkers in the blood and risk of heart disease, stroke and mortality. In particular, inflammatory blood markers and measures of blood stickiness. It has also published on cataract and macular degeneration, areas that are far less researched. It has been involved in large meta-analyses as part of the ERFC collaboration. For example, a recent paper from the ERFC group has updated the World Health Organization risk algorithm for the prevention of cardiovascular disease worldwide. This used data from the Speedwell as well as many other studies across both high income and low middle income countries to develop and validate a risk prediction model which has utility for all countries and has tremendous public health potential benefits.

Expected Benefits:

The study was set up as a medical research project that may have benefits for clinical and public health around the determinants of common chronic diseases associated with ageing. The expected measurable benefits are variable depending on the nature of the actual research project and the results. It is hard to quantify the benefits but as these are common diseases which are now transitioning into low middle income countries the potential benefits are large. It is hoped that this sort of information will be used by government to guide expenditure and rational planning of services but there are many other fiscal factors that may impact on this. This makes it hard to give a specific time frame by which benefits can be expected as this is clearly outside the control of the researchers. The following describes different scenarios that could have benefits: (a) The results suggest a novel aetiological mechanism. As the data are observational they need to be reproducible and triangulated with other evidence e.g. animal studies. These sort of results may then lead onto further experimental work to develop a potential intervention or using existing therapeutics for a novel indication. In this way it may translate into better health care but this may take a long time (b) Descriptive study looking at time trends. The data from Speedwell reflect the experience on men born in the 20-40s. As such this is important in relation to data from more recent cohorts so, for example, researchers can synthesise different studies to track what is happening with obesity or hypertension as well as socioeconomic differences. These descriptive results are valuable to health care providers, commissioners and government to see whether the health of the UK population has or has not improved over time and whether socioeconomic differences have widened, narrowed or stayed the same. (c) Diagnostic or prognostic information. Results from risk models can be used to derive algorithms to stratify individuals in low, medium, high risk of future events or mortality. These are usually are on well-established risk factors. Such models are extremely valuable to help identify who may have the most benefit from an intervention. Primary care doctors now use the QRISK algorithm routinely in counselling and managing patients.

Outputs:

Data held by the University of Bristol and the University of Cambridge will result in academic publications that will add to scientific knowledge and understanding about the causes of diseases. The ERFC has a very well established track record of publication in high impact journals and collaborates with major organizations such as the World Health Organization or charities such as the British Heart Foundation. Results may also be presented at conferences or other meetings. Planned outputs for current analyses are as follows: 1. Determining the reductions in life expectancy according to different ages at diagnosis of diabetes mellitus. The proposed journal for publication is the Lancet. 2. Development and validation of updated CVD risk prediction models for Europe (in collaboration with European Society of Cardiology (ESC) 2021 guideline committee). The paper will be submitted to the European Heart Journal. 3. Estimating the association between renal function and CVD incidence in the general population. The paper will be submitted to the Lancet. 4. Use of lifetime risk for cardiovascular disease risk assessment. This paper will be submitted to the journal Circulation. 5. Risk prediction for composite cardiovascular outcomes. The paper will be sent to the European Heart Journal. 6. Sequential strategies for CVD screening, including health-economic evaluation. The output will be submitted to the British Medical Journal. Data in such outputs is in aggregate form such as counts in a table or measures of association e.g. correlation or regression coefficients. Cell counts less than 7 are either suppressed or aggregated up to a bigger category. Dissemination is usually through standard academic routes e.g. journals, conferences however depending on the newsworthiness the main findings may be disseminated through newspapers radio or television features, social media, websites and NGOs (e.g. British Heart Foundation) who may wish to highlight the work especially if they have funded this. This ensures that the general public, medical professionals and other academics are aware of the work. For example, the recent work on cardiovascular risk charts was presented at the European Society of Cardiology (ESC) Congress 2019 - 31 August - 04 September 2019, Paris, France (Presenters: Lisa Pennells and Stephen Kaptoge,Methodology of the revised WHO CVD risk charts).

Processing:

Identifying data was shared with ONS to carry out the linkage between the study data and civil registration data. Participants' records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at University of Bristol of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in March 2016. Data is currently held in a secure relational database where it has its own table. This can then be merged as required for specific data queries so it can be linked to the explanatory variables that have been collected as part of the research with the participants’ consent and knowledge. Further processing is usually done by writing a script within a statistics package that can then derive or categorised variables e.g. number of cigarettes smoked none, 1-14, 15-24, 25+. Once the data has been cleaned and derived the main tabulations and regression models are run to quantify any associations as effect estimates (95% confidence intervals, p-values) in a variety of multivariable models. In the ERFC this is done independently for every dataset they hold and the results are pooled (using meta-analysis) to get the most precise estimate so that individual results from a single study are often not even seen as they are part of a much bigger average. The University of Bristol shared data with the University of Cambridge in 2002 with updates in subsequent years. Data was originally transferred by secure email. Later extracts were encrypted and password protected and the data link was sent using secure data transfer software (FLUFF). The password was transmitted to the data manager by text to their mobile phone. These were pseudonymised individual level data (initially under the ONS accredited researcher scheme). On the advice of the Office for National Statistics, the date of any events had either (a) random noise added or (b) the age of the participant at the date of the event e.g. 76.4 years. Furthermore, any rare events which had fewer than 7 occurrences within the dataset were suppressed by aggregating up so the exact cause was not identifiable but a higher level category was still available. Any published outputs are also checked to suppress cell sizes less than 7. In most cases the results are shown as the average effect across many cohorts so data from the Speedwell study is not even identifiable. No further linkages are undertaken to any other external or publicly available data. Data is linked to the patient data collected as part of the research clinics and questionnaire with the event data. There have been no further data flows in either direction. The linkage is done through the study unique identifier so is pseudonymised. The University of Bristol currently hold within the database a link file which has identifiable data e.g. name of participant. This is not available to the University of Cambridge researchers. The University of Bristol also holds the signed consent forms which it needs to maintain to prove individual consent. All analyses are undertaken by research academics who are substantive employees based at the University of Bristol or the University of Cambridge. As such they are fully aware of the need to maintain confidentiality and not attempt to re-identify participants. It is normal practice for the Universities to ensure staff are fully aware of the GDPR principles as part of their mandatory training. The data stored at the University of Bristol is encrypted on University protected servers with appropriate access requirements (e.g. password protection) supported by their respective IT departments. The server has specific study folders that are in a managed group. This requires staff to have permissions for access. Permissions can only be obtained by the PI formally submitting a request to the IT department for a University of Bristol staff member to have access. Remote access is possible if it is a University of Bristol laptop that has been set up to create a VPN which would require authentication with a University username and password. At the University of Cambridge, the data is stored on University of Cambridge servers in a password protected, restricted access environment and is accessible by only the "Data Manager". When the "Data Manager" is requested to provide a dataset for analysis by a University of Cambridge researcher, the data manager makes that data available to the relevant researcher on a case by case basis. The subsequent analysis dataset is stored on the same University servers in a password protected, restricted access directory which is accessible by only the researcher and the "Data Manager". From this point on the data and performed analysis remain on the same University servers. No identifying data for study participants, such as name, address etc are held in either University of Oxford or University of Cambridge.

MR141 - CAERPHILLY ISCHAEMIC HEART DISEASE STUDY — DARS-NIC-148336-V4SL1

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes (Section 251 NHS Act 2006)

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2019-04-01 — 2020-12-31 2016.04 — 2024.11. breached contract — audit report.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BRISTOL

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
  5. Cancer Registration Data
  6. Civil Registrations of Death
  7. Demographics

Objectives:

The Caerphilly Prospective Study (CaPS) study was initially set up in the late 1970s. The initial objective of the (CaPS) study was to establish the relation between specific biochemical and physiological variables and the prevalence and incidence of ischaemic heart disease (IHD). Over the years the number of outcome measures (phenotypes) has been enlarged with a specific focus on cognitive impairment, dementia and ageing traits in the later years.

The overall aim of the CaPS study is to enhance the understanding of life course influences on the aetiology of chronic disease and physiological traits by examining life style, genetic and other exposures at various time in the life course and determine whether these predict a wide range of different outcomes.

The University of Bristol wishes to obtain and process data for this study, covering different outcomes, such as cardiovascular disease, dementia, cancer, ageing traits and mortality.

The study population comprised of almost three thousand men aged 45-59 years selected at random from the electoral register of Caerphilly Urban District.

The initial design attempted to contact all men aged 45 to 59 years from the town of Caerphilly and adjoining villages. 2512 subjects (response rate 89%) identified from the electoral register and general practice lists were examined between July 1979 and September 1983 (phase I). Men were initially seen at an evening clinic, where they completed a questionnaire, had anthropometric measures and an ECG taken. They also completed a food frequency questionnaire at home (Fehily et al 1994). They subsequently re-attended an early morning clinic to have fasting blood samples for a wide variety of tests.

Quality control was examined by the use of both "blind" split samples as well as a second repeat measure on a random sub-sample to examine intra-individual variation.

Phase II of the study was undertaken between July 1984 and June 1988. An additional 447 new men were included who had moved into the study areas. This is known as the “reconstructed” cohort. In addition to the tests undertaken at phase I, new tests included audiometry.

Phase III of the study was undertaken between November 1989 and September 1993. It followed the same methods as Phase I and II. The main new features were a standardised battery of cognitive function tests as well as a variety of new platelet and bleeding time tests.

Phase IV of the study was undertaken between October 1993 and February 1997. Audiometry measured at phase II was repeated as was cognitive function measured at phase III.

After phase IV men have been contacted on two further occasions by post. This has enabled data on stroke events as well as new non-fatal myocardial infarctions to be collected.

Phase V was undertaken between August 2002 and June 2004. This repeated questionnaire data but also now had a special memory clinic to assess men who scored poorly on the cognitive assessments to see if they have may have any cognitive impairment or dementia.

Since then men have received a postal questionnaire on the Warwick Edinburgh Well-Being scale.

All men have been followed up for incident IHD through mortality flagging, self-reported information confirmed by medical records, positive history to the Rose angina questionnaire, checking hospital admissions and new evidence of ECG ischaemia. The World Health Organisation HO criteria were used to define cases of non-fatal myocardial infarction.

At each phase, 40-50 mls of blood were taken and stored at either -40 or -80 C. This insightful decision has enabled subsequent researchers to rapidly test new hypotheses (e.g. the role of H. Pylori, cytomegalovirus and C. Pneumoniae with respect to IHD risk: see Strachan et al 1999, 1999, 1998). A large amount and variety of samples (serum, plasma, sodium citrate, etc.) remain for future potential analyses.

The research from the MRC (Medical Research Council) Caerphilly Prospective Study has already resulted in over 150 publications and this will continue to increase as currently data from CaPS contributes to various consortia that undertake meta-analyses across multiple epidemiological cohort studies. (e.g. Emerging Research Factor Collaboration, University of Cambridge).

This Agreement permits the University of Bristol to continue to hold the data on cause of death and cancer registration that has been released since 1980 and to receive new data on any events since 2016 to update the database. These data currently contain identifying information but the University of Bristol has agreed a strategy in the future to move to a fully pseudonymised dataset. Mortality and cancer data enables the study team to examine associations between their exposures and health related outcomes such as cause specific mortality and cancers (fatal and non-fatal).

The data is based on all men who lived in the Caerphilly area and a complete coverage of events since inception of the cohort will reduce any selection bias and maximise statistical power. There are no alternative methods to obtain these data as the vast majority of the original participants have died or are very old (80 years plus) and it is no longer appropriate to recontact them as it is now 40 years since the study commenced.

The processing of these data are in the public interest (article 6(1e)) as they contribute to a greater understanding of health related risks and how these may be tackled in terms of public health prevention and as such serve as public interest. Such research can identify new risk factors, be they environmental or genetic that may lead to new causes of disease with the potential for developing new interventions to prevent disease. In some cases, new genetic discoveries may lead to the reuse of existing therapeutics or the development of new drug targets. The study has also contributed to life course meta-synthesis that looks at a risk factor or trait over the life course by merging datasets that have data over different life stages e.g. childhood, young adulthood middle age, older age etc. This has shown the interesting pattern as how blood pressure changes over the life course (see Wills et al 2011). This highlights important ages where prevention strategies may have more impact on health and would be covered by GDPR section 9(2)(i).

The University of Bristol does not see any moral or ethical issues around the data processing as all the participants were fully aware they were voluntarily participating in a longitudinal health research project and consented for the research team to have access to their medical records, though given the historical nature of this study, as was normal at that time, the participants were not formally informed that their vital status would be reported through NHS Digital. The participants were fully aware that the study collaborated with other researchers and wished to follow them until death. There is no obvious risk of potential harm to the public by the dissemination of the results which are always at an aggregate or summary level.

By obtaining new data to add onto the existing dataset, the study will be able to enhance its statistical power and will be unusual in having such a long follow-up period. This should lead to better public information on health risks and potential prevention strategies.

The University of Bristol is the sole data controller and also processes the data for this study. No other organisations process the data for this purpose.

Under previous versions of this Agreement and in line with permission at the time, the University of Bristol has shared pseudonymised subsets of the data with third party researchers within and outside of the UK. The data was mostly collected by the University of Bristol from other sources and no data covered under this Agreement has been directly shared. Information derived from data under this Agreement has been shared.

Under this Agreement, the University of Bristol is not permitted to share any further data covered under this Agreement or derived from data covered under this Agreement. To permit such data sharing in the future, the University of Bristol will be required to apply for and receive approval for an amendment to this Agreement granting such permissions.

Most of the cohort have now died, the exact percentage of survivors is not known. A decision was made a few years ago not to try and recontact the cohort (current age range is between 82-98 years) as most are likely to be frail and some will have dementia. In addition, some will no longer be residing at home having moved to family or care homes so it is unlikely the participants could be found. It is therefore believed that linkage is the least intrusive approach to obtain these valuable data. NHS Digital already hold the original study ID that was established when the cohort was originally flagged. In the future the University of Bristol team propose to add a new study member identifier to replace the original one thereby ensuring a fully pseudonymised study.

The study does not currently receive any grant funding but is supported by the Population Health Sciences department, University of Bristol through staff time and support and infra-structure. It also requests data access costs as cost recovery from studies when appropriate.

Yielded Benefits:

The University of Bristol have contributed to a number of important meta-analyses with other studies that have looked at genetic and metabolomic risk factors for chronic diseases. In addition, the Caerphilly study has highlighted how men who have healthy life styles (non-smoking, not obese, high fruit and vegetable intake, regular physical activity and low or moderate alcohol intake) have increased disease free survival as well as reduced risk of cognitive impairment and dementia (Elwood et al PLoS One 2013). Such work is important from a public health perspective and can feed into the evidence base for organisations such as Public Health England for whom dementia is a major priority as it will place ever increasing demands on both and health and social care services as our population in the UK continues to get older. Its ability to test how risk factors for cardiovascular disease are also linked to dementia is important to organisations like PHE and the British Heart Foundation and is part of the basis of the "What's good for the heart is good for the brain" movement. Some exemplars of important work that have come from CaPS (with other studies) is for example the importance of hearing loss as a predictor of future dementia. This was one of the risk factors identified by the Lancet Commission on dementia (Livingston et al 2017) as a potentially modifiable risk factor for dementia. The inclusion of CaPS in the MRC Dementia Platform UK (https://portal.dementiasplatform.uk/) will enable a large international community of researchers access to CaPS data to further our understanding of dementia risk. Other examples include identifying new genetic pathways to disease or risk factors. CaPS was one of 13 cohorts that were used to identify the FTO gene, the first major genetic determinant of obesity, which is a growing public health issue for children and young adults. CaPS has also been a contributor to the Emerging Risk Factors Collaboration (ERFC) that have looked at cardiovascular risk factors. Recently the ERFC have produced new World Health Organisation (WHO) CVD algorithms for application in multiple global regions and CaPS was one of the datasets included in this large piece of work. Recently variations in genetics have been used to study environmental exposures using an approach known as Mendelian Randomization. CaPS has contributed to the publication testing whether an inflammatory marker, C-Reactive Protein, was associated with coronary heart disease (CHD). It was also included in a large meta-analysis of pulse wave velocity and CHD to see if this new measure can improve risk prediction of CHD over and above normal risk factors such as blood pressure. These results and cheaper technology have the potential to change the way doctors practice medicine and by better risk stratification has the potential to improve health care delivery.

Expected Benefits:

The Caerphilly Prospective study (CaPS) has already contributed to a large volume of published research of high quality. There are several hundred papers that are either based on data from CaPS itself or more recently it has contributed to a wide variety of multi-study collaborations which combine data across many studies in what is known as meta-analysis. These sort of studies look at the associations between a variety of different exposures and disease outcomes including death. Such research can identify new risk factors be they environmental or genetic that may lead to new causes of disease with the potential for developing new interventions to prevent disease. It has also contributed to life course meta-synthesis that looks at a risk factor or trait over the life course by merging datasets that have data over different life stages e.g. childhood, young adulthood middle age, older age etc. This has shown the interesting pattern as how blood pressure changes over the life course (see Wills et al 2011). This highlights important ages where prevention strategies may have more impact on health.

Outputs:

The outputs produced from the data provided is new knowledge in relation to the epidemiology of cardiovascular disease (e.g. heart disease and stroke), cancers, dementia and other chronic diseases. These outputs are usually in the form of scientific publications in peer reviewed journals, book chapters, monographs etc. They will also contribute to oral presentations and other media. Such outputs may contribute to policy formulation either through groups that formulate clinical or public health guidelines (e.g. NICE, WHO, British Heart Foundation) or through other bodies that synthesise evidence for the purpose of commissioners and/or policy leaders (e.g. Lancet Commission).

The Caerphilly Prospective Study (CaPS) is a very detailed and richly phenotyped study that has data both on lifestyle, clinical, biochemical and genetic data. It is therefore used for a wide variety of hypotheses rather than a single specific one and can be used to examine a wide range of different outcomes such as heart disease, cancer and dementia. It is therefore impossible to pre-specify all hypotheses and for genetic research it is often used as part of a replication study to see if it can confirm new findings from discovery studies.

The results presented in such outputs are summary tables e.g. percentage of smokers and effect estimates such as a measure of risk e.g. the risk ratio of dying from cardiovascular disease comparing obese with non-obese subjects. Any small number cells will be suppressed in line with the HES analysis guide so that no cells have fewer than 7 subjects. In some of the meta-analyses the results are aggregated across many studies and the specific study cannot even by identified.

Processing:

NHS Digital already hold the flags for the cohort of participants with identifying information. The cohort is closed so no additional cohort members will be sent to NHS Digital.

NHS Digital has previously sent identifying data (mortality and event notifications) to the University of Bristol where it is processed and added to the master database. Under this Agreement, the University of Bristol requires a Members and Posting report which will include identifying data, to ensure the cohort is reconciled and correctly flagged. The University of Bristol is also requesting back-dated events and mortality data, including identifying data, from September 2016. The University of Bristol will then provide a new study member identifier to NHS Digital and request a second members and posting list including the new study member ID, as well as the original member ID, to ensure that linkage has been successful with the new identifier. Once this is in place, the University of Bristol will proceed to an amendment whereby they will move to a pseudonymised dataset where all personal identifying data are removed, other than a new unique identifier which will replace the old identifier so data cannot be linked to existing paper records.

The department of Population Health Sciences at the University of Bristol will not hold the link file (old ID and new ID) so will not be able to back-link the data but this link file will be kept by three independent bodies for safety reasons (DPUK, NHS Digital and Data Bris who are the University of Bristol Research Data Repository) so that any newly derived data from stored blood or DNA samples can be added to the database using the link file. All previously supplied identifying details, supplied by NHS Digital, will be destroyed and evidenced by a Certificate of Data Destruction.

There is no data linkage other than to research data collected by the University of Bristol as specified above. There is no matching to publicly available data. All external parties are aware that there will be no attempt to re-identify individuals. Such data will be stored on a secure server (with appropriate password protection) hosted by the academic organisation and staff who undertake any analysis will have received training in data protection and confidentiality.

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).

Using geographic variation in hospital care to identify opportunities to improve the effectiveness and efficiency of patient care — DARS-NIC-17875-X7K1V

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

Purposes: No (Academic)

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

When:DSA runs 2018-08-07 — 2021-08-06 2017.09 — 2024.11. breached contract — audit report.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Outpatients
  3. Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
  4. Civil Registration - Deaths
  5. Diagnostic Imaging Dataset
  6. HES:Civil Registration (Deaths) bridge
  7. Civil Registration (Deaths) - Secondary Care Cut
  8. Hospital Episode Statistics Admitted Patient Care (HES APC)
  9. Hospital Episode Statistics Outpatients (HES OP)
  10. Civil Registrations of Death
  11. Diagnostic Imaging Data Set (DID)
  12. Civil Registrations of Death - Secondary Care Cut
  13. HES-ID to MPS-ID HES Admitted Patient Care
  14. HES-ID to MPS-ID HES Outpatients

Objectives:

University of Bristol (UOB) School of Social and Community Medicine (SSCM) will use the data for a programme of work based around identifying the magnitude and causes of variations in outpatient care, unplanned admission rates and procedure use. The work is funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West) (see: http://clahrc-west.nihr.ac.uk/).
The CLAHRC West brings together a collaboration of the local providers of NHS services and NHS commissioners, universities (including UOB-SSCM), patients and members of the public. It conducts applied health research and implements research evidence, to improve health and healthcare across the West of England.

The purpose of this programme of work is threefold:
1. Estimating the magnitude of variation
UOB-SSCM aims to identify the clinical areas where outpatient care, unplanned admission rates and procedure use differ substantially across England. High variation is likely to be the result of clinical uncertainty in the optimal pathway of care including: when to refer patients for a specialist opinion; when to admit patients, and which procedures they should receive once admitted. Identifying high variations in care allows research funders and NHS managers to prioritise research towards the areas where additional evidence has the greatest potential to improve and standardise healthcare. For example, UOB-SSCM have previously demonstrated that admissions for hip fracture, where the diagnosis and need for admission are clear cut, vary much less than admissions for senility/dementia where making a diagnosis and judging the need for admission is more difficult.
As the aim of this analysis is to identify new areas of exploration, rather than simply confirm that variation is present in clinical areas where it is already known to exist (e.g. mental health care, tonsillectomy), it is essential that it starts from a broad base. UOB-SSCM previously used the HES data from 200708-2011/12 to identify the most geographically variable therapeutic procedures. This study considered the 154 most common procedures which were recorded in 17.8 million finished consultant episodes. UOB-SSCM’s proposed analysis of the latest data will be at least as large and will require an unfiltered dataset. UOB-SSCM requires data on patients admitted in the previous ten years to investigate how geographic variation has evolved over time.
Ref: www.ncbi.nlm.nih.gov/pubmed/25879119

2. Investigating the causes of variation
UOB-SSCM aims to explore the causes of variation in hospital outpatient care, admission rates and procedure use. UOB-SSCM will use other freely available datasets (e.g. quality and outcomes framework, GP patient survey) to better understand how the characteristics of an area (e.g. age-sex composition, deprivation) or an organisation (e.g. availability and continuity of primary care) are related to hospital admission rates / procedure use. Understanding the causes of geographic variation will help inform the design of interventions that may be most successful in standardising care around best practice. UOB-SSCM has previously used HES data to demonstrate the associations between unplanned hospital admissions, GP proximity to A&E departments and hospital bed availability. This type of observational evidence has played a crucial role in current initiatives to co-locate GP services with A&E departments to triage and prevent unnecessary admissions.
Refs: http://www.ncbi.nlm.nih.gov/pubmed/21719477; http://www.ncbi.nlm.nih.gov/pubmed/21183192

3. Identifying opportunities for disinvestment
UOB-SSCM will work with the seven partner CCGs of the CLAHRC West to identify clinical areas where there may be an over-use of care locally. Identifying and reducing over-utilisation to free up resources for other, more productive activities is commonly termed ‘disinvestment’. For example, in previous work UOB-SSCM worked with a local CCG to explore why local rates of laser capsulotomy (to improve 'cloudy' vision after initial cataract surgery) were apparently much higher than the national average. Analysis revealed that locally procedures were performed as (more expensive) day cases, whereas elsewhere the procedure was done in the (cheaper) outpatient setting, therefore identifying an opportunity for CCG savings.
Part of these investigations will include a time trend analysis to identify if local high utilisation is a recent phenomenon or if differences are more entrenched over time which will require multiple years of inpatient and outpatient data.
UOB-SSCM’s plans for this programme of work have been strongly supported by local NHS organisations through the Bristol Health Partners (a strategic collaboration between the city's three NHS trusts, three clinical commissioning groups, two universities and its local authority) and the West of England Academic Health Science Network (a collaboration of healthcare organisations, industry, universities, research bodies and patients).
Ref: www.ncbi.nlm.nih.gov/pubmed/25879119

UOB-SSCM require multiple years of data to investigate if geographic variation has increased over time. Having previously received only inpatient data, UOB-SSCM requires outpatient data because many minor procedures may be performed in the outpatient clinic or as day cases. In accordance with the Data Protection Act, UOB-SSCM are minimising the data held by requesting a smaller amount of outpatient data, excluding earlier years when data were considered experimental.
UOB-SSCM will be requesting their HES extracts to be updated annually. With each update, UOB-SSCM will destroy the oldest year of data on its server meaning that only ten years of data will be held on the server and be available for active data analysis at any time. UOB-SSCM will follow established best practice by archiving the dataset underpinning work published in medical journals for five years after publication to ensure that queries or disputes can be appropriately addressed.

Yielded Benefits:

The research has generated the following publications: Hollingworth, W., Rooshenas, L., Busby, J., Hine, C. E., Badrinath, P., Whiting, P. F., ... & Beynon, C. (2015). Using clinical practice variations as a method for commissioners and clinicians to identify and prioritise opportunities for disinvestment in health care: a cross-sectional study, systematic reviews and qualitative study. https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0081522/ In this project University of Bristol developed a method by which policy-makers could use geographical variation as a starting point to identify procedures where health technology reassessment or RCTs might be needed to inform policy. Commissioners can use benchmarking to identify procedures with high local use, possibly indicating over treatment. However, coding inconsistency and limited evidence are major barriers to achieving disinvestment through benchmarking. Increased central support for commissioners to tackle disinvestment is needed, including tools, accurate data and relevant evidence. Early engagement with patients and clinicians is essential for successful local disinvestment. Bhimjiyani, A., Neuburger, J., Jones, T., Ben-Shlomo, Y., & Gregson, C. L. (2018). Inequalities in hip fracture incidence are greatest in the North of England: regional analysis of the effects of social deprivation on hip fracture incidence across England. Public health, 162, 25-31. https://doi.org/10.1016/j.puhe.2018.05.002 University of Bristol have demonstrated that, after accounting for age, marked regional variation in hip fracture incidence exists across England, with the greatest absolute burden of incident hip fractures observed in the North East for both men and women. Furthermore, absolute and relative inequalities in hip fracture incidence linked to local area deprivation were greatest in the North of England for both men and women. University of Bristol findings highlight the need for fracture prevention programmes that aim to reduce regional and social inequalities in hip fracture incidence, with arguably the greatest need in the North of England. The RCP FLS-DB offers an opportunity to audit regional variation in such fracture prevention programmes. Bhimjiyani, A., Neuburger, J., Jones, T., Ben-Shlomo, Y., & Gregson, C. L. (2018). The effect of social deprivation on hip fracture incidence in England has not changed over 14 years: an analysis of the English Hospital Episodes Statistics (2001–2015). Osteoporosis international, 29(1), 115-124. https://link.springer.com/article/10.1007/s00198-017-4238-2 University of Bristol have demonstrated firstly that, after accounting for age, hip fracture incidence is declining in women, but is rising in men; secondly, deprivation predicts increased hip fracture incidence in both women and men, with a stronger relative impact among men. However, owing to the overall higher incidence of hip fractures in women, deprivation has a greater impact on the number of hip fractures among women. Thirdly, despite UK Government and public health initiatives to both address health inequalities and prevent hip fractures, absolute inequalities in hip fracture incidence have persisted among both men and women, with the health inequality gap marginally widening among women. The findings stress the need for reassessment of current national public health strategies to prevent hip fractures. Particular focus is needed on the development of health policies that address persisting social and gender inequalities. Hollingworth, W., Jones, T., Reeves, B. C., & Peto, T. (2017). A longitudinal study to assess the frequency and cost of antivascular endothelial therapy, and inequalities in access, in England between 2005 and 2015. BMJ open, 7(10), e018289. http://dx.doi.org/10.1136/bmjopen-2017-018289 Based on the IVAN trial, Dakin et al estimated that the NHS could save £102 million per year by switching from ranibizumab to bevacizumab. In the US, Hutton et al estimated that a similar switch would save Medicare $18 billion over a 10-year period. The patent on ranibizumab is due to expire in Europe in 2022; in the meantime, based on current trends, the NHS may spend billions on anti-VEGF injections before biosimilar drugs become available. Given the lack of political and regulatory support for clinicians to use bevacizumab, it is unsurprising that most in England do not use it. This has led to the very unusual situation whereby the NHS is paying for more expensive therapy than healthcare insurers in the US. Bristol University, demonstrating large variations between CCGs in the numbers of patients accessing anti-VEGF services also suggests that there is considerable potential unmet need in some areas of the country. Given that many CCGs are already in financial deficit, most will struggle to afford to treat more patients unless they are able to switch to bevacizumab. The political decision not to support NHS use of bevacizumab in eye conditions is in stark contrast to decisions taken in other EU countries and has very large negative consequences for NHS patients. University of Bristol need to address the fundamental problem that NICE has not included cost-effective but unlicensed drugs in technology appraisals or clinical guideline recommendations. Biggart, R., Finn, A., & Marlow, R. (2018). Lack of impact of rotavirus vaccination on childhood seizure hospitalizations in England–An interrupted time series analysis. Vaccine. https://doi.org/10.1016/j.vaccine.2018.06.029 The strength of the University's study is its robust ecological size, comparing trends over a decade across the whole of the English paediatric population. Although an alternative study design, University of Bristol analysed 80–100-fold more seizures requiring medical attention than previous cohort studies. These found varying strengths of direct protective association, with the lowest reported as a 20% risk reduction in risk of seizures. Despite the inherent flaws of an ecological study design, if such a significant effect existed in England the University of Bristol believe the much larger study would have detected a signal, given that our vaccine uptake is also higher. Thus the University of Bristol argue that this is an important negative finding; if a protective association of the monovalent vaccine cannot be detected at this population level then the effect is unlikely to be clinically, or economically, significant. Jones, T., Carr, A., Beard, D., Linton, M.-J., Rooshenas, L. Donovan, J., & Hollingworth, W. (submitted in 2018). Use and cost of subacromial decompression surgery: the need for effective evaluation of surgical procedures to prevent overtreatment and wasted resources. NHS England pays for nearly 30,000 shoulder subacromial decompression procedures each year at an annual cost of over £125 million, with little evidence that they are effective or cost-effective. The rates of this operation in other countries are even higher. This raises serious questions around the regulatory and professional processes governing the adoption and widespread use of surgical interventions. High quality RCTs should be funded early to examine the effectiveness and cost-effectiveness of expensive procedures using methods to optimise recruitment, and robust processes should be developed to reduce the use of ineffective procedures. Marlow, R., Finn, A, & Henderson, J. (accepted in 2018). Assessing the Association between Bronchiolitis in Infancy and Recurrent Wheeze – A Whole English Birth Cohort Case Control Study. Thorax. Fundamentally these data highlight the inability to prospectively clinically distinguish between wheeze phenotypes. It is reassuring that 80% of children with even severe bronchiolitis do not go on to wheeze. Academic interest aside, the reason for this study is to be able to answer parents’ questions of “will this happen again?” Although these data cannot elucidate the cause, they are helpful to describe likely respiratory trajectories for children. University of Bristol now plan to expand this research by also examining wheeze attendances in the emergency department and primary care. The following presentations were also given: Arti Bhimjiyani - Hip fracture admissions are increasingly complicated by advanced chronic kidney disease in England. American Society for Bone and Mineral Research, Atlanta, USA, Sept 16-19, 2016 [J Bone Miner Res 31 (Suppl 1). MO0002; page S296] The effect of social deprivation on hip fracture incidence has not changed over 10 years in England. National Osteoporosis Society, Birmingham, UK, Nov 7-9 2016 [Osteoporos Int (2016) 27 (Suppl 2). P103; S672] Advanced chronic kidney disease increasingly complicates hip fracture admissions in England. National Osteoporosis Society, Birmingham, UK, Nov 7-9 2016 [Osteoporos Int (2016) 27 (Suppl 2). O14; S619] The effect of social deprivation on hip fracture incidence in men and women over 14 years across regions in England. Bone Research Society, Bristol, UK, June 25-27, 2017 Rachel Biggart - "Has there been an impact of rotavirus vaccination on childhood seizure hospitalizations in England? European Society for Paediatric Infectious Diseases", Malmo, Sweden, May 28 – June 2, 2018 Moses Ikpeme - "Investigating Inequalities in Paediatric Burn Injuries in England: Findings from Analyses of Hospital Episodes Statistics (HES) data from 2009-2015". Royal College of Surgeons of England, London, UK, May 3-5, 2017. "Ethnic inequalities in paediatric burns: Findings from a systematic review and analyses of hospital episodes statistics data from 2009 to 2015". Royal College of Paediatrics and Child Health Annual Conference, Birmingham, UK, May 24-26, 2017. http://www.adc.bmj.com/content/102/Suppl_1/A59.1 Tim Jones: "The cost of turning a blind eye to unlicensed medicines: the impact of NICE recommendations on patient access to anti-VEGF therapy" - Health Services Research UK Symposium, July 6-7, 2017.

Expected Benefits:

Estimating the magnitude of variation
UOB-SSCM will disseminate lists of the most variable conditions / procedures using journal articles. These articles will be aimed at research funders, commissioners and clinicians. The output will help research funders identify where the most important treatment uncertainties exists and prioritise research to these clinical areas. For example, in previous work high variation in transluminal and combined varicose vein procedures flagged up the clinical uncertainty about the use of minimally invasive techniques and the criteria for when each procedure is appropriate. This research has the potential to reduce treatment uncertainties and lead to more standardised and better quality care, and improved patient outcomes. Although the immediate impact of this research will be difficult to measure, UOB-SSCM would expect benefits from 2017 onwards.
Ref: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0081522/
Investigating the causes of variation
Work exploring the causes of geographic variation will be aimed at NHS commissioners. The output will help NHS commissioners by providing insight into the influence of population and organisational factors on admission rates / procedure use. For example, in current work UOB-SSCM identified continuity of GP care, rather than accessibility of GP care, as a key factor in reducing unplanned hospital admission rates.
UOB-SSCM has previously used HES data to investigate how demographic, geographic and NHS institutional factors affect emergency hospital admissions which has added to the debate around the most appropriate structure of English general practice. This type of observational evidence has played a crucial role in the design of the NHS and has directly influenced recent government-led initiatives to provide 7-day primary care access and increase hospital staffing levels at weekends.
UOB-SSCM expects the analysis to have an effect on NHS policy and, although the effect will be difficult to evaluate, UOB-SSCM would expect benefits from 2017 onwards.
Identifying opportunities for disinvestment
Work identifying opportunities for disinvestment will be aimed at commissioners in the seven partner CCGs of the CLAHRC West. UOB-SSCM will collaborate with individual partner CCGs to better understand the causes of high admission rates or procedure use and, where appropriate, help design interventions to reduce utilisation to more appropriate levels. Helping commissioners appropriately disinvest from poor-value healthcare will free up resources for more cost-effective treatments and will result in patient benefit.
In a previous project UOB-SSCM undertook a benchmarking process with Suffolk PCT to identify clinical areas where disinvestment was necessary. UOB-SSCM identified high utilisation of carpal-tunnel surgery, which was centered on one of the two hospitals in the area, leading to the PCT to change the provider of these services which reduced costs and released funds for other healthcare activity.

Outputs:

Estimating the magnitude of variation
1) Publish national-level analysis of variations in procedure rates in peer-reviewed medical journal by December 2017.
2) Publish national-level analysis of variations in unplanned admissions and outpatient care in peer-reviewed medical journal by December 2017.
Investigating the causes of variation
1) Explore temporal and geographic variations in specific procedures and medical admissions in a series of peer-reviewed medical journals by December 2018.
Identifying opportunities for disinvestment
1) Benchmark local CCG unplanned admission and procedure rates against the national average. Provide report to each local CCG by December 2017.

All outputs will include only aggregate data with small numbers suppressed in line with the HES analysis guide. No record level data will be shared with third parties including the partner CCGs.

Processing:

The data will be processed in the following way:
Data preparation

Upon receiving the data from the HSCIC, UOB-SSCM will store it on its secure server located Canynge Hall, Bristol. The data can only be accessed by authorized personnel with user accounts on UOB-networked computers. The network can be accessed remotely but all processing is logically on the server based at Canynge Hall and no data is removed from that server and the authorised personnel are all employees of UOB.

UOB-SSCM will take following steps to create analysis datasets for the programme of research.
1. Analysis datasets will be created using an SQL query. UOB-SSCM will use filters (e.g. procedure codes, diagnosis codes), and restrict the data fields to those that are strictly required, to ensure the size of the analysis dataset is minimised.
2. Identify the finished consultant episodes to be included in the analysis based on diagnosis or procedure codes.
3. Count the number of unplanned hospital admissions / procedures within each CCG and GP practice.
4. Use appropriate methods (e.g. indirect standardisation, Poisson regression) to adjust for differences in need (e.g. age, deprivation) between CCGs and practices.
Descriptive analysis
This analysis will use the data produced from the ‘Data Preparation’ phase. Descriptive analysis will involve all ten years of data, to understand how the characteristics of patients has changed over time.
1. Describe the characteristics of patients admitted for each condition / procedure including demographics (e.g. age), admission details (e.g. source, method) and discharge details (e.g. source, method).
Estimating the magnitude and understanding the causes of variation
This analysis will use the data produced from the ‘Data Preparation’ phase. UOB-SSCM will calculate estimates of variation for each of the ten years of data.
1. Use appropriate methods (e.g. hierarchical models) to quantify variation in unplanned admission rates / procedure use between CCGs.
2. Rank conditions / procedures from the most to least variable.
3. Use appropriate methods (e.g. regression) to calculate trends in variability over time.
4. Use appropriate methods (e.g. Poisson regression) to investigate how demographic, geographic and NHS institutional factors affect unplanned hospital admissions and procedure use.
Identifying opportunities for disinvestment
This analysis will use the data produced from the ‘Data Preparation’ phase. UOB-SSCM will use the most recent year’s data to identify opportunities for disinvestment and will supplement this with a time trend analysis describing how local and national have differed over the previous ten years.
1. Rank conditions / procedures based on the difference between the local and national rate for each partner CCG. This will provide a starting point for conversations around potential opportunities for disinvestment.
2. Calculate time trends in the difference between national and local rates to understand if local high utilisation is a recent phenomenon or if differences are more entrenched.

MR1048b Continuation of AVON LONGITUDINAL STUDY OF PARENTS AND CHILDREN (ALSPAC) with for the ‘Children’ aspect only — DARS-NIC-152414-W3P6Q

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes, No (Section 251, Section 251 NHS Act 2006, Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006)

Legal basis: Section 251 approval is in place for the flow of identifiable data, National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

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

When:DSA runs 2019-01-01 — 2021-12-31 2018.06 — 2024.10. breached contract — audit report.

Access method: One-Off, Ongoing

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Outpatients
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Critical Care
  4. Hospital Episode Statistics Admitted Patient Care
  5. Mental Health Minimum Data Set
  6. Mental Health and Learning Disabilities Data Set
  7. MRIS - Flagging Current Status Report
  8. MRIS - Cohort Event Notification Report
  9. Hospital Episode Statistics Accident and Emergency (HES A and E)
  10. Hospital Episode Statistics Admitted Patient Care (HES APC)
  11. Hospital Episode Statistics Critical Care (HES Critical Care)
  12. Hospital Episode Statistics Outpatients (HES OP)
  13. Mental Health and Learning Disabilities Data Set (MHLDDS)
  14. Mental Health Minimum Data Set (MHMDS)
  15. Cancer Registration Data
  16. Civil Registrations of Death
  17. Demographics
  18. Emergency Care Data Set (ECDS)
  19. Mental Health Services Data Set (MHSDS)

Objectives:

Background

ALSPAC is a transgenerational prospective birth cohort study that recruited women during pregnancy in the early 1990s. ALSPAC is designed to investigate influences on health, wellbeing and development across the life course. To inform these investigations ALSPAC collects information on genetic, epigenetic, biological, psychological, social and environmental exposures and a similar range of health, social and developmental outcomes. ALSPACs primary objective is to manage a long-term relationship with the study families and through this to build a DataBank resource that can be used to inform the investigation of diverse health and social hypotheses across the life course. To achieve this objective, data are collected through postal questionnaires, study clinical assessments, the collection of biological samples and through linkage to routinely collected health and social administrative records (including those held by the NHS Digital). ALSPAC is part of the Population Health Science group within the Bristol Medical School at the University of Bristol. Over £100m has been invested into ALSPAC by UK funding councils, charities (e.g. Wellcome Trust, British Heart Foundation, Asthma UK, Cancer UK), the NHS NHIR and directly from UK Government Departments. ALSPACs primary funding comes from the Wellcome Trust, The Medical Research Council and the University of Bristol.


The Study

The study seeks approval to link to, extract and use NHS Digital data (Flagging and Tracing, HES and MHSDS) to inform a set of specific research investigations (listed below). These are specific questions – that require linked data - that have arisen from existing work, are led by University of Bristol investigators and are tied to health service improvements (as described later in the application).


Scope/Cohort

The Avon Longitudinal Study of Parents And their Children (ALSPAC), popularly known as “Children of the 90s”, 
enrolled pregnant women in the early 1990s into a study which has followed the health and development of the 
resulting children and their parents/carers for nearly twenty years. These children are now adults.  ALSPAC will work to continue to collect data from the young people and their parents, as well as seeking to extend enrollment to the offspring of the study children: the third generation of the ALSPAC cohort. 

Legal Basis

This DSA is supported by Section 251 (s251) support for other participants.

When reviewing the application for s251 the Health Research Authority’s Confidentiality Advisory Committee (CAG) recommended that the conditions attached to the support should differ depending on the sensitivity of the data in question. Health data (which are all considered sensitive within the Data Protection Act) were considered to be either ‘sensitive’ or having ‘particular sensitivity’. It was considered that health records relating to Mental Health, Sexual Health and termination of pregnancy should all be considered as being particularly sensitive. This means the s251 legal basis differs between records of standard sensitivity (e.g. A&E admission for a broken bone) and those with particular sensitivity (e.g. admission for psychiatric disorder). The ‘primary application’ provides support to access and use all records with a standard sensitivity.

Primary application reference: ECC 1-05(b)/2012 – ALSPAC Study Young Adults: Enrolment and Consent for Record Linkage (Lead: Macleod);

The s251 support from this primary application is conditional on the particularly sensitive records being excluded from the extraction (e.g. those relating to mental or sexual health conditions cannot be extracted). However, this condition can be overridden by subsequent supporting applications, which justify at a project level the case for ALSPAC to access particularly sensitive records. Within each of these applications the researchers request support to extract and use a range of particularly sensitive records. ALSPAC have received s251 support for five of these supporting applications.

Supporting applications:
CAG 7-06(a)/2013 – Accuracy of estimates for selfharm
14/CAG/1032 – Association between IQ and selfharm
15/CAG/0175 – Early life causes of depression and anxiety
15/CAG/0176 – Predictors, prevalence and impact of chlamydia
15/CAG/0177 – Substance use and mental health

To accommodate the filtering needed for s251 cases (both to remove certain particularly sensitive records and national patient objectors) the ‘pipelines’ have been split in the flow diagram and narrative description between MR1048a: consent (applied for under a separate agreement), and, MR1048b: s251.

ALSPAC participants are free to object to the studies use of their records in this way at any time. Records of objections are stored in the central ALSPAC database. ALSPAC will ensure that objectors wishes are upheld and they will not be included in the list of MR1048b participants for whom records are requested.


Previous data extracts

ALSPAC received flagging and tracing extracts for many years. Also, in 2013, ALSPAC received an extract of HES records for ~3,000 consented index children . This extract was envisaged to be a technical pilot and to investigate exemplar hypotheses.


Impact on Health and Social care

ALSPAC work with NHS clinicians and advisors in a range of disciplines. Current projects include work conducted with: Director of the National Chlamydia Screening Programme, NHS ‘Bristol Health Partners’ Director of the Sexual Health Improvement for Population and Patients Health Integration Team, National Suicide Prevention Strategy Advisory Group member, NHS ‘Bristol Health Partners’ Director of the Addictions Health Integration Team and Chair of the National Advisory Group to Welsh Government on Suicide and Self Harm prevention. In this way it is ensured that the improved understanding of health and social care generated by the use of ALSPAC-NHS Digital data are flowing back into the NHS, through: academic routes (publication and conferences such as the Society for Academic Primary Care and Farr Institute Conferences); through clinical groups (e.g. the Bristol Health partners HITs) and advisory boards (e.g. National Suicide Advisory Group); direct feedback into improving service provision (e.g. National Chlamydia Screening Programme); and feedback into Government policy (e.g. ALSPACs contributions to the Marmott Review ‘Fair Society, Healthy Lives’).

A past example of this is the role ALSPAC played in the ‘back to sleep’ intervention that aimed to reduce rates of sudden infant death syndrome (aka ‘Cot Death’). ALSPACs used its early life information to research the long-term development pathways of children put to sleep on their back. ALSPAC's findings reassured sceptical health professionals (concerned that putting children to sleep on their backs impacted on child motor development) and contributed to policy change in the UK and overseas; a policy change which has subsequently been credited with substantially cutting rates of sudden infant death.


Specific purposes

Linked health record extracts are requested to inform investigations into the following 10 questions:

1. The effect of substance use in adolescence on mental health (see HRA CAG 15/CAG/0177)
Investigators: Senior Research Associate for PEARL, Professor in Clinical Epidemiology and Primary Care (all University of Bristol contracted staff).
HES and MHSDS data will be used, along with GP data, to investigate the association between mental health outcomes in young people and substance use in adolescence. ALSPAC will consider the use of three of the most widely used substances (alcohol, cannabis and tobacco), and their association with a diagnosis of a mental or psychological disorder in general, and specifically a clinical diagnosis of mood disorder (e.g. depression), anxiety or psychotic disorder (e.g. schizophrenia). ALSPAC collected data will provide information on substance use exposure and NHS Digital and GP data will provide objective assessments of mental health outcomes. NHS Digital and GP data may be used (where possible) to assess reporting accuracy within the self-reported data and to inform strategies to deal with missing data. This research will improve understanding of the risks of substance use, and the patterns of health service use for young people with mental health problems.

2. Chlamydia testing, infection, and sequelae in young people (see HRA CAG 15/CAG/0176)
Investigators: Senior Research Associate for PEARL, Professor in Clinical Epidemiology and Primary Care.
ALSPAC will use HES data, along with GP records, to examine which factors influence Chlamydia testing, infection, and sequelae in young people. HES records will be used in the identification of pelvic inflammatory disease, ectopic pregnancy and reduced fertility amongst female ALSPAC participants with different evidence of exposure to Chlamydia (only negative tests, any positive tests, no evidence of testing). Reduced fertility will also be considered for male participants.

3. Assessing the Validity of Self-Reported Hospital Admissions and the Implications of study non-response (covered by CAG ECC 1-05(b)/2012)
Investigators: Data Linkage and Information Security Manager, Senior Research Associate, Research Associate in Statistics/Epidemiology and Data Manager (PEARL) (all full University of Bristol employees)
ALSPAC will investigate and describe 1) the reliability and validity of self-reported hospital admissions and those recorded in HES and MHSDS and 2) assess if individuals with adverse health status profiles are more likely to be missing from study follow-up assessments. This is methodological work which will support interpretation of ALSPAC data in other research projects (including the studies listed in this application) and also to support wider understanding and interpretation of bias in self-reported health status (e.g. in the NHS Survey of Mental Health and Wellbeing). This is increasingly important as ‘Big Data’ approaches in contemporary Data Science are being used to inform health policy development through the analysis of combined study data and routine records.

4. Investigating the accuracy of current estimates of self-harm (See HRA CAG 7-06(a)/2013)
Investigators: Professor of Epidemiology, Research Fellow, Senior Research Fellow (all full University of Bristol employees)
ALSPAC will use the data to investigate a) the accuracy of current estimates of self-reported self-harm in the community (exploring the impact of non-response bias and mis-reporting) b) the long-term risk of hospital admission for self-harm in those self-harming in the community. This information is of critical importance to prevent over or under-estimation of the magnitude of self-harm, as policies based on inaccurate estimates may lead to the wrong policy decisions and incorrect prioritisation of particular health risk factors. Findings will also help to identify risk factors for future self-harm hospitalisation, and improve understanding regarding the relevance of findings from population-based studies using self-report to clinical practice.

5. Early life causes of adolescent depression and anxiety (See HRA CAG 15/CAG/0175)
Investigators: Senior Research Associate, Professor in Clinical Epidemiology and Primary Care (all University of Bristol contracted staff)
The main research objective is to obtain accurate estimates of the association between maternal smoking and binge drinking during pregnancy and depression and anxiety in late adolescence and to investigate how (a) nonresponse and (b) misreporting in questionnaires affects estimates of this association. GP data will be used to provide depression and anxiety data for those individuals for whom we do not have self-reported information (just over 65% of the cohort). The secondary objective is to obtain accurate estimates of the prevalence of depression and anxiety in late adolescence.

6. Investigating the association between IQ and self-harm (see HRA CAG 14/CAG/1032).
Investigators: Senior Research Associate, Professor in Clinical Epidemiology and Primary Care (all University of Bristol contracted staff)
The main research objective is to obtain a more accurate estimate of the association between IQ and suicidal and non-suicidal Self-harm among adolescents and to investigate how (a) nonresponse and (b) underreporting in questionnaires affects estimates of this association. GP, hospital admissions and A&E data will be used to provide self-harm data for those for whom self-reported information is unavailable. The GP and hospital data will also be used to correct for any underreporting. The secondary research objective is to examine the extent to which adolescents seek GP help for self-harm and suicidal feelings.

7. Enabling the cross validation of asthma diagnosis using combinations of symptom and physiological data with GP and Hospital records (supported by ECC 1-05(b)/2012)
Investigators: Senior Research Associate, Data Linkage and Information Security Manager, Professor in Clinical Epidemiology and Primary Care, Professor of Paediatric Respiratory Medicine, Research Fellow (all University of Bristol contracted staff).
ALSPAC will use the data to investigate a) the accuracy of current estimates of self-reported asthma in the community (exploring the impact of non-response bias and mis-reporting) and b) to calculate the extent of asthma severity from recorded hospital attendance/admissions as well as primary care emergency visits and treatment steps. There is concern that asthma may be socially patterned and that it is known that key exposure and confounders collected through observational studies certainly are. Therefore the concern is that assumptions made about the associations and confounding structures of relationships between environmental exposures and asthma outcomes may not be valid. Insights into the accuracy of ALSPAC self-reported and study clinic assessed asthma and the severity of asthmas will support our investigations into the genetic and environmental influences of asthma and current work into the impact of traffic pollution on asthma. ALSPAC will investigate i) the natural history of early wheeze in relation to later asthma outcomes; 2) the relationships between early wheezing and later clinical records to determine if a ‘severe asthma’ profile can be detected in early childhood; 3) compare the impact of smoking and biomarker data from ALSPAC and respiratory function; 4) investigate the relationships between childhood infections and wheezing phenotypes with asthma and lung function in later childhood. This may help confirm an association (identified elsewhere between early respiratory infection and decreased lung-function during childhood that may be antecedent to adult respiratory morbidity and possibly mortality; and, 5) investigate the relationships between treatment for asthmas in primary care, adherence to treatment and outcomes of asthma and lung function in later childhood and early adulthood.

8. Antecedent factors predictive of later ear disease (covered by CAG ECC 1-05(b)/2012)
Project: Serious ear disease in later childhood and adulthood is distressing and burdensome on those effected and incurs treatment costs on the NHS. This project will investigate whether early signs of ear disease identified in ALSPAC at age 9 (categorised from photographs of the ear drum) are predictive of the development of serious ear disease requiring hospital treatment in later childhood and adulthood (as identified through HES).

9. Parental and child alcohol use and later child criminality and injury outcomes (covered by CAG ECC 1-05(b)/2012)
The impact of parental and child alcohol use on child health and education is unclear, and have possible societal and service provider costs. ALSPAC has multi informant measures of parental alcohol use reported by the mothers and partners during pregnancy and throughout childhood (allowing comparison of maternal and paternal effects). ALSPAC have also collected child self-reported alcohol use and family-reported measures of child criminal and anti-social behaviour. These self-reported measures will be used to help understand associations between alcohol use and child outcomes including child alcohol use, criminal and antisocial behaviour and injury. As part of this investigation linked HES records will be used to contribute information on hospital admission (with codes related to injury linked to external causes of morbidity, i.e. alcohol) and attendance at A&E due to accidents and injuries.


10. Patterns of engagement with health and education services as predictors of child looked-after or in-need status (covered by CAG ECC 1-05(b)/2012).
HES data will be used, along with ALSPAC self-reported data and education records (e.g. attendance rates) and extracted general practice data, to examine whether patterns of health service engagement (e.g. missed routine appointments, regular attendance at A&E or out-of-hours services, receipt of care for accidental injuries) are useful predictors of a child becoming in need or looked-after. ALSPAC are engaged with the nascent National Child Looked After Observatory and local (Bristol) safeguarding teams in order to effectively disseminate the findings. Findings will also be published in appropriate academic journals and through conferences and local workshops (in partnership with the South West BRC, NHS CLHARC West and Bristol Health Partners).

Yielded Benefits:

University of Bristol received the data in late August 18 and are still processing and documenting it. Applied analysis is due to start in early 2019. There have been data quality issues with the HES data received - a full resupply will be given, so that correct analysis can be taken. Therefore no yielded benefits have been realised.

Expected Benefits:

The described investigations have defined primary objectives to improve the understanding amongst some of the most concerning and prevalent areas of adolescent health; i.e. those relating to depression, psychosis, self-harm and suicide and substance use. Through this innovative use of a cohort study of adolescents linked to health records ALSPAC can study exposure/outcome associations in marginalised groups (i.e. those in need/in care and those suffering from mental health conditions). Secondary objectives relate to a better understanding of self-reported measurement error which will be used to inform interpretation of evidence emerging from longitudinal research studies and therefore improve the accuracy of evidence informing health and social care policy development.

The project level anticipated benefits include:


Project 1 (The effect of substance use in adolescence on mental health): This research will lead to a better understanding of the risks associated with substance use in adolescence, and the
aetiology of mental health difficulties. It therefore has the potential to impact on public health policy. here is unlikely to be any major direct benefit to study participants, although the study involves a wider public health benefit. Study participants experiencing mental health problems may benefit from improved understanding of the cause of these, but such benefit is difficult to quantify.


Project 2 (Chlamydia testing, infection, and sequelae in young people): Effective reduction of adverse sexual health outcomes depends in part on an understanding of the factors and processes that predispose an individual to experience these outcomes. Such understanding depends on the ability to consider the influence of exposures acting across the life course from early childhood. This research will lead to a better understanding of sexual health and testing behaviours in young adults. It therefore has the potential to impact on public health policy.


Project 3 (Assessing the Validity of Self-Reported Hospital Admissions and the Implications of study non-response): Self-reported data suffers from participant reporting bias introduced by factors such as recall error (i.e. the ability to accurately remember and report information) or social desirability (i.e. where perceived social influences impact on the answers individuals give). This project will help inform researchers, public health officials and policy makers as to how to interpret findings generated using self-reported data. Separately, it is known that participants who respond to studies are different to those who do not, and there is potential for health effects to impact on individual’s likelihood to take part. Findings from this study will improve the understanding of study error (e.g. error’s in prevalence estimates introduced where the likelihood of follow-up is differentiated by social, demographic or health conditions).

The potential benefits of Project 3 are illustrated by Project 4 and 5. While Project 3 will look at this in broad terms, Project’s 4 and 5 will study some of the same issues at more depth within the context of specific health status’s.


Project 4 (Investigating the accuracy of current estimates of self-harm): Outputs from this project are of critical importance to prevent over or under-estimation of the magnitude of self-harm, as policies based on inaccurate estimates may lead to the wrong policy decisions and incorrect prioritisation of particular health risk factors. Findings will also help to identify risk factors for future self-harm hospitalisation, and improve understanding regarding the relevance of findings from population-based studies using self-report to clinical practice.


Project 5 (Early life causes of adolescent depression and anxiety): Rates of anxiety and depression among children and adolescents in the UK have increased markedly in recent decades. Maternal smoking and alcohol consumption during pregnancy have been shown to be associated with many
adverse psychological and behavioural outcomes among children, including in ALSPAC. ALSPAC would like to find out if these are risk factors for adolescent depression/anxiety. It is possible that the predictors of depression/anxiety may be different among individuals for whom self reported
data is available, compared to those who are no longer participating in the study. Outputs will inform the methodological understanding of self-reported depression and anxiety and public policy development.


Project 6 (Investigating the association between IQ and self-harm): Findings from the research will add value to epidemiological research on self harm and have wider benefit for the scientific community as it will increase ALSPACs knowledge of how best to combine self harm data from different sources. With the inclusion of GP data, it will build on work being undertaken by colleagues and allow researchers to make appropriate decisions regarding missing self reported data in their analyses. This research also has the potential to impact on public health policy as it will lead to a better understanding of who is at greatest risk of self harm. This is important in terms of the appropriate design and targeting of interventions.


Project 7 (Enabling the cross validation of asthma diagnosis using combinations of symptom and physiological data with GP and Hospital records): Findings will improve the understanding of asthma research based on the ALSPAC study and other studies using similar methodologies. Specifically, longitudinal approaches will allow greater understanding on precursor GP reporting (e.g. presenting with wheeze) prior to diagnosis of asthma status. Accurate asthma status informed by objective assessment and therapeutic data will enable more accurate assessment of the environmental and genetic development influences of asthma and other respiratory conditions.


Project 8 (investigating early signs of ear disease): Information about the prognosis of these early signs and their likely development into serious disease will inform clinical decision making about the need for early preventative surgical intervention, which is currently not known. Study findings will be published in appropriate journals and presented locally and nationally through specialist Networks.


Project 9 (parental and child alcohol use and later criminality and injury outcomes): In part, this research will address the evidence gap on in utero substance use exposure on child outcomes. The importance of this work has recently been highlighted in a systematic review of the effects of maternal alcohol consumption in pregnancy on later child outcomes (see http://www.bris.ac.uk/news/2017/september/drinking-during-pregnancy.html for more details), and the confusion this generates with conflicting press reporting of 'safe' levels of substance use public health guidance for pregnant women. The research will also consider childhood exposure to parental alcohol consumption and later child/adolescent/young adult alcohol consumption and resulting patterns of criminality and personal injury. Evidence of complex health and social associations is lacking due to the challenge of building sufficiently rich and diverse data to inform these investigations. Our aim is that linked ALSPAC-HES-General Practice-Education records will inform understanding in this area and allow dissemination via relevant journals, press releases and appropriate networks as outlined in Outputs for Project 9.


Project 10 (Patterns of engagement with health and education services as predictors of child looked-after or in-need status.
It is known that children in care have poorer health and education outcomes than those not in care. Early identification of children at risk of care status will aid early intervention. If the project identifies strong predictors it will investigate the potential for them being incorporated into a predictive tool to be used by health or social care professionals. Such a tool could be embedded in clinical software and improve the early identification of risk, a key challenge in the safe-guarding of children.

Outputs:

All investigations are due to be conducted between 2018 and 2020. Timings of the dissemination via journal articles will be constrained by the nature of the peer-review system. ALSPAC employ dedicated communications experts to assist with dissemination and engagement. Public and professional publicity (e.g. press releases, twitter posts, newsletter and facebook articles) will be coordinated with the publication of findings. Dissemination via conferences and workshops will occur throughout the project period using interim results. For all the investigations, ALSPAC are committed to feeding back findings to our participants. Participants will be informed through the ALSPAC print and social media newsletters. ALSPAC have a strong track record of running study engagement events which are designed with input from participants. In recent years ALSPAC have held ‘data linkage’ themed evening lectures (e.g. http://www.bristol.ac.uk/alspac/external/presentations/how-we-are-using-your-records.pdf) and ‘ResearchFest’ (http://www.bristol.ac.uk/alspac/events/researchfest2012/), a day-long event with a wide series of public lectures in Bristol. Periodically the study produces a book (e.g. http://www.bristol.ac.uk/alspac/go/21st-book/) or YouTube videos (https://www.youtube.com/user/children90s) that describe findings and how participant data is used. ALSPAC works with national and local media to disseminate findings, along with local attractions such as the MSHED museum of Bristol Life. Study findings from the applications described in this application will be incorporated into future activities.

ALSPAC will work with the University of Bristol press office and the team at Understanding Patient Data to promote the findings from these investigations (e.g. https://understandingpatientdata.org.uk/case-study/investigating-self-harm-young-people). The participants will be informed of the outputs through our press-release system (http://www.bristol.ac.uk/alspac/news/) and via our newsletters (http://www.bristol.ac.uk/alspac/participants/newsletters-leaflets/) and social media (https://en-gb.facebook.com/childrenofthe90s/ or https://www.youtube.com/user/children90s)


Our specific project level dissemination plans are:


Project 1 (The effect of substance use in adolescence on mental health):(See HRA CAG-15/CAG/0177)
The findings will be disseminated through appropriate epidemiological and public health academic journals (e.g. Addiction, International Journal of Epidemiology, Epidemiology, Wellcome Open) and findings (including interim results) at conferences (e.g. Society Academic Primary Care, MRC Farr Institute). ALSPAC will also work with members of the NHS Bristol Health Impact Team to feed findings to local service providers.


Project 2 (Chlamydia testing, infection, and sequelae in young people): (see HRA CAG 15/CAG/0176)
This research will lead to a better understanding of sexual health and testing behaviours in young adults. It therefore has the potential to impact on public health policy. Findings will be published in an appropriate epidemiology journals or those dedicated to sexual health fgindings (e.g. International Journal of Sexual Health). The Senior Research Associate will lead professional dissemination based on understandings gained from his role as the Deputy Chair of the NICE Public Health Advisory Committee (PHAC-F), a committee responsible for the development of NICE public health guidance and is the Director of the NHS Bristol Health Partners sexual health for population and patients’ health integration team.


Project 3 (Assessing the Validity of Self-Reported Hospital Admissions and the Implications of study non-response):(see ECC1/05(b)/2012)
Insights from this work will be published in an appropriate epidemiology/survey methods journal (e.g. Society of Longitudinal and Life Course Studies, BMC Medical Research Methodology, Survey Research Methods), at similar conferences and via ALSPAC study website and the CLOSER longitudinal research consortium website. To ensure this information is fedback to the NHS ALSPAC will send the project findings to the Care Quality Commission ‘Survey Coordination Centre’ who facilitate NHS Surveys.


Project 4 (Investigating the accuracy of current estimates of self-harm):(see HRA CAG 7-06(a)/2013 )
Results from the study will be published in a suitable epidemiology/psychiatry journal and via the ALSPAC study website. Preliminary work (based on those participants who provided consent to link their data with medical records) has been published in Archives of Suicide Research (http://dx.doi.org/10.1080/13811118.2015.1033121), and has been selected as a case study by the Wellcome Trust ‘understanding patient data’ taskforce (https://understandingpatientdata.org.uk/case-study/investigating-self-harm-young-people). To ensure this information is fed back to the NHS ALSPAC will communicate the project findings to the Bristol Health Partners ‘Improving Care in Self-Harm’ STITCH Health Integration Team. Professor David Gunnell (The project PI) is the academic lead for STITCH. DG is also a member of both England’s and Bristol’s Suicide Prevention Advisory Groups and works closely with Public Health England, and will feed back relevant findings into NHS and Public health strategy.


Project 5 (Early life causes of adolescent depression and anxiety): (see HRA CAG 15/CAG/0175)
Outputs will be published in academic journals (e.g. BMJOpen, International Journal of Epidemiology) and will inform methodological understanding of self-reported and public policy development. The Investigators will work with Prof. Ann John (University of Swansea, who will not have access to the data) to disseminate findings; Prof. John chairs the National Advisory Group to Welsh Government on Suicide and Self harm prevention and is honorary Consultant in Public Health Medicine with Public Health Wales.


Project 6 (Investigating the association between IQ and self-harm):(see HRA CAG 14/CAG/1032)
Findings will be published in academic publications topical to the condition and/or epidemiological methods (e.g. BMC Medical Research Methodology). The researchers will work with Professor Gunnell to ensure wide dissemination of study findings within relevant NHS community (see Project 4).


Project 7 (Enabling the cross validation of asthma diagnosis using combinations of symptom and physiological data with GP and Hospital records):(supported by ECC1/05(b)/2012)
Findings will improve the understanding of asthma research based on the ALSPAC study and other studies using similar methodologies. Understanding will be disseminated via the Medical Research Council and Asthma UK funded STELAR asthma research consortium. Findings will help support research by the Medical Research Council and Natural Environment Research Council ERICA study that will assess associations between traffic pollution exposure and asthma outcomes in ALSPAC index children. The findings will support Prof. Henderson’s programme of work, as a part of which he was a lead contributor to the Royal College of Physicians ‘Every Breath We Take’ report into the lifelong impacts of air pollution (https://www.rcplondon.ac.uk/file/2914/download?token=qjVXtDGo).


Project 8 (Antecedent factors predictive of later ear disease): (supported by ECC1/05(b)/2012)
The Senior Research Associate in Medical Statistics and the Professor of Community Child Health will use the data to conduct the research evaluation. Clinical expertise will be provided by a Research Fellow in Social and Community Medicine and a Lecturer/NHS ENT surgeon, neither of whom will be provided with access to the data. Academic findings will be published in journals (e.g. International Journal of Audiology, BMJ Open, PLoS ONE). Study findings will be disseminated via the ENT liaison with the local CCGs Clinical Policy Review Groups. On a national level the ENT Specialty Lead for the NIHR Clinical Research Network: West of England will disseminate via the ENT National specialty group.


Project 9 (parental and child alcohol use and later criminality and injury outcomes): (supported by ECC1/05(b)/2012)
This work has been funded by the UK Medical Research Council and findings will be disseminated through academic routes (i.e. public health and health practitioner journals such as the BMJ as well as conferences such as the Society of Academic Primary Care), press releases and feedback to Department of Health policy makers. The Director of the NHS Bristol Health Partners ‘Drug and Alcohol’ Health Impact Team and will feed findings through into local care providers via this network.


Project 10 (Patterns of engagement with health and education services as predictors of child looked-after or in-need status): (supported by ECC1/05(b)/2012)
Research findings will be disseminated by the emerging National Family Justice Observatory and the Children Looked After and In Need strands of the Administrative Data Research Network. We will publish our findings in relevant academic journals (e.g. Epidemiology, Wellcome Open, Child & Family Social Work, British Journal of Social Work, Adoption and Fostering). We will disseminate relevant project findings to charities (e.g. NSPCC) and the NHS England ‘National Looked After Children Safeguarding Sub Group’.

Processing:

Filtering based on Legal Basis:

The CAG committee (in ECC 1-05(b)/2012) requested that ALSPAC distinguish between health records with normal sensitivity (e.g. relating to a broken leg or having asthma) and those that are particularly sensitive (including all mental health and sexual health records). ALSPAC have listed (using health codes) all the particularly sensitive types of records in existence. This list will be used to ‘filter’ out the particularly sensitive records for which there is not s251 support and must therefore be excluded from the extract. This filter list has been altered to include the particularly sensitive records needed for the research investigations included in this project and which are allowed under ALSPACs further s251 approvals. This has resulted in an ‘inclusion list’ of all the codes that have s251 support, and are to be extracted and provided by NHS Digital to ALSPAC. The technical feasibility of applying this inclusion list within the ALSPAC extract has been considered and agreed by NHS Digital staff. Steps are taken when generating the extract to ensure that particularly sensitive records which are not in the inclusion list neither appear in the extract, nor their presence can be inferred by ALSPAC when they receive the data. This is little difference in principle than a typical minimised data request based around a specific event (e.g. to extract coronary heart disease records only), only in this instance, there is a very wide range of specific events.



Process Stage 1: Linking ALSPAC participants to the NHS/NHS Digital demographic database
(this stage has already taken place and further linkage will only be applicable for those cohort participants not originally linked)

ALSPAC have provided the NHS Digital (then NHS IC) with the personal identifiers of its study participants. NHS Digital commissioned linkage of the ALSPAC identifiers to the NHS central demographic register (now the NHS Spine). The product of this linkage (a link between ALSPAC MR1048 ID to NHS ID for each participant) is stored by NHS Digital and can be used to identify ALSPAC participants amongst NHS Digital records. Additional linkage may be required for newly enrolled cohort participants (approximately 15,000 of 20,000 eligible families are enrolled, but small numbers of the remaining 5,000 continue to enrol). A new Study ID will be allocated to these records.

ALSPAC will securely provide NHS Digital with separate lists identifying (by Study ID) our MR1048b:s251 participants. The lists will be filtered for up-to-date consent/dissent/withdrawal from ALSPAC status prior to sending.


Process Stage 2: NHS Digital Extraction of Records
HES and MHSDS records of ALSPAC participants will be identified using the existing MR1048 link and NHS Digital will extract copies of participants records where found (with the same processing for ‘new’ cohort participants). The extract for MR1048b: s251 will be filtered (as described above) to erase the existence of the ‘sensitive’ records (in such a way that it cannot be determined that they previously existed) and to exclude any participants who have registered a national patient data sharing objection.

The MR1048b:s251 extracts will be sent to the ALSPAC Data Safe Haven. The extracts will be identified by Study ID and a check identifier (Date of Birth) to allow validation of the linkage. The extract will be sent to ALSPAC via the NHS Digital secure methodology (e.g. secure download site in an encrypted file). As ALSPAC are able to map MR1048 ID back to the ALSPAC administrative database these data extracts should be considered as being identifiable (even if pseudonymised).

The extracts will be received into the ALSPAC Data Safe Haven; which is managed by a small, specialist, team of ALSPAC health informatics experts (employed by the University of Bristol). The data will be stored on a secure encapsulated virtual machine located at the University of Bristol. The safe haven is kept separately from the ALSPAC administrative database (which contains participant identifiers). The Data Safe Haven design has been adopted to restrict access to identifiable data used for secondary purposes and to support the de-identification of the data prior to the bulk of the data uses. The Data Safe Haven governance arrangements have been reviewed and approved by an NHS Research Ethics Committee (REC) and the Health Research Authorities Confidentiality Advisory Group (HRA CAG). The Data Safe Havens security arrangements have been independently audited and certified to the NHS IG Toolkit and ISO27001 security standards (described below).


Process Stage 3: Data processing in the ALSPAC Data Safe Haven
The ALSPAC Data Safe Haven was designed in accordance with NHS policy [3]. Incoming, identifiable, data is stored in an encrypted format on encrypted and firewalled demarcated server space. Access to this server space is restricted to the Data Safe Haven team (by user access controls and access is only permitted from a small number of desktop computers based in secure offices at the University of Bristol). On entry to the Data Safe Haven a copy of the data is archived. The data are processed for the following purposes:

i. Assess Data & Data Linkage Quality: The data extract is compared against the agreed extract specification to ensure the content (both in terms of variables supplied and patients included) is correct. The linkage between ALSPAC participant and NHS record is quality checked using check variables (e.g. NHS ID to ALSPAC ID link is checked using date of birth and gender). The data values will be subject to logical error checks to assess if the value is consistent with the expected values (as defined in the source documentation). Inconsistent values will be recoded to missing (i.e. ALSPAC will not attempt to infer a correct value);

ii. Derivation: Derived data are created in order to assist in the de-identification of the data (e.g. Age in days at the time of a health event will be derived from Date of Birth and the event date) and to distil records extracted from multiple sources into a cohort longitudinal record (e.g. age in days will allow accurate sequences of events to be created when combining NHS Digital data with other data), and to assist the research process (e.g. 1) a range of read codes, hospital admissions and prescription data are used to derive an indicator to whether an individual has had any interaction with the NHS relating to/or being coded as asthma, and 2) routine records are used to inform statistical techniques, such as multiple imputation, which can address missing self-reported data). All derivation routines are applied through computer syntax, which is stored along with a documented record of the derivations;

iii. Linkage: The extract is linked to the internal ALSPAC individual ID numbers. The quality of the match is checked (see above). Linkage success or failure is assessed and documented within the data set (e.g. ALSPAC attempts to distinguish between failure to link due to a patient not seeking consultation, with failure to link due to insufficient identifiers and failure to link as the individual is resident outside of the catchment area of the data extract in question). The extract is processed to ensure it is harmonised with the ALSPAC longitudinal data set;

iv. De-Identification: The Safe Haven de-identification processes are designed to minimise the risks of disclosure through either: direct identification of an individual from a dataset (either accidentally or maliciously); through inference or through the potential of variables in combination to identify individuals; or the potential of inappropriately described outputs to identify individuals. The data are pseudonymised through removing NHS ID, name and address (where present). The extract is stored, within the Data Safe Haven, until information from it is requested for a research investigation.

v. Collation, Storage & Archiving: Copies of the data shared with researchers will be held securely within the Data Safe Haven. These will be used for audit purposes, to keep a record of research project sample selection (in order to allow follow-up assessments) and to fulfil the requirements that peer-reviewed findings are reproducible.
The identifiable data are only used for these data processing purposes, i.e. to facilitate and support research. The Identifiable data are not used in research investigations.


Process Stage 4: Participant Tracing Data
Where the data extracted from the NHS Digital relates to participant contact details and status (e.g. left England and Wales, fact of death) the members of Data Safe Haven staff will swap the ID used to extract the data for ALSPACs internal system ID and will then pass the information to the ALSPAC team whose role it is to maintain communications and relationships with participants. Neither NHS IDs or clinical data (beyond ‘alive/deceased’ status) will be provided to this team. The details are then used to update ALSPACs administrative database. These details are not provided to researchers, although address information is used to derive spatial identifiers and other values which are used in some research projects in a non-disclosive form.

ALSPAC will use a MRC Farr Institute ‘UK Secure eResearch Platform (UKSeRP) as a ‘secure research environment’ to combine records from different sources and to manage access to effectively anonymous sub-sets of combined records to specific researchers at a project level. UKSeRP is the technological infrastructure which supports the SAIL databank of Welsh routine health and administrative records. UKSeRP was developed by the Welsh MRC Farr Institute and is operated by two organisations: The NHS Wales Informatics Service (NWIS) and the University of Swansea Health Informatics Research Unit (HIRU). HIRU, through the MRC Farr Institute are making the UKSeRP infrastructure available to other research organisations. This means ALSPAC can make use of the full advantages of the secure research infrastructure developed to support SAIL by contracting the University of Swansea to provide a copy of the infrastructure to host ALSPAC data and data linked to ALSPAC. In this contractual arrangement, the University of Swansea will be Data Processor working to instruction from the University of Bristol who will be Data Controller (the contract will bind the University of Swansea to the same conditions (where relevant) as the University of Bristol have agreed to in their contract with the NHS Digital). UKSeRP has ISO27001 certification. This principle has been previously agreed as suitable for hosting linked NHS Digital records.


Process Stage 5: Linking ALSPAC participants to the UKSeRP
(this stage has already taken place and will not need repeating).
UKSeRP operates on a ‘split file’ approach to handling data; where identifiers are handled separately from clinical or individual attribute data. Identifiers are processed by NWIS (within the confines of the NHS); where they are processed by an algorithm which consistently converts incoming identifiers (e.g. NHS ID, name, date of birth) into an encrypted ‘Anonymous Linkage Field’ (ALF). In this way identifiers relating to the same person coming from multiple sources can be linked to the same ALF.

ALSPAC have already sent the identifiers to NWIS along with an externally meaningless ID number (KEY ID). NWIS have used the identifiers to create ALF IDs for ALSPAC participants. This is managed in such a way that 1) neither ALSPAC nor HIRU (who manage clinical data) are able to trace back ALF to a person’s identity and 2) ALSPAC are able to send clinical and other attribute data linked to KEY ID into the system which can then be automatically replaced with ALF in a ‘black box’ process.


Process Stage 6a & 6b: Sending NHS Digital and ALSPAC data from ALSPAC into the UKSeRP
ALSPAC research staff will replace the IDS on the de-identified data from the ALSPAC resource with the Key ID. The data will then be securely sent (using AES-256bit encryption) into the ALSPAC UKSeRP via the automated ‘gateway’ upload appliance.

ALSPAC data safe haven staff will also conduct the same process on the de-identified (see Stage 3) HES and MHSDS data. The HES and MHSDS data will then be securely sent (using AES-256bit encryption) with Key ID into the ALSPAC UKSeRP via the automated ‘gateway’ upload appliance.


Process stage 7:
The UKSeRP automated gateway system automatically replaces Key ID on incoming data with ALF ID (yet the system has no access to identifiers of the individuals used to produce ALF as these never leave the NWIS trusted third party). The data are then deposited in the ALSPAC UKSeRP. Meaning the ALSPAC staff have no means of linking ALF back to the ALSPAC databases, yet can use ALF to join records coming in from different sources or at different times (e.g. longitudinal updates).


Process Stage 8: Sub-setting and further anonymization of data prior to analysis
The researchers with approval to access the ALSPAC HES and MHSDS data will be created project specific ‘containers’ in UKSeRP that they can access. ALSPAC Data Safe Haven staff will sub-set the extracted data to minimise it to only the information needed to conduct the project investigation. Each project data set will be given its own unique ID. The researchers will not have access to the ALSPAC administrative database and therefore – given the technological, contractual, training and data management steps involved – the data can be considered to meet the Information Commissioner’s Office ‘effectively anonymous’ requirements (as defined in the ICO Anonymisation Code Of Practice – a separate document is included describing how our process meets the ICO requirements). Information about these hypotheses – and the use of NHS data sourced from the NHS Digital – will
be posted on the study website:

www.bristol.ac.uk/alspac/participants/young-people/.

Participants have been notified about this information, and each study newsletter includes updates and reminders (e.g. page 2 of:

www.bris.ac.uk/alspac/external/newsletters/Childrenofthe90s_familynewsletter_2015.pdf )

Participants are able to opt-out of each individual study (before the study starts). This mechanism for providing on going fair processing information was developed with the HRA CAG with input from the Information Commissioners Office.

Project specific datasets are risk assessed and disclosure control is applied as deemed appropriate. Further disclosure control ranges from suppression of rare values and outliers to a state where the possibility of disclosure is rendered so challenging that the data can be considered as being effectively anonymised in line with the HSCIC Anonymisation Standard for the publication of Health and social Care Data [4]. Case selections will be assessed for risks of disclosure through inference (e.g. where a sample selection is made on the basis of a health condition), where this is a risk the Safe Haven staff will add control or masking cases.

The ALF used in the hypothesis specific dataset will undergo secondary encryption (reversible by ALSPAC) using an algorithm specific to each project. This means that a researcher with multiple project will not be able to join data across the different datasets using ALF.


Process Stage 9: Researcher access to data
Researchers are all contracted to University of Bristol (as described below). They will only be able to access the sub-partition(s) of the ALSPAC UKSeRP where their project specific data set is located. The UKSeRP technology restricts the actions that researchers can take, for example, it is not possible to plug in a USB stick, or to copy and paste or to connect from within UKSeRP to the internet. These restrictions – in conjunction with the training and binding agreements the researchers enter into – ensure good governance is maintained. Furthermore, the anonymization processes undertake (stages 3 and 6) are sufficient to reduce the risks of participant identifiably to a point that they are so remote that the data can be appropriately treated as effectively anonymous.

Researchers are allowed to remove data outputs (e.g. statistical findings, graphs, tables of aggregated findings) from UKSeRP through a controlled process where each output is reviewed and assessed for disclosure risk by ALSPAC Data Safe Haven staff prior to being released. ALSPACs Data Access policies require that researchers submit all publications, prior to submission for publication, to the ALSPAC Executive. The Executive Committee assess the publications for issues including checks for potential disclosure risks (e.g. tables summarising statistical outputs containing small cell counts). Disclosure checks will ensure compliance with the small number suppression rules contained within the HES Analysis Guide.

Data Specification: ALSPAC require life-course data from birth (i.e. maternity HES from 1990-1993) to the most recent finalised datasets (it is appreciated that the records contained within different HES domains start at different points in time). This will allow the assessment of changing health status over time, changing severity of health status and the precursor health events leading up to health outcomes. ALSPAC require detailed information about these in order to build event sequence records comprising study collected information, linked health and social care records from NHS Digital and linked records from other providers (e.g. national pupil database records). The data request is limited to the cohort participants, but not limited geographically (given that our participants have moved away from the original cohort catchment area). ALSPAC is requesting that the extract is filtered to remove some particularly sensitive fields (to comply with the s251 approval conditions), but are not filtered for any other reason (i.e. a full range of health event information is needed in order to establish health status sequences for our diverse projects).

Information Security: ALSPAC are committed to maintain high standards of information security and recognise that this is a key component of the trust relationship with participants and data owners alike. To achieve these standards ALSPAC have developed an Information Security Management System and associated management and governance structure that has been certified as meeting the ISO/IEC 27001:2013 Information Security standard. ALSAPC have submitted an NHS IG Toolkit assessment (edition 14: 2016/2017) which scored 97% in our last assessment.

In the event the participant changes their mind, then ALSPAC have a defined ‘withdrawal of consent’ protocol, which is available to participants via the study website:

- http://www.bristol.ac.uk/alspac/participants/

The policy allows participants to tailor their involvement in the study; either by altering permissions for the use of their health records in a specific project, the use of their health records in general, or their continued involvement in the study.

Research Purposes: Observational epidemiology aims to build a body of evidence related to any given topic. The investigations detailed below are designed to add to the relevant evidence base within that field. In themselves, these will typically not directly change NHS process. However, if replicated elsewhere and found to be important through systematic review then this could lead to policy change (e.g. NICE guidelines are frequently developed using systematic reviews of evidence). This is in contrast to other types of research (e.g. randomised controlled trial interventions or drug trials) that may provide stronger evidence of causation and can hence can lead to more immediate impact. To ensure full potential for impact on health and social care system, ALSPAC will ensure that the findings of the investigations are well placed to feed into this process through ensuring publication in peer-reviewed journals that are fully indexed (e.g. pubmed, medline) and contain strong descriptive keywords (i.e. the findings will be discoverable by those conducting systematic reviews). This is the standard pathway to impact for observational research. Where possible, ALSPAC will also directly feed findings into national or local health care initiatives, and this is described where relevant (see below).

The ALSPAC Data Safe Haven team who will process the data are:Data Linkage and Information Security Manager, Data Manager (PEARL), Research Associate in Statistics/Epidemiolog and the Senior Research Associate. All are University of Bristol contracted staff. The Safe Haven team will prepare the data extracts and also give ‘Data Science’ input into the research process (i.e. through offering expert guidance on ALSPAC, data linkage processes, and on the interpretation and statistical processing of linked records within an epidemiological context). As such they will undertake processing which from data management to research analysis.

None of the data requested will be linked with any other data, apart from the linkages permitted in the DSA. Additionally there will be no attempt made to re-identify individuals from the the previous extract of consenting index children

MR1240 - Evaluation of centralisation in head and neck cancer — DARS-NIC-147901-2XMLG

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2019-06-01 — 2020-05-31 2017.09 — 2024.10. breached contract — audit report.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY HOSPITALS BRISTOL AND WESTON NHS FOUNDATION TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Members and Postings Report
  4. MRIS - Flagging Current Status Report
  5. MRIS - Scottish NHS / Registration
  6. Cancer Registration Data
  7. Civil Registrations of Death
  8. Demographics

Objectives:

The overall aim of the programme is evaluate and disseminate the outcome of centralization in Head and Neck cancer (H&N). In order to accomplish this we will create a clinical cohort of 5,000 people with H&N and follow up this cohort. This study will be large enough to compare groups by age, site and stage. Data are already collected on the care provided to patients with H&N as part of an ongoing National Head and neck cancer audit. The proposed studies will complement these National audit data by investigating the role of patient characteristics not recorded as part of routine care and by examining a broader range of patient centred and clinical outcomes. We will collect data on people with H&N that would include age, sex, diagnosis and treatment. Additional data will be collected on socioeconomic status (including occupation, education and housing): lifestyle (including smoking and alcohol intake); questions on psychological status and general and cancer specific quality of life questions. We will collect a venous blood, saliva and tissue sample for use in future translational studies. The outcome of the study will allow clinicians and managers to design effective patient centred multidisciplinary centralised services for people with H&N.

Yielded Benefits:

To date, 15 peer reviewed papers arising from the study have been published, and these analyses have been presented at a number of scientific meetings. The study is currently supporting around 30 ongoing analysis projects and are part of the World Health Organisation’s International Agency for Research on Cancer (IARC) international consortia, exploring the role of germline and tumour genetics on Head and Neck cancer aetiology and prognosis. As well as published papers findings have been presented at clinical conferences such as BAHNO (British Association of Head & Neck Oncologists) and BAHNON (British Association of Head & Neck Oncology Nurses) and the International Quality of Life Conference for Head & Neck Cancer. To date the findings from Head and Neck 5000 have contributed to knowledge around aetiology and prognosis in people with head and neck cancer. To date these findings have not resulted in any formal changes to policy or guidance but it is anticipated that the work will provide evidence that will inform practice and improve the management of people with head and neck cancer in terms of risk stratification, lifestyle modification and prognostic prediction.

Expected Benefits:

Head and neck cancer (H&N) is one of the commoner cancers with around 7,000 cases per year in England and Wales. The incidence appears to be increasing. The two year all cause mortality is around 35%. A person with H&N requires care from a range of disciplines. These include surgical teams to resect the tumour, dissect the neck and reconstruct the defect; radiotherapists and oncologists to provide radiotherapy and chemotherapy; clinical nurse specialists to offer pre and postoperative support; nutritionists to help with postoperative feeding and nutrition; speech therapists to assist with speech and swallowing; restorative dentists to fit and maintain prostheses and treat dental caries; palliative care physicians to support patients in the terminal stages of H&N and psychologists to provide psychological support. In an attempt to move beyond clinical outcomes, such as the surgical result or survival, quality of life scores have been developed for people with H&N and are being used to guide and monitor response to treatment. Despite their importance there is limited evidence on the modifiable psychological and social determinants of coping for people with H&N. There is thus a need to assess a broad range of patient centred outcomes in studies of H&N.

Outputs:

We will continue the follow up through flagging so participants that survive remain in the study for
10+ years. The MRIS will enable us to trace and identify those that have died to ensure that we do not send out further questionnaires. Furthermore, the flagging will provide ongoing notifications about our participants and will allow the study to compare morbidity and mortality outcomes across different centres. We will also be able to analyze the broad range of patient centred outcomes collected in the study in relation to morbidity and mortality.

Processing:

The overall objective of the study is to recruit a clinical cohort of 5,000 people with H&N and then follow up this cohort for two years. This study will be large enough to compare groups by age, site and stage. Specifically, the objectives are to:
1. Compare morbidity and mortality outcomes across different centres.
2. Compare quality of life outcomes across different centres.
3. Describe the individual economic cost of head and neck cancer care.
4. Identify prognostic indicators for head and neck cancer.
5. Create a resource for translational and applied research in head and neck cancer.
Research nurses at each participating H&N cancer centre together with the research team will recruit and collect data:
• Obtain consent
• Baseline collection
- Collect blood, saliva and tissue sample accordance with the established biological sample protocol
- Administer the base line questionnaire at the clinic
- Provide the additional baseline questionnaire pack to be completed at home which should be sent back to the research team in the provided prepaid envelope.
• The patients will be flagged with the NHS Information Centre (NHSIC) and followed for two years.
• At 4 months, the research team will send out the 4 month questionnaire pack to the participants enrolled for self completion at their home together with a prepaid envelope to return the questionnaire pack.
• At 12 months, the research team will send out the 12 month questionnaire pack to the participants enrolled for self completion at their home together with a prepaid envelope to return the questionnaire pack.

The High-volume Haemodiafiltration vs High-flux Haemodialysis Registry Trial (H4RT) — DARS-NIC-166879-K4Z0S

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No, Identifiable (Consent (Reasonable Expectation))

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

Purposes: No (Academic)

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

When:DSA runs 2020-12-10 — 2023-12-09 2021.04 — 2024.09. breached contract — audit report.

Access method: One-Off, Ongoing

Data-controller type: NORTH BRISTOL NHS TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Critical Care
  3. Hospital Episode Statistics Outpatients
  4. Civil Registration - Deaths
  5. HES:Civil Registration (Deaths) bridge
  6. Civil Registration (Deaths) - Secondary Care Cut
  7. Civil Registrations of Death - Secondary Care Cut
  8. Hospital Episode Statistics Admitted Patient Care (HES APC)
  9. Hospital Episode Statistics Critical Care (HES Critical Care)
  10. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

End-stage kidney disease (ESKD) affects around 55,000 people in the UK, with around 7,000 newly affected people each year. The survival probability at one, three and five years is around 90, 70 and 50%, respectively. Morbidity is high, with dialysis patients in the UK spending around 15 days in hospital per year. Quality of life on dialysis is also well below that of the general population. There is therefore an unmet and urgent need to improve ESKD patient treatment. Renal replacement therapy (dialysis or transplantation) is necessary when approximately 90% of kidney function is lost. Currently around 90% of existing dialysis patients are on some form of haemodialysis (HD) or haemodiafiltration (HDF). Although HD and HDF can be performed at home, the majority is performed in-centre.

Most people with kidney failure receive blood cleaning treatment (HD) 3 times a week at a hospital or clinic. Adding filtration (the removal and replacement of fluid) to regular HD (which allows toxins to leave the blood with minimal fluid removal/ replacement) results in HDF. As far as the patient is concerned, the two procedures are very similar – they both involve about 4 hours treatment 3 times a week, the dialysis machine is just set up slightly differently. HDF does, however, require a greater volume of high quality water at an increased cost to the NHS and the environment. By removing toxins more effectively, HDF should in theory have benefits, especially if high volumes are used (i.e. more than 21L of water removed and replaced per dialysis session). On the downside, such volumes of filtration could remove essential proteins from the blood stream or introduce toxins or infections from the water supply.

For patients with ESKD who are suitable for kidney transplantation the average waiting time in the UK is 2.8 years. Minimising damage from ESKD during this time is likely to improve their long-term outcomes. For others, kidney transplantation is not an option and quality and quantity of life needs to be optimised. The high-volume HDF vs high-flux HD registry trial (H4RT) is important to patients and the public because existing evidence suggests there may be up to a 40% reduction in mortality if patients receive high-volume HDF. This evidence is weak though, as patients have not previously been randomised to high-volume HDF vs high-flux HD, so the survival advantage may represent the fact that patients who achieve high-volume HDF are fitter. Despite a lack of strong evidence regarding increased patient benefit and cost-effectiveness, around 15% of patients in the UK are currently receiving HDF, with wide centre variation and plans for further adoption. Before this technology diffuses more widely across the UK, a definitive trial is needed to determine whether HDF should be made available to all patients, certain sub-groups of patients, or none.

The H4RT is therefore randomly allocating ESKD patients into either intervention (high-volume HDF) or control (high-flux HD) groups. Patients are 18 or over, and already attending a dialysis unit for maintenance HD or HDF 3 or more times a week in one of 235 possible dialysis units across the UK. Recruitment commenced 1st November 2017 and is ongoing, with funding currently approved until 31st August 2021. All patients have been provided with information about the nature of the trial and how their personal and sensitive data will be processed. Ethical issues have been considered and appropriately addressed, and there are no further issues anticipated. Patients with lack of capacity to consent; predicted life expectancy of less than 3 months; scheduled transition to living kidney donor transplant or home dialysis within 3 months; lack of clinical suitability for HDF; or who started maintenance HD or HDF within 4 weeks are excluded from the trial.

The primary outcome of the trial will be the determination of any difference between high-volume HDF and high-flux HD in terms of non-cancer mortality, and hospital admission due to a cardiovascular event or infection. The secondary outcomes will be the understanding of the impact of high-volume HDF on: cause specific and all causes of mortality; quality of life (generic, health utility, disease-specific and time to recover following dialysis); indirect effects such as inflammation, anaemia and bone mineral disorder management; and NHS costs/ cost-effectiveness (incremental cost per quality adjusted life year).

H4RT was funded on the basis of its "efficient study design", with baseline data collected by research nurses and all follow up being done through (1) linkage with routine healthcare data and (2) centrally administered patient quality of life questionnaires. The move to efficient study designs is in response to a recognition that randomised controlled trials have become very expensive in recent years, making them only affordable when there is a new product being tested with potential to generate profit under a patent. In efficient studies, there are no research visits after the baseline visit, and all subsequent data is collected by mailed/ emailed quality of life questionnaires and linkage to routine healthcare databases.

Data are needed at the individual patient level to follow up each patient in the trial. The University of Bristol will send a cohort including patient identifying information to NHS Digital for linkage, and NHS Digital will return the linked data in a pseudonymised form, providing many of the primary and secondary outcomes for the trial:

• Hospital Episode Statistics – Admitted Patient Care. This is required to derive part of the composite primary outcome, hospital admissions due to cardiovascular and infection events.
• Hospital Episode Statistics – Critical Care. This is required for the heath economics analysis, as admission to intensive care increases hospital admission costs considerably and HDF could influence cardiovascular and infection events that would lead to critical care admission.
• Hospital Episode Statistics – Outpatients. This is required for the health economics analysis, as HDF could influence cardiovascular and infection events that would lead to additional outpatient attendances.
• Civil Registration (Deaths) Secondary Care Cut – This is required to derive the composite primary outcome, non-cancer mortality.

Pseudonymisation minimises the risk of sensitive clinical data on an individual patient being intercepted and traced to them. There are no alternative, less intrusive ways to collect the follow up data for this trial. These data will be combined with the baseline data collected by research nurses in a secure environment at the University of Bristol to compare the effectiveness of the two treatments. NHS Digital data will be required for each patient from their individual trial start date, between 2017-2022, until the end of the study, anticipated 2024.

Only data items necessary for the analysis to derive the primary and secondary outcomes have been requested. Data has been further minimised by requesting only NHS Digital data for each patient from the date they joined the trial.

Purpose of processing:

HES and Civil Registration data will be processed to derive the primary outcome and secondary outcomes for the trial following a statistical analysis plan which has been developed and will be signed off by the trial management group.

The primary objectives will be to determine the relative effectiveness of high-volume HDF compared with high-flux HD on the first event of non-cancer mortality, hospital admission due to a cardiovascular event or infection (primary outcome).

The secondary objectives are to determine the effect of high-volume HDF on:
• Mortality: from all-causes as well as cause specific
• Morbidity: hospital admissions related to cardiovascular events and infection events
• Quality of life: generic, health utility, disease-specific and time to recover following dialysis
• Indirect effects: laboratory indicators of inflammation, anaemia, bone mineral disorder management
• NHS costs and cost-effectiveness: incremental cost per quality-adjusted life year gained

The joint data controllers are the University of Bristol and North Bristol NHS Trust. The data will be processed at Bristol Randomised Trials Collaboration which is part of the University of Bristol. The Chief Investigator and all co-investigators accessing NHS Digital data are substantive employees of the University of Bristol.

The lawful basis for processing personal data for the H4RT are Articles 6(1)(e) and 9(2)(j) of the General Data Protection Regulation (2018). These lawful bases can be justified as follows:

Article 6(1)(e), i.e. that the processing is being undertaken as a 'public task': H4RT is an NIHR HTA competitively funded, peer-reviewed randomised controlled trial. It is being Sponsored by an NHS organisation (North Bristol NHS Trust) and delivered by a UK Higher Education Institute (University of Bristol).

Article 9(2)(j), i.e. that the processing is being undertaken in the 'public interest': The need for better evidence on the effectiveness of high-volume HDF to inform NHS care was recognised and prioritised by NIHR (and has subsequently been recognised by NICE). Data is only being processed on participants in the trial, who have all had the research (including the linkage of their trial data with routine healthcare databases) explained to them in an approved patient information sheet by a research nurse with Good Clinical Practice training. All current guidance has been followed to mitigate risk from data processing to participants. There will be no processing of data on members of the public who have not provided consent to take part in the trial.

Both North Bristol NHS Trust and the University of Bristol therefore have a public interest to undertake such processing of personal and sensitive data to advance the evidence base for clinical care and drive improvements in patient survival, hospitalisation and quality of life on dialysis.

The UK Renal Registry will be providing data to the University of Bristol on advanced chronic kidney disease outcomes. Members of the study team, including the chief investigator, were previously part funded by UKRR but employed by NHS. These employees are no longer being funded by UKRR and UKRR is not acting as a data processor.

Public Health England will be asked to provide data to the University of Bristol for infections they collect, such as methicillin-resistant Staphylococcus aureus and methicillin-susceptible Staphylococcus aureus.

The funder is NIHR Health Technology Assessment. NIHR do not determine the purpose or the manner in which the data will be processed.

Expected Benefits:

The benefits from this dissemination will not be realised for health care until the main results of the trial are published in 2024:

- If HDF proves safe and effective at improving survival and/ or quality of life, it is likely to become the main form of HD in the UK, Europe and even the USA. Trial publications could result in changing NICE recommendations (the trial has already led to NICE changing its draft recommendation on HDF in 2018) and associated Renal Association guidance. This in turn would change medical practice, with renal units gradually converting their machines and consumables to be able to provide HDF to all patients. This will lead to improved outcomes for people with end-stage kidney disease – 25,000 people in the UK at the moment and 2 million people worldwide. If the estimates from post-hoc analyses of prior trials are correct, HDF could reduce mortality on dialysis by up to 40%.

- If HDF proves unsafe or ineffective, the renal units in Europe that have been adopting it before evidence of safety/ effectiveness exist will need to reconsider this (and probably revert to the current standard, high-flux HD). This will lead to reduced harm (from unsafe HDF) and/ or a reduced economic and environmental cost from HDF (i.e. 6,000L of water per patient per year). It will also refocus efforts by dialysis innovators to look for new ways of delivering dialysis that actually do lead to improvements in survival.

Depending on whether the trial shows a benefit from high-volume HDF or not, the beneficiaries will be:
1/ patients – who will either have a reduced risk of dying on dialysis or more efforts put into developing new dialysis technologies that will extend their lives/ improve their quality of life
2/ healthcare economies – who may be able to negotiate lower cost contracts for delivering HD if they do not have to pay for HDF
3/ the environment – with 6,000L less water being used per patient per year.

This is not expected to be seen until after the results of the trial in 2024.

Outputs:

Study progress and results will be disseminated through the existing communication channels of the UK Renal Registry and the UK Renal Association via newsletters to the renal community. Both have active twitter accounts with more than 3,000 followers. Newsletters and social media accounts at the University of Bristol and North Bristol NHS Trust will additionally be used to disseminate and publicise the study progress and results. An H4RT twitter account has been set up to keep interested patients, carers, clinicians, managers and policy makers up-to-date with trial progress. Representatives from the ​Kidney Care UK and National Kidney Federation will also use their established channels for communicating the progress and findings of the study to patients such as regular newsletters, active social media accounts, a network of kidney patient associations and annual meetings.

Abstracts for posters and/ or oral presentations will be submitted to national and international conferences, such as UK Kidney Week, ERA-EDTA, American Society of Nephrology and World Congress of Nephrology (estimated 2024).

Peer-reviewed publications will include:
1. Methods paper. Once finalised (estimated Dec 2021), the protocol will be published in an open access academic journal.
2. Main results paper. The primary analysis is expected to occur in Spring 2024, with the main paper being submitted for publication in Summer 2024. With the key findings likely to be practice changing and of interest to a wide range of clinicians and policy makers, they will be of interest to high impact journals such as the BMJ, the New England Journal of Medicine and the Journal of the American Medical Association. The Bristol Randomised Trials Collaboration has a track record of publishing output from its complex trials in high impact clinical journals and highly respected methodological journals.

Two public and patient involvement (PPI) groups: the Patient Council and local Kidney Patient Association - both comprising 15-20 dialysis and former dialysis/ transplant patients, guided the objectives of this study. Patients wanted to know whether HDF improves survival, symptoms and quality of life, and whether it is safe. Some raised concerns about its environmental impact. A PPI co-applicant helped draft elements of the study protocol. Patients and the public remain active in the running of the trial through the steering committee and patient advisory group. The latter involves annual – biannual meetings where progress and results from the study are presented and patient interpretation sought. Patients in the group then advise on the best way to disseminate the study findings to other patients, including the production of plain English summaries that will be used by patients and carers to assist them in making evidence based treatment decisions and further developing dissemination policy.

The funder (NIHR) requires sight of all output before it is made public (with the exception of individual tweets). The trial management group (chaired by the chief investigator, Fergus Caskey) will determine the dissemination strategy, with approval by the Sponsor (North Bristol NHS Trust) and trials unit (University of Bristol).

Data will only be published in anonymised, aggregate form in line with the HES Analysis Guide.

Processing:

Good clinical practice-trained research staff provide eligible patients with information about the trial in the form of a participant information sheet. If the patient agrees to participate, they complete and sign a consent form. The research nurse completes paper forms containing (a) administrative data (with identifying information) and (b) clinical data. These documents are returned securely (by recorded delivery in tamper proof envelopes) to the Bristol Randomised Trials Collaboration (BRTC) unit at the University of Bristol.

The trial administrator and trial manager at the University of Bristol receive the paper documents from the recruiting sites and enter them into either the administrative or clinical database. The two databases are kept separate and would not be re-linked.

Patient clinical data is pseudonymised with unique study IDs. Email addresses are collected with the clinical data as they are essential for the correct functioning of a required survey feature. The ‘Email Address’ field is flagged as an identifier and not included in the export for the statistician, so the data set can be considered pseudonymised at export and does not need further processing. Further pseudonymised clinical data from the UK Renal Registry, Public Health England, and trial case report forms and patient questionnaires collected by researchers at the recruiting sites, is added to the clinical database over the course of the trial.

DATA REQUESTED
Pseudonymised record level 6 years of HES APC, CC, and OP linked to Deaths data - An initial historical drop of AR 2017/18, 2018/19, 2019/20, plus 2020/21 M07 at agreement sign-off and thereafter
a drop of AR 2020/21 in Sept/Oct 2021, and
a drop of AR 2021/22 in Sept/Oct 2022 and
a drop of AR 2021/22 in Sept/Oct 2023
[7 APYs dropped in 4 disseminations].

The pseudonymised data will include only those records for each patient that occur on or after the patient's start date.

METHODOLOGY
- The University of Bristol will send a file containing identifiable study cohort data to NHS Digital.

The cohort will contain the Study ID, NHS Number, Date of Birth, and Gender. No special category data, specifically no health data, will be sent from the University of Bristol.

- NHS Digital will link the study cohort records to HES Outpatients, Critical Care, Admitted Patient Care and Civil Registrations (Deaths) Secondary Care Cut data sets. A pseudonymised file containing the pseudonym study IDs and health data for the study cohort will then be returned to the University of Bristol.

- This will then be linked using the pseudonym study IDs to the other clinical data already held by the University of Bristol. The record level personal data provided to the University of Bristol by NHS Digital, UK Renal Registry and Public Health England will remain at the University of Bristol and will not be released to any other organisations, unless in the form of aggregated, suppressed data in line with the HES analysis guide.

The pseudonymised clinical dataset will be held on a dedicated server storing only H4RT data in one of two secure data centres. These centres have physical and network security measures in place including a firewall set to only allow access only from specific static IP addresses over specific ports. This means that only machines registered by the persons responsible for the data and configured by IT Services will be allowed to gain access to this information. The University of Bristol statisticians analysing the NHS Digital data do not also have access to the administrative database containing patient identifiable information. The trial manager and trial administrator have access to both databases to deposit clinical information, however there will be no requirement or attempt to re-identify individuals. Data processing will only be carried out by substantive employees of the data processor who have been appropriately trained in data protection and confidentiality.

HES DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION
In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, you must make sure that:
· cell values from 1 to 7 are suppressed at a local level to prevent possible identification of individuals from small counts within the table.
· Zeros (0) do not need to be suppressed.
· All other counts will be rounded to the nearest 5.
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.

Aspirin after hospitalisation with Pneumonia to prevent cardiovascular Events randomised Controlled Trial (ASPECT) — DARS-NIC-637916-K3L3D

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: Non-Sensitive

When:DSA runs 2024-02-09 — 2027-02-08 2024.06 — 2024.06. breached contract — audit report.

Access method: One-Off

Data-controller type: NORTH BRISTOL NHS TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Outputs:

The expected outputs of the processing hope to be as follows:
• A report of findings confirming the outcomes of the study
• A report of findings for the Data Monitoring and Safety Committee to confirm the safety of the study (annually)
• Submissions to peer reviewed journals at the end of the study
• Presentations to healthcare professions, research and participants
• Presentations at appropriate health- related conferences
• Publication of dashboards on Bristol Trial Centre’s website
• A database to be utilised as a resource for health research (under this DSA sublicensing and onward-sharing of NHS England Data is not permitted).

The outputs will contain only 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 hope to be communicated to relevant recipients through the following dissemination channels:
• Journals, such as Lancet and New England Journal of Medicine.
• Webinars open to healthcare professionals, researchers, participants
• Social media, such as X (formerly Twitter)
• Public reports
• Posters displayed at appropriate conferences
• Press/media engagement
• Public promotion of the research
• Participant newsletters - The study team aim to send the results of the study to participant by email or post if they have opted-in for this. This is information is collected on their baseline CRF.

Processing:

Three data drops are required on an ad-hoc basis based on a cumulative cohort which will be uploaded on each occasion. Data is limited to consented cohort members. For each new cohort member, there will be one drop of 5 years of historic HES APC Data prior to the Date of Randomisation, and then latest available HES Data per drop for each cohort member between the Date of Randomisation and 90 days post randomisation.

University Hospitals Bristol and Weston NHS Foundation Trust will securely transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender and a unique person ID - also known as a Study ID) for the cohort to be linked with NHS England data. The cohort file will also contain the date of randomisation. The first cohort is estimated to be approximately 2,000 individuals but is cumulative over time.

NHS England will then provide the University of Bristol with the relevant record-level Data from the HES APC and Civil Registrations Deaths datasets. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the data with other record level data already held by the recipient.

NHS England Data will be stored on secure servers and a virtual backup datacentre hosted onsite at the premises of the University of Bristol and accessed via an Encapsulated Virtual Machine (eVM). Data from the University of Bristol will additionally be stored as a secondary back-up in geographically separate UK-situated datacentre owned by Virtus Datacentres on equipment owned by the University of Bristol. Virtus Datacentres provide the University of Bristol (via a third-party contract) with the building and rack-space, and provide IT assistance with the hardware, but have no access to the Data held on the systems.

NHS England Data will not be transferred to any other location, other than those stated above.

Direct access will be granted to substantive employees or agents of University of Bristol who are authorised by the ASPECT study team. Authorised personnel are prohibited from downloading or copying data to local devices.

All authorised personnel accessing the data have been appropriately trained in data protection and confidentiality. Identifying data items will be stored in a separate database to the linked dataset used for analysis on the secure server and access is limited to the ASPECT study team.

The data will not leave England at any time.

The data will be linked at person record level with data obtained from relevant local hospitals and study data via the pseudonymised Study ID.

CHIEF-PD (Cholinesterase Inhibitor to prEvent Falls in Parkinson’s Disease): A phase 3 randomised, double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease. — DARS-NIC-628591-K2Q2V

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: Yes (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2023-11-27 — 2026-11-26 2024.05 — 2024.05. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Emergency Care Data Set (ECDS)
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)
  3. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

University of Bristol Medical School (UOB-BMS) requires access to NHS England data for the CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease) trial. CHIEF-PD is a large NIHR-funded phase 3 trial which will establish whether cholinesterase inhibitor (ChEi) treatment, compared to placebo, prevents people with Parkinson’s Disease (PD) from falling and is cost-effective. This will be achieved through a multi-centre randomised controlled clinical trial.

The primary objective is to determine the difference in fall rate over 12 months between people with PD treated for 12 months with a ChEi and those treated with a placebo. Data from NHS England will be used to extract data on the hospital-based care received by CHIEF-PD study participants and used to identify hospitalisations due to falls and estimate whether ChEi treatment has any impact on the costs of NHS hospital care. When combined with other data collected in the CHIEF-PD trial, the aim is to calculate whether ChEi treatment is effective for patients and cost-effective for the NHS.

The following NHS England Data will be accessed: Hospital Episode Statistics (HES) Admitted Patient Care (APC), Outpatients (OP) and Emergency Care Data Set (ECDS) necessary to calculate the cumulative cost of hospital care.

The level of the Data will be identifiable.

The Data will be minimised as follows:
• Limited to a study cohort of approximately 600 patients who consented to the CHIEF-PD trial from various secondary care settings across >20 sites in the United Kingdom recruited between January 2020-April 2023.
• Limited to Data from recruitment to up to 12 months post recruitment date for each participant.
• Data that will identify cause of hospitalisations (to enable the trial team to identify those due to falls) and to describe and cost hospital care for trial participants.

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. Research is a task that University of Bristol performs in the public interest, as part of their core function as a university.

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.

The work is in the public interest because it aims to improve public health by providing evidence to help NHS decision-makers identify effective and cost-effective healthcare for patients with Parkinson’s Disease.

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.

Funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the CHIEF-PD trial. The funder will have no ability to suppress or otherwise limit the publication of findings.

Only approved University of Bristol substantive employees who are part of the CHIEF-PD research team will have access to the data from approved University of Bristol computers.

In relation to Public and Patient Involvement and Engagement group, those with Parkinson’s Disease have helped to refine the purpose of the research and will be involved in every phase of the research trial. This will involve group meetings, specific roles on the trial management group, review of the protocol, participant information, consent and data collection forms and informing dissemination of the research findings to participants. The group strongly supported the collection of the data for the purposes described above.

Commercial benefit:
Luye Pharma AG is a manufacturer of a cholinesterase inhibitor and supply this for the study.

There is a potential commercial benefit where NHS Trusts or clinicians are influenced by the findings of this study and might choose to use the Luye Pharma AG manufactured cholinesterase inhibitor at the end of the intervention phase where participants require continuation of treatment with a cholinesterase inhibitor or if the results of the study demonstrate that cholinesterase inhibitor is effective and is adopted into clinical practice.

Luye Pharma AG have not had any role in the study design, data collection or funding. They will not have any role in analysis or presentation of the research findings.

Outputs:

The expected plan for dissemination of the research findings will include:
• Presentations to participants. Many participants are frail and therefore the findings will be disseminated to them via post using large print summaries which will be designed with our PPI panel. The trial has partnered throughout with Parkinson’s UK – the main research charity supporting people with the condition who have supported PPI recruitment and dissemination activities.
• a comprehensive report of the trial findings will be submitted in approximately Autumn 2024 for publication in the NIHR journals library. It is expected that all project publications to be published within 12 months thereafter.
• submission to peer-reviewed scientific journals (e.g. British Medical Journal).
• Presentations at "The Movement Disorder Society" and "Parkinsonism International Congress" conferences.
• Summaries of results disseminated to the public and trial participants.

All papers will be published on the University of Bristol’s website.

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
- Postal updates to participants at the end of the trial. The demographics of the patients that participate are such that they tend to prefer paper updates as opposed to online material.
- Research newsletters hosted by Parkinson’s UK, such as ‘Progress’, will be utilised to reach people living with Parkinson's Disease.

A series of PPI workshops aimed at people with Parkinson’s from underrepresented groups including from BAME (Black, Asian and minority ethnic) and / or socioeconomically deprived backgrounds are planned to further inform the means by which are findings are disseminated.

The target date for production and dissemination of the outputs will be Autumn 2024.

Processing:

The University of Bristol will transfer data to NHS England. The data will consist of identifying details (specifically Participant ID, NHS Number and Date of Birth) for the cohort to be linked with NHS England Data. The University of Bristol will also provide the participant 'Recruitment Date' to the study date to NHS England.

NHS England will provide the relevant records from the HES APC, HES OP and ECDS datasets to The University of Bristol.

The Data will contain no direct identifying items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at the University of Bristol.

In the event that Data will be accessed 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.

- 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 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).

The Data will not leave England.

Access will be restricted to employees of the University of Bristol who have authorisation from the CHIEF-PD Chief Investigator. All such individuals are substantive employees of the University of Bristol.

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

The team will aggregate the HES Data with small numbers suppressed, to patient-level summaries (for example, to calculate the total number and cost of hospital admissions for each patient). The primary analysis of NHS England Data will be a comparison of healthcare use and costs between patients randomised to receive ChEi treatment or placebo.

At no point will the research team at The University of Bristol link the NHS England Data back to direct patient identifiers (NHS number) in an attempt to re-identify individuals, or attempt to link to any other datasets collected outside of the auspices of the trial. Analysts/researchers from the University of Bristol will process/analyse the Data for the purposes described above. The Data will not be linked with any other data.

Using national-level linked administrative data to explore prevalence of mental health concerns and characteristics of mental health services received by children in State care in England before, during and after the COVID-19 pandemic. — DARS-NIC-382333-M5J9W

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(5)(d), Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2022-10-27 — 2024-10-26 2023.03 — 2024.05. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Emergency Care Data Set (ECDS)
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Admitted Patient Care
  4. Hospital Episode Statistics Outpatients
  5. Mental Health Services Data Set
  6. Hospital Episode Statistics Accident and Emergency (HES A and E)
  7. Hospital Episode Statistics Admitted Patient Care (HES APC)
  8. Hospital Episode Statistics Outpatients (HES OP)
  9. Mental Health Services Data Set (MHSDS)

Objectives:

The University of Bristol requires access to NHS Digital data for the purpose of the following research project: "Using national-level linked administrative data to explore prevalence of mental health concerns and characteristics of mental health services received by children in State care in England before, during and after the COVID-19 pandemic".

Background
Children in State care constitute a vulnerable group of children in society. At any given time in England, there are around 80,000 children being looked after by the State. The majority of these children are taken into State care due to experiences of severe maltreatment such as abuse or neglect. Research studies indicate that mental health concerns in this vulnerable child population are high with 50% of children in State care having a diagnosable mental health concern, when compared to 12% of children in the general population. Despite this high prevalence of mental health concerns, there is no established evidence base on the characteristics and vulnerabilities of children in care who are referred to mental health services (MHS) and their prognosis and pathways through the MHS system in England, including the impact of the COVID-19 pandemic. This has been flagged by the Children’s commissioner of England and the Education Committee as a serious concern that needs to be addressed.

Objectives
The primary objective of this project is to fill this gap in knowledge and to establish new and timely information on the prevalence of mental health concerns in the population of children in care; provision of MHS; and children’s prognosis and pathways through the MHS compared with children in the general population before, during and after the COVID-19 pandemic. A secondary objective of this project, to be pursued at such time as the required data from the Department for Education (DfE) becomes available, is to deliver a novel linkage which will demonstrate potential for combining NHS health records with routine social care records. Although children in care who have referrals to MHS and who are in receipt of MHS are recorded by the NHS, this data is not routinely linked back to their care or education records.

The project aims to answer these research questions, with an emphasis on exploring any change before/during/after the Covid-19 pandemic:
1. What are the pathways to mental health referral, treatment, discharge and re-referral for children in care compared with the children and young people in the general population?
2. What is the prevalence of the different mental health conditions of children in care referred to MHS and how does this compare with the children and young people in the general population?
3. Is there a difference in the MHS provision and outcomes for children in care when compared with children in the general population?
4. Do the referrals and MHS provision differ for specific groups of children in care? (e.g. by ethnicity/ age/ gender/ disability/ type of placement/ legal status/ previous experience of maltreatment/ number of placements in care)
5. What are the characteristics of children in care in England who are in receipt of MHS and are they different to children in care who are not in receipt of MHS?
6. Is there any variation between local authorities on the mental health service referrals and outcomes for children in care?
7. Controlling for other factors, what is the association between children’s yearly collected scores on the Strengths and Difficulties Questionnaire (SDQ) collected by the DfE and their referrals to MHS?
8. What are the characteristics and preceding care experiences of children in care who are admitted to hospitals for mental health related concerns and children in care who are referred to mental health services?
9. How useful is the newly linked social care-education-mental health data in exploring the mental health service provision, prognosis and pathways of children in care through the MHS provision in England?

The project is planned to be carried out in two phases. This data sharing agreement covers the first phase, wherein mental health episodes of school-aged children will be identified from (unlinked) NHS Digital data. It is intended that a subsequent amendment to this agreement will be made to cover the second phase, wherein NHS Digital data will be linked with data from the DfE.

Data Requirements
The study design is an analysis of pseudonymised, individual-level data from national, population-level data sources. Individual-level data is required to track individual trajectories over time/ across datasets. It is important not to narrow the sampling frame geographically in order to capture a sufficient number of children in care to provide enough statistical power for analyses and to obtain a detailed picture of their mental health prognoses and service provisions. National data is also requested to enable analyses of local authority level variation. There are no alternative, less intrusive ways of achieving the purpose.

Sample
The data subjects for this project will be any children or young people who could have been a pupil in England; in key stage 1-5 education; at any time since 1st April 2015; and have had a mental health episode recorded during their childhood (up to the age of 18). Baseline data for the analyses will be calculated with data on all children, who were not in care; and who could have been a pupil in England; in key stage 1-5 education; at any time since 1st April 2015; and have had a mental health episode recorded during their childhood (up to the age of 18). This covers children born between 1997 and 2017.

Datasets
In Phase 1, the research team request access to all available current and historical hospital and mental health episodes, up to the age of 18, for all children and young people who had been a pupil in England since 1st April 2015 from the following NHS Digital datasets:

• Mental Health Services Dataset (MHSDS): This national dataset, centrally collated and held by NHS Digital, includes person-based information on all individuals in England who are in contact with the Mental Health Services. Data on children and young people have been available in the MHSDS since 1st April 2016. The information contained in this dataset includes, for example, reason for referral, mental health legal status, assessment outcomes, disability, primary/secondary diagnoses, type of treatment/therapy programme and waiting times. It also identifies children and young people looked after by the State. Children and Young People’s Improving Access to Psychological Therapies (CYP IAPT) data form part of the MHSDS. This is a programme of evidenced-based psychological therapies to provide emotional and wellbeing support to children and young people in England through outpatient clinics in the community. IAPT services are characterized by routine outcome monitoring, which will be used for analyses in this research.

• Hospital Episode Statistics (HES): HES is a database containing details of all admissions, A&E attendances, and outpatient appointments at NHS hospitals in England. Important mental health information can be found within the HES centralised secondary care records. The University of Bristol request data from Admitted Patient Care (APC) (e.g., recording admissions into psychiatric care); Accident & Emergency (A&E)/ the Emergency Care Data Set (ECDS) (e.g. presenting for care following self-harming or overdose); and Outpatients (e.g. follow-up outpatient treatments for mental health). HES APC and HES OP data are being requested from 2003/04 to enable capture of historical mental health linked episodes of care linked to children and young people who have been pupils in England since 1st April 2015. With the same justification, HES A&E data are being requested from 2007/08 as the earliest available data from this domain, to enable the same type of longitudinal analyses as for the HES APC and HES OP data.

The MHSDS includes a variable which flags ‘children looked after by the State’ and HES includes a ‘discharge destination’ field, which flag children going back into placements in State care. Therefore, the unlinked and pseudonymised record level data from MHSDS and HES (including ECDS) data being requested from NHS Digital in this initial Data Sharing Agreement will enable the University of Bristol to answer research questions 1, 2, 3, 9 and to partially answer research question 4.

For the intended phase 2, the University of Bristol proposes to link the NHS’s national dataset on mental health services (MHSDS) and hospital episode statistics (HES) data with administrative datasets held by the Department for Education (DfE) on all pupils (NPD data) and children in State care (SSDA903 data). This is planned to enable answering of research questions 4, 5,7, 8 and 9.

Data linkage and access
Phase 1 of the research involves linkage between NHS’ MHSDS and HES datasets. No external data will be linked in this phase.

Data minimisation
The research team’s approach to minimisation is based on two key approaches: 1) that only variables necessary for the investigation are being requested; and 2) only the records of relevant health events are being requested where possible. The researchers believe there is no less intrusive manner to achieve the research than the use of pre-existing administrative data.

In phase 1, HES APC data is being filtered by diagnosis code, and HES OP is being filtered by treatment function code in order to retrieve records related to mental health admissions. As HES OP only has diagnosis codes populated for ~5% of records, this would be an inappropriate method by which to filter the data. MHSDS will only cover mental health-related episodes, and therefore does not require further filtering by diagnosis. All HES A&E and ECDS episodes are required, as the research is examining the number of emergency admission episodes which may represent an opportunity for a mental health referral. Vulnerable children tend to use A&E services in the first instance rather than their GP. Where vulnerable children relocate between carers, there is value in reviewing their behaviour in regard to accessing health care and mental health care during periods when in care and periods when they are not. In addition, HES A&E does not contain any single variable which can be filtered on to classify an episode as pertaining to mental health. A combination of variables must be used to make this inference.

The University of Bristol's request is minimised to include only children and young people who have had a mental health episode during their childhood. The request cannot be minimised further due to statistical power and sample diversity issues. The research aims to compare the mental health burden in children looked after by the State versus the wider population. It will investigate explanatory factors behind differences and whether they differ for subgroups of children (for e.g., by gender, ethnicity, mental illness, local authority). To draw sufficiently heterogeneous controls (when selected at random) is unlikely unless using a large ratio of children and young people in State care to those in the general population. To use a smaller control population would add considerable complexity, potential for bias, and resource implications for limited minimisation benefits. Given the very low prevalence of some mental illnesses (for example, the prevalence of panic disorder in the population is 0.6%), data on all children and young people referred to mental health services is required to enable enough power for analyses of these sub-groups. Access to data on all children and young people referred to mental health services is therefore believed to be proportionate to the aims of this project.

Data needs to be retained for all children and young people referred in order to track re-referrals of those who were not diagnosed/ put on treatment pathways before (indicating a potentially high risk group, with a requirement for earlier intervention). The University of Bristol will perform any final filtering of the NHS Digital datasets to ensure that no relevant episodes for the analysis are lost needlessly. Any data surplus to study requirements will be destroyed.

Legal Bases
The University of Bristol’s legal basis to process this data is under Article 6(1)(e) of the GDPR because the 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 research is in the public interest as it will provide a new evidence base on the mental health of a most vulnerable group of children in the population to enable better service provision and patient care. The University of Bristol’s legal basis for processing special categories of data is Article 9(2)(j) – scientific, historical research purposes or statistical purposes. The processing is carried out in accordance with Article 89(1) of the UK GDPR and is in the public interest.

Organisations
The University of Bristol is the sole data controller for this project, who also process the data.

This research project has a study advisory group who help to interpret the small numbers suppressed results from the analyses, review reports and provide advice on how the results can feed back into policy and practice. The advisory group contains members from the NHS (a designated nurse for looked after children), DfE, charities and academic institutions.

NHS Digital will provide pseudonymised health data directly to the Bristol Medical School eVM (encapsulated virtual machine) in phase 1. The eVM is a secure research environment. All statistical output created will also be checked by the eVM team (the eVM team are all substantive employees of the University of Bristol and are accredited to Office for National Statistics (ONS) standards to check data releases) for disclosure before being released to the research team. There will be no attempt made to re-identify individuals within the dataset.

The project is funded by the Nuffield Foundation.

None of the above organisations are involved in determining the purpose or the means of the data processing and are not considered joint data controllers. Only the University of Bristol will process NHS Digital data under this Agreement.

Expected Benefits:

It is a priority of government to understand how COVID-19 has had a disproportionate effect on the more vulnerable populations, specifically children in state care with a need for mental health services. The project report and linked academic publications are expected to provide new evidence to address these government and the Scientific Advisory Group for Emergencies (SAGE) research priorities involving vulnerable children, particularly in relation to the COVID-19 pandemic : SAGE priority area - RQ32 (Understanding vulnerable patients: How are underlying conditions defined, and what is the impact of infection on a range of outcomes, and what are the benefits of 'shielding' and other preventive interventions? AND Linked question: COVID-19 Risk prediction (Relevant to “How do we best understand and protect vulnerable populations?”) and RQ62 (How has the delivery of primary care to vulnerable patient groups changed during the NHS response to the COVID-19 pandemic?).

The ultimate beneficiaries of this research are expected to be children in State care as identification of characteristics of the groups of children most at risk can facilitate preventive work with the high-risk groups. To enable this conversion of the results into practicable actions and policy changes, the results of the study will be communicated to a number of stakeholders including; (1) Policy makers (e.g. Department for Education, Department of Health and Social Care, Parliamentarians); (2) Practitioners and service providers (e.g. Directors of Children’s Services, social workers, Child and Adolescent Mental Health Service (CAMHS) practitioners, GPs; local authority (LA) managers, designated nurses, medical advisers for looked after children, psychiatrists, psychologists, virtual school heads, school counsellors) and; (3) Third sector organisations such as charities and organisations campaigning for children’s rights and better service provision for children in care (e.g. Children’s Commissioner, NSPCC).The National Clinical Advisor of the NHS England Children and Young People’s Mental Health programme has asked to be kept informed of the developments from this project.

The information generated from this research is hoped to provide a new evidence base on the mental health of children in care and enable policy makers, practitioners and other organisations who champion children’s mental health to better inform policy formation, policy implementation and effective resource allocation to improve the mental health standards of children in care, who will be the ultimate beneficiaries of this research. The research output, in terms of identifying the groups of children most at risk for mental health service provision is anticipated to be useful for social work decision making. It is also hoped to benefit looked after children’s nurses, medical advisers, GPs, Child and Adolescent Mental Health Service (CAMHS) teams, Children and Family Court Advisory and Support Service (CAFCASS) and educational services in terms of signposting children who may be most in need of their support.

Monitoring impact and measuring change:
In the short-term: Google analytic reports will be used to measure web traffic and downloads; monitoring and tracking email requests to the research team; press coverage; and social media take-up.
In the medium to long-term: Mentions in parliament; changes to local/national-level policies and practices; continued use of Google analytic reports.

Outputs:

To enable the conversion of the results into practicable actions, the results of the study will be communicated to a number of stakeholders including; (1) Policy makers; (2) Practitioners and service providers and; (3) Third sector organisations such as charities and organisations campaigning for children’s rights and better service provision for children in care.

The research already benefits from an advisory group with representation from all of these sectors. The advisory group comprises the following organisations:

Care Leaver's Association, NHS, CoramBAAF, Anna Freud Centre (children’s mental health charity), Children’s Rights Advocacy Service, Thinking Allowed (children and adolescent mental health service for children looked after or adopted), BECOME (the leading national charity for children and young people in care and young care leavers), Department for Education, University of York, University College London and the University of Oxford.

Planned outputs:
• Three interim reports, final report and another two separate briefing papers, addressing the main research questions.
• The project website will provide information on the study, research outputs and links to stakeholders. The project webpage hosted by the Nuffield Foundation (https://www.nuffieldfoundation.org/project/mental-health-service-provision-children-in-state-care-england) will provide information on the study and publish all project reports when they become available.
• At least three academic papers addressing the research questions intend to be submitted to leading journals (such as Child Development, the British Medical Journal, Journal of Child Psychology and Psychiatry, Child Abuse and Neglect, European Journal of Child & Adolescent Psychiatry, and Developmental Psychopathology).
• Syntax/code will be deposited at the UK Data Service, to enable future use by other researchers.
• Mental health of children and the impact of COVID-19 is a topical issue. The study is expected to be publicised through press releases, policy blogs and briefing papers in collaboration with the University of Bristol press office, Nuffield Foundation press office and Policy Bristol. The results of the recently concluded Economic and Social Research Council funded study led by the principal investigator (PI) were covered by numerous national media outlets (e.g. The Independent, The Guardian, Community Care, Children and Young People Now, The Conversation, LBC Radio).
• The study output will also be shared with social workers and other practitioners via the British Association for Adoption and Fostering (the PI sits on the research advisory group of CoramBAAF - an independent membership organisation for professionals, foster carers and adopters, and anyone else working with or looking after children in or from care, or adults who have been affected by adoption), through the ‘Research in Practice’ network, and via other publications targeted at practitioners, such as ‘Community Care’ and ‘Children and Young People Now’.
• Register the study at the Parliamentary Office of Science and Technology (https://post.parliament.uk/contributing-to-a-postnote-as-an-expert/), which creates briefing notes for parliamentarians on key subject areas. Academics and subject experts are able to suggest policy relevant topic areas to the Parliamentary Office of Science and Technology team.
• Lobby parliamentarians for policy changes through stakeholders and involvement in All Party Parliamentary Groups (APPGs) on abused and neglected children; looked after children and care leavers.
• Joint conference with stakeholders.
• The Children’s Commissioner will be provided a copy of the study outputs.

Access to the data is strictly controlled by cyber and physical security by the UoB IT department. All statistical outputs will be checked by the UoB team for disclosure. All results will be presented as aggregated data with small number counts suppressed in line with the HES Analysis guide.

Funding is in place for this project until December 2023 by when the results and papers are expected to be completed and available for public dissemination.

Processing:

In the first phase of the project, covered by this Data Sharing Agreement, NHS Digital will flow pseudonymised record-level Hospital Episode Statistics (HES), Emergency Care Data Set (ECDS) and Mental Health Services Data Set (MHSDS) data covering school-aged children to the Bristol Medical School eVM (encapsulated virtual machine), a secure research environment.

There will be no subsequent flows of data. All data analysis by the University of Bristol will be carried out on the pseudonymised datasets held in the Bristol Medical School eVM. First, a missing data analysis will be carried out to explore the best method to handle missing data in the linked dataset. Second, statistical analyses will be conducted to explore the differences between children in care and the general population group in relation to the research questions. The analyses will then be extended to explore if differences exist between local authorities (LAs). Modelling techniques will be used to establish the risk of referral/re-referral to mental health services for children in care, compared with children in the general population; and to explore whether children's age, such as being a teenager, has any influence on mental health referrals and outcomes.

In the first phase of the project, NHS Digital data will not be linked to any other data. In the second phase of the project – to be covered by a revision to this Data Sharing Agreement – it is intended that NHS Digital data will be linked to pseudonymised Department for Education (DfE) data using a common pseudonymised identifier, as described in ‘Objectives for Processing’.

In order to access data in the Bristol Medical School eVM, all researchers have gone through the ONS accreditation process and hold ‘basic/enhanced disclosure’ certificates that are no more than 2 years old. All statistical output created will also be checked by the eVM team for disclosure before being released to the research team and there will be no attempt made to re-identify individuals within the dataset.

The output will be based on aggregates, with the local authorities (LA) as the smallest geography for reporting. The output of all analyses using administrative data (such as tables and figures) will be checked by the senior research associate and the principal investigator for disclosure risk and numbers smaller than 10 will be suppressed before publication.

The data will be accessed at a secure setting of the Bristol Medical School eVM or remotely via an encrypted link. Only the research team will have access to the data files. All data processing will be carried out by substantive employees of the data processor(s) or data controller(s). The project principal and co-investigators have existing ONS approved researcher status and can facilitate certification for new members of staff.

Researchers involved in this project have taken the extended Medical Research Council training on the Data Protection Act 2018 and research confidentiality, as well as University of Bristol training on the Data Protection Act 2018 and on the General Data Protection Regulations (GDPR). All researchers requesting data access work in a professional research organisation which operates to ISO27001 standards. There is specialist research governance training which is mandatory to all staff and experts to help with guidance and training.

University of Bristol - Longitudinal Linkage Collaboration — DARS-NIC-420168-K4N1F

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - Statutory exemption to flow confidential data without consent, Anonymised - ICO Code Compliant, Yes, No, Identifiable (Statutory exemption to flow confidential data without consent)

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002, CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 - s261(5)(d), CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 - s261 - 'Other dissemination of information', , CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

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

When:DSA runs 2021-05-10 — 2022-05-09 2021.05 — 2024.05. breached contract — audit report.

Access method: One-Off, Ongoing

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: Yes

Datasets:

  1. Personal Social Services Survey of Adult Carers
  2. Mental Health Services Data Set
  3. Mental Health Minimum Data Set
  4. Personal Social Services Adult Social Care Survey
  5. Mental Health and Learning Disabilities Data Set
  6. Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set
  7. Cancer Registration Data
  8. Civil Registration - Deaths
  9. Community Services Data Set
  10. COVID-19 Hospitalization in England Surveillance System
  11. COVID-19 Second Generation Surveillance System
  12. Covid-19 UK Non-hospital Antibody Testing Results (Pillar 3)
  13. Covid-19 UK Non-hospital Antigen Testing Results (pillar 2)
  14. COVID-19 Vaccination Adverse Reactions
  15. COVID-19 Vaccination Status
  16. Demographics
  17. Emergency Care Data Set (ECDS)
  18. GPES Data for Pandemic Planning and Research (COVID-19)
  19. Hospital Episode Statistics Accident and Emergency
  20. Hospital Episode Statistics Admitted Patient Care
  21. Hospital Episode Statistics Critical Care
  22. Hospital Episode Statistics Outpatients
  23. Improving Access to Psychological Therapies Data Set
  24. Medicines dispensed in Primary Care (NHSBSA data)
  25. MSDS (Maternity Services Data Set)
  26. Improving Access to Psychological Therapies Data Set_v1.5
  27. MSDS (Maternity Services Data Set) v1.5
  28. Civil Registrations of Death
  29. Community Services Data Set (CSDS)
  30. COVID-19 General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR)
  31. COVID-19 Second Generation Surveillance System (SGSS)
  32. COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2)
  33. Hospital Episode Statistics Accident and Emergency (HES A and E)
  34. Hospital Episode Statistics Admitted Patient Care (HES APC)
  35. Hospital Episode Statistics Critical Care (HES Critical Care)
  36. Hospital Episode Statistics Outpatients (HES OP)
  37. Improving Access to Psychological Therapies (IAPT) v1.5
  38. Maternity Services Data Set (MSDS) v1.5
  39. Mental Health and Learning Disabilities Data Set (MHLDDS)
  40. Mental Health Minimum Data Set (MHMDS)
  41. Mental Health Services Data Set (MHSDS)
  42. Personal Social Services - Adult Social Care Survey (ASCS)
  43. Personal Social Services - Survey of Adult Carers in England (SACE)
  44. COVID-19 SGSS First Positives (Second Generation Surveillance System)
  45. Improving Access to Psychological Therapies (IAPT) v2

Objectives:

For clarification regarding the distinct staff groups noted in the agreement:
Study staff = staff from the contributing cohorts;
University of Bristol (UoB) staff = staff of UK Longitudinal Linkage Collaboration (LLC) employed by UoB;
UK LLC staff = staff employed by UK LLC (UoB and University of Edinburgh (UoE) staff).

The LLC project itself is cross-institutional and has staff based at University of Bristol and the University of Edinburgh. The University of Edinburgh are collaborators however they have no role in determining how the data will be processed nor will they have any access to the record level data.

BACKGROUND
The UK Chief Scientific Advisor has established (October 2020) a programme of National Core Studies (NCS) for SARS-CoV-2 (Covid-19) research as a coordinated, long-term, national research initiative. This will consider Covid-19 in terms of a viral pandemic (including issues of cases, transmission, symptoms, and outcomes) and in terms of the health and social impacts of behavioural restrictions designed to mitigate the harms of the pandemic.

The NCS has six different sub-programmes which are addressing major Covid-19 research areas; one of these is the Longitudinal Health and Well-being (LH&W) NCS which is designed to use data from longitudinal studies to address the impact of Covid-19 and of associated viral suppression measures on health and well-being. The LLC is the central hub component of the Longitudinal Health and Well-being NCS.

The UK LLC has been designed to underpin the LH&W NCS, although not exclusively as the NCS are designed to support each other, where for example: the LLC could form the infrastructure for the long-term patient follow-up of consenting trial participants (e.g. participants in the RECOVERY trial) or, where UK longitudinal population studies (LPS) are being used to collect specific new study data which is not available through routine records (e.g. the ALSPAC birth cohort is providing a frame to collect biological samples to inform the Immunology NCS research programme; the assayed results of which will be uploaded into the LLC). For this reason, users of the LLC may come from across the full range of NCS studies and the resource will be accessible to other legitimate UK-based researchers investigating Covid-19 through a sub-licence framework. The NCS is planned to be a two/three-year research programme commencing October 2020.

THE UK LLC & DATA SUBJECTS
UoB (for LLC purposes) will underpin the NCS programme by combining, within a Trusted Research Environment, study data from >15 major inter-disciplinary UK LPS with a combined total of 1 – 2 million UK participants, centrally link to a wide range of Covid-19 relevant and non-health administrative records to utilise alongside the UK Biobank, the Zoe Symptom Tracker cohort and other sources. The integrated data, infrastructure and accompanying governance aspects will collectively be known as the UK LLC.

The de-identified data from contributing studies will be used to establish a UK LLC participant and household register, this will be used within the UK LLC to index and catalogue available data. Researchers will be able request access to the integrated data via the Health Data Research UK Gateway (https://www.healthdatagateway.org/) which through the NCS programme is being established as the de facto application point for UK Data Science projects and as a systematic and coordinated infrastructure for assessing the legitimacy and ‘safe’ credentials of a project. The value of these LPS data assets will be significantly enhanced through linkage to Covid-19 relevant health and other routine records (e.g., employment status, occupation, and benefit receipt records). This will allow the use of objectively assessed diagnoses and other records and the collection of data not amenable to self-report (such as detailed records of care, or health service utilisation). It will also allow researchers to assess and quantify/document bias and error through triangulating data collected across different organisations and settings.

Throughout the development of the UK LLC, UoB have worked collaboratively with UK LPS to co-design and develop the protocol and methodology. One of the strengths of the collaborative approach championed by the UK LLC is that UK LPS are committed and enthusiastic partners in this work: this initiative comes from within the community. The UK LLC will provide infrastructure to support the LPS and researchers working within the UK to investigate high priority COVID-19 research questions. UK LLC/UoB will continue to seek input from the LPS into decision making, guidance in future development and operation. Crucially, the LPS’s all maintain and manage ‘their’ relationships with ‘their’ participants including making critical decisions about data use, and communicating with participants about the existence of, and work of, the UK LLC and providing reassurance that this does not alter the participants existing relationship.

ROLE OF NHS DIGITAL

COHORTS TO BE INCLUDED
The contributing studies whose data will be linked to NHS Digital data in this application are:
1) The National Study of Health and Development (NSHD); which is owned by University College London (UCL; sole Data Controller). UCL have an existing Data Sharing Framework Contract with NHS Digital and NSHD have already flagged its cohort at NHS Digital (MR1) and has active data sharing agreements for the MR1 study (Ref: DARS-NIC-148100-6RFK9 (application covered by consent) and DARS-NIC-86954-Y0R2N (s251)). NSHD brings value as a nationally representative ageing cohort (age ~74) with lifelong follow-up and relevant Covid-19 data collections.

2) The Southall And Brent REvisited (SABRE); which is owned by University College London (UCL; sole Data Controller). UCL have an existing Data Sharing Framework Contract with NHS Digital. SABRE have not flagged its cohort members at NHS Digital (meaning a new study flagging will be established on behalf of SABRE through this application) and do not have an active NHS Digital data sharing agreement. SABRE brings value as a tri-ethnic cohort with considerable participant heterogeneity. It also characterises a relatively deprived urban area of the UK.

3) Avon Longitudinal Study of Parents and Children (ALSPAC aka “Children of the 90s”); which is owned by University of Bristol (UoB; sole Data Controller). ALSPAC has existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (a DARS approval for consenting participants Ref: NIC 13133-B7B3K; and a DARS approval for s251 participants: NIC 152414-W3P6Q). ALSPAC brings value as a multi-generational cohort: our original parents (Generation 0, G0), our index participants born in the early 1990s (Generation 1, G1) and now their children (Generation 2, G2) with relevant Covid-19 data collections.

4) TwinsUK; which is owned by Kings College London (KCL; sole Data Controller). TwinsUK has existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (a DARS approval for consenting participants Ref: NHS Digital. DARS-NIC-147955-M8D2Q-v1.3. undergoing amendment for HES, demographics, MRIS, Flagging status. TwinsUK have passed DSPT 19/20 (Details of ISO 27001)). TwinsUK brings value as largest adult twin registry in the UK and the most clinically detailed in the world.

5) Twins early Development Study (TEDS); which is owned by Kings College London (KCL; sole Data Controller). TEDS do not have existing NHS Digital DARS approval. TEDS brings value through collection of genetic and environmental information through Twins early development to adolescence.

6) Genetic Links to Anxiety and Depression Study (GLAD); which is owned by Kings College London (KCL; sole Data Controller). GLAD do not have existing NHS Digital DARS approval. GLAD brings value through coverage of a population over the four nations and collecting information around risk factors for depression and anxiety.

7) English Longitudinal Study of Ageing (ELSA); which is owned by University College London (UCL; sole Data Controller). ELSA has existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme across the three data controllers’ organisations: IFS: DARS-NIC-32854-Y8P8B-v2.2, UCL: DARS-NIC-30493-Y0C0K-v1.4, NatCen: DARS-NIC-32854-Y8P8B-v2.1. ELSA brings value as a national ageing cohort with regular follow-up and detailed information on physical and mental health as well as finances and attitudes to ageing.

8) 1958 National Child Development Study (NCDS); which is owned by the University College London Centre for Longitudinal Studies (CLS) (UCL; sole Data Controller). NCDS has an existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (DARS-NIC-49297-Q7G1Q). 1958 NDS brings value as a national birth cohort with information relating to lifelong factors influencing health and wellbeing development as well as economic inequalities, and now how these relate to retirement and ageing.

9) 1970 British Cohort Study (BCS 70); which is owned by the University College London Centre for Longitudinal Studies (CLS) (UCL; sole Data Controller). BCS 70 has an existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (DARS-NIC-49826-T0J7C). The 1970 British Cohort Study brings value as a birth cohort providing insight, amongst other things into education and social development, economic circumstances in a population of now 50+ year olds.

10) Next Steps; which is owned by the University College London Centre for Longitudinal Studies (CLS) (UCL; sole Data Controller). Next Steps has an existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (DARS NIC-51342-V1M5W) for the extraction and use of linked NHS records in its research programme. Next Steps brings value with detailed information on academic performance through links to the National Pupil Database records and planned links to higher education and Universities, the cohort comprises people born in England in 1989-1990.

11) The Millenium Cohort Study (MCS); which is owned by the University College London Centre for Longitudinal Studies (CLS) (UCL; sole Data Controller). MCS has an existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (DARS-NIC-384504-N2V5B). The Millenium Cohort Study brings value through following the lives of 20 - 22 year olds and their residential parents, providing insight into family life and relationships.

12) INTERVAL; which is owned by the University of Cambridge (UoC; sole Data Controller). INTERVAL has an existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (DARS-NIC-156334-711SX). INTERVAL provides value through their representation of blood donors who have frequently given blood to investigate impacts on wellbeing.

13) COMPARE; which is owned by the University of Cambridge (UoC; sole Data Controller). COMPARE has an existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (DARS-NIC-156334-711SX). COMPARE provides value through information on blood donors haemoglobin.

14) STRIDES BioResouce; which is owned by the University of Cambridge (UoC; sole Data Controller). STRIDES do not have existing NHS Digital DARS approval. STRIDES provides value as a research blood donor resource and panel of volunteers willing to participate in medical and health related studies.

15) Track-COVID; which is owned by the University of Cambridge (UoC; sole Data Controller). Track-COVID do not have existing NHS Digital DARS approval. Track-COVID provides value with a subset of INTERVAL COMPARE and STRIDES bioresource to determine risk factors for infection.

16) NIHR (National Institute for Health Research) BioResouce; which is owned by the Cambridge University Hospitals NHS Foundation Trust (sole Data Controller). NIHR BioResource provides value through holding unique genetic information including eating and neurological disorders.

17) Extended Cohort for E-health, environment, and DNA (EXCEED); which is owned by the University of Leicester (UoL; sole Data Controller). EXCEED do not have existing NHS Digital DARS approval. EXCEED provides value through collecting information on environment and DNA to provide insight into environmental influences on long-term health.

18) Understanding Society; which is owned by the University of Essex (UoE; sole Data Controller). Understanding Society do not have an existing NHS Digital DARS approval. Understanding Society provides value as a household study providing a generational perspective and changes over the long-term, particularly social, and economic factors.

19) Born in Bradford; which is owned by Bradford Teaching Hospitals NHS Foundation Trust (BTHFT; sole Data Controller). Born in Bradford do not have an existing NHS Digital DARS approval. Born in Bradford provides value through representation of a multi-ethnic population and regional cohort from an area which has high levels of deprivation.

20) The National Study of Health and Development (NSHD); which is owned by University College London (UCL; sole Data Controller). UCL have an existing Data Sharing Framework Contract with NHS Digital and NSHD have already flagged its cohort at NHS Digital (MR1) and has active data sharing agreements for the MR1 study (Ref: DARS-NIC-148100-6RFK9 (application covered by consent) and DARS-NIC-86954-Y0R2N (s251)). NSHD brings value as a nationally representative ageing cohort (age ~74) with lifelong follow-up and relevant Covid-19 data collections.

21) The Southall And Brent REvisited (SABRE); which is owned by University College London (UCL; sole Data Controller). UCL have an existing Data Sharing Framework Contract with NHS Digital. SABRE have not flagged its cohort members at NHS Digital (meaning a new study flagging will be established on behalf of SABRE through this application) and do not have an active NHS Digital data sharing agreement. SABRE brings value as a tri-ethnic cohort with considerable participant heterogeneity. It also characterises a relatively deprived urban area of the UK.

22) Avon Longitudinal Study of Parents and Children (ALSPAC aka “Children of the 90s”); which is owned by University of Bristol (UoB; sole Data Controller). ALSPAC has existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (a DARS approval for consenting participants Ref: NIC 13133-B7B3K; and a DARS approval for s251 participants: NIC 152414-W3P6Q). ALSPAC brings value as a multi-generational cohort: our original parents (Generation 0, G0), our index participants born in the early 1990s (Generation 1, G1) and now their children (Generation 2, G2) with relevant Covid-19 data collections.

23) TwinsUK; which is owned by Kings College London (KCL; sole Data Controller). TwinsUK has existing NHS Digital DARS approval for the extraction and use of linked NHS records in its research programme (a DARS approval for consenting participants Ref: NHS Digital. DARS-NIC-147955-M8D2Q-v1.3. undergoing amendment for HES, demographics, MRIS, Flagging current status. TwinsUK have passed DSPT 19/20 (Details of ISO 27001)). TwinsUK brings value as largest adult twin registry in the UK and the most clinically detailed in the world. Only data covering participants in England will be included.

There is a longer-term objective to include a larger number of studies into the UK LLC to boost statistical power, increase participant heterogeneity and sample size in population and outcome sub-groups and to increase the range of self-reported information. Any additional study would be included as an amendment to this application. Additional studies not included in this agreement will be added as an amendment to this agreement.

The UoB scientific programme requires the extraction and use of the NHS Digital data compiled with Covid-19 relevant datasets (primary care, secondary care, community, mental health care provision, Covid-19 testing and outcomes data, NHS service use interactions such as NHS 111 records, mortality, disease registry and demographics data) for the purpose of establishing the UK LLC.

The UK LLC has conducted an assessment as to whether the data held and processed within the UK LLC is identifiable/potentially identifiable and therefore Personal Data which is subject to the Data Protection Act 2018 (DPA), UK General Data Protection Regulations (UK GDPR) and Common Law Duty of Confidentiality (Common Law) in accordance with guidance issued by the Information Commissioner’s Office. The assessment determined that the infrastructure, incorporating all data flows, should be considered as containing Personal Data and being subject to the DPA/UK GDPR and Common Law requirements. However, within this the assessment identified that the UK LLC sits at the threshold of being considered as holding pseudonymous data (Personal Data) and de-identified data where the risk of re-identification is not reasonably likely (not Personal Data), and that this differing status manifests when considering the data from the perspective of the different high-level groups of UK LLC data users and their distinct processing activities. It is evident that for the contributing studies, the use of data is either identifiable (for the provision of identifiers for linkage purposes) or pseudonymous (for the provision of data into the UK LLC and the processing of study data by study staff in their demarcated study processing area) and is therefore Personal Data. Yet, for the UK LLC staff and researcher users, the risk of re-identification of data within the UK LLC is not reasonably likely. This status, for these users, has been achieved through the deployment of data level as well as contextual controls which mitigate the risk of identification. The principal amongst these is the UK LLC operates as a ‘Trusted Research Environment’ which ensures that minimised data are used by minimised number of legitimate users within a secure environment for approved and proportionate purposes.

To contribute data into the UK LLC, LPS’s will be required to flow identifiers to the NHS to establish/filter a linkage between each participants' study record and their NHS registry record(s). A reasonable expectation will have been set through establishing fair processing for the use of NHS records via the UK LLCs infrastructure and for the sharing of these for public benefit research. Studies will update their privacy notices and notify participants of their involvement with UK LLC, explaining what this means and provide options to ‘opt-out’, in line with existing policy and practice.

UK LLC TRUSTED RESEARCH ENVIRONMENT (TRE)
The LLC will be built on a UK Secure eResearch Platform (UKSeRP). This is a well-established infrastructure for data science: it has ISO27001 and NHS Data Security Protection toolkit and Office for National Statistics accreditation under the Digital Economy Act 2017. Other instances of this environment are already used to host LPS and NHS Digital data and have been audited and commended as being well suited to the purpose and low risk (e.g. https://digital.nhs.uk/binaries/content/assets/website-assets/services/dars/data-sharing-post-audit-review_university-of-bristol-.pdf).

The UK LLC TRE will be owned, operated, and managed by the LLC team (data management based at UoB). Under instruction from UoB, contributing LPS and data owners including NHS Digital will provide data to the UK LLC TRE using the ‘split file’ approach which is used across UKSeRP. This split file approach (details below) ensures the physical and processing operational separation of personal identifiers and participants de-identified study data and health records. This separation means that no party involved in this process can see both identifiers and data. This split file approach is coupled with the technological and socio-governance controls applied at the UK LLC (e.g., training, contracts, policy and procedures, penalties for misuse). The UK LLC is classified as containing pseudonymous data (Personal Data under UK GDPR). This is the case for studies who contribute pseudonymous data into the UK LLC and access data for their participants within the UK LLC. For UK LLC staff and research users the risk of re-identification is controlled to the point that it is not reasonably likely.

UK LLC C-19 RESEARCH PROGRAMME
The UK LLC is specifically commissioned as a database resource to inform the LH&W NCS but is also designed to be a resource for the investigation of other Covid-19 questions as these are identified and prioritised through the Scientific Advisory Group for Emergencies (see the Health Data Research UK and SAGE research prioritisation funnel - current versions available through the HDRUK SAGE report, see - https://www.hdruk.ac.uk/covid-19/).

Given these questions are likely to change over time (e.g., the identification of ‘Long COVID’ as a potential new set of complex outcomes is introducing important new research questions), the research programme the LLC is designed to inform can be defined as the investigation of Covid-19 questions using data from longitudinal studies linked to routine records to address the impact of Covid-19 and of associated viral suppression measures on health and wellbeing. For the use of linked longitudinal studies and NHS records this definition is refined to make clear the investigations primary outcomes must be focused on generating benefits to the health and social care system.

The investigation of Covid-19 questions using data from longitudinal studies linked to routine NHS records to address the impact of Covid-19 and of associated viral suppression measures on health and wellbeing: where the primary research outcome is designed to benefit the health and social care system. These linked data will be of unique value in underpinning a programme of research on Covid-19 informed by the data assets within the UK LLC.

This program will seek to understand the patterns and predictors of infection, (including re-infection) and disease outcomes (such as ‘long covid’), and the role of antecedent and current health behaviours, health status, medication use, sociodemographic status, built and natural environmental factors, in impacting these outcomes. It will also explore population level changes to physical and mental health, including hospital admission and mortality, in association with viral suppression measures and how these relate to changes in health behaviours.

Given the impact of the Covid-19 containment measures, it is important to investigate the role of socio-economic and neighbourhood/environmental factors in determining population level impacts to physical and mental health, to identify both groups at risk, and factors which offer resilience to adverse outcomes. Within this, UK LLC users will analyse changes in health care service use (using self-reported data and NHS health records) to determine if patterns in these have changed during the Covid-19 pandemic. Linked NHS records will also inform consideration of service use in relation to pre-pandemic health status and regular service interactions (e.g., screening, health reviews and routine service take up (such as annual seasonal flu vaccinations)).

This programme, through the LH&W NCS will specifically seek to answer the following questions:
i) What are the mental health consequences of Covid-19 infection, and of viral suppression measures? How do these differ by key demographics, socioeconomic status and by prior mental health status?
ii) What are the risks, determinants, and expressions of the physical health consequences of long-Covid?
iii) What are the disruptions to health care services (primary and secondary), and what are the health consequences of these disruptions? How do they vary by geography, demographics, and socioeconomic status?
iv) What are the risks of re-infection?
v) How do measures of historical health & physiology impact risk of C-19 infection and its consequences?
vi) How do we best identify cases in population studies, triangulating symptoms, antigen, and antibody testing? How do antibody profiles differ by case status (e.g., those with and without symptoms), how do antibody profiles vary over time? What are the health determinants of such variability?
vii) What are the long-term socioeconomic consequences of viral suppression measures? How do these in turn impact on health and on health care utilisation?

These research themes have been scientifically reviewed by the UK Chief Scientific Advisor and the UK Chief Medical Officer and are high priority questions of critical national interest.

OTHER DATA PROCESSING PURPOSES
In addition to the primary research themes, UoB will:
1) use linked NHS data to help inform descriptive and documentary analysis of the UK LLC dataset. This will describe the combined LPS population and make clear the LLC denominator, its characteristics and how this sub-set of the population relates to the wider population (through comparison with aggregated populations statistics). This will inform research users and those (e.g., policy makers) seeking to draw inferences from findings.

2) conduct feasibility assessments to help determine the viability of proposed projects. To do this, UK LLC staff will query the UK LLC integrated dataset (LPS data and linked NHS Records) to determine if UK LLC have sufficient case numbers to be able to inform specific research proposals. This purpose enhances the ethical and governance case for the resource as it means data are not shared where they cannot meaningfully inform the science, it also helps ensure the efficient use of research funding and resources.

DATA REQUEST & JUSTIFICATION
UoB propose linking Covid-19 relevant data from the studies listed above to the following datasets managed by NHS Digital. The proposed uses of these data include but are not limited to:
1. Demographics Data i.e., area of residence, neighbourhood socio-economic indicators such as Indices of Multiple Deprivation to help characterise the UK LLC participants and to inform sub-group analysis;
2. Civil Registration (Deaths) Data and Cancer Registration Data to determine Covid-19 mortality and to consider the impact of the pandemic on general rates of mortality and cancer diagnosis and outcomes;
3. GPES Data for Pandemic Planning and Research (COVID-19) to define Covid-19 caseness, Covid-19 symptoms and outcomes (including ‘long COVID’, wider health outcomes (including mental health, substance use, addiction), patterns in health service interactions, uptake of Covid-19 vaccine and vaccine behaviours in general, to define pre Covid-19 health status, case ascertainment across non Covid-19 outcomes and multi-morbidities;
4. Hospital Episode Statistics (Accident and Emergency; Critical Care; Admitted Patient Care; Outpatients; Emergency Care Data Set) for reasons stated under GPES.
5. Mental Health Services DataSet and Improving Access to Psychological Therapies DataSet to consider changes in mental health outcomes and to define changes in help seeking behaviours and health care interactions;
6. COVID-19 Testing Data to determine testing, caseness and Covid-19 outcomes;
7. NHS 111 records to define Covid-19 symptoms and caseness, wider health symptoms (including mental health status) and consider changing patterns in help seeking behaviours and health care interactions;
8. Community Services Data Set to consider changing patterns in help seeking behaviours and health care interactions;
9. The Shielded patient list to conduct sub-group analysis and to investigate outcomes and behaviours specific to this group and people co-habiting with this group;
10. Vaccine and adverse reaction datasets (as and when they become available via NHS Digital) to inform uptake of Covid-19 vaccine, patterns in uptake, and vaccine behaviour in sub-groups.

The UK LLC will separately apply to the relevant data controllers to link to other datasets not available through NSH Digital. These other datasets will be integrated with study and NHS Digital data where necessary for specific research projects. This will include NHS records from other NHS authorities (i.e., Scotland, Wales, Northern Ireland) and other health databases (e.g. ICNARC, NICOR, SSNAP, Diabetes registers) necessary to measure long-term adverse health outcomes (not requested from NHS Digital). The LHW NCS also considers the intersections between health and social circumstances relating to COVID-19 and the impact of COVID-19 restrictions on health outcomes. To inform these investigations the UK LLC will apply to access and integrate administrative records (e.g. occupation, employment status, benefits provision, education attainment, attendance and school census data) and environmental data related to the space in which people live (e.g. air pollution, greenspace) and the neighbourhood (population density, service provision, broadband facilities).

Through separate approval mechanisms these will be further linked with data from the Office for National Statistics (e.g. the ONS Covid-19 Infection Survey); records from the Zoe Symptom Tracker application; and geo-spatial data modelling environmental exposure estimates (including but not restricted to air pollutants and noise) and indicators describing the natural and built and social environment (including but not restricted to deprivation indices, urban/rural status, neighbourhood characteristics such as housing density, service provision and facilities, green and blue space). It will not be permitted for users to link any additional public data, but they can seek approval for UK LLC staff to do this on their behalf subject to disclosure and other IG risk assessments.

All data will be de-identified (and the UK LLC is classified as containing pseudonymous data (Personal Data under UK GDPR). This is the case for studies who contribute pseudonymous data into the UK LLC and access data for their participants within the UK LLC. Yet for UK LLC staff and research users the risk of re-identification of data within the UK LLC is not reasonably likely.

It is necessary to request the full NHS Digital Covid-19 dataset in terms of years and geographical area of coverage to inform the most accurate assessments of pre-pandemic health status and comprehensive understanding of behaviours with those during the pandemic (including risk factors for Covid-19 and its outcomes) and to be inclusive of all UK LLC participants resident and/or seeking health care services in England. There is no alternative source of this objectively recorded data.

DATA MINIMISATION
The datasets and data items requested have been restricted to only those directly relevant to the Covid-19 research programme that this infrastructure is designed to support. UoB fully adopt the standard NHS Digital definition of the Covid-19 relevant dataset.

As described, the UK LLC C-19 research programme is wide ranging and seeks to understand patterns and predictors of infection, disease outcomes, the role of antecedent and current health behaviours, health status, medication use, sociodemographic status, built and natural environmental factors, in impacting these outcomes. Datasets requested include measure of Covid-19 related outcomes and pre-Covid-19 baseline datasets (allowing the value of these longitudinal data to be maximised).

The linked data requested are minimised to include only data covering the period each contributing study was in follow-up. The data requested are further minimised to include only records of participants of studies contributing to the UK LLC and those who have objected to this use of their data are excluded. Information on participants who have ‘opted-out’ will be uploaded to the UK LLC quarterly so that those participants’ data will be excluded from future studies.

UoB are unable to minimise datasets further based on fields or episodes at this time as work continues to be conducted to inform the UK’s Covid-19 research programme which aims to be responsive to health and government policy makers. For example in HES, UoB cannot consider only episodes with a specific diagnosis or procedure at this time, UoB do not yet understand the longer-term health implications from Covid-19 infection or whether there exist patterns and predictors of C

Expected Benefits:

The UK LLC is a critical component of the LH&W NCS programme of work that has been set up by the Chief Scientific Adviser for the United Kingdom. The NCS are designed to support and accelerate the UK’s research response to COVID-19, the research questions within the programme have been developed with the most senior UK health and policy planners and this research could directly inform the SAGE. The NCS will use health data to identify and respond to essential questions to rapidly inform policy, operations and planning and maintain resilience against COVID-19 across the UK this winter and beyond. The magnitude of the Covid-19 pandemic means that almost all UK residents could be impacted by measurable benefits of the NCS programme in terms of a greater understanding of Covid-19 amongst health and government policy makers and in terms of improved service planning and delivery.

The UK LLC is a key part of this programme of work providing a place where longitudinal population studies can be linked in an efficient way to NHS, kept updated with regular refreshes of data, linked to other Covid -19 relevant records, and then accessed by researchers on Covid-19 to provide answers to essential questions as they arise through the course of the pandemic. The LH&W NCS will focus on the impact of Covid -19 and of associated viral suppression measures on health and wealth to inform mitigating strategies. Rapid research on the impact of not only Covid-19, but also the suppression measures on the people of the UK is crucial in understanding what challenges will be facing health and social care across the four nations of the UK for the next several years at the very least.

All of the research done as part of the NCS programme will be rapidly disseminated ensuing evidence on COVID-19 risk factors to key stakeholders (e.g., policymakers, healthcare organisations and the scientific community) by writing policy papers that will be sent direct to the SAGE Committee and through preprints and other rapid forms of communication, as well as through traditional publication routes.

The creation and use of the UK LLC can be considered as a measurable benefit in terms of its broader access and use for approved Covid-19 research (use beyond the central LH&W NCS questions) and its ability to support rapid and changing requests for evidence from policy makers.

DISSEMINATION OF FINDINGS
The LH&W NCS is designed to be responsive to health and government policy makers. The Director of the LH&W NCS reports directly to a programme board including senior decision makers, such as the UK Chief Scientific Advisor. The LH&W NCS will report all findings into the HDR UK SAGE fortnightly research briefings (https://www.hdruk.ac.uk/covid-19/) to help flow insights as quickly to key decision makers as possible.

It is envisaged that many requests for evidence will have short time frames and will take the form of rapid synthesis of available evidence; this will be coupled with in depth epidemiological and social science investigations using standard research methodologies and dissemination outputs (Covid-19 specific research seminars, other conferences, academic papers).

To ensure the rapid flow of insights, the LH&W will submit all submitted manuscripts to ‘pre-print’ servers to allow them to be immediately picked up (prior to the completion of the review process).

The UK LLC is committed to transparency and there will be public (lay language) facing dissemination of all data usage, proposals and their outcomes, and research outputs. These will be available via the LLC website and its social media channels.

The UK LLC is also committed to open science approaches and will publish all code lists used in research inside the resource and will also make available syntax for interrogation and reuse. All derived variables created during research investigations will be documented and added into the resource for reuse (with equivalent data control obligations to the source data).

To recap, the work of the UK LLC has a wide range of benefits encompassing many stakeholders as outlined above through the noted dissemination pathways, including but not limited to:

THE PUBLIC:
Recommendations based on the research conducted within the UK LLC can lead to a better-informed public, and improvements in policy in relation to Covid-19, which may benefit the public health and well-being as well as the economy.

This program of research will seek to provide information on key questions such as the seek to understand the patterns and predictors of infection, (including re-infection) and disease outcomes (such as ‘long covid’), and the role of antecedent and current health behaviours, health status, medication use, socio-demographic status, built and natural environmental factors, in impacting these outcomes. It may provide insight and directions for improvements in health and well-being inequalities and understanding risks. The novel UK LLC design which brings together many studies is designed to help deliver statistical power for sub-group analysis including those of vulnerable and marginalised groups: this in turn should result in greater equity in the impact of research. Examples of key impacts on the public could be better outcomes from long Covid through understanding key determinants and successful interventions, and lead to better public health through behavioural change and public service health interventions. NCS studies are seeking to better understand risk factors for post-Covid-19 disease and better characterise long Covid. Other public health benefits would be better understanding and improved behaviours around physical activity or consumption.

Given the impact of the Covid-19 containment measures, it is important to investigate the role of socio-economic and neighbourhood/environmental factors in determining population level impacts to physical and mental health, to identify both groups at risk, and factors which offer resilience to adverse outcomes. Within this, UK LLC users will analyse changes in health care service use (using self-reported data and NHS health records) to determine if patterns in these have changed during the Covid-19 pandemic. UK LLC data could provide insight into populations, barriers, and other specifics to provide information on the difficulties in accessing healthcare. Linked NHS records may also inform consideration and improvement of services use in relation to pre-pandemic health status and regular service interactions (e.g., screening, health reviews and routine service take up (such as annual seasonal flu vaccinations)).

POLICY MAKERS/GOVERNMENT:
As above, the broad-ranging research conducted within the UK LLC support could lead to increased knowledge which may inform public health policy including, key decisions on health and social care interventions, exploring better communication and interventions to initiate population level changes to physical and mental health, including hospital admission and mortality, in association with viral suppression measures and how these relate to changes in health behaviours. Examples of how the LH&W NCS and Long COVID programme is designed to improve understanding and policy development include:
1) improve case ascertainment understanding;

2) study the impact of disrupted health care help seeking/service provision and identify patterns that may impact on future prevalence of health conditions, or distinct patterns in disruption across different population groups (thus informing predictive models and the development of dashboard tools);

3) identify patterns/prevalence of behaviours at the intersection of health and social situation resulting from the pandemic and lockdown (e.g., self-harming, gambling, anxiety/depression) which may have yet to manifest in help seeking but which may impact on planning and commissioning decisions for post-pandemic;

4) understand patterns and predictors of vaccine hesitancy and uptake patterns (including consideration of previous vaccine uptake) to inform vaccine programme strategies and public health messaging. The executive group of LH&W comprises key stakeholders and findings will be publicly available.

HEALTHCARE SYSTEM PLANNERS AND COMMISSIONERS/CARE PROVIDERS:
Recommendations based on the research programme outlined above conducted within the UK LLC may be used to guide best practice in public health and other areas of health and wellbeing as above. The wide-ranging information could lead to improvements in a range of areas of public health and social behaviours and outcomes and may inform best practice in healthcare. The impact could result in a reduced burden on the healthcare system. Currently, most understanding of Covid-19 disease is based on patients admitted to hospital. Fortunately, only a minority of people infected with Sars-Cov-2 are admitted to hospital. The size of this minority and how this varies according to age, sex, other aspects of social position, vaccine exposure and prior health is not known. This study could answer these questions allowing rational planning of secondary care provision based on population prevalence. What is also unknown is the proportion and characteristics of infected individuals who seek help in primary care. Since the study will link cases identified in population-based studies to primary care records the UK LLC could also answer this question. Furthermore, the UK LLC could clarify patient characteristics and symptom patterns associated with both acute presentation and with "Long Covid", the subsequent clinical course of both, the effects of primary care treatment and the extent of adherence to relevant clinical guidelines. All this information may enable a more effective health service response to Covid-19 related need, mitigation of longer-term sequel and evidence-based commissioning.

STUDY PARTICIPANTS:
The creation of UK LLC will allow participants of studies (and whose wish is to) to contribute longitudinal data as an integral part of high priority covid-19 research within the safe and secure ‘trusted research environment’, in the knowledge that their consent could lead to a broader impact. The impact of this is research is likely to directly benefit these participants and their families given its likely whole-population improvements (i.e., benefits resulting from system improvements, not individual intervention).

RESEARCHERS:
UK LLC provides a centralised responsive enriched resource that could enable approved researchers to investigate high priority Covid-19 research questions utilising longitudinal data within the trusted research environment. It is hoped researchers would have access to an expanded and enriched data-source which may allow novel questions to be asked with greater certainty in the findings.

The UK LLC is committed to open science approaches and will publish all code lists used in research inside the resource and will also make available syntax for interrogation and reuse. All derived variables created during research investigations will be documented and added into the resource for reuse (with equivalent data control obligations to the source data). The UK LLC suggests a model for new ways of working going forward which could result in increased research benefits and security, within minimal additional burdens on participants and efficiencies in research and NHS expenditure.

LPS STUDIES:
Benefit from infrastructure of the UK LLC (accessing pseudonymous linked data of their participants within study specific working area) whilst being able to co-design and develop UK LLC enabling LPS’s to contribute as an integral part of high priority covid-19 research within safe and secure the ‘trusted research environment’. There is an economy of scale in sharing data in this way, and opportunity for sharing of best practice through collaboration. The structure of the UK LLC enables all LPS’s to maintain and manage ‘their’ relationships with ‘their’ participants including making critical decisions about data use, and communicating with participants about the existence of, and work of, the UK LLC.

Many of the findings that the UK LLC could enable regarding behaviours, social inequalities and barriers to healthcare access could have broader-ranging impact in relation to other health or social challenges beyond Covid-19.

Outputs:

The UK LLC is likely to generate diverse outputs, with these forming a mix of rapid insight reports to policy makers and substantive research reports. The NCS is specifically designed to establish a clear channel between decision makers and researchers and the UK LLC is designed to enable rapid response and up-to-date information needed to support this. The likely outputs include:

* Peer-reviewed scientific publication (and pre-print publications of initial drafts prior to review which are designed enable rapid awareness of the findings), first publications are expected during 2021;

* Conference presentations and workshop presentations (to academic, health service practitioners and planners, government policy makers, Scientific Advisory Group for Emergencies (SAGE) members), first outputs expected within the first 6 months;

* Reports to health service practitioners and planners, government policy makers and Committee’s (e.g., National Institute for Health and Care Excellence (NICE), SAGE), these are expected during 2021

* Rapid evidence synthesis reports as requested by health and government policy makers (through the entirety of the 3-year NCS programme);

* Lay summaries provided through websites, Blogs, social media posts, privacy notices and outputs designed to promote the transparent use of data and the wider research process (anticipated within the first 6 months).

All outputs from the TRE will be assessed for disclosure risk and will be anonymous population level findings. The framework for this is based on leading 'five safes’ approach and is closely adapted from equivalent processes accredited to standards of the Office for National Statistics and the UK Statistics Authority.

All ‘meta’ products of the UK LLC research (such as code list definitions, syntax, workings for derived variables) will be made available for reuse and interrogation/replication. Access to the UK LLC is ‘open’ in the sense that any legitimate researcher conducting Covid-19 research can apply for access using a transparent and consistent decision-making process. As such, the UK LLC enhanced resource should be considered as an important ‘output’ and a measurable benefit of the UK LLC/LH&W NCS.

The high profile of Covid-19 means that many findings may have media interest. Importantly, the UK LLC is establishing a Patient/Participant Involvement and Engagement strategy within its communication work-package package with a dedicated budget and experienced Communications PPIE Officer. The package will build on existing and established relationships with participants to involve public/participants in the co-design of mechanisms to engage and effectively communicate UK LLC findings more widely with the public. UoB are committed to public involvement in our design and communications. UoB have already included HDRUK PPIE panel members (public representatives) in a consultation exercise and will draw on the extensive network of participants to further explore and co-develop dissemination mechanisms, in developing the end-to-end animation in the first instance. UoB are also developing with the studies opportunities for a subgroup of participants to be involved, in the data access decision making process for example. UoB have ensured that the programme of work is adequately resourced to compensate the public for their time, this has been an integral part of the project planning.

The UK LLC is a novel research infrastructure. The creation of this for Covid-19 research may provide methodological insights and illustrations of a new way of working for linkage in longitudinal research. Insights from this will be provided to the longitudinal community and its funders/key stakeholders (through academic papers, presentations, and contributions to advisory groups).

Processing:

The UK LLC processing methodology has clear separation of functions to conduct the necessary data flows and processing activities to achieve the stated objectives. Importantly, the methodology separates all handling and management of identifiers (restricted to the contributing studies, a trusted third party, and the NHS and other data owners for example UK Government COVID relevant admin records) and the attribute data (restricted to the contributing studies and data owners and the UK LLC).

1) Processing personal identifiers for linkage and consent/dissent filtering
The LPS data will be split by the LPS data managers into a file of personal identifiers (File 1) which also contains an externally meaningless ‘Link ID’. Separately, the attribute data (File 2) will be de-identified (direct and pseudo-identifiers will either be dropped or transformed into less identifiable research variables) and indexed using the same ‘Link ID’ as File 1. Each contributing study will ensure that case selection is filtered to exclude those who have dissented to the use of NHS records in study research programmes or those who have withdrawn from the study.

Each contributing LPS will encrypt and send their File 1 to the UK LLC Trusted Third Party (TTP) for linkage. This linkage TTP service will be conducted by NWIS acting as Data Processor to UoB.

The Study File 1 will contain:
* participant identifiers (current and historic name, address, date of birth, place of birth, gender);
* NHS ID where known;
* Study Name
* Study DARS ID where existing (I.e. the study reference ID flagged by DARS against the PDS);
* Link ID (a unique ID specifically generated for this process).

The TTP will receive the File 1. It will de-duplicate this into a single list of unique individuals and compile the File 1 lists from across all the contributing studies into a single file. Each individual will be allocated a ‘Key ID’ (a mapping ‘bridging file‘ of Link ID to Key ID will be retained). NWIS will then act as a linkage ‘broker’ and facilitate linkages across the four NHS authorities (and other contributing data sources) by sending appropriate files of the unique identifiers and study membership ID(s) for linkage. For England, NWIS will forward the combined File 1 to NHS Digital.

The NWIS combined File 1 will contain:
* Participant identifiers (current and historic name, address, date of birth, place of birth, gender);
* NHS ID where known;
* Study Name(s) (could be multiple study names if the participant is included in more than one study);
* Study DARS ID(s) where existing (I.e. the study reference ID flagged by DARS against the PDS);
* Key ID (a unique ID specifically generated for this process).

UoB require NHS Digital to then:
1) take receipt of the NWIS combined File 1, and using study membership IDs, to determine whether these participants are already ‘flagged’ on the NHS Patient Demographic Service (PDS).

To then,
i) If the cohort already has an established ‘flagging’ then NHS Digital will refresh this (to add new cases, to remove dissenting cases) using the Study Name and the Study DARS ID information in the combined File 1.
ii) where the cohort does not have an established ‘flagging’ then this will be established through NHS Digital conducting linkage of the identifiers in the File 1 to the PDS records using their standard methodology for this;

2) To add Link ID will be added to the PDS flagging record as a ‘UK LLC Study ID’ (supplementary to any existing Study ID set by the contributing LPS). This will enable subsequent refreshes of the data to be based on a consistent ID;

3) Using this flagging NHS Digital will then create an ID selection of the UK LLC ‘cohort’ and identify the participants Covid-19 records from within the NHS Digital data catalogues.

4) The identified records will then be extracted and de-identified and formatted to a File 2 specification (where each NHS Dataset is produced as a distinct File 2).

Process steps 1 and 2 above will need a quarterly refresh to reflect the dynamic nature of LPS membership where participants enter studies (through recruitment or birth) and leave studies (through registering an opt-out or withdrawing from the study).

Process steps 2 and 4 will be repeated monthly to refresh the UK LLC with timely flows of Covid-19 records.
The NHS Digital File 2(s) will contain:
* Linked NHS Digital attribute data
* Key ID

NHS Digital will then encrypt the FIle 2 and securely send this into the UKSeRP ‘gateway’. An automated process within the Gateway will ingest the NHS Digital File 2 and then encrypt Key ID (using an encryption SALT which is unknown to LLC staff) into eKey ID. This will result in an NHS Digital ‘File 3’, which will be deposited into the LLC TRE.

The NHS Digital File 3(s) will contain:
* Linked NHS Digital attribute data
* eKey ID

In parallel to this, the contributing LPS will send their File 2 equivalents into the UKSeRP ‘gateway’. Separately, NWIS will create a file containing Link ID mapped to Key ID and send this into the UKSERP ‘gateway’. The automated Gateway process will ingest the LPS File 2 and map Link ID to Key ID. Key ID will then be encrypted into eKey ID (using the same SALT). This will result in an LPS ‘File 3’, which will be deposited into the UK LLC TRE.

Within the TRE, UK LLC staff will be able to join the data together using eKey ID. This process enables data to be linked and ingested from multiple sources, and for this to be repeated with updates over time, and for the same participants data to result in being allocated the same eKey ID. The UK LLC will facilitate the linkage through establishing the contracts and data sharing agreements needed to permit this and to define this process methodology – but will not handle or have access to the study participant identifiers (File 1s) at any stage.

There is no requirement for UK LLC staff or researchers to re-identify (or attempt to re-identify) the de-identified data within the UK LLC TRE. All handling of identifiers is managed through a trusted third party and takes place outside of the UK LLC TRE. All users will be bound by substantive contract to maintain confidentiality: this includes UoB Staff contract for UK LLC staff and the processing contract for processors or the data access contract for research users.

ELUCIDate: “ELUcidate long-term consequences of Childhood Infections using administrative and research Data” — DARS-NIC-534549-M1N3P

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

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

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2023-07-07 — 2025-07-06 2023.12 — 2023.12. breached contract — audit report.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. COVID-19 SGSS First Positives (Second Generation Surveillance System)
  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 Critical Care (HES Critical Care)
  6. Hospital Episode Statistics Outpatients (HES OP)
  7. Medicines dispensed in Primary Care (NHSBSA data)

Objectives:

The University of Bristol and the London School of Hygiene & Tropical Medicine (LSHTM) require access to NHS England data for the purpose of the following two research themes (RTs):
• RT1: Do children and adolescents experience post-COVID syndrome or ‘long-COVID’, and how is this characterized?
• RT2: Do long-term health outcomes differ in children and adolescents who experienced SARS-CoV-2 infection with symptoms, compared to those who experienced infection without symptoms?

The following is a summary of the aims of the research provided by the University of Bristol and LSHTM.
“Our study is called “ELUCIDate”, which stands for, “ELUcidate long-term consequences of Childhood Infections using administrative and research Data”.
“COVID-19” is caused by severe acute respiratory syndrome coronavirus, SARS-CoV-2. Several aspects of the disease remain unclear, including the symptom profile and the determinants of symptomatic disease following infections in children and young people (CYP).

The Schools Infection Survey (SIS)-1 – jointly run by the ONS, the UK Health Security Agency (UKHSA) and LSHTM – systematically tested a large random sample of school children for SARS-CoV-2 roughly twice every term over the school year 2020/2021 and collected data on symptoms and other characteristics using electronic questionnaires. The purpose of this Agreement is to link NHS England data to data from the SIS-1 in order to investigate the above RTs. SIS-1, enriched by the requested linkages, provides a unique and convenient opportunity to examine these important research questions and provide further insight into the COVID-19 pandemic.

Little is known about the long-term consequences of SARS-CoV-2 infection and COVID-19 disease among CYP. Uncertainty in the diagnosis and presentation of what is colloquially known as ‘long-COVID’ (hereon referred to as ‘post-COVID syndrome’), means that even a basic understanding of the incidence and prevalence of the condition is lacking. In adults, the REal-time Assessment of Community Transmission 2 (REACT-2) study found that one in three individuals with SARS-CoV-2 infection had at least one of 29 symptoms persistent after 12 weeks since infection. Acute COVID-19 illness is milder among CYP, but this doesn’t mean that long-term consequences of infection do not impact this age group. As the infection impacts differently on CYP compared to adults, it is likely that the clinical presentation, those most at risk and the illness trajectory of post-COVID syndrome also vary.

The National Institute for Health and Care Excellence (NICE) currently uses the following definitions:

• Acute COVID-19: signs and symptoms of COVID-19 for up to 4 weeks.
• Ongoing symptomatic COVID-19: signs and symptoms of COVID-19 from 4 to 12 weeks.
• Post-COVID-19 syndrome: signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis.

NICE also defines ‘long-COVID’ as, “signs and symptoms that continue or develop after acute COVID 19”, i.e., including both ongoing symptomatic COVID 19 and post COVID 19 syndrome. Studies in CYP have looked at ongoing symptomatic COVID-19 with estimates of long-lasting symptoms attributable to SARS-CoV-2 ranging between 3-14%. For example, in a cohort study of UK CYP aged 5-17 years, 4.4% who tested positive for SARS-CoV-2 infection experienced symptoms for at least 28 days, compared to 0.9% of matched negative controls (suggesting ~3% had SARS-CoV-2-attributable symptoms). A similar study found that 30% of CYP positive for SARS-CoV-2 had at least three symptoms 15 weeks later, compared to 16% of CYP who tested negative (suggesting 14% had SARS-CoV-2-attributable symptoms). No studies of CYP have yet to investigate the longer-term health outcomes associated with SARS-CoV-2, meaning the risk of post-COVID-19 syndrome is particularly poorly understood in this population.

A lack of consensus on the symptoms which constitute ongoing symptomatic COVID-19 and post-COVID-19 syndrome, especially in CYP, means that identifying the scale of the problem has been challenging. Different studies have looked at different symptoms, although some commonalities between the most frequently-reported symptoms (e.g., headache, fatigue) have been found. Furthermore, many of the reported post-COVID syndrome symptoms are non-specific, and therefore differentiating between those caused by SARS-CoV-2 and other conditions is difficult, especially when an adequate control group is lacking. Looking more widely at symptoms, and incorporating other sources of data such as health service utilisation and diagnoses, would give a more complete picture of how the COVID-19 pandemic has affected the long-term health of CYP.

The first research theme aims to investigate the acute and long-term health consequences of SARS-CoV-2 infection in CYP using SIS-1. Data will be used on reported symptoms and school absences, and information on clinical diagnosis, prescriptions and health service utilisation during 2019 (to generate risk factor data) and since the start of 2020 (to use as outcome data), obtained from linking SIS-1 to data from electronic health records (EHRs). The analysis will use a novel approach of investigating the association of SARS-CoV-2 infection with each of the chapters of diagnoses from the 10th revision (2019 version) of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) that relate to all and any respiratory, cardiovascular, gastrointestinal, psychological/psychiatric, and nervous system diseases, as well as with signs and symptoms not elsewhere classified (which includes fever, headache, fatigue and pain), and with selected chapters of the British National Formulary for Children (BNFC) that relate to the same conditions, thereby covering all possible outcomes of SARS-CoV-2 infection, insofar as the outcomes considered are those that have most clinical relevance for CYP, and avoiding assumptions about the nature of post-COVID syndrome in children. These outcomes will be investigated for (1) between 4-12 weeks and (2) more than 12 weeks following (first) SARS-CoV-2 infection), where possible, in line with NICE’s definitions for ongoing symptomatic COVID-19 and post-COVID-19 syndrome, respectively, thereby generating some of the first evidence of the risk and nature of post-COVID-19 syndrome in children. In summary, the first research theme will:

1. Examine whether SARS-CoV-2 infection (versus no SARS-CoV-2 infection) increases the risk of adverse health outcomes, and the predisposing socio-demographic and clinical factors for adverse health outcomes, as defined by:
a. reported survey symptoms persisting for (1) 4-12 weeks and (2) more than 12 weeks;
b. any diagnosis of a symptom/condition from selected ICD-10 chapters for (1) 4-12 weeks and (2) after 12 weeks since (first) SARS-CoV-2 infection;
c. any pharmacological product prescribed in primary care for selected BNF chapters for (1) 4-12 weeks and (2) after 12 weeks since (first) SARS-CoV-2 infection;
d. health service utilisation: (a) primary care visit (b) A&E visit; (c) hospital admission; (d) outpatient visit, for (1) 4-12 weeks and (2) after 12 weeks since (first) SARS-CoV-2 infection;
e. number of school absences due to illness (as a proxy measure of illness).
2. Investigate the predisposing socio-demographic and clinical factors associated with an increased risk of the adverse health outcomes following a SARS-CoV-2 infection
3. Explore the use of time-varying clustering to group self-reported symptoms and diagnoses and identify common post infection sequalae in CYP.

At present, it is very difficult to know whether post-COVID syndrome is different to the long-lasting effects of other infections in CYP, as these were not well understood even before the SARS-CoV-2 pandemic. Co-infections may be an important influencing factor on the development of post-COVID syndrome; however these are particularly poorly understood. The health consequences of SARS-CoV-2 infection in CYP will be compared to those following other infections, using acute fever (reported in SIS-1) as a marker, and again, exploring the influencing clinical and sociodemographic characteristics. Since fever is a specific, but not sensitive, marker for infection, as a first step, patterns of fever and other symptoms will be described. The marker for infection may be widened to consider other symptoms. The study team will examine the modifying effect of infectious agent in the analyses, where possible (including exploring co-infections), since acute fever has multiple possible infectious causes.

This research is hoped to generate an understanding of how post-COVID syndrome compares to long-term outcomes of other infections in children. The additional knowledge and understanding gained about the long-term outcomes of SARS-CoV-2 infection will generate additional value from the linked SIS-1 dataset, and is expected to increase the clinical relevance of the research.

The second research theme as part of this study will aim to characterise acute symptomatic SARS-CoV-2 infection in school-aged children in England and investigate determinants for symptomatic compared with asymptomatic infection in this population, including socio-demographics, virological, clinical and pharmacological characteristics. There remains a paucity of research characterising the symptom profile and determinants of acute SARS-CoV-2 infection and symptomatic COVID-19 disease among school-aged CYP. Additionally, there is limited evidence about how new variants of SARS-CoV-2 have contributed to a changing symptom profile in CYP. Available reports indicate that some of the new variants have changes that allow them to spread more easily in both children and the general population, but with no evidence of increased susceptibility compared to adults. However, due to some groups of CYP remaining largely unvaccinated it is useful to understand the symptom profile of COVID-19 in this group, as well as to elucidate who is most at risk of symptomatic infection and if they are at higher risk of subsequent clinical progression of disease. In addition, understanding who gets asymptomatic infection may help in exploring the role of CYP as transmitters.”

The following NHS England data will be accessed:
• Hospital Episode Statistics Admitted Patient Care, Critical Care, Outpatients, and Accident & Emergency data and the Emergency Care Data Set (ECDS) – necessary to capture secondary care data on demographics, healthcare utilisation, symptom reporting, diagnoses and comorbidities
• General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR) (pending the confirmed support of the British Medical Association and Royal College of General Practitioners, and subject to an amendment to this Agreement) – necessary to capture primary care data on demographics, symptom reporting, healthcare utilisation, diagnoses and comorbidities
• COVID-19 Second Generation Surveillance Systems (SGSS) – necessary to capture data on SARS-CoV-2 infection
• Medicines dispensed in Primary Care NHS Business Services Authority (NHSBSA) – The NHSBSA Medicines Data Directions 2019 drives the linkage of medicines data with other datasets to provide intelligence about the safety and effectiveness of medicines. This hypothesis-generating study aims to produce intelligence about the medicines that are prescribed following post-COVID syndrome, which will be able to inform subsequent studies of the safety and efficacy of these medicines in CYP with post-COVID syndrome.

The linked dataset will greatly enrich the capability to find records within the SIS-1 cohort with symptoms as a result of SARS-CoV-2 infection, as well as other data to explore for potential association with the risk of developing symptomatic COVID-19. As SARS-CoV-2 is a relatively new infection, new findings are being generated about the long-term implications of infection, and the study team require all of the described data in order to respond to new findings and investigate these areas.

The level of the data will be pseudonymised.

The data will be minimised as follows:
• Limited to a study cohort identified by the Office for National Statistics (ONS) – including only pupils involved in the SIS-1;
• Limited to data between 2019 and 2023

The University of Bristol as research sponsor, and LSHTM 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 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.

This research is in the public interest because it is expected to:
1. Produce a definition or definition(s) of post-COVID syndrome in CYP
2. Identify which CYP are at greatest risk of acute SARS-CoV-2 symptoms and of post-COVID syndrome
3. Identify the sociodemographic and clinical characteristics of those children and young people with symptoms who attend primary care and those who do not.
This project will inform and support the clinical management of adverse SARS-CoV-2 related outcomes in children and young people through the following outputs:
Output 1: Generating a definition(s) of post-COVID syndrome in children and young people for the better identification of this condition
Output 2: Identifying which groups of children and young people are most at risk of long- and short-term effects of SARS-CoV-2 to inform clinical management and prevention strategies
Output 3: Informing the extent to which children and young people with post-COVID syndrome attend primary care (and hence the potential unmet need for care), and the influencing socio-demographic and clinical characteristics
Output 4: Producing appropriate information and messaging for the support of children and young people and their families.

The funding comes from multiple sources. Current funders include:
• National Institute for Health Research (NIHR) School of Primary Care Research (SPCR) – Funding is in place until 30/06/2024.
• HDR UK - Funding has been provided to set up the study and carry out some preliminary analysis.
• NIHR Advanced Fellowship – Funding is in place until 31/07/2027.
Funding to continue the work described will be sought on an ongoing basis.

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

The ONS is a processor acting under the instructions of the University of Bristol and LSHTM. ONS’s role is limited to providing the study cohort to NHS England and providing access to the linked SIS-1 and NHS England data in the Secure Research Service (SRS).

Crown Hosting Data Centres provide cloud-based infrastructure to the ONS and will store the data as contracted by ONS.

iTS Computing Group (formerly known as Equiniti) provide implementation and maintenance services for the ONS SRS’s Crown Hosting Data Centres infrastructure.

UKHSA are collaborators on SIS but are not responsible for designing the research of this current study and are not accessing the NHS England data.

For the patient and public involvement and engagement (PPIE) activities, views about post-COVID syndrome in children were gathered from young people, parents and doctors between 9 March and 30 April 2021 to inform the research questions and methods through:
• an online meeting with seven young people aged 13-18 years from the NIHR Bristol Biomedical Research Centre Young People’s Advisory Group (YPAG);
• an online meeting with five families whose children, aged 10-16 years, have post-COVID syndrome or suspected post-COVID syndrome ;
• a survey completed by four GPs and one paediatrician, and an online meeting with two paediatricians.

PPIE contributors said that:
1. The COVID-19 pandemic is ongoing and there are many knowledge gaps.
2. Clinical understanding of post-COVID syndrome in CYP is currently extremely limited. Post-COVID syndrome in CYP is not well defined, and it may be difficult for doctors to distinguish between post-COVID syndrome and other conditions. It still needs to be understood whether post-COVID syndrome is a new condition in itself, or a group of conditions like post viral fatigue.
3. For these reasons, post-COVID syndrome is likely to have been under-diagnosed to some extent to date, although it is still unclear what exactly ‘post-COVID syndrome ’ in CYP means.
4. Symptoms attributed to post-COVID syndrome varied between the families spoken to, and the symptoms their children had experienced were more wide-ranging than those listed on the NHS website. Not all had been tested at the time of their infection.
5. The families whose children have post-COVID syndrome or suspected post-COVID syndrome ranked extreme tiredness, shortness of breath, chest pain, heart palpitations, depression, anxiety, feeling sick or stomach pain, diarrhoea, headaches or fever, and allergies in the top 3 most harmful symptoms at least once.
6. Of the symptoms listed by the NHS for long-COVID, feeling sick or stomach pain, extreme tiredness, and headaches were the symptoms commonly ranked as most ‘harmful’ by young people and by families whose children have post-COVID syndrome or suspected post-COVID syndrome .

From this it was concluded that:
1. Considering a wider range of symptoms, and looking more broadly at things like GP and hospital visits, and school attendance, might be a better way at this time of assessing how COVID-19 has affected CYP. It is important to be aware of things like the extent to which healthcare is accessed according to need. The impact on CYP with milder symptoms may be missed if only EHR data are examined.
2. Feeling sick or stomach pain, extreme tiredness, and headaches will be important symptoms to consider in the study.
3. Some SARS-CoV-2 infections which occurred early in the pandemic will not have been recorded, affecting the measurement of long term health outcomes (e.g., misclassification of exposure bias).

These findings and conclusions have directly influenced the diagnoses/symptoms that will be looked at in the study (i.e., taking a broad, exploratory approach), what data will be used to investigate the long term adverse effects SARS-CoV-2 has on CYP to include both EHR and research data, and consideration of potential biases such as those due to testing strategy leading to misclassification of exposure.

Expected Benefits:

It is expected that this research will help quantify the impact of adverse health outcomes of SARS-CoV-2 infection in children. It is also anticipated that this research will help determine the risk factors for developing symptomatic disease following infection, and long-term outcomes, such as age, gender, ethnicity and the nature of the SARS-CoV-2 infection itself.

By understanding the impact of the COVID-19 pandemic on children, healthcare services should be better placed to support children and young people (CYP). Understanding the impact of disease and who it most affects will help to enable the appropriate targeting of resources, e.g., to mental health services, or to chronic fatigue clinics, or to cardiac care. It also helps to inform policy decisions around testing for SARS-CoV-2 infection in children, vaccinating children against SARS-CoV-2 infection including decisions around cost-effectiveness and dosing, and mitigation measures such as school closures.

The COVID-19 pandemic has affected everyone. Public health policies on vaccination, testing, school closures and restriction of movement have widespread economic, health and social impact. Health resources are finite. It is in the public interest for there to be transparency in the underlying evidence supporting public health policies and resource distribution.

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 such as future vaccination and pandemic planning strategies
• 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 (here, CYP) or conditions (here, post-COVID syndrome)
• 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.

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 concerning the management and support of children and young people’s recovery following the pandemic. The Schools Infection Survey (SIS) is a national study and it is anticipated that results from this project will influence national policy, with learnings generalisable to school settings internationally.

The study team recently produced a report of PPIE activities for the study. The report is entitled, “Long COVID in children: A report summarising the views of young people, parents and doctors.” This report was written for both an academic and public readership and was published on the COVID-19 Mapping and Mitigation in Schools (CoMMinS) website (https://commins.org.uk/news/july2021/). A press release was produced by the University of Bristol in collaboration with Health Data Research (HDR) UK, ONS, LSHTM and UKHSA, and the report was subsequently taken up by BBC Points West and BBC South Today. Key media outlets expressed a keen interest in doing features about the findings from the study when available, and contacts will be followed up with the findings. The report was featured in blogs and news stories on the CoMMinS website, IEUREKA! website, University of Bristol news website and HDR UK website. HDR UK, the University of Bristol, ONS and LSHTM all tweeted about the report. The PPIE contributors were also contacted directly to share the published report with them. It is expected that a similar strategy will be taken when it comes to publicising the study findings.

The SIS and CoMMInS leadership teams, which include members of the Scientific Pandemic Influenza Group on Modelling and Joint Committee on Vaccination and Immunisation advisory groups, as well as national government bodies (ONS and UKHSA), will be utilised to disseminate findings to a wide audience.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer reviewed journals – a minimum of 2 papers in high-impact open access journals are expected
• Presentations at key academic conferences such as the Royal College of Paediatrics and Child Health, the International Society for Infectious Diseases, and International Conference on Emerging Infectious Diseases conferences.
• Developed code shared via the HDR UK Innovation Gateway/ other appropriate information sharing platforms

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
• Social media
• Press/media engagement
• Blogs, press reports and news stories on the websites of the study team and funders
• Public reports
• Direct bilateral engagement with policy makers and the UK Health Security Agency
• Executive summaries for local and national policy makers
• ONS newsletters to key stakeholders including central Government
• Information sheets for patients and their families, clinicians, headteachers/schools and the public, as appropriate.

The target dates for production and dissemination of the outputs are Q2 2024 – Q2 2025.

Processing:

The Office for National Statistics (ONS) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR) (pending the confirmed support of the British Medical Association and Royal College of General Practitioners, and subject to an amendment to this Agreement); Emergency Care Data Set (ECDS); HES Admitted Patient Care, Critical Care, Outpatients, and Accident & Emergency; Medicines dispensed in Primary Care (NHSBSA), and COVID-19 Second Generation Surveillance Systems (SGSS) dataset to the ONS.

The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the data with other record level data already held by the recipient.

The data will not be transferred to any other location.

The data will be stored on servers at the ONS.

The ONS stores data on the Cloud provided by Crown Hosting Data Centres.

The data will be accessed by authorised personnel via remote access. The data will remain on the servers at the ONS at all times.

Personnel are not technically capable of downloading or copying data to local devices.

The data will not leave the UK at any time.

Access is restricted to employees of the University of Bristol and London School of Hygiene and Tropical Medicine (LSHTM) who are named ONS-accredited researchers, and substantive employees of the ONS.

Access to confidential patient identifiable data is restricted to employees of the ONS. The identifying details will be stored in a separate database to the linked dataset used for analysis. There would be no circumstances in which ONS would need to re-identify a study participant in relation to this study.

Employees of the University of Bristol and LSHTM are permitted to access pseudonymised data only.

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

The data will be linked at person record level with the Schools Infection Survey (SIS)-1 held by the ONS.

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

Researchers from the University of Bristol and LSHTM will analyse the data with the support of the ONS for the purposes described above.

Improving Medicines use in People with Polypharmacy in Primary Care — DARS-NIC-263738-V6V9N

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

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

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2021-07-26 — 2024-07-25 2023.12 — 2023.12. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Emergency Care Data Set (ECDS)
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Admitted Patient Care (HES APC)
  5. Hospital Episode Statistics Outpatients (HES OP)

Expected Benefits:

It is hoped that the research and outputs from the aforementioned dissemination will:
• Improve outcomes for patients with polypharmacy.
• Reduce use of health services (including fewer prescriptions) and reduce medication waste.
• Improve awareness amongst clinicians, patients and policymakers of the problems of polypharmacy.
• Inform National Institute for Health and Clinical Excellence, Royal Pharmaceutical Society and Royal College of General Practitioners guidance on the management of polypharmacy in primary care.
• Inform future policy in terms of making best use of the growing number of practice pharmacists (to include NHS England’s Clinical Pharmacist in General Practice programme, Primary Care Networks).
• Potentially provide an effective model (IMPPP) for the management of polypharmacy.

Outputs:

University of Bristol are planning a range of outputs from the IMPPP study (Phases 1, 2 & 3); most of these are planned to be produced in the final 6-month dissemination period (unless otherwise stated):

• Academic papers, including: intervention development (produced after Phase 1); trial-based effectiveness and cost-effectiveness; patient experience of the intervention and usual care; and process evaluation
• NIHR final report including executive and Plain English summaries (completion date March 2023)
• Printed and electronic promotional material targeting NHS managers, commissioners and policy makers within Clinical Commissioning Groups across England (to include medicines management teams, regional medicines optimisation groups, NHS England’s Clinical Pharmacist in General Practice programme, Primary Care Networks)
• Policy briefing documents, drawing upon research findings plus feedback from stakeholder engagement exercise at a national workshop
• IMPPP informatics tool for practices, including remote dashboards for CCGs. The system will be readily scalable, so easily distributed to other EMIS Web practices in the short term, and in the longer term to practices using other computer systems
• Educational materials on polypharmacy for clinicians, including students will be provided to Medicines Management Groups within Clinical Commissioning Groups across England and to UK Universities delivering undergraduate and post graduate programmes in medicines optimisation via email and oral presentation.
• Information leaflets for patients about polypharmacy and medication review*.
• The maintenance of an IMPPP study website (providing patient information, and research updates throughout project including final results).
http://www.bristol.ac.uk/primaryhealthcare/researchthemes/imppp/

*The research question and study design were discussed with Personal and Public Involvement (PPI) advisors prior to the funding application being submitted. Since the funding has been secured, PPI advisors have been involved in the development of the plain English summary for the protocol and ethics application and the patient-facing documents (to include participant information sheets, consent forms, interview topic guides, questionnaires and the invitation letter and supporting documents sent to participants prior to the medication review appointment). The study team aim to work closely with public and other patient groups when publicising the findings.

Brain tumour diagnoses by hospital eye services: is there evidence of a Barker effect? ( ODR1920_288 ) — DARS-NIC-656873-Q2C7L

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Identifiable, 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 2023-06-27 — 2024-06-26 2023.08 — 2023.08. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations
  2. NDRS Linked Cancer Waiting Times (Treatments only)
  3. NDRS Linked DIDs
  4. NDRS Linked HES AE
  5. NDRS Linked HES APC
  6. NDRS Linked HES Outpatient
  7. NDRS National Radiotherapy Dataset (RTDS)
  8. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objectives:

University of Bristol requires access to NHS England data for the purpose of the following research project: Brain tumour diagnoses by hospital eye services: is there evidence of a Barker effect?

Papilloedema refers to swelling at the back of the eyes caused by increased pressure inside the head and can indicate life- or sight-threatening disease, e.g., a brain tumour, meningitis, or blood clot. In 2016, an optometrist Honey Rose was convicted of gross negligence manslaughter after failing to diagnose papilloedema in an 8-year-old boy called Vincent Barker who later died. As a result of the Honey Rose court case, the number of referrals from optometrists to hospital eye departments of people suspected to have papilloedema increased sharply. The aim of the project is to find out whether people with intracranial tumours were diagnosed earlier and more often by hospital ophthalmologists in England since 2016.

The following is a summary of the aims of the research project provided by University of Bristol.

To determine the time to diagnosis and outcome of patients with intracranial tumours before vs after the Honey Rose case in 2016.

1. To determine whether time to diagnosis depends on route to diagnosis before/after Honey Rose?
2. To determine whether outcomes (mortality/survival) depend on time and/or route to diagnosis for patients before/after Honey Rose.
3. To determine whether time and route to diagnosis and outcomes are influenced by tumour type, sex, ethnicity, smoking, age, geography and deprivation?

The current study is approved by the Health Research Authority (IRAS 286872; REC 20/LO/0948) and is sponsored by the University of Bristol (2020-4244).

University of Bristol aim to use the data requested to better understand the referral pathways for patients with suspected papilloedema/raised intracranial pressure from primary care (GP or optometrist). The results of this work will contribute to the wider outputs of the Improving the Diagnostic accuracy of referrals for Papilloedema (DIPP study), run by the University of Bristol by the same study team, which has the aim of "Improving the Diagnostic accuracy of referrals for PaPilloedema." One of the aims of the DIPP study is to develop evidence-based referral guidelines to ensure people with papilloedema are accurately identified in primary care, referred to the appropriate service in secondary care and without unnecessary delay. Currently, such referral pathways do not exist.

The DIPP study team and project are guided by the ‘Brain tumour diagnoses by hospital eye services: is there evidence of a Barker effect?’ steering group, comprised of an independent chair, independent clinical researcher, the Chief Investigators and two PPI representatives from the study.

The following NDRS data products are being requested previously and disseminated in 2021.

• NDRS Cancer Registry
• NDRS Cancer Wait times (CWT)
• NDRS Hospital Episode Statistics Admitted Patient Care (HES APC)
• NDRS Hospital Episode Statistics Accident & Emergency (HES A&E)
• NDRS Hospital Episode Statistics Outpatients (HES OP)
• NDRS Diagnostic Imaging Dataset (DIDs)
• NDRS Systemic Anti Cancer Dataset (SACT)
• NDRS Radiotherapy Dataset (RTDS)

The following NDRS data products are being requested as a refresh under this application.

• NDRS Cancer Registry (mortality fields only)

The level of the data is Pseudonymised. This level of data is necessary to capture true positive referrals (patients who do have intracranial tumours), cancer stage, treatment, and mortality (where relevant). Since the study team are investigating route to diagnosis of intracranial tumours, the plan is to work backwards from the date of diagnosis within the Cancer Registry, and cross reference this with the date of the diagnostic intracranial imaging in the DIDs dataset and the specialty of the clinician requesting the imaging from linked HES data (APC, A&E, OP). To compare the outcomes of people who underwent different routes to diagnosis, the study team will investigate their cancer wait times (CWT), and outcomes from the Radiotherapy (RTDS) and systemic anti-cancer treatment (SACT) datasets to establish if there are treatment differences between groups. The quantum of data could not be reduced without significantly affecting achievement of the project aims.

The data will be minimised and limited as follows to data for a study cohort identified by NHS England as meeting the following criteria:

• Limited to data between [2013- 2018];
• Benign and malignant intracranial tumours
• Limited to conditions relevant to the study identified by specific ICD or OPCS codes; C69-C72, C720-C725, C751-C753, D32, D42, D330-D334, D352-D354, D430-D434, D443-D445.
• Limited to the geographic area of England only.

University of Bristol is the research sponsor and the data 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 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.

This project will determine how routes and time to diagnosis of people with intracranial tumours have been affected by the widespread media coverage of the Honey Rose/Vincent Barker case and the subsequent impacts of increased optometry referral numbers and hospital service demands in secondary care. It will highlight the strengths and weaknesses of different routes to diagnosis for people diagnosed with intracranial tumours.

The outputs from this work will be in the public interest. Firstly, the results of this analysis will contribute to the development of evidence-based referral guidelines by the DIPP study team that will improve the identification of people with intracranial tumours in primary care and reduce their time to diagnosis and risk of mortality. Secondly, these results will raise public awareness about the benefits of regular eye examinations to check on general health.

The study entitled "Brain tumour diagnoses by hospital eye services: is there evidence of a Barker effect?" is funded by educational grants from the University of Bristol. However, funding of the wider DIPP study is provided by two grants from the National Institute of Health Research (NIHR) that support parallel research to investigate geographical variations in referral practices and management of patients with papilloedema across England. This funding is in place until May 2024. The National Institute of Health Research (NIHR) will not have access to, nor process the NHS England data.

University of Bristol is the Sole Data controller and sole data processor who provide all IT support for the provision of this project.

The DIPP study has a steering group, comprised of an independent chair, independent clinical researcher, the Chief Investigators and two PPI representatives from the study. All members of the steering group, except the Chair, are based in Bristol. The Chair, who is based at the University of Manchester, is working in an advisory capacity and has no access to the data and no data controllership responsibilities.

Data will only be accessed by substantive employees of the data controller. This includes the supervision of postgraduate students at the University of Bristol who may be processing the data. Postgraduate students at the University of Bristol undergo mandatory training in Information Governance and Data Protection.

The DIPP study has a hospital PPI group comprising 6 volunteers from the Brain Tumour Support Group who were diagnosed with a brain tumour after presenting to their optician with visual problems. The study team asked the PPI group about their views on using data from NHS England to find out "whether the Honey Rose case affected the time to diagnosis of people with brain tumours and whether more brain tumours are diagnosed by eye specialists now compared with the time before the Honey Rose case".
There were 4 responses, which were all positive:
“I would be very happy to allow a team of research scientists access such information.”

“Personally, I would be happy for any information to be passed on, anything to help with the research, but not personal info! Eg, mobile numbers or actual addresses, other than that I certainly wouldn’t have a problem.”

“Please do use my information, as it is thanks to my optician that I was diagnosed.”

“I would have no problem with information about me being accessed by research scientists. Although my meningioma was removed in 1999, it was my optician who diagnosed that something was seriously wrong. I do hope that you are able to access the cancer registry data.”

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

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

Yielded Benefits:

To date, the results of this data analysis project have supported two successful NIHR grant applications that aim to produce clinical guidelines and educational materials to help GPs and optometrists to make the diagnosis of papilloedema. The guidelines will also inform GPs, optometrists and their patients about what to expect when they refer/are referred to hospital and which secondary care services are the most appropriate destinations for these referrals. The continued analysis of the data from NHS England in this project will further inform these guidelines. In addition, The University of Bristol have forged several new collaborations with other universities and representatives of major stakeholders to support our NIHR-funded research, including: • University of Exeter (Sam Merriel) • Queen Mary University London (Beth Stuart) • College of Optometrists (Mike Bowen) • Specsavers opticians (Frank Moore) • Bristol North Somerset South Gloucestershire (BNSSG) integrated care board (Paul Roy) • REACH emergency care hub (Jonathan Benger) • NIHR Applied Research Centre-West (Teresa Redaniel) Moreover, The University of Bristol have well-established patient, public, involvement (PPI) groups to represent patients and the public, who have been highly supportive of the ongoing work and engagement of our research team.

Expected Benefits:

High street optometrists currently provide an important primary care service for eye health. GPs often rely on high street optometrists to screen people for common eye conditions, like glaucoma and cataract, and to refer patients to them when they detect a problem.

Hospital eye specialists (ophthalmologists) also rely on the skill of high street optometrists to refer patients with serious eye problems to them and to reassure others who simply need glasses to improve their vision.

The study results to date suggest that optometrists are referring more people who they suspect to have papilloedema to secondary care than before the Honey Rose case. The impact is that more people with intracranial tumours are diagnosed by eye specialists than other health specialists following the Honey Rose case but they are having to wait longer for their appointments because so many more people are referred to secondary care overall who do or do not have anything wrong with them.

In future analysis of the data, the study team will determine the impact of increased waiting times for hospital appointments with eye specialists on patient outcomes and survival, but it is likely that people who wait longer for their diagnosis and treatment will have worse morbidity and mortality rates. The study team are conducting further research (as described above) to produce clinical guidelines and educational materials that will help community optometrists and GPs to diagnose people who do or do not have papilloedema so that patients with papilloedema are investigated and treated quickly and those who do not are reassured. The study team anticipate these guidelines will save the NHS money by avoiding the costs of missed or delayed diagnosis and false positive diagnostic cascades.

As a result, 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 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).


The results of this study will determine how the widely publicised Honey Rose court case have affected NHS service demands and patient outcomes for people in England diagnosed with intracranial tumours and they will highlight the strengths and weaknesses of different routes to diagnosis for people diagnosed with intracranial tumours. By understanding where these strengths and weaknesses lie, the study is hoped to help the design and planning of referral pathways and services to become more reliable, safe and ensure higher quality patient care and patient experience. It is also hoped the study can also target interventions and funding to identified geographical and service areas of need.

The study’s communication goals are: (i) to make eye care and other health professionals and GPs aware of the study and availability of DIPP guidelines and training; (ii) to inform patients and the public about what the study means for them; (iii) to make policy and commissioning audiences, e.g. NHS England, aware of the guidelines and training to improve the quality and cost-effectiveness of patient care; (iv) to gain support among funders and the academic community for further dissemination and implementation work.

Throughout the project, The University of Bristol will update the DIPP study website and publicise via key stakeholder groups, including the Royal Colleges (Ophthalmologists, GPs, Physicians, Emergency Medicine) College of Optometrists, third sector organisations like Specsavers opticians and patient groups like Brain Tumour Support with a view to disseminating the outputs nationally. The College of Optometrists also runs a very successful series of online webinars (1000+ delegates / session) and an annual conference, Optometry Tomorrow (800+ delegates).

As mentioned above, The University of Bristol will use media and social media channels; media engagement; organisational newsletters; local, regional, and national networks established by the Centre for Academic Primary Care to draw attention to the project and disseminate the findings, guidelines and training resources.

The University of Bristol will publish and present DIPP guidelines at national meetings and conferences like the Annual Congress of The Royal College of Ophthalmologists, Optometry Tomorrow or Society for Academic Primary Care. Additionally, then the study team will publish educational materials tailored to the following health professionals: optometrists, GPs, ophthalmologists, neurologists, emergency care practitioners, policymakers.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer reviewed journals aiming for at least 2-3 publications within high-value journals within 2 years.
• Presentations at Appropriate conferences. Such as the Association of Research in Vision and Ophthalmology conference in April 2023, Annual Congress of The Royal College of Ophthalmologists, Optometry Tomorrow or Society for Academic Primary Care.

The outputs will not contain NHS Digital 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.

In 2022, the University of Bristol published the results of a study showing an immediate 5- to 6-fold increase in the number of referrals to Bristol Eye Hospital of patients suspected to have papilloedema after the Honey Rose case and these referrals have remained as high as this ever since. Most of these patients did not actually have papilloedema (>60-70%), suggesting that optometrists had a much lower threshold to refer patients to secondary care since the Honey Rose case. On the other hand, University Of Bristol found that more patients who did have papilloedema were picked up than before the Honey rose case but had to wait longer for their appointments.

The study’s intention is to use the data obtained from Public Health England’s ODR (now NHS England) to determine whether the Honey Rose case had a nationwide impact on the number of patients diagnosed with intracranial tumours by hospital eye specialists. This is because brain tumours are one of the most serious causes of papilloedema. Results so far are comparable to experiences in Bristol; in other words, more brain tumours are diagnosed by hospital eye specialists nationally than before the Honey Rose case, but these patients have had to wait longer for their appointments. The study also found that hospital eye specialists are diagnosing eye tumours more quickly (another type of intracranial tumour) and this is probably because optometrists are working more vigilantly since the Honey Rose case; however, there is some geographical variation in referral waiting times that reflect how primary eye care services are commissioned in different areas of England.

Given these temporal and geographical variations in referral waiting times across England for patients with intracranial tumours, University of Bristol now wish to investigate how this impacts patient outcome and survival. The study team plan to present preliminary findings at the Association of Research in Vision and Ophthalmology conference in April 2023 and to present analysis of patient outcomes in 2024. University Of Bristol also intend to publish these results in high impact peer-reviewed journals; given the time to prepare, submit, and revise manuscripts following peer review, the study team anticipate these publications will become available in 2023-2025.

University Of Bristol have also been successful in two grant applications to the National Institute for Health Research (NIHR) to fund the DIPP study: "Improving the Diagnostic accuracy of referrals for Papilloedema". The DIPP study team will further investigate geographical variations in referral practices and the management of patients with papilloedema across England by completing Freedom of Information requests to Integrated Health Boards about their service provision and surveying primary and secondary care health professionals about their practices. University Of Bristol intend to use the results from this data analysis project and the NIHR-funded research to develop some clinical guidelines and educational materials to improve referral practices, the quality of patient care, patient outcomes, and the experiences of patients navigating the healthcare system. For this purpose, the study team have created the DIPP study website and publicised the study through social media channels; media engagement; organisational newsletters; local, regional, and national networks established by the Centre for Academic Primary Care to draw attention to the project and disseminate our findings, guidelines and training resources. Furthermore, the study team shall host workshops with key stakeholder groups including optometrists, ophthalmologists, GPs, emergency care practitioners, neurologists, and patients. The study team shall publish and present DIPP guidelines at national meetings and conferences like the Annual Congress of The Royal College of Ophthalmologists, Optometry Tomorrow or Society for Academic Primary Care. The NIHR-funded research began in May 2022 and will continue until at least May 2024. Additionally, the University of Bristol plan to apply for a NIHR programme grant to continue this work.

Processing:

No data will flow to NHS England for the purposes of this Agreement.

NHS England will provide the relevant records from the NDRS Cancer Registry, NDRS Cancer Wait times (CWT), NDRS Hospital Episode Statistics Admitted Patient Care (HES APC), NDRS Hospital Episode Statistics Accident & Emergency (HES A&E), NDRS Hospital Episode Statistics Outpatients (HES OP), NDRS Diagnostic Imaging Dataset (DIDs), NDRS Systemic Anti Cancer Dataset (SACT), NDRS Radiotherapy Dataset (RTDS) to University of Bristol. The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the data with other record level data already held by the recipient previously disseminated. Data will not be linked to other data out of scope of this agreement.

The data will not be transferred to any other location.

University of Bristol will extract the disseminated pseudonymised data extracts using a secure electronic file transfer system (SEFT) and make this available to the study team based at University of Bristol.

The Data will be processed and stored within the University of Bristol’s secure Research Data Storage Facility. The University of Bristol’s Research Data Storage Facility (RDSF) is only accessible to members of the University of Bristol who have been added to the project's unique RDSF folder as users and have entered their user specific password.

The University of Bristol's Advanced Computing Research Centre (ACRC) is responsible for providing the University's advanced computing systems. Data that is stored in the University's Research Data Storage Facility is backed up to tape libraries housed in the ACRC.

The data will be accessed onsite at the premises of the University of Bristol only. The data will be accessed by authorised personnel via remote access conducted via secure VPN. The data will remain on the servers at the University of Bristol at all times. Personnel are prohibited from/ and not technically capable of downloading or copying data to local devices.

The data will not leave England.

Access is restricted to individuals within Bristol Medical School at the University of Bristol who have authorisation from the Principal Investigators. All such individuals are substantive employees of University of Bristol and postgraduate students enrolled at the University of Bristol who may be processing the data under supervision. One substantive employee of the University of Bristol will change roles during the term of the agreement and at such time will transfer to an honorary contract with the University of Bristol to undertake the research. Postgraduate students and substantive employees (and any individual working under honorary contract) at the University of Bristol undergo mandatory training in Information Governance and Data Protection.

There will be no requirement and no attempt to reidentify individuals when using the data, and no data will be transferred to third parties.

Analysts/researchers from Bristol Medical School at the University of Bristol will process/analyse the data for the purposes described above.

The processing of data includes interrupted time series analysis and the use of Cox proportional hazards models to investigate the impact of the Honey Rose case on time to diagnosis, the proportion of intracranial tumours diagnosed by hospital eye specialists, and the effect on patient outcomes (mortality/survival) whilst adjusting for age, sex, ethnicity, and geographical location.

CAP study: Cluster randomised triAl of prostate specific antigen (PSA) testing for Prostate cancer (ODR1617_022) — DARS-NIC-656775-N0V8C

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: Sensitive

When:DSA runs 2023-01-11 — 2024-01-10 2023.04 — 2023.04. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations

Objectives:

This is a request from the University of Bristol to receive a more up-to-date drop of identifiable National Disease Registration Service (NDRS) Cancer Registry Data in support of the Cluster Randomised Trial of PSA Testing for Prostate Cancer (CAP) study and the ProtecT trial. The ProtecT trial is the intervention arm of the CAP study.

Few international issues in health care are as controversial as prostate cancer screening. Prostate cancer has a major impact on public health in the UK. There were 8,500 deaths from prostate cancer in England and Wales in 1998, making it the second leading cause of cancer mortality in men. The aetiology of prostate cancer remains unclear and opportunities for primary prevention are limited. Developments in diagnostic tests for prostate cancer, in particular the introduction of Prostate-Specific Antigen (PSA) testing, has led to increased interest in the possibility of secondary prevention through population screening.

Screening to identify prostate cancer while it is localised to the gland has provoked much public and scientific attention and there is intense debate about its role in improving men's health. Current UK health policy does not advocate population screening, but the policy remains under active review by the UK National Screening Committee. Major concerns remain about the lack of evidence about the effectiveness of treatments (the rationale for the ProtecT treatment trial) and the potential for diagnosis and over-treatment of tumours that might never become clinically significant. In the UK the introduction of routine prostate cancer screening is being delayed until adequate evidence becomes available to inform policy.

The CAP Study is a long-running study randomised cluster-controlled trial in which GP practises in 8 centres in England and Wales have been randomly allocated to either population-based PSA testing akin to screening (the ProtecT study) or standard (unscreened) practice. In the ProtecT practices, men aged 50 to 69 years were invited between 2001-2008 to undergo PSA testing. In the control arm practices men ages 50 to 69 years undergo standard NHS management. All men are being followed up for vital status, incident and fatal prostate cancer via NHS digital.

Pseudonymised NDRS Cancer Registry Data for this study has previously been shared with the University of Bristol when the data was controlled and managed by Public Health England (PHE).

The data requested and disseminated under previous iterations of this agreement (under PHE) has been used to evaluate the effectiveness and cost-effectiveness of population screening for prostate cancer by establishing a cluster randomised trial allocating general practices to either intensive case-finding (the ProtecT trial) or unscreened standard practice.

The CAP study will be delivered by the team at The Population Health Sciences Unit at Bristol Medical School. Part of the University of Bristol who are the sole data controllers and data processors. The Population Health Sciences Unit is a leading centre for research in population health sciences. Their multi-disciplinary approach contributes to significant healthcare improvements and policy changes around the world. The CAP study is funded by The Department of Health and Cancer Research UK, these organisations play no role in determining the purpose and means of processing, and have no access to data disseminated under this Agreement.

The CAP study has 3 primary health improvement goals for men diagnosed with prostate cancer.

• To provide an unbiased estimate of the effect of a single screen for prostate cancer on prostate cancer-specific and all-cause mortality in the population.

• To contribute to the international effort to investigate the impact of prostate cancer screening.

• To estimate the cost implications of prostate cancer screening and use the data collected to develop and refine a probabilistic model of the cost-effectiveness of prostate cancer screening in the UK.

To support the study in achieving these goals dissemination of data from the National Cancer Registry Dataset is requested as a one-off request and will be linked to the CAP trial cohort generated by the University Of Bristol.

To address the GDPR Principle of Data Minimisation, this request is limited to all GP practices and patients who fall under the scope of this trial. GP Practices randomised to the intervention arm (ProtecT trial) will be approached and informed consent will be sought from the senior partner for inclusion of the practice.

The legal basis for personal data to be obtained and processed is the UK General Data Protection Regulation (GDPR) Article 6 (1) (e) processing is necessary for the performance of a task carried out in the public interest with a basis in law. This study has been determined to be in the public interest as this research has the potential to provide an evidence base for public policy decision-making, the basis in law is the University’s Royal Charter.

The legal basis for processing health data is Article 9 (2) (i) processing is necessary for reasons of public interest in the area of public health and is completed under the supervision of a medical professional (the PI is registered with the General Medical Council). The processing also falls under Article 9 (2)(j) , processing is necessary for reasons of public interest in the area of research with a basis in law. The research has the potential to provide an evidence base for public policy decision-making, the basis in law is the University’s Royal Charter.

Yielded Benefits:

Data for this study has previously been share when the data were controlled and managed by Public Health England (PHE). As such there are some yielded benefits to be observed from the access to the data for the study prior to NHS Digital becoming data controller. These yielded benefits are noted below: The primary analyses including stage and grade data were undertaken at average 10-year follow-up (i.e. 2018) and published in JAMA (DOI:101001/jama.2018.0154) . These results published: (1) have informed UK and international guidelines on PSA-based screening; and (2) were used to update GP and Patient Information sheets produced by Public Health England (January 2020), aimed at enabling men to make a fully informed decision about whether or not to undergo screening. The results also influenced international screening guidelines for example: In the USA, the results of CAP had a major influence on the recommendations of the United States Preventative Services Task Force (USPSTF), a public health body, published in May 2018.

Expected Benefits:

The median 10 year follow-up was completed and published in JAMA in 2018 doi: 10.1001/jama.2018.0154. The long lead-time for prostate cancer mortality, confirmed by the CAP publication, necessitates follow-up beyond 10 years to comprehensively evaluate the full impact of screening. Prostate cancer screening remains controversial because of concerns about overdiagnosis and over treatment, and uncertainties about the scale of the mortality and quality of life benefit. The 15-year follow-up will directly inform UK policy on prostate cancer screening and treatment and have wide influence internationally. The prostate cancer stage and grade data are key in interpreting the results from CAP.
The expected measurable benefits to health arise from the ability of these data to allow an unbiased comparison between men screened for prostate cancer and those not screened. The data generated will provide both clinical and policy relevant data on one of the most controversial issues in health care nationally and internationally: the potential benefits and harms to the UK population of screening for prostate cancer.

Outputs:

Annual reports will be produced for Cancer Research UK. Papers will be prepared for publication in general, epidemiological and urological peer-reviewed journals. The findings will also be presented at national and international conferences and fed directly to other appropriate bodies such as the NHS National Screening Committee.

The median 15-year follow-up were reached in 2021 and it is anticipated that the publication will report these results in 2023, the University would nevertheless wish to apply for additional funding for longer term follow-up. CAP plan to publish median 15-year results in The Journal of the American Medical Association (JAMA), as was the case with the median 10-year results, https://jamanetwork.com/journals/jama/fullarticle/2673968

A statistical analysis plan detailing the median 15-year analyses was uploaded onto the University of Bristol research information repository prior to analysis being carried out (https://research-information.bris.ac.uk/en/publications/cluster-randomised-trial-of-psa-testing-for-prostate-cancer-cap-s) and also https://osf.io/7y3g6. Statistics involved in these papers usually refer to measures such as rate ratios and 95% confidence intervals rather than actual numbers of cases. CAP will apply statistical disclosure control for example NHS Digital non-disclosure rules for small numbers of cases and will not include any counts of less than 7 in a Table.

The papers will be available on the University of Bristol PURE pages https://research-information.bris.ac.uk/ - these publications are available to download with open access allowing anyone to access publications. The University of Bristol also publish with open access rights when submitting to journals, ensuring they maintain CRUKs publication ethos of ensuring research funded by them is available to all. Publications are also uploaded to 'researchfish' allowing the research community to clearly see what has been published.

Processing:

Upon receipt of the requested data, the University Of Bristol will analyse the data to produce statistical tables for inclusion in the outputs specified in the ‘Expected Outputs’ section of this Agreement.The primary analysis will be based on those deaths classified as from prostate cancer.

Other analysis of interest could include a comparison of underlying rates of prostate cancer in men who do and do not receive screening. This would be derived by comparing rates in men in intervention practices who do not attend for case-finding with those in control practices, assuming that men in the control practices represent comparable populations of men who would and would not have attended screening if invited..

The CAP study data management and security systems comply with the Data Security Protection Toolkit (DSPT). The study will use a designated safe haven server to store personal details and identifiable data. Access to the secure server is restricted to staff employed on CAP and the University of Bristol IT Services staff only.

Once at Social Medicine, the abstracted information will be stored on the safe haven server. This server and associated PCs will form their own network, which will be separate from the main University network, and is protected by local firewall and hardware. Only the University’s IT staff have authority to manage system security.

UPSTREAM Phase II – Further Follow Up Study (Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods). — DARS-NIC-305864-D0Y3W

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

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

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2023-01-30 — 2026-01-29 2023.03 — 2023.04. breached contract — audit report.

Access method: One-Off

Data-controller type: NORTH BRISTOL NHS TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)
  3. Hospital Episode Statistics Outpatients (HES OP)

Yielded Benefits:

UPSTREAM PHASE 1 of the study is the randomised trial part of the study identified that the urodynamic arm is non-inferior (primary outcome), but the rate of surgery was not lower (key secondary outcome). Additional analyses identified specific contributions of separate components of the diagnostic pathway, along with qualitative information, and thresholds for testing. This information was derived without using NHS Digital data.

Expected Benefits:

Lower urinary tract symptoms (LUTS) are a common feature of ageing. They can be categorised as problems with voiding (passing urine) or storing urine. In men with voiding LUTS, benign prostate enlargement (BPE) with ageing causes benign prostatic obstruction (BPO). For such patients, prostate surgery, such as transurethral resection of the prostate (TURP), may improve LUTS. However, voiding LUTS can also be caused by bladder dysfunction: e.g. poor expulsion strength of the bladder muscle, called ‘detrusor underactivity’ (DU). In such men, it is hard to justify prostate surgery if BPO is not present, especially in view of potential adverse effects.

The clinical pathway in findings of the main trial (“UPSTREAM - Phase I”) showed no difference between the two arms in the key secondary outcome of surgery rates. However, the clinical pathway proved to take longer than expected, such that some patients listed for surgery did not receive it by the end of their participation in the trial, or underwent surgery close to the 18-month follow up. This was an unexpected problem, representing failure of sites to comply achieve with NHS referral-to-treatment targets. This deficiency, which worsened during the trial, is potentially a fundamental issue, as the trial is predicated on differential surgery rates between the two arms (we hypothesised that the Urodynamics intervention arm would be non-inferior for symptoms, but at a lower surgery rate). Thus, the study team need scrupulous surgery data captured over a sufficient timescale to be able to report whether surgery rates were indeed lower.

LUTS are complex and it is recognised that: they are potentially a long-term problem; prone to manifest a placebo response, including with surgery; and they respond differentially to treatment (most importantly that storage LUTS, such as urgency and nocturia, are less likely to respond to surgery relieving BOO than voiding LUTS are). Following completion of the main trial (UPSTREAM - Phase I), the men with persisting voiding symptoms managed conservatively may subsequently have received surgery in the ensuing years (with a surgical recommendation based on "in case symptoms improve"/ "nothing else to offer") in the ensuing years. Thus, further follow up (“UPSTREAM - Phase II”), that includes the use of data extracted from NHS Digital, is needed to address the issue of uncertainty whether surgery rates were fully captured. This, which would be a definite step to maximising impact, avoiding the "doing the operation anyway, regardless of assessment" mentality sometimes encountered in clinical practice.

Thus, this long-term further follow up may help understanding of the sustained response, placebo impact and the behaviour of storage LUTS over time. This further follow up may help us to state for sure whether or not UDS delivered non-inferior symptom outcomes with lower surgery rates. Furthermore, there is very little information documented about men’s long-term experience on LUTS and its treatments, and the European Association of Urology (EAU) has identified this as a priority research need.

UPSTREAM is potentially very important. It will be the first large scale randomised study with long-term data for men who underwent comprehensive diagnostic assessment for LUTS. Hence, for participants it is hoped to provide proper insight into the merits of the diagnostic tests and the implications of test results for therapy outcomes. For society it may enable the best use of resources to focus on testing as relevant to therapy. For clinicians, it may counteract the "do the operation anyway, regardless of assessment" mentality sometimes encountered in clinical practice; it is expected that they may now be able to recommend intervention with evidence-based justification.

The one-off bespoke data extraction of routine data obtained via NHS Digital may allow the study team to answer some of the key objectives of the longer term follow up (i.e. “UPSTREAM – Phase II”). Using research nurses (and/or other suitable staff) at 26 hospitals to collect such follow up data would add considerable cost and time.

The health economics analysis will use specified HES and Civil Registration death datasets to understand the probability that diagnostic tests for LUTS is cost-effective compared to usual care. More specifically, it is expected that the intervention arm has the potential to lead to lower amounts of hospital care and thus hospital resource use including costly prostate surgery, as well as the expectation that the intervention arm could lead to improved quality of life post-care.

Good quality evidence which suggests this is the case would lead to more efficient use of resources across hospitals in England. A measure of the difference in hospital resource use, resulting from data requested from NHS Digital, has the potential to lead to changes in clinical practice where resources are allocated more efficiently within hospitals. In turn the improved allocation of resources could lead to a reduction in surgery waiting times for patients who have benign prostatic obstruction, where prostate surgery may be the most appropriate treatment for their LUTS.

Outputs:

The UPSTREAM project is formed of two phases. The original trial (“UPSTREAM - Phase I”) started 01 April 2014 and ended 30 September 2018. The start date for the second phase of UPSTREAM (“UPSTREAM - Phase II, Further Follow Up”) was 01 Juy 2019, and the study duration is expected to be 36 months, to May 2022. (subject to change)

Outputs from “Phase I” have already been disseminated and a full list of journal articles (and more) is available via the study website: http://www.bristol.ac.uk/population-health-sciences/projects/upstream/outputs-and-latest-updates/journal-articles/

This includes the protocol and statistical analysis plan, the baseline characteristics and initial diagnostic testing outcomes for the trial, as well as results of the main outcomes. Furthermore, qualitative evidence regarding the attitudes to, and experience of, UDS testing from men at each end of the clinical pathway, and men’s perspective on treatment decision-making for LUTS are also published. The study team expect to publish additional findings following completion of the further follow up, UPSTREAM-Phase II.

Planned reporting for “Phase II” is expected from Spring 2023 onwards (subject to change). Dissemination for the further follow up study will be like that of the trial (“UPSTREAM - Phase I”), and a comprehensive plan will be developed by the Project Management Group. For example, once results are available, the main forms of dissemination will be through the academic press, NIHR HTA monograph report, guidelines and workshops for clinical staff and by lay summaries on websites and other more accessible forms for patients.

All participants will be offered a lay summary of the main findings of the study (e.g. via newsletters and the study website). Dissemination to clinicians will be through papers in major urology journals and conferences (e.g. the European Association of Urology), workshops and presentations to national meetings e.g. the British Association of Urological Surgeons (BAUS) which is the specialist body with the responsibility for guiding clinical practice, policy matters, research priorities, governance and training in matters related to male lower urinary tract symptoms. BAUS is well placed to implement the findings by informing NHS policy (NICE) and dissemination of evidence-based clinical practice to its members. The Patient Panel working with the project will assist in the best methods to disseminate the results to patients, including interacting with the relevant charities in this area.

The UPSTREAM trial is part of the portfolio of the new Royal College of Surgeons of England Surgical Centre in Bristol so will be used as a platform for clinical trial training for new surgeon investigators, as well as the opportunity to conduct methodological research in surgical trials which would be disseminated by the surgical centre through workshops and publications. UPSTREAM study data will not be used for sales and marketing purposes.

As noted in participant information materials and the study protocol, no one will be able to identify participants from any publications that result from the study. Data will only be published in anonymised, aggregate form.

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)”

For this application, here UPSTREAM refer only to the processing activity related to the “data extraction via NHS digital” element of “UPSTREAM – Phase II”; information about “UPSTREAM – Phase I” and the questionnaire component of “UPSTREAM – Phase II” are not detailed, unless relevant.

“UPSTREAM-Phase II” - NHS Digital data extraction component.
(1) Between October 2014 and December 2016, patients were invited to take part in the UPSTREAM randomised controlled trial, referred within this application as “UPSTREAM – Phase I”.

(2) Written informed consent to take part was obtained for 820 eligible patients, which included agreement that information relevant to the UPSTREAM study may be collected from the patient’s hospital and NHS records, including Office of National Statistics (ONS), NHS central registers and the Health & Social Care Information Centre, and that this data may be used to follow their ongoing health after the study. When a patient joined the study, they were allocated a unique Participant Study I.D. number to main pseudonymisation. Participants will continue to utilise this I.D number throughout all stages of the project.

(3) As part of the 5-year follow up (“UPSTREAM – Phase II”), a member of The University of Bristol (UoB) research team will review relevant data of all existing UPSTREAM participants; these data will be extracted from the existing UPSTREAM databases, and manual checking of the UPSTREAM (Phase I) consent forms and withdrawal/change of permissions forms, if required. Specifically, the team will check that the participants did not withdraw permission for the study to continue to access sections of their medical notes and NHS records, ONS and NHS Central registers information, at the time of their 18-month timepoint; data extraction via NHS Digital will only be requested for participants meeting these criteria.

To access the desired information, (UoB) will securely send NHS Digital a cohort file for linkage to specified HES and HES-ONS datasets. The cohort file will include: UPSTREAM Study Identification (I.D) number, patient identifying NHS number, forename, surname, date of birth, gender and postcode (current postcode as per study records), plus date of initial randomisation and 5-year follow up.

(4) NHS Digital will use the patient identifiers to achieve linkage to the specified datasets for the periods of time specified per participant. NHS Digital will prepare a file(s) containing the UPSTREAM I.D number (but removing other direct identifiers, e.g. NHS number, name etc.). NHS Digital will then securely transfer the file(s) to the UPSTREAM project team at UoB

(5) The UPSTREAM team at UoB will store the data in a secure environment with appropriate security firewalls and controls in place and with secure access via approved personal. UoB substantive colleagues are the only individuals who will access the record level data being disseminated.

(6) Data from NHS Digital will be linked via the unique study (participant) I.D number to other pseudonymised data collected as part of the trial (including case report forms and questionnaires) to enable full analysis as per the study objectives. Data analysis will be performed by specific members of the UPSTREAM team, who are employed by the UoB. Analysis will take place on designated encrypted computer(s) working with data stored on the EVM. In line with the UoB DSPT, data processing will only be conducted by substantive employees of the data processor(s) and or data controller(s) who have been appropriately trained in data protection and confidentiality.

Raw, individual level data from NHS Digital will only be processed at UoB and will not flow out of UoB. It will be used to derive event rates (e.g. hospital admission rates and rates of death) in an analysis file. As noted in previous sections of this application, data from NHS Digital will be used to address key objectives for this further follow up (“UPSTREAM - Phase II”). These will be added to the main analysis files for the trial. A Statistical Analysis Plan (SAP) and Heath Economics Analysis Plan (HEAP) have been developed and will be signed off by the Trial Management Group, and wider Independent Trial Steering Committee, prior to analysis. UoB plan to publish aggregated data, which is appropriate for the public domain, however no patient will be identifiable from such publications, as noted in our participant information materials.

The data from the original UPSTREAM (Phase I) study are kept safely on the University of Bristol secure file system. The NHS digital data, collected as part of Phase II, will be stored securely using the University’s Encapsulated Virtual Machine (EVM). Analysis will take place on designated encrypted computer(s) working with data stored on the EVM. As an additional precaution, the identifiers used in Phase I will not match the identifiers used in Phase II. The trial statistician and health economist will have access to the “linking” IDs for analysis purposes only. They will stored in a secure place, separately to the Phase I and Phase II datasets.

As stated in the study protocol, pseudonymised research data will be stored and kept for future analysis. Any requests to access to NHS Digital Data will require an amendment to this data sharing agreement subject to approval by NHS Digital.

The UPSTREAM research team will not be sharing the NHS digital data with anyone not listed as a data controller or processor. No other 'teams' at UoB will be able to put in a request for individual-level NHS Digital data. No individual-level NHS Digital data will be shared with other 'teams' at UoB. No other areas of UoB will access record level data supplied under this agreement.

This project (“UPSTREAM – Phase II”) has been allocated a Bristol Medical School Data Security and Protection Authorisation Number (DSPAN; reference A1034). This DSPAN permits us to proceed with the research study under the umbrella Bristol Medical School DSP application [UNIVERSITY OF BRISTOL - Bristol Medical School (EE133799-BRMS)]. The UPSTREAM team have taken the following steps/actions to meet the BMS (UoB) DSPT:

a) Detailed information of the researchers accessing, processing and handling data have been provided to the UoB BMS DPS Administrator and has met the UoB DSPT eligibility criteria. Researchers have been kept to a minimum to support data management. If staff members/access requirements change, the team will update UoB as required.

b) Named researchers accessing, processing and handling data have completed the UoB “GDPR Information Security Training”.

All named researchers who will be processing and handling the data are substantive employees at the University of Bristol.

c) Identifiable data will not appear in study outputs, nor will it be supplied to third parties.

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

The ROMIO Study. Randomised Oesophagectomy: Minimally Invasive or Open (ODR1718_315) — DARS-NIC-595667-K4S9R

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

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

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2022-09-12 — 2025-09-11 2023.03 — 2023.03. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY HOSPITALS BRISTOL AND WESTON NHS FOUNDATION TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registry
  2. NDRS Linked HES A&E
  3. NDRS Linked HES APC
  4. NDRS Linked HES Outpatient
  5. NDRS National Radiotherapy Dataset (RTDS)
  6. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)
  7. NDRS Cancer Registrations
  8. NDRS Linked HES AE

Objectives:

Patients with gullet (oesophageal) cancer are often offered surgery to remove part of the gullet (oesophagectomy), usually following up-front chemotherapy and/or radiotherapy. It is unclear whether patients recover, and survive better following combined open and keyhole surgery (called 'combined' surgery) or standard open surgery.

Surgery improves survival rates but there is a reduction in quality of life. Minimally invasive, or "keyhole" surgery is technically demanding for a procedure as complex as oesophagectomy, but its use in the treatment of other cancers suggests that there may be benefits in terms of faster recovery. Open surgery is complex with large incisions made to the abdomen, chest and, sometimes, neck. Unfortunately, 30% of patients experience complications, and about 3% of patients die soon afterwards.

The Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study compares 'combined' surgery (laparoscopic abdominal surgery and thoracotomy) with open surgery (open oesophagectomy), to find out whether 'combined' surgery allows faster recovery than open surgery, without changing the survival benefit of having surgery. The study also compares open and 'combined' surgery in terms of health-related quality of life, complications experienced by patients after surgery and cost-effectiveness.

The study is a pragmatic randomised controlled trial (randomising patients 1:1 between 'combined’ and standard 'open' surgery) at 9 participating major UK cancer centres. A sub-study run at 2 of the centres also randomly allocated participants to receive a fully minimally invasive ‘keyhole’ oesophagectomy (TMIO) as a sub-study. The sub-study will provide descriptive data on 'keyhole' TMIO surgery which is only undertaken at about 10% of UK cancer centres. The main trial was developed and seamlessly followed an internal pilot ROMIO study.

Participants have been recruited across seven participating centres. All those being considered for oesophagectomy were screened for trial eligibility by the multidisciplinary team caring for the patient. Where the individual is found to be eligible for the study the research nurse would give the patient information about the trial, and if the patient was content to participate informed consent would be obtained prior.

To support this work the study requires pseudonymised subsets of the following National Cancer Registration and Analysis Service (NCRAS) datasets:
• NDRS Cancer Registrations
• NDRS Systemic Anti-Cancer Dataset
• NDRS Radiotherapy Dataset (RTDS)
• NDRS Linked Hospital Episode Statistics (HES)- inclusive of the Admitted Patient Care, Outpatient and Accident and Emergency subsets

To address the GDPR Principle of Data Minimisation this request is limited to ~300 individuals that have consented to take part in the trial. Further to this, the NHS Digital Data Production team have had an extensive discussion with the study team to ensure that only the minimum amount of data necessary for achieving the purposes outlined within this Data Sharing Agreement (DSA) is being requested.

The study has determined that there is no alternative, less intrusive means of achieving the purpose of the study.

The lawful basis for processing personal data is General Data Protection Regulation (GDPR) Article 6(1)(e) ‘Public Task’, the processing is necessary for the performance of a task in the public interest. The exemption for processing special category data is GDPR Article 9(2)(j) ‘Archiving, research, and statistics (with a basis in law)’, the processing is necessary for scientific research purposes that are in the public interest.

University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust (the study sponsor) have been determined to be joint Data Controllers. The University of Bristol processes data for the purposes outlined within this DSA. The study receives funding from the National Institute of Health and Care Research (NIHR) Health Technology Assessment (HTA), beyond funding the project the NIHR play no role in the study.

Expected Benefits:

This study aims to determine whether there are differences in patient recovery, readmissions, cost, survival, and clinical effectiveness between ‘open’ and ‘combined’ keyhole surgery to remove the oesophagus. Carrying out research in this area may help inform optimal clinical practice in the future, ultimately this benefits the provision of health and social care in England and can be deemed to be in the public interest.

Should the study shed light on ways to optimise current clinical practice, and should these findings be incorporated into clinical guidelines, the study findings may:
• Contribute to a reduction in patient recovery times
• Contribute to a reduction in readmissions
• Allow more cost-effective practices
• Increase survival rates in oesophagectomy patients
• Lessen the impact on Quality of Life following oesophagectomy

Outputs:

It is anticipated that the study findings will be published in peer-reviewed journals and will also be presented at relevant conferences.

Should the opportunity arise, the study may publish findings on the University webpages, hold open lectures or engage with the press, this will aid the dissemination of the findings and will reach interested groups in civil society.

The study team are also required to provide NIHR, the study funder, with a final report that outlines the study's findings.

Following the publication of the study results, the contract with the funder requires that the study makes data available for further research projects. The study team have confirmed that, while they will not be sharing any data during the length of this Data Sharing Agreement, they anticipate that data shared following publication will be aggregated with appropriate suppressions rules applied and/or derived data. Before the study looks to share any data, they will submit a specification of the variables they wish to share to NHS Digital. NHS Digital will then assess the specification and confirm whether they are content that the specification aligns with the definition of derived data contained within the University’s Data Sharing Framework Contract (DSFC).

Processing:

University Hospitals Bristol and Weston NHS Trust will securely provide NHS Digital with the following identifiers to facilitate linkage to the study cohort:
• Study ID
• NHS Number
• Date of Birth
• Postcode

The NHS Digital Data Production team will identify cohort members in the NDRS Cancer Registrations Dataset, NDRS Systemic Anti-Cancer Dataset, NDRS Radiotherapy Dataset (RTDS) and NDRS Linked Hospital Episode Statistics (HES)- inclusive of the Admitted Patient Care, Outpatient and Accident and Emergency subsets. Before data is transferred securely to the University of Bristol, the NHS Digital Data Production Team will remove all personal identifiers. However, the data released will be inclusive of the Study ID (a pseudo-identifier). All data released under this Agreement is pseudonymised.

Once the study team receive the data, it will be linked to data generated by the trial to complete the study database. All data contained within the study database will be pseudonymised, there is no requirement to re-identify individuals whose data is contained within the study database. The study team will perform statistical analyses on the data to test the study's experimental hypotheses.

All data will be processed by substantive employees of the University of Bristol, all of whom have received appropriate training in data protection and confidentiality.

Data will be stored in the University of Bristol encapsulated Virtual Machine (eVM) which will be set up by the University of Bristol’s IT specialists before receiving the data. The ‘encapsulated virtual machine’ (eVM) is a purpose-built secure research server. It provides a secure way for approved University of Bristol substantive employees who are part of the research team to access the data from approved University of Bristol computers. The University of Bristol eVM is compliant with the existing University of Bristol organisational Data Security and Protection Toolkit (DSPT).

The University of Bristol have taken the following steps/actions to meet its Data Sharing and Protection Toolkit:
1. Detailed information of the researchers (including name, department, building and computer IT system number) accessing, processing and handling data has been provided to the Information Governance Team at the University of Bristol and has met the eligibility criteria for the DSPT.
2. Named Researchers accessing, processing and handling data have completed the "GDPR Information Security Training" and "Medical Research Council Research, GDPR and Confidentiality Training" scoring 80% or higher.
3. Once the data is obtained and stored in the respective eVM, the University of Bristol Information Governance Team will carry out a Data Quality Audit.

Virtus and AQL Leeds provide secure buildings within which University of Bristol equipment is hosted and maintained. Virtus and AQL Leeds do not access data held under this agreement as they only supply the building and are therefore not listed as a Data Processor. Therefore, any access to the data stored under this agreement would be considered a breach of the agreement. This includes granting access to the database containing the data.

National Child Mortality Database (NCMD) request for mortality data (COVID-19) — DARS-NIC-331142-P5K6M

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, No (Statutory exemption to flow confidential data without consent)

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002, CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 - s261(5)(d)

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2021-11-18 — 2022-11-17 2022.02 — 2022.11. breached contract — audit report.

Access method: Ongoing, One-Off

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

Sublicensing allowed: No

Datasets:

  1. Civil Registration (Deaths) - Secondary Care Cut
  2. Emergency Care Data Set (ECDS)
  3. Hospital Episode Statistics Accident and Emergency
  4. Hospital Episode Statistics Admitted Patient Care
  5. Hospital Episode Statistics Outpatients
  6. MSDS (Maternity Services Data Set) v1.5
  7. Civil Registrations of Death - Secondary Care Cut
  8. Hospital Episode Statistics Accident and Emergency (HES A and E)
  9. Hospital Episode Statistics Admitted Patient Care (HES APC)
  10. Hospital Episode Statistics Outpatients (HES OP)
  11. Maternity Services Data Set (MSDS) v1.5
  12. Mental Health Services Data Set (MHSDS)

Objectives:

The National Child Mortality Database (NCMD) Programme is an NHS England funded and Healthcare Quality Improvement Partnership (HQIP) commissioned programme that collects and analyses information on all children who die across England.

The NCMD Programme is delivered by the University of Bristol in collaboration with the University of Oxford, University College London (UCL) Partners and the software company Quality Education Solutions (QES); QES are the NCMD system developer. The NCMD Programme also includes representation from bereaved families through the NCMD charity partners: Child Bereavement UK, The Lullaby Trust and Sands, who advise the Programme in their capacity as members of the NCMD Steering Group.

NHS England and HQIP are joint data controllers of the NCMD data. The University of Bristol and QES are data processors of the NCMD data. The NCMD partners – the University of Oxford and UCL Partners – each lead on different strands of the NCMD main contract of work e.g., on public and patient involvement and on quality improvement of the local mortality review processes respectively. University of Oxford and UCL do not require direct access to NCMD data or NHS Digital data for processing and analysis in performing their roles as such are not considered data controller nor data processor for the data requested under this agreement.

The NCMD national data collection and analysis system is the first of its kind anywhere in the world to record comprehensive data, standardised across a whole country (England), on the circumstances of children’s deaths. The purpose of collating information nationally is to ensure deaths are learned from, learning is widely shared and actions are taken, locally and nationally, to reduce the number of children who die.

NCMD collates data from the reviews of all child deaths in England by the Child Death Review Partners (CDRPs) via their Child Death Overview Panels (CDOPs). This is a statutory process and provision is made within the Children Act 2004 for the collection and processing of this data without consent. More specifically, NCMD collect data on all children born in England who die before their 18th birthday.

NCMD do not hold data relating to stillbirths or legal terminations of pregnancy.

NCMD’s national data collection started on 1st April 2019 and includes information about children who have died since 1st April 2019 as well as information about those who died prior to 1st April 2019 where their death review process was still ongoing on that date.

The aims of the NCMD Programme are to:
• Capture, analyse and disseminate appropriate data and learning from child death reviews
• Drive the quality of child death review at every stage through bench-marking and quality improvement (QI) methodology
• Study and analyse the patterns, causes and associated risk factors of child mortality in England, providing information to target preventative health and social care and to assist in policy decisions
• Develop a sustainable model after the lifetime of the project.

NCMD provides a unique opportunity to accelerate understanding of how COVID-19 is impacting children and identify opportunities for intervention. The knowledge and evidence base about how COVID-19 will threaten the lives of new-born babies, infants and children is limited and more information is needed on:
• The impact of chronic morbidities in children on their risk of dying due to COVID-19
• Sudden unexpected death in infancy (SUDI)
• Babies born preterm, where the mother had severe COVID-19.

At the start of the COVID-19 epidemic, the NCMD Programme was tasked by NHS England to set up a child mortality surveillance system. The purpose is to provide the means for real time surveillance on child mortality in England to inform NHS England and the Department of Health and Social Care (DHSC).

This system is helping to reduce the uncertainties around child deaths related to COVID-19 (direct and indirect), which in turn is helping to inform agency decision-making to limit the direct and indirect impacts of the epidemic.

Through daily data linkage with Public Health England (PHE) virology database, NCMD has the most up to date information on all child deaths (including deaths outside hospital) with positive COVID-19 test results. NCMD provides daily and weekly child mortality figures and weekly trend reports to NHS England and to the National Clinical Director for Children and Young People and intelligence from these reports is feeding up to the National Medical Director and the Chief Medical Officer.

More recently, NHS England have requested NCMD to carry out further, deeper analysis on neonatal deaths as part of the real-time surveillance of child death in the pandemic. Neonatal deaths make up one third of all child mortality (below 18 years) and deaths in maternity/neonatal units form the largest proportion of child deaths.

HQIP, as controller, has determined the most appropriate legal basis for the NCMD Programme 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 overall aim of the NCMD programme is to drive improvements in the quality of health and social care for children in England and to help reduce premature mortality. The design and outputs from this programme will provide the data and intelligence to enable strategic focus on the most significant causes and contributory factors in child mortality in England in the medium and long term. They stimulate quality improvement and support organisations to find out if healthcare is being provided in line with nationally agreed standards. This processing is therefore undertaken in the public interest.

HQIP rely on Article 9 (2)(i) (processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy). This is justified as the NCMD programme aims to drive improvements in the quality and safety of care and to improve outcomes for patients.

NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance.

Expected Benefits:

NCMD is commissioned to identify how and why children die and to make recommendations for how to reduce the number of children who die. It is part of the statutory child death review (CDR) process, which applies to all children in England who die before their 18th birthday. NCMD’s role in the CDR process is to collate and analyse multi-agency data from Child Death Overview Panels (CDOPs) and, via annual and thematic reports, to put forward evidence-based recommendations to agencies for implementation at a national level.

The multi-agency aspect of the programme enables NCMD to identify potential issues with the delivery of any service engaging with children and young people (CYP) and their families including healthcare, social care, education, law enforcement, charity sector and bereaved families themselves. It also allows for identification and analysis of the wider social determinants of health including those factors in the child, social environment, parenting capacity and physical environment which may play a part in child mortality.

The value of the statutory CDR data collection and NCMD national analysis is even more significant during the COVID-19 pandemic as the results from the NCMD real-time child mortality surveillance system and the recommendations from the NCMD commissioned thematic reports enable immediate actions to reduce child deaths and improve the health and wellbeing of children and families in England.
More specifically, the benefits from linking with the NHSD records on all children who die, will have an impact in the following areas:

1. Health and social care government policies
The data from the NCMD real-time surveillance of child mortality in England during the COVID-19 epidemic aids immediate learning and understanding of the impact of the epidemic on child mortality at a country level. The NCMD surveillance data informs the Joint Committee on Vaccination and Immunisation (JCVI) and the Scientific Advisory Group for Emergencies (SAGE) and is being used by the Chief Medical Officer at Education Select Committee meetings informing decisions on children returning to schools.

Linking up information received from the child death review process notifications with the data sourced from Civil Registration (Deaths) Data, Hospital Episodes Statistics, Maternity Services Data Set and Demographics is essential for completing and validating the NCMD data and ensuring the findings are representative of all child deaths in the country at given point in time.

The benefits to health and social care also arise from the individual child death reviews, which include learning points and recommended actions for service improvements and address any potentially avoidable modifiable and contributory factors related to deaths in the future. For instance, NCMD is currently supporting with evidence the impact of trauma deaths and violence and violence reduction is one of the ten priorities of the health and care vision for London. An increase in trauma deaths and violence is a potential emerging consequence from the indirect impact of the pandemic on the society. Linking up with NHSD records will ensure the information is as complete and accurate as possible so more meaningful analysis can be produced to better inform service improvement actions and policies.

2. The society as a whole
The information collated from all the child deaths reviewed may identify themes from across a number of reviews. The impact of some these will be to bring benefits for the society as a whole as the qualitative analysis on the identified themes can inform recommendations leading to reducing the number of children who die. For instance, NCMD explores the link between child mortality, deprivation and ethnicity to identify the specific factors related to deprivation in the child's life that should be tackled to improve the lives of children living in more disadvantaged areas or circumstances. NCMD provides the complete and timely cohort of child deaths at country level, however improving ethnicity data completeness will enable greater insight into this area which will support reliable analysis. In addition, more work is required to understand why communities of colour are over-represented in child mortality data including looking at communication and information sharing with these communities, access to services (including but not limited to healthcare) and analysing good practice where it exists. This is particularly important and the need for it even more immediate in the context of the COVID-19 pandemic as there is substantial evidence now that the pandemic is disproportionally affecting different ethnic groups and the more deprived population. Linking up with the NHSD records will improve the NCMD data completeness allowing for more reliable analysis of the relationship between deprivation, ethnicity, and child mortality, potentially leading to reducing health inequalities and the number of child deaths in future.

3. The NHS
There are also benefits for the NHS. NCMD data provides information on how COVID-19 may be impacting the extremely vulnerable children. The analysis of the NCMD data contributes to the development of paediatric early warning scores for managing rapidly deteriorating children. There are additional benefits from analysing the information from the reviews of asthma and other chronic conditions deaths to identify any modifiable factors related to the care that children receive to inform service improvement. The ICD-10 coded data on underlying conditions and comorbidities for all children that die from the records held at NHS Digital will be crucial to achieve this as these nationally standardised and quality assured data will allow NCMD to carry out the more in-depth thematic analysis on the categories of death to support the real-time child mortality surveillance and reporting to NHS England. Children with underlying conditions may be more vulnerable to COVID-19, and this makes the need for data linkage even more immediate.
NCMD is also currently working on a thematic report aiming to quantify the impact of perinatal events on all-cause child mortality, and their contribution to longer term childhood mortality as the children grow; and in particular the impact of the COVID pandemic on this. The findings and learning from the report will inform what further policies and interventions may be required to reduce the number of children who die or are left severely disabled as a result of events occurring during the perinatal period, aligning with this objective in the NHS Long Term Plan. The report will also present emerging themes on the indirect impact of the Covid-19 pandemic on perinatal and longer-term mortality of children surviving significant perinatal events.

Outputs:

All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide

1. The following is hoped to be produced as a result of the data processing. This may include (but is not limited to) the following:

a. Reports - the NCMD weekly reports to NHS England, not publicly available and the NCMD commissioned annual and thematic reports (aggregate data only). NCMD is commissioned to publish 3 public facing reports annually: one annual report and 2 thematic reports, which will be on a different theme every year as informed from the data in consultation with the wider programme stakeholders group and as required by NHS England. The stakeholders are the NCMD Programme Steering and Professional Advisory Groups. The terms of reference documents for both groups are available from our website, and I add the links for each here; they both include the membership:
NCMD Professional Advisory Group (PAG) - PPPI-Advisory-Group-TOR-Version-1.3-02.09.19.pdf (ncmd.info)
NCMD Steering Group – NCMD-Programme-Steering-Group-TOR_Version-1.5.pdf
Only aggregate numbers with small numbers suppressed in line with the HES analysis guideline of child deaths are included in these reports. Linking the NCMD dataset with the records held at NHS Digital will ensure the national data is as complete as accurate to allow for reliable reporting of child deaths at country level to meet the Programme's overall objective - to learn from child deaths and to reduce the number of children dying in future.

b. Submissions to peer reviewed journals - the Lancet, the BMJ, Archives of Disease in Childhood

c. Presentations - findings from these reports will be presented at conferences (e.g. the Royal College of Paediatrics and Child Health), dissemination events organised by NCMD launching the programme's commissioned reports with stakeholders and interested individuals and organisations.

d. Conferences - findings from these reports will be presented at conferences (e.g. the Royal College of Paediatrics and Child Health)

In the reports to NHS England from the real-time child mortality surveillance system only aggregate data by category of death is included. There may be small numbers included for some of the categories. These reports are only shared with NHS England and are not available in the public domain. The NCMD commissioned annual and thematic reports are public facing and only include aggregate data with small numbers supressed.

The dissemination activities will target an audience of researchers, scientists, innovative technology-focused organisations, research participants. Activities should also reach beyond the scientific community to engage with policy makers. The aim of the dissemination activities shall be two-fold: to enable the engagement with the scientific and policy-making communities / to ensure that knowledge developed by the research can benefit these communities. Dissemination channels: journals, workshops, webinars, social media, public reports, direct bilateral engagement using new and established relationships, industry newsletters, briefing documents, co-hosted events, open source frameworks, etc.

Communication of results/outputs - The NCMD Programme employs a Senior Communications and Engagement Officer who leads on the NCMD’s stakeholders engagement and communications planning and activities. NCMD has a well established communications and stakeholders engagement strategy which ensures that any information about the programme, its findings and impact reaches all interested groups and the programme engages with these groups in knowledge-sharing and dialogue. A wide variety of communication channels are used, including the NCMD website (https://www.ncmd.info/about/) and newsletters (https://www.ncmd.info/newsletters/). NCMD also organises a series of free webinars (https://www.ncmd.info/webinars/) dedicated on different topics of interest to key stakeholders as well on the programme’s published reports. As an example, the first webinar organised by NCMD launched a “Call to Action” for professionals to provide COVID-19 specific data and was attended by over 100 child death review (CDR) professionals across England.

In addition, NCMD in collaboration with its PPPI group and partner charities, develops leaflets for families (https://www.ncmd.info/2020/10/15/families-postcard/) and public and families engagement materials (https://www.ncmd.info/families/) to raise awareness and understanding of the key activities carried out by the programme. For instance, at the start of the COVID-19 pandemic, as part of its COVID-19 communications strategy, NCMD developed the C-H-I-L-D acronym to engage child death review professionals and ensure reporting of all COVID-19 related deaths (https://www.ncmd.info/2020/03/20/covid19/). It prompted professionals to think beyond COVID-19 to help in fully understanding the impact of the virus on children. NCMD develops detailed communications plans for all main commissioned reports and all other published outputs and journal publications. These include also detailed plans for how the programme responds to press and media enquiries.

As part of the NCMD real-time surveillance system, the reporting to NHS England and escalation from that by NHS England to government and the Scientific Advisory Group for Emergencies (SAGE) is currently ongoing.

Exploitation of results/outputs - Increasingly, research can be about the development of algorithms, the testing and development of tools and new technologies. This may involve: the creation of evaluation environments for the assessment and validation of processes, tools and technologies; the development of a service offering; the creation of commercial exploitation pathways of outputs when these are tools, new processes and new technologies (during the lifetime of the project or beyond the project’s completion); further research and development in the same/similar context. Issues to explore include:
• Data and knowledge ownership
• Data and knowledge management
• Access rights
• Open access
• Rights usage

The NCMD child mortality surveillance system and the overall NCMD programme of work is data driven. The data quality assurance processes and national analysis carried out by NCMD on the information collated from the local child death review processes provides the environment for continuous evaluation of how the data collection works and what can be done to further improve it. This includes evaluation also of how the technical solution works, which for instance helps to identify how the wide range of different scenarios in data flows from the different reporting agencies may be impacting data quality. System changes e.g., new questions added to the data collection forms or changes in the structure and order of questions, go through a formal process of review, approval and user testing before they are released in the live database environment.

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 i.e. employees, agents and contractors of the data recipient who may have access to that data).

There will be no data linkage undertaken with NHS digital data provided under this agreement that is not already noted in the agreement. NHS Digital data will only be used for the purposes described in this agreement.

The University of Bristol will link data about all children who have died, with mortality data, to identify the exact cause of death of all children who die in England.

The child death review process collects information on and identifies the causes of death of the child. However, this information is only collected and recorded in free text, which is how it is supplied to NCMD for analysis. Linking up with the NHS Digital's mortality data sets will allow NCMD to have access to the ICD-10 coding (International Statistical Classification of Disease and Related Health Problems) for these causes of death as reported in mortality statistics to enable analyses and accurate reporting. The mortality data provided by NHS Digital is linked to the data held by NCMD so analysis can take place based on age (gestation), sex, ethnicity and categories of death.

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. Aggregate, anonymised data about ICD-10 coding for cause of death may be included in the reports to NHS England as part of the real-time child mortality surveillance and monitoring system and when investigating signals from this system on different categories of death and underlying conditions, e.g. perinatal events, acute medical conditions (e.g. asthma), trauma, SUDI (sudden unexpected death in infancy).

It is expected there may be registered deaths from the NHS Digital feeds that have not as yet been notified to NCMD by the CDOPs. It will be important to link these cases with the PHE COVID-19 virology results so most up to date is available for the child mortality surveillance system.

The identifiers used for the linkage with Public Health England (PHE) are as follows:
- Child name / surname,
- NHS number,
- DOB,
- DOD,
- Sex,
- Postcode
- and categorisation of death as assigned by NCMD.

NHS Digital will run a cohort of everyone who has died under 18 between certain dates and link that to HES, Mortality and MSDS, then flow data back to the University of Bristol.

Before the case list is sent to PHE, all cases are being reviewed, coded and categorised by the NCMD clinical and CDOP expert group daily. For the deaths from this feed, the cause of death information will be used. No data (supplied by NHS Digital) is processed outside of the NCMD Programme (based at the University of Bristol) and the SQL database supported by QES is used for the linkage.

There will be no flow of data to NHS Digital. The data linkage with the following NHS Digital controlled datasets –
- Hospital Episodes Statistics,
- Civil Registrations - Deaths
- Maternity Services Data Set
are required to improve the accuracy and completeness of information included in the child mortality surveillance reports and other future reports from NCMD during the pandemic. The data linkage will ensure that all chid deaths since 1st April 2019 (the start of the NCMD data collection and analysis) are notified to NCMD, all case demographic and death registration information are as complete and accurate as possible and that NCMD has a full record of the children’s underlying conditions and comorbidities to enable timely, deeper analysis into emerging signals from the surveillance system.

Only data for children up to their 18th birthday who have died is being requested. This may include health records for children who have died from 1st April 2019 (the start of the NCMD data collection) and were born and may have hospital admissions from the start of the data collections that NCMD will be linking to. For some of these, this may mean that the linkage will be on data going back to the early 2000s. For instance, for a 17-year-old child with an underlying condition who died in 2019, linking to their hospital admissions’ records going back to the time they were born in 2002 would contribute to improving the understanding of how their early years’ health experiences or maternal or pregnancy related risk factors may be related to their health outcomes later in life.

The University of Bristol will be the sole processor of the linked data and only a small number of the NCMD analytical team will have access to the record level data that is supplied by NHS Digital for the purposes of linkage and analysis. The data processing will be only carried out by substantive NCMD employees who have all been appropriately trained in data protection and confidentiality. All staff are required to complete their mandatory information governance training as per the University of Bristol policies and procedures (a couple of training modules should be completed every year: GDPR Information Security training and GDPR Data Protection Essentials) as well as the NHS Digital Data Security Awareness Level 1 training.

For the purposes of linkage, the data from NHS Digital will be held in a separate database on the same server where the NCMD data is stored (SQL Server). This is technically supported by QES, but no processing or analysis is carried out by QES as per the conditions of the QES subcontract with the University of Bristol.

Routine Data Extraction for CAP (Cluster randomised trial of PSA testing for Prostate cancer) MR783 — DARS-NIC-319171-G7H8K

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N, Yes - patient objections upheld, Anonymised - ICO Code Compliant, Identifiable, Yes (Mixture of confidential data flow(s) with support under section 251 NHS Act 2006 and non-confidential data flow(s))

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , 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(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(a), Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

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

When:DSA runs 2018-09-01 — 2020-02-29 2017.09 — 2022.11. breached contract — audit report.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. Hospital Episode Statistics Accident and Emergency
  4. Hospital Episode Statistics Admitted Patient Care
  5. Hospital Episode Statistics Critical Care
  6. Hospital Episode Statistics Outpatients
  7. Diagnostic Imaging Dataset
  8. Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
  9. MRIS - Scottish NHS / Registration
  10. Demographics
  11. Cancer Registration Data
  12. Civil Registration - Deaths
  13. MRIS - Members and Postings Report
  14. Diagnostic Imaging Data Set (DID)
  15. Hospital Episode Statistics Accident and Emergency (HES A and E)
  16. Hospital Episode Statistics Admitted Patient Care (HES APC)
  17. Hospital Episode Statistics Critical Care (HES Critical Care)
  18. Hospital Episode Statistics Outpatients (HES OP)
  19. Civil Registrations of Death

Objectives:

Cluster randomised trial of testing for Prostate cancer (CAP) is a pragmatic, cluster Randomised Clinical Trial (RCT) that compares an invitation to attend for population-based Prostate Specific Antigen (PSA)-testing for prostate cancer (intervention arm) with standard NHS care (control arm) amongst men aged 50 to 69 years registered with GP practices in eight centres in England and Wales. Recruitment to the DH/CRUK-funded CAP trial was completed in 2009 and it is currently in the follow-up phase. Over 415,000 men are being followed-up for incident and fatal prostate cancer via the Health and Social Care Information Centre (HSCIC).
Where cost implications of any national screening programme are considerable, and where survival is relatively good whatever form of management is adopted, it is essential to incorporate analysis of cost-effectiveness. To obtain timely and comprehensive UK-wide coverage to estimate the cost effectiveness of prostate cancer screening in the UK CAP are applying for permission to perform record linkage for all 415,000 men in the CAP trial with the HSCIC for the provision of resource use information.

Yielded Benefits:

Research from the University of Bristol led to the Department of Health decision in 1997 that screening for prostate cancer would not be introduced in the UK until there was evidence that benefits outweighed harms. University of Bristol led, and collaborative research subsequently provided evidence to support informed decision-making in the NHS. A formal review by DH in 2010 endorsed the policy and confirmed that any change would be based on evidence from the teams randomised trials. The results published in 2018 have again informed this decision, and this research has ensured UK men have avoided known harms of prostate cancer screening in the context of uncertain benefits and saved the UK economy. The CAP Trial, which spanned almost 600 GP practices in the UK and included more than 400,000 men aged 50-69, is the largest trial ever to investigate prostate cancer screening. The trial compared 189,386 men who were invited to have a one-off PSA test with 219,439 men who were not invited for screening. After an average of 10 years follow up, there were 8,054 (4.3%) prostate cancers in the screened group and 7,853 (3.6%) cases in the control group. Crucially, both groups had the same percentage of men dying from prostate cancer (0.29%). These results have informed national and international guidelines for the use of PSA testing as a screening tool for prostate cancer detection. In the UK, the CAP trial results have provided the Public Health England (PHE) National Screening Committee (NSC) with high-quality, UK-based evidence to inform a review of the balance of benefits against harms of PSA based prostate cancer screening. In the USA, the results were included in the recommendations of the US Preventive Services Task Force (https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancerscreening). Alongside the RCT the CAP Study have been able to carry out important methodological work which has helped inform the use of routine data sources in pragmatic randomised trials. The dataset already held by SAIL has been used to develop the STATA do files and confirmed the feasibility of extracting unbiased health-related costs for comparison across the two groups in the budget impact analyses.

Expected Benefits:

The main outcomes of the trial are the effectiveness of Prostate Specific Antigen (PSA) testing in reducing prostate cancer mortality, and its cost-effectiveness (i.e. comparing the health-related costs in the two groups in combination with the effectiveness of PSA testing, in order to assist policy makers in their decisions about how to achieve the best use of resources).

The expected measurable benefits to health arise from the ability of these data to allow an unbiased comparison between men screened for prostate cancer and those not screened. The data generated will provide both clinical and policy relevant data on one of the most controversial issues in health care nationally and internationally: the potential benefits, harms and costs to the UK population of screening for prostate cancer.

Research from the University of Bristol led to the Department of Health decision in 1997 that screening for prostate cancer would not be introduced in the UK until there was evidence that benefits outweighed harms. University of Bristol led and collaborative research subsequently provided evidence to support informed decision-making in the NHS. A formal review by DH in 2010 endorsed the policy and confirmed that any change would be based on evidence from the team’s randomised trials. This research has ensured UK men have avoided known harms of prostate cancer screening in the context of uncertain benefits, and saved the UK economy.

The median 10 years follow-up will be reached in 2016 and it is anticipated that the first publication will report these results, the University would nevertheless wish to apply for additional funding for longer term follow–up.

Outputs:

CAP plan to publish median 10 year results in The New England Journal of Medicine (NEJM) or The Journal of the American Medical Association (JAMA) in 2016. A statistical analysis plan detailing the analyses that will be included in the publications has been uploaded onto the University of Bristol research information repository (http://hdl.handle.net/1983/6d41509f-ab93-4f96-9869-c320acbc4ae1). Statistics involved in these papers usually refer to measures such as rate ratios and 95% confidence intervals rather than actual numbers of cases. CAP will follow ONS non-disclosure rules for small numbers of cases and will not include any counts of less than 5 in a Table. As stated above the median 10 years follow-up will be reached in 2016, the applicant would nevertheless wish to apply for additional funding for longer term follow–up.

As stated above the primary outcome is reached at a median 10 years follow up in 2016 there are however a number of recent publications directly related to the study, listed below:

Williams NJ, Hill EM, Ng SY, Martin RM, Metcalfe C, Donovan JL, Evans S, Hughes LJ, Davies CF, Hamdy FC, Neal DE, Turner EL, for the CAP Cause of Death Committee. Standardisation of information submitted to an endpoint committee for cause of death assignment in a cancer screening trial – lessons learnt from CAP (Cluster randomised triAl of PSA testing for Prostate cancer). BMC Medical Research Methodology (2015) 15:6 (doi:10.1186/1471-2288-15-6)

Turner EL, Metcalfe C, Donovan JL, Noble S, Sterne JAC, Lane A, Avery K, Down L, Walsh E, Davis M, Ben-Shlomo Y, Oliver S, Evans S, Brindle P, Williams N, Hughes LJ, Hill E, Davies C, Ng SY, Neal DE, Hamdy FC, Martin RM. Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP). British Journal of Cancer (2014) 110; 2829-36 (doi: 10.1038/bjc.2014.242)

Lane JA, Donovan JL, Davis M, Walsh E, Dedman D, Down L, Turner EL, Mason MD, Metcalfe C, Peters TJ, Martin RM, Neal DE, Hamdy FC, for the ProtecT study group. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncology (2014) 15: 1109-18 (http://dx.doi.org/10.1016/ S1470-2045(14)70361-4)


Hill EM, Turner EL, Martin RM & Donovan JL. "Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study. BMC Medical Research Methodology (2013) 13:72 (doi: 10.1186/1471-2288-13-72)

Williams NJ, Hughes LJ, Turner EL, Donovan JL, Hamdy FC, Neal DE, Martin RM, Metcalfe C. Prostate-specific antigen testing rates remain low in UK general practice: A cross-sectional study in six English cities. British Journal of Urology International (2011) 108:9; 1402-08 (doi:10.1111/j.1464-410X.2011.10163.x)

Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL. Latest results from the UK trials evaluating prostate cancer screening and treatment: The CAP and ProtecT studies. European Journal of Cancer (2010) 46; 3095-3101 (doi:10.1016/j.ejca.2010.09.016)

Outputs will also be fed directly to funders, Cancer Research UK and Department of Health. Other appropriate bodies such as NICE or the Cochrane Centre will also be informed.

The papers will be available on the University of Bristol PURE pages https://research-information.bris.ac.uk/ - these publications are available to download with open access allowing anyone to access publications. We also publish with open access rights when submitting to journals, ensuring we maintain CRUKs publication ethos of ensuring research funded by them is available to all. Publications are also uploaded to 'researchfish' allowing the research community to clearly see what has been published.

Processing:

In this amendment request, the linked HES data would be accessible to investigators at the University of Bristol in the form of a pseudonymised dataset housed at the Secure Anonymised Information Linkage (SAIL) Databank. This means that it is totally separate to the identifiable data and can never be linked to it.

Processing steps -

1.HSCIC will utilise the identifier (unique study ID) for MR783 and MR738A and link these data from the HES dataset held at the HSCIC. The HES data extract and unique study ID for the cohort will be sent to SAIL by the HSCIC.

2.The applicant will transfer a study ID and the following primary and secondary mortality outcome variables to SAIL: month and year of birth; date of prostate cancer diagnosis; prostate cancer stage and grade, if present; month and year of death, if deceased; prostate cancer attributed death, if deceased; date of censor, if no longer in follow up; month and year of censor.

3.SAIL will then link these data to the HES extract from the HSCIC. SAIL will also encrypt the unique study ID to create a unique pseudo anonymised ID number for each individual, area identifiers will also be pseudonymised

HES data will be used to identify all inpatient and outpatient resources used by men in CAP. Costs will be assigned to the identified events and used alongside the linked outcome data to conduct the CAP cost-effectiveness analysis from the perspective of the UK NHS (secondary care).

This dataset will be remotely accessed from Bristol for analysis and only aggregated results tables (verified by SAIL to be unidentifiable) would be extracted from the dataset.

Routine Data Extraction for CAP (Cluster randomised trial of PSA testing for Prostate cancer) MR783A — DARS-NIC-119910-K6W9Q

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Anonymised - ICO Code Compliant, Identifiable, No (Mixture of confidential data flow(s) with consent and non-confidential data flow(s))

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

Purposes: No (Academic)

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

When:DSA runs 2018-09-01 — 2020-02-29 2017.09 — 2022.11. breached contract — audit report.

Access method: One-Off, Ongoing

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Accident and Emergency
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Critical Care
  4. Hospital Episode Statistics Outpatients
  5. Diagnostic Imaging Dataset
  6. Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
  7. MRIS - Cause of Death Report
  8. MRIS - Cohort Event Notification Report
  9. Cancer Registration Data
  10. Civil Registration - Deaths
  11. Demographics
  12. MRIS - Members and Postings Report
  13. Diagnostic Imaging Data Set (DID)
  14. Hospital Episode Statistics Accident and Emergency (HES A and E)
  15. Hospital Episode Statistics Admitted Patient Care (HES APC)
  16. Hospital Episode Statistics Critical Care (HES Critical Care)
  17. Hospital Episode Statistics Outpatients (HES OP)
  18. Civil Registrations of Death

Objectives:

Cluster randomised trial of testing for Prostate cancer (CAP) is a pragmatic, cluster Randomised Clinical Trial (RCT) that compares an invitation to attend for population-based Prostate Specific Antigen (PSA)-testing for prostate cancer (intervention arm) with standard NHS care (control arm) amongst men aged 50 to 69 years registered with GP practices in eight centres in England and Wales. Recruitment to the DH/CRUK-funded CAP trial was completed in 2009 and it is currently in the follow-up phase. Over 415,000 men are being followed-up for incident and fatal prostate cancer via NHS Digital.

Where cost implications of any national screening programme are considerable, and where survival is relatively good whatever form of management is adopted, it is essential to incorporate analysis of cost-effectiveness. To obtain timely and comprehensive UK-wide coverage to estimate the cost effectiveness of prostate cancer screening in the UK CAP are applying for permission to perform record linkage for all 415,000 men in the CAP trial with NHS Digital for the provision of resource use information.

Yielded Benefits:

Research from the University of Bristol led to the Department of Health decision in 1997 that screening for prostate cancer would not be introduced in the UK until there was evidence that benefits outweighed harms. University of Bristol led, and collaborative research subsequently provided evidence to support informed decision-making in the NHS. A formal review by DH in 2010 endorsed the policy and confirmed that any change would be based on evidence from the teams randomised trials. The results published in 2018 have again informed this decision, and this research has ensured UK men have avoided known harms of prostate cancer screening in the context of uncertain benefits and saved the UK economy. The CAP Trial, which spanned almost 600 GP practices in the UK and included more than 400,000 men aged 50-69, is the largest trial ever to investigate prostate cancer screening. The trial compared 189,386 men who were invited to have a one-off PSA test with 219,439 men who were not invited for screening. After an average of 10 years follow up, there were 8,054 (4.3%) prostate cancers in the screened group and 7,853 (3.6%) cases in the control group. Crucially, both groups had the same percentage of men dying from prostate cancer (0.29%). These results have informed national and international guidelines for the use of PSA testing as a screening tool for prostate cancer detection. In the UK, the CAP trial results have provided the Public Health England (PHE) National Screening Committee (NSC) with high-quality, UK-based evidence to inform a review of the balance of benefits against harms of PSA based prostate cancer screening. In the USA, the results were included in the recommendations of the US Preventive Services Task Force (https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancerscreening). Alongside the RCT the CAP Study have been able to carry out important methodological work which has helped inform the use of routine data sources in pragmatic randomised trials. The dataset already held by SAIL has been used to develop the STATA do files and confirmed the feasibility of extracting unbiased health-related costs for comparison across the two groups in the budget impact analyses.

Expected Benefits:

The main outcomes of the trial are the effectiveness of Prostate Specific Antigen (PSA) testing in reducing prostate cancer mortality, and its cost-effectiveness (i.e. comparing the health-related costs in the two groups in combination with the effectiveness of PSA testing, in order to assist policy makers in their decisions about how to achieve the best use of resources).

The expected measurable benefits to health arise from the ability of these data to allow an unbiased comparison between men screened for prostate cancer and those not screened. The data generated will provide both clinical and policy relevant data on one of the most controversial issues in health care nationally and internationally: the potential benefits, harms and costs to the UK population of screening for prostate cancer.

Research from the University of Bristol led to the Department of Health decision in 1997 that screening for prostate cancer would not be introduced in the UK until there was evidence that benefits outweighed harms. University of Bristol led and collaborative research subsequently provided evidence to support informed decision-making in the NHS. A formal review by DH in 2010 endorsed the policy and confirmed that any change would be based on evidence from the team’s randomised trials. This research has ensured UK men have avoided known harms of prostate cancer screening in the context of uncertain benefits, and saved the UK economy.

The median 10 years follow-up will be reached in 2016 and it is anticipated that the first publication will report these results as soon as possible following this, the University would nevertheless wish to apply for additional funding for longer term follow–up.

The dataset already held by SAIL has been used to develop the STATA do files, and confirmed the feasibility of extracting unbiased health-related costs for comparison across the two groups.

Outputs:

CAP plan to publish median 10 year results in The New England Journal of Medicine (NEJM) or The Journal of the American Medical Association (JAMA). A statistical analysis plan detailing the analyses that will be included in the publications has been uploaded onto the University of Bristol research information repository (http://hdl.handle.net/1983/6d41509f-ab93-4f96-9869-c320acbc4ae1). Statistics involved in these papers usually refer to measures such as rate ratios and 95% confidence intervals rather than actual numbers of cases. CAP will follow ONS non-disclosure rules for small numbers of cases and will not include any counts of less than 5 in a Table. As stated above the median 10 years follow-up will be reached in 2016, the applicant would nevertheless wish to apply for additional funding for longer term follow–up.

As stated above the primary outcome is reached at a median 10 years follow up in 2016 there are however a number of recent publications directly related to the study, listed below:

Williams NJ, Hill EM, Ng SY, Martin RM, Metcalfe C, Donovan JL, Evans S, Hughes LJ, Davies CF, Hamdy FC, Neal DE, Turner EL, for the CAP Cause of Death Committee. Standardisation of information submitted to an endpoint committee for cause of death assignment in a cancer screening trial – lessons learnt from CAP (Cluster randomised triAl of PSA testing for Prostate cancer). BMC Medical Research Methodology (2015) 15:6 (doi:10.1186/1471-2288-15-6)

Turner EL, Metcalfe C, Donovan JL, Noble S, Sterne JAC, Lane A, Avery K, Down L, Walsh E, Davis M, Ben-Shlomo Y, Oliver S, Evans S, Brindle P, Williams N, Hughes LJ, Hill E, Davies C, Ng SY, Neal DE, Hamdy FC, Martin RM. Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP). British Journal of Cancer (2014) 110; 2829-36 (doi: 10.1038/bjc.2014.242)

Lane JA, Donovan JL, Davis M, Walsh E, Dedman D, Down L, Turner EL, Mason MD, Metcalfe C, Peters TJ, Martin RM, Neal DE, Hamdy FC, for the ProtecT study group. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncology (2014) 15: 1109-18 (http://dx.doi.org/10.1016/ S1470-2045(14)70361-4)


Hill EM, Turner EL, Martin RM & Donovan JL. "Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study. BMC Medical Research Methodology (2013) 13:72 (doi: 10.1186/1471-2288-13-72)

Williams NJ, Hughes LJ, Turner EL, Donovan JL, Hamdy FC, Neal DE, Martin RM, Metcalfe C. Prostate-specific antigen testing rates remain low in UK general practice: A cross-sectional study in six English cities. British Journal of Urology International (2011) 108:9; 1402-08 (doi:10.1111/j.1464-410X.2011.10163.x)

Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL. Latest results from the UK trials evaluating prostate cancer screening and treatment: The CAP and ProtecT studies. European Journal of Cancer (2010) 46; 3095-3101 (doi:10.1016/j.ejca.2010.09.016)

Outputs will also be fed directly to funders, Cancer Research UK and Department of Health. Other appropriate bodies such as NICE or the Cochrane Centre will also be informed.

The papers will be available on the University of Bristol PURE pages https://research-information.bris.ac.uk/ - these publications are available to download with open access allowing anyone to access publications. We also publish with open access rights when submitting to journals, ensuring we maintain CRUKs publication ethos of ensuring research funded by them is available to all. Publications are also uploaded to 'researchfish' allowing the research community to clearly see what has been published.

Processing:

In this renewal request, the linked HES data would be accessible to investigators at the University of Bristol in the form of a pseudonymised dataset housed at the Secure Anonymised Information Linkage (SAIL) Databank. This means that it is totally separate to the identifiable data and can never be linked to it.

Processing steps -

1.NHS Digital will utilise the identifier (unique study ID) for MR738A and link these data from the HES dataset held at NHS Digital. The HES data extract and unique study ID for the cohort will be sent to SAIL by NHS Digital.

2.The applicant will transfer a study ID and the following primary and secondary mortality outcome variables to SAIL: month and year of birth; date of prostate cancer diagnosis; prostate cancer stage and grade, if present; month and year of death, if deceased; prostate cancer attributed death, if deceased; date of censor, if no longer in follow up; month and year of censor.

3.SAIL will then link these data to the HES extract from NHS Digital. SAIL will also encrypt the unique study ID to create a unique pseudo anonymised ID number for each individual, area identifiers will also be pseudonymised

HES data will be used to identify all inpatient and outpatient resources used by men in CAP. Costs will be assigned to the identified events and used alongside the linked outcome data to conduct the CAP cost-effectiveness analysis from the perspective of the UK NHS (secondary care).

This dataset will be remotely accessed from Bristol for analysis and only aggregated results tables (verified by SAIL to be unidentifiable) would be extracted from the dataset.

Only individuals substantively employed by the University of Bristol will have access to the data.

All processing of ONS data will be in line with standard ONS terms and conditions.

All outputs will be restricted to aggregate data with small numbers suppressed in line with the HES Analysis Guide.

The funding organisation, CRUK, has confirmed in writing that it agrees that no NHS Digital data will be shared with it or with 3rd parties, and that in the unlikely event that they would wish to share the data they would direct any request through NHS Digital.

How effective is FITNET-NHS for children and young adults with CFS/ME — DARS-NIC-279476-Y8N7J

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2021-11-17 — 2024-11-16 2022.05 — 2022.07. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set
  2. Emergency Care Data Set (ECDS)
  3. Hospital Episode Statistics Admitted Patient Care
  4. Hospital Episode Statistics Outpatients
  5. Mental Health Services Data Set
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)
  7. Hospital Episode Statistics Outpatients (HES OP)
  8. Mental Health Services Data Set (MHSDS)

Objectives:

University of Bristol (UOB) Bristol Medical School (BMS) require data from NHS Digital for a research project, the FITNET NHS (Fatigue In Teenagers on the interNET in the NHS) trial.

The FITNET-NHS Trial is a large randomised controlled trial which will investigate the clinical and cost-effectiveness of the FITNET-NHS intervention compared with Activity Management [a], among children/young people (aged 11-17 years) with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) who do not have a local NHS specialist CFS/ME service. The FITNET-NHS intervention delivers specialist cognitive behavioural therapy for CFS/ME via the internet. Participants and their parents/carers work through 21 modules and have e-consultations with therapists. Activity Management is used as the comparator in this study as recommended by the National Institute of Health and Clinical Excellence (NICE guidance CG53 published August 2007) and is currently the best alternative for children/young people in regions without a local specialist CFS/ME service.

[a] Activity Management is an individualised approach that aims to establish a baseline (the same every day) level of cognitive (schoolwork, social activities and hobbies) and physical activity (walking, any exercise) using diaries. This usually requires an initial reduction in activity on some days and an increase on other days but overall, activity levels are unchanged. Both physical activity and cognitive activity are then gradually increased in a flexible approach (when participants feel able to do so). If participants’ symptoms increase, they are advised to either plateau (keep activity the same) or reduce activity depending on the severity and cause of the symptoms. Activity management is delivered by specialist therapists (e.g. occupational therapists, physiotherapists) via video calls with patients.

Many adolescents have severe fatigue but the prevalence of CFS is less common. The prevalence of CFS in children and adolescents is between 0.11% and 4%. CFS/ME can have a devastating impact on children in terms of quality of life, school, social life, and family function at the crucial time of development. It also has an impact on health service provision. Children with CFS/ME have an increase in medical consultations, tests, and prescriptions, up to five years before receiving a diagnosis. Most children/young people attending a specialist service attended 40% of school or less. About one-third of them suffer from comorbid anxiety and/or depression.

The National Institute for Health and Clinical Excellence (NICE) recommended Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective (NICE Guidance CG53 published August 2007). Despite this, most children/young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but it is not known if it is effective in the National Health Service (NHS) or if it is cost-effective.

This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS. The findings from this study be used to inform decision-making within the NHS. More specifically, the results will aim to provide evidence on whether FITNET-NHS, when compared to Activity Management, is better value for money for: (a) children/young people suffering from CFS/ME; and (b) children/young people suffering from CFS/ME with mild/ moderate comorbid mood disorders. If FITNET-NHS is effective and cost-effective, it could be made available to all children/young people and adolescents with CFS/ME in the UK. Its provision by the NHS has the potential to deliver substantial health gains for the large number of children/young people suffering from CFS/ME but unable to access treatment because there is no local specialist service.

The original recruitment target of the trial was 734 individuals. The trial revised its recruitment target due to under-recruitment, and the NIHR HTA agreed to fund a 6-months extension to the overall project timeframe. The new and current revised recruitment target was adjusted to 314. The trial recruitment start date was 1/11/2016. The trial successfully achieved the recruitment target of 314 on 11/11/2020 and is now in its follow-up phase. The end of the follow-up period is 11/11/2021 (the absolute follow-up end date is 11/02/2022) with the overall project end date being 30/04/2022.

FITNET was developed in consultation with adolescents. The study team have discussed this project with a UK Young People’s Advisory Group and employed a research nurse to provide trial information and discuss reservations or misunderstandings during recruitment.

The University of Bristol is both the Data Controller who will also process the data. The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA). The NIHR HTA Programme funds research about clinical and cost-effectiveness and broader impact of healthcare treatments and tests for those who plan, provide or receive care from NHS and social care services. The NIHR HTA do not make any decisions determining the purposes and means of the processing of data or the study purpose and methodology, and are therefore not considered a Data Controller.

The co-applicants listed on the protocol are members of the trial management and oversight committee and are involved in supporting and advising the trial team on various aspects of the study. They support the study in an advisory capacity and do not make any decisions determining the study purposes, determine the manner in which the data will be processed, nor have any access to record-level pseudonymised data. These co-applicants are not considered by the FITNET-NHS study team as Data Processors or Data Controllers.

University of Bristol obtained consent to use routinely collected Hospital Episode Statistics (HES) data and Mental Health Services Data Set (MHSDS) (previously called Mental Health and Learning Disabilities Data Set (MHLDDS)) from NHS Digital. Data from the HES Admitted Patient Care (APC), Outpatients (OP), Accident and Emergency (A&E) and Emergency Care Dataset (ECDS)datasets, and the MHSDS will allow measurement of the use of Child and Adolescent Mental Health Services (CAMHS) among trial participants in both treatment arms (i.e. Activity management and FITNET-NHS) in the year after they enrol in the trial. Health care use will be costed using National Unit Costs where available (e.g., NHS Reference Costs, Annual Survey Of Health and Earnings) to estimate whether FITNET-NHS reduces the use and cost of healthcare needs among children with CFS/ME.

The main objectives of the trial for the processing the requested data is to:

1. Estimate the cost-effectiveness of FITNET-NHS compared to Activity Management:
- Primary analysis: The study's primary economic evaluation to assess the cost-effectiveness of FITNET-NHS compared to Activity Management will compare incremental NHS costs and health gains, measured in Quality Adjusted Life Years (QALYs). Data will be collected directly from participants on primary care use and link to administrative data (HES and MHSDS) for secondary care and longer-term outcomes. Further details are provided in the published protocols here:
A) https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2500-3)
B) https://doi.org/10.1186/s13063-019-3895-1

2. Estimate the cost-effectiveness of FITNET-NHS compared to Activity Management for those with mild/moderate comorbid mood disorders (anxiety/depression).
- Appropriate statistical analysis will be used to explore the interaction between pre-morbid mood disorders and the cost-effectiveness of FITNET-NHS.

GDPR Legal basis for processing:
On the advice received from the Research Data Governance Office at the University of Bristol, to access patient data, for this research project can rely on the following GDPR Articles for the processing of health data to be received from NHS Digital:

1) Article 6(1)(e) of the GDPR, i.e. processing is necessary for the performance of a task carried out in the public interest. Research is a task that University of Bristol performs in the public interest, as part of their core function as a university.
2) Article 9(2)(j) of the GDPR, i.e. processing is necessary for research purposes or statistical purposes. The work is in the public interest because it helps the NHS to maximise public health from the limited resources available to it. The study's work aims to improve public health by providing evidence to help NHS decision-makers identify effective and cost-effective healthcare for children with CFS/ME.

Patient and Public Involvement is dealt with in Section 5(c) Expected Output.

Data held for analysis will not be transferred outside of the University of Bristol to any third countries or organisations. Outputs will be aggregated with small number suppression applied as per the HES analysis guide.

Only data/items relating to the purpose of the study are requested. University of Bristol have not requested identifying data fields. Details of the proposed data linkage were provided to trial participants in the study Patient Information Leaflet (PIL) and data is only requested for those participants who have provided their consent. Study participants who have consented are also able to withdraw their consent at any time during the study and only data between the date of consent and date of withdrawal will be requested.

University of Bristol cannot filter on diagnosis codes to minimise the data requested because:
i) Chronic fatigue is often underdiagnosed and healthcare contacts which are related to chronic fatigue may well be coded using a diverse range of diagnosis codes.
ii) Diagnosis codes in HES OP and ECDS in particular, are not recorded in a way suitable for the applicant to process in accordance with their purposes.

Outputs:

A comprehensive report of the trial findings will be submitted in approximately May 2022 for publication in the NIHR journals library. To increase dissemination, University of Bristol also intend to publish research outputs in a small number of high impact peer-reviewed scientific journals (e.g. British Medical Journal) during 2022/2023. University of Bristol also plan to disseminate the findings through conference presentations – for example, Paediatric Conference in the United States of America, The Royal College of Paediatrics and Child Health (RCPCH UK) and Academic GP Conference. University of Bristol will also work with the University of Bristol press office and the Science Media Centre to disseminate plain English summaries of results to the public. In line with NIHR policy, papers will be open access and made publicly available for free on University of Bristol’s website.

University of Bristol intend to keep the participants informed by sending them annual study newsletters (the first batch of newsletters were sent in February 2020) and by updating study websites. University of Bristol also organised a Research Festival in September 2020 where all participants and their families recruited on FITNET-NHS Trial were invited to attend. The event was attended by research and clinical teams based at the University of Bristol and The Bath Royal United Hospital. Members of the Patient Advisory Group (PAG) were also invited. The purpose was to update the families and patients of any changes made to the trial – how University of Bristol are using and will use their data; hold workshops and questions and answer sessions to address trial related queries.

All outputs will include only aggregate data with small numbers suppressed in line with the HES Analysis Guide. No record level data will be shared with any third party not named in this agreement.

Previous research from the study trail was cited by NICE in their most recent evidence review and guidance (NICE Guidance NG206 published October 2021) – for example, see references below. The study team expect that evidence from the FITNET trial will inform the next iteration of NICE guidance.

Beasant L, Mills N, Crawley E. Adolescents and mothers value referral to a specialist service for chronic fatigue syndrome or myalgic encephalopathy (CFS/ME). Primary Health Care Research & Development. 2014; 15(2):134-142

Crawley E, Mills N, Beasant L, Johnson D, Collin SM, Deans Z et al. The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). Trials. 2013; 14:415

Crawley EM, Gaunt DM, Garfield K, Hollingworth W, Sterne JAC, Beasant L et al. Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: Randomised controlled trial. Archives of Disease in Childhood. 2018; 103(2):155-164

Processing:

Each child/young person recruited to the trial is assigned a unique study identifier (Pseudo-ID) to maintain pseudonymisation. Towards the end of the trial follow up (October 2021), University of Bristol will provide NHS Digital with a file containing this study identifier and other patient identifiers (NHS number, date of birth and postcode) for all trial participants recruited in England who have consented to linkage to routinely collected data. University of Bristol will also provide the participant 'Date of Recruitment' as the study only requires HES records from the date of recruitment until the end of the follow-up period. The file will be securely transferred to NHS Digital via Secure Electronic file Transfer (SEFT) system.

2. NHS Digital will use the patient identifiers to achieve linkage to the datasets requested for the years encompassing trial recruitment and follow up (projected to be 2016/17 to end 2021 inclusive). NHS Digital will prepare data files containing the required HES/ECDS/MHSDS data fields. NHS Digital will remove the direct patient identifiers (e.g. NHS Number, Date of Birth and Postcode) but retain the Study Pseudo-ID. The pseudonymised files will be securely transferred to the FITNET-NHS study team at the University of Bristol via Secure Electronic file Transfer (SEFT) system.

3. The FITNET-NHS Trial team will store the data in the University of Bristol encapsulated Virtual Machine (eVM) which will be set-up by University of Bristol’s IT specialists prior to receiving the data. The ‘encapsulated virtual machine’ (eVM) is a purpose-built secure research server. It provides a secure way for approved University of Bristol substantive employees who are part of the FITNET-NHS research team to access the data from approved University of Bristol computers. The University of Bristol eVM is compliant with the existing University of Bristol organisational Data Security and Protection Toolkit (DSPT). The record-level pseudonymised data that NHS Digital supplies will be linked via the study identifier (Study ID) to the pseudonymised patient data collected as part of the trial. For example, this will allow University of Bristol to compare whether healthcare use differs according to the severity of CFS/ME at the time of trial enrolment and before the start of treatment. The cohort identifiers will be kept separate from the pseudonymised study data on the eVM.

4. All data analysis will be performed by substantive employees of the University of Bristol who are members of the FITNET-NHS study team. The team will aggregate the HES and MHSDS data (e.g. to calculate the total number and cost of hospital admissions for each patient). The primary analysis will be a comparison of healthcare use between patients randomised to receive activity management or FITNET-NHS.

At no point will University of Bristol link the NHS Digital data back to direct patient identifiers (e.g. NHS number) in an attempt to re-identify individuals, or attempt to link to any other datasets collected outside of the auspices of the trial.

The FITNET-NHS study team will only be able to access the data from designated encrypted university owned computers with an assigned Internet Protocol (IP) address on site at University of Bristol. Remote access is not permitted. All analysis will take place on designated encrypted computers working within the eVM. Download of NHS Digital data to device hard-drives is not permitted.

University of Bristol believe that using routine data, with consent, to measure healthcare use across England represents the least intrusive way of collecting this data. The NIHR final report is scheduled for 30/04/2022. University of Bristol anticipate that the research outputs will be submitted and peer-reviewed within 12 months of the NIHR final report (i.e. approximately 30/04/23). At the end of the archiving period of 15 years, University of Bristol will securely destroy the data received from NHS Digital and provide a certificate of Data Destruction as evidence.

University of Bristol have taken the following steps/actions to meet their Data Sharing and Protection Toolkit:
1. Detailed information of the researchers (including name, department, building and computer IT system number) accessing, processing and handling data have been provided to the Information Governance Team at the University of Bristol and has met the eligibility criteria for the DSPT.
2. Named Researchers accessing, processing and handling data have completed the "GDPR Information Security Training" and "Medical Research Council Research, GDPR and Confidentiality Training" scoring 80% or higher.
3. Once the data is obtained and stored in the respective eVM, the University of Bristol Information Governance Team would carry out a Data Quality Audit.

Virtus and AQL Leeds provide secure buildings within which University of Bristol equipment is hosted and maintained. Virtus and AQL Leeds do not access data held under this agreement as they only supply the building and are therefore not listed as a Data Processor. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database containing the data.

MHSDS, HES and ECDS DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION
In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, you must make sure that:
· National-level figures only may be presented unrounded, without small number suppression
· cell values from 1 to 7 (inclusive) are suppressed at a local level to prevent possible identification of individuals from small counts within the table.
· Zeros (0) do not need to be suppressed.
· All other counts will be rounded to the nearest 5.
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.

Inequalities in stillbirth and preterm birth and their risk factors — DARS-NIC-430380-F7L4Z

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 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2021-07-01 — 2024-06-30 2022.06 — 2022.06. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. MSDS (Maternity Services Data Set)
  2. MSDS (Maternity Services Data Set) v1.5
  3. Maternity Services Data Set (MSDS) v1.5
  4. Maternity Services Data Set (MSDS) v2

Objectives:

The University of Bristol requires data from the Maternity Services Data Set (MSDS), for the purpose of investigating inequalities in rates of stillbirth (SB) and preterm birth (PTB) and their risk factors in England.

Background:
The Secretary of State for Health has defined a national target to halve SB by 2025, with a reduction from 4.7 per 1000 to 2.3 per 1000. There is a similar ambition to reduce PTB from 8% to 6% in the same time frame. There has been an increased national focus on improving maternity outcomes, with a range of initiatives developing from the government, the NHS and professional bodies. Though much is still to be discovered, we know a lot about excellence in maternity care, but less about how to ensure that this is accessible to all women beyond centres of excellence. The main purpose of this study is to contribute towards achieving the primary aim of the consortium to reduce SB and PTB in the UK.

The rates of SB have been mapped for 2017 by MBRRACE-UK: Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK. The rate of SB in 2018 is 4.1/1,000 total births. Wide variations have been identified throughout the UK. Some NHS Trusts have SB rates of more than 15% lower than the national average, but other units have rates more than 5% higher than the national average. These inequalities remain after adjusting for differences in patients and Trust characteristics. Inequalities in PTB have been identified in England and Wales by maternal residential area (regions) but there is no data on variations between NHS Trusts and over time. The risk factors that contribute to these geographical variations remain unclear. Identifying and understanding the variations in SB and PTB should help care providers to identify best and poor practices and evaluate the effectiveness of intervention or guidelines aiming to improve care practices and clinical outcomes. However, clinicians and mothers need to be able to identify the risk of PTB and SB as early as possible to prevent these outcomes. Based on the Office for National Statistics data, the study team are expecting about 2.56 million births in England captured in the MSDS database from 2015 – 2019.

The literature on risk factors of PTB and SB is substantial. These risk factors could be used to form the basis of a predictive tool that would help clinicians identifying at-risk women at booking or during the early antenatal visit and therefore identify adequate antenatal care pathways for these mothers. The tool could also help identify women at risk of PTB and/or SB throughout their pregnancy, especially during acute hospital preterm presentation or late pregnancy presentation and offer them appropriate screening, care and delivery strategies.

By analysing data from the MSDS data, would provide the information necessary to address these knowledge gaps. It provides a standardised collection of data on maternity care, maternal and perinatal outcomes, across all of England since 2015. It also contains numerous maternal, babies and NHS Trust characteristics including clinical features. This is therefore a unique source to develop and test risk prediction tools for SB and PTB. The size and coverage of the MSDS data offer the statistical power to consider rare variables and rare outcomes such as SB. Moreover, by providing information from multiple maternity units, it captures the diversity of clinical practices across England and generalisability to the results. Finally, MSDS data are ideal to conduct quasi-experimental studies at the national- or local care provider-level investigating the change in SB and PTB induced by the implementation of new clinical guidelines, or public health initiatives generally implemented independently of the data collection process and the research evaluation team. The study team will also assess changes on PTB or SB rates over time and/or induced by specific intervention impact(s) on neonatal death (ND), i.e. baby death within 30 days of delivery.

Legal basis justification:
The study team's project is justified by Article 9(2)(j) of the GDPR "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". Data processing is needed to help describe evidence of inequalities and geographical variation in rates of PTB and SB across maternity units, and to identify risk factors that would explain why such variation exists.

The study team's project is justified by article 9(2)(j) of the GDPR "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular, professional secrecy". This is justified as this project's aim is to drive improvements in the quality and safety of maternity care and to improve outcomes for mothers and babies.

Cohort identification:
Data subjects are those in the MSDS data. All births which occurred in England and captured in the MSDS data since the inception of the dataset (2015/2016) to 2018/19 will be eligible. All the non-preterm and non-stillbirths data is required to provide an appropriate cohort control for all the preterm and stillbirth in England captured in the MSDS database from 2015 – 2019.

Data required:
For the cohort described above, data is needed from the MSDS dataset. NHS digital would provide a one-off report of MSDS data. The team are only requesting access to the pseudonymised variables from the MSDS data source. One of the main aims of this project is to develop and validate an algorithm/model for early detection of pregnancies at risk of stillbirth and/or preterm birth for prompt interventions. Thus, they are interested in estimating the absolute risk of having a stillbirth/preterm birth which will require the whole data rather than using a fraction of all the non-preterm and non-stillbirths data as control.

The outcomes of interest are stillbirth (SB) and preterm birth (PTB) and they will consider how changes on these birth outcomes have impacted on neonatal death (ND).
- SB is defined as the death of a baby before or during birth after 24 completed weeks of gestation. SB is determined by clinicians as part of the care delivered in the local maternity unit. The SB status is recorded by clinicians in the hospital electronic medical records and directly captured in the MSDS. ND is defined as death within the first 30 days of life.
- PTB is defined as the birth of a baby before 37 weeks of pregnancy (i.e. <37+0 weeks). PTB status is derived from the length of gestation at birth recorded by clinicians in the hospital electronic medical records. Gestational age at birth (age of baby at birth) is recorded in the MSDS and will be used to define the preterm birth status and the different level of prematurity.

Risk factors of interest will include mothers age, ethnicity, obstetric history (e.g. previous pregnancies, caesarean sections, preterm births, birth weight), antenatal care (e.g. body mass index, smoking, alcohol, diabetes), labour and delivery (e.g. induction, drugs in labour, delivery method).

To describe geographical variation in rates of PTB and SB outcomes, the team require information on the name of maternity units at which the delivery took place, including name of NHS Trust, and higher levels of geography including the clinical commissioning group (CCG) areas.

Regarding date and time of event variables, the MSDS contains information on time of admission, time of onset of labour, time of second stage, time of third stage, time of induction and time of delivery. The team would like to be provided with variables containing the duration of labour, duration between stages or duration between the time of a particular stage and time of admission. The derived variables (date as MM/CCYY, time and duration) will maintain patient confidentiality.

Data minimisation reasoning:
The study team are only requesting MSDS data relevant to assessing the outcomes of PTB and SB and have limited the data requested to the cohort described. The team are not requesting further hospital data beyond the birth outcome.

Data analysis plan:
1. Explore the inequalities in the rates of SB and PTB between care providers across England, their variations over time;
Rates of SB and PTB will be derived for each NHS maternity unit or Trust, depending on the availability of information at the unit level. A cross-sectional investigation of SB/PTB rates for a particular year will be supplemented by a longitudinal investigation with rates estimated for each care provider and by time-period of relevant length. SB is a rare outcome and to retain patient confidentiality, time-period will be defined to aggregate no less than five cases/patients per unit/Trust for any given period. Funnel plots, statistical process control charts, Geographical Information System maps and caterpillar plots will be considered to report the findings.

Multilevel generalized linear regression models will be used to compute the rates and their 95% Confidence Intervals. This will allow the team to determine whether relevant risk factors of interest explain observed geographical variation in rates of PTB and SB outcomes across maternity units.

2. Examine the impact of SB/PTB on neonatal deaths.
Several interventions including national guidelines, specific clinical or organizational interventions, or any other initiatives susceptible to impact adverse outcomes such as SB or PTB have been implemented. This work package will also examine how changes on the rates of SB and PTB have been affecting neonatal deaths. This work package will involve comparing trends in SB, PTB and ND.
Also, the effect of differences in the incidence of SB/PTB between maternities on neonatal death will be examined using generalised linear (mixed) regression model.

3. Investigate the impact of initiative(s) implemented to improve maternity care or SB/PTB;
We will identify initiatives aimed at improving maternity care provision and/or care quality over the time period of interest (2015 to present). These include national guidelines, specific clinical or organizational interventions, or any other initiatives susceptible to impact adverse outcomes such as SB or PTB. The initiative could be implemented at the national level, or at the local level within one or several maternity unit(s) or Trust(s). This work package is based on a quasi-experimental (before-after) study design. We will use the date of introduction of the studied initiative to define the relevant period of exposure: births that occurred before the intervention will be considered
as unexposed and births that occurred thereafter will be considered as exposed to this initiative Statistical models such as generalised linear (mixed) regression models, including interrupted-time series, will be used to perform these analyses.
4. Further the knowledge on the risk factors of SB and PTB prior and develop risk prediction models for these two adverse outcomes. We will investigate the associations between SB status and maternal, baby and care provider level characteristics available in the MSDS data. A similar approach will be conducted to investigate the risk factors of PTB. Two approaches will be used. We will use traditional generalised linear (mixed) regression such as logistic or Poisson models to identify the characteristics associated with the outcome of interest. These factors will be used to define predictive models for SB and/or PTB. The validation of the predictive model will be done with strategy such as the bootstrap approach or Area under the Curve. We will repeat these analyses with machine learning models using supervised learning approaches (Lasso regression, Support vector machines, Gradient boosting machines model etc) and explore the potential for unsupervised approaches to refine these predictive models.

Data Controller statement:
The University of Bristol is the sole data controller and processor, given the University of Bristol are solely determining, through the study team, the way the data is being processed. The University of Bristol is the data controller responsible for determining the purpose for all data flows described and will be the data controller for the data received.

Funding:
This study is funded by the charity TOMMY’s, which established a National Centre for Maternity Improvement in September 2019 aiming to identify the best care practices to reduce SB and PTB and spread them to all care providers across the UK. Tommy Centre is being led by the Royal College of Obstetrics and Gynaecologists (RCOG) with the Royal College of Midwives (RCM). The team at the University of Bristol is a member of the new TOMMY centre and is leading on statistical analysis of national maternity data to address the aims of the centre.

Expected Benefits:

This project is a core part of the work planned by our Tommy’s centre. This centre is contributing to the Department of Health target to half stillbirth (SB) and preterm birth (PTB) by 2025. The quantitative evidence provided by the proposed work will help to describe and understand the inequalities between care providers. This will help to identify units with low rates of SB and PTB, and those requiring support. The proposed work will also help to identify the effectiveness of existing national or regional/local programmes and provide evidence around the sustainability of their effect or relevance of scaling up a regional initiative to the national level. Finally, our work on the prognostic model should inform the development of clinical tools which would help clinician identifying at-risk patients as early as possible, to reveive individualised and tailored care.

The study’s overarching aim is to contribute towards reducing the incidence of SB and PTB by identifying high-risk pregnancies for prompt interventions. By Identifiing cases of high-risk pregnancies to receive the currently recommended interventions for the management of PTB and SB in the UK would assist in alleviating the current burden of stillbirths and preterm births nationally.
There is wide variation in standardised stillbirth and perinatal mortality rates throughout the UK with over a 20% difference between the highest and lowest reported rates whether by geographical region or Health Trust. This difference is not explained by a lack of current research recommendations, but rather by variation in local adoption and implementation of existing guidelines and good clinical practice, along with differences in availability and organisation of local resources. This study will explore in details the disparities in SB/PTB, their range, potential associations/causes and provide recommendations. Findings from this study will also reveal the impact of SB/and/or PTB on ND. These findign will help understand and develop clinical decision-making tools to personalise care for women.

The study will support a PhD research study.

Outputs:

Throughout all stages of this programme, the key stakeholders including the patients, public, the Royal College of Obstetricians and Gynaecologists, the Royal College of Midwives, NHS managers and healthcare professionals will be engaged for interpretation, dissemination, and direct communication of the main findings.

The data obtained from NHS Digital will be examined to generate the following publications to achieve the project's objectives.
(1) Inequalities in the rates of SB between care providers/LSOA across England
(2) Inequalities in the rates of PTB between care providers/LSOA across England
(3) Impact of the implemented interventions to improve SB.
(4) Impact of the implemented interventions to improve PTB.
(5) Associated risk factors of SB.
(6) Associated risk factors of PTB.
(7) Development and validation of a prediction model for SB.
(8) Development and validation of a prediction model for PTB.

Some of the journals where the team plan to publish these papers include but are not limited to the following: the Lancet, BMJ, Journal of the American Medical Association, British Journal of Obstetrics and Gynaecology and European Journal of Obstetrics & Gynaecology and Reproductive Biology and American Journal of Obstetrics and Gynaecology.

All outputs will adhere to the NHS Digital guidelines so that data are only shown in aggregate form with small numbers suppressed.

The research team will work alongside Tommy’s, other charities and learned societies to disseminate the findings of this study using established platforms that include social media such as Twitter and a study website, as more pregnant women are now turning to these resources for information about pregnancy. The research team will develop plain English summaries of findings for communication to women of reproductive age and members of the public.

The data produced by this study will inform NHS England, for whom elimination of inequalities and reduction in SB and PTB are priority targets. Incorporation of the findings from this project to maternal care services will not be challenging as the study will be led by the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives.

Disseminating outputs for pregnant women and the public:
The outputs of this research will be hugely valuable in creating messages and information products directed at very large groups including pregnant women, women of reproductive age, men, the wider public. Several social media platform (Twitter, Instagram, Facebook) will be deployed to disseminate the findings of this study to pregnant women and the public.

Disseminating outputs to collaborators and stakeholders:
Tommy’s research centre is supported by representatives from the main charities which work to reduce stillbirth, miscarriage and preterm birth such as SANDS. The centre is also supported by the RCOG Women’s Voices Involvement Panel, an online group of over 500 members of the public who want to use their experience of women’s health services to influence the work of the College and the wider women’s health sector. A member of the RCOG Women’s Network is also involved in the centre’s advisory group. Women have therefore been involved in the writing of our grant application and are involved in the development of each work package. They have contributed to the development of the above research questions and will be involved in the interpretation and presentation of the related findings. The research team will continue to work with collaborators and stakeholders to enable the wide dissemination of findings.

Disseminating outputs to commissioners, operational managers and facilitators of change:
The team plan to engage the CCGs to get their buy-in to adopt the findings from this study. This study has the potential to contribute towards reducing SB and PTB by understanding the differences in SB/PTB, assessing the impact of the implemented interventions, evaluating the impact of chanes on SB/PTB on ND and developing a clinical decision-making tool for early identification of pregnancies at risk of SB/PTB for prompt interventions. The research group will adopt multiple approaches such as workshops, policy to dissemination, led by the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives which have skill and capacity in this area.

Disseminating outputs to health care professionals:
The TOMMYs national centre is being led by the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives. Other relevant healthcare professionals were involved in the development of this study. Continuous engagement of all relevant healthcare professionals in pregnancy care will be sustained throughout the implementation of the study through meetings/newsletter. The Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives will lead the dissemination of the study’s findings to their colleagues through various platforms including scientific meetings, national conference and workshops.

As this study is support of a PhD Research study a PhD Thesis will be produced and published.

All outputs are expected to be published between 2021 and 2024.

Processing:

Under this agreement, data on all births that occurred in England and recorded in the MSDS database from April 2015 to March 2019 will be transferred to the University of Bristol by NHS Digital.

Regarding date and time of event to be checked, the team are requesting that the data provided to them have dates transformed to the MM/CCYY format to protect patient confidentiality. Time variables in the MSDS are generally registered as CCYY-MM-DDTHH:MM:SS. The team are requesting that all time variables are provided to them as HH:MM:SS without the DD/MM/CCYY. The team are also requesting for the time of events to be converted in duration as explained in the section above. The derived variables (date as MM/CCYY, time and duration) will maintain patient confidentiality. The data will be exclusively stored on the University of Bristol SafeHaven (server) and will not be accessible to any third parties.

Data flow:
1. A patient-level, pseudonymised MSDS dataset (no personal data are requested, and mums/babies will be identified with a pseudonymised ID) would be provided by NHS Digital.
2. NHS Digital will supply the pseudonymised data to the University of Bristol via Secure Electronic File Transfer (SEFT).
3. The University of Bristol will store data in the University of Bristol SafeHaven and access to the data will be restricted to the statistical team at the University of Bristol.

Statistical analyses of the dataset will be performed as described in section 5a. All outputs will contain only data that is aggregated with small numbers suppressed.

The MSDS data will be located at the University of Bristol SafeHaven, which has established procedures for the transfer of data, its secure storage and for erasing data at the end of projects (www.bristol.ac.uk/infosec/policies/docs/). The data will be access-controlled at the University of Bristol in safe data havens, with password and firewall protection that guards against external users and access will be limited to the staff named in this application.

Only substantive employees of the University of Bristol will access the disseminated data and only for the purposes described in this agreement. Specified University of Bristol study personnel will be granted access to the data safe-haven after they have completed the necessary information governance training; The Project Lead will have responsibility for managing those individuals who have access. The data will be managed by a member of the project team based at the Learning and Research Building at the University of Bristol. The data will be used exclusively for the purpose of this project.

Once this agreement is near to expiring an extension application will be submitted to NHS Digital, to allow the continued processing and storing of the data. As at the end of the study, the data will need to be safely held in a password protected project-specific safe data haven at the University of Bristol for 42 months and, in that time, it will be accessed only to answer questions arising from publications and other publicity. The expected time frame for completion of the data processing, production and dissemination of the outputs is currently 4 years, with a further 18 months retention of data after this to respond to changes based on peer review comments from journals and from funding bodies.

The study team are requesting a pseudonymised dataset and there will be no requirement/attempt to re-identify individuals. No data will be shared.

The NHS Digital data will not be linked to any other data.

This Data Sharing Agreement does not permit data to 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 unless a third party has received separate approval from NHS Digital to receive the data covered by this Agreement. To prevent inadvertent reidentification of the participants, we plan to take the following steps:
(1) Only applying to access depersonalised, pseudonymised MSDS data
(2) No personalised data are requested and mothers/babies will be identified with an anonymised ID
(3) The data will be securely stored in a University of Bristol server and access to the data will be restricted to the statistical team at the University of Bristol and a PhD student employed by the University of Bristol
(4) The study team plan to merge data from multiple years before analysis to prevent the results from having small numbers: the statistics will be reported in output using rates, .ie. aggregated numerators and denominators, that will not allow identification of individual data or individuals
(5) If these rates are derived from small data, i.e. small numerators <5 cases, we will consider, whenever possible to elongate the length of each period modeled (i.e. 3 months instead of one month, 6 months instead of 3 months etc) to prevent the production of rates based of data too sparse.
(6) If despite these measures, results include small rates that are still based on numerators, or numbers <5 cases, they will be suppressed and not reported to secure patient confidentiality

NHS Digital reminds all organisations party to this agreement of the need to 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).

The Brighter study. Breast Reconstruction: Investigating long term clinical and cost-effectiveness in the National Mastectomy and Breast Reconstruction Audit cohort. — DARS-NIC-363140-V3X2W

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2021-04-26 — 2022-04-25 2021.07 — 2021.08. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Demographics
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Admitted Patient Care (HES APC)
  5. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The Brighter study aims to address the lack of clinical and cost effectiveness evidence to guide patients and clinicians when choosing treatment options following a mastectomy for breast cancer. This application is the first part of the Brighter Study and as such is a first steps of the study and is not a standalone application.

The purpose of the study is to enable better informed, more evidence-based treatment decisions to be made, to improve clinical outcomes for the 55,000+ women who are diagnosed with breast cancer in the UK each year (though the impact of the study will be worldwide) and facilitate optimum health resource allocation in the NHS and beyond. The primary objective of Brighter is to compare the long term clinical and cost effectiveness of implant based and autologous (pedicled and free flap) breast reconstruction to help patients, health professionals and commissioners make more informed decisions about reconstructive breast surgery. Secondary objectives are to compare outcomes in patients undergoing immediate and delayed breast reconstruction and to explore long term outcomes in patients undergoing mastectomy. The study has three parts: a clinical outcomes cohort study including the use of HES, a patient reported outcomes cohort study, and a cost effectiveness analysis. This application relates a clinical outcomes cohort study including the use of HES.

The Brighter cohort will be women (age 16+) and whose sex is registered as female with NHS Digital and who have had a mastectomy for invasive breast cancer or preinvasive (ductal carcinoma in situ) disease, or a delayed breast reconstruction following a previous breast cancer diagnosis in an NHS England setting between 1 January 2008 and 31 March 2009. The cohort (estimated to number around 16,000) will necessarily be identified using routine sources (HES / Personal Demographics Service) rather than a direct approach from clinicians or the study team. The cohort will be supplied with fair processing materials when they are contacted and asked to consent to the patient reported outcomes cohort study. The Confidentiality Advisory Group (20/CAG/0021) agree that there is no alternative to identifying the study cohort using routine health records. This will be the second part of the study and not this application.

University of Bristol’s justification for processing is GDPR Article 6 (1) (e): The processing necessary to perform this task is in the public interest and the task has a clear basis in law. This is an issue of patients choosing treatment options following a mastectomy for breast cancer allowing them to be better.

GDPR Article 9 (2)(j): processing is necessary for scientific research purposes and shall be proportionate to the aim pursued, respect 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 requested will allow the study team to replicate the eligibility criteria of the National Mastectomy and Breast Reconstruction Audit (NMBRA) (Royal College of Surgeons) carried out in the UK in 2008/9. The NMBRA cohort was drawn from independent as well as NHS hospitals, and some NHS trusts outside of England. The Brighter study cohort will be drawn solely from NHS England patients so although there will be overlap between the NMBRA and Brighter cohorts they will not be the same. The data requested will allow the Brighter study team to invite the cohort to participate in the study. Using HES and a range of Patient Reported Outcomes Questionnaires (BREAST Q, EQ5D, ICECAP-A), long term (10 year) clinical and cost-effectiveness of various reconstruction types following a mastectomy for breast cancer can be evaluated.

The National Institute for Health Research (NIHR) has funded the Brighter study. Although the study adopts the eligibility criteria of the NMBRA there is no merging of any other data. Brighter is a stand-alone project, separate from any other study, and the data can be deleted when analysis is complete.

The Chief Investigator of Brighter is an Oncoplastic Breast Surgeon who is a substantive employee of the University of Bristol in her capacity as a Consultant Senior Lecturer in Oncoplastic Breast Surgery in the Bristol Centre for Surgical Research at the Bristol Medical School, University of Bristol. The Brighter study team are all substantive employees of the University of Bristol. As such the University of Bristol is the data controller, and also the Data Processor. Members of the Royal College of Surgeons are part of the study’s steering committee and act in advisory capacity only. They are not involved in the processing, and as such only aggregated disclosure-controlled output will be shared with them. Similarly, a statistician from the University of the West of England is also on the study steering committee to provide statistical advice to the study team but will not have access to, or be involved in, processing of identifiable data. As with other members of steering committee the statistician will access only aggregated disclosure controlled output, to advise on the statistical analysis of HES. No record level data will be shared with the statistician. The University of Bristol are the only organisation making the decision about how the personal data will be processed under this agreement.

The National Institute for Health Research (Research for Patient Benefit) are funding the project but are not actively involved in carrying the project out and will not have access to any identifiable data. Only aggregated output with small numbers suppressed in line with HES analysis guidelines will be shared with them.

Admitted Patient Care data is requested from the year before eligibility (2007/8) to the most recent extract to derive a one-year Charlson Comorbidity Index and to allow for ten year follow up analysis. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. To describe comorbidity all diagnostic and operation codes need to be included in the HES data. Outpatients data is requested but this will be minimised to 3 years from the eligibility dates as adjuvant therapy is the key information that is required from these data sets, and 3 years should be sufficient to obtain this and the contact details of the cohort are required from the Personal Demographic Service to allow the study team to contact the cohort and provide fair processing materials. To achieve sufficient statistical power, and to match as closely as possible the National Mastectomy and Breast Reconstruction cohort, requesting national data (NHS England) is necessary.

Expected Benefits:

Breast reconstruction surgery is offered to improve quality of life for the 20,000 women every year facing mastectomy for breast cancer.

Decision-making for breast reconstruction, however is difficult as there are lots of different options available for women.

Although the short-term complications of different operations are well-established there is currently no evidence regarding the long-term clinical and patient reported outcomes of different approaches to breast reconstruction. This includes how different types of reconstruction may look or feel in the long term or how many additional operations they may need on their reconstructed breast over time. This means that women are not able to make fully informed about their breast reconstruction options and many patients experience high levels of decisional regret. This adversely impacts their quality of life and may result in increased outpatients/GP attendances and revisional surgery with attendant resource implications and broader impacts on society.

The results of the Brighter study it is hoped provide women and health care professionals with much needed information about the long term outcomes of different types of breast reconstruction. It is hoped this will allow women to make better and more informed decisions about the best type and timing of breast reconstruction for them. It is hoped this will reduce decisional regret and directly improve outcome for women undergoing surgery in the future. Improved satisfaction it is hoped will result in fewer outpatient/GP visits; reduced requirements for revisional surgery.

Details of the long-term cost-effectiveness of different approaches to breast reconstruction it is hoped will allow clinical commissioning groups to make evidence-based decisions regarding the ongoing provision of reconstructive services in the UK. Evidence-based policy decision-making it is hoped will address the inequalities in access to reconstructive services identified the in AAPGBC 2018 report and promote the development of fair and equitable services that allow optimal use of scarce healthcare resources.

It is anticipated that these improvements it is hoped start to occur within 6-12 months of the completion of the analysis as the findings are shared with the stakeholder groups outlined above.

It is hoped the results of the study will be generalisable, and of great interest to other countries as well as the UK, so the study can be expected to benefit breast cancer patients across the world.

Outputs:

Dissemination will include reports, submissions to peer reviewed journals, and presentations at conferences . All outputs will be aggregated and disclosure controlled with small numbers suppressed in line with HES analysis guide.

To be specific, submissions reporting the findings from the clinical and patient-reported outcomes studies are planned to high-impact factor journals including but not restricted to ‘JAMA Surgery’, ‘Annals of Surgery’, ‘British Journal of Surgery’ and the ‘British Medical Journal’. The cost-effectiveness findings will additionally be targeted to appropriate specialist journals including ‘Health Economics’ and ‘Value in Health’. At least 4 publications are planned. It is anticipated that these outputs will be generated and submissions made within 6-12 months of completing the planned analyses. Timelines for publication will be dependent on the process of editorial review.

Conference presentations are planned for national and international meetings, including but not limited to, the Association of Breast Surgery meeting (May 2021) and San Antonio Breast Cancer Symposium (December 2021). The timing of conference submission will depend on the timelines for delivery of data. It is anticipated that conferences in 2021/22 will be targeted. All conference presentations will be dependent on COVID19 restrictions.

Lay summaries will be produced in collaboration with our patient steering group members and shared with Independent Cancer Patients’ Voice (IPCV) and breast cancer charities including Breast Cancer Now. IPCV will help disseminate the summaries and we will liaise with other charities to also help disseminate the summaries.

Executive summaries of key findings will be prepared and shared with commissioners of healthcare services locally and nationally; the National Institute of Health and Care Excellence, the Breast Clinical Expert Group and the All Party Parliamentary Group on Breast Cancer (APPGBC). The APPGBC has previously highlighted inequalities in access to reconstructive surgery across the UK (June 2018). Long-term clinical and cost-effectiveness data generated from the Brighter study will allow commissioners of healthcare services to make evidence-based decisions on the provision of breast reconstruction services. It is anticipated that evidence-based decisions will be fairer and more transparent and promote equality of access to reconstructive services across the UK.

Brighter Steering Group members are active members of the professional associations with leadership roles. The study team will work with the Association of Breast Surgery (ABS) (Potter, Brighter Chief Investigator, ABS Academic and Research Committee Secretary; Holcombe ABS President-elect), the British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) (O’Donoghue), the Royal College of Nursing (RGN) (Gulliver Clarke) to produce updated patient materials informed by the study’s findings. This will include producing 1-2 page patient summaries, in collaboration with patients, to be hosted on the patient-facing breast reconstruction information sections of the association websites. This information will include a summary of the long-term clinical and patient-reported outcomes of different approaches to breast reconstruction for women considering surgery and will help them to them make more informed decisions about their reconstructive options.

All outputs are planned for within 6-12 months of completion of the analysis.

Findings will be further disseminated to clinical colleagues, commissioners, the study participants and the public via social media (Twitter account), and the study website. Dissemination via social media channels will occur throughout the study.

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)”

There will be no flow of data into NHS Digital. The cohort would be defined by NHS Digital applying the eligibility criteria in HES, and NHS Digital would send the study team the data (HES and contact details of the cohort) and send the third-party mailing company contact details of the cohort only. Identifiable data will be stored on a bespoke encapsulated server and access is restricted to study team members (all substantive employees of the University of Bristol – the data processor and controller). The third-party mailing company will not be able to access this server. They will receive the contact details of the cohort only and will delete these upon completion of the mailing. The cases in HES will be identifiable by unique study ID only. Hospital records will not be connected to any identifiers except the unique study ID. The transfer of identifiable contact details and data items have been approved by CAG (20CAG0021).

Up to date contact details of the cohort are required, with vital status confirmed, from the NHS Personal Demographics Service. Gathering this information in conjunction with the eligibility criteria from HES is the only way to identify the cohort. Less obtrusive ways are not available. The Confidentiality Advisory Group have provided support for this purpose under CAG reference 20CAG0021. The identifiable data set of contact details will be linked to the pseudonymised HES extracts with a unique study ID. This study ID will be used to identify the HES records of those who opt out, and all the HES records relating to them will be deleted permanently and removed from the study. Following a period of two months where the cohort has the opportunity to opt of out the HES analysis, this identifiable data will be securely destroyed in line with NHS Digital guidance. The only variables and data sets being requested are only those necessary and for necessary time periods.

Admitted Patient Care data is requested from the year before eligibility (2007/8) to the most recent extract to derive a one-year Charlson Comorbidity Index and to allow for ten year follow up analysis. To describe comorbidity all diagnostic and operation codes need to be included in the HES data. Outpatients data is requested but this will be minimised to 3 years from the eligibility dates as adjuvant therapy is the key information that is required from these data sets, and 3 years should be sufficient to obtain this and the contact details of the cohort are required from the Personal Demographic Service to allow the study team to contact the cohort and provide fair processing materials. To achieve sufficient statistical power, and to match as closely as possible the National Mastectomy and Breast Reconstruction cohort, requesting national data (NHS England) is necessary.

Analyses of the HES extracts include descriptions of the number, type and timing of revision procedures, reconstruction failures, secondary reconstructions and delayed reconstructions by surgical procedure and timing. Also, multi-variable logistic regression will be used to examine the relationship between revision surgery, reconstruction failure, secondary reconstruction and socio-demographic factors (age, ethnicity, deprivation), Charlson Index and treatment centre. Similar methods will be used to explore the association between the uptake and delayed reconstruction and socio-demographic, tumour related and treatment factors.

Among the storage locations for data held by the University of Bristol is Virtus London. This site is purely a storage location for some data held by the University of Bristol. All processing will be carried out within University of Bristol premises at the Canynge Hall site using three specified encrypted PC's connected to a bespoke encapsulated server. The data storage locations will be as per other applications from the University of Bristol that involve data storage on encapsulated virtual servers at the department of Population Health Sciences at the University of Bristol.

The process of providing fair processing to study participants (supplying them with information materials and the means to consent to the patient report study and dissent to the use of NHS hospital records relating to them) will be by mailing information packs to all of the eligible cohort. A third party mailing company, Bascom Limited (also known as Bristol Mailing Services/Mail Handling International Limited/Higher Education Communications but it is one single organisation) will carry out the mailing of the personalised mail packs. They have the facility to receive an encrypted email form NHS Digital containing the address details for the cohort. The company has ISO27001 data security accreditation, and an NHS Digital Data Security and Protection Toolkit status of Standards Met (see details in the Processor section). The address details of the cohort are the only identifiable data items that will be processed at a location other than the University of Bristol (by the third party mailing company).

With the exception of the mail out requiring the addresses of the cohort, all data will only be accessed and processed by substantive employees of University of Bristol and will not be accessed or processed by any other third parties not mentioned in this agreement.

The SIPS study — DARS-NIC-336857-P6C9Q

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(2)(a)

Purposes: No (Academic)

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

When:DSA runs 2020-08-06 — 2023-08-07 2020.10 — 2021.07. breached contract — audit report.

Access method: One-Off

Data-controller type: MANCHESTER UNIVERSITY NHS FOUNDATION TRUST, THE UNIVERSITY OF MANCHESTER, UNIVERSITY OF BRISTOL, THE UNIVERSITY OF MANCHESTER, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. HES:Civil Registration (Deaths) bridge
  2. Hospital Episode Statistics Outpatients
  3. Hospital Episode Statistics Admitted Patient Care
  4. Civil Registration - Deaths
  5. Civil Registration (Deaths) - Secondary Care Cut
  6. Civil Registrations of Death - Secondary Care Cut
  7. Hospital Episode Statistics Admitted Patient Care (HES APC)
  8. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

Pressure ulcers are a serious problem for patients and their carers. They range in severity from red skin (Stage 1) to deep wounds through muscle to bone (Stage 4). Pressure ulcers have a major impact on quality of life; they may heal slowly and become infected and can increase the risk of dying in older people. They are also a costly problem for the National Health Service (NHS). People with pressure ulcers are usually treated in the community but may need hospital care. Common treatments for pressure ulcers include pressure relief, dressings and encouraging movement and change of position. Surgery can be used to try and close deep pressure ulcers but in the United Kingdom (UK) this treatment is not common. Finding out whether surgery works as a treatment is very important to people affected by pressure ulcers. Currently, it is not clear which patients with pressure ulcers may benefit from an operation and which of the different ways of doing the surgery seems best. NICE guidance on pressure ulcers makes no recommendations about surgical management in relation to reconstruction (although there is guidance on debriding which is not the focus of this study).

The University of Bristol, Manchester University NHS Foundation Trust and University of Manchester are joint data controllers for the SIPS (Surgical interventions to treat severe pressure sores) study, which aims to find out more about how best to conduct research in this area by undertaking three workstreams, these can be summarised as:
(i) literature reviews and interviews with healthcare professionals
(ii) retrospective cohort studies
(iii) formal consensus methods with healthcare professionals and patients.

The data requested under this agreement will be used for workstream ii - retrospective cohort studies.

The study will analyse data collected routinely in the NHS over a period of 8 years. The study will describe the care that has been provided in England to patients with severe pressure ulcers, the kinds of patients who have been treated in different ways and examine how care is different in different places. To inform whether surgical treatments should be more widely available, the study will identify patients who were similar when admitted to hospital with a severe pressure ulcer and compare health outcomes (such as going back to hospital and death) among those who did and did not have surgery.

The data requested from NHS Digital will be used alongside data from Clinical Practice Research Datalink (CPRD) GOLD. CPRD GOLD provides Primary Care data collated from General Practitioners across the UK. This data will provide a valuable insight to Primary care provisions for patients with pressure sores in addition to the Hospital Episode Statistics and mortality data provided by NHS Digital.

The CPRD GOLD data will not be linked with NHS Digital data in any way. CPRD GOLD data is fully anonymised and therefore the study team would have no way to link this data with the pseudonymised HES data.

In order to identify patients who have received hospital care for pressure sores, the data controllers request that a cohort is created by NHS Digital. The study team have undertaken preliminary work to determine which clinical codes are used to identify an admission with a severe pressure ulcer. The study requires that a cohort be created including adult patients in England for the period 01/04/2011-31/03/2019 with an index admission with one or more ICD-10 codes relating to full skin thickness pressure ulcers - codes L89.2, L89.3 and L89.9 (used after 01/04/2012) and prior to this date code L89.X. These codes have been selected to ensure that we only request the data that we are going to analyse within the study

These index admissions are identified from the HES APC data set. The study then requests that these identified patients (the “cohort”) are linked to all HES APC and HES OP data, and Civil Registration (deaths) data for the period 01/04/2011 to 31/03/2019.

Only pseudonymised data is requested. This record level data will allow the study to understand pathways taken by
patients with severe pressure ulcers through the hospital system, including pathways which end in patient death. Data for all of England is required as the number of surgical reconstructions undertaken for severe pressure ulcers in England is very small, and a large geographical spread should allow the study to pick up as many reconstructions as possible. This also justifies the number of years of data requested, coupled with the expectation that patients with pressure ulcers are
generally unwell and are anticipated to have numerous episodes of contact with healthcare providers. The data requested under this agreement is only that required to describe the patients with a diagnosis of severe pressure ulcer on hospital admission, their care pathways after admission and frequencies of health outcomes.

University of Bristol - who are the host organisation for the Chief Investigator and Clinical Trials Unit (CTU) - determine ‘why’ and ‘how’ the personal data under this agreement will be processed. University of Manchester host the co-Chief Investigator for the study and are responsible for making decisions regarding how the data are processed. For this reason, University of Bristol, Manchester University NHS Foundation Trust and University of Manchester will be Data Controllers for the purpose of this agreement.

Only University of Bristol will process data under this agreement. The Clinical Trials Unit (CTU) for this study is the Bristol Trials Centre, Clinical Trials and Evaluation Unit, this CTU is part of the University of Bristol. CTU staff are based on University Hospitals Bristol NHS Foundation Trust property, however all processing activities will be undertaken on University of Bristol computers. Staff responsible for processing the data will hold honorary contracts with University Hospitals Bristol NHS Foundation Trust, and substantive contracts with the University of Bristol. As such, University of Bristol is the only organisation which processes personal data on behalf of the Data Controllers.

Other named study collaborators on the collaboration agreement will not have a role as either data controller or data processor - their role in the study is as co-applicant and these organisations are represented on the study management group. University Hospitals Bristol NHS Foundation Trust, University of Leeds and University of Oxford will have no control or influence over the data under this Agreement and will have no access to any data. These applicants were involved in the design of the study but will not be involved in data processing or directly determine how personal data should be processed. University Hospitals Bristol NHS Foundation Trust have an additional role in the study as they hold the funds for the study and will be the organisation invoiced for this application.

The SIPS study has been funded by the NIHR under the NIHR Health Technology Assessment award, which commenced in November 2019. The funder does not make any decisions regarding the data requested under this agreement.

Data is being processed under Article 6(1)(e) and Article 9(2)(j) as a task in the public interest, as part of an NIHR funded ethically approved clinical trial. All data will be pseudonymised.

The alternative to using routine data sources would be to undertake a prospective study of patients with severe pressure ulcers undergoing reconstructive surgery. However, it would be challenging to recruit a sizeable cohort and results would take many years. A retrospective study will allow analysis of a large sample and for the study aims to be addressed more quickly and cost-effectively.

Expected Benefits:

The data will be used to undertake a retrospective cohort study to collect information on care pathways for patients with severe pressure ulcers, and to compare patient outcomes in patient who do/do not have reconstructive surgery.

There is a dearth of research in this field, and this will be a valuable source of information relating to the treatment of severe pressure ulcers. This study is part of a wide project which aims to provide a package of research to enable the design of a randomised controlled trial of reconstructive surgery for severe pressure ulcers. Surgical reconstruction of pressure ulcers is rarely carried out in the UK and the impact of major surgery on people with severe ulcers has not been investigated in detail. There is also very limited information about how surgical reconstruction impacts on health-related quality of life. This is an important area of research as severe pressure ulcers have a significant chronicity and cause serious problems for patients, their carers and the NHS. The research is also important because of uncertainty about the patients in whom reconstructive surgery to repair a pressure ulcer is effective in the short, medium and long-term, and the surgical techniques that should be used. Preliminary analyses showed that, over a 2-year period, over 81,000 patients in England had an index hospital admission for a severe pressure ulcer.

The study funder - the NIHR - originally asked for a randomised controlled trial of surgical management of severe pressure ulcers. However, the study team found that there was no sufficient data to be able to define the populations, interventions and comparators of interest. The aim of the SIPS study is to describe and define those parameters, and through consensus meetings provide guidance on the parameters of most importance to patients and healthcare professionals. The outputs of this study will be used to inform a consensus process of healthcare professionals and patients, which will ultimately lead to the creation of a series of recommendations about which treatments are appropriate for whom and when. These recommendations will be published by the study team at the University of Bristol and other study co-applicants, and will act as the basis for the design of a randomised controlled trial. The consensus process is one of the study workstreams and a key output. The Study's Personal and Public Involvement (PPI) co-applicant is working to bring together a group of patient representatives and the study team are also in contact with various patient organisations. Surgeons and nurses who complete the study surveys will be invited to leave their contact information if they are interested to participate in the consensus meeting.

The results of the SIPS study will be written up by October 2021, and it is anticipated by the study team that this evidence would inform policy makers shortly after this. The aim is for the results to inform the design of a randomised controlled trial, which would be undertaken in the following years.

This study is not related to a PhD/post graduate research study.

Outputs:

The study team will report findings at conferences and in high-impact, peer-reviewed journals, such as The Lancet or British Medical Journal (BMJ). The study team will also produce a final report for the funder (NIHR) in October 2021. Outputs will report aggregate data with small numbers suppressed, as per NHS Digital's HES Analysis Guide.

Findings will be reported to NHS England’s National Wound Care Strategy, which will provide a key avenue to communicate findings. The findings will have an impact on clinical practice through engagement with professional bodies; the study team have strong links with relevant organisations including the Tissue Viability Society and NICE.

The study team will draft media-friendly articles for relevant trade journals such as the Nursing Times and Nursing Standard. They will summarise the work using widely-accessed, research-focused resources such as The Conversation and Kudos. The study team will also contact the NIHR Dissemination Centre to ask for advice where there are specific findings they wish to publicise. Publications will be supported by targeted social media activity, especially through Twitter, using a study specific account as well as currently running accounts that link to a wide range of relevant stakeholder groups to ensure widespread dissemination. Where required, press releases and media support will be provided.

With respect to dissemination of findings to patients and their carers, The SIPS study team will ensure members of the Patient and Public Involvement forum are actively involved in carrying out activities relating to dissemination and public engagement. Opportunities such as talks to local groups and other events will be considered on a case by case basis.

A lay summary of the research and its findings will be written and added to the University of Bristol websites and relevant blogs. The study team also have close links with local Trusts and will aim to distribute the lay summary locally at relevant patient events in addition to online content. To support further engagement work, the study team will liaise with experienced colleagues at the NIHR Manchester Biomedical Research Centre and Public Programmes at Manchester University NHS Foundation Trust to undertake a range of engagement activities at public events including the Manchester Science Festival. These activities will raise the profile of pressure ulcers and research to improve their management. The study team will link with existing networks at the University of Manchester to ensure their findings are presented locally to both academics, clinicians and members of the public, for example the Manchester Institute for Collaborative Research on Ageing, seminars for which are regularly well attended by each of these groups.

Patient and public involvement will be encompassed in all steps of the study.

Dissemination to participants is not relevant for this study, as there is no active patient involvement.

Processing:

This study does not require any flow of data to NHS Digital. NHS Digital will create a cohort using index admissions and then linked to HES APC, OP and mortality data. The study requests that the cohort created by NHS Digital is linked to HES APC and OP data for the preceding 12 months and to HES APC, OP and mortality data from the point of index admission to 31/03/2019. This pseudonymised linked cohort will then flow from NHS Digital to the study team at the University of Bristol. There will be no further flow of data. This linked cohort will include personal data, including health data. However, all outputs will be pseudonymised. Only the University of Bristol will process the data under this agreement.

The data provided by NHS Digital will be processed at the University of Bristol in order to;
- describe the patients with a diagnosis of severe pressure ulcer on hospital admission,
- describe their care pathways after admission and
- determine the frequencies of health outcomes including death.

Processing will also take place in order to compare health outcomes in matched groups of patients who were similar on admission and who did/did not have a surgical reconstruction operation. This will include a comparison of mortality rates.

METHOD
1) NHS Digital will create a cohort by identifying participants which meet the criteria provided by the study (relevant ICD-10 codes)

2) NHS Digital will link cohort to HES Outpatients, HES Admitted Patient Care and Civil Registrations (Deaths) data for the period April 1st 2011 - March 31st 2019

3) Within this period, only data 12 months prior to a participant's index admission date and subsequent data up until March 31st 2019 will be provided.

At no point will identifiable information be provided to NHS Digital by the University of Bristol, or by NHS Digital to the University of Bristol.

DATA MINIMISATION
The data sets, episodes and fields requested are those required to complete analyses for this NIHR funded study. Mortality data is required for completeness of patient pathways. Only relevant data fields for the study have been chosen (for example, no items from the sections on Maternity, Neo-natal Mortality, or Psychiatric)

- The study requires data for the specific time period between April 1st 2011 - March 31st 2019, however, only data 12 months prior to a participant's index admission date and subsequent data up until March 31st 2019 is requested and will be provided by NHS Digital.
- only those patients 18 years and over
- only those patients treated in hospitals in England.
- Only those patients with the ICD-10 codes: L89.2, L89.3 and L89.9 (used after 01/04/2012) and prior to this date code L89.X for any full skin thickness pressure ulcer.

All data will be pseudonymised and no attempt will be made to re-identify patients. The data received by the University of Bristol will not be used for any purpose other than to meet objectives as stated in this Data Sharing Agreement and will not be shared with any other third party or organisation.

In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, you must make sure that:
· cell values from 1 to 7 are suppressed at a local level to prevent possible identification of individuals from small counts within the table.
· Zeros (0) do not need to be suppressed.
· All other counts will be rounded to the nearest 5.
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.

Staff responsible for processing will hold honorary contracts with University Hospitals Bristol NHS Foundation Trust, and substantive contracts with the University of Bristol. HES and mortality data will be stored on University of Bristol managed servers and will only be accessible by authorised users with system access permissions. Some University of Bristol's servers are located on University Hospitals Bristol NHS Foundation Trust premises, but University Hospitals Bristol NHS Foundation Trust employees have no access to this data.

Data will not be accessed remotely. Data will be downloaded directly from NHS Digital's Secure Electronic File Transfer (SEFT) service to a University of Bristol Safe-Haven folder. Access to this folder is restricted to specific users, with access logs kept for 12 months and data encrypted at rest on the server.

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). Mortality data Terms and Conditions will be adhered to.

Evaluation of alcohol health champions programme in Greater Manchester — DARS-NIC-268750-B3T4W

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(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 2020-03-23 — 2022-03-22 2021.06 — 2021.06. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Accident and Emergency
  2. Hospital Episode Statistics Accident and Emergency (HES A and E)

Expected Benefits:

The dissemination of A&E attendances data is anticipated to be in the public interest as well as to benefit the provision of health care and the promotion of health through impacts on the NHS, by reducing the number of A&E attendances, should the intervention be shown to be effective.

The stated purpose of this data request is to measure effectiveness of the CICA programme in terms of to reducing A&E attendances in the Greater Manchester area. The expected outputs from this research will be based directly on results of statistical analyses of time trend A&E attendances data. Expected outputs from this research include: an intervention manual to give insight into the context of successful delivery; journal articles, presentations at conferences (locally, nationally and internationally); and a model for further development of the CICA programme (Communities In Charge of Alcohol) that will likely be of considerable interest across the UK and internationally.

The primary benefit of performing statistical analyses of A&E attendances data using the data under this Agreement is analysing the effectiveness of the CICA programme. Other outcomes examined by the wider project (not part of this data request) will be impacts of CICA on reducing ambulance call-outs, alcohol-related hospital admissions, and crimes such as anti-social behaviours fuelled by alcohol use. Measurements used in these analyses include statistical analyses such as panel data analyses, mixed models, and growth curve analysis. Statistical analyses are anticipated for completion in June 2021. These benefits are part of Work Package 2 of the wider evaluation project.

The comprehensive evaluation of the CICA programme also includes 2 additional independent work-packages that are not part of this data request application. Work package 1 is a process evaluation which will provide understanding of the particular components of the intervention that has been effective or ineffective. Work package 3 is an economic evaluation will enable policy makers locally and nationally to appraise the cost effectiveness of the CICA project, which will influence future commissioning decisions.

The magnitude of the impact of the CICA programme will be measured as part of all work packages previously mentioned – in terms of reductions in alcohol harms (A&E attendances, ambulance call-outs, hospital admissions, and crimes), cost-effectiveness of the intervention program, and effectiveness of the process of delivering the program itself. Results of statistical, economic, and process evaluation analyses will be shared to the public, stakeholders, government, and researchers, to enable future interventions to be more effective by having a greater understanding of the key facilitators and challenges to alcohol reduction interventions, and how these are impacted by dose, reach, and alcohol culture.

The University of Bristol hope that the dissemination of results of CICA project will foster a sense of community engagement through engaging the community in a common purpose, empowering them to address the availability of alcohol in the local environment. In this regard, recent NICE guidance on ‘community engagement: improving health and wellbeing and reducing health inequalities’ has highlighted that ensuring that ‘local communities, community and voluntary sector organisations and statutory services work together to plan, design, develop, deliver and evaluate health and wellbeing initiatives’ is an overarching principle of good practice.

Additional benefit will be the training of 350 AHCs to level 2 Award ‘Understanding Alcohol Misuse’ delivered by the Royal Society for Public Health. The individuals involved may benefit from increased skills, confidence and employability.

Outputs:

“Results” of the data processing are planned to be included in project outputs such as reports, submissions to peer reviewed journals, presentations, and conferences specifically refer to results of the statistical analyses such as Odds Ratios, regression coefficients, standard errors, confidence intervals. p-values, descriptive statistics (percentages, standard deviations, total numbers). Expected outputs will not contain raw data received from NHS Digital. If total numbers are displayed in any outputs, small numbers of <7will be suppressed in line with the HES Analysis Guide. It is anticipated that all outputs described below that contain main results of the statistical analyses will be published in early 2022, whereas target publication date for outputs that contain preliminary findings is 2021.


Specific outputs expected include:
1. A report that includes the results of statistical analyses will be submitted for publication in key journals such as BMJ, Journal of Epidemiology and Community Health, Public Health with open access (as required by NIHR funding conditions) and peer-review, as well as made available via NIHR PHR Journal (and associated websites).

2. Presentations, report briefs, and newsletters that include results of statistical analyses are planned through the following channels:
a. The Royal Society of Public Health (RSPH) will prepare newsletters to Health Champions/wider workforce and publicise findings in its journal Perspectives in Health and to the Membership of RSPH. The RSPH networks with cross-Government departments, the UK Public Health National Advisory Group, Department of Health and Health Education England.
b. University of Bristol PI (Work Package 2 Leader) as a member of the NIHR School for Public Health package on alcohol-related harms.
c. Project Co-PI will make use of Local Government Association networks and the communications departments of the Association of Directors of Public Health.
d. Project Collaborator, through Greater Manchester Combined Authority Reform Research, will disseminate to the Office of the Police and Crime Commissioner, Public Protection Managers and Elected Members.
e. National conferences (e.g. Public Health England Conference) allow for direct dissemination of the results of statistical analyses to public health practitioners. Key conferences (Kettil Bruun Society-Social and Epidemiological Research on Alcohol: Annual Conference and the European Public Health Conference) will be used to promote the results of statistical analyses to an international audience.

3. Media outputs
a. The study results are planned to be disseminated through social media and Twitter, e.g. university, RSPH and Public Health Matters Websites, Facebook and Linkedin Networks. The strong links between Salford University and MediaCityUK increase potential for media coverage and research team members are accustomed to appearing on regional and national television and liaising with the press. Press days will be organised to facilitate this.

Processing:

The University of Bristol will not flow any data into NHS Digital.

The University of Bristol requires routinely collected aggregated HES Accident & Emergency data with small numbers unsuppressed.

The University of Bristol requires two tabulations (i.e. aggregated data). The first tabulation will provide a count of Accident and Emergency attendances taking place between 2010/11 – 2019/20 latest available, where the patients’ home postcode was in England. Records are to be grouped by Local Authority Code, LSOA and month. There will be sub-sets of the data based on the day and time of admission, as well as reference information relating to the LSOAs. The second tabulation will provide data from 2019/20 latest available to May 2020.

NHS Digital will flow these data to the University of Bristol. This flow of data out of NHS Digital will not contain any personal record level data or identifying information.

The data will be stored in the University of Bristol servers. Within the University of Bristol servers, only two people will have access to the data, the Work Package 2 lead and co-lead. Statistical analyses and management of data will be conducted using Stata 15 and R statistical software. Statistical analyses will be conducted at the LSOA level. There will be no flows of the data under this Agreement out of the University of Bristol and the data will not be made available to any third parties. Data management includes procedures like recoding missing data, creating variables such as seasons (winter, spring, summer, and autumn), total episodes starting on weekdays (defined as Monday to Friday 9am to 5pm) or weekends (defined as Friday 3pm to Sunday 3pm), and reformatting the month and year variables into numeric variables.

The University of Bristol will not link any NHS Digital data to other tabulated data specifically requested from NWAS and the Greater Manchester Police for the purpose of this study. Data requested from NHS Digital may be matched, at the LSOA level, to data requested from PHE (which is the monthly sums of alcohol-attributable fractions (AAF) that PHE assigned to hospital admissions data) for 2016 only. These AAF sums do not represent any individual hospital admissions and do not contain numbers of people so there is no risk of any identification of individuals. The WP2 lead and co-lead confirm that there will be no requirement nor attempts to re-identify individuals.

Once the A&E data have been received, the University of Bristol Lead and Co-lead will first perform statistical analyses on the trends in A&E attendances (counts and/or rates of attendances) over time in LSOAs in Greater Manchester where the CICA intervention programme was conducted. The University of Bristol Lead and Co-lead will also select 1-3 LSOAs that are similar to the CICA (intervention) LSOAs in terms of population size, deprivation, average age, sums of alcohol-attributable fractions applied to hospital admissions by PHE and crime rates. The population size, deprivation, average age, and crime rates data is available as part of the A&E attendances dataset. The University of Bristol Lead and Co-lead will conduct statistical analyses comparing trends in A&E attendances in the CICA (intervention) LSOAs with similar LSOAs in Greater Manchester as well as in England (outside of Greater Manchester). From the results of the statistical analyses, figures and tables will be produced. Tables would contain results of the statistical analyses such as regression coefficients and statistical significance values. Figures and tables produced will not contain actual counts of A&E attendances and/or rates but may contain average numbers or percentages of A&E attendances and/or rates of A&E attendances. In the unlikely event that counts are displayed, the University of Bristol will take further precaution of suppressing small numbers according to NHS Digital suppression policy where any counts <5 will be displayed as an asterisk and any counts >8 will be rounded to the nearest 5.

Data processing will be carried out by the WP2 lead and co-lead who are employed by the University of Bristol and have completed mandatory training in data protection and confidentiality described below:
“The University has created two mandatory online training modules covering data protection (specifically the General Data Protection Regulation - GDPR) and information security, and all members of staff and research postgraduates must complete this training as part of induction and the annual review process.”

All data will be stored in a folder located on a secure server at the University of Bristol's Data Centres. This network folder will be created by the University of Bristol IT Services. Access to this folder will be limited to the WP2 lead and co-lead. Logins to this folder would require using the Leader and Co-Leader’s University of Bristol usernames and passwords. This folder will be encrypted at rest and between server and computer using AES-256 standard, accessible only from Windows managed desktops, and controlled by IP address. This folder is compliant with 14-day Data Destruction Notice and NHS Digital DSPT. Access logs are kept for 12 months and audit reports are available monthly on an on-demand basis.

Servers that provide the system hosting are located in secure data centres within the University of Bristol estate, at the Computer Centre, Tyndall Avenue, Bristol BS8 1UD and their co-location data centre in Slough.

The building at the University of Bristol is protected by secure automatic locking doors, requiring appropriate University Card (MiFare2) and biometric second factor controlled access to enter (for limited authorised personnel only) and are monitored by CCTV by University security services. Locations have appropriate intruder alarm and fire detection systems.

The University of Bristol offsite data centre is located in Slough and is run by Virtus.

To gain access to the Virtus site one needs to pass at least two locked turnstile gates through a buzzer and video system linked to the security desk. Once at security one needs to reference a previously created access ticket and show photo ID to gain access to the general site.

The pass gives access only to the data hall within which the University of Bristol equipment is hosted. Access is gained through an “air lock” secure door system where one door will only open after the first door has been shut. Visitor access can only be gained if a ticket is created in advance and the visitor is accompanied by a holder of the photo ID pass issued by Virtus.

Once inside the data hall, the University of Bristol equipment is located within a containment shared with one other University. This containment is locked at either end and surrounds the racks on all sides.

The racks themselves are locked by a combination lock backed up by a key lock which can only be overridden with the correct key. The code and physical locks are specific to three groups of rack: network, business systems and specialist research equipment. The combination or key for one type of rack will not provide access to the other types of rack.

Access controls:
-The photo ID will only be issued after completing an induction with the Virtus security team.
-Induction is only available to individuals named on the Master Access List (MAL) which is password controlled and governed by two named individuals within IT Services.
-Access is further controlled through lists of individuals named on each contract for each of three groups of equipment.
-Virtus do not routinely access the area used by the University of Bristol though reserve the right to should exceptional circumstances arise.

Psychiatric co-morbidity in Autism: Using a UK-based population-based study to assess the burden of psychiatric comorbidity in individuals with Autism and understand the environmental factors associated with poorer mental health outcomes. — DARS-NIC-402975-T8R3T

Type of data: information not disclosed for TRE projects

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

Legal basis: 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 2021-03-11 — 2022-03-10 2021.03 — 2021.05. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Adult Psychiatric Morbidity Survey
  2. Adult Psychiatric Morbidity Survey (APMS)

Objectives:

The University of Bristol (UoB) requires the Adult Psychiatric Morbidity Survey (APMS) data to investigate the level of Psychiatric comorbidity for people with Autism living in the UK.

Autism spectrum disorders are characterised by early-onset difficulties in social interaction, communication and restricted, repetitive patterns of interests and behaviour. Autism is now thought to affect at least 1% of the population although estimates of prevalence have increased over the last two decades. Yet there is still limited understanding of the adult outcomes of these conditions. The largest currently available population-based studies have found higher rates of anxiety disorders and psychosis in individuals with autism. However, these studies rely on registers of individuals who have received a diagnosis. The Adult Psychiatric Morbidity Survey (APMS) is a representative sample of the whole population and used the abbreviated Autism Quotient (AQ20), a structured questionnaire designed to capture signs of ASD in adult participants; and the Autism Diagnostic Observation Schedule (ADOS) scores, a standard measure of social and communication deficits associated with the spectrum of autism. The survey also included responses from those such as older adults, who may have not been given an autism diagnosis due to limitations on diagnostic facilities for adults, but who were able to be assessed for autistic traits. Psychiatric comorbidity in autism is associated with worse outcomes for individuals and a greater burden for their families and society. Understanding the psychiatric comorbidities which affect adults with autism is therefore essential to the planning of community services and optimising quality of life.

The data will be processed in line with EU GDPR Article 6 (1e) “for the performance of a task carried out in the public interest” and EU GDPR Article 9 (2j) “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1)”. Rates of autism have risen significantly over the last decade, and while this increase may have resulted from widening diagnostic criteria or increased awareness, a true increase in prevalence cannot be ruled out and a greater number of adults are now living with autism than ever before. People with autism have higher rates of premature mortality. Psychosocial adversities are known to be associated with mental illness and have been reported in Autism but have not been adequately investigated in population‐based studies. Understanding these will help to identify modifiable risk factors to prevent the development of mental illness in this population. Participants have freely participated in the Adult Psychiatric Morbidity Survey (APMS) and were aware that their data would be used for research purposes. At the time of recruitment, they consented to this. All APMS 2014 data is pseudonymised, protecting the identities of participants.

Using the APMS data, the University of Bristol will assess the relative risk of someone with either an autism diagnosis or autistic traits developing an anxiety disorder, depression, psychosis or experiencing self-harm or suicidality compared with the general population. the University of Bristol will also consider the risks in the presence or absence of learning disability. Autism diagnoses and autistic traits are measured in the survey using self-reported data and a semi-structured assessment carried out by a clinically trained research interviewer (AQ20 and ADOS scores). In a secondary analysis using the APMS survey data the University of Bristol will estimate the respective risk of having several adverse life events for people with autism and autistic traits compared with the general population. Anxiety disorders and psychosis have been found to be significantly raised in population-based studies of autism in Sweden in data published this year with particularly high rates in individuals without comorbid learning disabilities (8, 10), however this work has not been replicated using a large UK data-set and the 2014 APMS will allow the measures of psychosocial stressors to be examined and their association with psychiatric comorbidity to be assessed. If the numbers of individuals with Autism in the 2014 dataset are low, then the dataset will be combined with the 2007 dataset which this project group has access to.

This research will be undertaken as part of an Academic Clinical Fellowship studying the mental wellbeing of adults with autism and identifying the psychosocial factors associated with psychiatric comorbidity.

The data subjects for this study are UK residents aged over 16 years living in private households who have completed the APMS survey. There is no control group. The level of data required is pseudonymised and there will be no further data linkage and no attempt to identify individuals. The full dataset is to allow for control of the confounding factors. There is no requirement for there to be geographical spread of the data. When the UK data service give the dataset, they provide the whole dataset as there is no facility to select individual variables. The UK data service holds the data on behalf of NHS digital and once access it granted by NHS digital, the data will be provided from the UK data service. The data will not be linked to any other dataset. No data will be shared with third parties. The data is requested for 12 months to allow time for submission to academic journals and revision of data at the request of peer reviewers.

The University of Bristol is the sole Data Controller who also process data.

NIHR School for Public Health Research are funding the Academic Clinical Fellowship for which this research project is being conducted. NIHR will only get notified of an publication output and do not request or require any data before that. NIHR does not control the scope or conduct of the research work. The university of Bristol will also be hosting the data on their safe haven file storage. For all of these reasons the university of Bristol will be the only data controller on this agreement.

Expected Benefits:

This data will be able to support clinicians working with people with Autism. Research from Swedish cohort data suggests that individuals with Autism have a greater degree of psychiatric comorbidity, however this has not been replicated in a large cross-sectional study using data from the UK.

1) Outcomes of this project will demonstrate the need for improved training for recognising psychiatric comorbidity in Autism and the need for staff working in mental health services to be equipped with skills enabling them to work effectively with people with Autism; and
2) If sociodemographic factors are found to be associated with the development of psychiatric comorbidity then this will enable evidence driven prevention and reduction of risks.

It is estimated that the lifetime financial cost of supporting an individual with autism is £1.5 million for someone who also has intellectual disability and £0.92 million for someone without intellectual disability. £21797 a year is estimated to be lost in productivity loss for individuals with Autism without intellectual disability and improving mental health outcomes will improve overall morbidity and increase opportunities for participation and employment for people with autism. Results will be submitted for presentation at the Royal College of Psychiatry Southwest division biannual conference in Spring 2021. The research paper will be submitted to an academic peer-reviewed journal specialising in psychiatry or neurodevelopmental disorders, such as the Journal of Autistic and Developmental disorders in August 2021. We will work with the University of Bristol’s open access team to allow open access to any publication, where possible, to increase dissemination of research outputs. We will work closely with the autistic community via the UK’s national autism research charity, Autistica to enable further dissemination of results to people with autism.

Recommendations to clinicians will include actions relating to the assessment of autism in individuals presenting with mental health problems and to guide policy for training mental health staff in working with people with autism. This research will guide future projects by the data controller which will consider how to adapt and tailor treatments and advice for individuals with autism. It will also identify modifying risk factors for the development of mental health problems in individuals with autism. The need for the NHS to “improve its understanding of the needs of people with learning disabilities and autism, and work together to improve their health and wellbeing” was highlighted in the 2019 “NHS Long Term Plan” and the results of this project will help to address this. Where it highlights that needs are not being met, this information will be key to informing decisions about resource allocation and the design and targeting of interventions and services. This project aims for results to be submitted to an academic journal by August 2021 and made available for clinicians, people with autism and their family and carers shortly after this.

Outputs:

The research will provide outputs to support secondary services and to autism awareness, screening and guidance for working with people with autism. Also, the outputs will provide support for professionals working with people presenting with psychiatric illness, if it is found that higher rates of psychiatric illness is present in people with autism. Secondly, the outputs will provide evidence to support research into interventions to treat psychiatric illness for people with autism. Thirdly, the outputs will identify psychosocial associations which may enable preventative strategies for the development of psychiatric illness in people with autism.

The reports will only include figures based on aggregated data. Results will be submitted for presentation at the Royal College of Psychiatry Southwest division biannual conference in Spring 2021. The research paper will be submitted to an academic peer-reviewed journal specialising in psychiatry or neurodevelopmental disorders, such as the Journal of Autistic and Developmental disorders in August 2021. Results will also be broadcast through Twitter (https://twitter.com/NimmoDr). If outputs are of public health interest, information will also be made available for local community mental health teams to advise regarding the importance of screening for or recognising autism in individuals presenting with mental health problems. The results, if substantial, will allow the formation of protocols for future research into treating anxiety disorders in adults with autism.

Outputs to be included in the peer-review journal is expected to be submitted by August 2021. The expected date for presenting at a conference is May 2021. Any paper or poster submitted for publication or review will involve acknowledgement of and review by the original authors of APMS 2014. Where possible, research outputs will be published to open access journals. The University of Bristol has an open access team to allow open access for a publication, where possible, to increase dissemination of research outputs.

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement.

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 i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

This request is for the APMS 2014 dataset. Once this agreement is active the actual flow of data will be from the UK Data Service (UKDS) who are the data processors on behalf of NHS Digital. UKDS will grant system access to pseudonymised APMS data to the University of Bristol. There will be no subsequent flows of data, for example, there will be no identifying or linking to other healthcare data.

Data will be stored and upheld in line with the University of Bristol’s Data Security and Protection policy. It will be marked as highly confidential and only be accessed by the principal research team through the University of Bristol Safe Haven source. The Safe Haven source is Encrypted at rest on the server, accessed only by a controlled username, has access logs kept for audit reports and is not backed up, to comply with data destruction notices. The principal research team consist of an Academic Clinical Fellow, a PhD student and senior researchers (including a senior clinical lecturer). All are employees of or honorary members of staff with contracts at the University of Bristol. The honorary member of staff has undergone data protection training with the University of Bristol and with the employing NHS Trust (Avon and Wiltshire NHS trust). The employment contract with the NHS trust states that the member of staff must abide by data protection regulations as a term of their service. A copy of the honorary contract with the University of Bristol has been provided to NHS Digital.

Logistic regression will be carried out on the data for the main statistical analyses. All statistical testing will be conducted using Stata version 15. All files, including coding instructions, will be deleted upon conclusion of this agreement.

All APMS participants data will be included in the research. No linkage to other sources will be conducted and so there will be no requirement or attempt to re-identify individuals. APMS Data are pseudonymised.

The 2014 APMS dataset (English adult population (aged 16 and over) is held on behalf of NHS Digital by the UK Data Service (UKDS) (www.ukdataservice.ac.uk ) and UKDS are responsible for dissemination under direction by NHS Digital. The University of Bristol will receive the full dataset; there is no facility to select individual variables.

The University of Bristol will be able to download the dataset from UKDS for the period specific within the data sharing agreement (DSA) and they must securely destroy all local copies of the dataset when the DSA expires and notify the Data Access Request Service (DARS) in line with standard procedures.

Learning Disabilities Mortality Review Programme - ONS mortality data link — DARS-NIC-121996-T2R7B

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7), National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(2)(b)(ii); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2019-05-10 — 2020-05-09 2019.06 — 2021.03. breached contract — audit report.

Access method: One-Off, Ongoing

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

Sublicensing allowed: No

Datasets:

  1. Civil Registration - Deaths
  2. Civil Registration (Deaths) - Secondary Care Cut
  3. Civil Registrations of Death - Secondary Care Cut

Objectives:

The overall purpose of the application was to link data about people with learning disabilities who have died, with mortality data, to identify the exact cause of death of people with learning disabilities in England.

Analysis of Medical Certificates of Cause of Death (MCCD) is important for monitoring the health of the population, designing and evaluating public health interventions, recognising priorities for medical research and health services, planning health services, and assessing the effectiveness of those services. However, at present, you cannot identify people with learning disabilities from analyses of MCCD or population level vital statistics, so there is little information about causes of death at population level in relation to people with learning disabilities, nor of ways in which services should be prioritised in relation to avoiding premature mortality in this population group.

Since the 1990s there have been a number of reports and case studies that have consistently highlighted that in England people with learning disabilities die younger than people without learning disabilities. Recent calculations by Public Health England using data drawn from the Clinical Practice Research Database indicates that the Standardised Mortality Ratio for people with learning disabilities in England as a whole is approximately three times that of people with no learning disabilities. Some research evidence about causes of deaths also exists (for example from the Confidential Inquiry into premature deaths of people with learning disabilities (2013)), but none drawn from national data.

Such is the concern about premature deaths of people with learning disabilities, and the lack of robust data about their patterns of mortality, NHS England has funded the national Learning Disabilities Mortality Review (LeDeR) programme until the end of May 2020. The University of Bristol submitted a tender for the work, and was awarded the contract in May 2015.

The programme is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England. The data controller is the Healthcare Quality Improvement Partnership (HQIP). A contract is in place between HQIP and the University of Bristol who process the data for the purpose of this study. No other organisations process the data for this purpose.

Processing of data referred to in this application relates to people who are already known to be deceased therefore GDPR does not apply.

A key part of the LeDeR Programme is to support local areas to review the deaths of people with learning disabilities. The programme is developing and rolling out a review process for the deaths of people with learning disabilities, helping to promote and implement the new review process, and providing support to local areas to take forward the lessons learned in the reviews in order to make improvements to service provision. The LeDeR Programme will also collate and share the pseudonymised information about the deaths of people with learning disabilities so that common themes, learning points and recommendations can be identified and taken forward into policy and practice improvements.

The programme team successfully delivered the Confidential Enquiry into premature deaths of people with learning disabilities (CIPOLD) from 2010-2013, funded by the Department of Health. During this time, the University of Bristol obtained mortality data including coding for all causes of death. It was found from undertaking CIPOLD and work to-date with the LeDeR programme that although local reviews identify the cause of the death of the individual, the ICD-10 coding for these causes of death as reported by ONS in mortality statistics is required to be sure of accurately reporting nationally and internationally comparable causes of death in this population. For example, some local reviews of deaths will simply report that a person died of pneumonia, but the ICD-10 code would be required for the pneumonia to be able to identify if this was an infectious or aspiration pneumonia.

The full coding for cause of deaths (rather than just the underlying cause of death) is required for processing because of two pressing reasons:

1. Possible inconsistencies in reporting causes of deaths for people with learning disabilities. As an example, during work on CIPOLD, it was found that some deaths of people with Down's Syndrome who had Alzheimers dementia to be coded as 1a. Dementia 1b. Down Syndrome (no Part 2 recorded). However, in other cases a similar set of circumstances leading to death was coded as 1a. Dementia Part 2 Down Syndrome. If the coding only was provided for underlying causes of death important evidence would be missed in the understanding of the extent of dementia in people with Down Syndrome. It is essential that data is linked to personal identifiers for this, so that the cause of death reported by reviewers can be assessed against the causes of death coded in ICD-10 descriptors.

2. A significant proportion of people with learning disabilities die with conditions that are not their underlying cause of death, for example pneumonia. Pathways to the immediate cause of death from the underlying cause of death are needed to assess whether there are any service improvements that can be made for this population that would affect this pathway. It is essential that data is linked to personal identifiers for this, so that the circumstances leading to death at individual as well as group levels can be assessed.

The number of people with learning disabilities who die each year is small, approximately 3,000 each year in England. When these deaths are sub-divided into ICD-10 chapters and sub-sections, the numbers become smaller still. Data is required over a number of years to have robust, large scale data to be able to draw accurate conclusions. The feasibility of selecting a reduced number of geographical areas to represent the nation rather than requesting national data was considered but was ruled out this approach because it would effect the validity of the findings. At present it is suspected that there may be pockets of particular causes of death (e.g. deaths related to epilepsy) in particular geographical regions according to the characteristics of those living there and the support and services available to them. It would be important to understand regional variation to guide local service improvement initiatives. Without using national data, it is not possible to guarantee that the reduced data select are accurately representative of England and without this certainty, the analysis would be weakened and the findings less credible. Given the potential impact of the findings on NHS policy and the provision of services to people with learning disabilities, it is essential to minimise uncertainty.

The applicant will not link the data in this application other than where specified within the scope of this application.

This is important, because if recommending service improvements (such as early diagnosis, or improvements in national cancer screening programmes) in relation to common causes of death of people with learning disabilities, there is a need to have a robust evidence base upon which to base recommendations.

The only way that the causes of death of people with learning disabilities can be accurately obtained, is to link the cause of death data with a list of known decedents with learning disabilities - as the LeDeR programme provides. There are no other alternative, less intrusive ways of achieving this purpose.

All efforts have been taken to minimise the data flowed to NHS Digital.

Yielded Benefits:

NHS England has now established a 'Learning into Action' group at national level to the address key findings from LeDeR. Separate workstreams are taking actions in relation to sepsis; adherence to the Mental Capacity Act; recognising deterioration in a person with learning disabilities, and constipation. A national conference was held in March 2019 to share the early work. At local level, significant work is being undertaken to address problems with care locally. Many of these have been reported in the 2018 annual report so that they can be shared across the health and care sector. In addition, a 2-monthly bulletin is produced for health and social care providers that shares examples of positive practice, and offers a briefing paper to frontline carers about a specific topic.These are also available on the study website.

Expected Benefits:

Merely reviewing deaths and obtaining ICD-10 coding for causes of death is insufficient in itself. It is what happens to the learning and recommendations gained as a result of the reviews that is so important in being able to improve service provision for people with learning disabilities.
The benefits to health and social care will arise from
a) individual level reviews which will offer recommendations for service improvements as a result of that review of an individual's death, which may benefit others and address any potentially avoidable contributory causes to deaths in the future
b) collated information which may identify themes from across a number of reviews that local areas may wish to target (e.g. addressing rates of falls leading to deaths, or targeting deaths with ICD-10 codes for aspiration pneumonia).

The potential impact of service improvement initiatives for the 1.5 million people with learning disabilities is great. When CIPOLD was conducted a paper was published about the impact of the study (Heslop and Marriott 2015 British Journal of Learning Disabilities). Impacts were identified at individual, local, regional and national levels. At national level this work resulted in policy changes to the extension of Annual Health Checks for people with learning disabilities to those aged 14-17, an extension of GP held registers of adults with learning disabilities to all age registers, and guidance about treating people with learning disabilities as a priority group for seasonal flu vaccinations. At individual and local levels service providers focused on issues such as the early identification of illness in people with learning disabilities, and 'flagging' people with learning disabilities in healthcare systems.
In June and July 2017 a series of workshops were held across England to discuss with members of Steering Groups how they will translate the available information from mortality reviews into service improvements, how they would monitor and evaluate such initiatives, and the reporting mechanisms back to the LeDeR programme to demonstrate the effectiveness of mortality reviews in improving service provision. Benefits are already being felt in health and social care provision from the additional scrutiny that mortality reviews brings.

Outputs:

Annual report for Secretary of State (December, annually)
The Secretary of State has requested that the LeDeR programme reports directly to him on an annual basis. The annual report will contain only aggregate level data with small numbers suppressed in line with ONS Terms and Conditions. This report is high-level and would only be available to the funders (NHS England) and government.

Public-facing annual report (December, annually, with possible interim reports in final year)
A public-facing annual report will be produced each year, that will be freely available via the website. The annual and any interim reports will contain only aggregate level data. They are likely to be in the form of infographics illustrating key points, as well as charts of data, with no possibility of identifying any individuals from the data. Copies of the public-facing reports are sent to the Study's contact list of interested practitioners, professionals, family networks, advocacy groups and providers of services. In addition they are send to all of those involved in undertaking reviews of deaths of people with learning disabilities and their relevant area-based Steering Groups.

Academic and practitioner journal articles
Population-level data about causes of deaths of people with learning disabilities will be of interest to both academics and practitioners, and the data will be published in both academic (Journal of Applied Research in Intellectual Disabilities; Health and Care in the Community; Journal of Epidemiology and Community Health) and practitioner-focused (BMJ Open, Nursing Times; Community Care) journals. It is unlikely that there will be sufficient data to publish before May 2020. Again only aggregate level data, with small numbers suppressed will be published, likely to be by ICD-10 chapter and main sub-sections of each chapter relating to causes of death at different ages, and by sex.

Accessible briefing papers
The LeDeR programme puts people with learning disabilities and their families at the centre of their work, and findings would be shared with networks of people with learning disabilities and family carers, advocacy and voluntary sector organisations. This is likely to be in summer/autumn 2019 onwards once sufficiently robust data is available. All accessible briefing papers will be freely available, in paper form or downloadable on the website. They are likely to present 'headline' data only, accompanied by fully anonymised case stories to illustrate the data in a more meaningful way. All case studies would have the consent of families prior to use.

Website/social media
The study website (www.bristol.ac.uk/sps/leder) is also used to aid dissemination. Additionally LeDeR has a Twitter and facebook presence to share information.} The website will provide a link to open access papers and include free downloads of accessible briefing papers, reports and summaries of findings.

Processing:

All data transfers have now concluded and data now is being analysed. Any reference to data flows are now historic.

Data is processed in accordance with the S251 application which covers all parts of the data flow process. No data (supplied by NHS Digital) is processed outside of the LeDeR programme (based at the University of Bristol), and all data is processed using the dedicated secure web-based platform, thus avoiding the need for hard copies of patient-identifiable information.

Data flows for the reviews of deaths (to place the application in context)
a) All relevant deaths are notified to the LeDeR programme (various senior level health and social care practitioners) via a central reporting point (a confidential 030 telephone line, or a dedicated online platform based at the University of Bristol).
b) The LeDeR team inform the Local Area Contact of the area in which the death occurred about the death and its need for review. The Local Area Contact allocates the case to a local reviewer via the secure web based platform.
c) Once the review of the death is completed, the final report is approved by the Local Area Contact and send to the LeDeR team via the secure web based platform for the programme.
d) Following a quality assurance process (to ensure that all reviews are of the required standard), the report is pseudonymised and returned to the Local Area Contact to be discussed at the next regional LeDeR Steering group meeting. The Steering Group is tasked with understanding patterns of mortality of people with learning disabilities in that geographic area, and taking forward any recommendations relating to individual deaths, or patterns arising from multiple deaths, into service improvement initiatives.
e) The LeDeR team uses the pseudonymised data for quantitative and qualitative analysis. Pseudononymised information about deaths of people with learning disabilities will be shared with local Steering groups, in the LeDeR programme annual report, and in presentations to academic, practitioner audiences, and those including people with learning disabilities and their families. Prior to use, the information will be checked to ensure that no potentially identifying information (e.g. unusual sequence of events leading to death) is being used.

Data flows for obtaining ONS mortality data (the subject of this application)
a) Each 6 months, (January and June) the LeDeR team will batch together the personal identifiers of the deaths notified to the LeDeR programme. Personal identifiers may include (depending on availability): NHS numbers (which is available for approximately 80% of deaths); date of birth; date of death; sex; name; postcode.
b) The LeDeR team will securely transfer a file of identifiers plus the Unique Study ID to NHS Digital.
c) NHS Digital returns linked mortality data including the Unique Study ID and no other identifiers. Mortality data returned includes ICD-10 codes for causes of death listed and identified in Part 1a, 1b, 1c and 1d, and Part 2 of the MCCD.
d) The LeDeR team stores the data on a secure server in the University of Bristol. The data is stored in a separate location to the participant identifiers. The two datasets will not be re-linked.
e) Data will only be accessed by substantive employees of the University of Bristol who are members of the LeDeR team, and who have authorisation from the Programme Lead to access the data for the purpose(s) described.
f) 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 ONS Terms and Conditions. Aggregate, anonymised data about ICD-10 coding for cause of death will be included in reports about the mortality of people with learning disabilities, including in the LeDeR programme annual report to the Secretary of State for Health.

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).

No data will be shared with 3rd parties.

The Data will only be used for the purposes described in this agreement.



REducing unwarranted variation in the Delivery of high qUality hip fraCture services in England and Wales; the REDUCE study (Work package 1) — DARS-NIC-334549-B1Y6X

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

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(2)(a)

Purposes: No (Academic)

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

When:DSA runs 2020-08-20 — 2023-08-19 2020.12 — 2020.12. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Outpatients
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Admitted Patient Care
  4. HES:Civil Registration (Deaths) bridge
  5. Civil Registration - Deaths
  6. Civil Registration (Deaths) - Secondary Care Cut
  7. Civil Registrations of Death - Secondary Care Cut
  8. Hospital Episode Statistics Accident and Emergency (HES A and E)
  9. Hospital Episode Statistics Admitted Patient Care (HES APC)
  10. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The research group based at the University of Bristol requires HES and mortality data linked to National Hip Fracture Database (NHFD) data, for the purpose of investigating sources of variation in the delivery of hip fracture care and its effects on patient outcomes for the REDUCE study. This study is being undertaken at the Musculoskeletal Research Unit (MRU) within the University of Bristol.

Each year in the UK approximately 80,000 older adults fracture a hip, incurring £1.2 billion in direct medical costs alone and conveying a 30% 1-year mortality and a 22% reduction in quality-of-life. Fracture services are provided through complex multidisciplinary organisational structures. Despite UK standards and guidelines, the research group and others have shown substantial variation in hospital delivery of hip fracture care, potentially reflecting local organisational legacies and lack of commissioning expertise. Nationally, there is wide variation in hip fracture outcomes between hospitals (e.g. mortality, functional recovery, requirement for institutionalised care); whilst in part explained by patient-level risk factors, it is hypothesized that organisational factors are responsible for unwarranted variation in fracture care pathways and hence patient outcomes. Understanding sources of variation in care delivery (i.e. healthcare access), its effects on patient outcomes (i.e. inequity), permits service-level interventions to reduce unwarranted variation, maximise health equity and ultimately improve patient experience.

Researchers will analyse NHFD-HES-mortality data which covers hospitals in England, together with multiple publicly available organisational-level audits and data sources which characterise each service providing care to patients with hip fractures. The research group will quantify organisational capacity to manage fragility fractures, including delivery of emergency, orthopaedic, orthogeriatric, anaesthetic, nursing, and rehabilitation services. Statistical analyses using multi-level models, will identify the organisational factors that are responsible for the greatest variation in patient outcomes (e.g. death, length of hospital stay, osteoporosis treatment, hospital readmission's) and which typify care pathways with high-quality, consistent outcomes. Health Cost analyses will calculate NHS resource, in the year following hip fracture, attributable to organisational factors.

The research group at the MRU recently performed and published two analyses of HES data, examining inequalities in hip fracture incidence in England over the previous 14 years, and by geographic region (see https://www.ncbi.nlm.nih.gov/pubmed/28965213 and https://www.ncbi.nlm.nih.gov/pubmed/29945041). These papers examine patient-level factors. The REDUCE study follows on from this work and aims to examine how organisational-level factors explain avoidable variation in hip fracture care.

The researchers require data for processing under General Data Protection Regulation Article 6(1) (e) and Article 9(2) (j). The researchers believe that this research is in the public interest as findings will inform future commissioning/ service planning priorities for hip fracture care; provide hospital summary reports outlining their strengths and vulnerabilities; inform national review processes for hip fracture services; and together with a new Toolkit, this programme will minimize avoidable variation in fracture care and improve the quality of care for patients across the UK. The REDUCE study is a 3.5-year funded programme of work which commenced the 1st Oct 2019. It consists of three work packages. This application is for disseminated data for Work package 1:

Work package 1 (WP1)
Data are requested from the NHFD (which records all hip fractures in the NHS in England and Wales), linked to national Hospital Episodes Statistics (HES) providing clinical, surgical, anaesthetic and hospital admissions data, linked to data from the Civil Registration which records deaths, requested from NHS Digital. (For hospitals in Wales the research group have a similar dataset from the NHS Wales Informatics Service, Patient Episode Database for Wales.) To these datasets the research group will link audit and publicly available data sources, detailing how fracture services are delivered at each hospital. This will include for example, how busy the hospital’s emergency department is each year and how often patients are delayed before being found a bed, how many orthopaedic surgeons, orthogeriatricians and specialist fracture nurses each hospital employs, whether weekend orthogeriatrician cover is routine, how frequently anaesthetics for hip fracture are given by senior anaesthetists, how much post-operative physiotherapy is usually delivered, what access to rehabilitation beds is available, whether services have routine multi-disciplinary clinical governance meetings, whether bone density scanning equipment is available on site, and much more. The research group will determine which components of these hospital services account for poor patient outcomes, and which services successfully lead to good patient outcomes (both will need specific evaluation in work package 2 and will inform work package 3). There are dependencies between WP1 and WP 2 and 3.
Outputs from WP1 will:
(1) determine which four hospitals will be visited for the semi-structured interviews in WP2.
(2) identify the key organisational components impacting patient outcomes. These will be included in the WP2 semi-structured interview topic guide, to identify the best delivery models for these components of care, and barriers and facilitators to implementation.
(3) identify which organisational components of the hip fracture care pathway to focus on for the WP3 Implementation Toolkit.
(4) inform the Toolkit cost-benefit calculator for WP3 through cost analysis.

These analyses will allow The research group to distinguish between how much of these patient outcomes are explained by the health of the patient themselves and how much by the hospital services which they encounter. The research group will consider ‘competing outcomes’, e.g. a service may appear to have a short length of hospital stay, but this is explained by a high rate of early death; The research group will take such factors into account in the analyses.

The research group will provide reports for each hospital treating hip fracture in England summarising their performance using aggregated data. The research group will calculate how much is spent financially on patients in the year after hip fracture, and specifically how much is attributable to the different services hip fracture patients receive (HES Admitted Patient Care, Outpatients and Accident and Emergency). Summaries of these financial calculations will inform development of work package 3.

Work package 2 (WP2)
First, The research group will visit two hospitals with high and two hospitals with low variation in performance and conduct detailed interviews with all principal members of their hip fracture teams to understand the barriers faced by hospital services when trying to provide consistent high-quality fracture care, and the solutions that some hospitals have found which enable them to perform to a higher standard. Second, the research group will analyse 20 detailed reports which have been produced by the British Orthopaedic Association (BOA) over the last 6 years. These reports have been produced when underperforming UK hospitals have requested a ‘peer-review’, so that they can improve their hip fracture service. These reports also include a series of recommendations made by the multi-disciplinary assessment team; however, they have never been collectively analysed. There will be common themes and solutions (“lessons learnt”) in these reports which the research group believe will be of benefit to other hospitals, and which they plan to identify to inform of the outputs.

Work package 3 (WP3)
The research group will work with the Royal Osteoporosis Society (ROS) who have established experience developing Toolkits for use by hospital managers, clinical leads, and service commissioners; they have many years of experience in driving quality improvement initiatives within the osteoporosis field. Together the research group will develop an ‘Implementation Toolkit’ which will be freely available online and provide a series of instructions and guides (i.e. ‘tools’) for managers, clinical leads and commissioners to use to improve their hospital hip fracture services, encompassing service redesign/restructuring, organisational culture, and approaches to improve efficient use of limited healthcare resources. Tools will include a service improvement guide, a resource to help write a business case, a cost calculator to help budget savings versus expenditure, and a project plan. The research group will launch this Toolkit with the ROS, the British Orthopaedic Association (BOA) and the Royal College of Physicians (RCP). The ROS will provide ongoing free online access and maintenance of this Toolkit beyond the duration of this study through its website.

This application is for Work package 1 with these specific aims:

1. To determine which organisational-level factors account for patient-level outcomes (e.g. mortality, osteoporosis treatment, functional recovery, institutionalisation, re admissions and length of stay) after hip fractures across England. Mortality following a hip fracture will include deaths inside and outside hospital, based on Civil registration mortality data.

2. To calculate health costs attributable to hip fracture, incurred in the year following hip fracture, e.g. due to readmission's, long ‘super-spell’ length of stay.

The University of Bristol request linked patient-level data without personal information to enable the above analyses.

Data subjects include all men and women aged 60+ years who sustain a hip fracture, admitted to an English hospital from 1st April 2016 to 31st March 2019. However, additional HES APC data from the 1st April 2013 - 31st March 2020 are required because HES APC data for 3 years prior to the hip fracture episode and 1 year post hip fracture episode are necessary to calculate comorbidities and to derive outcomes.

The University of Bristol has considered data minimization and has taken steps to ensure the data requested are justified and limited to patients in England diagnosed in 2016-19 with hip fracture or matching the NHFD. The study team will provide a list of diagnosis ICD codes which relate to fracture of the hip (femur) and restrict the request to only those patients with these specific fractures.

In order to capture all episodes of hip fracture the researchers will use the list of diagnosis ICD codes which relate to fracture of the hip. ICD10 codes are being requested on top of the audit cohort because it will help to pick up anyone who was not captured in the audit data but had presented with the same clinical need. This HES/CRD dataset will be linked to NHFD data. It is expected that the HES/CRD extract will contain episodes not matched to NHFD data, because some hospitals may not have fail-safe systems established to capture every single hip fracture that occurs (e.g. may miss one admitted on a Sunday). It is essential to have hip fractures determined by ICD codes to allow verification of the proportion of hip fractures captured by the NHFD, and to determine how the hip fracture care pathways and outcomes compare for the group of individuals not included in the NHFD data (as those not included may be looked after by systems that are not so efficient in their care). Hip fracture is very painful and usually results in hip fracture surgery during the same episode of care, it is recommended that surgery take place within 36 hours of admission. Of note only a small proportion (<5% have a hip replacement, most are fixed using other types of operative fixation).

The University of Bristol requires details of all of the data subjects' episodes of inpatient care 3 years prior to the hip fracture episode, to understand their past medical history to see if the individuals have comorbidities. It is not feasible to limit the types of previous hospital episodes to specific ICD codes as this would bias the findings of the study.

The University of Bristol is requesting all inpatient hospital episodes and linked mortality data after the individual’s hip fracture and mortality data up to 2020, to calculate mortality, readmission (e.g.re-fracture/re operation, follow-up care), length of total hospital stay, and for calculation of health service costs post hip fracture. The date of death will enable researchers to accurately censor the patients within the survival and health costs analysis e.g. when investigating the true rate of readmission's (i.e. someone who has died cannot be readmitted).

HES APC, Outpatients, and Accident & Emergency data from 2016 - 2020 are required to derive costs to the NHS for hip fracture care in admitted patient and outpatient care and unplanned admission rates in the year following hip fracture. The research team will cost NHS resources used in the year post hip fracture, using ICD10 and OPSC4 (Intervention & Procedure) codes and spell durations, to derive Healthcare Resource Group (HRG) codes for inpatient stays and readmissions. Clinic codes will identify further outpatient and Emergency Department visits. The research team will value resources using Department of Health reference costs [References: Leal J, Gray AM, Prieto-Alhambra D, et al. Impact of hip fracture on hospital care costs: a population-based study. Osteoporosis International 2016; 27(2): 549-58 and Department of Health. NHS reference costs, 2016] and follow the statistical multiple imputation model to impute missing cost data.

Linked NHFD data are required for more detailed information regarding the hospital stay and discharge destination after hip fracture.

National data are required in order for the results to be generalizable, for all hip fractures and treating hospitals to be included and avoid selection bias. The number of years requested is necessary to account for trends in outcomes and changes in services and is limited to a specific time period. There is no alternative, less intrusive ways of achieving the study purpose.

The sole Data Controller is the University of Bristol. The Data Processor is the University of Bristol. Of the REDUCE quantitative study team, only substantive employees of the University of Bristol will access the disseminated data and only for the purposes described in this document.

The role of non-University of Bristol personnel or organisations involved in the wider REDUCE study, as described in the study protocol, have solely advisory responsibilities, contributing to the interpretation and implementation of aggregated findings, no data access/processing would be undertaken by them and all decisions about data analysis would remain with the University.

This research is funded by the research charity Versus Arthritis (VA). The funder has no role in the study design, data collection and analysis, and decision to publish, or preparation of any manuscripts.


Expected Benefits:

Benefit

This programme of work is novel in terms of its scale and the unique datasets which gives the research group a rare opportunity to robustly assess what is a complex system of care and the very real impacts this system has on patients. It is hoped that findings will inform future commissioning/ service planning priorities for hip fracture care; provide summary reports for hospitals outlining their strengths and vulnerabilities; inform national review processes for hip fracture services; and together with a new Toolkit, which will be maintained by the Royal Osteoporosis Society (ROS) beyond the duration of this grant, this programme will minimize avoidable variation in hip fracture care and improve the quality of care for patients across the UK.

Impact

This research, using national clinical audit data, is hoped to identify unwarranted variation in the quality of fracture care and sources of such variation, to inform service leaders and commissioners of changes necessary in future structuring and clinical commissioning of services, to reduce inequities. For hospitals, the research group hope to identify hospital-specific causes of variation in key patient outcomes. The research group will provide local summary reports to each hospital, bench-marking against national standards, to drive better commissioned/delivered fracture services. The research groups stakeholders will advise how best to target key clinical leads. Reports will be made publicly available. National-level solutions to variation in hip fracture outcomes will be provided by the research group new Implementation Toolkit, available to all hospitals, and by providing a much-needed evidence-base to support the expanding British Orthopaedic Society (BOA) hospital-initiated peer-review process (PRP) for hip fracture services, which will aid Toolkit dissemination. Future NHFD & Fracture Liaison Service Database (FLS-DB) audits will enable measurement of national impact of the Toolkit.

The target date for output and dissemination to begin to produce measurable benefit is 24 months from receipt of data.


Outputs:

Throughout all stages of this programme, the research team will engage with key stakeholders including NHS managers, healthcare professionals, patients and the public for interpretation, dissemination, and direct communication of the main findings. This will be facilitated through collaborations including those with the Royal Osteoporosis Society and Patient and Public Involvement (PPI) representation.

The following list shows the outputs that will be disseminated using the data received from NHS Digital specific to work package 1.

1) REducing unwarranted variation in the Delivery of high qUality hip fraCture services in England and Wales; the REDUCE study. (Journal article and conference presentations)

2) Health costs associated with REducing unwarranted variation in the Delivery of high qUality hip fraCture services in England and Wales; the REDUCE study. (Journal article and conference presentations)

3) Toolkit development for REducing unwarranted variation in the Delivery of high qUality hip fraCture services in England and Wales; the REDUCE study. (Journal article and conference presentation)

4) Provision of hospital trust summary reports (n=173), with bench-marking against national standards to hospital managers. Online publication of these reports 12 months later.
However, as mentioned there are dependencies between WP1, WP 2 and 3, which include: WP1 will inform the Implementation Toolkit development, and qualitative work package.
New freely available Implementation Toolkit for service leads to inform improved hip fracture care (developed with and maintained online by the Royal Osteoporosis Society).
Revised evidence-base to support the current British Orthopaedic Association hospital peer-review process.

These will be delivered sequentially over the course of the 3.5-year programme with the first publication targeted for submission by the end of 2020. The types of journals to be targeted will depend on the nature of the findings.

The intention is for aims 1) and 2) to produce at least one peer-reviewed published paper (target journals include: The BMJ, Osteoporosis International, Journal of Bone and Mineral Research) and at least one conference abstract for national/international presentation (target conferences: The Royal Osteoporosis Society conference, the European Fragility Fracture Network conference, The Bone Research Society, the American Society of Bone and Mineral Research).

All outputs will adhere to the HES analysis guide so that data are only shown in aggregate form with small numbers suppressed.

The research team will work alongside charities and learned societies to disseminate the findings of this study using established platforms that include social media such as Twitter and a study website, as more patients are now turning to these resources for information about hip fracture care. The research team will develop Plain English summaries of findings for communication to patients and members of the public.

This research is funded by the research charity Versus Arthritis (VA) and hence the research group will work with the VA publicity office to disseminate the research findings.

The data produced by this study will inform Public Health England (PHE), for whom elimination of health inequalities is a priority target. One of the leaders of the study is well placed as National Hip Fracture Database (NHFD) clinical lead to feedback the findings to key stakeholders, such as the Royal College of Physicians. Findings will further be disseminated by the NHFD Publications and Scientific Committee, of which the applicant is chair.

Disseminating outputs to commissioners, operational managers and change agents

The commissioning landscape is changing with CCGs working together in communities that express their aims and priorities through plans for integrated care, including the integration of falls and fracture services, such as the Fracture Liaison Service (FLS). It is the research groups assessment that the precise arrangements for commissioning, including job roles, organisational structure, funding flows and so on will change during the course of this research. The research group will adopt a flexible approach to dissemination, led by the Royal Osteoporosis Society (ROS) which has skill and capacity in this area.

Disseminating outputs to health care professionals

There is a well-developed and well-motivated cohort of clinicians working in the fields of osteoporosis and fracture care. The ROS has a team of professionals and a set of networks and activities already in place that engages with this community.

Disseminating outputs for patients and the public

The outputs of this research will be hugely valuable in creating messages and information products directed at very large groups including patients with diagnosed disease; people at higher risk of fragility fracture; and the wider public. Accurate and compelling information on standards of hip fracture care help to create a favourable climate for change through mechanisms such as membership of health and well-being boards; membership of foundation trusts; messages about what patients should expect from their hip fracture teams in terms of standards of care (to compliment current NHFD patient standards); and messages about the potential for improving fractures services through a proven and cost-effective service model.

Disseminating outputs to collaborators and stakeholders

Close work with collaborators and stakeholders will enable wide dissemination of findings and the Toolkit to ‘coalface service users.

The interim expected time frame for completion of the data processing, production and dissemination of the outputs would be 24 months, with a further 18 months retention of data after this to respond to changes based on peer-review comments from journals and from funding bodies.

Processing:

Under this agreement, the patient cohort will be provided for linkage by Crown Informatics (who are the Data processors for the NHFD but play no other role and receive no linked data) who will supply NHS number, Sex, Date Of Birth (DOB), NHFD date of hip fracture admission and postcode (match within +/- 32 days of the admission date). The University of Bristol will receive a patient level pseudonymised extract of HES/Civil Registration mortality data linked to NHFD data.

The data will be exclusively stored on University of Bristol servers and will not be accessible to any third parties. The University of Bristol will not link these data to any other individual-level datasets.

The University of Bristol will not be providing any data to NHS Digital, but just requesting all episodes of care for patients who have an episode containing pre-determined ICD codes associated with hip fracture or linking to NHFD data.


Data flow:
1. The patient cohort will be provided for linkage by Crown Informatics (who are the Data processors for the NHFD but play no other role and receive no linked data) who will supply NHS number, Sex, Date Of Birth (DOB), NHFD date of hip fracture admission and postcode (match within +/- 32 days of the admission date) to NHS Digital.
2. NHS Digital will link HES and Civil Registration data to the cohort and patients with related ICD/diagnosis codes.
3. NHS Digital will supply the linked pseudonymised data to the University of Bristol.
4. The University of Bristol will store data in the study-specific safe data-haven

Statistical analyses of the linked dataset will be used to derive patient-level outcomes; construct multilevel regression models to describe the association of organisational-level factors on patient-level outcomes, whilst adjusting for patient case-mix, and allowing assessment of interactions between patient- and organisational-level factors.

Health cost analyses will calculate NHS resource, in the year following hip fracture, attributable to organisational factors
All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The NHFD, HES and Civil Registration Mortality linked dataset will be transferred to the University of Bristol, which has established procedures for the transfer of data, its secure storage and for erasing data at the end of projects (www.bristol.ac.uk/infosec/policies/docs/). The data will be access-controlled and held in three locations at the university of Bristol in safe data havens, with password and firewall protection that guards against external users.

Only substantive employees of the University of Bristol will access the disseminated data and only for the purposes described in this agreement. Specified University of Bristol study personnel will be granted access to the data safe haven, after they have completed the necessary information governance training; the Chief Investigator will have responsibility for managing those individuals who have access. The data will be managed by a REDUCE study researcher based at the Musculoskeletal Research Unit (MRU) at University of Bristol. The data will be used exclusively for the purpose of this project.

At the end of the study, the data will be safely held in a password protected project-specific safe data haven at the University of Bristol for 42 months and, in that time, it will be accessed only to answer questions arising from publications and other publicity. The interim expected time frame for completion of the data processing, production and dissemination of the outputs would be 24 months, with a further 18 months retention of data after this to respond to changes based on peer-review comments from journals and from funding bodies.

No attempts will be made to identify any individual from the data being supplied. No data will be onwardly shared.

Outcomes of patients undergoing lower limb vascular procedures in the National Vascular Registry — DARS-NIC-203730-Y4V0Z

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

Legal basis: National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(2)(b)(ii); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

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

When:DSA runs 2020-09-15 — 2021-09-14 2020.12 — 2020.12. breached contract — audit report.

Access method: One-Off

Data-controller type: NORTH BRISTOL NHS TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Civil Registration - Deaths
  3. HES:Civil Registration (Deaths) bridge
  4. Civil Registration (Deaths) - Secondary Care Cut
  5. Civil Registrations of Death - Secondary Care Cut
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

The purpose of this service evaluation project is to investigate patient outcomes after lower limb vascular surgery in the United Kingdom. Peripheral arterial disease (PAD) affects 20% of the UK population aged 55-75, equating to a total of approximately 850,000 people, and the National Vascular Registry (NVR) includes data on approximately 41,000 patients who underwent lower limb vascular surgery from 2014 to 2016. The most severe manifestation, critical limb ischaemia, has an estimated annual cost to the National Health Service (NHS) of more than £200 million. This study will look specifically at the time 01/01/2014 to 31/12/2016, which covers a total of 40,890 patients who underwent lower limb vascular procedures recorded in the NVR, equivalent to 13,630 procedures per year. Unfortunately, little is known about the longer-term outcomes of this patient group in the 12 months after they leave hospital. Linking NVR data to HES-Civil Registration Mortality data held by NHS Digital would allow study of these longer-term outcomes and investigate any clinical or demographic risk factors for poor outcomes. The published findings would thus enable clinicians and patients to be better informed and facilitate future research on patient risk prediction for these procedures.

The data subjects are 40,890 patients who underwent lower limb vascular surgery procedures recorded in the NVR from 01/01/2014 to 31/12/2016.

The data request to NHS Digital will help achieve the aim identified above as they describe the longer-term patient outcomes after lower limb vascular surgery in the UK. This will provide valuable information for patients and clinicians with the ability to improve the provision of care and treatment.

North Bristol NHS Trust have experience of working with data from the NVR. However, this specific project does not relate to any other piece of completed work.

The proposed project seeks to undertake a descriptive analysis and basic statistical assessment of the linked dataset provided by NVR/NHS Digital. Any further work in the future will be covered by an appropriate application at that time.

The legal basis for processing falls under GDPR Article 6(1)(e) and GDPR Article 9(2)(i) . Processing and dissemination of these data meet the public interest criteria since it will grant clinicians, healthcare organisations and patients a greater understanding of the clinical outcomes patients experience after undergoing lower limb vascular surgery in the United Kingdom. As such, more will be known about current standards and outcomes of clinical practice and clinicians and patients will be better informed prior to surgery.

HES and Civil Registration Mortality data is required because the HES inpatient dataset contains inpatient hospital activity and as such will allow identification of re-admissions and re-interventions in the cohort of interest. The mortality data are necessary to calculate post-operative mortality up to 12 months after the date of procedure. Identifying data are to be provided by NVR to NHS Digital for the purpose of data linkage. Then data will be pseudonymised before it is shared with the project team at North Bristol NHS Trust. As such, no identifiable information will be shared outside of NVR/NHS Digital, as per CAG s251 approval.

The s251 support in place is for non-research purposes (i.e. service evaluation/improvement/audit etc).

The number of years requested matches the date range of the NVR dataset. The geographical spread is nationwide to cover all eligible patients and vascular surgical centres. There are no alternative ways of achieving the purpose, as the necessary outcome data is not available from any other source.

Only data for the 12-month period after each patient's date of surgery is requested. This epoch will be individually defined for each patient, such that the minimum data are required.

The joint Data Controllers are University of Bristol and North Bristol NHS Trust. The Data Processor is North Bristol NHS Trust.

NVR are flowing identifiable patient data to NHS Digital and pseudonymised patient data to University of Bristol but will not be processing NHS Digital data so as such are not a considered a data processor for this purpose.

The project is funded by a Research Fellowship from the Bristol Health Research Charity. The funder has no direct role in the project; played no part in the design of this project; nor will they be involved in the processing or dissemination of the data requested.

Data received from NHS Digital will be pseudonymised at source prior to being sent to North Bristol NHS Trust. Any results from subsequent analyses that are shared publicly will be aggregated.

Expected Benefits:

The expected measurable benefits are through the increase in knowledge which will facilitate better provision of health care to this patient population. Patients will be able to make better informed decisions about their choice of treatment.

This project will help address the current uncertainty and variation in clinical practice, due in part to an absence of published data on the longer-term clinical outcomes of patients after these procedures. Patients and clinicians will therefore have a new source of information to help guide their treatment decisions going forwards.

Dissemination will benefit the provision of health care to vascular surgical patients in the United Kingdom, both those who are considered for lower limb vascular surgery and those who ultimately undergo a procedure.

The outputs will raise awareness of the health outcomes of the patients involved.

Patient presentation and newsletters will ensure the results of the study are communicated to the patient group it relates to. This will enable patients to be better informed about vascular surgery, but also enable them to ask questions and find out more about the condition they have and the treatment they might undergo. It may also serve as a reference to inform discussions with patients around planning future studies.

The benefits to patient care and patient outcomes will be reflected in the annual reports released by the National Vascular Registry. The aggregate data reported will allow measurement of the changes in surgical care for these patients after the dissemination of the outputs and demonstrate how their care and outcomes have improved. it will also be possible to measure the interest and reach of the published outcomes, by tracking metrics such as article downloads and citations.

Finally, this initial analysis may form the foundation of future projects and grant applications to examine this patient group further and potentially develop risk prediction models for these surgeries, as has been done for other vascular surgery (e.g. the British Aneurysm Repair Score, which was developed using the NVR). The timescale for any such work would be in the order of several years as grant applications, research ethics approval and appropriate time for analysis would be required.

Outputs:

The aim is to disseminate the results of the project to researchers, scientists, clinicians, and patients involved in vascular surgery and anaesthesia. All data contained in outputs will be presented in aggregate form with small numbers suppressed as per the HES analysis guide. No personal identifiable data will be released or published.

The project is supported by the Bristol Hospitals Research Charity. The Charity will be acknowledged in any outputs but will have no input into the design, analysis, or write-up of the project.

The expected outputs of the data processing are submissions to peer-reviewed journals such as the British Journal of Surgery or the Journal of Vascular Surgery. The published outputs of this work will then be referenced in any future grant applications or proposals to study the subject further.

Additionally, conference presentations are also expected at The Vascular Society Annual Scientific Meeting or European Society for Vascular Surgery Annual Meeting, and a report for the local vascular patient group.

The aim is also to disseminate the results to patients: specifically a presentation will be given to the Bristol Vascular Surgery Patient and Public Focus Group.

The Bristol Vascular Patient and Public Involvement Group has 11 members who have previously undergone vascular surgery. The Group meet twice a year with clinicians from both vascular surgery and vascular anaesthesia. The Group have made significant contributions to both local and national vascular surgery research projects and other initiatives. For example, they are acknowledged as contributors in both the National Vascular Registry 2019 report (https://www.vsqip.org.uk/content/uploads/2019/12/NVR-2019-Annual-Report.pdf) and the Vascular Society Best Practice Clinical Care Pathway for peripheral arterial disease (https://www.vascularsociety.org.uk/_userfiles/pages/files/Resources/PAD%20QIF%20March%202019%20v2.pdf), having informed the infographics used in these documents.

Outputs will be communicated to interested parties using social media, namely Twitter to reach interested clinicians, researchers and patients across a range of disciplines and areas

The aim is to inform the relevant medical professionals, in order to inform their practice going forwards and to make patients aware of the findings, such that they are as well-informed as possible.

These outputs should be achieved within 12 months of data receipt, pending acceptance to relevant journals and conferences. The measurement of dissemination of the published work will be possible through monitoring citations and online discussion, for example using Altmetrics.

The target dates are as follows (from the receipt of data):
Submission for peer-reviewed publication within 12 months
Submission for conference presentation within 12 months
Presentation to Patient Group within 12 months according to scheduled meetings.

Processing:

Identifiable data will be provided from NVR to NHS Digital to facilitate the linkage and provide pseudonymised data to the study team at North Bristol NHS Trust. The NVR holds patient data with express written consent from patients, including the linkage of the patient’s data to other national health datasets and the sharing of pseudonymised data for the purposes of further study. Section 251 approval has been granted by the Confidentiality Advisory Group (reference 19/CAG/0005) to facilitate this process. This section 251 support is not for the purposes of research and covers only the flow of identifiable data from the National Vascular Registry into NHS Digital.

Data flow into NHS Digital will be from National Vascular Registry (Commissioned by NHS E and part of the National Clinical Audit Programme managed by HQIP). This will include identifying data; this includes the patient's NHS number and date of birth. This is to facilitate data linkage and is covered by the CAG s251 approval. The NVR study id will also flow.

Data flow out of NHS Digital will be to North Bristol NHS Trust. Personal identifiers will be removed by NHS Digital prior to transfer; the Study_ID will remain.

There will be no subsequent flows of data.

All data flows are individual patient level.

NHS Digital will receive the identifiers above from the NVR, and use these to perform data linkage with the HES and Civil registration Mortality data held by NHS Digital. All identifiers will then be removed, prior to any data being shared with the project team at North Bristol NHS Trust. Only pseudonymised data will be shared with the project team.

North Bristol NHS Trust will receive the pseudonymised linked dataset from NHS Digital, and pseudonymised data from NVR via University of Bristol, who are joint data controllers. North Bristol NHS Trust will not hold any identifiers and therefore cannot re-identify individuals, they will use the study id to link the data from NHS Digital and NVR. North Bristol NHS Trust will then perform the descriptive analyses on the linked dataset and prepare outputs for dissemination as outlined in the outputs section of this application. These analyses will include an aggregate description of the patient group undergoing these procedures, by producing summaries of demographic characteristics such as average age, male/female and medical comorbidities (descriptive statistics). The Trust will also be able to describe the number of patients having each type of surgery and produce a summary of their postoperative outcomes. For example, the percentage of patients needing to be readmitted to hospital, or the percentage who survive beyond 1 year from their operation. All data will be presented in aggregate form, for example in tables and graphs, with small numbers suppressed.

Data linkage will be performed by NHS Digital as described above. NVR will provide identifiers to NHS Digital (NHS number and date of birth) along with a pseudonymised patient ID. NHS Digital will then perform linkage with the datasets they hold, namely HES and Civil Registration mortality data. Approval for the data linkage has been granted by HQIP, controller of the NVR, and s251 approval has been gained from HRA CAG to permit the sharing of identifiable information between NVR and NHS Digital for this purpose.

No attempt will be made by the team at North Bristol NHS Trust to re-identify any individual. The steps to mitigate the risk of re-identification include the removal of all identifiers by NVR/NHS Digital before any data are shared with the project team. Some data fields will be reduced in granularity to reduce risk of re-identification: for example, date of birth will be converted to age; date/time of procedure in NVR will be reduced to Month/Year; date of hospital discharge and/or date of death will be converted to length of stay in days.

Data processing will only be carried out by appropriately trained employees and in accordance with all Organisation information governance and data protection policies. All data access will be done in secure environments with password-protected system access.

All data access will be done in secure environments which are access-controlled by ID badge. System access will be password-protected, as will individual files. There are no plans for remote access.

MR1214 - An Evaluation of the Integrated Drug Treatment System in English Prisons: A Case Control Study — DARS-NIC-147806-M11MB

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N, Identifiable, Yes

Legal basis: Section 251 approval is in place for the flow of identifiable data, , 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), 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)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2011-02-09 — 2026-02-08 2016.06 — 2019.03. breached contract — audit report.

Access method: Ongoing

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

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

Objectives:

This study is part of an evaluation of the Integrated Drug Treatment System (IDTS), which has recently been introduced to prisons in England. The primary purpose of the study is to assess whether differences occur in relation to short-term mortality rates, engagement with treatment services, and offending behaviour between 10,000 IDTS clients released from prison while still receiving Opiate Substitution Treatment (OST) (e.g. methadone or buprenorphine) and 10,000 IDTS clients released after detoxification from opiate dependence.

Expected Benefits:

Research in the UK and elsewhere has repeatedly shown that drug users have an increased risk of death immediately following release from prison, most commonly due to overdose after loss of a previous tolerance to opiates. The IDTS aims to provide a more integrated and comprehensive system of treatment for drug users. A significant aspect of this has been the increased use of OST in prisons, the aims of which are to lessen the likelihood of illegal drug use in prison, opiate related overdose upon release, and disengagement from community services upon release. We have been funded by the English Department of Health and the Ministry of Justice to evaluate the effectiveness of this aspect of the IDTS.

Outputs:

Data will be collected from various databases one year after recruitment and again at ten years, and linked to the participant identifying information. Mortality data provided by the MRIS is crucial, a comparison of short-term mortality rates between cases and control participants being our primary outcome. This mortality data will be modelled using multivariable regressions, adjusting for baseline covariates available to us from the Drug Intervention Record (DIR), completed on entry to prison. In addition, we will examine the prevalence of different causes of death within prison or in the first year after prison release. As such, we also require information on causes of deaths from the MRIS.

Our other analyses will rely on data from other sources, including the Police National Computer (PNC) and National Drug Treatment Monitoring System (NDTMS). Of particular interest in addition to mortality is a comparison of re-conviction rates / time to re-conviction between cases and controls and also of rates of engagement with community drug services.

Processing:

We aim to recruit a total of 20,000 adult opiate dependent participants from 42 prisons in England, over a period of 13 months: 10,000 cases released from prison opiate tolerant due to Opiate Substitution Therapy (OST) and 10,000 controls released from prison detoxified.
Each prisoner entering a participating prison who is triaged as being opiate dependent will be invited to participate in the study by a member of the prison’s Health Care or Psychosocial team. Once a prisoner signs the study consent form or refuses to participate, that is the end of his / her active participation. The consent will allow information to be collected about a participant from a number of national databases.

An individual’s participation in the study will be confirmed upon his / her release from prison, at which time his / her opiate tolerance status (detoxified / still in receipt of OST and therefore opiate tolerant) will be recorded, based on the prison’s OST dispensing data. These data will be collected and conveyed to the researchers using either encrypted data disks or sealed hard copy transferred using a secure parcel service. Participant prison release dates will be confirmed from dispensing data and the Local Inmate Database System (LIDS).

MR1048a Continuation of AVON LONGITUDINAL STUDY OF PARENTS AND CHILDREN (ALSPAC) with for the ‘Children’ aspect only — DARS-NIC-13133-B7B3K

Type of data: information not disclosed for TRE projects

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

Legal basis: 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, and Non-Sensitive

When:DSA runs 2019-01-01 — 2021-12-31 2018.06 — 2018.12. breached contract — audit report.

Access method: One-Off, Ongoing

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Mental Health Minimum Data Set
  2. Hospital Episode Statistics Accident and Emergency
  3. Mental Health and Learning Disabilities Data Set
  4. Hospital Episode Statistics Admitted Patient Care
  5. Hospital Episode Statistics Critical Care
  6. Hospital Episode Statistics Outpatients
  7. MRIS - Flagging Current Status Report
  8. MRIS - Cause of Death Report
  9. MRIS - Cohort Event Notification Report
  10. MRIS - List Cleaning Report
  11. Hospital Episode Statistics Accident and Emergency (HES A and E)
  12. Hospital Episode Statistics Admitted Patient Care (HES APC)
  13. Hospital Episode Statistics Critical Care (HES Critical Care)
  14. Hospital Episode Statistics Outpatients (HES OP)
  15. Mental Health and Learning Disabilities Data Set (MHLDDS)
  16. Mental Health Minimum Data Set (MHMDS)

Objectives:

Background

The Avon Longitudinal Study of Parents and Children (ALSPAC) is a transgenerational prospective birth cohort study that recruited women during pregnancy in the early 1990s. ALSPAC is designed to investigate influences on health, wellbeing and development across the life course. To inform these investigations ALSPAC collects information on genetic, epigenetic, biological, psychological, social and environmental exposures and a similar range of health, social and developmental outcomes. ALSPACs primary objective is to manage a long-term relationship with the study families and through this to build a DataBank resource that can be used to inform the investigation of diverse health and social hypotheses across the life course. To achieve this objective, data are collected through postal questionnaires, study clinical assessments, the collection of biological samples and through linkage to routinely collected health and social administrative records (including those held by the NHS Digital). ALSPAC is part of the Population Health Science group within the Bristol Medical School at the University of Bristol. Over £100m has been invested into ALSPAC by UK funding councils, charities (e.g. Wellcome Trust, British Heart Foundation, Asthma UK, Cancer UK), the NHS NHIR and directly from UK Government Departments. ALSPACs primary funding comes from the Wellcome Trust, The Medical Research Council and the University of Bristol.

The Study

The study seeks approval to link to, extract and use NHS Digital data (Flagging and Tracing, Hospital Episode Statistics and Mental Health Services Data Set) to inform a set of specific research investigations (listed below). These are specific questions – that require linked data - that have arisen from existing work, are led by University of Bristol investigators and are tied to health service improvements (as described later in the application).

Study Administration

Data provided by NHS Digital will be used by ALSPAC staff to facilitate study administration. Within this, the study will use participant contact details to help trace participants lost to follow-up (NHS contact details will be kept separate from the primary administrative database which will only be updated in the event of a participant responding to a contact request). The database will also be updated with fact of death and date of death in order to stop inappropriate future contact attempts.

Scope

This data processing agreement (NHS Digital reference number: MR1048) relates to the records of the ALSPAC index children (i.e. those born in the early 1990s). Eligibility for ALSPAC is defined as all mothers who were pregnant and due to deliver between 01/04/1991 and 31/12/1992 while resident in certain health administrative areas within the County of Avon. There were 19,600 live born children resulting from these pregnancies. At the point where the index children had reached 18 years of age, ALSPAC had enrolled 14,775 live born children from 15,247 pregnancy events. Recruitment of the remaining eligible index children, and members of their extended family units, remains ongoing. The ‘children’ are all now adults (mean 26 years old). Detailed description of eligibility and enrolment into ALSPAC are provided in two ‘Cohort Profile’ publications (http://www.bristol.ac.uk/alspac/researchers/cohort-profile/). This agreement is for data relating to the ~5,000 (precise numbers vary over time as eligible children enrol or, conversely, if enrolled children withdraw) index children who are enrolled into ALSPAC and where consent is the legal basis for these uses of their health service data. The index children have moved across the UK over time, so the cohort is no longer geographically distinguishable and cannot be filtered by geographical area.

Legal Basis

All the projects detailed below are considered to be supported through explicit participant consent as a legal basis. The consent statements provide an explicit participant declaration for the linkage, extraction and research use of the records held by NHS digital.


ALSPAC participants are free to object to the studies use of their health records at any time through contacting the study. Records of objections are stored in a central database. ALSPAC will ensure that objectors wishes are upheld and they will not be included in the list of MR1048 participants for whom we request records.


Specific purposes

Note: All specified researchers accessing NHS Digital data are University of Bristol contracted staff. Additional researchers and clinicians will advise the research team, but will not have access to individual personal information (i.e. only anonymous tabular information and statistical outputs that has been assessed for disclosure risk before consultation).

1. The effect of substance use in adolescence on mental health
Project: The study will use HES and MHSDS data, along with linked ALSPAC, GP data and education data, to investigate the association between mental health outcomes in young people and substance use in adolescence. The study will consider the use of three of the most widely used substances (alcohol, cannabis and tobacco), and their association with a diagnosis of a mental or psychological disorder in general, and specifically a clinical diagnosis of mood disorder (e.g. depression), anxiety or psychotic disorder (e.g. schizophrenia). ALSPAC collected data will provide information on substance use exposure and NHS Digital and GP data will provide objective assessments of mental health outcomes. NHS Digital and GP data may be used (where possible) to assess reporting accuracy within the self-reported data and to inform strategies to deal with missing data. This research will improve understanding of the risks of substance use, and the patterns of health service use for young people with mental health problems.

2. Chlamydia testing, infection, and sequelae in young people
Project: The study will use HES data, along with ALSPAC Data, GP records and linked National Chlamydia Screening records, to examine which factors influence Chlamydia testing, infection, and sequelae in young people. HES records will be used in the identification of pelvic inflammatory disease, ectopic pregnancy and reduced fertility amongst female ALSPAC participants with different evidence of exposure to Chlamydia (only negative tests, any positive tests, no evidence of testing). Reduced fertility will also be considered for male participants.

3. Assessing the Validity of Self-Reported Hospital Admissions and the Implications of study non-response
Project: The study will investigate and describe 1) the reliability and validity of self-reported hospital admissions and those recorded in HES and MHSDS and 2) assess if individuals with adverse health status profiles are more likely to be missing from study follow-up assessments. Self-reported data suffers from participant reporting bias introduced by factors such as recall error (i.e. the ability to accurately remember and report information) or social desirability (i.e. where perceived social influences impact on the answers individuals give). This project will help inform researchers, public health officials and policy makers as to how to interpret findings generated using self-reported data. Separately, it is known that participants who respond to studies are different to those who do not, and there is potential for health effects to impact on individuals’ likelihood to take part. Findings from this study will improve the understanding of study error (e.g. errors in prevalence estimates introduced where the likelihood of follow-up is differentiated by social, demographic or health conditions).

4. Investigating the accuracy of current estimates of self-harm
Project: The study will use the data to investigate a) the accuracy of current estimates of self-reported self-harm in the community (exploring the impact of non-response bias and misreporting) b) the long-term risk of hospital admission for self-harm in those self-harming in the community. This information is of critical importance to prevent over or under-estimation of the magnitude of self-harm, as policies based on inaccurate estimates may lead to the wrong policy decisions and incorrect prioritisation of particular health risk factors. Findings will also help to identify risk factors for future self-harm hospitalisation, and improve understanding regarding the relevance of findings from population-based studies using self report to clinical practice.

5. Early life causes of adolescent depression and anxiety
Project: The main research objective is to obtain accurate estimates of the association between maternal smoking and binge drinking during pregnancy and depression and anxiety in late adolescence and to investigate how (a) non-response and (b) misreporting in questionnaires affects estimates of this association. GP data will be used to provide depression and anxiety data for those individuals for whom we do not have self-reported information (just over 65% of the cohort). The secondary objective is to obtain accurate estimates of the prevalence of depression and anxiety in late adolescence.

6. Investigating the association between IQ and self-harm
Project: The main research objective is to obtain a more accurate estimate of the association between IQ and suicidal and non-suicidal Self-harm among adolescents and to investigate how (a) nonresponse and (b) underreporting in questionnaires affects estimates of this association. GP, hospital admissions and A&E data will be used to provide self-harm data for those for whom the study does not have self-reported information. ALSPAC self-reported data will provide information on IQ and linked education records will provide proxy information on educational attainment. The GP and hospital data will also be used to correct for any under-reporting. The secondary research objective is to examine the extent to which adolescents seek GP help for self-harm and suicidal feelings.

7. Enabling the cross validation of asthma diagnosis using combinations of symptom and physiological data with GP and Hospital records
Project: The study will use the data to investigate a) the accuracy of current estimates of self-reported asthma in the community (exploring the impact of non-response bias and misreporting) and b) to calculate the extent of asthma severity from recorded hospital attendance/admissions as well as primary care emergency visits and treatment steps. There is concern that asthma may be socially patterned and that it is known that key exposure and confounders collected through observational studies certainly are. Therefore the concern is that assumptions made about the associations and confounding structures of relationships between environmental exposures and asthma outcomes may not be valid. Insights into the accuracy of ALSPAC self-reported and study clinic assessed asthma and the severity of asthmas will support our investigations into the genetic and environmental influences of asthma and current work into the impact of traffic pollution on asthma. The study will investigate i) the natural history of early wheeze in relation to later asthma outcomes; 2) the relationships between early wheezing and later clinical records to determine if a severe asthma profile can be detected in early childhood; 3) compare the impact of smoking and biomarker data from ALSPAC and respiratory function; 4) investigate the relationships between childhood infections and wheezing phenotypes with asthma and lung function in later childhood; 5) compare exposure to traffic pollution and asthma incidences (included A&E and admitted care). These projects may help confirm an association (identified elsewhere between early respiratory infection and decreased lung-function during childhood that may be antecedent to adult respiratory morbidity and possibly mortality; and, 6) investigate the relationships between treatment for asthmas in primary care, adherence to treatment and outcomes of asthma and lung function in later childhood and early adulthood.

8. Antecedent factors predictive of later ear disease
Project: Serious ear disease in later childhood and adulthood is distressing and burdensome on those effected and incurs treatment costs on the NHS. This project will investigate whether early signs of ear disease identified in ALSPAC at age 9 (categorised from photographs of the ear drum) are predictive of the development of serious ear disease requiring hospital treatment in later childhood and adulthood (as identified through HES).

9. Parental and child alcohol use and later criminality and injury outcomes
Project: The number of children who are affected by parental alcohol misuse is largely unknown
although estimates suggest a third of all UK children live with at least one parent who uses
alcohol hazardously. How this impacts on their health, mental health and education is
unclear. ALSPAC has multi informant measures of parental alcohol use reported by the mothers and partners during pregnancy and throughout childhood (allowing comparison of maternal and paternal effects) and child self-reported alcohol use. Self-reported and linked health and social outcome data will be assessed to help understand associations between parental alcohol use, child alcohol use and child cognitive, behavioural and emotional development. This research will study child engagement in criminal activities and injury. Linked HES records will contribute information on admission rates, accidents and injuries.

10. Understanding drug use pathways and resulting accident and injury
Project: When reaching their early twenties, almost 60% of ALSPAC participants have reported cannabis use at some point in their life, one in five has used ecstasy, and around one in ten young adults has used amphetamines, cocaine, or magic mushrooms. Given the adverse effects of adolescent drug use on adult outcomes, these numbers are alarming. This project will seek answers to the following questions:
• Why do so many young people experiment with drugs?
• How many of them are regular users?
• Is the use of illicit drugs systematically linked to alcohol and tobacco use?
• How are temporary and chronic use reflected in psychosocial adjustment and accomplishment of normative development milestones?
• Can protective factors be identified that increase the likelihood for youngsters to abstain and users to desist from using drugs before they can leave lasting damage?
HES data will be used in combination with ALSPAC self-reported data and data from linked GP and Education records. The linked HES data will contribute outcome data on A&E admissions patterns and injury outcomes.

11. Understanding drug use pathways and resulting mental health outcomes.
Project: When reaching their early twenties, almost 60% of ALSPAC participants have reported cannabis use at some point in their life, one in five has used ecstasy, and around one in ten young adults has used amphetamines, cocaine, or magic mushrooms. Given the adverse effects of adolescent drug use on adult outcomes, these numbers are alarming. This project will seek answers to the following questions:
• Why do so many young people experiment with drugs?
• How many of them are regular users?
• Is the use of illicit drugs systematically linked to alcohol and tobacco use?
• How are temporary and chronic use reflected in psychosocial adjustment and accomplishment of normative development milestones?
• Can protective factors be identified that increase the likelihood for youngsters to abstain and users to desist from using drugs before they can leave lasting damage?
HES and MHSDS data will be used in combination with ALSPAC self-reported data and data from linked GP and Education records. The linked HES and MHSDS data will contribute outcome data on mental health (cognitive function, depressive symptoms, psychotic symptoms).


12. Parental and child alcohol use and later mental health and development outcomes
Project: The study will use the data to investigate the associations between maternal substance use in pregnancy (where 'substance use' is defined as alcohol, tobacco, medicinal and recreational drug use and other stimulants (e.g. caffeine)) on child physiological, developmental and mental health outcomes. This component of ELASTIC will extend our research into child health and social outcomes of parents with differing alcohol consumption patterns by using linked HES and MHSDS records to study mental health outcomes including self-harm, suicide, addiction, anxiety, depression and psychosis. Linked education records will allow assessment of impacts on educational attainment and attendance.

13. Investigating the incidence and aetiology of psychosis.
Project: Psychotic experiences (PEs) are reported by around 5-10% of the general population. Although usually transient, they are associated with increased risk of schizophrenia over time, but the natural progression of PEs and transition to schizophrenia in adulthood has not been examined in detail previously. This study will:
i) Examine the proportion of children and adolescents with PEs who transition to clinical disorder in adulthood, and estimate the extent to which these individuals are identified by primary/secondary care services (i.e. highlighting potential unmet needs)
ii) Use detailed data on ALSPAC participants to identify those at highest risk of transition to psychotic disorder and inform tools for prediction
iii) Examine the extent to which associations observed between risk factors (e.g. cannabis use) and psychosis outcomes in ALSPAC and other cohort studies are likely to be over- or under-estimated due to selective loss to follow-up.
Linkage to primary and secondary care (HES and MHSDS) records is necessary to accurately identify individuals who have sought help for psychotic psychopathology, estimate the unmet public health needs of non help-seeking individuals with PEs, and examine the extent of potential biases in identifying risk factors. Access to full mental health data within primary care records will enable us to identify early (prodromal) symptoms in individuals who have not yet transitioned into a full-blown illness, to inform identification of those at highest risk of developing psychosis, and where closer medical supervision might therefore be appropriate.

14. Antecedents and health outcomes of intellectual disabilities and autism.
Project: The overarching aim of this project is to make use of HES and MHSDS data in conjunction with GP data, education records and ALSPAC parent and self-reported and clinic measures, to understand the i) prenatal and early life antecedents and ii) later life outcomes children with intellectual (learning) disabilities and autism. ALSPAC data will be used to identify prenatal and early life antecedents including maternal stress, anxiety and depression, substance use (including smoking, alcohol, cannabis and other drugs). The linked data will be used to cross validate individuals with intellectual disability and autism identified through questionnaire/clinic data and school records and identify further cases which may have been missed. Later life outcomes will include questionnaire and clinic measures of mental health as well as health service usage and diagnoses recorded in the linked data. The study will use the wealth of socioeconomic and lifestyle data collected in ALSPAC as potential confounders or mediators as appropriate. This research will further the understanding of the causes and adolescent and early adulthood outcomes including health needs and health inequalities of children with intellectual disabilities and autism.

15. Patterns of engagement with health and education services as predictors of child looked-after or in-need status.
Project: We will use HES and MHSDS data, along with ALSPAC self-reported data and extracted general practice data, to examine whether patterns of health service engagement (e.g. missed routine appointments, regular attendance at A&E or out-of-hours services, receipt of care for real or alleged ‘accidental’ injuries) are useful predictors of a child becoming in need or looked-after. The study will also use HES and MHSDS data to investigate health outcomes and health service usage in ALSPAC participants who were in need or looked-after as children. Both mental and physical health will be considered. ALSPAC are engaged with the nascent National Child Looked After Observatory and local (Bristol) safeguarding teams in order to effectively disseminate the findings. Findings will also be published in appropriate academic journals and through conferences and local workshops (in partnership with the South West BRC, NHS CLHARC West and Bristol Health Partners).

16. Comparison of proposed HES extract with ALSPACs historical HES extract.
Project: ALSPAC has previously extracted HES records on ~3,000 consenting participants. This extract has informed published scientific investigations (e.g. Mars et al 2016: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4841016/). In line with established scientific method it is necessary for ALSPAC to retain data supporting these investigations to support scientific challenges or replication studies. NHS Digital have expressed their preference that this historical extract is now securely destroyed. This project will compare – for the subset of consenting participants – if the initial extract is fully replicated in the proposed extract (bar change introduced through participants withdrawing consent) and if the data within these records are exact matches. If it is found that the historic extract is fully represented in the proposed extract then ALSPAC commit to securely destroying the historic extract (following the methodology provided in the security documentation). If it is found that the historic extract differs from the proposed extract then ALSPAC will securely archive the historic extract within the ‘safe haven’ and only make it available for scientific challenge/replication with prior consultation and approval of NHS Digital. It is not the intention to publish findings of this evaluation as it is for internal data management purposes.

Yielded Benefits:

There have been >2,000 articles published using ALSPAC data; details of these can be found on the ALSPAC study website. A lay summary of some of the key ALSPAC findings is available here: http://www.nature.com/news/children-of-the-90s-coming-of-age-1.10396 Notable examples of how ALSPAC findings have informed health and social policy include the following: (i) providing evidence to help persuade policy makers to support the ‘back to sleep’ policy change. This campaign started in the UK prior to ALSPAC's initiation, and initially advised parents not to place their babies to sleep in the prone position to reduce the risk of cot death. ALSPAC reassured sceptical health professionals and policy makers to proceed to recommending the supine position by demonstrating that this position was not associated with factors detrimental to child health.This finding also helped to persuade the US National Institutes of Health to carry out their own ‘Back to Sleep’ campaign that started in 2004. (ii) The finding that the application of skin creams containing peanut oil as a base ingredient to broken skin sensitized children to peanut allergy has led to some manufacturers altering the composition of the creams and the Committee on Safety in Medicines recommending that warning labels be included on all medicinal products containing peanut oil. (iii) ALSPAC has contributed to the debate on the consumption of fish during pregnancy. Established advice in the UK and USA was that on balance the risks of consuming toxins while eating more than two portions of fish per week outweighed the known benefits of eating fish. ALSPAC findings have influenced UK and US guidelines concerning fish consumption in pregnancy by demonstrating that benefits to child behaviour and verbal IQ, early development and visual stereoacuity outweigh potential harm of neurotoxicity from mercury and other sources of contamination. (iv) Evidence from ALSPAC including the influence of socio-economic position on life chances and aspirations were used to support the Independent Review on Poverty and Life Chances by Frank Field MP ‘The Foundation Years: Preventing Poor Children becoming Poor Adults’ and the Marmot Review Fair Society, Healthy Lives. Genetic investigations using the candidate approach to studying gene variation and phenotypic outcome have described the influence of the filaggrin gene (FLG) on child susceptibility to atopic eczema and asthma. ALSPAC was the largest follow-up sample in the discovery that variation at the FTO gene is associated with increased adiposity and predisposition to obesity; using DXA assessment measures ALSPAC showed that the association was only present for fat mass and not lean mass. ALSPAC holds DNA collected at multiple time points, allowing researchers to explore DNA methylation and epigenetics. To realize the full potential of the resource ALSPAC is involved in genetic consortium studies including UK10K and EGG (early growth genetics). Environmental studies have explored the antecedents of asthma where environmental exposures including prenatal maternal anxiety and paracetamol use, exposure to a range of cleaning products and excessive hygiene regimes have been found to influence the development of asthma in the child. Analysis of early life influences including maternal age, diet and smoking do not appear to influence blood pressure in the child although maternal weight gain in pregnancy is associated with increased risk of child adiposity and adverse cardiovascular risk factors. ALSPAC has also shown that fat mass contributes to higher bone mineral density. Full references available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3600618/

Expected Benefits:

The described investigations have defined primary objectives to improve the understanding amongst some of the most concerning and prevalent areas of adolescent health; i.e. those relating to depression, psychosis, self-harm and suicide and substance use. Through this innovative use of a cohort study of adolescents linked to health records we can study exposure/outcome associations in marginalised groups (i.e. those in need/in care and those suffering from mental health conditions). Secondary objectives relate to a better understanding of self-reported measurement error which will be used to inform interpretation of evidence emerging from longitudinal research studies and therefore improve the accuracy of evidence informing health and social care policy development.

The project level anticipated benefits include:

Project 1 (The effect of substance use in adolescence on mental health):Based on study findings being disseminated in public health academic journals and conferences outlined in the Outputs for Project 1 This research will lead to a better understanding of the risks associated with substance use in adolescence, and the aetiology of mental health difficulties. It therefore has the potential to impact on public health policy.

Project 2 (Chlamydia testing, infection, and sequelae in young people): Effective reduction of adverse sexual health outcomes depends in part on an understanding of the factors and processes that predispose an individual to experience these outcomes. Such understanding depends on the ability to consider the influence of exposures acting across the life course from early childhood. Based on study findings being disseminated in public health academic journals and conferences outlined in the Outputs for Project 2 this research will lead to a better understanding of sexual health and testing behaviours in young adults. It therefore has the potential to impact on public health policy and General Practice administration of testing and testing guidance. The Deputy Chair of the NICE Public Health Advisory Committee ((PHAC-F) - a committee responsible for the development of NICE public health guidance), will lead professional dissemination


Project 3 (Assessing the Validity of Self-Reported Hospital Admissions and the Implications of study non-response): This methodological work that will support interpretation of ALSPAC data in other research projects (including the studies listed in this application). The work also has potential to support wider understanding and interpretation of bias in self reported health status (e.g. in the NHS Survey of Mental Health and Wellbeing). This is increasingly important as ‘Big Data’ approaches in contemporary Data Science are being used to inform health policy development through the analysis of combined study data and routine records. Study findings are to be disseminated via the appropriate academic journals and conferences outlined in the Outputs for Project 3 The potential benefits of Project 3 are illustrated by Project 4 and 5. While Project 3 will look at this in broad terms, Projects 4 and 5 will study some of the same issues at more depth within the context of specific health status.

Project 4 (Investigating the accuracy of current estimates of self-harm): Outputs from this project are of critical importance to prevent over or under-estimation of the magnitude of self-harm, as policies based on inaccurate estimates may lead to the wrong policy decisions and incorrect prioritisation of particular health risk factors. Findings will also help to identify risk factors for future self-harm hospitalisation, and improve understanding regarding the relevance of findings from population-based studies using self-report to clinical practice. . Study findings are to be disseminated via the appropriate academic journals and conferences outlined in the Outputs for Project 4. Preliminary work (based on those participants who provided consent to link their data with medical records) has been published in Archives of Suicide Research (http://dx.doi.org/10.1080/13811118.2015.1033121), and has been selected as a case study by the understanding patient data taskforce that is developing mechanisms to communicate recommendations from the third Caldicott Review to the public


Project 5 (Early life causes of adolescent depression and anxiety): Rates of anxiety and depression among children and adolescents in the UK have increased markedly in recent decades. Maternal smoking and alcohol consumption during pregnancy have been shown to be associated with many adverse psychological and behavioural outcomes among children, including in ALSPAC. The study would like to find out if these are risk factors for adolescent depression/anxiety. It is possible that the predictors of depression/anxiety may be different among individuals for whom self-reported data is held, compared to those who are no longer participating in the study. Study findings are to be disseminated via the appropriate academic journal outlined in the Outputs for Project 5 and will inform the methodological understanding of self-reported depression and anxiety and public policy development.


Project 6 (Investigating the association between IQ and self-harm): Findings from our research will add value to epidemiological research on self-harm and have wider benefit for the scientific community as it will increase our knowledge of how best to combine self-harm data from different sources. With the inclusion of GP data, it will build on work being undertaken by colleagues and allow researchers to make appropriate decisions regarding missing self-reported data in their analyses. This research also has the potential to impact on public health policy as it will lead to a better understanding of who is at greatest risk of self-harm. This is important in terms of the appropriate design and targeting of interventions.

Project 7 (Enabling the cross validation of asthma diagnosis using combinations of symptom and physiological data with GP and Hospital records): Findings will improve the understanding of asthma research based on the ALSPAC study and other studies using similar methodologies. Specifically, longitudinal approaches will allow greater understanding on precursor GP reporting (e.g. presenting with wheeze) prior to diagnosis of asthma status. Accurate asthma status informed by objective assessment and therapeutic data will enable more accurate assessment of the environmental and genetic development influences of asthma and other respiratory conditions and be disseminated through the network of Clinical Respiratory Paediatricians.

Project 8 (investigating early signs of ear disease): Information about the prognosis of these early signs and their likely development into serious disease will inform clinical decision making about the need for early preventative surgical intervention, which is currently not known. Study findings will be published in appropriate journals and presented locally and nationally through specialist Networks.

Project 9 (parental and child alcohol use and later criminality and injury outcomes): In part, this research will address the evidence gap on in utero substance use exposure on child outcomes. The importance of this work has recently been highlighted in a systematic review of the effects of maternal alcohol consumption in pregnancy on later child outcomes (see http://www.bris.ac.uk/news/2017/september/drinking-during-pregnancy.html for more details), and the confusion this generates with conflicting press reporting of 'safe' levels of substance use public health guidance for pregnant women. The research will also consider childhood exposure to parental alcohol consumption and later child/adolescent/young adult alcohol consumption and resulting patterns of criminality and personal injury. Evidence of complex health and social associations is lacking due to the challenge of building sufficiently rich and diverse data to inform these investigations. Our aim is that linked ALSPAC-HES-General Practice-Education records will inform understanding in this area and allow dissemination via relevant journals, press releases and appropriate networks as outlined in Outputs for Project 9.

Project 10 (Understanding drug use pathways on accident and injury)
Answering questions addressed in this research programme is crucial to understand drug use pathways and their antecedents and outcomes, through the life course. Contemporary and robust evidence drawn from large population samples is challenging given the complex and illicit subject matter. The aim is through linking a large scale population cohort (ALSPAC) with rich information on drug use with routine medical records (HES), we will be able to improve the understanding of the impact of drug use on accident and injury. The intention is that this evidence will help inform effective policy development and to help understand the resource burden on A&E and other injury treatment services resulting from drug use.

Project 11 (Understanding drug use pathways on mental health outcomes)
Answering questions addressed in this research programme is crucial to understand drug use pathways and their antecedents and outcomes, through the life course. Contemporary and robust evidence drawn from large population samples is challenging given the complex and illicit subject matter. The aim is through linking a large scale population cohort (ALSPAC) with rich information on drug use with routine medical records (HES and MHSDS), we will be able to improve the understanding of the impact of drug use on mental health and inform effective policy development.

Project 12 (parental and child alcohol use and later mental health and development outcomes): In part, this research will aim to address the evidence gap on in utero substance use exposure on child outcomes. The importance of this work has recently been highlighted in a systematic review of the effects of maternal alcohol consumption in pregnancy on later child outcomes (see http://www.bris.ac.uk/news/2017/september/drinking-during-pregnancy.html for more details), and the confusion this generates with conflicting press reporting of 'safe' levels of substance use public health guidance for pregnant women. The research will also consider childhood exposure to parental alcohol consumption and later child/adolescent/young adult alcohol consumption and resulting patterns of mental health and development outcomes. Evidence of complex health and social associations is lacking due to the challenge of building sufficiently rich and diverse data to inform these investigations. Via dissemination of study findings through the appropriate academic journals, press releases and local networks outlined in the Outputs for Project 12, the aim is that linked ALSPAC-HES-MHSDS-General Practice-Education records will inform understanding in this area.

Project 13 (aetiology of psychosis)
The main research objective is to obtain accurate estimates of how common psychosis-related outcomes are in the general population at the age of 24 years, and to use data from primary and secondary care to test whether the Psychosis-like Symptoms (PLIKS) interview used in the ALSPAC cohort is a valid measurement of psychosis. This will inform the interpretation of evidence from other studies using the PLIKS assessment. The secondary research objectives of this study are: i) to use the data from primary and secondary care to examine whether individuals lost to follow-up in the ALSPAC cohort are more or less likely to have a psychotic disorder, to help us understand to what extent research into psychosis in the ALSPAC cohort may be subject to bias; and ii) to identify early symptoms (prodromes) that occur in individuals who subsequently develop a psychotic disorder. The identification of prodromes may inform future initiatives to develop predictive algorithms and other tools to aid early identification of individuals with psychotic tendencies and study findings will support this via dissemination in relevant academic publications’ as detailed in the outputs for Project 13.




Project 14 (antecedents and health outcomes of intellectual disabilities and autism): Despite being disabling long term conditions, there is still very little research done on the causes or later life consequences of intellectual disabilities using unselected samples. Much of the research comes from clinical populations without control groups and thus liable to selection bias and confounding. This research will enhance the understanding of the antecedents and outcomes of these neurodevelopmental conditions including health inequalities. The project will improve the evidence base, and highlight issues that will be important for public health, service planning and commissioning. Dissemination routes detailed in outputs for Project 14

Project 15 (Patterns of engagement with health and education services as predictors of child looked-after or in-need status.
It is known that children in care have poorer health and education outcomes than those not in care. Early identification of children at risk of care status will aid early intervention. If the project identifies strong predictors it will investigate the potential for them being incorporated into a predictive tool to be used by health or social care professionals. Such a tool could be embedded in clinical software and improve the early identification of risk, a key challenge in the safe-guarding of children.

Outputs:

All investigations are due to be conducted between 2018 and 2020. Timings of the dissemination via journal articles will be constrained by the nature of the peer-review system. ALSPAC employ dedicated communications experts to assist with dissemination and engagement. Public and professional publicity (e.g. press releases, twitter posts, newsletter and facebook articles) will be coordinated with the publication of findings. Dissemination via conferences and workshops will occur throughout the project period using interim results. For all the investigations, we are committed to feeding back findings to our participants. Participants will be informed through the ALSPAC print and social media newsletters. ALSPAC have a strong track record of running study engagement events which are designed with input from participants. In recent years we have held ‘data linkage’ themed evening lectures (e.g. http://www.bristol.ac.uk/alspac/external/presentations/how-we-are-using-your-records.pdf) and ‘ResearchFest’ (http://www.bristol.ac.uk/alspac/events/researchfest2012/), a day-long event with a wide series of public lectures in Bristol. Periodically the study produces a book (e.g. http://www.bristol.ac.uk/alspac/go/21st-book/) or YouTube videos (https://www.youtube.com/user/children90s) that describe findings and how we use participant data. We work with national and local media to disseminate findings, along with local attractions such as the MSHED museum of Bristol Life. Study findings from the applications described in this application will be incorporated into future activities.

Our specific project level dissemination plans are:

Project 1 (The effect of substance use in adolescence on mental health): The findings will be disseminated through appropriate epidemiological and public health academic journals (e.g. Addiction, International Journal of Epidemiology, Epidemiology, Wellcome Open) and findings (including interim results) at conferences (e.g. Society Academic Primary Care, MRC Farr Institute). The study will also work with members of the NHS Bristol Health Impact Team – Directed by the Professor in Public Health and Epidemiology & Head of Population Health Sciences - to feed findings to local service providers.

Project 2 (Chlamydia testing, infection, and sequelae in young people): This research will lead to a better understanding of sexual health and testing behaviours in young adults. It therefore has the potential to impact on public health policy. Findings will be published in an appropriate epidemiology journal(s) or those dedicated to sexual health findings (e.g. International Journal of Sexual Health) and presented at conference (e.g. Society of Academic Primary Care).

The Deputy Chair of the NICE Public Health Advisory Committee ((PHAC-F) - a committee responsible for the development of NICE public health guidance) - who is also the Director of the NHS Bristol Health Partners sexual health for population and patients health integration team, will lead professional dissemination.

Project 3 (Assessing the Validity of Self-Reported Hospital Admissions and the Implications of study non-response): Insights from this work will be published in an appropriate epidemiology/survey methods journal (e.g. Society of Longitudinal and Life Course Studies, BMC Medical Research Methodology, Survey Research Methods), at similar conferences and via ALSPAC study website and the CLOSER longitudinal research consortium website. To ensure this information is fed back to the NHS we will send our project findings to the Care Quality Commission Survey Coordination Centre who facilitate NHS Surveys.

Project 4 (Investigating the accuracy of current estimates of self-harm): Results from the study will be published in a suitable epidemiology/psychiatry journal and via the ALSPAC study website. Preliminary work (based on those participants who provided consent to link their data with medical records) has been published in Archives of Suicide Research (http://dx.doi.org/10.1080/13811118.2015.1033121), and has been selected as a case study by the understanding patient data taskforce that is developing mechanisms to communicate recommendations from the third Caldicott Review to the public (https://understandingpatientdata.org.uk/case-study/investigating-self-harm-young-
To ensure this information is fed back to the NHS we will communicate our project findings to the Bristol Health Partners Improving Care in Self-Harm ‘STITCH’ Health Integration Team. The Professor of Epidemiology is the academic lead for STITCH and also a member of both England’s and Bristol’s Suicide Prevention Advisory Groups and works closely with Public Health England, and will feed back relevant findings into NHS and Public health strategy.

Project 5 (Early life causes of adolescent depression and anxiety): Outputs will be published in academic journals (e.g. BMJ Open, International Journal of Epidemiology) and will inform methodological understanding of self-reported and public policy development. The Investigators will work with the Professor in Public Health and Psychiatry (University of Swansea, who will not have access to the data) to disseminate findings.

Project 6 (Investigating the association between IQ and self-harm): Findings will be published in academic publications topical to the condition and/or epidemiological methods (e.g. BMC Medical Research Methodology). The researchers will work with the Professor of Epidemiology and the Professor in Public Health and Psychiatry to ensure wide dissemination of study findings within relevant NHS community (see Projects 4 and 5).

Project 7 (Enabling the cross validation of asthma diagnosis using combinations of symptom and physiological data with GP and Hospital records): Findings will improve the understanding of asthma research based on the ALSPAC study and other studies using similar methodologies. Understanding will be disseminated via the Medical Research Council and Asthma UK funded STELAR asthma research consortium. Findings will help support research by the Medical Research Council and Natural Environment Research Council ERICA study that will assess associations between traffic pollution exposure and asthma outcomes in ALSPAC index children. The findings will support the Professor of Paediatric Respiratory Medicine’s programme of work, as a part of which he was a lead contributor to the Royal College of Physicians Every Breath We Take report into the lifelong impacts of air pollution (https://www.rcplondon.ac.uk/file/2914/download?token=qjVXtDGo). Study findings will be disseminated through the network of clinical respiratory paediatricians.

Project 8 (Antecedent factors predictive of later ear disease):
The Senior Research Associate in Medical Statistics and the Professor of Community Child Health will use the data to conduct the research evaluation. Clinical expertise will be provided by a Research Fellow in Social and Community Medicine and a Lecturer/NHS ENT surgeon, neither of whom will be provided with access to the data. Academic findings will be published in journals (e.g. International Journal of Audiology, BMJ Open, PLoS ONE). Study findings will be disseminated via the ENT liaison with the local CCGs Clinical Policy Review Groups. On a national level the ENT Specialty Lead for the NIHR Clinical Research Network: West of England will disseminate via the ENT National specialty group.

Project 9 (parental and child alcohol use and later criminality and injury outcomes): This work has been funded by the UK Medical Research Council and findings will be disseminated through academic routes (i.e. public health and health practitioner journals such as the BMJ as well as conferences such as the Society of Academic Primary Care), press releases and feedback to Department of Health policy makers. The Director of the NHS Bristol Health Partners ‘Drug and Alcohol’ Health Impact Team and will feed findings through into local care providers via this network.

Project 10 (Understanding drug use pathways on accident and injury)
We will publish in academic journals (e.g. Injury, Injury Prevention) and present at conferences (e.g. Society Academic Primary Care). The Director of the NHS Bristol Health Partners ‘Drug and Alcohol’ Health Impact Team and will feed findings through into local care providers via this network.

Project 11 (Understanding drug use pathways on mental health outcomes)
We will publish in focused academic journals (e.g. Drug and Alcohol Review) and present at similarly focused conferences (e.g. Managing Drug & Alcohol Problems in Primary Care Conference). The Director of the NHS Bristol Health Partners ‘Drug and Alcohol’ Health Impact Team and will feed findings through into local care providers via this network.

Project 12 (parental and child alcohol use and later mental health and development outcomes): Findings will be disseminated through academic routes (i.e. public health and health practitioner journals such as the BMJ as well as conferences such as the Society of Academic Primary Care), press releases and feedback to Department of Health policy makers. The Director of the NHS Bristol Health Partners ‘Drug and Alcohol’ Health Impact Team and will feed findings through into local care providers via this network. Findings relating to self-harm and suicide will be disseminated via the Professor of Epidemiology and the Professor in Public Health and Psychiatry.

Project 13 (Investigating the incidence and aetiology of psychosis). The Professor of Psychiatry and the co-director of the NHS Bristol Health Partners Psychosis Health Impact Team will use their clinical networks to disseminate findings. In addition to these clinical routes, the team will disseminate findings via academic publication (e.g. Psychological Medicine, Social Psychiatry and Psychiatric Epidemiology, European Psychiatry, Journal of Affective Disorders, Biological Psychiatry) and conferences (e.g. RCPsych International congress, IMFAR, Society for Epidemiological Research, The International Society for Developmental Origins of Health and Disease).

Project 14 Antecedents and health outcomes of intellectual disabilities and autism) Research findings will be disseminated via appropriate academic journals in the field of medicine, psychiatry, epidemiology and public health (e.g. BMJ, British Journal of Psychiatry, International Journal of Epidemiology, Wellcome Open) with findings and preliminary results being presented at conferences (e.g. RCPsych International congress, IMFAR, Society for Epidemiological Research, The International Society for Developmental Origins of Health and Disease). We will also engage clinicians and service users through a variety of routes including ALDERN (Avon Learning Disability Education and research network- a network of clinicians, researchers and people with learning disabilities and their families. The lead investigator is an NHS consultant psychiatrist with extensive NHS roles.

Project 15 (Patterns of engagement with health and education services as predictors of child looked-after or in-need status.
Research findings will be disseminated by the emerging National Family Justice Observatory and the Children Looked After and In Need strands of the Administrative Data Research Network. We will publish our findings in relevant academic journals (e.g. Epidemiology, Wellcome Open, Child & Family Social Work, British Journal of Social Work, Adoption and Fostering). We will disseminate relevant project findings to charities (e.g. NSPCC) and the NHS England ‘National Looked After Children Safeguarding Sub Group’.

Project 16 (Comparison of proposed HES extract with ALSPACs historical HES extract). The findings will not be disseminated but will be used internally to determine further data management options.

Processing:

Process Stage 1: Linking ALSPAC participants to the NHS/NHS Digital demographic database
(this stage has already taken place and further linkage will only be applicable for those cohort participants not originally linked)

ALSPAC have provided the NHS Digital (then NHS IC) with the personal identifiers of its study participants. NHS Digital commissioned linkage of the ALSPAC identifiers to the NHS central demographic register (now the NHS Spine). The product of this linkage (a link between ALSPAC MR1048 ID to NHS ID for each participant) is stored by NHS Digital and can be used to identify ALSPAC participants amongst NHS Digital records. Additional linkage may be required for newly enrolled cohort participants (approximately 15,000 of 20,000 eligible families are enrolled, but small numbers of the remaining 5,000 continue to enrol). A new Study ID will be allocated to these records.

ALSPAC will securely provide NHS Digital with separate lists identifying (by Study ID) the MR1048:consent participants. The lists will be filtered for up-to-date consent/dissent/withdrawal from ALSPAC status prior to sending.

Process Stage 2: NHS Digital Extraction of Records
HES and MHSDS records of ALSPAC participants will be identified using the existing MR1048 link and NHS Digital will extract copies of participants records where found (with the same processing for ‘new’ cohort participants).

MR1048 extracts will be sent to the ALSPAC Data Safe Haven. The extracts will be identified by Study ID and a check identifier (Date of Birth) to allow validation of the linkage. The extract will be sent to ALSPAC via the NHS Digital secure methodology (e.g. secure download site in an encrypted file). As ALSPAC are able to map MR1048 ID back to the ALSPAC administrative database these data extracts should be considered as being identifiable (even if pseudonymised).

The extracts will be received into the ALSPAC Data Safe Haven; which is managed by a small, specialist, team of ALSPAC health informatics experts (employed by the University of Bristol). The data will be stored on a secure encapsulated virtual machine located at the University of Bristol. The safe haven is kept separately from the ALSPAC administrative database (which contains participant identifiers). The Data Safe Haven design has been adopted to restrict access to identifiable data used for secondary purposes and to support the de-identification of the data prior to the bulk of the data uses. The Data Safe Haven governance arrangements have been reviewed and approved by an NHS Research Ethics Committee (REC) and the Health Research Authorities Confidentiality Advisory Group (HRA CAG). The Data Safe Havens security arrangements have been independently audited and certified to the NHS IG Toolkit and ISO27001 security standards (described below).

Process Stage 3: Data processing in the ALSPAC Data Safe Haven
The ALSPAC Data Safe Haven was designed in accordance with NHS policy [3]. Incoming, identifiable, data is stored in an encrypted format on encrypted and firewalled demarcated server space. Access to this server space is restricted to the Data Safe Haven team (by user access controls and access is only permitted from a small number of desktop computers based in secure offices at the University of Bristol). On entry to the Data Safe Haven a copy of the data is archived. The data are processed for the following purposes:

i. Assess Data & Data Linkage Quality: The data extract is compared against the agreed extract specification to ensure the content (both in terms of variables supplied and patients included) is correct. The linkage between ALSPAC participant and NHS record is quality checked using check variables (e.g. NHS ID to ALSPAC ID link is checked using date of birth and gender). The data values will be subject to logical error checks to assess if the value is consistent with the expected values (as defined in the source documentation). Inconsistent values will be recoded to missing (i.e. ALSPAC will not attempt to infer a correct value);
ii. Derivation: Derived data are created in order to assist in the de-identification of the data (e.g. Age in days at the time of a health event will be derived from Date of Birth and the event date) and to distil records extracted from multiple sources into a cohort longitudinal record (e.g. age in days will allow accurate sequences of events to be created when combining NHS Digital data with other data), and to assist the research process (e.g. 1) a range of read codes, hospital admissions and prescription data are used to derive an indicator to whether an individual has had any interaction with the NHS relating to/or being coded as asthma, and 2) routine records are used to inform statistical techniques, such as multiple imputation, which can address missing self-reported data). All derivation routines are applied through computer syntax, which is stored along with a documented record of the derivations;
iii. Linkage: The extract is linked to the internal ALSPAC individual ID numbers. The quality of the match is checked (see above). Linkage success or failure is assessed and documented within the data set (e.g. we attempt to distinguish between failure to link due to a patient not seeking consultation, with failure to link due to insufficient identifiers and failure to link as the individual is resident outside of the catchment area of the data extract in question). The extract is processed to ensure it is harmonised with the ALSPAC longitudinal data set;
iv. De-Identification: The Safe Haven de-identification processes are designed to minimise the risks of disclosure through either: direct identification of an individual from a dataset (either accidentally or maliciously); through inference or through the potential of variables in combination to identify individuals; or the potential of inappropriately described outputs to identify individuals. The data are pseudonymised through removing NHS ID, name and address (where present). The extract is stored, within the Data Safe Haven, until information from it is requested for a research investigation.
v. Consent status checks: To account for changes in consent status over time the data extract is compared against a master consent list before being de-identified and made available for research (where further consent check stages are used, see Process Stage 6);
vi. Collation, Storage & Archiving: Copies of the data shared with researchers will be held securely within the Data Safe Haven. These will be used for audit purposes, to keep a record of research project sample selection (in order to allow follow-up assessments) and to fulfil the requirements that peer-reviewed findings are reproducible.
The identifiable data are only used for these data processing purposes, i.e. to facilitate and support research. The Identifiable data are not used in research investigations.

Process Stage 4: Participant Tracing Data
Where the data extracted from the NHS Digital relates to participant contact details and status (e.g. left England and Wales, fact of death) the members of Data Safe Haven staff will swap the ID used to extract the data for ALSPACs internal system ID and will then pass the information to the ALSPAC team whose role it is to maintain communications and relationships with participants. Neither NHS IDs or clinical data (beyond ‘alive/deceased’ status) will be provided to this team. The details are then used to update ALSPACs administrative database. These details are not provided to researchers, although address information is used to derive spatial identifiers and other values which are used in some research projects in a non-disclosive form.

ALSPAC will use a MRC Farr Institute ‘UK Secure eResearch Platform (UKSeRP) as a ‘secure research environment’ to combine records from different sources and to manage access to effectively anonymous sub-sets of combined records to specific researchers at a project level. UKSeRP is the technological infrastructure which supports the SAIL databank of Welsh routine health and administrative records. UKSeRP was developed by the Welsh MRC Farr Institute and is operated by two organisations: The NHS Wales Informatics Service (NWIS) and the University of Swansea Health Informatics Research Unit (HIRU). HIRU, through the MRC Farr Institute are making the UKSeRP infrastructure available to other research organisations. This means ALSPAC can make use of the full advantages of the secure research infrastructure developed to support SAIL by contracting the University of Swansea to provide a copy of the infrastructure to host ALSPAC data and data linked to ALSPAC. In this contractual arrangement, the University of Swansea will be Data Processor working to instruction from the University of Bristol who will be Data Controller (the contract will bind the University of Swansea to the same conditions (where relevant) as the University of Bristol have agreed to in their contract with the NHS Digital). UKSeRP has ISO27001 certification. This principle has been previously agreed as suitable for hosting linked NHS Digital records.

Process Stage 5: Linking ALSPAC participants to the UKSeRP
(this stage has already taken place and will not need repeating).
UKSeRP operates on a ‘split file’ approach to handling data; where identifiers are handled separately from clinical or individual attribute data. Identifiers are processed by NWIS (within the confines of the NHS); where they are processed by an algorithm which consistently converts incoming identifiers (e.g. NHS ID, name, date of birth) into an encrypted ‘Anonymous Linkage Field’ (ALF). In this way identifiers relating to the same person coming from multiple sources can be linked to the same ALF.

ALSPAC have already sent the identifiers to NWIS along with an externally meaningless ID number (KEY ID). NWIS have used the identifiers to create ALF IDs for ALSPAC participants. This is managed in such a way that 1) neither ALSPAC nor HIRU (who manage clinical data) are able to trace back ALF to a person’s identity and 2) ALSPAC are able to send clinical and other attribute data linked to KEY ID into the system which can then be automatically replaced with ALF in a ‘black box’ process.

Process Stage 6a & 6b: Sending NHS Digital and ALSPAC data from ALSPAC into the UKSeRP
ALSPAC research staff will replace the IDS on the de-identified data from the ALSPAC resource with the Key ID. We will then securely (using AES-256bit encryption) send the data into the ALSPAC UKSeRP via the automated ‘gateway’ upload appliance.

ALSPAC data safe haven staff will also conduct the same process on the de-identified (see Stage 3) HES and MHSDS data. We will then securely (using AES-256bit encryption) send the HES and MHSDS data with Key ID into the ALSPAC UKSeRP via the automated ‘gateway’ upload appliance.

Process stage 7:
The UKSeRP automated gateway system automatically replaces Key ID on incoming data with ALF ID (yet the system has no access to identifiers of the individuals used to produce ALF as these never leave the NWIS trusted third party). The data are then deposited in the ALSPAC UKSeRP. Meaning the ALSPAC staff have no means of linking ALF back to the ALSPAC databases, yet can use ALF to join records coming in from different sources or at different times (e.g. longitudinal updates).

Process Stage 8: Sub-setting and further anonymization of data prior to analysis
The researchers with approval to access the ALSPAC HES and MHSDS data will be created project specific ‘containers’ in UKSeRP that they can access. ALSPAC Data Safe Haven staff will sub-set the extracted data to minimise it to only the information needed to conduct the project investigation. Each project data set will be given its own unique ID. The researchers will not have access to the ALSPAC administrative database and therefore – given the technological, contractual, training and data management steps involved – the data can be considered to meet the Information Commissioner’s Office ‘effectively anonymous’ requirements (as defined in the ICO Anonymisation Code Of Practice – we include a separate document describing how our process meets the ICO requirements). Information about these hypotheses – and the use of NHS data sourced from the NHS Digital – will
be posted on the study website:

- www.bristol.ac.uk/alspac/participants/young-people/.

Participants have been notified about this information, and each study newsletter includes updates and reminders (e.g. page 2 of:

- www.bris.ac.uk/alspac/external/newsletters/Childrenofthe90s_familynewsletter_2015.pdf )

Participants are able to opt-out of each individual study (before the study starts). This mechanism for providing on going fair processing information was developed with the HRA CAG with input from the Information Commissioners Office.

Project specific datasets are risk assessed and disclosure control is applied as deemed appropriate. Further disclosure control ranges from suppression of rare values and outliers to a state where the possibility of disclosure is rendered so challenging that the data can be considered as being effectively anonymised in line with the HSCIC Anonymisation Standard for the publication of Health and social Care Data [4]. Case selections will be assessed for risks of disclosure through inference (e.g. where a sample selection is made on the basis of a health condition), where this is a risk the Safe Haven staff will add control or masking cases.

The ALF used in the hypothesis specific dataset will undergo secondary encryption (reversible by ALSPAC) using an algorithm specific to each project. This means that a researcher with multiple project will not be able to join data across the different datasets using ALF.

Participant consent status is checked as a final stage before making the data available to researchers.

Process Stage 9: Researcher access to data
Researchers are all contracted to University of Bristol (as described below). They will only be able to access the sub-partition(s) of the ALSPAC UKSeRP where their project specific data set is located. The UKSeRP technology restricts the actions that researchers can take, for example, it is not possible to plug in a USB stick, or to copy and paste or to connect from within UKSeRP to the internet. These restrictions – in conjunction with the training and binding agreements the researchers enter into – ensure good governance is maintained. Furthermore, the anonymization processes undertake (stages 3 and 6) are sufficient to reduce the risks of participant identifiably to a point that they are so remote that the data can be appropriately treated as effectively anonymous.

Researchers are allowed to remove data outputs (e.g. statistical findings, graphs, tables of aggregated findings) from UKSeRP through a controlled process where each output is reviewed and assessed for disclosure risk by ALSPAC Data Safe Haven staff prior to being released. ALSPACs Data Access policies require that researchers submit all publications, prior to submission for publication, to the ALSPAC Executive. The Executive Committee assess the publications for issues including checks for potential disclosure risks (e.g. tables summarising statistical outputs containing small cell counts). Disclosure checks will ensure compliance with the small number suppression rules contained within the HES Analysis Guide.

Data Specification: ALSPAC require life-course data from birth (i.e. maternity HES from 1990-1993) to the most recent finalised datasets (we appreciate that the records contained within different HES domains start at different points in time). This will allow the assessment of changing health status over time, changing severity of health status and the precursor health events leading up to health outcomes. ALSPAC require detailed information about these in order to build event sequence records comprising study collected information, linked health and social care records from NHS Digital and linked records from other providers (e.g. national pupil database records). The data request is limited to the cohort participants, but not limited geographically (given that our participants have moved away from the original cohort catchment area).

Information Security: ALSPAC are committed to maintain high standards of information security and recognise that this is a key component of our trust relationship with participants and data owners alike. To achieve these standards ALSPAC have developed an Information Security Management System and associated management and governance structure that has been certified as meeting the ISO/IEC 27001:2013 Information Security standard. ALSAPC have submitted an NHS IG Toolkit assessment (edition 14: 2016/2017) which scored 97% in our last assessment.

Participant Consent: ALSPAC have provided fair processing materials to all participants via a postal campaign (those we failed to contact will be excluded from the data extract request). The fair processing materials included a form through which participants could provide an explicit decision as to how they wanted their records to be used (returning this form was optional and the materials clearly described how ALSPAC would proceed with data sharing in the event of non-response). While the ‘fair processing’ campaign has concluded (having completed our REC approved protocol) ALSPAC continue to provide fair processing information via newsletters, the website and social media. Where we meet participants (e.g. at a study data collection clinic), we ask them to complete a form outlining their explicit preferences.

In the event the participant changes their mind, then ALSPAC have a defined ‘withdrawal of consent’ protocol, which is available to participants via the study website:

- http://www.bristol.ac.uk/alspac/participants/

The policy allows participants to tailor their involvement in the study; either by altering permissions for the use of their health records in a specific project, the use of their health records in general, or their continued involvement in the study.

Research Purposes: Observational epidemiology aims to build a body of evidence related to any given topic. The investigations detailed below are designed to add to the relevant evidence base within that field. In themselves, these will typically not directly change NHS process. However, if replicated elsewhere and found to be important through systematic review then this could lead to policy change (e.g. NICE guidelines are frequently developed using systematic reviews of evidence). This is in contrast to other types of research (e.g. randomised controlled trial interventions or drug trials) that may provide stronger evidence of causation and can hence can lead to more immediate impact. To ensure full potential for impact on health and social care system, we will ensure that the findings of our investigations are well placed to feed into this process through ensuring publication in peer-reviewed journals that are fully indexed (e.g. pubmed, medline) and contain strong descriptive keywords (i.e. the findings will be discoverable by those conducting systematic reviews). This is the standard pathway to impact for observational research. Where possible, we will also directly feed findings into national or local health care initiatives, and we describe this where relevant (see below).

The ALSPAC Data Safe Haven team who will process the data are University of Bristol contracted staff. The Safe Haven team will prepare the data extracts and also give ‘Data Science’ input into the research process (i.e. through offering expert guidance on ALSPAC, data linkage processes, and on the interpretation and statistical processing of linked records within an epidemiological context). As such they will undertake processing which from data management to research analysis.

Previous data extracts

ALSPAC received flagging and tracing extracts for many years. The study also, in 2013, received an extract of HES records for ~3,000 consenting index children. This extract was envisaged to be a technical pilot and to investigate exemplar hypotheses. While successful (see https://understandingpatientdata.org.uk/case-study/investigating-self-harm-young-people) this extract had restricted potential due to its small sample size. The overlap between the data extract requested in this application and this past application will be evaluated. If the data are found to be exact duplicates then the previous extract will be securely destroyed. If they are not equivalents, then the previous extract will be encrypted and archived. It will not be made available for new research, but may be used if our previously published work is challenged. Once the recommended period for retaining data is complete, it will then be securely destroyed.

MR529 - Early Life Origins of Insulin Resistance — DARS-NIC-148227-4H7DT

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Yes

Legal basis: , Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2012-01-18 — 2027-01-18 2018.01 — 2018.01. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

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
  5. MRIS - Personal Demographics Service
  6. MRIS - Scottish NHS / Registration

Objectives:

This project is designed to further understanding of the insulin resistance syndrome (syndrome X) which is characterised by impaired glucose tolerance, hypertension, elevated serum triglycerides and central adiposity, in relation to a range of risk factors acting throughout foetal development and during infancy and early childhood.

The research will involve tracing and conducting a follow up clinical examination and questionnaire survey on a group of 951 offspring of pregnant women who were enrolled in to a dietary supplementation trial in South Wales between 1972 and 1974.

Re contacting this cohort will allow antenatal maternal factors, indicators of foetal development, growth from birth to age five, infant feeding practices, illness during the first five years of life, socio-economic factors and blood pressure at age 5 to be related to the development of components of syndrome X in early adulthood.

The study will represent a considerable advance over previous investigations which have in general focused solely on post-natal measures such as birth weight and weight at one year or adult determinants of disease risk.

This cohort will be able to extend our understanding to both pre-natal and early childhood factors the may either directly influence risk of developing non-insulin dependant diabetes mellitus or interact with later risk factors such as adult body mass index and fat distribution.

The impact of geographic and socioeconomic variation on the incidence of hip fracture, and upon death and recovery after hip fracture. — DARS-NIC-30645-Z2Z2K

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Anonymised - ICO Code Compliant (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012, Section 251 approval is in place for the flow of identifiable data, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , 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, and Non Sensitive, and Non-Sensitive

When:DSA runs 2017-10-01 — 2020-09-30 2017.06 — 2017.11. breached contract — audit report.

Access method: One-Off

Data-controller type: UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Office for National Statistics Mortality Data
  3. Civil Registration (Deaths) - Secondary Care Cut
  4. HES:Civil Registration (Deaths) bridge
  5. Civil Registrations of Death - Secondary Care Cut
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

This request is necessary to enable a new study which will determine how much social deprivation affects outcomes after hip fracture in terms of death, recovery, institutionalisation, and readmission. The study will identify areas in the UK where hip fracture patients receive inequitable health care which is below the expected standard. The findings are designed to drive equal access to high quality services for all hip fracture patients across the country by influencing policy and the commissioning of services.

This 3 year program aims to establish:

1. Variation in the incidence of hip fractures across the different regional healthcare economies in
England and Wales, and how deprivation relates to incident hip fractures within these regions.

2. After sustaining a hip fracture, the effect of individual social deprivation on; (i) Day 7,
Day 14, Day 21, Day 30, Day 60, Day 90, Day 120, Day 182, Day 274, Day 365
mortality, (ii) length of hospital stay, (iii) walking ability (iv) return home (vs. need for institutionalised care), (v) 30-day readmissions and (vi) days spent in hospital over the next 12 months.

3. Whether the effect of social deprivation on the outcomes in Aim 2 varies across different regional healthcare economies in England and Wales; identifying healthcare providers/CCGs with suboptimal outcomes necessitating revision to commissioned services.

4. The financial cost to the NHS, by healthcare provider/CCG and deprivation, of readmissions (all and fracture-related) over the 12 months after hip fracture, or until death; generating valuable intelligence for NHS commissioners, supported by a systematic review of readmission avoidance post hip fracture.

Reducing health inequalities is a fundamental health care goal. This proposal is important as it will address the lack of information on the extent of regional variation on hip fracture incidence, or the impact of social deprivation across the different regional healthcare economies on fundamental health outcomes after hip fracture such as a death, mobility, institutionalization, and readmissions which carry such a high financial burden. Results are intended to influence national commissioning of hip fracture services and thus reduce health inequalities.

Yielded Benefits:

Yielded benefits are yet to be achieved whilst work continues on the analysis of the held data.

Expected Benefits:

Reducing health inequalities is a fundamental health care goal. This proposal is important as currently the extent of regional variation on hip fracture incidence is not known, nor the impact of social deprivation across the different regional healthcare economies on fundamental health outcomes after hip fracture such as a death, mobility, institutionalization, and readmissions which carry such a high financial burden.

Benefits to patients and the health system:

Around 60,000 older adults fracture a hip each year in England. As our population ages, fracture numbers are predicted to rise. Fractures represent a major trauma for individuals and a significant societal burden, both through direct medical costs (UK predicted £2.2 billion by 2025), and important social sequelae. Details regarding 95% of hip fractures are now routinely recorded through the National Hip Fracture Database (NHFD); after adjusting for case-mix, by 30-days between 3 and 17% of patients will have died and 5 to 75% will have returned home; percentages vary across the 186 NHS hospitals. Mean acute hospital length of stay varies from 9 to 32 days. Health and healthcare inequalities still persist.

Previous research has established lower socioeconomic status is a predictor of poorer health outcomes, associated with increased rates of incident hip fracture in Nottingham, whilst regional variation across the country is unknown. Previous research also shows that nationally there are identified geographic and socioeconomic variation in the provision of elective hip replacement , found that socioeconomic deprivation predicts poorer post-operative outcomes, and showed socioeconomic deprivation reduces the chance of returning to one’s own home following a hospital admission with a fall. Recent results suggest patients from deprived areas in southwest England, despite being younger, are more likely to be transferred to community rehabilitation hospitals following hip fracture, than be discharged directly home, with consequently longer lengths of stay in the NHS.

A third of hospital expenditure is spent on those in the last year of life, with 58% of UK citizens dying in hospital. Hip fracture is the commonest cause of injury related death. One-year mortality following hip fracture is approximately 30%. Lower socioeconomic status predicts higher inpatient mortality after hip fracture in England; however, the relationship with 30-day and one year mortality has not been defined nationally.

This research will investigate and quantify the true impact of deprivation on hip fracture outcomes and to identify deprived healthcare regions, with potentially the poorest outcomes, where peri-operative inpatient care may not be optimal.

Emergency 30-day readmissions following hip fracture have risen progressively over 10 years in England from 8.3% to 12.0%. The extent to which survival, co-morbidity, geographic and socioeconomic factors influence this trend has not been assessed. Given the high financial burden of readmissions, such data will have high utility to policy makers (e.g. Public Health England) and those commissioning local hip fracture services (e.g. Clinical Commissioning Groups (CCGs) in England).

Understanding the effects of deprivation on the incidence of hip fracture, the outcomes after hip fracture and the cost implications, and how this all varies across different parts of the country, will identify those health systems with greatest need, in greatest need of reform, and potentially those to be high-lighted as ‘gold-standards’. This research will ensure these patterns can be understood in order to design and implement change, to drive down the current health inequalities, improve patient health outcomes and reduce the economic burden on the health system.




Outputs:

The intention is for each of the 4 aims to produce at least one peer-reviewed published paper (target journals include: The BMJ, Osteoporosis International, Journal of Bone and Mineral Research) and at least one conference abstract for national/international presentation (target conferences: The National Osteoporosis Society conference, the European Fragility Fracture Network conference, The Bone Research Society, the American Society of Bone and Mineral Research). These will be delivered sequentially over the course of the 3-year programme with the first publication targeted for submission by the end of 2016.

The types of journals to be targeted will depend on the nature of the findings. All outputs will contain only aggregated data, with small number suppressed in line with the HES analysis guide.

As part of this programme, a systematic review assessing the effects of deprivation on hip fracture incidence will also be completed and published.

In preparing this proposal advice was obtained from a Commissioner at NHS England, advisor to the National Osteoporosis Society (NOS) and RCP Fracture Liaison Service Database committee representative. He is well positioned, and with a vested interest, to help to disseminate our research findings in the interests of improving models of hip fracture care. He has a voice amongst NHS commissioners which will permit this research a direct path so that the findings directly influence national commissioning and hence lead to improved patient care. The rates at which patients need to move to care homes and the costs incurred through hospital readmissions are of crucial importance to commissioners.

This research is funded by the NOS and hence we will work with the NOS’ publicity office to disseminate our research findings.

The data produced by this study will inform Public Health England (PHE), for whom elimination of health inequalities is a priority target: PHE direct local organisations towards appropriately commissioned services.

Given current political priorities, it is also planned that findings will be disseminated directly to Westminster MPs. Furthermore, the Welsh Assembly clearly prioritized the tackling of health inequalities in its publication ‘Fairer Health Outcomes for All: Reducing Health Inequalities in Health Strategic Action Plan’; stating that currently there is little evidence of differential impacts on different socio-economic groups. One of the leaders of the study is well placed as National Hip Fracture Database (NHFD) clinical lead to feedback the findings to key stakeholders, such as the Royal College of Physicians. .

Findings will further be disseminated by the NHFD Publications and Scientific Committee which the applicant takes over as chair of this committee in May 2017.

Processing:

Only substantive employees of Bristol University will access the disseminated data and only for the purposes described in this document .

Under this application/Agreement, a pseudonymised extract of linked NHFD and HES/ONS data will supplied by NHS Digital to University of Bristol. The data will be exclusively stored on University of Bristol’s servers and will not be accessible to any third parties.

Data flow:
1. The cohort will be provided for linkage from Crown Informatics (who are the DP for the NHFD but play no other role in this application and receive no linked data) who will supply NHS number, DOB and postcode.
2. NHS Digital will link HES and ONS data to the cohort and patients with related ICD/diagnosis codes.
3. NHS Digital will supply the linked pseudonymised data to Bristol (replacing date of death with death status at various stages in one year).

Over the course of a 3-year programme, the data will be analysed to produce research outputs in relation to the four aims listed above. The processing activities for each aim will take place in sequential order but there will be overlaps between the processing activities for different aims. The analyses and statistical programmes written will differ for each aim and different variables will be used.

For the 4 study aims, the respective processing activities are as follows:
1. Three years of data will be analysed to calculate rates of different types of hip fracture for different age groups amongst men and women across 11 geographical regions in England and Wales. Then the study will look at how these rates vary according to levels of social deprivation. Social deprivation will be measured using the Index of Multiple Deprivation (IMD).

2. The study will determine how levels of social deprivation relate to a range of outcomes after hip fracture, including:
a. A patient’s ability to walk indoors and outdoors 30 days after sustaining a hip fracture
b. Rates of death 2 days, 14 days, 21 days, 30 days, 60 days, 90 days, 120 days, 182 days, 274 days and 365 days after sustaining a hip fracture
c. How long patients stay in hospital, and afterwards in rehabilitation hospitals, after sustaining a hip fracture
d. How often patients are able to return to their own home, or whether they need to move to live in a care home, after a hip fracture How often patients need to be readmitted to hospital having been discharged after an admission with hip fracture; calculating the total number of days spent in hospital in the year following a hip fracture.

3. The study will investigate how the relationships established in Aim 2, between social deprivation and hip fracture outcomes, vary across 11 different geographical regions (and smaller subgroups within these regions) in England and Wales. It will be determined whether these relationships vary according to whether patients live in rural or urban environments, or whether they are treated in larger teaching hospitals or smaller district general hospitals). The study will determine to what extent hospital characteristics explain difference in patient outcomes after hip fracture, such as delays in operating, access to medical assessment, specialist geriatricians, a full multidisciplinary team, fracture liaison services

4. The study will calculate the total costs associated with hospital readmissions following a hip fracture for each region and clinical commissioning group. The study will also perform a detailed review of the scientific literature to assess measures to avoid hospital readmission after hip fracture so that both the financial impact and the current evidence based can be presented to commissioners and policy makers.

Project 35 — DARS-NIC-207953-Q9H2M

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

Purposes: ()

Sensitive: Sensitive, and Non Sensitive

When:2016.04 — 2016.11. breached contract — audit report.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Flagging Current Status Report
  3. MRIS - Personal Demographics Service

Objectives:

The Cleft Collective project's aim is to create the infrastructure, capacity and resources necessary to gain important new knowledge that will advance our understanding of the causes of cleft lip and/or palate, inform treatment and ultimately improve the lives of children, adolescents and adults with the condition through the creation of a Birth cohort study and a Five-Year cohort study.  

We are conscious of the fact that a member of our cohort may die while we are out of contact with the study family and we wish to minimise the risk of upsetting them by attempting to make contact without knowing the circumstances.

We also believe that learning of an individual's cancer registration will provide vital health information for this research project. Through continued notification of these data, The Cleft Collective will accumulate data that will enable studies to be undertaken on the environmental and genetic factors related to cleft.

To clarify, we would like to receive the full range of data provided by the IC Flagging and Tracing service.

Statistical analysis will take place at such times as the numbers in any particular group suggest that this would be feasible. Statisticians and researchers do not have access to the personal details of the study participants. Disclosure control mechanisms will be employed to limit the risk of disclosure through small cell counts.

Project 36 — DARS-NIC-147773-9G6ZN

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N

Legal basis: Section 251 approval is in place for the flow of identifiable data, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Purposes: ()

Sensitive: Sensitive

When:2016.04 — 2016.11. breached contract — audit report.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

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

Objectives:

The purpose of the proposed research is to evaluate the effectiveness and cost-effectiveness of population-based screening for prostate cancer. This study will allow an unbiased comparison between men screened for prostate cancer and those not screened. The data generated will provide policy relevant data for one of the most controversial issues in health care: the potential impact on the UK population of screening for prostate cancer

Project 37 — DARS-NIC-30560-W4V1T

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

Purposes: ()

Sensitive: Non Sensitive

When:2016.04 — 2016.08. breached contract — audit report.

Access method: One-Off

Data-controller type:

Sublicensing allowed:

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care

Objectives:

Between 2003 and 2006 the DRIFT study recruited premature infants with post-haemorrhagic ventricular dilatation. Infants were randomised to receive a novel treatment (drainage, irrigation and fibrinolytic therapy [DRIFT]) or standard therapy which consisted of lumbar punctures and if needed a ventricular reservoir to drain cerebrospinal fluid. Initial results (at age 2) were promising.

In 2014, the NIHR Health Technology Assessment programme funded the DRIFT research team (based at University Hospitals Bristol and the University of Bristol) to conduct long term follow up of children at school age (i.e. 9 to 11 years). The aims of this long term follow up were to:

1) To compare cognitive function, visual function, sensorimotor ability and emotional wellbeing, between the two treatment groups in the DRIFT trial at school age.
2) To quantify functional status and use of community and specialist health and educational services.
3) To estimate the economic cost and outcomes of the DRIFT intervention by age 11, and model long-term costs and outcomes.
4) To quantify degree of ventricular dilatation and neurosurgical sequelae in the two treatment groups by clinical neuroimaging.

As part of aim 3, the University of Bristol requests data from HSCIC on hospital care received by DRIFT participants since birth. The specific requirement is for Hospital Episode Statistics (HES) data on the subset of DRIFT participants who were born in England and whose parents have provided consent for us to access routinely collected health data.

The analysis of HES data is taking place solely at the University of Bristol. The data will not be made available to any third party. Without these data from the HSCIC it would not be possible to judge whether the initial cost of the DRIFT procedure results in subsequent savings to the NHS through reduced hospital care during the first 11 years of life. If the initial costs of DRIFT are justified by NHS savings and improved health outcomes for children, this procedure will become used widely across the NHS.

Expected Benefits:

Infants born prematurely are at high risk of brain injury and major disabilities/neurodevelopmental impairments later in life. Bleeding into the ventricles of the brain is one of the most common consequences of being born very early and has a very high rate of serious disability such as cerebral palsy and learning difficulties. Drainage, irrigation and fibrinolytic therapy (DRIFT) was developed as a method of washing out the ventricles to clear the effects of the bleeding. The DRIFT randomised trial was conducted in 2003-2006 among 74 premature babies (with parental consent) with bleeding into the ventricles. Babies were randomly allocated to get either DRIFT or standard therapy. When neurodevelopment was assessed by “blinded” observers at 2 years, severe disability or death was significantly reduced in the DRIFT group. There was a large reduction in severe learning difficulties from 59% to 31% in the DRIFT group compared to the control group. However longer term follow up at school age is needed as cognitive testing at 2 years is limited and can be difficult in children with motor impairment.

In its current guidance to the NHS, NICE currently does not recommend drainage, irrigation and fibrinolytic therapy (DRIFT) because there is insufficient evidence. If the DRIFT school age follow up study demonstrates that DRIFT is effective for children and cost-effective for the NHS, NICE will update its recommendations. If so, measurable health benefits among thousands of premature infants with bleeding into the ventricles of the brain treated with DRIFT would be expected from 2017 onwards. Expected benefits range from saving babies' lives to improving lives (e.g. by enabling children to attend ordinary schools rather than specialised schools).

Results will also be relayed to the patient group via newsletters and will be shared with relevant charities such as Bliss.

Outputs:

1) Final report to the NIHR HTA which will contain a chapter including a comparison of the use and cost of hospital care among participants in the DRIFT trial. It is anticipated that the final report based on the HES data will be submitted in Autumn 2016.

2) Peer reviewed article reporting on the cost effectiveness of the DRIFT procedure in a high impact medical journal. Target date late 2016.

3) Results of the DRIFT school age trial will be presented at the European Academy of Paediatric Societies, Geneva October 2016.

4) The University of Bristol will notify the NICE interventional procedure advisory committee of its findings so that they can update the NICE guidance, should the evidence support this.

All outputs will include only aggregate data with small numbers suppressed in line with the HES Analysis Guide. No record level data will be shared with any third parties.

Processing:

1. The DRIFT project team at University Hospitals Bristol (UHB) will prepare a file containing the DRIFT study participant ID and patient identifiers (NHS number, date of birth and postcode at birth) to allow linkage to HSCIC data. Parents have provided informed consent for hospital episode statistics to be used in this research project. This file will be securely transferred to the HSCIC.

2. The HSCIC will use the identifiers to link to non-sensitive HES data on hospital admissions since birth. The HSCIC will prepare a file containing the DRIFT study participant ID linked to HES Pseudo ID (where a match has been found) and HES data. This file will be securely transferred to the DRIFT project team at the University of Bristol under the provisions of the Health & Social Care Act 2012.

3. All data analysis will be performed by the DRIFT project team at the School of Social Medicine, University of Bristol (UOB-SSCM) according to its System Level Security Policy (SLSP) for HES data.

4. Upon receiving the data from the HSCIC, UOB-SSCM will store it on its secure server located at Canynge Hall, Bristol. The data can only be accessed by authorized personnel with user accounts on UOB-networked computers. The network can be accessed remotely but all processing is logically on the server based at Canynge Hall and no data is removed from that server. Data will only be accessed by substantive employees of University of Bristol.

5. The data will be used to compare the use of hospital care between children who received the DRIFT procedure and those who received standard care. The pseudonymised data supplied by the HSCIC will not be reidentified nor linked with the UHB’s identifiable data or any other data.

Project 38 — DARS-NIC-148033-FMST7

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Purposes: ()

Sensitive: Sensitive

When:2016.04 — 2016.08. breached contract — audit report.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Scottish NHS / Registration

Objectives:

The Avon Longitudinal Study of Parents and Children (ALSPAC) is a prospective birth
Cohort study with detailed biological and behavioral data from before birth through till late adolescence and is organised as a resource for the whole scientific community (www.alspac.bris.ac.uk). Past assessments of ALSPAC participants have substantially been based on postal questionnaires, study clinics and increasingly through information obtained through linkage to routinely collected data.

The data collected via this arrangement will be processed and provided in a suitably secure and non-disclosive form to our research collaborators. The ALSPAC resource is used extensively to investigate a wide range of research questions. To date there have been over 450 publications (http://www.bristol.ac.uk/alspac/sci-com/pubs/) with many more topics being actively investigated.

Additionally these data will be used in an administrative function to help prevent causing distress to our study families through contacting them if there has been a bereavement. Embarkation and health authority data are used in our cohort tracking and tracing initiatives.

ALSPAC conduct many data extraction and linkage projects in order to answer our research questions. The use of NHS ID number allows for greater efficiency and accuracy. ALSPAC will provide full information and seek prior approval from NHS IC before commencing any research projects using the NHS ID number.