NHS Digital Data Release Register - reformatted
London School of Economics and Political Science (LSE)
Project 1 — DARS-NIC-354497-V2J9P
Opt outs honoured: No - data flow is not identifiable (Does not include the flow of confidential data)
Sensitive: Non Sensitive, and Sensitive
When: 2017/12 — 2020/02.
Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)
Categories: Anonymised - ICO code compliant
- Hospital Episode Statistics Admitted Patient Care
- HES:Civil Registration (Deaths) bridge
- Hospital Episode Statistics Accident and Emergency
- Patient Reported Outcome Measures (Linkable to HES)
- Hospital Episode Statistics Outpatients
- Civil Registration - Deaths
The London School of Economics (LSE) research team undertaking this application comprises researchers from LSE Health and Social Care and the LSE Research Laboratory. The research team will principally use HES and PROMs data to make three distinct contributions to health and social care within a single programme of research. The first contribution is to analyse the impact that various aspects of policy-development and reform of the NHS have had on patient outcomes, waiting times, and provider behaviour. The second contribution compares health care system performance in several countries with the aim of spreading best practice across different countries, with specific focus on lessons that can be learnt for health and social care policy within the NHS. The third contribution develops and tests a range of multi-dimensional indicators of health care quality and outcomes. All project outputs are published at an aggregate provider level, and the identification of individual patients or clinicians is not possible nor their behaviour identifiable. The purpose of receiving the data is to analyse the impact of on-going NHS reforms implemented between 2000 and the present day using pseudonymised non-sensitive patient-level data (further details of these reforms are provided below). These reforms were primarily associated with the introduction of two Acts of Parliament (the National Health Service Act 2006 and the Health and Social Care Act 2012) that changed both the organisational and payment structures of the NHS. The second Act of Parliament relies on on-going productivity gains to maintain efficient NHS output. The objective of the research programme is to assess the change in policy direction arising from these reforms, to better understand the impact of these reforms on patient outcomes and to improve the measurement of the impact of these reforms and to aid the efficiency with which they are implemented. Research deliverables are currently underway to examine the impact of the following reforms to the NHS and include the following: * Introduction of Payment by Results (2003-2006). * Implementation of waiting time targets for first outpatient appointment, elective surgery, and A&E attendances (2001-2005). * Introduction of the Quality and Outcomes Framework (2004). * Introduction of patient choice of hospital and GP surgery (2006-2008). * Introduction of independent care providers, both as part of the Independent Sector Treatment Centre programme and under the Any Qualified Provider programme (2003-2010). * Introduction of Walk in Centres for ambulatory care (2000-2010). * Introduction of the Alternative Provider of Medical Services GP contract (2004). * Expansion of primary care provision under the Equitable Access to Primary Care initiative (2007-2010). * Implementation of Equality and Human Rights Commission (EHRC) Memorandum of Understanding with the Care Quality Commission on equality and human rights in the context of healthcare (2011) * Introduction of Clinical Commissioning Groups in place of Primary Care Trusts (2013-2014). * Progress towards the Nicholson productivity challenge (2009-2015). * Introduction of new signals of hospital outcomes and performance, including the NHS Choices website (2006), Patient Reported Outcome Measures (2009), the NHS Staff Survey (2003), and various NHS Patient Satisfaction and Patient Experience surveys. Each of these research deliverables form part of the first contribution to health and social care outlined above, by analysing a specific policy introduced within the NHS over the last 15 years. Each of these deliverables also forms part of the third contribution to health and social care, in that each focuses on analysing the impact of a particular policy or reform on one or more multi-dimensional indicators of health care quality and outcomes. The research team has primarily progressed the second contribution to health and social care – a cross-country comparison of health care system performance – via a project entitled “Do Financial Incentives Trump Clinical Guidance?: The case of Hip Replacements in England and Scotland” that examines the impact of financial incentives on clinicians’ decisions in England and Scotland. Making further progress toward this second contribution to health and social care will be a major focus of the research programme over the next 2-3 years. Using patient-level data is necessary for risk adjustment at the patient level, thereby allowing control of confounding factors that will affect the analysis. Using patient-level data is also necessary to construct various inputs into the analysis -- for example, percentiles of distance from patient's GP surgery to hospital of admission, which are needed to construct indices that define hospital referral markets and potential areas of competition. All programme outputs produced thus far have been published at an aggregate provider level, where no individual patients or clinicians are identified or identifiable. The applicant intends to continue publishing project outputs on this basis, i.e. at the provider level and without identifying individual patients or clinicians.
The main outcome of the presentation at the Wennberg International Collaborative was simply to raise awareness about the research findings amongst policymakers and practitioners. Earlier work compiled by the research team (Cooper et al 2011) was cited by the then Prime Minister in support of the Health and Social Care Act 2012, which expanded choice and competition within the NHS. The research also helped to ensure that these reforms did not introduce price competition between health care providers, as had initially been proposed. The work on hospital quality and on choice and competition has been used by NHS Monitor (now NHS Improvement) in their measurement and analysis of hospital efficiency measurement, which forms one strand of their work to identify inefficient hospital trusts. The project lead has since worked with NHS Improvement to aid this strand of their work, and the work in this area also led to him becoming an adviser to the UK Competition and Markets Authority investigation into the Private Health Care Market which led to a range of measures being implemented in 2014 (see https://www.gov.uk/cma-cases/private-healthcare-market-investigation).
The applicant’s research programme has multiple outputs that are being, and will continue to be, continuously disseminated to policymakers and policy analysts, via the types of channels outlined in the previous sections. The aim of the research is to benefit English health and social care by contributing to a better understanding of the impacts of past and existing health and social care policies. In so doing, the applicant hopes to contribute to more informed policymaking in the future. Previous success in disseminating the applicant’s research to policymakers is attested to by the fact that, in 2012, Prime Minister Cameron referred to their research outputs in a speech in support of his reforms to the NHS. Further evidence of the success of these dissemination efforts in delivering benefits to health and social care is attested to by the attached letter of support (SD2) for the applicant’s research programme from the Prime Minister’s adviser for health and adult social care. Referring to the draft project output “Does Competition Improve Public Hospitals’ Efficiency? Evidence from a Quasi-Experiment in the English National Health Service”, as well as to past research outputs produced by the applicant, states that the applicant’s research “has informed the policy thinking at the highest levels of government and materially impacted policy formation for the better. His work serves as a prime example of how research can improve policy and make a positive impact that is felt outside of academia.” LSE's research on NHS Walk-In Centres, which had already been disseminated to policymakers in Monitor and Department of Health at the time of last application, has now percolated down to CCG level and is being used to inform commissioning decisions. See for example: • http://www.dorsetccg.nhs.uk/Downloads/aboutus/CCG%20Board/18%20March%202015/09.7%20x%20Appendix%201%20180315.pdf. • https://www.bristolccg.nhs.uk/media/medialibrary/2016/09/bccg_front_door_rapid_evidence_review2016-09-16.pdf.
The expected outputs consist of research reports and published papers, and discussions and presentations to UK health and social care policymakers, policy analysts, and clinicians. A list of outputs to date is provided below. The primary target audience for these outputs is the health policy community. This includes policymakers, as a key aim of the research is to investigate the impact of recent changes to health and social care policy, with an ultimate objective of influencing future policy formation. However, it also includes other policy analysts, such as (but not limited to) those at the Health Foundation, the King’s Fund and Nuffield Trust, who, while they may not be directly involved in the policy formation process, do have an important influence over the terms under which health policy is debated and therefore formulated. A secondary target audience is the medical community that has been responsible for implementing many of the policy reforms analysed, and whose decisions therefore determine the success of these reforms, and the nature of their impacts. The main outputs of these reports and papers will be estimates of the statistical relationship between different variables and the pursuit of establishing causal linkages between policy reform and health and social care outcomes. A few of these variables (e.g. whether a patient is discharged as dead) appear directly in HES, but most (e.g. length of hospital stay, patient severity aggregating across multiple diagnoses, hospital productivity, or intensity of competition to which a hospital is exposed) are constructed using multiple underlying HES variables. HES data will only feature directly in the outputs of these research projects in tables of summary statistics that report properties of key variables used in the analysis (such as minimum, maximum and average values). No data or datasets using HES data will be published or made available, either at the individual patient level or at an aggregate level, as part of this programme of work. The data will not be used for any commercial purpose. Several project outputs are already available in draft form, and are expected to be published in final form over the next 1-5 years. Draft project outputs already produced In the applicant’s field of work, the life cycle of a research project can be roughly summarised as follows: work in progress presentation (slides only); unpublished mimeo; Working Paper (which may also be a final output, or may be progressed to academic journal submission); submission to academic journal (if relevant); and publication of final report or journal article. Irrespective of the final publication location, the research team takes substantial effort to disseminate its outputs by presenting findings to policymakers and policy analysts. The following research projects are at work in progress stage (slides available on request): • Ted Pinchbeck: “Taking care of the budget? Clinical decisions and Patient Outcomes under recent NHS reforms”. • Tom O’Keeffe and Matthew Skellern: “Do altruistic hospitals and profit-maximising hospitals respond differently to competition?”. • Zack Cooper and Stuart Craig: “Home for the Holidays: Evidence on the Relationship Between Prospective Payment, Length of Stay, and Patient Outcomes”. The following research projects are at mimeo stage (papers available on request): • Matthew Skellern: “The hospital as a multi-product firm: Measuring the effect of hospital competition on quality using Patient-Reported Outcome Measures”. • Zack Cooper, Steve Gibbons and Matthew Skellern: “Independent Sector Treatment Centres in the English NHS: Effects on neighbouring NHS hospitals”. The following research projects are at Working Paper stage: • Ted Pinchbeck: “Walk This Way: Estimating Impacts of Walk in Centres at Hospital Emergency Departments in the English National Health Service”, SERC Discussion Paper 167, http://www.spatialeconomics.ac.uk/textonly/SERC/publications/download/sercdp0167.pdf. • Zack Cooper, Stephen Gibbons, Simon Jones and Alistair McGuire: “Does Competition Improve Public Hospitals’ Efficiency? Evidence from a Quasi-Experiment in the English National Health Service”, CEP Discussion Paper 1125, http://cep.lse.ac.uk/pubs/download/dp1125.pdf. The following papers are under review for academic journal publication (papers available on request) • Alistair McGuire and Irene Papanicolas: “Do Financial Incentives Trump Clinical Guidance?: The case of Hip Replacements in England and Scotland” (for slides see: http://www.slideshare.net/OHENews/do-financial-incentives-trump-clinical-guidance-apr15). • Alistair McGuire and Irene Papanicolas: “Measuring and Forecasting Hospital Quality”. Dissemination of draft project outputs This is a non-exhaustive list of the formal and informal methods by which the applicant has disseminated their draft project outputs to policymakers, policy analysts and clinicians. The attached ESRC Outstanding Impacts Application Form by Professor Zack Cooper, a founding member of the applicant’s research team, outlines some of the applicant’s efforts to disseminate draft project outputs to policymakers through to 2013. Since 2013, draft outputs of the applicant’s research projects have been disseminated directly to policymakers in the following ways: • Seminar presentation to Department of Health, July 2015. • Seminar presentation to Office of Health Economics, May 2015 (attended by representatives from Monitor and Department of Health). • Presentation of research to Department of Health group, March 2015. • Meetings to report draft project outputs to representatives of Monitor and Department of Health. In addition, the draft project outputs have been presented to the following fora that have been attended by policymakers and policy analysts: • Health Economics Study Group (January 2015). • Royal Economics Society Meeting (March 2015). • LSE Spatial Economics Research Centre Conference (March 2015). • LSE STICERD Work in Progress Seminar (October 2013) (attended by representatives of Royal College of Surgeons). • Informal workshop involving representatives from King’s Fund, and former Prime Ministerial advisors and heads of regulatory bodies (June 2015). • Joint LSE-Dartmouth College workshop on Medical Practice Variations (September 2014). Finally, the research outputs have been reported in media sources widely read by health policymakers and thought leaders, including (this is a very incomplete list) the Health Services Journal, The Guardian, The New Statesman, The Daily Telegraph, and The Financial Times. For further details, see the attached ESRC Outstanding Impacts Application Form by Professor Zack Cooper. (SD1) Update October 2016: New Work in Progress • Alistair McGuire and Victoria Serra-Sastre (2016), “The relationship between new technologies and workforce in English hospitals”, October. New mimeos (available on request): • Tom O’Keeffe and Matthew Skellern (2016), “Do altruistic hospitals and profit-maximising hospitals respond differently to competition?”, April. • Tommaso Gabrieli, Mireia Jofre-Bonet, Alistair McGuire, and Matthew Skellern (2016), “Patients’ choice and hospital quality competition: Unintended impacts of the signals”, October. • Jose-Luis Fernandez, Alistair McGuire, and Maria Raikou (2016), “Coordinating Hospital Discharges: Bed Blocking in England”, October. New Working Papers: • Ted Pinchbeck (2016), “Taking Care of the Budget? Practice-level Outcomes during Commissioning Reforms in England”, SERC Discussion Paper 192, February, http://www.spatialeconomics.ac.uk/textonly/SERC/publications/download/sercdp0192.pdf. • Zack Cooper, Stephen Gibbons and Matthew Skellern (2016), “Does Competition from Private Surgical Centres Improve Public Hospitals’ Performance? Evidence from the English National Health Service” CEP Discussion Paper 1434, June, http://cep.lse.ac.uk/pubs/download/dp1434.pdf. New academic journal publications: • Irene Papanicolas and Alistair McGuire (2016), “Measuring and forecasting quality in English hospitals”, Journal of the Royal Statistical Society: Series A, May, ISSN 0964-1998. • Irene Papanicolas and Alistair McGuire (2015) “Do financial incentives trump clinical guidance? Hip replacement in England and Scotland”, Journal of Health Economics 44, pp.25-36, ISSN 0167-6296. Since the last application, LSE have disseminated their research to individual contacts in NHS Improvement, Department of Health, the Competition and Markets Authority, and the Health Foundation. In 2015, LSE presented their research on the tension between financial incentives and clinical guidance to a Department of Health Seminar. In September, LSE presented their research on the impacts of hospital competition to the Wennberg International Collaborative on unwarranted variations in health care utilisation and outcomes. This high-level forum included representatives from Monitor/ NHS Improvement, NHS England, and NHS Scotland, as well as senior representatives from other health care systems around the world. In November 2016, LSE will be presenting their research on the impacts of hospital competition to a seminar at the Competition and Markets Authority. Our findings have a direct bearing on the CMA’s decision-making process concerning hospital mergers. In November 2016, LSE will also be presenting their research on the impact of new medical technologies within the NHS to the Health Foundation. This will be a stepping stone to disseminating this research to widely to policymakers and the broader health policy community.
Data provided by HSCIC is stored on a dedicated secure data server housed within the LSE that is only accessible to researchers authorised to use the data. Within the Secure Server, the raw HES data is stored on a SQL Server, providing a second layer of security. Researchers extract only the HES records they need using an ODBC connection that securely imports the required data into Stata. Statistical analysis conducted in Stata is also restricted to take place on the Secure Server -- the data remains on the Secure Server at all times. Individual project data are held in working files on the Secure Server. All data held on the Secure Server is encrypted; see the attached System Level Security Policy for further details. Once final tables of results (e.g. regression tables, summary statistics) are produced, there is a monitored and highly restricted facility allowing researchers to remove such outputs from the Secure Server, to allow reproduction within reports and other deliverables. As noted above, these final outputs contain aggregate provider level data only, do not identify (or allow the identification of) any individual patients or clinicians, and comply with the HES Analysis Guidelines on suppression of small numbers. All data users are required to sign a data use agreement forbidding the removal of patient-level data from the Secure Server. All printing functionality on the Secure Server is disabled. HES and PROMs data have been merged together at the individual patient level using the epikey field provided for this purpose by HSCIC. A small number of other publically available data sources (e.g. North West England unemployment rates) have been merged to the HES/PROMs data, in order to allow researchers to control for demographic or socio-economic characteristics of health care providers or geographical areas at a given point in time. These data sources include postcodes and latitudes/longitudes of health care providers to help define referral markets and areas of potential competition; area deprivation indices to aid in the risk-adjustment of outcomes; and hospital-level data such as annual admissions and NHS Staff Survey results. These data sources are only ever merged on the basis of provider-level fields (e.g. trust code, site code, region of England, or MSOA) and date fields (year, financial year, quarter or month). While it is not feasible to provide an exhaustive list of data sources that will be merged into HES/PROMs or of HES/PROMs fields that will be used for merging – on the grounds that research is fundamentally a discovery process and it may become desirable, in the future, to incorporate new data sources, merged on the basis of hitherto unused (for merging) HES/PROMs fields -- as the research progresses, merging of data will only be undertaken at the provider level and therefore will not compromise the anonymity of patients or clinicians. Any additional data sources used are always (with a single exception, noted in the next paragraph) fully anonymised, publicly available data that do not contain any individual-level information, but report average characteristics of large-scale geographical areas or health care providers at a given point in time. As such, the highly aggregated data that is merged into HES/PROMs cannot be used for patient identification, and cannot increase the risk of patient identification beyond the level of risk that is inherent to the pseudonymised patient level HES data itself. In addition to the small number of fully anonymised, publicly available data sources that the applicant will merge to HES/PROMs, the applicant intends to merge one additional data source to HES/PROMs that is fully anonymised but is not publicly available – namely the World Management Survey or WMS (http://worldmanagementsurvey.org/) which was conducted for English NHS hospitals in 2006 and 2009. The WMS data consists of survey responses by individual hospital managers concerning hospital management practices. There are between zero and two survey responses per hospital trust, with one observation per survey response. This data source will be merged to HES/PROMs using the trust code field. The WMS data is fully anonymised in that it does not contain any personally identifiable information about the hospital managers that completed the survey, other than the trust code. It is not, however, publicly available, in the sense that a research application must be submitted and approved the WMS Oversight Committee in order to obtain the version of the data that contains trust codes. No record-level data will be shared outside of the organisations named in the agreement.
Project 2 — DARS-NIC-309029-P7H1D
Opt outs honoured: No - data flow is not identifiable (Does not include the flow of confidential data)
Sensitive: Non Sensitive
When: 2020/12 — 2020/12.
Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)
Categories: Anonymised - ICO code compliant
- Hospital Episode Statistics Admitted Patient Care
This request to process HES data is made on the legal basis outlined in the GDPR, Article 6.1.(e). That is, this research establishes a task in the public interest as it is undertaken within the London School of Economics, and is necessary for the university to fulfil its function in the public interest (Article 6(e)). The LSE considers this project to be a task in the public interest due to the potential societal implications of the policy being evaluated - the Health in Pregnancy Grant (2009-2011). It is also impossible to analyse the impact of the grant on prematurity without this data, as gestational age is unavailable elsewhere. In terms of processing special category data (such as ethnicity), the legal basis is Article 9(2)(j) - that is, the research is conducted for archival, research or statistical purposes that are in the public interest. The research is proportionate to the aim pursued (see below). The researchers have agreed to respect the right to data protection at all times, and will carry out suitable and specific measures to safeguard the fundamental rights and the interests of the data subject, including ensuring non-disclosive output and the maintenance of data protection measures when using the data. This research establishes a public interest due to the societal implications of the policy under evaluation - the Health in Pregnancy Grant, 2009-2011. This grant was a lump sum of £190.00 given to all pregnant women in the UK from the third trimester of pregnancy, regardless of income or work status. In order to receive the grant, pregnant women had to make an appointment with their GP or midwife, when they would be invited to fill out a form. Participants would receive the money via a bank transfer within seven days. When the grant was introduced, policymakers made it clear that it had two main aims: first, to reduce low birthweight; second, to reduce prematurity. Both low birthweight and prematurity are associated with low-income and lack of funds during pregnancy for healthy nutrition and lifestyle. The rationale of the grant, therefore, was that boosting women's incomes during pregnancy, would facilitate the purchase and consumption of healthier food, invest in healthy lifestyle choices and reduce any financial stress caused by having a baby (for example, the grant could help to cover the large one-off cost of buying a buggy). This would, the government argued, improve birthweight and reduce prematurity. The grant cost over £130 million pounds a year and is estimated to have affected over 700,000 pregnant women a year. It is therefore a matter of public significance both in terms of its human impact and its cost to the public purse. The grant was also abolished in 2011 specifically on the grounds that it was ineffective. No follow-up study of the grant was made, and take-up was not recorded. A robust analysis of whether the grant was effective, therefore, is needed to investigate how public money is used, and whether it is being used efficiently and effectively. There is very strong evidence that health outcomes during pregnancy - birthweight and prematurity have a significant impact on future health, through childhood and adulthood. The grant was therefore seen as an early intervention policy which aimed to alleviate pressure on NHS services by reducing health problems throughout the lifecycle. By accessing the HES data, it is possible to identify whether the grant achieved this aim. To assess the impact of the Health in Pregnancy Grant on birthweight and prematurity in England, the London School of Economics will use a methodology called a 'Regression Discontinuity Design' which makes use of the arbitrary eligibility rule that was attached to the grant: all babies with due dates on or after 6 April 2009-16 April 2011 were eligible. This meant that if the mother had a due date of 5 April 2009, you were not eligible for the grant, but if you had a due date of 6 April 2009 you were. Since it is random whether you have a due date on 5 or 6 April, the LSE can make use of this to isolate the causal impact of the grant on birth outcomes. The methodology essentially mimics the setup of a randomised control trial, which is considered the gold standard in estimating the causal impact of policies. Expected week of birth (calculated using week of birth and gestational age) will be used as a proxy for whether an individual was likely to receive the grant or not. The LSE researchers require data from 2006-2014 as this includes a 3-year window before and after the grant was introduced. This will enable the researchers to check whether there were any notable changes in birthweight or prematurity over the period and check that the methodology is valid. The London School of Economics require NHS Digital to create a 'week of birth' variable. The week of birth variable is required in order to calculate women’s due dates, since due dates were eligibility criteria for the Health in Pregnancy Grant (all women with due dates of 6 April 2009 - 16 April 2011 inclusive were eligible for the grant). Month of birth would be too large a category as it would not enable the researchers to precisely identify how close a baby’s due date was to the eligibility cut-off, and it would therefore significantly reduce the effectiveness of their methodology. Date of birth would be very fine-grained, by contrast, but it would be identifiable. Based on existing research using birth registrations data accessed through the ONS, the researchers have concluded that week of birth is a practicable alternative to using date of birth.’ The data subjects are women who gave birth in England from 2006-2012 and their babies. Since the grant had a cut-off eligibility date, all births before 6 April 2009 act as the control group. The research builds on previous work conducted by the London School of Economics (LSE) using ONS Birth Registrations microdata (provided through the ONS's Secure Research Service). This work was awarded a Distinction and an academic prize as part of a Masters programme undertaken by one of the researchers at the LSE. This proposed follow up to the research has secured funding from the Social Policy Department at the LSE. It will be a standalone research project, unconnected to any wider programmes of work. This is a small standalone project, which is funded and will be disseminated on its own. However, it does run alongside a similarly-themed, wider programme of work within the Centre for Analysis of Social Exclusion (CASE) at LSE on the impact of recent social policy changes on outcomes. The Funder will not place any restriction or limitations on any publications and there is no time restriction on the funding given that the work is due to be completed in July 2020. The dataset requested and the variables selected within it are essential for this research. The LSE researchers need access to anonymised, record-level data including crucially: week of birth of the baby, birthweight and gestational age. The ONS's birth registrations data do not include gestational age, so it is impossible to assess the impact of the grant on prematurity without the HES data. 'Week of birth' will be used to avoid having to use identifiable (full date of birth) in calculating due dates and to minimise the amount of data required. Due dates will be used as a proxy to separate the sample into a treatment and control group. Gestational age is needed for two reasons: first, to calculate due dates (in conjunction with week of birth); second, to construct an outcome variable for prematurity. Other important outcome variables are birthweight, first antenatal assessment date (to see whether the grant incentivised women to seek medical advice earlier during pregnancy), healthy neonate indicator, postnatal stay, neonatal level of care, and the well baby flag. Other useful variables to serve as controls are sex of the baby, birth status, number of babies, number of previous pregnancies, ethnic category, and mother's age at birth. To see whether the impact of the grant differed depending on levels of deprivation, the researchers also need access to the Index of Multiple Deprivation and Lower Super Output Area. This will enable them to see how the effect of the grant varied across different groups (by IMD, ethnicity, etc), given that it may have mattered more to more disadvantaged groups. The purpose of the research cannot be achieved in a less intrusive way, as record-level data is necessary to implement this analysis of the impact of the grant on birthweight and prematurity. No identifiable or sensitive variables are being requested. The data has not been narrowed by demographics (e.g. age), clinical factors (e.g. diagnosis/procedure) or live/singleton birth status, since the aims of the Health in Pregnancy Grant were broad-based and universal, and as such were intended to improve birth outcomes for all women and babies, regardless of these characteristics. The researchers would like to investigate and compare the impact of the grant on stillbirths, live births, and multiple births, as it may be that the grant affected these groups differently. In terms of episodes, only maternity episodes are required - and specifically those variables that have been previously specified. The unborn child and neonatal records are fundamental to the purpose of this research as they enable the measurement of the health and status of the baby, which was the main target of the Health in Pregnancy Grant. In selecting the necessary variables, the researchers have been careful to minimise the amount of fields necessary to achieve the purpose of the research. Indeed, the request does not include any identifiable/high risk field. The data controller is the London School of Economics. The Data Processor will be the LSE specifically the LSE Secure Research Computing Governance Group, whose secure environment will be used for the data controllers to access the data. The VIRTUS datacentre provides physical storage of the data only - the processing is conducted by LSE only. The research is funded by the Social Policy Department at the LSE, and their role will be to help publish the findings of the research. This will include a public seminar, and the publication of a free working paper and/or copy of a peer-reviewed journal article via LSE Research Online.
The dissemination of the data benefits the provision of health because the stated aim of the Health in Pregnancy Grant was to promote and improve healthy birthweight and to reduce prematurity. Given the long-term impact of low birthweight and prematurity on a range of child and adult health outcomes, this is an issue of crucial importance. Assessing whether the Health in Pregnancy Grant was, in fact, effective at boosting these health incomes is therefore important to health. If the researchers found, for example, that the grant was effective in promoting healthy birth outcomes, then one possible implication could be that the grant should be re-introduced in order to improve the health of the population. Indeed, the researchers' preliminary research using ONS Birth Registrations data indicates that the grant led to an approximate 20 gram increase in average birthweight in England and Wales. The grant interacted with health services, since it was conditional on attending an ante-natal check-up from 25 weeks, and there is evidence to suggest that in Scotland the grant led pregnant women to seek health advice earlier in their pregnancy (Leyland et al., 2017). Using the 'first antenatal appointment' variable, the researchers will be able to examine the impact of the grant on how early women seek medical help during pregnancy. An evaluation of the effectiveness of the grant, and the political implications of that analysis, are therefore directly relevant to health and maternity services. The dissemination is in the public interest because the Health in Pregnancy Grant came at a significant fiscal cost to the public purse and was justified on the grounds of improving health outcomes. The public therefore have an interest in ascertaining whether that public money was well spent, and if so, whether the grant should be re-introduced to the public benefit. The outputs (peer reviewed journal submission and public seminar) will expand the evidence base on the impact of the Health in Pregnancy Grant on birth outcomes. It is hoped that it will be used to inform current policy debates about public health and early intervention. The researchers are in contact with a range of Members of Parliament who were vocal about the grant, and plan to keep them updated about the findings of the research. The findings of the research will also be communicated beyond academia to the public sphere and to citizens through engagement with politicians and stakeholders, a CASE seminar, writing blogs and articles, and social media. It is anticipated that a submission to a peer-reviewed journal will be made in 2021, when a CASE seminar can also be held. Given that the researchers' preliminary research from ONS Birth Registrations data suggests the Health in Pregnancy Grant had a positive impact on birth weight in England and Wales, it is anticipated that this will be mirrored with the HES data and possibly also hold for prematurity as an outcome. Positive outcomes could encourage politicians to consider the re-introduction of the Health in Pregnancy Grant. The Health in Pregnancy Grant cost £130 million a year and is estimated to have affected over 700,000 pregnant women and their babies a year. If this research found that the grant was effective and it were to be re-introduced, it could therefore have significant implications both fiscally and in terms of patient health. Conversely, if the research found that the grant was not effective and it confirmed that its abolition in 2011 was justified, this would strengthen the argument that it was a wasteful use of public funds and consolidate efficiency savings within the NHS. In terms of expanding the evidence base on the impact of the Health in Pregnancy Grant, that benefit would be achieved with the publication of the research in a peer-reviewed journal
The main output from the data analysis will be a submission to peer-reviewed academic journals, specifically the Journal of Health Economics alternatively the Journal of Public Health All figures produced will be aggregate figures (e.g. coefficients, means) and the researchers will ensure that each figure contains a sufficient cell count (e.g. the ONS's requirement of 10) to avoid disclosure of patient data. In addition to the peer-reviewed journal submission, the researchers intend to hold a public seminar at the Centre for Analysis of Social Exclusion (CASE) at the LSE at which the findings of the research will be presented to a range of stakeholders, policymakers and members of the public. The peer-reviewed journal is likely to require a fee from readers for access, but the full content will be made available for free via LSE Research Online, as part of LSE’s commitment to the Open Access model. The researchers may also write blogs or other short articles summarising the findings to ensure they communicate the findings of the research to wider audiences, including interested groups and civil society. The researchers' preliminary research from ONS Birth Registrations data suggests the Health in Pregnancy Grant had a positive impact on birth weight in England and Wales. Findings from this research will inform whether the Health in Pregnancy Grant was effective. The target date for the submission of the peer-reviewed journal and the CASE Seminar is 2021. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
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 flow of data from the London School of Economics into NHS Digital. Pseudonymised HES Admitted Patient Care data will flow from NHS Digital and will contain special category data including baby's week of birth and health status. There will be no subsequent data flows after the initial transfer of data from NHS Digital to the London School of Economics. The data will be processed by the LSE Secure Research Computing Governance Group. Please note that VIRTUS is the hosting environment (the physical data centre) of the LSE Secure Research Environment - it is LSE’s off-site data centre, managed by VIRTUS as a third-party organisation. As such, it is only the physical bricks and mortar location of the server - the actual processing is done by the end user (LSE), who works remotely and analyses data on the server after connecting. Once the data has been received to the LSE Secure Research Computing Governance Group, the data will then be analysed in the LSE Secure Research Computing Governance Group Environment, exclusively by the LSE researchers . All figures produced will be aggregate figures (e.g. coefficients, means) each figure contains a sufficient cell count (e.g. the ONS's requirement of 10) to avoid disclosure of patient data. The data will be cleaned, with duplicate records removed, and missing values and outliers dropped in an appropriate manner. To implement the regression discontinuity design, the researchers will use the baby's week of birth and gestational age to create a new variable for their due date. This variable will be used to separate the sample into a control and treatment group, such that observations are classed in the treatment group if they have an expected week of birth between 6 April 2009 and 16 April 2011 inclusive, and they are in the control group otherwise. The researchers will then implement the agreed methodology using econometric techniques within statistical software. The outcomes of the treatment and control group will be compared, enabling estimates to be reached of the causal impact of the Health in Pregnancy Grant. After the study has ended, the LSE would like to store the research data for a further 18 months and will apply for an extension to this Data Sharing Agreement. This will enable LSE to respond to any critiques or peer-review of the research and to make the necessary adaptations. The data will be stored in the LSE Secure Research Computing Governance Environment with the usual security arrangements in place at all times, and only the researchers will have access to the data. Data is not being matched to publicly available data. Both researchers accessing the data are ONS Accredited Researchers and have undergone training and assessment by the Office of National Statistics' Secure Research Service in data confidentiality and data protection. Both have experience using confidential sensitive microdata. Similarly, all employees of the LSE Secure Research Computing Governance Group who will be receiving and processing the data have undergone appropriate training. Data will be accessed within the LSE Secure Research Computing Governance Environment at the LSE in London. There will be no data linkage undertaken with NHS digital data provided under this agreement that is not already noted in the agreement. Data will only be accessed and processed by substantive employees of the LSE and will not be accessed or processed by any other third parties not mentioned in this agreement. There will be no attempts made by the LSE to re-identify individuals involved in this project as there is no requirement to do so.
Project 3 — DARS-NIC-258494-J2Q5M
Opt outs honoured: No - data flow is not identifiable (Consent (Reasonable Expectation))
When: 2021/01 — 2021/05.
Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)
Categories: Anonymised - ICO code compliant
- Civil Registration - Deaths
Mortality data is required from NHS Digital for the purposes of the DETERMIND study. The DETERMIND (DETERMinants of quality of life, care and costs, and consequences of INequalities in people with Dementia and their family carers) study is a multi-centre research study funded by the Economic and Social Research Council (ESRC), led by the University of Sussex, who are the Data Controller. It will gather new data, longitudinally, from a cohort of 900 people with a recent diagnosis of dementia and their carers (total = 1800). The objective is to provide a range of quantitative and qualitative evidence, interpreted using a theory of change framework, about inequalities in experiences, outcomes and costs following a diagnosis of dementia. . The study includes 7 separate workstreams. Workstream 1 covers the recruitment of, and fieldwork with, the cohort of 1800 comprising people with dementia and their carers and Workstream 7 covers the development of the theory of change framework, an inductive process drawing upon emerging evidence from all of the workstreams, to provide an overall ‘theory of change model’ mapping the causal chains between service inputs and outcomes of interest - and identifying the contextual factors that influence the pathways people take and the outcomes they achieve. Workstream 2 considers access to services and the factors that may influence inequalities in service access. Workstream 3 looks at service and other costs associated with different patterns of service access and with different levels of outcome. Workstream 4 looks at the experiences, costs and outcomes of self-funders relative to other care users. Workstream 5 considers the role of psychological factors on differential service access and/or outcomes. Workstream 6 looks at how the timing of diagnosis impacts outcomes. The DETERMIND dataset will include many measures in order to identify factors associated with variation in access , costs and outcomes, using evolving theories about how factors may be linked - informed by complementary qualitative research, consultation with stakeholders and existing evidence - to develop a theory of change that is plausible and consistent with the evidence gathered during the study. The project runs for 5 years from January 2019 to December 2023. The requested mortality data is to support the conduct of research undertaken as part of the DETERMIND study. Mortality data obtained from NHS Digital will be used to support and augment the gathering of data from a cohort of 900 people with a recent diagnosis of dementia and their carers (total 1800 people). Specifically, it will be used for the following purposes: a. to include fact of death, place of death and cause of death in pseudonymised individual-level research (survey) data-sets generated by the research project, thus allowing these variables to be systematically included in statistical analyses b. to formally withdraw study participants and their carers from the research study in a managed and timely manner (the expectation is that approximately 10% of those with a diagnosis of dementia in the cohort will die each year, approx. n=90 per annum). As well as supporting effective project management, this is designed to avoid inappropriately including the deceased participant and bereaved carer for participation in further survey rounds, or approaching them to invite them to participate in associated qualitative research or linked studies. c. to prompt administration of a carer bereavement survey to members of the cohort who have given their consent to be contacted about involvement in further research. The University of Sussex is a public authority responsible for conducting scientific research for academic and public benefit. Data in the DETERMIND study is processed to enable the University of Sussex to perform its public task. University of Sussex rely on the following legal bases for processing data under the General Data Protection Regulation • GDPR Article 6 (1) (e), public task and, for special categories of data (including health information and information concerning ethnicity and sexual orientation), Article 9.2(j), archiving, research and statistics. Possible ethical issues have been considered and addressed throughout the process, including those considered by the HRA REC approval process.” Eligibility and procedures for recruitment of the cohort includes anyone with a recent diagnosis of dementia in three participating NHS Foundation Trusts - (Gateshead Health NHS Foundation Trust, South London and Maudsley (SLAM) NHS Foundation Trust and Sussex Partnership NHS Foundation Trust) with no exclusion criteria. The cohort also includes their listed carers. There are no control groups, as the study has a non-experimental design. University of Sussex request mortality data for the study cohort of 900 people with a recent diagnosis of dementia and their carers, (total 1800) covering fact of death, alongside information about place and cause of death. The data requested is proportionate to the purposes set out above and there are no alternative, less intrusive ways of achieving these purposes. The extent and level of data will allow individual cohort members to be appropriately withdrawn and approached about involvement in further research studies (as relevant), and to allow fact of death, place of death and cause of death to be included in multi-variate analyses of pseudonymised individual-level survey data gathered from the cohort. As a multi-centre study, the project team includes a range of research partners in addition to the University of Sussex (the Data Controller). All of these research partners are co-applicants on the research grant (not sub-contractors) and their roles and responsibilities are consequently governed by DETERMIND’s governance framework (including the study protocol and ethical approvals). The majority of these research partners are data processors (i.e. for primary data gathered in the course of the study for the 900 people with a recent diagnosis of dementia and their carers (total 1800)). The roles and responsibilities of research partners (and co-applicants to the research grant), and their involvement in processing mortality data obtained from NHS Digital, are as follows. South London and Maudsley (SLAM) NHS Foundation Trust; Gateshead Health NHS Foundation Trust; Sussex Partnership NHS Foundation Trust (SPFT) Local Principal Investigators and Research Assistants in three local NHS memory assessment services (located within NHS Foundation Trusts) will work, on behalf of the University of Sussex and the project as a whole, to recruit the cohort of 900 people with a recent diagnosis of dementia (300 in each NHS Foundation Trust) and their carers (1800 in total) and will administer a face to face survey (at baseline assessment and annually for a further three years) to members of the cohort. The Local Principal Investigators are clinical consultants within the NHS Foundation Trusts and are co-applicants on the research grant, thus included within the governance framework for the project (e.g. protocol and ethical approvals). To facilitate the involvement of the NHS Trusts in research, each Local Principal Investigator holds an academic affiliation in addition to their clinical roles within the NHS Trusts; the Local Principal Investigator at SPFT has an affiliation with the University of Sussex, the Local Principal Investigator at SLAM has an academic affiliation at King’s College London (KCL) and the Local Principal Investigator at Gateshead Health NHS Foundation Trust has an academic affiliation at Newcastle University. The roles of the three NHS Foundation Trusts are described fully in the study protocol. There are, additionally, associated capacity and capability agreements/ statement of activities in place for the participating NHS organisations. The University of Sussex, the London School of Economics and Political Science (LSE) and the University of York will be responsible for directly analysing pseudonymous, individual-level survey datasets generated by the study and conducting follow-up qualitative research with purposive samples of people with dementia and their carers from the cohort. Mortality data from NHS Digital will be used, where participants agree, to include fact of death, place of death and cause of death as variables in survey datasets. Before being shared with LSE and the University of York, these datasets will be pseudonymised; that is, they will not include personally identifiable data (i.e. name, full address or postcode, date of birth or NHS number) and each participant will only be directly identified in the dataset by their study ID number. However, LSE and the University of York will be provided with non-pseudonymised data for individuals (including fact of death, place of death and cause of death) to support qualitative recruitment, fieldwork and analyses. The Study Coordinator at the University of Sussex will provide the researchers with contact details for a small number (approx 20-30 per qualitative study) of participants from the cohort of people with a recent diagnosis of dementia and their carers where they meet specified sampling criteria and have given consent to be approached for involvement in follow-up qualitative research. Cambridge University and Newcastle University Cambridge University’s and Newcastle University are neither Data Controller or Data Processor. Neither organisation is involved in deciding how data is used, or in gathering or directly analysing data from the cohort of 900 people with a recent diagnosis of dementia and their carers (total of 1800) or consequently, any mortality data obtained from NHS Digital for members of the cohort. University of Cambridge will provide expert advice and Newcastle University will support consultation and dissemination of findings. The role of research partners at the University of Cambridge is to provide expert advice on analysis plans for DETERMIND data, based on previous experiences of analysing similar large-scale data sets. Cambridge will not carry out any analyses of the data directly and University of Sussex can choose to either accept or reject any advice provided. They will also advise statisticians on secondary analysis of publicly archived data from the Cognitive Function and Ageing Study (CFAS II), which is a study that was designed to investigate dementia and cognitive decline in a representative sample of more than 18,000 people aged over 65 years, and a further study - the English Longitudinal Study of Aging (ELSA). This secondary analysis is undertaken early on in the DETERMIND project to help generate hypotheses to inform the DETERMIND survey and theory of change framework. The Economic and Social Research Council (ESRC) are funding the project. The ESRC is the national research council for economic and social research. It has funded the research but plays no role in directing or undertaking the research, and is neither a data controller or processor.
The DETERMIND research study has been funded by the Economic and Social Research Council (ESRC), following peer review and was consequently assessed against a range of quality criteria including the likely benefits it would provide to health and social care research and provision. In particular, the project will build an evidence base, of new data and theories of change, to inform policy and practice. The overall aims of the study, and of all of the constituent study outputs, are to ensure that findings about costs and about unequal access and outcomes, and the reasons for these inequities, as well as potential solutions and responses are used to inform policy-making and service-planning, as well as the agendas of national organisations seeking to influence policy and practice in dementia care. As detailed in Objectives for Processing, above, these focus on inequities in access to services and what drives these, inequities based on whether self-funding or not, inequities due to psychological factors (e.g. self-esteem), and inequities based on the timing of diagnosis, as well as the costs associated with these different pathways. The programme will also generate new data, research findings and theory about inequalities in access, outcomes and costs for people with dementia and for their families and carers that will be of key academic interest. This will support and prompt new and innovative research that, in turn, is capable of improving health and social care. Multiple opportunities for career development and capacity-building have also been built into DETERMIND, with post-doctoral and early career researchers embedded into the research team and two linked studentships. Dementia research and research into social care provision, in particular, are areas where the need for more high-quality research and researcher capacity is widely recognised in order to ensure ongoing research benefit to these sectors is realised.
All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. In the DETERMIND study, survey and qualitative data will be gathered from members of a cohort of 900 people with a recent diagnosis of dementia and their carers (total 1800) with a view to better understanding a range of inequalities in dementia care, costs and outcomes. A number of published outputs will be produced and shared using an active public engagement/ communication strategy. The specific publications to be produced will be determined as the project progresses, reflecting the evolving and theory-led nature of the study. The project team are committed to producing multiple peer-reviewed journal papers in high-quality, internationally recognised dementia and social policy journals and various related outputs to reach a range of policy, practice and lay audiences, (including blogs, policy briefings, conference presentations and media interviews and articles). Target audiences are discussed in more detail below. There will be a number of over-arching publications and outputs, covering findings from the project as a whole, as well as specific outputs for each of the seven constituent workstreams. These will be promoted through a dedicated DETERMIND website (https://determind.org.uk), with links from the institutional websites of organisations involved in this study. The project team will work with dissemination partners. In particular, there are funds available to work with the Alzheimer’s Society to promote findings across the Alzheimer's Society networks and website. The project team will also work closely with Making Research Count, a national network of social work and social care departments in 10 English universities with partnerships with local agencies. A summary of planned outputs are as follows: • An early peer-reviewed journal paper has already been accepted for publication. This is a protocol paper, which summarises for academic audiences the reasons for undertaking the research and describes the research design and methods. • The project team will prepare descriptive reports of findings after analysis of data from each of the three waves of the longitudinal survey (baseline, wave 2 and wave 3, conducted across 3 consecutive years). These will be written in an accessible format and contain a clear summary of descriptive findings, with use of suitable infographics. These will be posted online and distributed to stakeholders, including to research participants. The project is partnered with the Oxford charity, DIPEx, who are responsible for the highly successful healthtalk.org website that has disseminated text and audio-visual outputs covering more than 100 research studies. DIPEx will develop and manage a dedicated DETERMIND website and produce video and audio summaries for professional and lay audiences. These will be linked to the project team's organisational websites and by the project's dissemination partners, including the Alzheimer’s Society. • Research partners leading each of the workstreams will produce further high-quality, international peer-reviewed journal papers for academic audiences and other publications for professional and lay audiences in their specific topic areas, with integrated and cross-cutting outputs agreed during the course of the research study as the research evolves. • At the end of the project, the project team will produce a policy‐based report summarising the findings and associated implications for policy, practice and future research. This will be disseminated as described above, and the project team will hold a major final event, inviting all the stakeholders engaged with throughout including politicians, policy‐makers, academics, carers, people with dementia and the voluntary sector. • The above policy-based report will be accompanied by fact sheets providing accessible information about the study's overall findings. • The project team will also produce a guide for the wider public connecting research findings to the everyday life and challenges of people with dementia, families and carers. This guide will include infographics, pictures and real‐life testimonials, thereby contextualising and humanising the academic evidence. • Findings will be used to update projections of future expenditure on dementia care and update the ESRC-funded MODEM (Modelling the Costs and Outcomes of Dementia) study legacy model (this was previously produced, under a separate grant, by a project team that included team members from the current study, from University of Sussex and LSE) to assist policymakers, commissioners and others to plan services In all publications, the data will be reported thematically and aggregated with small numbers suppressed. No individual participants taking part in the study will be identified. It is unlikely that any data presented could lead to an individual being identified, however specific efforts will be made to manage this risk by, for example, changing details in examples and quotes presented in qualitative research findings and by suppressing small numbers in reported statistical findings. The project team will hold seminars and workshops throughout the study to obtain stakeholder views on our plans and emerging findings. They will invite people with dementia, carers, professional staff and stakeholder organisations, including DHSC, NHS England, the Alzheimer’s Society, and the Association of Directors of Adult Social Care. The team members have strong existing links with all these groups. The team also plans to present findings from the research at relevant academic and policy conferences, provide briefings for relevant parliamentary committees, request a special session on the project to be presented at the All Party Parliamentary Group on Dementia and feed into relevant government consultations. Target audiences for findings from the research include the public, people with dementia and family carers, clinicians and care staff, the third sector, health and social care commissioners, policy-makers, policy networks, groups representing older people and their families, regulatory and other sector-specific bodies, and various knowledge brokers and change agents. Supported with a small dedicated budget from the study, the Alzheimer’s Society will work closely with the DETERMIND team to assist in reaching these audiences effectively and to support the project’s knowledge exchange and communication strategy. The Alzheimer’s Society will also help to facilitate wide stakeholder engagement throughout, including in the annual stakeholder workshops that will be held to make sense of evolving findings (using a theory of change model) to inform development of the study and the specific research questions that will be addressed in successive rounds of analyses. Key organisations that the DETERMIND project team will engage with include the following: • Association of Directors of Adult Social Services (ADASS), • Age UK, • Alzheimer’s UK, • Carers UK, • Care and Support Alliance, • UK Home Care Association, • Care England, • Care Quality Commission (CQC), • Skills for Care, • Social Care Institute for Excellence (SCIE), • The National Institute of Health and Care Excellence (NICE) and • Think Local Act Personal, with whom the research team already, collectively, have strong links.
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. Data will only be accessed and processed by substantive employees of those organisations who are data processors and will not be accessed or processed by any other third parties not mentioned in this agreement. There will be no attempts made by The University of Sussex to re-identify individuals involved in this project as there is no requirement to do so. DETERMIND is a multi-centre research project, funded by the Economic and Social Research Council (ESRC) and led by University of Sussex. Co-applicants on the research grant are University of York, the London School of Economics and Political Science, the University of Cambridge, Newcastle University and clinical consultants (with academic affiliations) in three NHS Trusts (Gateshead Health NHS Foundation Trust, South London and Maudsley (SLAM) NHS Foundation Trust and Sussex Partnership NHS Foundation Trust). The study protocol clarifies, in detail, the roles of these different research partners. In summary: • The University of Sussex is the sole data controller and is the lead partner within the research team. It is solely responsible for deciding how research data gathered from the cohort of 900 people with a recent diagnosis of dementia and their carers (total 1800) is used. It is also solely responsible for decisions about how mortality data obtained from NHS Digital for members of this cohort is used. • Gateshead Health NHS Foundation Trust, South London and Maudsley (SLAM) NHS Foundation Trust and Sussex Partnership NHS Foundation Trust (SPFT) will recruit the cohort of 900 people with a recent diagnosis of dementia and their carers (total of 1800) and collect and process participants’ data, on behalf of the University of Sussex and the project as a whole. This will include obtaining and processing mortality data for members of the cohort. • The University of Sussex, LSE and the University of York will analyse pseudonymised individual-level research (survey) datasets generated by the research project and undertake recruitment, fieldwork and analyses for qualitative research using identifiable data for eligible individuals (meeting sampling criteria and having provided consent to be approached for qualitative research). • Cambridge University and Newcastle University are co-applicants on the research grant but are not data processors; they play no role in collecting, managing or analysing data gathered from the cohort of 900 people with a recent diagnosis of dementia and their carers, nor the associated mortality data obtained from NHS Digital. Data management arrangements in DETERMIND in support of these roles The process for managing the flow of data gathered from and about the 900 people with a recent diagnosis of dementia and their carers (total 1800) is designed to minimise the extent to which research data can be linked to personally identifiable data. This is achieved by ensuring that a clear distinction is made between research data and personally identifiable data, that these are stored separately and by controlling who is able to access each of these two different datasets. • Pseudonymised research data, identified only by Study ID, will be stored with the data controller (University of Sussex), using REDCap, a secure web application for building and managing online surveys and databases - https://www.project-redcap.org. Research Assistants located at each of the NHS sites will enter pseudonymised research data into REDCap. Once research data has been entered into REDCap, the Research Assistants will no longer be able to access it without contacting the Study Co-ordinator at the University of Sussex. No personally identifiable data will be stored in the REDCap system. • Direct access to personally identifiable data (participant name, address, date of birth and NHS number) will be limited to authorised staff (Local Principal Investigators and Research Assistants) at Gateshead Health NHS Foundation Trust, South London and Maudsley (SLAM) NHS Foundation Trust and Sussex Partnership NHS Foundation Trust (SPFT. Authorised staff will also have access to participants’ Study ID numbers and thereby comprise the only route through which research data is capable of being re-identified (i.e. de-pseudonymised). Personally identifiable information will be entered into a locally-held Participant Contact log, which will exist independently at each site. This will also contain additional information concerning contact preferences, consents for NHS Digital data linkage, consents to be contacted about further studies and other meta-data associated with research visits. No research data or information about participants’ health will be stored in the Participant Contact log. This log will be updated as needed (e.g. following survey visits, following any communication or following receipt of notification of death from NHS Digital). Data management arrangements for processing data from NHS Digital. Flows out of data into NHS Digital: Research Assistants at the three local NHS sites will send personally identifiable data about members of the cohort of 1800 comprising people with a recent diagnosis of dementia and their carers to NHS Digital quarterly (until the full cohort is achieved), using agreed and authorised methods of data transfer. The legal basis for processing data throughout DETERMIND is GDPR Article 6.1(e) and Article 9.2(j). Consent will be sought from participants to provide their data to NHS Digital for the purposes of data linkage to mortality records and data linkage will not be sought for any participants that do not provide this consent. This is the only time that personally identifiable data will be shared outside of the research team. Study ID, NHS Number, Date of Birth, Gender and Postcode will be shared with NHS Digital to facilitate linkage. Flows of data out of NHS Digital: NHS Digital will return mortality data identified by Study ID number to the Study Coordinator at the University of Sussex. Flows of NHS Digital data within DETERMIND: The mortality data from NHS Digital will remain with the local NHS sites and will not be further circulated. However, it will prompt a number of actions. • Upon receipt of information concerning someone's death, the locally-held Participant Contact log will be updated • A REDCap form will also be completed. This will inform the Study Co-ordinator at University of Sussex that a participant has died. The participant will be identified as deceased in the research (survey) dataset, and variables about place and cause of death will also be included in the research (survey) dataset. Participants in the research (survey) dataset are identified by Study ID number only and no personally identifiable information is included. This is the dataset that will be analysed by researchers at University of Sussex, the London School of Economics and Political Science, and the University of York. • The deceased participant and their carer will be formally withdrawn from the main study (annual face-to-face survey) and from consideration for involvement in associated qualitative research. There are two reasons for DETERMIND to have the data linkage: 1) To withdraw people from the study so they are not approached inappropriately 2) To invite bereaved carers to participate in relevant linked studies, where they have consented and expressed interest in being informed of further studies (and that they are contacted appropriately in doing so) All data processing for the study is only carried out by substantive employees of the data processor(s) and or data controller(s) and these employees have been appropriately trained in data protection and confidentiality.