Good TREs work

University Of Birmingham projects

1280 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

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

Discovery and evaluation of patient pathways using ECDS — DARS-NIC-717428-M3S8H

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2024-06-28 — 2025-06-27 2024.07 — 2024.09.

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

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. Uncurated Low Latency Hospital Data Sets - Emergency Care

Expected Benefits:

As a new and novel research project, benefits and their measurements will be subject to ongoing research input. The project outputs are anticipated to help evaluate new tools for secondary healthcare improvement. If successful, the new tools can help to understand patient flows within an emergency department, anticipate peak patient attendance times and case mix and potential new recommendations for changes in patient flows (e.g. diagnosis, treatments, investigations).

NHS trusts could realise organisational improvements, such as:
1. Resource management improvement (e.g. bed use, patient flow)
2. Improved efficiency (e.g. staff per patient)
3. Most effective use of staff levels
4. Data driven approaches to improving service delivery
5. More detailed cost benefit analysis of patient experience and outcomes

The wider health and social care system improvements would stem from better emergency care outcomes:
1. Greater hospital capacity for emergency care
2. Reduced expenditure on most costly interventions
3. Tangible and interpretable models which can be scrutinised by operational managers and clinical experts
4. Reduction of emergency bed use and readmissions

Notable benefits for arm's length bodies, policy makers and decision makers include:
1. The development of a data driven evidence base for analysing performance and recommending new best practice
2. Ability to scrutinise trusts practices and outcomes, particularly being able to recommend achievable transformations bey proposing a sequence of service changes
3. The development of event simulation models for process redesign, which would build evidence for policy changes and impacts of change
4. National health bodies, such as the Department of Health and Social Care, NHS England, NICE and Integrated Care Boards (ICB) could use this work for management of healthcare policies and recommendations for improving best practices
5. National and local healthcare leaders are expected to be able to understand better vs worse NHS trust performance, including accounting for geographical/ demographic differences between trusts
6. Service process models could help to develop new policy and guidance with a more nuanced and locally developed view

The use of the data could:
> help the system to better understand the health and care needs of populations.
> lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
> advance understanding of regional and national trends in health and social care needs.
> advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes.
> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
> 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).

Patients are ever more reliant on efficient and effective healthcare. The dissemination of this data will help national and local organisation managers and clinicians deliver these outcomes. Potential benefits for patients are therefore expected to be recommendations for and implementation of service improvements. These improvements will help NHS trusts utilise current resources more efficiently and identify better best practice. Benefits for patients could include:
1. Lower waiting times
2. Better potential outcomes
3. Reduced unnecessary follow-up appointments
4. Improved bed capacity

The intention is that the new tools that are to be produced as part of this project could be used for the analysis and description of patient flows to provide recommendations for emergency care service redesign improvement. Such recommendations could form part of decision support tools for the management of hospital services: staff scheduling, patient demand management and official guideline conformance checking.

This project aims to inform new guidance at local and national levels, integrate operational knowledge from NHS England’s Performance Analysis team (UEC), and disseminate new recommendations to analysts, researchers, and policy makers.

Public interaction via established public/ patient engagement groups will be used to help promote and develop outputs. The University of Birmingham will provide access to existing channels, such as the OPTIMAL research project patient advisory group (PAG).

The project team will disseminate the findings of this exploration of best practices in emergency care delivery through patient advisory groups, arm's length bodies (NHS England) and healthcare research communities (University of Birmingham).

Outputs:

The expected outputs of the processing will be:
> Submissions to peer reviewed journals such as Springer Link Process Science, Foundations and Trends in Systems and Control and Management Science. 2-3 journal submissions are expected.
> Presentations at appropriate conferences such as International Conference on Process Mining, Information Processing in Sensor Networks and Institute of Electrical and Electronics Engineers (IEEE) International Conference on Data Mining
> Production of new programming and theoretical framework tools which will be made available publicly. These tools can be used for the analysis and description of patient flows to provide recommendations for emergency care service redesign improvement and will be free of charge.
> Internal channels and policy groups, such as the urgency and emergence care transformation programme and elective care
> Press releases by the University of Birmingham, Health Data Research UK (HDR UK) and NHS England for appropriate results, for example, via formal web publications or technical blogs. This includes lay descriptions of the project and its results for use in public discourse

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.

Production of outputs are expected to be by September 2027, with completed results before that date if available.

Processing:

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

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

NHS England will provide access to the relevant records from the Emergency Care Data to the University of Birmingham. The Data will:
• Contain special categories of personal data but with no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

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

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

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

The Data will be stored on servers at NHS England.

Remote processing will be from secure locations within the UK.

The Data will not leave the UK at any time.

Access is restricted to students of the University of Birmingham who have authorisation from the Principal Investigator.

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

The Data will not be linked with any other data.

Analysts from the University of Birmingham will analyse the Data for the purposes described above.

Agreement for holding the HES data beyond IQVIA HES-THIN sublicense agreement — DARS-NIC-242146-J2W3T

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2019-09-19 — 2022-09-18

Access method: Ongoing

Data-controller type: UNIVERSITY OF BIRMINGHAM

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. Hospital Episode Statistics Accident and Emergency (HES A and E)
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)
  7. Hospital Episode Statistics Critical Care (HES Critical Care)
  8. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The University of Birmingham (UoB) have specialist skills in the extraction and analysis of routinely collected data.

UoB currently host and utilise The Health Improvement Network (THIN) database, and HES linked data supplied by data provider IQVIA (which holds a data sharing agreement with the NHS Digital) in order to conduct a wide variety of clinical epidemiological study design.

GP practices in England that contributed to the The Health Improvement Network (THIN) data collection scheme between 2011 and 2014 have their non-identified patient data linked with Hospital Episode Statistics (HES) data for the purpose of producing enhanced datasets for use in medical research studies. This linkage was carried out in collaboration with an Enhanced Trusted Third Party (eTTP) who had developed a secure encryption technology which enabled the THIN data linkage to take place without the need to export any patient identifiable data from the data providers (THIN practices and NHS Digital).

HES data allows the validating of secondary care diagnoses recorded in THIN data, and provides further information on hospital attendances, procedures, diagnoses, length of stay and outcomes. In order to enable UoB to continue the research, UoB need to be able to retain the HES data that has been provided by IQVIA via a sub-licence agreement. This agreement has been reviewed and approved by NHS Digital. Record level data are not shared with any third party and only used by the University of Birmingham. The funding for the next three years to meet the objectives of processing is provided by the University of Birmingham (sole data controller) with support from the National Institute for Health Research (NIHR) and Medical Research Council (MRC).

The request for HES-linked data in this application to continue the completion of a variety of epidemiological studies would fulfil the GDPR rules for lawful processing. As UoB, in its capacity as an academic institute is a Public authority, lawful processing falls under Article 6 (1)(e) of the GDPR whereby “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 task being carried out in the public interest relates to conducting epidemiological research which will provide benefits to public health in terms of; health service research, health care evaluation and epidemiology of diseases to better understand their causal pathways.

This request also fulfils the exemptions noted in Article 9 (2) (i) and Article 9 (2) (j). The data being requested will be used for scientific and research purposes whereby appropriate data protection safeguards will be implemented to allow for the safe processing of the data. In addition, the data being processed will be used for the benefit of public health as mentioned above. Specifically, it will be to evaluate and improve the standards of quality and safety of health care, medicinal products and medicinal devices.


Each project conducted using the proposed linked dataset will undergo a peer-reviewed ethics procedure. This will be to ensure that ethics considerations are addressed prior to the dissemination of research. Confidentiality, security and safety of the data will be paramount throughout processing. Any data given to UoB will be processed on secure encrypted hard-drives and cloud services. The data will remain in an pseudonymised format to ensure no risk of identifying individual patients from the dataset.


Use of the linked THIN-HES data is limited to only the following areas of medical research: epidemiology, pharmacoepidemiology, health services and public health research, including risk factor identification, policy evaluation and outcome studies, and health economics research.

There are several example areas which would demonstrate the use of such data linkage.

1. Delivering a programme of applied health services research under the West Midlands Collaboration for Leadership in Applied Health Research and Care programme (CLAHRC) and its successor: The CLAHRC covers multiple themed research streams to answer research questions involving patient flows through primary and secondary care systems and the resulting patient outcomes. CLARHC sits within UoB and so the sole data controller would remain UoB. To do this UoB requires contextual data on the English acute hospital population to make valid comparisons, using metrics such as length of stay, in-hospital mortality rates and readmission applied to various groups of patients, determined by epidemiology, demography or service use derived from HES and THIN data.

2. Maternal and child health research workstream: Pregnancy and birth events are poorly recorded in primary care. HES linked data enables UoB to improve the current research in maternal and child health by providing missing information surrounding birth events, improving the linkage of anonymised mother and child data and allowing to follow these individuals up over time to identify a range of associations and the impact of family history in a variety of conditions. Another example specifically for conditions relating to abuse in childhood and adulthood is that the exposure of abuse is poorly recorded in primary care data. Therefore, linkage with hospital data allows for a more accurate description and identification of exposure. This enables associations with poor health consequences including cardiovascular, gastrointestinal, respiratory, musculoskeletal, neurological as well as multiple other body systems explored through cohort study designs. Thirdly this allows to link individual family data to explore the consequences of intergenerational abuse. Mothers and babies are linked in primary care using family number and pregnancy codes. By linking these families, it is possible to identify what the outcome of a specific exposure to a mother is on their children.
a. Automated infant mother linked studies
b. Long term impact of pre-incision antibiotics born by caesarean sections
c. Long term impact of recurrent caesarean sections
d. Novel risk factors and long-term health effects of postpartum haemorrhage
e. Women with adverse metabolic profiles and their offspring outcomes
f. Long term conditions, disability and complications in pregnancy with maternal and child health outcomes.
g. Abuse (child and adulthood) and ill health outcomes
h. Reproductive factors and risk of cardiometabolic outcomes

3. Non-communicable and communicable disease epidemiology stream: Often incidence and prevalence studies to assess the burden of the disease are particularly challenging due to limitation in recording in primary care alone. Therefore, linkage with HEs data allows for capture-recapture methods which can estimate the burden of disease comparing with hospital attendance, improving the disease burden estimates. In addition, linkage to hospital data provides invaluable information for the hospital admission burden related to specific disease. In addition, it provides additional information about specialist treatments that occur in secondary care, of which the effects can be investigated in long term primary care data. This can provide the opportunity to conduct healthcare evaluation using such methods.
a. Epidemiology of cardiovascular disease
b. Epidemiology of diabetes and endocrinological conditions (such as hyperthyroidism treatment modalities, polycycstic ovarian syndrome outcome studies)
c. The impact of Ramadan fasting on health
d. Epidemiology of rare diseases (e.g. Idiopathic intracranial hypertension)
e. Epidemiology of gastrointestinal disease
f. Infectious disease workstream

4. Overdiagnosis, overtreatment and health services research workstream: Similarly, to the above, linkage to HES data provides useful information about the delivery of certain procedures and therapies that are delivered in secondary care. When combined with primary care data it provides the opportunity to evaluate whether these services are being given to the correct patient population. This will provide significant benefit to the population as it will give an indication as to whether health professionals are suggesting unnecessary treatments for patients. Therefore, the output of the research will be able to provide guidance to health professionals as to the dangers of overtreatment to their patient cohort. An example study being the exploration of indication for tonsillectomies. It has been previously reported using primary care by the research team that tonsillectomies may be inappropriately delivered, and so possibly exposing patients to risks which may not weigh up with the possible benefit.

5. Wider determinants of health workstream: A specific example relates to the West midlands air quality improvement programme WM-Air will provide improved understanding of pollution sources and levels in the region, and new capability to predict air quality, health and economic impacts of potential policy measures. The project runs for a five-year period from 2018. In this project UoB will link present day and future air quality metrics, with literature derived air quality health multipliers, to identify disease-specific exposure estimates for the West Midlands population (or subsets thereof). Geocoded air pollution exposure will be linked to demographic and health information (HES, THIN) sources to develop impact multipliers for disease conditions and for susceptible population groups. The linkage of data will allow for a more complete dataset when exploring certain demographics such as ethnicity, where there is currently much missing data in primary care alone.

Specific projects listed above have received funding already. For example, workstream 1 (CLAHRC) is an NIHR funded programme. Projects within workstream 2 have also received funding from NIHR. Workstream 3 have received funding from organisations from the British heart foundation, and workstream 5 from the natural environment research council. In addition, UoB anticipate funding from charities such as the British heart foundation and also from industry partners such as Sanofi. HES data will not be used for any commercial purposes. Funders will be not be involved in data processing, study design or interpretation of the results. UoB determines which data are processed for each project/research question and ensures the legal basis for requesting, storing and processing these data are met. UoB will remain the sole data controller therefore it will be the responsibility of UoB to ensure that the data uses are within the scope listed within this agreement. For each project, the data controller UoB will ensure that the project meets the relevant GDPR exemption and be in line with the stated purposes within the scope of this agreement. If any project does not meet this exemption, the project will not be completed using data set out in this agreement.

In the studies mentioned above and planned work using the THIN-HES linked data, UoB anticipate utilising multiple different observational study methods. These will include undertaking cross-sectional, case-control and cohort studies. In addition, UoB look to explore the possibility of time-series methods to evaluate healthcare interventions and policy. As a result of the variety of methods, the exposed and control groups will change dependent on the question being asked. A simple example being the outcomes of cardiovascular disease following a diagnosis of hypothyroidism. In this example, the expose cohort group would consist of women who have experience intimate partner violence identified through Read codes and ICD 10 codes. They will be matched to suitable groups who do not have an exposure code present. Then both sets of patients will be followed up in the dataset until an outcome of interest occurs (cardiovascular disease).

As mentioned above, in order to fulfil the aims of the workstreams above, UoB will require a THIN-HES linked dataset key code. In order to achieve the aims requested, the dataset can be pseudonymised as there is no need for patient identifiable data such as name and address. In order to maximise the usefulness of the dataset, UoB will require the number of years of HES data to match the THIN database. HES data is from 1997 to 2018. There are many scientific and medical reasons why so many years of data are required. In order for real world evidence studies in patient data to be scientifically sound, all information relating to a patient’s past medical events should be considered as this will influence their doctor’s decision and affect their current care. Historical data on patient contact with secondary care is important because the lead up to diagnosis of many conditions, can be complex and lengthy. Real world data can play a very important role in understanding disease incidence in prevalence. It is paramount to have a patient’s entire history to understand incidence of disease, especially within real world data sources. If the amount of available data was reduced this would decrease the number of patients forming cohorts which could impact understanding of disease incidence and progression. As THIN is a national database, in order to link the datasets, HES data such equally match the THIN data geographically. As there are no other national hospital datasets available, there is no other method of joining national primary care and secondary care data.

There are no other organisations involved in the processing of data. However, it is likely that many of the projects utilising the dataset will be connected to funding. Funders will be not be involved in data processing, study design or interpretation of the results.

Should UoB want to do any additional projects they would be required to make an application to amend this agreement and seek approval from NHS Digital.

Expected Benefits:

THIN database has been used extensively to undertake population based medical research studies with the publications in high ranking peer-reviewed journals including BMJ and PLOS Medicine advancing medical knowledge and understanding in both disease management and in public health, capturing the attention of key opinion leaders within the medical communities, practitioners and patients. For example, the study utilising THIN-HES linked data in the development and validation of a frailty index resulted in the index being recommended for use by NICE in the NICE NG56 guideline (Multimorbidity: clinical assessment and management). This work was carried out by the University of Birmingham in a collaboration with the University of Leeds and University of Bradford (and has now been finalised and completed). Therefore, UoB anticipate that the outputs of the linked dataset will lead to numerous high impact publications which will go onto change practice. Examples of high impact journals which the team have been able to publish large dataset work in include; BMJ, JAMA neurology, European respiratory journal, diabetes care and Gut. Therefore, the anticipated work using this combined dataset will continue to be submitted to high impact journals including the BMJ, Lancet series of journals, JAMA and other specialist journals. It is clear that examples of future work using this dataset will provide information that can change practice. For example, the outcomes of the study titled “Long term impact of pre-incision antibiotics born by caesarean sections” will be able to provide insight and information for expectant mothers and clinicians as to the risks/benefits of providing antibiotics at C-section. Each of the streams of work are public health orientated affecting a sizeable proportion of the population. Therefore, if risks are identified or propose mitigating interventions, this can lead to population wide suggestions for health improvement and promotion. Dissemination of results will be in the public interest, as this will act as another method to promote behaviour change to individual patient groups who may benefit directly from the research. As highlighted in the outputs section, information will be delivered to the public with the assistance of the UoB media and communications team, who will assist in providing lay summaries of the work conducted only. This will then be promoted via various media channels such as online news reports and social media.

There are multiple different areas within the proposed workstreams which could lead to measurable improvements and change to name a few:
1) Programme of research with CLAHRC: Service stakeholders to obtain information to improve patient pathways and outcomes across a number of different services, from small changes to reduce delays and improve access to appropriate care, up to and including complete service re-design. Knowledge transfer is a critical part of the CLAHRC philosophy in which capacity in analysis of clinical data is enhanced by service partners, across all areas of the collaboration;
2) Maternal and child health: It is anticipated that the funded caesarean section project will lead to a NIHR Health Technology Assessment report and lay information resource summarising the key findings with respect to the benefits and potential harms on pre-incision antibiotics will provide balanced information to help with decision making regarding the timing of antibiotic prophylaxis. UoB anticipate that the findings will inform the next revision of the NICE Clinical Guideline 132 on Caesarean Section, and hospital policies regarding prophylactic antibiotic administration for Caesarean section. In addition, it is clear that work focusing on abuse such as domestic abuse, may play a role in shaping future government bills such as the upcoming domestic abuse bill, if the project identifies a need for a change in practice.
3) Non communicable disease: This will for example help planning of existing services for cardiovascular health or inform the Public Health England health protection practice relating to infectious diseases.
4) Overdiagnosis, overtreatment and health services research: This workstream will inform the service providers and NHS commissioners of unwarranted variation (e.g. Tonsillectomies), and potential cost savings;
5) Wider determinants of health: An example being the WM-air work will help predict air quality, and will test the health and economic impacts of potential policy measures.

The use of the dataset will also be crucial and integral to multiple post graduate research streams. UoB anticipates that for each of the projects listed, there will be a minimum of 1 post-graduate student assisting with the delivery of each of the research projects - all of the PhD students are employees of the University of Birmingham.

Outputs:

All findings will be disseminated to relevant stakeholders. They will include health care professionals who directly provide care to patients, policy makers, health service administrators and patients.

All projects listed in the agreement have yet to publish any outputs due to delays in provision of data. The initial projects currently underway using this dataset include; “Long term impact of pre-incision antibiotics born by caesarean sections,” “Risk of postpartum haemorrhage among users of SSRI in a cohort of pregnant women with anxiety or depression”, “Postpartum haemorrhage and the incidence of cardiovascular diseases”, “Postpartum haemorrhage and the incidence of mental health conditions”, “Use of progestogen only and combined oral contraceptive pill and risk of postpartum haemorrhage” etc. Once these projects are published, the expected outputs will include several of the following.

Outputs will include but not limited to;
• Reports
• Submissions to peer reviewed journals
• Presentations
• Conferences
• Dashboards
• Government white papers
• Policy documents
Outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide.


UoB will aim to facilitate the dissemination of the research to stakeholders during the project and after its completion. The dissemination activities will target an audience of researchers, scientists, innovative technology-focused organisations, research participants. UoB will also aim to make contact with policy makers as a result of the research conducted using the dataset. The nature of the stakeholder groups will be dependent on the project conducted. For example, the project titled “Long term impact of pre-incision antibiotics born by caesarean sections” mentioned above includes clinical and non-clinical stakeholders. These include individuals such as; maternal health clinical staff, the patient and public involvement group involved in the study, professional organisations with an interest in maternal health and also government led maternal and baby units.

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. There will be multiple channels of dissemination to this group including journals, websites and social media.

UoB will ensure active communication of results and outputs to any of the interested parties and groups such as the general public or lay members of society. This will occur through channels such as press releases, websites and newsletters to name a few. Results of the work conducted using the joint database will be disseminated in a similar manner to how the results of the THIN dataset work have been shared. These results have been relayed to the UoB press office, whom then advertise the work on the UoB main website. Via the press office, UoB have been able to liaise with journalists to relay information to the general public with multiple studies gaining national news coverage. A recent example has been a study undertaken exploring the association between domestic abuse and mental illness. The results of this study were relayed to the general public via; UoB website, social media, national news channels: BBC, Sky news, ITV, print newspaper: guardian, independent, express, blogs, and even international news channels.

Research taken from linked data will also be used to lead to 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. These future projects can only be undertaken following an amendment to this agreement and subsequent approval from NHS Digital. To reiterate - these future projects are not covered as a processing activity under this version of the agreement.

Processing:

The UoB will not to attempt to try and re-identify patients taken from the linked dataset. The linkage will be between THIN and HES. A previous method of data linkage conducted by the THIN data providers IQVIA is as follows; a) the patient identifier was encrypted using NHS number in the both provider data sources to create an encryption key; b) the keys were uploaded to a secure website along with the pseudonymised THIN and HES patient IDs; c) the matching keys were linked using only the pseudonymised THIN and HES patient IDs; d) the pseudonymised THIN and HES ID is then used to extract the data for the linked patients. The same approach will be adopted by the University of Birmingham for new datasets if they are to be provided by NHS Digital in the future.

Data processing will only be conducted by substantive employees of the organisation (which also includes the PhD students working on the data) and they will have undertaken appropriate data protection and confidentiality training. Once linked, data delivered to UoB will be accessible using secure servers onsite at the University. In order to access the secure environment, the organisation will ensure that each substantive employee has a secure password to enter the secure environment to view the pseudonymised data and facilitate analysis to happen within this secure environment. Data will be stored on the UoB premises and managed by UoB.

Analysis of Adult Psychiatric Morbidity Survey 2014-Mood disorders and Personality Disorders — DARS-NIC-176695-S5L5T

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2019-04-01 — 2022-03-31

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The University of Birmingham requires Adult Psychiatric Morbidity Survey (APMS) data for an analysis of mood disorders and personality disorders.

The purpose of the study is to complete research on mood disorders and personality disorders, in order to ultimately improve the health care that this group receive. The aims of the research are to analyse the APMS data to better understand the causes of mental disorders, health services access, inequalities and links to other disorders. The University of Birmingham is the data controller and also processes the data for this study. No other organisations process the data for this purpose.

The justification for processing personal data is GDPR Article 6(1)(e) - Public task: 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 and 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 processing is necessary as it will be a targeted and proportionate way of achieving the purpose. The public interest aligns with the aims of the research purpose use of the data; that is to investigate the causes of mental disorders, health services access, inequalities and links to other disorders. This will enable a deeper understanding of these issues and for evidence to be generated which can impact on public policy and planning of publicly funded health care services. The University of Birmingham has determined that there does not appear to be any moral or ethical issues raised by the dissemination of the APMS, which will be through publication of research papers, blogs and potentially media outlets and public events and that the risk of potential harm to the public appears low.

The APMS data request will achieve the aims identified by using the data for quantitative data analysis. The analyses will use multiple variables available in the APMS dataset regarding mood disorders, personality disorders and clinical and socio-economic variables. Techniques to be used will include descriptive statistics, regression modelling (linear, logistic, probit, multi-variate), the use of parametric and non-parametric tests and path (mediation) modelling. These analyses will be written up for publication in academic papers, and also for forms suitable for the lay public, where appropriate.

The background to this data request is that the applicant was the lead for providing the justification of data collection related to bipolar disorder for the Adult Psychiatric Morbidity Survey 2014 and was involved in the basic analysis. The applicant is the lead author of the chapter on Bipolar Disorders (chapter 9) in the main APMS 2014 report published by NHS digital. The applicant is also part of the ongoing APMS 2014 group and has worked on the public data from the previous APMS surveys and examples of these analyses and outputs are:
https://www.sciencedirect.com/science/article/pii/S0165178112005379
https://academic.oup.com/schizophreniabulletin/article/40/2/269/1944312
https://www.sciencedirect.com/science/article/pii/S2215036615000553

This data request project is not specifically linked to any other research programme, but as stated above there may be synergistic analyses with colleagues who are working on the APMS data (and already have the data), consistent with normal academic practice.

The data subjects are those that participated in the Adult Psychiatric Morbidity Survey, which was a general population household survey.

The purpose of the project is that mood and personality disorders are common and are amongst the top 10 global causes of life years lived with disability (Gore et al., 2011). Costs to society are high, (Pari et al., 2014) in part because of the loss of functioning and employment these conditions entail (MARWAHA et al., 2013) as well as direct healthcare costs. Rates of self-harm and completed suicide are also high, and this group die earlier than the general population, not only because of suicide but because of increased rates of cancer and cardiovascular diseases (Hayes et al., 2015). Despite the substantial needs and morbidity of this population there is still a limited understanding of the socio-economic, physical and clinical correlates of people with these conditions. Also, the extent to which they use health and social care services and what factors might impact on this require further investigation.

The primary aims of this work will to understand the socio-economic, clinical and service level associations with having a mood disorder and / or personality disorder in order to better develop mental health care in the UK.

The data that is required is the full dataset of the Adult Psychiatric Morbidity Survey 2014. This dataset will allow analysis as detailed above and in the protocol. The dataset is pseudonymised. Multiple analyses are planned which does tend to take substantial time to be done correctly. Writing up the analysis for publication and other forms of dissemination will also take substantial amounts of time. The dataset is also requested for a three-year period to take into consideration the time taken to employ researchers or for PhD students to work on data. The whole dataset is requested to ensure there is geographical spread so that results are representative.

There are no less intrusive ways of achieving the purpose, because there are no other sources of data of sufficient quality for the proposed analysis, and in order to achieve the study aims. The data requested is the minimum needed to ensure that analyses are robust and provide the needed information in the public interest.

Birmingham and Solihull Mental Health Foundation NHS Trust may provide funding for a research fellow whose role may include analysis of this data. They would have an honorary contract with the University of Birmingham and would abide by the data/ ICT and IG requirements of a substantive university employee. There are no funders or commissioners involved at this stage. However, a funding application may be made to the Medical Research Council, the National Institute of Health Research or others in order to fund analysing particular aspects (as yet undefined) of the data.

Expected Benefits:

The overall benefits of this work will be:
1. To better understand the mechanisms by which mental disorders develop.
2. Understand their nature and associations (clinical, socio-economic, physical).
3. How this knowledge can be used to improve interventions to help people with mental health problems.
4. This knowledge will be used to develop better mental health services, improve their accessibility and ensure those who need it , get timely effective treatment.

The dissemination will benefit the provision of health care or adult social care by informing clinicians, researchers and policy makers about the needs of people with mood disorders and / or personality disorders for care, whether those needs are being met, where inequalities exist in service provision and what the parameters, facilitators and barriers might be to overcoming these issues. They will be engaged by dissemination activities such as journal publications, blogs and articles which are publicly available and meetings, all subject to available funding.

Dissemination is in the public interest given that people with mental disorders and their families / partners / carers all have a legitimate interest in the knowledge that will be generated. Subject to funding patient/ carer groups will be engaged. Overall up to 10% of the population may have a mood disorder (common mental disorder) or personality difficulty at any one time so the proportion of people who might be impacted by the research is large. Public bodies such as the NHS also have a duty to provide equitable and high quality care and to correct deficits in this care where possible and the proposed work and dissemination will highlight where care could be better, as well as aiding the understanding of the causes, associations and treatment of mental disorders.

This application is not directly in support of an existing PhD/post graduate research study. However, the data may also be used for the same purpose as described in this agreement by PhD / post graduate students who are registered for their degree with the University of Birmingham and are being supervised by Professor Marwaha at the Institute for Mental Health.

Outputs:

Papers will be submitted for publication in peer reviewed journals (e.g. British Journal of Psychiatry, Journal of Affective Disorders) within two years, which will be made open access wherever possible so that academics, researchers, clinicians and the public can benefit from the findings. Many of the analyses will focus on healthcare use and will be used to drive thinking and debate around the accessibility and organisation of mental health services (and other services), prevention of mental health problems and key components of interventions. In total, the results of analysis will target improving mental health care and outcomes of people with mood disorders and personality disorders. A further dissemination plan will be developed if funding can be obtained.

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. Subject to funding, engagement with policy makers will be by talks and meetings about results.

Subject to funding, presentations will be given about the results at conferences (e.g. the International Congress of the Royal College of Psychiatrists, European Psychiatric Association) after sufficient data analysis and results will be highlighted via well engaged social media accounts. The press will be engaged via the Institute for Mental Health’s communications department.

The target dates for the production of the outputs, are anticipated to be one output with the associated publication or other output resource per 18 months as a minimum and therefore would expect at least 2-3 outputs over the lifetime of the project.

The level of data contained in the outputs will be aggregate data and statistical analyses. Small numbers will not be linked to geographical distribution to protect anonymisation.

APMS low numbers and suppression
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 (http://www.statisticsauthority.gov.uk/assessment/code-of-practice/index.html) and the ONS Statistical Disclosure Control (https://gss.civilservice.gov.uk/statistics/methodology-2/statistical-disclosure-control/) for tables produced from surveys;
• apply methods and standards specified in the Microdata Handling and Security Guide to Good Practice (http://www.data-archive.ac.uk/media/132701/UKDA171-SS-MicrodataHandling.pdf) for disclosure control for statistical outputs.

Processing:

This request is for flow of data out of NHS digital in the form of the APMS 2014 dataset. Some of this relates to health-related data given that some screening questionnaires were used in the conduct of the survey. The flow of data will be to the University of Birmingham and will be in pseudonymised form. There are no subsequent flows of data.

The data is being statistically analysed by University of Birmingham, using the data for quantitative data analysis. The analyses will use multiple variables available in the APMS dataset regarding mood disorders, personality disorders and clinical and socio-economic variables. Techniques to be used will include descriptive statistics, regression modelling (linear, logistic, probit, multi-variate), the use of parametric and non-parametric tests and path (mediation) modelling, as described above and in the protocol, in order to achieve the stated purpose. Data will not be linked to other datasets. There will be no requirement or attempt to re-identify individuals.

Currently data processing will only be carried out by substantive employees of the University of Birmingham, who have been appropriately trained in data protection and confidentiality.

In addition, Birmingham and Solihull Mental Health Foundation NHS Trust may provide funding for a research fellow whose role may include analysis of this data. They would have an honorary contract with the University of Birmingham and would abide by the data/ ICT and IG requirements of a substantive university employee. They would undergo induction training (including related to data protection and confidentiality) consistent with that required by substantive University of Birmingham employees. The data may also be used for the same purpose as described in this agreement by PhD / post graduate students who are registered for their degree with the University of Birmingham, and are being supervised by Professor Marwaha at the Institute for Mental Health.

The data will be accessed and secured in line with university regulations, this includes access which is controlled by username and password and hardware which is encrypted for security.

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

MR1215 - ASTRAL - Angioplasty and Stent for Renal Artery Lesions — DARS-NIC-147809-M6YZK

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable

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 2016-02-29 — 2026-04-20

Access method: Ongoing

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. MRIS - Personal Demographics Service

Objectives:

ASTRAL - Angioplasty and Stent for Renal Artery Lesions

The ASTRAL trial was designed to address the issue of whether renal arterial revascularisation with balloon angioplasty and/or endovascular stenting could safely prevent progressive renal failure among a wide range of patients with artherosclerotic renovascular disease (ARVD).

MR503 - Adjuvant Tamoxifen Treatment - Offer -More? - ATTOM — DARS-NIC-148286-3RWRG

Type of data: information not disclosed for TRE projects

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

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , 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); Other-Section 251, National Health Service Act 2006 - s251 - 'Control of patient information'., National Health Service Act 2006 - s251 - 'Control of patient information'.; Other-Section 251, National Health Service Act 2006 - s251 - 'Control of patient information'. ; Other-Section 251, Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: Yes (Academic)

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

When:DSA runs 2019-03-18 — 2022-03-17 2018.03 — 2024.08.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

Background Information
Breast cancer is the most common female cancer. In the 1990’s 5-years of tamoxifen treatment was the standard but there was uncertainty as to whether tamoxifen should be given for longer. The aTTom (Adjuvant Tamoxifen Treatment - Offer -More?) trial, which commenced in 1991, was designed to determine if giving tamoxifen for longer than 5 years was beneficial. aTTom is a clinical trial of an investigational medicinal product and falls under the clinical trials regulations for medicinal products.

The original 10-year follow-up period for the aTTom trial patients was in reached October 2015. However long term toxicity remains a concern and continued follow-up of these patients is vital to determine the impact of extended tamoxifen on breast cancer specific and overall survival. To this end (and following the recommendations of the Medicines and Healthcare products Regulatory Agency) ethical approval (research ethics and CAG approval) has been sought for a follow-on study called aTTom-Extended (Extended follow-up of patients enrolled in the aTTom trial). aTTom-Extended falls outside of the remit of clinical trials governing medicinal products. aTTom-Extended will continue to follow-up the aTTom patients for an additional 10 years (REC specified end date December 2027).

Data Controller
The University of Birmingham requires mortality data and data on any new cancer registrations relating to the cohort for use in the aTTom/aTTom-Extended studies for the purpose described below.

Organisations Involved
aTTom and aTTom-Extended are sponsored (in accordance with the Research Governance Framework for Health and Social Care) by the University of Birmingham which is the Data Controller. The Chief Investigator is based at the University of Birmingham. The CRCTU is one of two trials units within the University of Birmingham the other being the Birmingham Clinical Trials Unit (BCTU) which is responsible for the analysis of aTTom (performed by the Trial Statistician). The statistical lead moved from the University of Birmingham to the University of Oxford in September 2010. Under this Data Sharing Agreement this individual is not permitted to access the data. The University of Birmingham expects to enter into formal contractual arrangements with the University of Oxford which would enable the latter to become a data processor on behalf of the former. Once that is signed, the University of Birmingham will provide a copy of the signed contract and apply for an amendment to this Data Sharing Agreement to authorise access to the data by the statistical lead and his team.

Information about patients with breast cancer who took part in the aTTom trial was collected from NHS organisations (oncology hospitals and General Practitioners) in compliance with the clinical trials regulations, this included patient identifiers and medical information about the patients breast cancer diagnosis and treatment in addition to date and cause of death (where known). This data was collected on a Case Report Form (CRF) and supplied to the aTTom Study Office, University of Birmingham where it was entered onto the trial database. Data from NHS Digital is also supplied to the aTTom Study Office, University of Birmingham and date and cause of death entered into the same trial database.

The data supplied by NHS Digital will only be accessed by individuals with Approved Researcher accreditation who hold substantive contracts with the University of Birmingham. Ethics and ONS approval was granted in January 2015 to send the date and cause of death received from ONS to the NHS organisation treating the patient to clarify discrepancies in the data supplied by the NHS organisation and to request additional information about site and date of recurrence of the patients breast cancer. This practice will come to an end when the aTTom trial is closed with participating NHS organisations which is planned for the end of 2017. Other than this exception, access to data supplied by NHS Digital will be restricted to individuals, working under appropriate supervision on behalf of the University of Birmingham, who are subject to the same policies, procedures and sanctions as substantive employees of this organisation.

Why is This Work Being Undertaken?
The University of Birmingham is undertaking this work to improve the care of patients with breast cancer not only in the UK but worldwide. Breast cancer is the most common female cancer, with over 45,000 new patients diagnosed in the UK per annum and 1.1 million worldwide. Five years of tamoxifen treatment remains the standard of care for many women worldwide with oestrogen receptor positive breast cancer but there remains uncertainty as to whether tamoxifen should be given for longer. Ultimately this work could save the lives of thousands of women per annum. The continued provision of date and cause of death is vital to this goal.

Aims of the Work
The objective of the aTTom trial is to determine if treating women with oestrogen receptor positive breast cancer with adjuvant tamoxifen treatment for an additional 5 years above the current standard of care is better in terms of disease-free survival, overall survival and late toxicity. The original intent was to follow aTTom patients annually for at least 10 years after recruitment. This time point has now been met and preliminary analyses performed. However late toxicity remains a real concern. This will be addressed by continued collection of ONS survival and cause of death data as part of aTTom-Extended.

Other Relevant Background
The aTTom trial randomised 8863 women from 178 UK hospitals between July 1991 and March 2005. Data has been received from ONS since its conception in the mid-1990s. The overall objectives for aTTom (and latterly aTTom-Extended) have remained the same.
The aTTom trial has been funded by a number of organisations over the years including the Medical Research Council and more recently Cancer Research UK.


Date and cause of death are required from ONS via NHS Digital in order to perform Kaplan-Meier disease-free and overall survival analyses for the aTTom/aTTom-Extended trials and to determine other potential causes of death (e.g. endometrial cancer). For aTTom this data was collected to provide missing data for patients taking part in the trial who were no longer seen by a medical practitioner or were lost to follow-up for the purposes of the trial. For aTTom-Extended data provided by ONS will be the only source of data for these analyses.

Yielded Benefits:

Tamoxifen is still in widespread use and is saving thousands of lives world-wide. The aTTom trial has shown that taking tamoxifen for 10 years is more effective than taking tamoxifen for 5 years. Many women are now being advised to take tamoxifen for 10 years. Tamoxifen can often lead to side effects such as hot flushes. Putting up with these for 10 years can be quite a burden for some patients. Rare but serious side effects from tamoxifen include an increased risk of endometrial cancer (cancer of the womb lining). The aTTom-Extended study was recommended by the Medicines and Healthcare products Regulatory Agency to continue the long term follow up of patients enrolled into this study. No benefits have yet been yielded as a result of the aTTom-Extended study.

Expected Benefits:

The intention is to analyse the data at sequential time points and to publish this information in peer reviewed journals.

The benefit in analysing and publishing the aTTom data are that they will allow clinicians to make evidence based decisions for women with early breast cancer taking endocrine therapy. Acting on this data on a world wide scale will potentially save many relapses and deaths from breast cancer in the future but clinicians need to see long term data on breast cancer events and overall survival

The magnitude of any effect in aTTom is incompletely captured at present which is why long term follow up is essential to capture late events.

Tamoxifen is an inexpensive drug so drug costs are a minor component to any cost benefit analysis. The data from aTTom will allow clinicians to provide individualised advice on the risks and benefits of extended adjuvant therapy based on the individual risk of late recurrence. The higher the risk the greater the impact of treatment in reducing risk will be.

Because individualised decisions will be made making detailed calculations of the health economic benefits is a complex project which can only be accurately conducted with complete data. Extrapolating from the data there is the potential to reduce cancer mortality by 2-3% if the whole population is treated but if a risk stratified approach is used then the absolute reduction will be somewhat smaller in the whole population but can be much larger in the treated group is restricted to high risk cases such as node positive disease only. Different approaches will be used in different parts of the world.

aTTom is one of only two adequately powered studies designed to determine the clinical utility of extended adjuvant tamoxifen after 5 years of prior tamoxifen. The ATLAS study has already published the first analysis of the data from the hormone receptor positive subset (hormone receptor unknown cases have been excluded from this analysis). This study shows a significant reduction in breast cancer relapse and breast cancer death. aTTom has reported preliminary findings in abstract form only showing very similar results but has not yet submitted to a peer reviewed journal as further follow up for overall and breast cancer specific survival was needed.

The preliminary results of the aTTom trial in the context of ATLAS are already impacting on International guidelines such ASCO, National Comprehensive Cancer Network (NCCN) and St Gallen International Breast Cancer Guidelines. These guidelines are provisional based on the abstract reports and are subject to review pending the full manuscript publication of aTTom and updated analysis from ATLAS. The National Institute for Health and Care Excellence (NICE) are currently updating guidelines for the management of early breast cancer and will only cite peer reviewed journal articles thus the publication of aTTom is of critical importance to the completeness of an ongoing NICE work stream. Ahead of NICE the association of Breast Surgeons (ABS) and the UK breast cancer group UK Breast Cancer Group (UKBCG) are currently formulating adjuvant endocrine therapy guidelines.

The continued collection of data and the subsequent publication of future analysis is essential to ensure that the recommendation to continue tamoxifen treatment for up to 10-years do not have any foreseen long term negative health effects or that where these do exist such as the known increased risk of endometrial cancer and endometrial cancer death are as fully documented as possible. Target dates are as specified in response to the specific outputs question.

aTTom is a high profile study which has been presented in provisional format at an ASCO and ESMO plenary sessions. The current findings are very widely known and the peer reviewed manuscript will be submitted to the Lancet which has a very high impact factor thus information will be very well publicised and readily available to guideline groups and individual breast cancer clinicians making patient level recommendations.

In summary ongoing analysis of the aTTom trial will result is a series of future publications that will add to the totality of evidence of the benefits and possible harms of extended adjuvant tamoxifen. This data is essential to policy makers and clinicians to guide treatment decisions for patients in the future.

Outputs:

The outputs produced for aTTom to date include presentation of the preliminary results of the trial at the American Society for Clinical Oncology (ASCO) (Journal of Clinical Oncology 31, No.18 Suppl: 5-5) and at the European Society for Medical Oncology (ESMO) (European Journal of Cancer 49, Suppl 2, S1-S1028) in 2103. The results were presented as plenary presentations at these auspicious oncology meeting. The results demonstrated a relapse-free survival benefit for extended tamoxifen treatment. However an increase in endometrial cancer was also reported. This work has yet to be published as further follow up for overall and breast cancer specific survival was needed prior to publication and there have been subsequent delays caused by issues with ONS data access.

The intent is to publish this work in the Lancet Oncology (a high impact peer review journal) as soon as possible. A draft publication has been written but further analysis is on hold pending the approval of this application. Any resultant publication will be open access. It is anticipated that there would be a press release from Cancer Research UK and the University of Birmingham associated with the publication of this paper.

Further publications in peer reviewed journals are also planned on long term toxicity and survival.

A lay version of the findings will be made available on the Cancer Research UK aTTom website and on the CRCTU aTTom website.

All outputs will contain only data that is aggregated in line with the ONS and HES Analysis Guide.

Processing:

Data Flow
ONS data is received from NHS Digital. The data is provided to the Operational Director of the CRCTU within the University of Birmingham.

The downloaded files are saved in a restricted access folder on a clinical trials server within the University of Birmingham’s CRCTU. Patients within the downloaded files are identified by supplied member number and name. The patient’s date and cause of death and information on new cancers are manually entered into the relevant patient record within the aTTom trial database (i.e. the two datasets are combined). The files downloaded from the Data Exchange Service and the aTTom trial database are stored in separate areas of the same clinical trials server. Only approved researchers who are substantive employees of the University of Birmingham have access to this folder and the aTTom database.

Permissions to the database are granted by the CRCTU Database administrators. Permissions to the restricted access folder are granted by the CRCTU IT team.

Data containing no identifiers other than the patient’s unique trial number, date of birth, date and cause of death (obtained from the NHS or ONS) in addition to the medical data collected for the trial, is extracted for analysis from the trial database using remote access methods by the trial statistician who is based in BCTU. Data downloads are taken for statistical data cleaning, presentation, or publication. The first planned publication being after 10-years of follow has been completed as part of the aTTom trial. The statistical output is saved in a restricted access folder on the BCTU clinical trial server.

Patient record level data from ONS will not be made available to any third parties other than those specified except in the form of aggregated outputs in line with the HES Analysis Guide. For clarity, no data will be shared with the University of Oxford or individuals from the University of Oxford under this Data Sharing Agreement.

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

Record level data or data containing small numbers will not be shared with any other organisation.

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).

MR787 - CHILDHOOD CANCER SURVIVOR STUDY — DARS-NIC-148313-G56YY

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes, No, Anonymised - ICO Code Compliant

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 , National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7), Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007, National Health Service Act 2006 - s251 - 'Control of patient information'., , Health and Social Care Act 2012 - s261 - 'Other dissemination of information'; National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2011-08-08 — 2031-08-07 2016.06 — 2024.08.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The objectives are to establish a national population-based cohort of 34000 individuals diagnosed with cancer before aged 15, between 1940 and 2005 inclusive, in Britain, and surviving at least 5 years from diagnosis. Investigate observed and expected risks of specific causes of death, subsequent primary cancers and other serious non-cancer morbidity using existing registries and databases including the national death and cancer registries, Hospital Episode Statistics for England, the Patient Episode Database for Wales, the Information Services Division linked database for Scotland and the Myocardial Ischaemia National Audit Project for England and Wales.

BASIL-3 Clinical Trial: BAlloon vs. Stenting in Severe Ischaemia of the Leg-3 — DARS-NIC-341768-K2T6V

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2022-10-31 — 2025-10-30 2023.07 — 2023.11.

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death - Secondary Care Cut
  2. HES:Civil Registration (Deaths) bridge
  3. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

University of Birmingham (UoB) requires access to NHS Digital data for the purpose of the following research project:
The BASIL-3 Clinical Trial: BAlloon vs. Stenting in Severe Ischaemia of the Leg-3. This is when blood vessels between the hip and knee are blocked.

Basil-3 is a multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting stents, and plain balloon angioplasty with a bare metal stent revascularisation strategies for severe limb ischaemia secondary to femoro-popliteal disease. Severe limb ischemia is the most serious and debilitating form of lower limb peripheral artery disease and is a seriously disabling, life and limb threatening, condition. The aim of BASIL-3 is to evaluate the clinical efficacy and cost-effectiveness of the interventions for people with severe limb ischaemia.

The following NHS Digital data will be accessed:
• Hospital Episode Statistics (HES) Admitted Patient Care (APC)
• Civil Registration Deaths (Secondary Care Cut)

UoB require mortality and hospital data as this will allow them to double-check the main outcomes against routine data sources, and extend the follow-up of patients in the trial and collect the long-term outcome and health resource usage data without needing further contact with the study participants. This is important as it will link a trial of treatments that may become a clinical standard of care to long-term outcomes that are routinely collected in clinical data but will not be collected during the follow-up period of the trial.

The level of the data will be identifiable which is necessary because although the NHS Digital data is pseudonymised for analysis, on occasions, there could be a justifiable reason for requiring a cohort member to be reidentified within the clinical trial by linking the unique person ID.

The data will be minimised as follows:
• Limited to data for a study cohort of 481 patients who met the inclusion criteria (including having Severe Limb Ischaemia) and consented to participate.
• Limited to data between 2015/16 to 2023/24. For each individual patient, data will only be provided from the date they joined the trial.
• Limited to pseudonymised data only for analysis purposes.

University of Birmingham 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 processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme, the funding is specifically for the BASIL 3 Trial as described. Funding is in place until January 2024.

The trial has two oversight committees, which comprise of external members who are senior clinicians and statisticians. The Data Monitoring Committee (DMC) safeguards the interests of patients and the integrity of the trial by assessing the safety and efficacy of the intervention and ensuring the trial collects the necessary data. The DMC receives interim analyses provided by the trial statistician but does not have access to trial data. The DMC reports to the Trial Steering Committee (TSC) which provides oversight of the trial and provides advice to the Trial Management Team. The TMC considers DMC recommendations, but do not receive interim analyses or have access to trial data.

Data will only be accessed by substantive employees of the UoB.

A Public and Patient Information and Engagement (PPIE) group was consulted regarding the collection of the data for the purposes described above. PPIE were involved in the setting up of the BASIL-3 trial and were consulted during and after the pause to recruitment post publication of the Katsanos et al., (2018) meta-analysis and they continue to attend yearly meetings and review any amendments to protocols or patient facing documents.

Expected Benefits:

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

The use of the data could
• help the system to better understand the health and care needs of populations.
• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• advance understanding of 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.

It is expected to provide the most clinical and cost-effective method of treating people with Femoro-popliteal Severe limb ischaemia. This is when blood vessels between the hip and knee are blocked.

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

Outputs:

The expected outputs of the processing will be:
• A report of findings to the funder and Research and Ethics Committee (REC) at the end of the study.
• Submissions to peer reviewed journals at the end of the study.
• Presentations to the ICVS - International Conference on Vascular Surgery and the VSGBI - Vascular Society of Great Britain and Ireland and any other appropriate conferences.
• Publication of information on the BASIL 3 website.

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 datasets from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:
• Journals
• Co-hosted events, for example, conferences
• Public promotion of the research on the study website and social media

Target dates for production and dissemination of the outputs will be Spring 2024.

Processing:

University of Birmingham will transfer data to NHS Digital. The data will consist of identifying details (specifically NHS Number and Date of Birth plus a unique person ID and the individual start date for each participant ('randomisation date') for the cohort of 481 patients to be linked with NHS Digital data.

NHS Digital data will provide the relevant records from the HES APC and Civil Registration Deaths Secondary Care Cut datasets to University of Birmingham.

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 University of Birmingham.

The data will be accessed onsite at the premises of the University of Birmingham only.

The data will not leave England/Wales at any time.

Access is restricted to individuals within the Birmingham Clinical Trials Unit of University of Birmingham who have authorisation from the Principal Investigator. All such individuals are substantive employees of University of Birmingham.

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

Using the Study ID, the NHS Digital data will be linked at person record level with Basil 3 trial data obtained by UoB. NHS Digital data will not be linked to any other data resources used by the trial.

The identifying details will be stored in a separate database to the linked dataset used for analysis. There are technical and organisational controls in place to ensure the NHS Digital data is kept separate from any identifying dataset. All analyses will use the pseudonymised dataset. However, on occasions, there could be a justifiable reason for requiring a cohort member to be reidentified within the clinical trial.

Researchers from the UoB will process the data for the purposes described above.

Cancer Survivorship Studies: national comparator data from routinely collected health service data — DARS-NIC-461060-D7X5H

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2022-12-19 — 2025-12-18 2023.02 — 2023.07.

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The British Childhood Cancer Survivor Study (BCCSS) is a national population-based cohort of almost 35,000 individuals who were diagnosed with cancer under the age of 15 years, between 1940 and 2006, in England, Wales or Scotland, and who survived at least 5 years from diagnosis. The original childhood cohort (MR787) relates to a cohort of individuals diagnosed with cancer between 1940 and 2006, aged under 15 at diagnosis and who survived at least 5 years from diagnosis, in Britain. This cohort was flagged with NHS Digital back in 2008/09 and legislation in place at the time allowed NHS Digital to liaise with Information Services Division (ISD) / NHS Central Register (NHSCR) Scotland to obtain details of cancers, deaths and demographic (NHS status) information for those cohort members who were diagnosed with cancer in Scotland, died in Scotland or who were domiciled in Scotland and registered with a Scottish GP and forward this information routinely to the CCCSS.

The Teenage and Young Adult Cancer Survivor Study (TYACSS) is a national population-based cohort almost 201,000 individuals diagnosed with cancer when aged 15 to 39 years inclusive, between 1971 and 2006, in England or Wales and who survived at least 5 years from diagnosis.

The BCCSS and TYACSS cohorts are maintained by the CCCSS at the University of Birmingham, established in 1998 with charity funding from Cancer Research UK and the Kay Kendall Leukaemia Fund.

The CCCSS proposes to combine the BCCSS and TYACSS cohorts. This will build the cohorts into one cohort that is as up to date as possible.

The record level data for the Cancer Survivorship cohort required for this study is the subject of a separate application (DARS-NIC-148313-G56YY).

There is no comprehensive national system to monitor adverse health and social outcomes among the entire population of survivors of childhood, teenage and young adult cancer in Britain. However, the University of Birmingham is requesting tabulated data with small numbers in order to categorise the contacts the cohort has with the NHS and understand the full health service burden of late effects of treatment. The research has to characterise this burden in terms of: clinical diagnoses, surgical procedures, service contacts and health economics. For this reason the CCCSS requires population-level data to the 3-character ICD-10 code level, OPCS-4 procedure codes, counts of service contacts for the general population of England to which the health service exposure in the cohort will be compared.

The tabulation data requested is “Aggregated - Small Numbers Not Suppressed”. There are two important reasons why small, unsuppressed numbers are required; one is epidemiological, and one is statistical.

From an epidemiological perspective, the CCCSS is looking at the entire burden of disease in the combined cohort. Thus far cancer survivor cohorts have concentrated on causes of mortality rather than the burden of morbidity. Evidence is emerging that some of the large risk increases observed amongst survivors are in diseases which are rare in the general population though not necessarily diseases which are the primary or underlying cause of death.

From a statistical perspective, historically risk differences have been calculated at individual person years. In many epidemiological studies it is common to observe risk differences in five-year age bands in the general population diseases, especially in chronic diseases which typically will not have a very large gradient of incidence or prevalence within an age band. In cancer survivors however, as their survival typically does not translate into a normal life course, the gradient in a 5-year or 90-year age-band would potentially dilute a risk difference signal. It is accepted practice in cancer survivor cohorts to calculate standardised incidence ratios in single year of age. This means that the CCCSS will require expected admission counts, for example, for all diagnoses for all survivors aged 40, 41, 42 etc., to calculate standardised admission ratios using the accepted method. As some of the diagnoses are likely to be for rare conditions, it is highly likely that some of the data points needed to obtain them are going to contain numbers that are less than 5.

The study aim will be to establish a system to monitor the risks of adverse health outcomes and related healthcare activity and cost among these survivors, and to determine how observed risks and costs compare with those expected from the general population to determine subgroups of survivors who experience substantially increased risk and those service users who require more support.

Adverse health outcomes and associated costs would be obtained from electronic record linkage of the cohorts with existing national registries/databases.

The report by the Independent Cancer Taskforce “Achieving World-Class Cancer Outcomes –A Strategy for England 2015-2020” emphasised the importance of risk stratification of cancer survivors in relation to their risk of developing serious adverse health conditions to ensure that the intensity of clinical follow-up care is in proportion to such risk. It is an unfortunate fact that individuals who have survived cancer experience greater risks of adverse health conditions, and greater risks of dying, than is expected from rates of these events in the general population.

The National Cancer Research Institute, NHS-England and Public Health England have each produced cancer strategies which also emphasise the importance of such risk stratification. It is estimated that by 2030 there will be 4 million individuals living with the long-term consequences of cancer and its treatment, but unfortunately there is to date very little research on the problems which they experience, the causes and how they might be prevented or reduced in the future.

The purpose and legal basis for the processing of these cohorts by the University of Birmingham to carry out research in their Centre for Childhood Cancer Survivor Studies (CCCSS) does so in the public interest and processing is necessary for archiving purposes in the public interest, scientific or historical research purposes.

In particular the legal basis for the processing of these cohorts is covered under GDPR article 6.1(e): Public task: “the processing is necessary for you to perform a task in the public interest or for your official functions, and the task or function has a clear basis in law”.

Also since the university are processing special category data (health data) this is covered by GDPR 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 CCCSS is seeking to establish a comprehensive system to monitor the risks of adverse health and social outcomes among survivors of childhood, teenage and young adult cancer in Britain by combining the BCCSS and TYACSS cohorts and undertaking national population-based record linkage based investigations of the absolute and excess risks of :

Specific causes of death experienced by 5-year survivors of childhood, teenage and young adult cancer, using civil registration data from the national death registries.

Subsequent primary cancers experienced by 5-year survivors of childhood, teenage and young adult cancer, using the cancer registration data from national cancer registries.

Hospitalisation for non-neoplastic conditions among 5-year survivors of childhood, teenage and young adult cancer, using the national Hospital Episode Statistics database for England.

The uptake of the full spectrum of mental health services available within the community among 5-year survivors of childhood, teenage and young adult cancer using the national Mental Health Services Datasets.

Further linkage will be undertaken with additional national datasets relating to education, employment, cardiac outcomes and treatment history (chemotherapy and radiotherapy) subject to the appropriate data sharing agreements and ethic approvals being obtained.

By identifying and monitoring the risks of adverse health and social outcomes, and the related healthcare activity and cost among these cancer survivors, the CCCSS can identify how observed risks and costs compare with those expected from the general population and determine subgroups of survivors who experience substantially increased risk and who may place a higher demand on services.

Such large-scale population-based investigations have so far provided the most reliable and unbiased evidence available for:

counselling, educating and empowering survivors;
developing plans for the follow-up and care of survivors;
providing educational material for health care professionals including GPs;
evaluating risks and benefits of proposals for types of treatment in the future;
providing advice to national authorities in relation to specific groups of survivors who may require further follow-up, surveillance or clinical intervention, and those groups of survivors who could be discharged from follow-up;
providing economic evaluation of the expected and actual costs to the health services of treating and supporting cancer survivors

Justification for collection of routinely collected NHS data:
In order to identify and compare the observed adverse health and social outcomes in the cohort with the general population of England the CCCSS will require numbers and types of the equivalent adverse health and social outcomes identified from amongst the general population.

Treatment interventions for children and young adults with cancer have changed over the last three decades, and continue to do so. This is especially relevant to our cohort who have been diagnosed with cancer historically over a long period of time. The CCCSS is seeking to elucidate late effects of treatment, and as treatment has changed of the lengthy period of diagnostic interest, it is essential to undertake a longitudinal study covering the longest period of observation possible for which good quality routinely collected NHS data are available. For this reason the CCCSS has requested data from financial year 1997-8 to the latest available financial year available for the datasets of interest.

In order to understand the full health service burden of late effects of treatment, it is necessary to categorise the contacts the cohort has with the NHS. The research has to characterise this burden in terms of: clinical diagnoses, surgical procedures, service contacts and health economics. For this reason the CCCSS requires population-level data to the 3-character ICD-10 code level, OPCS-4 procedure codes, counts of service contacts for the general population of England to which he health service exposure in the cohort will be compared.

The CCCSS has carefully reviewed all fields in the Admitted Patient Care dataset with reference to intended processing purposes and outputs and is requesting count data by single year of age and sex of all ICD-10 diagnosis codes and OPCS-4 procedure codes for each of the financial years requested. For the other data sets of interest (e.g. Critical Care, Accident and Emergency, mental health) CCCSS have only requested counts of NHS contacts by single year of age, and sex in the general population of England. The CCCSS will not be capturing any other data items.

The combined BCCSS and TYACSS cohorts provide a unique national resource in that it provides national registers of survivors of both childhood cancer and of teenage and young adult cancer. Independent senior researchers in the UK have approached the CCCSS to use subsets of the BCCSS and TYACSS cohorts as a starting point for their own research investigations avoiding duplicating all the work the CCCSS has undertaken in establishing the registries of survivors which the BCCSS and TYACSS represent. These independent researchers need to have funded and peer-reviewed projects and they need to obtain their own separate ethical and legal permissions (if needed) to undertake the research as necessary. Data sharing agreements would be required with input from both Legal Services and Research Governance teams at the University of Birmingham.

The CCCSS understands that equivalent permissions and agreements need to be in place to accommodate the equivalent legislation in Scotland. The CCCSS is currently completing an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP) via the Electronic Data Research and Innovation Service (eDRIS).

The University of Birmingham is the sole Data Controller as it determines the purposes and means of the processing of personal data. The University of Birmingham also process data disseminated by NHS Digital for the purposes of this research.

The Brain Tumour Charity, Children with Cancer, Dutch Cancer Society and Public Health England are funding the study and have no influence on the study design or study outcomes.

Patient and Public Involvement (PPI)
PPI representatives provided initial feedback on the study protocol, and they are keen to be involved with the project and support the dissemination of the study results.

Research Priority Setting Partnership overseen by the James Lind Alliance. The research proposed here has been identified as being among the top-ten research priorities in three Research Priority Setting Partnership initiatives overseen by the James Lind Alliance. Survivors are central to identifying such research priorities in James Lind Alliance led initiatives.

Specific PPI group established for research funded by The Brain Tumour Charity. In the development of our successful grant application to The Brain Tumour Charity, CCCSS consulted with their Research Involvement Network (RIN) which is comprised exclusively of survivors of a brain tumour. Twelve members of the RIN fed-back in detail on research proposals and this impacted the research. CCCSS have agreed that two members of the RIN will join the Project Steering Group and therefore be involved over the entire lifetime of the project.

Local group of survivors of childhood cancer. The Consultant Paediatric Oncologist at the Birmingham Children’s Hospital has established a local group of about 20 survivors to be consulted on for both clinical and research questions. The Consultant Paediatric Oncologist has indicated that this group may be asked to provide guidance to the survivorship research relating to survivors of childhood cancer.

Birmingham Cancer Research UK Centre PPI Group. There is a Cancer Research UK funded Senior Research Nurse at the Birmingham Cancer Research UK Centre who maintains a group of about 20 survivors of a variety of cancer diagnosed at a range of adult ages. CCCSS have consulted with, and will continue to consult with, this group of survivors.

Pancare. The CCCSS Director is a founding member of PanCare, an organisation for childhood cancer survivors and their families; clinicians caring for those with, or cured of, cancer; researchers addressing the needs of those with, or cured of childhood cancer. This pan-European organisation meets twice each year and has a significant survivor membership. This provides an international forum to seek input from survivors into research being undertaken or planned.

The National Cancer Research Institute –Teenage and Young Adult & Germ Cell Tumour –Clinical Studies Group (NCRI-TYA&GCT-CSG). The CCCSS Director is a member of this national group and there are also two survivors of TYA cancer among the membership. This provides a national forum for input from survivors into survivorship research studies.

Expected Benefits:

It is estimated that by 2030 there will be 4 million individuals living the in UK who have been previously diagnosed with cancer. Unfortunately, there has been very little research on such survivors’ risks of potential side effects of the cancer and/or its treatment. The research that has been carried out so far relates mostly to survivors of childhood cancer and very little research is available relating to survivors of cancer diagnosed in adulthood. The necessary first step is to quantify the risks of potential side-effects experienced by survivors. Then more detailed studies may follow to understand the causes/mechanisms underlying the increased risks and this is likely to lead to insights for strategies to reduce, or ideally prevent, the occurrence of such side-effects developing among future survivors. Such risks also enable the risk stratification of the existing population of cancer survivors so that NHS resources are concentrated on those most at risk with a view to developing interventions aimed at preventing, or reducing the risk of, side-effects before they develop, or where this is not possible identifying the side-effects as early as possible with a view to improving the prognosis.

Proven impact of previous publications and next steps:

The evidence which had previously been produced has had an impact in a number of policy and clinical practice areas:
• The comprehensive risk stratification evidence produced already in relation to survivors of childhood, teenage and young adult cancer concerning their risk of serious adverse health outcomes in relation to their type of cancer, type of cancer treatment received, treatment era, age at treatment, years from cancer diagnosis, attained age and gender has had impact. The initial publication concerned with the long-term risk of the total burden of serious adverse health outcomes carried out as part of the National Cancer Survivorship Initiative, identified subgroups of survivors a high, medium and low risk. This publication has recently been used as key evidence in review which NHS England has undertaken of its Service Specifications. In the future every survivor of childhood, teenage or young adult cancer will be assessed in relation to their long-term risk of developing serious adverse health outcomes using our risk stratification tool at the end of treatment and this will inform clinical decisions regarding the intensity of clinical follow-up necessary ranging from survivor self-management with easy and rapid access back into the NHS system at one end, to regular hospital consultant led multi-disciplinary team care at the other.
https://www.engage.england.nhs.uk/consultation/childrens-cancer-services/user_uploads/service-specification-childrens-networks-and-principle-treatment-centres.pdf
https://www.engage.england.nhs.uk/consultation/teenager-and-young-adults-cancer-services/user_uploads/service-specification-tya-principal-treatment-centres-and-networks.pdf

• The recently established International Late Effects of Childhood Cancer Guideline Harmonization Group (www.ighg.org) led by key European and US investigators aims to produce standard clinical follow-up guidelines for survivors which are as evidence-based as possible and acceptable to clinical communities throughout the world. The CCCSS Director and Senior Colleagues have been closely involved in this initiative and in particular in the development of several recent and on-going international guidelines.

• Advising national health authorities of subgroups of survivors with particularly high risks of specific outcomes for potential recall or other intervention. There is on-going work concerning the introduction of screening (colonoscopy/faecal occult blood sampling) for bowel cancer in survivors of childhood cancer who received external beam radiotherapy to the abdominopelvic region; also on-going work into understanding whether there are any ways to reduce the substantial risks of stroke in survivors of childhood, teenage and young adult cancer who received external beam radiotherapy for an intracranial tumour.

• The CCCSS Director and Senior Colleagues regularly speak at the Annual Education Day organised by the Late Effects Group of the Children’s Cancer and Leukaemia Group. This is well attended (100 to 150 attendees) by those responsible for the care (doctors and nurses) of survivors of childhood cancer at Centres throughout the UK.

• The CCCSS Director and the Senior Lecturer are each full members of both the Children’s Cancer and Leukaemia Group (CCLG) and the Late Effects Group of the CCLG.

• The BCCSS receives formal clinical input into its research plans from a CCLG/BCCSS liaison/advisory committee jointly organised by the Late Effects Group of the CCLG and the Cancer Survivorship Group.

• The TYACSS receives formal clinical input into its research plans from the NCRI-TYA&GCT-Group of which the CCCSS Director is a full member, and who also chairs the Survivorship Subgroup of the main Group.

Three serious limitations of previous research relating to British survivors of cancer diagnosed when young relate to the absence of national databases relating to cardiovascular conditions, GP prescriptions and the use of mental health facilities accessed within a community setting – each of these limitations can now be overcome with the current proposal.

There has been very little previous research concerned with the healthcare costs relating to British survivors of cancer diagnosed when young and how these compare with those expected from the general population. This can now be addressed for England and Scotland because the data and expertise will be available to the project.

Uses of evidence produced for changing clinical practice and health policy:

Such large-scale population-based investigations of the risks of a comprehensive spectrum of fatal and non-fatal adverse health outcomes has provided the most reliable and unbiased evidence available for:
• feeding back to, counselling, educating and empowering survivors;
• developing evidence-based clinical follow-up guidelines;
• preparing “survivorship care plans”;
• providing educational material for health care professionals including GPs;
• evaluating risks as well as benefits of proposals for future treatment protocols;
• advising national health authorities in relation to subgroups of survivors at particularly high risk for consideration of potential recall for counselling, surveillance or other intervention;
• identification of low risk groups for potential discharge from hospital based follow-up;
• provide risk stratification information to national health authorities, particularly NHS England, to guide the evidence-based levels of intensity of clinical follow-up needed by different specific subgroups of survivors;
• provide health economic evaluations from financial information recorded in hospital activity registers to compare the observed and expected costs relating to survivors.

Impact and benefits for patients, healthcare professionals and policy makers over the next 3 years:
• The large-scale population-based design of CCCSS studies ensures that the risks produced are as comprehensive and accurate as it is possible to produce in practice.

• Every survivor of childhood, teenage and young adult cancer in England at the completion of treatment should be assessed by a clinician concerning their long-term risk of serious adverse health outcomes and whether the risk is high, medium or low. This is now stated in latest NHS England Service Specifications for survivors of childhood cancer and separately for survivors of teenage and young adult cancer. The risk stratification tool to be used was developed by CCCSS as part of the National Cancer Survivorship Initiative.

• The CCCSS plans with substantial input from survivors and healthcare professionals to establish a website were findings from the BCCSS and TYACSS cohorts will be summarized in lay terms. The CCCSS has a specific grant to fund meetings to develop the material for these websites amongst other research.

• The evidence which the CCCSS produces in relation to specific adverse health outcomes has been, and will be, included in the development of clinical follow-up guidelines relating to such specific adverse health outcomes through strong links the CCCSS has with the International Late Effects of Childhood Cancer Guideline Harmonization Group (www.ighg.org) led by key European and North American investigators. These guidelines are increasingly used in follow-up clinics throughout the world.

• Each survivor of cancer should be medically reviewed at the end of treatment and an individual survivorship care plan prepared which should be shared with the survivor and their GP. The risk stratification tool which the CCCSS developed, as mentioned above, and clinical follow-up guidelines which the CCCSS contributes to are both key elements in developing such care plans.

• The CCCSS will maintain its close links with NHS England so that our latest evidence is reflected in their Service Specifications relating to cancer survivors.

• The CCCSS will maintain its close links with the national UK professional organization of clinicians caring for children with cancer: the Children’s Cancer and Leukaemia Group (CCLG), The CCCSS Director and a Senior Colleague are full members of both the CCLG overall and its Late Effects Group. This facilitates the transfer of new evidence produced into clinical practice.

• The CCCSS will maintain its close links with PanCare (https://www.pancare.eu) a European-wide organization of healthcare professionals, survivors of childhood cancer and their families and researchers. This provides an international forum to seek input from survivors and inform survivors of new research findings relevant to them. The CCCSS Director is a founding member of PanCare.

• Continue to feedback to survivors, healthcare professionals and the NHS new evidence emerging through the various networks described above.

Outputs:

The CCCSS shall investigate the variation in absolute and excess risk of deaths, subsequent primary neoplasms and adverse health and social outcomes by comparing the observed cohort with the general population.

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

Manuscripts will be prepared for publication in international peer-reviewed journals. Authorship eligibility will be determined to be consistent with the requirements of the leading international general medical journal including New England Journal of Medicine, The Lancet, the Journal of the American Medical Association and the British Medical Journal.

There are already over 100 such manuscripts published using the BCCSS cohort, and about 10 published using the TYACSS cohort.

Funding bodies will need to be acknowledged within peer-reviewed publications, but they have no rights to alter, delay or prevent such publications.

The CCCSS intends to establish a website for the study which will contain information regarding progress and accessible summaries of the research in the form of regular newsletters. The Study Protocol, a complete list of publications and previous Newsletters will be available on the Study Website.

Senior members of the CCCSS regularly speak at the Annual Education Day organised by the Late Effects Group of the Children’s Cancer and Leukaemia Group. This is well attended (100 to 150 attendees) by those responsible for the care (doctors and nurses) of survivors of childhood cancer at Centres throughout the UK.

The CCCSS Director is a full member of both the Children’s Cancer and Leukaemia Group (CCLG) and the Late Effects Group of the CCLG.

The various Patient and Public Involvement (PPI) groups (as described in the Objectives of Processing section) are keen to be involved with the project and support the dissemination of the study results. These PPI groups are;
- Research Priority Setting Partnership overseen by the James Lind Alliance
- The Brain Tumour Charity Research Involvement Network (RIN)
- Local group of survivors of childhood cancer at the Birmingham Children’s Hospital
- Birmingham Cancer Research UK Centre PPI Group
- Pancare.
- The National Cancer Research Institute –Teenage and Young Adult & Germ Cell Tumour –Clinical Studies Group (NCRI-TYA&GCT-CSG).

Reports for funders and peer-reviewed publications. Specific outputs will comprise tables of standardized hospitalization ratios which will used to measure differences in secondary care usage between a cohort of cancer survivors and the general English population. This will be done for an extensive range of hospitalizations determined by primary and secondary diagnoses. The individual level equivalent data for the cancer cohort required for comparison

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).

NHS Digital will create the requested tabulated (small numbers not suppressed) datasets, then disseminate the data to the University of Birmingham, CCCSS, via SEFT.

The CCCSS will not attempt to re-identify any individual or carry out any other activity that may pick up individual characteristics that could lead to identification. The CCCSS will not flag members of cohort in the tabulated flow of data.

Risks of specific causes of death:
Each individual enters risk at the date of 5-year survival and contributes person-years until the exit date (first of emigration date or date of end of ascertainment). Standardised Mortality Ratios (SMRs) and Absolute Excess Risks (AERs) will be calculated as O/E and [(O-E)/py]*10000 where O and E are the observed and expected numbers of deaths, respectively, and ‘py’ is the person-years at risk accumulated. To investigate variation in SMRs and AERs across levels of risk stratification factors. Poisson regression models will be utilised. Poisson regression is the modelling of count data and is used to predict a dependent variable that consists of "count data" given one or more independent variables. Cumulative incidence of death from a specific cause will be estimated treating other causes of death as competing risks. Cumulative incidence of death from a specific cause will be estimated treating other causes of death as competing risks.

Risks of subsequent primary neoplasms (SPNs):
Similar statistical methodology to that described for deaths would be used to determine subgroups of survivors at substantially excess risk of specific SPNs, but the summary measures would be Standardised Incidence Ratios (SIRs) and Absolute Excess Risks (AERs defined as for deaths, in terms of observed (O) and expected (E) numbers of SPNs of a particular site/type, as in the previous work by the CCCSS.

Risk of non-neoplastic adverse health and social outcomes:
The period at risk begins from the start date for ascertainment of the specific outcome and ends at the current end date of ascertainment provided the survivor does not exit through emigration or death before this end date. The risk of a specific adverse health outcome would be compared over the period at risk using Poisson regression in relation to the risk stratification factors. In this way it would be possible to identify particular subgroups at greatest risk (Internal analysis).

The CCCSS are requesting tabulated data (with small numbers unsuppressed) from general population, for example, the general population hospitalisation, community mental health events classified by age, sex and calendar year. By dividing the number of events in each cell by the general population estimate of those at risk provides an expected rate for the derivation of expected numbers. Again, Poisson regression would be used to compare the observed and expected number, Standardized Hospitalization Ratio (SHR), over the levels of a particular risk factor adjusting for others (external analysis).

Cost analysis:
Unit costs will be assigned to healthcare activity using standard Department of Health (DoH) guidance. Healthcare Resource Group (HRG) codes will be assigned to secondary care episodes using the DoH Grouper software with sensitivity analysis between year-specific and common-base-year assignment. Prescriptions will be costed using the national tariff for branded medicines and the electronic medicines compendium for generic medicines. On this basis, the cost of subsequent primary neoplasms, the cost of non-neoplastic adverse events and the overall cost-profile of survivors will be described.

Comparison of overall costs and cost profiles will be made descriptively through cost-profile visualisation. In parallel with the risk analysis described above, internal analysis will identify predictors of cost using generalised linear models. External analysis based on the same cells as the risk analysis will estimate observed and expected cost compared with the general population.

Security:
Two of the hard drives will be stored in a fire-proof safe in a locked room within the CCCSS Study Centre which requires a swipe key and two physical locks to access. The third hard drive will be stored in a fire-safe in a separate location within the University of Birmingham College of Medical and Dental Sciences (COLMDS) that satisfies University Security requirements.

Only members of the CCCSS will have access to the encryption keys for the external hard drives.

Both a manual and electronic log will be kept to record details of access to, and changes to, the databases on the encrypted drives. Any adjustments to identifiable data will be replicated across each version of the database on each separate encrypted drive. The databases will be checked against each other for consistency. A manual log will be kept at the Study Centre along an electronic log with a description of changes, the dates the changes were made and who made the changes that will be kept on each encrypted drive and on the Study Centre network share.

The CCCSS and NHS Digital will be informed by COLMDS-IT Services prior to any changes to the location or storage situation of the encrypted drive stored in COLMDS outside of the Study Centre. Any such changes must be agreed between the CCCSS and COLMDS-IT Services.

The database of linked data will be stored and maintained according to the Information Security and Management Policy (ISMP) of the University of Birmingham.

The ISMP sets out the security arrangements under which sensitive data should be identified, processed and stored, while the Data Protection Policy deals with data protection and privacy.

Further information relating to University of Birmingham standards and guidance can be found at: http://itsecurity.bham.ac.uk/policy.

In accordance with the ISMP security practices shall be deployed to protect people technology and processes from deliberate attack based on a risk assessment within the framework of an Information Security Management System (ISMS) compatible with ISO27001 and related standards.

Data shall be stored on centrally managed stores (file servers) and archived in a manner to facilitate secure disposed of when no longer required. The file servers are located in locked, secure, specialised rooms with appropriate heating and ventilation, on the University of Birmingham Campus. For projects undertaken at the CCCSS the file servers reside in the College of Medical and Dental Sciences (COLMDS). Access to server rooms is limited to UBHAM Information Technology personnel only with swipe card systems.

Multiple tape back-ups of the servers occur daily (incremental) and weekly (full) and are stored in fireproof safes in separate locked locations within COLMDS. Access to rooms is limited to UBHAM Information Technology personnel only with swipe card systems.

File, database or disk encryption must be used except where compensating controls can be shown to provide an equivalent level and protection.

Data transferred over data communication networks shall be encrypted or otherwise protected to University Standards (at least AES 256 compliant). This includes email and other types of electronic messaging.
Removable media and mobile devices shall be encrypted to University Standards (at least 128-bit encryption).

Access to University systems, IT infrastructure and facilities will only be to authorized persons with a valid ID card, a University assigned username and a password that conforms to University standards (at least 8 characters long, one uppercase letter, at least one lower case letter, at least one digit, at least one non-alphanumeric character, enforced renewal every 180 days).

While all members of CCCSS staff have access to a personal file-store account a separate network share will be made available to all Study Centre staff only, for file sharing purposes and storage of the linked data.

All CCCSS staff who will have access to the NHS Digital data are substantive employees of University of Birmingham or CCCSS PhD students and have completed the mandatory training on Information Security Awareness, Data Protection and Freedom of Information. All Study Centre staff members are required to sign an undertaking of confidentiality which, if broken, would likely lead to dismissal. All Study Centre staff with access to patient identifiable information have received appropriate training and receive ongoing supervision and support to ensure they are aware of their responsibilities. Study Centre Staff will never disclose identifiable data to third parties.

Personal data will be processed according to a valid lawful basis and conditions for processing.

The BASIL-2 trial: comparing the clinical and cost-effectiveness of revascularisation strategies for severe limb ischaemia — DARS-NIC-291863-S9M0X

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: 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 2020-02-01 — 2023-01-31 2020.08 — 2022.11.

Access method: One-Off, Ongoing

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. HES:Civil Registration (Deaths) bridge
  3. Civil Registration - Deaths
  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 aim of the BASIL-2 (Bypass vs. Angioplasty in Severe Ischaemia of the Leg) trial is to determine whether a ‘vein bypass (VB) first’ or a ‘best endovascular treatment (BET) first’ revascularisation strategy represents the most clinically and cost-effective treatment for severe limb ischaemia (SLI) due to below the knee (infra-geniculate) arterial disease. The original BASIL trial, on which BASIL-2 builds, was carried out in 2000-2005 involving a separate cohort of 452 patients across 27 UK hospitals.

The data requested for BASIL-2 trial is crucially important in order to answer the study research question since the primary outcome of the trial is amputation free survival, defined as the time to major limb (above ankle) amputation of the index (trial) leg or death from any cause.

BASIL-2 is an individually randomised, multi-centre, pragmatic, two-arm, open trial of two alternative revascularisation strategies (VB first vs. BET first) for the management of SLI due to infra-popliteal (with or without inflow) disease. Patients are allocated to two intervention arms: part of patients will receive BET and another part receive VB surgery.

Patients affected by SLI due to below-the-knee disease, and who are suitable for both bypass surgery and endovascular treatment, are invited to be randomly allocated to one or other of the treatments.

The consent signed by participants and the BASIL 2 Trial application to NIHR’s Health Technology Assessment Programme (HTA Ref: 12-35-45) allows linkage to patient data available in the NHS routine clinical datasets, including mortality data from the Office of National Statistics (now referred to as Civil Registration (Deaths) data) through the Health and Social Care Information Centre (now NHS Digital) and other central UK NHS bodies. The linkage will allow University of Birmingham to double-check the main outcomes against routine data sources and extend the follow up of patients in the trial. It will also allow timely collection of accurate, long term outcome and health resource usage data without needing further contact with the study participants. This is important as it will link a trial of treatments that may become a clinical standard of care to long term outcomes that are routinely collected in clinical trial data but which will not be collected from participants during follow up period of the trial.

The GDPR lawful basis for University of Birmingham to process this data is Article 6(1)(e) and Article 9(2)(j). The study is in the interest of public health and advances of vascular science.

Processing is permitted under common law as all participants have consented; the consent form, participant information material and the original application (HTA Ref: 12-35-45) have been approved by the NRES Committee West Midlands - Coventry & Warwickshire (REC ref: 14/WM/0057).

The University of Birmingham are the Data Controller who will also process the data.

As well as the BASIL-2 trial sites in the UK, there are four trial sites located in Denmark and Sweden. No data provided under this agreement would be shared outside England and Wales; rather, the Danish and Swedish trial sites may provide their outcome information to the UK trial sites for comparison purposes, but not for any record level linkage.

The study Trial Steering Committee acts in an advisory capacity but does not have any decision making power over the purposes for which data will be processed, or the manner in which data shared under this agreement will be processed; therefore University of Birmingham are considered to be the sole data controller and the only organisation that will process data.

The trial was awarded NIHR funding in 2014 and this funding award is still active.

The trial has gone through a rigorous scientific peer review and undertaken a structured methodology which is set out in the study protocol and approved by the above Research Ethics Committee.

Regular newsletters are sent to participants, the latest one being Summer 2019, these provide participants with a regular update on the trial.

Yielded Benefits:

No data has been disseminated under the previous agreement so no yielded benefits have been achieved to date.

Expected Benefits:

The benefit of the study and of this particular exercise will be in the interest of public health and advances of vascular science.
Severe Limb Ischaemia (SLI) is the most severe form of lower limb peripheral arterial disease and is a seriously disabling, life and limb threatening condition. It is associated with a marked reduction in individual’s quality of life and has a poor prognosis. The current treatment options for SLI are vein bypass, endovascular intervention (angioplasty, stenting), amputation and end-of-life care. The SLI population covers one in every 1000-2000 diagnoses in the UK each year. Moreover, the incidence of SLI is rising primarily as a result of ageing population, increased incidences of diabetes and high rates of smoking. If the blood supply to the leg is not restored without delay, a patient is likely to lose their limb or die within 12 months.

At the societal level, caring for patients with SLI is extremely costly to NHS and social care services. This is mainly due to the often-prolonged recovery time from surgery and endovascular intervention. For example, in the BASIL-2 trial, patients on average spend 5-6 weeks in hospital during the first year after intervention, and 2-3 weeks per year thereafter. SLI patients are frequently discharged to nursing and residential homes and those that return home often require significant support in the community as well as costly adaptations to their houses.

It is clear that SLI presents a significant burden at both levels: at the society and personal level. For this reason it is important to determine which treatment (venous bypass or best endovascular treatment) is best at preventing amputation and death, avoiding ulcers and gangrene and relieving pain due to the blocked infra popliteal arteries.

It is also crucially important to study the relative costs of the two revascularisation strategies to see which method offers “the best value for money” for NHS and social care. This will only be achieved with robust data collection during the study.

University of Birmingham will process the personal data needed to establish the primary outcome (Amputation Free Survival – AFS) under GDPR Article 6(1)(e) 'task in the public interest' and Article 9(2)(j) 'scientific research'.

Differences in the primary outcome (AFS) between the trial arms will be assessed by comparing time from randomisation to major limb amputation or death from any cause between randomised groups, assessed up until the end of the follow up period up to 92 months. The trial will address the question of the choice of the first revascularisation strategy at the point of clinical equipoise. This will be answered by the planned Intention to Treat analysis for the primary outcome, where participants are analysed according to the first intervention they were allocated to, regardless of subsequent interventions received, or whether they actually receive the allocated intervention (a small proportion may not receive their allocated intervention).

The University of Birmingham aim to recruit a total 389 participants to the study (across all study sites) to randomise to two trial arms. Individual trial participants will not directly benefit from the study, but University of Birmingham will apply the generalisability of the results obtained from the chosen sample size to the population at large. The outputs of the study will be presented at conferences and vascular societies and the results drawn should inform policy makers to implement the guidelines and/or recommend further trials.

Outputs:

As a result of data processing final results will be disseminated to The Vascular Society for Great Britain and Ireland, trial stakeholders and most importantly to the trial participants and public. The results will be communicated via publications, conferences, various media channels, the trial website and to the wider society. University of Birmingham aim to disseminate the final output after April 2022, which is an expected end of trial date. It is important to emphasise that the outputs will only include the aggregate, small number suppressed data (in line with the HES Analysis Guide), and no individual data will be published.

In line with HRA guidelines the results will be made available to the trial participants, and to other interested groups of communities if appropriate, in the form of newsletters, leaflets or pamphlets. The trial participants will be provided feedback on the outcome of research towards which they contributed. Output material will include a summary of the findings and information/links where to find more comprehensive results.

The BASIL-2 trial is registered with the International Standard Randomised Controlled Trial Number (ISRCTN) registry, thus adheres to the recent guidelines of World health Organisation (WHO) International Clinical registry Platform (ICTRP) and International Committee of Medical Journal Editors (ICMJE) on improving the publicly available information about clinical trials. The registration ensures free public domain access and use all the trial metadata generated during the process of registration, updating and reporting.

At the end of the study a full account of the research will be available on another public domain, NIHR Journals Library. This will contain comprehensive accounts on the trial. Other, smaller publication formats may also be considered. All publications in journals will go through a rigorous scientific peer review.

To improve the awareness of clinicians, and The Vascular Society in general, the final results will be presented at conferences. The BASIL-2 trial has a yearly representation at the Vascular Society for Great Britain and Ireland (at the STARS – St Thomas' Advanced Revascularisation Symposium – conference), to which nationally and internationally recognised figures in the field of lower limb revascularisation are invited. The updates will be delivered via lectures, case demonstrations or open discussions. New developments in the field of lower limb revascularisation will be discussed and shared.

Processing:

The study commenced in 2014 and as at June 2020 has recruited 329 participants from all sites. The revised target recruitment to the study is 389 participants in total. While four trial centres are based in Denmark and Sweden, the rest of the 50 trial hospital sites are located in the UK. The dataset will be requested for patients from England and Wales only, since the NHS Digital data does not cover Scotland. No NHS Digital data will be shared with Denmark and Sweden.

Since the primary outcome of the study is amputation-free survival or death, as described in the previous section, University of Birmingham require the following variables:
i. Date of death;
ii. Cause of death;
iii. Major amputation (amputation of leg above ankle)
iv. Leg (left or right)
v. Date of amputation
vi. Hospital where amputation was carried out.
The requested data will be used for primary outcomes as well as cost-effectiveness analysis.

The data requested will be a patient level information and have the intention to answer a specific research question- the primary objective of the study. The data provided to NHS Digital will be linked using the NHS number and patient's date of birth (date of birth will be needed as a second identifier for confirmation). The research is undertaken using a structured methodology, set out in the protocol and approved by both an appropriate ethics and scientific approval committee. The study is being conducted in compliance with Good Clinical Practice, Data Protection Act and General Data Protection Regulation. The risk of re-identification of participants outside of trial management team is minimised by removing the participants identifiable information prior to entering their trial data on the database. Participants are allocated a unique trial number which will be used for data linkage and overall data management.

The information will be stored on a hard drive which is maintained and backed up by the University IT service. The data will only be processed on the Birmingham University campus computers, locally, in the Birmingham Clinical Trials Unit building. The access to the computers will be user restricted and only trial members who are all substantive employees of University of Birmingham will have access to it. The data retrieved from NHS digital will be transferred on the secure trial database to enable statistical analysis. The study data will not be shared with any other organisation except in the form of aggregate outputs 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).

Models of Resilience – Covid-19 and Non-Covid-19 Contexts — DARS-NIC-378657-B8F3K

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, and Non-Sensitive

When:DSA runs 2021-06-24 — 2024-06-23 2021.12 — 2022.06.

Access method: Ongoing

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. Civil Registration (Deaths) - Secondary Care Cut
  2. Emergency Care Data Set (ECDS)
  3. HES:Civil Registration (Deaths) bridge
  4. Hospital Episode Statistics Accident and Emergency
  5. Hospital Episode Statistics Admitted Patient Care
  6. Hospital Episode Statistics Critical Care
  7. Hospital Episode Statistics Outpatients
  8. Civil Registrations of Death - Secondary Care Cut
  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)

Objectives:

The University of Birmingham is requesting data from NHS Digital in order to help them to determine the impact of hospital-level variation in organisational and clinical approaches to acute care delivery at the hospital/community interface during waves of COVID 19 (e.g., prescribing strategies, staff redeployment, integrated community care planning, etc.) on indicators of healthcare resilience such as (a) operational outcomes (e.g. acute care flow, discharge rates), (b) clinical outcomes for COVID-19 related conditions (e.g. mortality, readmission, rates of pulmonary embolism), and (c) clinical outcomes for non-COVID-19 health conditions (e.g. rates of new onset heart failure, stroke). The data requested will make it possible to study five comparative periods of analysis: (i) Pre-COVID-19, no winter pressures, (ii) Pre-COVID-19, winter pressures, (iii) COVID-19 outbreak peaks, (iv) Post-COVID-19 peaks, and (v) Concurrence of COVID-19 and winter pressures (season 2020-2021).

The surge of COVID-19 has had a profound impact on the management and delivery of acute healthcare. To tackle the epidemic, trusts have redesigned organisational models with changes in processes of assessment and care delivery, redeployment of staff, new pathways of care, and different prescribing strategies. These changes have been implemented to provide a rapid increase in acute care assessment and treatment capacity across a system of care for patients with COVID-19-related symptoms, whilst also trying to maintain delivery of care for patients with non-COVID-19 healthcare needs.

The purpose of this agreement is to determine the optimal design of the acute care interface with the community, by correlating hospital-level care delivery approaches elicited by the Society for Acute Medicine Benchmarking Audit data (SAMBA) and hospital and patient outcomes from HES data before, during, and after the COVID-19 periods.

The data requested will support the achievement of the aim of the project through the construction and analysis of indicators of hospital and healthcare resilience, which is defined as (1) the ability to deliver acute care for COVID-19, and (2) the ability to provide standard care for non-COVID-19-related conditions that can present with acute complications. Examples of resilience indicators include readmission rates, length of stay, mortality, intensive care unit admission rates, number of specialist visits, number of elective and emergency hospital admissions (for COVID-19), rates of heart failure (for non-COVID-19-related conditions).
The datasets from NHS Digital will allow the University of Oxford (University of Birmingham's sole Data Processor) to construct indicators of hospital resilience for COVID-19, and non-COVID-19-related conditions that can evolve and develop complications that require acute care (such as, e.g., heart failure, stroke, cancer) by:
- Following patients across different types of health services that they use before, during, and after COVID-19 outbreak periods;
- Accounting for multiple episodes of hospital attendance/admission and study readmissions for COVID-19 and non-COVID-19-related symptoms;
- Estimate out-of-hospital mortality for patients using data from the Civil Registry (Deaths) - Secondary Cut.
The requested data (years 2018 to 2021) will allow the data processor (University of Oxford) to study five comparative periods of analysis:
(i) Pre-COVID-19, no winter pressures
(ii) Pre-COVID-19, winter pressures
(iii) COVID-19 outbreak peaks
(iv) Post-COVID-19 peaks
(v) Possible interactions between COVID-19 and winter pressures (season 2020-2021).
Due to the novel setting and disease that this project studies, and the as yet unknown COVID-19 and non-COVID-19-related medical complications that the current pandemic may cause, there is a major exploratory element to this study. The uncertainty related to the object of investigation requires access to multiple sources of data such as HES critical care, A&E, Outpatients and Inpatients, emergency care (ECDS), as well as the civil registry of deaths (secondary cut). The data processor, the University of Oxford, will use the pseudonymised code provided by NHS Digital to follow patients across the different NHS Digital products that are requested in this agreement.
The University of Oxford will use the hospital code in HES to complement the analysis with information at the hospital and catchment area level from publicly available datasets and the Society for Acute Medicine's SAMBA survey of practice, which provides information regarding the size and staffing organisation of each acute medical department in the UK, alongside strategies for care delivery as well as methods of interaction with community care providers. In particular, the project will use SAMBA data from the 2018 and 2019 Winter version, and the 2020 COVID-SAMBA survey.
The Society for Acute Medicine (SAM) is the national representative organisation for acute health care staff. Formed in 2000, the Society now has over 1000 affiliates, the majority of which are doctors training or specialising in acute medicine. SAM delivers annual SAMBA audits to assess acute medicine approaches and the sharing of good practices. These are England-wide surveys at the hospital level and, in the UK, they are recognised by the Healthcare Quality Improvement Partnership.

The study that is subject of this agreement is part of a broader project, which has three operational tiers:
(i) The first part includes literature reviews, engagement with stakeholders and a survey of healthcare delivery practices of UK acute medicine units at the hospital level, based on the Society for Acute Medicine Benchmarking Audit (SAMBA). This part of the project will not use NHS Digital data.
The Principle Investigator (PI) of the overall project is an active member of the SAM (Society for Acute Medicine) network, has delivered three previous national surveys through the SAMBA network, and has published peer reviewed papers analysing key points from previous audits.
(ii) The second part of the project is the empirical analysis of hospital resilience based on the NHS Digital data that the University of Birmingham (Data Controller) is requesting in this agreement. This part will rely on developing quantitative econometric analyses of indicators of healthcare resilience for COVID-19 and non-COVID-19 diseases with acute complications constructed from the HES data. Examples of indicators of healthcare resilience include mortality rates, readmission rates, rates of pulmonary embolism, average length of stay in intensive care units, rates of new onset heart failure or stroke, rates of A&E attendances and emergency admissions for heart attack and stroke/transient ischaemic attack (TI), during and after the first COVID-19 wave.
Hospitals will be grouped by common approaches to organisation of care from the SAMBA survey (see (i) above). The trust/hospital/deliverer-level variables that describe care delivery approaches elicited from SAMBA will constitute the main explanatory variables. The analyses will control also for patients' demographics and comorbidities, and data on pre-COVID-19 organisational practices and healthcare needs of the patients and of the population in the trust/hospital/deliverer catchment area. The analysis will deliver aggregate-level results that do not identify individuals, and the publications will not identify hospitals. All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide.
(iii) The third part of the overall project will develop a qualitative study to learn about healthcare seeking behaviour among patients with non-COVID-19 severe disease. For example, this part of the project will develop focus groups to understand the reasons behind the reorganisation/postponement and delay of diagnoses (e.g., for cancer-related screenings and the screening and treatment of heart failure). This final part of the project will also include qualitative work based on site visits (or remote interviews) in well performing systems of care, to understand how novel structures and organisational contexts were successfully implemented and embedded. This part of the study will not involve analyses of NHS Digital data nor any linkage to NHS Digital data.

The analysis will control for underlying health conditions, healthcare needs, and characteristics of the population in acute care units and in their catchment areas. Information on different care delivery approaches at the hospital level will be elicited from a national survey of organisation and delivery of acute care, the Society for Acute Medicine Benchmarking Audit (SAMBA). The SAMBA dataset is described below. Importantly, SAMBA contains information at the hospital level and does not entail patient-level linkages.

The findings from this programme of research will enable policy makers within the Department of Health and Social Care and NHS England to determine how best hospitals and community systems should organise and deliver care during and after waves of COVID-19.

The GDPR legal basis for processing data for this research comes under Article 6(1)E – "task in the public interest" The data processing will provide evidence to help (a) policymakers make evidence-based policy decisions, (b) hospital managers to develop evidence-based decisions on the organisation of acute medical services, and (c) acute care clinicians to understand which practices have improved the resilience of acute care services.
The public interest that justifies the processing of this data relates to the improvements that can be made to health-care provision within the NHS as a result of the findings. The University of Birmingham is proposing to process data under point (j) of Article 9(2).

The 2020 version of SAMBA for COVID-19 (COVID-SAMBA) collects hospital-level information about variations in organisational and care delivery approaches during the COVID-19 outbreak, such as the degree of integration across acute/community healthcare providers (e.g., discussion of guidelines and common planning for the referral and management of patients with ambulance services, primary care providers, and care homes), novel care pathways (e.g. prescription and patient screening strategies, staff redeployment), and novel structures/systems of care (e.g. home-based hospitalisation).
With regards to the analysis for which the University of Birmingham is requesting access to NHS Digital data, the SAMBA surveys will provide information at the hospital level on care delivery approaches. SAMBA data will be linked to HES data using hospital site codes and not at the patient level.

After the onset of the current pandemic, the Department for Health and Social Care (DHSC) asked the project team to analyse pressures as a consequence of COVID-19, as this is an overwhelming national priority in acute care. In particular, following the research focus commissioned by the DHSC, this project defines the concept of hospital resilience as the ability to meet the acute healthcare needs of the population during COVID-19. The researchers will assess which organisational and care delivery practices are associated with improved healthcare delivery performance.

Other parts of the study, which are not based on the requested data and do not include data analysis, involve literature reviews, consultations with stakeholders, health professionals and patients, and qualitative work in a sample of acute hospitals. The University of Birmingham’s data processor, the University of Oxford, will process the NHS Digital data received and conduct a quantitative analysis for this project.

The University of Birmingham holds the main NIHR research contract for the overall study and has entered into an honorary contract with the Chief Investigator (CI). The CI will formulate hypotheses to be tested and help to interpret the findings of the overall study. Hence, the University of Birmingham is the Data Controller. It will not, however, be involved in processing the data. In its capacity as the University of Birmingham’s data processor, the University Oxford team will hold and process the NHS Digital data. The University of Birmingham are determining the means and purpose of the processing of the personal data and the University of Oxford are providing their expertise as the data processor but have no role in determining the means and purpose of the processing. The University of Warwick, where the CI now resides, will not be involved in any decisions about the data nor the analysis of the data.

The University of Leicester employs the researchers undertaking the qualitative component of the wider study, that is the third part of the study as described above. The University of Leicester team will not access, process nor control the data.

Department for Health and Social Care (DHSC) has no role in the conduct of the study. It is providing the funding (through the NIHR) and will receive the outputs. It is not involved in deciding which analyses should or should not be conducted.
The overall project, including the collection of SAMBA data and the cross-mapping of SAMBA with HES data, received ethical approval.

Since the study is not an evaluation of a specific intervention, the research approach is not based on a distinction between treated and control groups. Rather, the empirical design relies on correlations between hospital-level care delivery approaches and health outcomes. More specifically, the analysis will correlate indicators based on patient clinical information, mortality data from civil death registry with hospital-level indicators that identify relevant elements in the organisation of acute care delivery during and after COVID-19 outbreaks, elicited from the SAMBA survey.
As the data processor on behalf of the University of Birmingham, Oxford will inform the analysis using data from all attendances at A&E specialist or outpatient clinics or admissions between January 2018 and September 2021. This project requires information on all patients attending/admitted to the hospital, with information on the referral status, the cause of attendance/admission, inpatient/outpatient visits and outcomes, the length of stay, and the clinical health outcome for each episode/service use. The analysis will be conducted with pseudonymised data and no individual patient data will be released.
The purpose of this project is to understand which acute care delivery approaches developed and implemented before, during and after COVID-19 outbreaks translate into better acute care and health outcomes for the population, and to identify the practices best able to make hospitals more resilient when there is an outbreak of a disease such as COVID-19 or the winter flu. Combining SAMBA and HES data will allow the data processor, the University of Oxford, to achieve this aim. While SAMBA contains all the information relating to the processes of care implemented by English hospitals, HES data make it possible to investigate how these processes affect patients and hospitals.
This project requires data from the following data sets:
Emergency Care Data Set (ECDS)
Hospital Episode Statistics Accident and Emergency (HESA&E), non sensitive data
Hospital Episode Statistics Admitted Patient Care (HESAP), non sensitive data
Hospital Episode Statistics Critical Care (HESCC), non sensitive data
Hospital Episode Statistics Outpatients (HESO)
HES: Civil Registration (Deaths) - Secondary Care Cut link
The ECDS data requested is not currently within the TRE dat offering and thus this request can not at this point in time be fulfilled by the NHS Digital TRE service.

Using the pseudonymised identifiers provided by NHS Digital to bridge the products requested, the data analysis will connect patient's admission episodes across the HES products (inpatient, outpatient, critical care) and with (i) readmissions, and (ii) out-of hospital mortality (through the Death Civil Registry). As the data processor, the University of Oxford will analyse this information also in conjunction with hospital-level care delivery approaches from the Survey of Acute Medicine Benchmark Audit (COVID-SAMBA and 2019, 2020 SAMBA - please see point 4 of this section and the attached documents for a description) and with aggregate metrics of general health and population characteristics in the acute department's catchment area from publicly available data sources.

Due to the as yet unexplored and as yet unknown context of a novel disease outbreak, and because this project studies how COVID-19-related care as well as non-COVID-19-related conditions relate to different healthcare provision approaches, information on all symptoms and causes of hospital admission is necessary. As features of acute illness are often non-specific (e.g. confusion, generalised functional decline, reduced mobility among older adults), the project requires all available health information without restriction to specific conditions. In addition, there is no guidance yet as to which groups of patients have had fewer admissions due to COVID-19 and its overall effect on hospitals' ability to deliver care: therefore looking at all hospital admissions is the most inclusive and correct approach.
Hospital Episode Statistics Accident and Emergency data will allow the data processor, the University of Oxford, to identify whether patients that attend A&E are discharged or admitted, and to classify the cause of attendance (COVID or non-COVID related).
HES A&E (and the ECDS, once a code will be developed), HES-Outpatient, HES-Inpatient, HES-Critical Care will make it possible to:
- Follow patients that attend A&E/ the hospital/ trust in the subsequent stage (i.e., inpatient / outpatient / discharged), record their process of admission and outcome (e.g., length of stay and clinical health outcome);
- Control for the utilisation of primary care before and after an acute illness that requires A&E attendance or
inpatient/outpatient admission;
- Construct and correlate indicators of acute care resilience with organisational changes and care delivery practices during and after COVID-19 outbreaks (from the SAMBA hospital-level data).
Civil Registration Deaths - Secondary Cut will allow the data processor at the University of Oxford to link attending/admitted patients with out-of-hospital mortality outcomes.
In particular, the University of Birmingham is requesting the following groups of variables:
- Admissions - Period of care (e.g., method, source, date, waiting time) to control for different circumstances and procedures of admission in the analysis of the correlation between hospital-level acute care delivery approaches and average health outcomes, and group patients’ health outcomes by heterogeneous characteristics;
- Augmented/critical care period variables, with information such as time, period, outcome, source, discharge, status, intensive care, high dependency of patient’s admission episodes, to construct outcomes for the analysis (e.g., average time in intensive care, mortality, probability of high dependency case), controlling for further clinical and admission characteristics;
- Clinical information with date of operation, cause of admission, primary and additional diagnosis codes, operation status, and durations, to control for these elements in the analysis, construct health outcomes by specific circumstances/causes/etc. of admission, and duration of the episode(s);
- Clinical information regarding patient classification and consultant/treatment specialty, and Practitioner/Referring organisation codes, to categorise patients’ health outcomes according to specific treatment groups either by own classification or consultant specialty or practitioner;
- Diagnosis codes and Alcohol Attributable Fraction;
- Discharge dates and methods (and flags), to control for length of admissions and cross-validate precision of the duration, and study time lags between readiness for discharge and actual discharge, and their trends before, during, and after peaks of acute care activity;
- Episodes and spells (Period of care) data, such as dates, durations, types, ward types, and Patient Pathway information, to form groups of similar episodes and to control for such characteristics in the analysis of the correlation between care delivery approaches and health, mortality, and readmission outcomes;
- Geographical codes (e.g., CCG, area, region, site code of GP practice, treatment, residence areas, ONS electoral ward codes), Healthcare resource groups (HRG), Organisation codes/information, and Socio-economic indicators (location-based IMD indexes), to control for/group health outcomes by locations, and associate health outcomes to other local-level information from publicly available data at the trust/catchment area level;
- Patient demographic data, to group patients by categories or control for patient characteristics in the empirical analysis of the correlation between hospital-level care delivery approaches and indicators of health care resilience from patient health outcomes;
- System Data to verify validity of assignment of patient/CDS/SUS codes.
The specification of a COVID-19 diagnosis for patients will be based on the ICD-10 code.
This project only requires pseudonymised data, because the analysis will follow patients in the different services/units. The analysis requires patient level records to analyse health outcomes by different patterns of use of the healthcare services and to be able to group/control for demographic characteristics, waiting times, diagnosis, procedures, etc. Furthermore, patient record data will allow the empirical estimations to follow patients/episodes of care across the various NHS Digital products such as, e.g., deaths registry data, outpatients, etc., to measure healthcare outcomes, before, during and after the pandemic. The University of Birmingham does not request any identifiable or "high risk" variable, and the estimation outcomes and findings of this project will be produced solely in aggregate form, with small numbers suppressed in line with the HES analysis guide.

Nonetheless, the results of the quantitative analyses will only be included in the study outputs and communicated at an aggregate level. There will be no way to identify individual or critically small/selected groups of people from the results of the study all outputs will be aggregated in line with the HES analysis guide. The estimations will only deliver coefficients of correlation between care delivery practices and aggregate categories of health outcomes and indicators (e.g., total A&E admissions, mortality rate, total admissions in cardiology, ICU admissions, average length of stay by non-identifiable demographic characteristics such as age groups).
This data request is limited to the years between 2018 and 2021 inclusive.
This will allow the University of Birmingham to study five comparative periods of analysis:
Pre-COVID-19, no winter pressures (2018-2019, spring-summer)
Pre-COVID-19, winter pressures (2018-2019, winter)
COVID-19 outbreak peaks (2019-2020 winter and spring)
Post-COVID-19 peaks (e.g., July-August 2020)
Possible interactions between COVID-19 and winter pressures in the winter season of 2020-2021.

The quantitative analysis will compare the outcomes of patients in different hospitals and acute care units across England and, as such, it needs data concerning all English hospitals.
There exists no possibility other than via HES to construct and analyse variables that are based on following patients across different units of care, multiple episodes of admission, and out-of-hospital mortality at the hospital/acute care unit aggregate level. This project requires patient-level information also to account for patients' demographic characteristics, and prevalence of as yet not know preconditions and co-morbidities in the reference population that may contribute to determining the success and failure of hospital/acute care unit care delivery organisational approaches and practices in terms of both COVID-19 and non-COVID-19 related care.

The University of Birmingham has minimised the request in the time dimension. In particular, the required data is limited to the years between 2018 and 2021, ending with the release of September 2021.
Due to the exploratory nature of the project and as yet unknown consequences of COVID-19 and care delivery approaches during the current pandemic, the request is not restricted to specific health conditions and causes of admission. The aim of this proposal makes it necessary to request and explore individual-level data because this study is the first of its kind, and the context of the COVID-19 pandemic is as yet unexplored. This analysis will request and explore all possible conditions, causes of admission, and demographic characteristics. It is not possible to pre-aggregate and request health outcomes at the hospital level. This is required to understand the pathways of each individual in the use of the health system, in response to the COVID-19 pandemic, and to group outcomes by (or control for) demographic characteristics, waiting times, diagnosis, and procedures in the analysis.

The ethnic category variable is requested because there is evidence that people from BAME communities are the most affected by the COVID-19 pandemic and the analysis needs to control for this factor. This project requires only pseudonymised data and the request does not include any identifiable or "high risk" variable. The results of the quantitative analyses will only be communicated and included in the study outputs at an aggregate level, further suppressing critically small/selected groups of people.

The request is further minimised by excluding data concerning maternity and psychiatry.

The University of Birmingham is the sole Data Controller. University of Birmingham are determining the means and purpose of the processing of the personal data and the University of Oxford are providing their expertise as the data processor but have no role in determining the means and purpose of the processing. The University of Oxford operates under specific protocols for processing of data directed by the University of Birmingham.

The University of Warwick is not carrying out joint data controllership activities, in light of the Chief Investigator holding an honorary contract with the University of Birmingham, but being a substantive employee of the University of Warwick. The University of Birmingham will remain the only Data Controller, according to its original contract with DSHC and NIHR . University of Leicester employs the researchers undertaking the qualitative component of the wider study. They are not involved in the NHS Digital data processing.

The Department of Health and Social Care (DHSC) is the commissioner of this project. DHSC has no direct influence over the analysis performed and will have access to a final report of the findings but not the data used. The project funder is National Institute fir Health Research (NIHR).

Expected Benefits:

The anticipated evidence produced by this research is hoped will be directly relevant to
a) patients and NHS beneficiaries,
b) policymakers, planners and decision-makers, and
c) health providers, managers and practitioners.

The study hopes to produce findings on what changes in the organisational and cultural approach of hospitals are associated with better coping with Covid-19. These are hoped will be relevant for the development of policy, the organization of NHS acute medical services and the management of patients with COVID-19 and of patients with other conditions during national or local increases in numbers of COVID-19 patients. The dissemination of the anticipated study findings is hoped will enable the NHS to take measures to improve patient care based on evidence gathered on the topics studied.

The project and its dissemination strategy is designed to rapidly inform the Funder (DHSC) and engage in ongoing debates and policy reviews. The University of Birmingham and its project partners have worked with the Patient and Public Involvement (PPI) panel group, study Steering Group and the Funder to agree an engagement and dissemination plan at the start of the project, with activities running throughout its course. The anticipated outputs from the study are centred on informing policy and acute service provision. The University of Birmingham and its team will use its varied professional networks and professional social media presence to raise awareness of the outcomes of this study and maximise engagement with its findings. The external stakeholder group of this project, comprising representatives from the Royal College of Emergency Medicine, the Society for Acute Medicine, NHS Providers and Care England, will consider the anticipated research findings and where it is hoped these will inform potential service improvement or further resources that could help service provision.

It is hoped that the study will identify which organisational and healthcare delivery approaches minimise the impact of COVID-19 in the community, and will identify which practices support the ability to deliver routine care in COVID-19 times. The two focuses of this research project benefit the public interest because they may lead to improved health outcomes, via adoption by the healthcare community. It is hoped that the short-term findings on clinical strategies and organisational approaches associated with high performance in “peak 1” of COVID-19 will inform policy for acute hospitals and acute community providers for any subsequent outbreaks, whether these outbreaks are national or more localised.

Medium term benefits are hoped will be the identification of strategies to maintain ‘business as usual’ healthcare for both acute non-COVID-19 illnesses and serious longer term disease.
Both sets of results will be available to policymakers and health care providers and their guidelines will benefit the public interest and the community.

This project has been solicited by the Department of Health and Social Care (DHSC), to understand how the current pandemic is affecting the delivery of acute care and the delivery of routine care for conditions that may develop into acute complications. By investigating which care delivery approaches entail a better performance for patients with COVID-19 as well as non-COVID-19-related conditions, this project it is hoped will be able to directly inform policy and treatment for future waves of COVID-19, and similar pervasive public health emergencies, and to inform development of new standards of care delivery. The anticipated project outputs and results are hoped will directly feed into policymakers’ decisions. The project team will share the results also with the academic, scientific, and general communities with help from professional networks and by drawing on the team’s personal networks.

The project dissemination plan includes the following list of activities and tentative timeline:

AUTUMN – WINTER 2021:
- Main interim report (draft stage): findings of the COVID-19 related research analysis
- PPI panel meeting
- External Stakeholder Group meeting

WINTER 2021:
- Journal article, first draft: results of the COVID-19 SAMBA questionnaire findings
- Journal article, first draft: results of the quantitative analysis of hospital resilience

SPRING 2022:
- External Stakeholder Group meeting: presentation of the interim results
- PPI panel meeting: presentation of the interim results
- Workshop: presentation of the interim results
- Paper articles: submission to scientific/academic journals

AUTUMN 2022-SPRING 2023
- Final analyses and report writing
- External Stakeholder Group meeting, with a press release
- PPI panel meeting
- End of project dissemination meeting with a press release.
- Press coverage: blog articles, social media-based dissemination activities

It is hoped that with the help of Funder, advisers and stakeholders this project will make findings available to DHSC, NHS England, NHS Acute Trusts and professional organisations so that they can use them to inform their decision-making. The plans for dissemination are set out above.

The University of Birmingham hopes that the findings of this project should lead to improved decision-making by policy-makers, NHS managers and clinicians. While it is not certain in advance of conducting the study what specific decisions will be made as a result, the findings of this project will lead to improvements in the organization and management of acute medical care that will in turn lead to improved quality of care for patients and improved outcomes.

There is potential for large numbers of patients with acute medical conditions to benefit from improvements to their care based on evidence provided by this study. There is also potential for efficiency if improved care leads to better outcomes, including fewer emergency re-admissions and fewer patients experiencing deterioration of their condition resulting in need for more intense and costly treatment. The benefits will accrue to NHS acute services and ultimately to patients.

The benefits could be monitored through future surveys and future analyses of HES and other data sets, if DHSC decides to conduct or fund such monitoring. The University of Birmingham envisages that benefits will start to accrue soon after dissemination of the findings. This may depend on the specifics of the findings and on decisions by DHSC and NHS managers and clinicians informed by the findings.

The study does not support a PhD/post graduate research study.

Outputs:

Outputs from the study will include:
(a) Tables of HES-based information aggregated at hospital level with any small numbers suppressed (if there are any), such as number of admissions in period t of patients with condition X;
(b) Correlation or regression coefficients from analyses of hospital level data, such as correlation between operational practice X and proportion of patients with COVID-19 who died within 28 days; and
(c) Possibly a composite resilience index for each hospital calculated as a weighted sum of some of the hospital level data.
The project team will disseminate the research findings to patients, clinicians, professional bodies, and policy makers, and publish the aggregate results of the study in academic journals. The project will produce reports for the Department of Health and Social Care and communicate findings through webinars and conference presentations.


The results of this study will consist of the coefficient of correlation (or effect size) between an organisational or healthcare delivery practice and aggregate outcomes such as:

i. Operational outcomes (e.g. acute care flow, discharge rates);

ii. Indicators of healthcare resilience based on clinical outcomes for patients with COVID-19, e.g.:
• Mortality rates,
• Readmission rates,
• Rates of pulmonary embolism,
• Probability of readmission for suspected COVID-19,
• Average length of stay in intensive care unit;

iii. Indicators of healthcare resilience based on clinical outcomes for patients who do not have COVID-19, e.g:
• Rates of new onset heart failure or stroke,
• Total numbers and rates of A&E attendances and emergency admissions for heart attack and stroke/TI, during and after the first COVID-19 wave.

The researchers will not publish any disaggregated data or information about single individuals or critically small and identifiable groups of individuals. The University of Oxford will ensure that discrete variables cannot be used (either alone or in combination) to identify an individual. Tabulations and summaries of outcomes that may contain very small sample numbers in some cells will not be reported. Tables and other outputs will not be published in a form where the level of geography would threaten the confidentiality of the data.

The project team will disseminate the research findings to patients, clinicians, professional bodies and policy makers, as well as publish in academic journals. The evidence produced by this research will be directly relevant to:

A. Policymakers, planners and decision-makers;
B. Health providers, managers and practitioners.

The dissemination activities are designed with the goal of informing and supporting health and care policy through developing evidence that is crafted and presented with the policy user in mind, rigorous and authoritative, and timely.
The dissemination activities will include a one-day conference for key stakeholders at the end of the project, seeking their responses to study results. The project will ensure that a range of relevant organisations are included at the conference, such as professional societies, CCGs, service users, and carers. This event will be press released.

The project will inform practice at local and national level, leveraging the national roles of co-applicants and collaborators to ensure a wide dissemination to policy makers, relevant Policy Research Units, and professional societies. The project will disseminate findings of hypotheses of health system resilience through practice networks, professional societies and ALBs.
The project will raise public awareness by producing lay summaries of the results in accessible formats, including through webinars and blog entries, which will ensure a broad dissemination thanks to the extensive resonance of the network of universities and stakeholders involved in the project.

The project team will leverage the national roles and visibility of its co-applicants, collaborators, and funding partner to ensure a wide dissemination of the products of the research to policy makers in ALBs (NHS Improvement, Getting It Right First Time, Health Education England) as well as relevant Policy Research Units (Commissioning, Older people and Frailty) and professional societies (British Geriatrics Society, Society for Acute Medicine). The project team will disseminate the findings of this exploration of best practices in acute care delivery and health system resilience in COVID-19 times through practice networks, professional societies and ALBs (Arms Length Bodies)

To raise public awareness, this project will produce a summary of the results in an accessible format with the help of the PPI Panel and distribute it to a range of stakeholders, e.g. the NHS, commissioning groups, policymakers and service users. The University of Birmingham and its data processor, the University of Oxford, will ensure that the research is synthesised and communicated in a meaningful and clear way, such that the results of this study can be employed by all beneficiaries in practice to deliver real healthcare benefits.

The results and outputs of this project do not involve the development of tools, technologies, algorithms, or any similar instruments that may entail issues related to data and knowledge ownership, management, rights, and access.

Target date for the preliminary analysis of acute care delivery during COVID-19 outbreaks: late Summer 2021
Target date for the preliminary analysis of acute care delivery during COVID-19 outbreaks and winter pressures (possibly occurring in winter 2020-2021): Autumn 2021 - Winter 2021/22
Target date for the final analyses, report writing, end of project dissemination meeting, and press release/press coverage: Winter 2022-Spring 2023.

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)”

No data is flowing into NHS Digital. The analysis will employ the requested data solely in its pseudonymised form. The ethnicity data flowing is not identifiable but is a sensitive field. The research team will not publish any individual-level or identifiable information, with patient level HES data used solely to produce a range of aggregate variables for each hospital and to produce information for healthcare resilience indicators. The results of the analyses will be disseminated in aggregate form (e.g., the mean value of a clinical outcome and its standard deviation), with small numbers suppressed in line with the HES analysis guide and the publications will not identify hospitals by name.

The organisation responsible for data processing is the University of Oxford. As the University of Birmingham’s data processor, the University of Oxford will analyse the correlation between hospital-level care delivery approach variables (from the COVID-SAMBA data) and HES-based indicators of healthcare resilience (e.g. readmission rates, mortality for COVID-19 related symptoms, length of stay in Intensive Care Units (ICU), etc.).

This project will develop a dashboard of indicators at the hospital level including information relating to care delivery approaches (from the SAMBA survey) and aggregate baseline acute health and frailty outcomes. These measures will be correlated with healthcare resilience indicators from the NHS Digital data using site-specific codes (i.e., hospital identifiers). As the University of Birmingham’s data processor, the University of Oxford will process that data. It will not link the requested NHS Digital data with any other data at individual patient level. The analysis will be based solely on information at hospital level derived from the requested HES data and hospital level information from other data sources, in particular with SAMBA survey data, but this will not involve any linkage at patient level.

HES data will be used exclusively in its pseudonymised form. The analysis will follow patients across the requested NHS Digital datasets using only pseudonymised codes, such as the Encrypted HESID. The data will not be linked to any other data about individual patients.

As the University of Birmingham’s data processor, the University of Oxford will add to the analyses at hospital level the SAMBA data, which is collected at hospital level from a survey of clinical practice, without any patient data. The project will use COVID-SAMBA and 2019, 2020 regular SAMBA datasets. In addition, the project will add site-level information from a range of publicly available data for hospitals, Commissioners of Health and Social Care and local authorities, using site codes.
The datasets are:
- Office for National Statistics (ONS) data (population aged 65+, IMD of area, rurality index), https://www.ons.gov.uk/;
- NHS workforce statistics (hospital staff, community staff, primary care staff) by CCG, https://digital.nhs.uk/data-and-information/publications/statistical/nhs-workforce-statistics ;
- NHS Digital NHS Outcome Framework (https://digital.nhs.uk/data-and-information/publications/statistical/nhs-outcomes-framework) ;
- Adult Social Care Outcome Framework measures https://digital.nhs.uk/data-and-information/publications/statistical/adult-social-care-outcomes-framework-ascof ;
- Skills for Care data on adult social care staff by LA, https://www.skillsforcare.org.uk/adult-social-care-workforce-data/Workforce-intelligence/publications/Data-and-publications.aspx;
Care Quality Commission (CQC) data on ratings of hospitals, https://www.cqc.org.uk/about-us/transparency/using-cqc-data; and
- NHS England SitRep data on hospital performance, closures, and bed pressures, https://www.england.nhs.uk/statistics/statistical-work-areas/winter-daily-sitreps/ .

The datasets include only variables that are aggregated at the hospital level or catchment areas and there is no identification of any patient.

There is no requirement for the study to re-identify individuals for this project and the University of Birmingham and its data processor, the University of Oxford, confirm that no attempts will be made to re-identify individuals.

As the University of Birmingham’s data processor, the University of Oxford will process the data received. This team resides at the University of Oxford, Nuffield Department of Primary Care Health Sciences (NDPCHS). All researchers and staff at the University of Oxford follow specific protocols for the protection and confidentiality of the data. All team members are also subject to training on these requirements initial upon start at the Department and annually thereafter. This team will retain the data on a secure, network server and limit access to only those researchers approved to access it via an encrypted remote desktop application.

MR785 - PD MED Trial- A randomised assessment of the cost of different classes of drugs for Parkinson's — DARS-NIC-147927-8K193

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Identifiable, Yes (Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006, Section 251 NHS Act 2006)

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2018-10-01 — 2020-05-31 2017.09 — 2022.05.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The data supplied will be used only for the approved medical research project MR785 - PD MED Trial- A randomised assessment of the cost of different classes of drugs for Parkinson's

Yielded Benefits:

Giving NHS commissioners this knowledge will impact the prescribing patterns of UK clinicians as they will be informed of the benefits which in turn with treatment of patients. This has already been demonstrated by the first PD MED results which have changed the prescribing patterns of the medications for those people with Parkinson’s in the UK The PD MED trial early results have already changed current clinical practice in the UK, as they were part of the 2017 update to the NICE guidelines for PD. https://www.nice.org.uk/guidance/ng71/evidence/full-guideline-pdf-4538466253). Previous publications: Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared to levodopa as initial therapy of Parkinson's disease: PD MED, a large pragmatic randomised trial. PD MED Collaborative Group (June 2014) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60683-8/fulltext Mapping from the Parkinson’s Disease Questionnaire PDQ-39 to the Generic EuroQol EQ-5D-3L: The Value of Mixture Models. (April 2015) Comparing results from long and short form versions of the Parkinson's disease questionnaire in a longitudinal study. Jenkinson C, Clarke C, Gray R, Hewitson P, Ives N, Morley D, Rick C, Wheatley K, and others. Parkinsonism & Related Disorders, Vol. 21, Issue 11, p1312–1316 (September 2015) Randomised trial comparing dopamine agonist, MAOB inhibitor and COMT inhibitor as adjuvant therapy in later Parkinson's disease (PD) (June 2016) Broadening the evaluative scope of quality of life in Parkinson's: testing the construct validity of the ICECAPO instrument. (June 2016) Too broad to be sensitive? An exploration of the responsiveness of the ICECAP-O capability wellbeing measure compared to the EQ-5D-3L to the change of clinical and QoL aspects in people with Parkinson’s (June 2017).

Expected Benefits:

The PD MED trial early results have already changed current clinical practice in the UK. Once the HES data has been effectively analysed for the PD MED cohort, the research team will have a detailed long-term look at the impact different classes of Parkinson’s medication have on People with Parkinson’s. These results will be directly applicable to the UK healthcare system.

The PD MED data, which includes both the hospitalisation and health economic analyses, will be used as a component of the data that will be supplied to National Institute for Health and Care Excellence (NICE) review process with regards to treatment of people with Parkinsons's. NICE is an independent public body that provides national guidance and advice to improve health and social care in England.

The outputs and benefits are the same for both the hospitalisations and health economic analysis.

From previous work (Muzerengi et al, and Low et al) the researchers know that there is about a 20% under-reporting of hospitalisations for people with PD. By having data from an established group where the PD diagnosis has been confirmed over a number of years, the quality of the data will be significantly improved. Furthermore, having the HES data and the clinical disease progression data allows further analyses to be undertaken.

Outputs:

The data will be included in analyses of hospitalisations and hospital usage that will be published in peer reviewed journals. Individuals will not be identifiable within these publications.

These results will also be disseminated to the participants in the PD MED clinical trial through newsletter articles.

The target date for publication of the first later disease (motor complications) results are due in autumn 2019. This publication will demonstrate a detailed long term look at the impact that different classes of Parkinson’s medication have on People with Parkinson’s, including the impact the different classes of Parkinson’s medication have on participant hospitalisations.

The following papers are currently being reviewed (all data will be presented as aggregate data):

i) Hospitalisation following different initial therapies in early Parkinson’s disease: analysis of Hospital Episodes Statistics from the PD MED EARLY trial.
Muzerengi S, Woolley RL, Rick C, Ives N, Dowling F, Gray R, Clarke CE, on behalf of the PD MED Collaborative Group.
Expected publication: by autumn 2019.

ii) Dopamine agonist versus monoamine oxidase B inhibitor or catechol-O-methyl transferase inhibitor therapy in later Parkinson's disease: a large pragmatic randomised controlled trial (PD MED LATER). PD MED Collaborative Group.
A draft paper was rejected from initial journal and we are now trying to find somewhere else to submit it spring 2020

The outputs for both the hospitalisation and health economic research will be presented as posters at conferences and published in scientific journals.

All outputs will only contain results in highly aggregated format and as statistical summaries and measures of association. Small numbers will be suppressed in line with the HES Analysis Guide. Record level information will not be released to any third party.

Processing:

Prior to this iteration of the Data Sharing Agreement, the University of Birmingham supplied identifying details of all trial participants originally to the Office for National Statistics (ONS) and later to NHS Digital when the service transferred from one organisation to the other, so that the cohort could be flagged for long-term follow up.

NHS Digital and predecessor organisations routinely reported information on cohort members' deaths, cancer registrations and changes in status of registration with NHS GP practices until September 2018.

Additionally, NHS Digital linked the cohort with HES data and supplied the HES data to the University of Birmingham containing no identifying details other than a unique patient ID which could be used to link the data with the identifiable PD MED database which includes information collected from various sources including patient questionnaires, treatment data from the participating hospitals and the mortality, patient demographic and cancer registration data from NHS Digital.

No new data will be supplied under this Agreement.

The HES data is already held for the PD MED follow-up trial but analyses are not yet complete.

HES data will provide more detailed information on hospitalisations and hospital usage for the cohort of trial participants.

When it has received data, the University of Birmingham has cleaned it against the PD MED database in accordance with a pre-determined validation process to ensure data quality.

The data was then stripped of any identifying information and stored in a separate database to other data collected by the PD MED trial in a standalone drive. The unique patient ID can be used for any subsequent linkages with PD MED trial data as required for the purposes of any analyses.

For such purposes, the University of Birmingham have linked the HES and mortality, patient demographic and cancer registration data to PD MED trial data including: baseline characteristics, diagnoses, clinical data including medication, adverse events, dates of hospitalisation, dementia and death, patient reported outcomes including quality of life and resource use.

Under this Agreement, the mortality, cancer registration and patient demographic data supplied under the previous Agreement may be securely retained but no additional processing of this data is permitted other than for the purpose of data destruction if required.

Under this Agreement, the HES data may be processed for the purpose of completing analyses for the purpose of the study described above.

Prior to this Agreement, the University of Glasgow has not received any of the data. Under this Agreement, pseudonymised HES data will be securely sent to the collaborators there to perform a health economic evaluation. Participant's identifying details are held separately to any trial data but is used as a key for when it is required to link the two parts back together. These identifiers will not be provided to University of Glasgow and therefore only pseudonymised data will be shared with University of Glasgow. Pseudonymised data will be transferred using a file sharing platform created and hosted by the University of Birmingham. The researchers in Glasgow will write up the results of their analysis of the HES data alongside the PD MED data and then publish them for the benefit of the UK healthcare system. The pseudonymised data and results of the analyses will be stored at the University of Glasgow for at least 25 years, as per the University of Birmingham archiving standard operating procedure for Clinical Trials.

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

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement.

Long term impact of giving antibiotics before skin incision versus after cord clamping on children born by caesarean section: longitudinal study based on UK electronic health records — DARS-NIC-121849-W0T5C

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2019-01-21 — 2021-01-20 2019.04 — 2020.03.

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The purpose of this government-funded research (carried out by the University of Birmingham) is to determine whether there is an association between the change in antibiotic prophylaxis in Caesarian section delivery and the incidence of subsequent admission of the child for a number of diseases. Before 2011, the National Institute for Health and Care Excellence (NICE) Clinical Guideline 132 on Caesarean Section (CS) advised administering intravenous prophylactic antibiotics for women undergoing CS after the baby’s cord had been clamped to prevent exposing the baby to antibiotics. In 2011, the guidance was changed to recommend giving antibiotics to women undergoing CS prior to skin incision. This was based on evidence that earlier administration reduces maternal infectious morbidity; although most such infections are mild and respond well to treatment. The current Cochrane review summarises data from 10 randomised trials (5,041 women) which showed a near halving of risk of all maternal infection (43%, 95% confidence interval (CI) 28-55%), endometritis (46%, CI 21-64%), and wound infection (41%, CI 19-56%) compared with giving antibiotics after clamping the baby’s umbilical cord.

Data provided by NHS Digital will include records only for mothers/babies who have had a birth/delivery event between 1st April 2005 and 31st March 2018.

The primary outcomes of interest in the study are asthma and eczema. They are the two most frequent allergy related doctor diagnosed conditions in childhood which are associated with gut microbiota composition in infants, are commonly seen in primary care, and are well recorded. With the prevalence of an asthma diagnosis in children 0-5 years of 3%, it is a common long-term health condition in childhood with the highest numbers of emergency hospital admissions for any long term condition in young children in the UK. There were 13,000 hospital admissions in England for asthma in this age group in 2014. Although deaths due to asthma in children are rare, they do occur, with 1-2% of all asthma deaths being in children. The study will also monitor infection rates in the mothers by capturing diagnosis codes during the spell in which delivery occurred and up to 56 days post delivery.

As the evidence regarding the role of the microbiota in the development of diseases is still evolving, researchers will also assess whether in-utero exposure to broad spectrum antibiotics immediately prior to birth increases the risk of a range of other immune system related health conditions in the first five years of life in children born by CS. Patient Public Involvement (PPI) input revealed that parents are interested in exploring as many potentially relevant health conditions as possible. As it is not known from the outset what other conditions will be of interest, the study requires details of all hospital episodes for the cohort for any reason and a full list of conditions to be investigated will be worked up during the course of the study based on the initial analysis, and with PPI support of this goal.

Diagnosis patterns for some of the conditions, such as asthma, have changed over the study period, e.g. due to changes in the disease management guidelines and other changes e.g. related to the introduction of the Quality and Outcomes Framework (QOF) indicators. The researchers will, therefore, use vaginally delivered children as a comparator group, as these children will not have routinely received antibiotic prophylaxis, but will have been subject to the same temporal changes in diagnosis as children born by CS.

The study involves deriving a population of children born between 1st April 2005 and 31st March 2018 which are matched back to their birth event and their model of delivery determined. They will then be tracked forward from the time of birth to the most recent time-point possible using admitted patient care data to determine what the relative risks of admission are for asthma, and a range of other conditions, between children according to their mode of delivery and whether they were born before or after the implementation of the change in guideline.

Yielded Benefits:

The study has discovered from the arm which does not use HES data that there is no extra risk to babies from the change in cord clamping procedure, in fact there appears to be slightly less likelihood of them developing auto-immune conditions that present in primary care This is both interesting and counter-intuitive as the study expected to find an increase. It is now imperative that the HES arm of the study is completed to provide confirmation of these findings, however this cannot be done with appropriate statistical rigor without the SITTRET field for the reasons stated in section 5b.

Expected Benefits:

The latest data (from 2016) suggest that 24.5% of all delivery events involve Caesarian section, with over 120,000 babies being delivered this way. This study will provide the much-needed evidence on any long term impacts of pre-incision antibiotics to resolve the current uncertainty and inform national guidance. It will either reinforce the current recommendation or, if negative impacts on child health are observed, will enable the study to assess the magnitude of the risks against the benefits of reduced maternal morbidity. This study is also highly relevant in the context of wider research on different drug safety in pregnancy, including in relation to the benefits and harms of treatment (e.g. for group B Streptococcus carriage) of large numbers of the population in the absence of evidence regarding the long term effects of such treatment on children.

The main aim of dissemination for this project is to ensure that parents‐to‐be and clinicians have clear information about the benefits and risks of pre‐incision prophylactic antibiotics for CS based on the latest evidence to facilitate shared decision making.

Outputs:

All outputs will only contain results in highly aggregated format and as statistical summaries and measures of association. Small numbers will be suppressed in line with the HES Analysis Guide. Record level information will not be released to any third party.

The following outputs will be produced:

1) Production of lay summary of the findings for wider dissemination, including a dissemination event at the end of the project with lay, clinical stakeholders and professional organisations. Target date 01/04/2020

2) A dissemination event to the clinical directors of maternity units. Target date 20/02/2020

3) At least one peer reviewed publication to be aimed at a journal of general medical interest. Target date: 01/04/2020

Any statistical outputs from the research will be highly derived, and principally consist of correlation co-efficients and odds ratios. A correlation co-efficient is a value that measures the strength and a direction of a relationship between two variables in a data set. An odds ratio is a ratio of the odds of an event happening in one population divided by the odds of an event happening in a comparator population. In this case, researchers are interested in the odds of admission in childhood for acute asthma and other conditions in children exposed to different modes of delivery and c-section deliveries pre and post guideline changes.

Publications: the team anticipate at least two peer‐reviewed publications in such journals as BMJ and BJOG, one reporting the overall results and their implications, and another paper on detailed results of subgroup analyses regarding the impact of prophylactic pre‐incision antibiotics on child health and maternal infectious morbidity.

Patient information resource: in collaboration with the PPI co‐applicant, second PPI advisor and during the PPI workshop, researchers will produce a lay information resource summarising the key findings with respect to the benefits and potential harms providing balanced information to help with decision making regarding the timing of antibiotic prophylaxis. UHB will disseminate it to the relevant stakeholders, including the patient organisations and clinical directors for maternity.

The University of Birmingham anticipates that the findings will inform the next revision of the NICE Clinical Guideline 132 on Caesarean Section, and hospital policies regarding prophylactic antibiotic administration for CS. Depending on the research findings, the outputs of this project will provide clear balanced information to parents‐to‐be about antibiotic prophylaxis for CS including information on benefits and any long term effects. The study methodology can be adopted for other future projects evaluating the impact of policy change using routine healthcare databases.

Processing:

Data provided by NHS Digital will be limited to women who have given birth in hospital between 1st April 2005 and 31st March 2018, and for those babies who are born in hospital in the same period. For the mothers, the HES data will be limited to episodes which start in the period from 30 days before birth to 56 days after birth. For the babies, HES data will be supplied for all episodes that begin before the child's 5th birthday. The period of data (2005-2018) covers a period of time either side of the change in antibiotic guidance, in order to understand the effect the change has had. Data will be supplied both for Caesarian Section deliveries (as the group of interest) as well as other delivery methods (to act as a comparator group).

Researchers will use this data to create three distinct HES data sets. Firstly to identify birth events of babies born in English hospitals between April 2005 and March 2018 (hereafter called the baby data set). Researchers will build continuous inpatient spells from these data, after having removed duplicate records or records with critical data items missing. The team will go on to build a second set of continuous inpatient spells containing delivery events (hereinafter called the delivery data set).

The next step will be to link the two data sets together, so that the mother and baby records are linked. The team will follow the method used previously in the peer reviewed literature as it has been properly validated. The method used was extensively described in linking Data for Mothers and Babies in De-Identified Electronic Health Data, by K.Harron et al, published in PLOS One (DOI:10.1371/journal.pone.0164667) in 2016.

Researchers will use the findings from the national survey of hospitals regarding the change in the timing of antibiotic administration as an indicator of the probability of exposure. Researchers will account for the cumulative increase of hospitals giving pre-incision antibiotics in the analysis. For the analysis of outcomes recorded in secondary care, researchers will be able to link the survey data regarding the timing of policy change at hospital level for each birth.

An extensive set of data cleaning algorithms will be run to identify duplicate episodes and exclude spells where the degree of data missingness would make even probabilistic linkage difficult to undertake. Researchers will then link baby and delivery spells in two phases. Firstly a deterministic linkage phase; this is when researchers have a clear linkage between two data items in which the likelihood of a spurious match is negligible. A matching of mother and baby records were completed if they had been admitted to the same hospital, had the same GP practice, maternal age, birth weight, gestation, birth order and sex. This approach will allow for missing values, as long as at least three of the agreeing variables are complete. For the probabilistic approach, the team will use match weights calculated using the probability of agreement on a particular variable may vary according to the value of that variable. Frequency weights will be derived for each value of gestational age, delivery place (intended), status of person conducting delivery, postcode district and ethnic group).

When pairs have been completed a unified child data set will be made containing the clinical data relating to the birth event (diagnoses, procedures, complications, demographic details relating to the mother) and demographic details of the child and its encrypted HES ID.

Once the mothers and babies are linked, the study will look at subsequent admissions. The team will use these data to flag children with the presence or absence of a subsequent admission and capture the diagnoses recorded in those admissions and calculate maternal infection rates.

The resulting data set will then only be used to populate statistical analyses to determine the relationship between the likelihood of admission in childhood with the characteristics of the delivery episode of the child at birth.

Manipulation of raw HES data to produce an analysis set will take place on the same server in the College of Medicine, on which the raw data are stored. The extracted data will then be analysed by the PI, the senior analyst and a designated statistician for the project. All statistical analyses will take place in secure password protected folders on the University of Birmingham network.

The data will not be used for commercial purposes, not provided in record level form to any third party and not used for direct marketing.

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).

MR470 - Electricity Supply Industry (ESI) Mortality Study — DARS-NIC-147805-HDHWM

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Yes, Identifiable (Does not include the flow of confidential data)

Legal basis: 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, 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(5)(d)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2018-09-20 — 2021-09-19 2017.09 — 2020.03.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The data supplied to University of Birmingham will be used only for the approved medical research project - MR470 - Electricity Supply Industry (ESI) Mortality Study

Yielded Benefits:

The worldwide literature on exposure to magnetic fields and cancer risks was last evaluated by a Working Group from the International Agency for Research on Cancer (IARC) in 2003, and published as Volume 80 of the Monographs programme (Vol 80: Non-ionising radiation, part 1, Static and extremely low frequency (ELF) electric and magnetic fields). The Working Group concluded that ELF electric and magnetic fields were possibly carcinogenic to children (Group 2B carcinogen) based on findings for childhood leukaemia, but that there was inadequate evidence of carcinogenicity in adults. Papers 1, 2 and 3 from the UK study were included in this evaluation; later papers were published after the IARC evaluation. But papers 5, 7, 8 and 9 will be evaluated when the topic of cancer risks and electric and magnetic field exposure is next evaluated by IARC. An International Workshop on neurodegenerative disease risks and magnetic field exposure was organised recently by the German Federal Office for Radiation Protection. It was held in Munich in December 2017. Findings from paper 10 were included in a meta analysis presented at the meeting by Dr Leeka Kheifets. Conclusions from the Workshop that received general approval were that there was enough evidence to both continue and improve the studies on neurodegenerative diseases and magnetic field exposure.

Expected Benefits:

Most of the expected measurable benefits from this study will be felt by more recent employees in the industry. This is because the study is looking for late effects of exposures that have already happened. Measurable benefits can only come from improved working conditions experienced by later generations of workers. There were previous excess cancer risks in female employees for nasal cancer and cancer of the small intestine (paper 7). These findings were not matched by similar excesses in male employees, but if a similar excess for either site of cancer were to be found in the updated analysis, this would be a strong indication that a real risk is present for women in this industry, and the UK HSE would have to consider what action was appropriate to take.

Earlier work in this study also indicated that the workforce had suffered an occupational excess of mesothelioma without any matching excess of lung cancer. Probably the most important current use of the study is to assist the HSE and the EU authorities in their on-going work to set appropriate exposure levels for magnetic fields. The study will also assist academic study into the investigation of health effects of magnetic field exposure. If the recent positive Dutch findings for exposure to magnetic fields and development of motor neuron disease (MND) (Koemen et al, Occup Env Med 2017 doi:10:1136/oemed-2016-103780) turn out to be true this would have a major impact on modern life.

All reports from this study of electricity supply industry will be sent to 1).The Director of the IARC Monographs Programme, International Agency for Research on Cancer, 2). The Chief Statistician, UK Health and Safety Executive (HSE), 3). The Chair of the HSE’s Workplace Health Exposure Committee (WHEC), and 4). the Scientific Secretary of the EU Scientific Committee on Occupational Exposure Limits (SCOEL). Magnetic field exposure is subject to EU directives and the world literature on magnetic fields and health outcomes will be the subject of future reviews,

Outputs:

The following outputs have been produced and published in high quality peer-reviewed journals.

1. Harrington JM, McBride DI, Sorahan T, Paddle GM, van Tongeren M.
Occupational exposure to magnetic fields in relation to mortality from brain cancer among electricity and transmission workers.
Occup Environ Med 1997;54:7-13.

2. Harrington JM, Nichols L, Sorahan T, van Tongeren M.
Leukaemia mortality in relation to magnetic field exposure: findings from a study of United Kingdom electricity generation and transmission workers,
1973-97.
Occup Environ Med 2001;58:307-314.

3. Sorahan T, Nichols L, van Tongeren M, Harrington JM.
Occupational exposure to magnetic fields relative to mortality from brain tumours: updated and revised findings from a study of United Kingdom
electricity generation and transmission workers, 1973-97.
Occup Environ Med 2001;58:626-630.

4. Sorahan T, Nichols L.
Mortality from cardiovascular disease in relation to magnetic field exposure: findings from a study of UK electricity generation and transmission workers,
1973-1997.
Am J Ind Med 2004;45:93-102.

5. Nichols L, Sorahan T.
Mortality of UK electricity generation and transmission workers, 1973-2002.
Occup Med 2005;55:541-548.

6. Sorahan T, Kheifets L.
Mortality from Alzheimer’s, motor neurone and Parkinson’s disease in relation to magnetic field exposure: findings from the study of UK electricity
generation and transmission workers, 1973-2004.
Occup Environ Med 2007;64:820-826.

7. Sorahan T.
Cancer incidence in UK electricity generation and transmission workers, 1973-2008.
Occup Med 2012;62:496-505.

8. Sorahan T.
Magnetic fields and brain tumour risks in UK electricity supply workers.
Occup Med 2014;64:157-165.

9. Sorahan T.
Magnetic fields and leukaemia risks in UK electricity supply workers.
Occup Med 2014;64:150-156.

10. Sorahan T, Mohammed N.
Neurodegenerative disease risks and magnetic field exposures in UK electricity supply workers.
Occup Med 2014;64:454-460.


Work is currently on-going to produce an update of Paper 7 and will include an additional seven years of cancer registration data. The paper will be entitled “Cancer incidence in UK electricity generation and transmission workers, 1973-2015”, and will be offered in the first instance to the medical journal Occupational Medicine. The publication is planned to appear before the end of 2019. If it were not to be accepted by that journal it will be offered to the International Journal of Environmental Research and Public Health (IJERPH). The paper will be published in Open Access format to enable study participants and the general public to read the study findings without charge; funding for Open Access publication has been provided by the Study Sponsor.

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

A simplified version of the findings will be made available both on the website of the Energy Networks Association (ENA) and in pensioner magazines for former employees of the electricity supply industry. The Press Office of the University of Birmingham will provide a media release for the updated cancer incidence paper. The study will also engage with the academic research community by presenting pre-publication results at the 13th UK + Ireland Conference on Occupational and Environmental Epidemiology (date and venue still to be announced).

An analysis of neurodegenerative disease risks and magnetic field exposure was published in 2014 (paper 10) and analysed health outcome data for the period 1973-2010 (Sorahan T, Mohammed N, Neurodegenerative disease and magnetic field exposure in UK electricity supply workers. Occ Med 2014;64:454-460 doi:10.1093/occcmed/kqu105). The study found no convincing evidence that magnetic fields were involved in risks of these diseases. But in the light of the recent positive findings from Holland between magnetic field exposure and ALS risks (Koeman et al, Occup Env Med, 2017 doi 10:1136/oemed-2016-103780) the UK study needs to be re-analysed for this topic, when further follow up has been added providing meaningful additional data. Funding has yet to be requested for this proposal.

Processing:

The flow of data to NHS Digital was historical and has now ceased. This historical data comprised names and dates of birth of employees in the electricity supply industry. The data at the University of Birmingham were pseudonymised in 2013 and all information on names, addresses, postcodes, National Insurance (NI) numbers, and NHS numbers were destroyed and replaced with a unique identifier that NHS Digital uses to identify study members in its own files. NHS Digital supplies individual record data containing the pseudonymised unique identifier (and no other identifier), dates of death and ICD codes for causes of death, dates of cancer registrations and ICD codes for site and type of cancer.

Data will only be accessed by individuals within the Institute of Applied Health Research who have authorisation from NHS Digital to access the data for the purposes described, all of whom are substantive employees of the University of Birmingham.

Data supplied by NHS Digital will not be linked to any data other than pseudonymised individual level study data containing details on dates of birth (month and year only) and work histories (dates of employment and job titles). There will be no attempt to re-identify individuals from the data. The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

Data is required for such a long time because cancer and neurodegenerative disorders can have very long intervals between exposure to a risk factor and the final clinical presentation of disease. National data is required because the study has been set up as a national study of all employees with some employment in the electricity supply industry in the period 1973-82. This national coverage provides maximum statistical power and provides findings that have national application. The study would be weakened with only regional subsets of data and the findings would be less credible. Given the potential impact of the findings on national policy for exposure to EMF it is essential to minimise uncertainty.

It would not be appropriate to filter the outputs for specific conditions because occupational exposures in this industry have the potential for a wide variety of possible harms. The study maintains the original data collected from employer records on dates of birth (month and year only) and dates of employment because these form an integral part of the analysis of the data, both in the statistical adjustment of age effects and the development of exposure histories.

The data requested from NHS Digital will be downloaded to a University of Birmingham computer, saving it in a restricted area of the University server that is only accessible to specified members of the research team. Data within this area of the server will be backed up internally (not on to tape), so that data can be fully deleted within two weeks of a deletion request from NHS Digital. All data will be processed and stored at the University of Birmingham.

On receiving the NHS Digital datasets, data on the pseudonymised id, dates of death, causes of death, dates of cancer registrations and site and type of cancer will be transferred to a ‘new follow-up’ spreadsheet, and saved into the same restricted area of the University server as the master study file. The main study file contains information on the pseudonymised ID, dates of birth (month and year only), work histories and death and cancer registration data supplied previously by NHS Digital (and its forerunners).

Death data are transferred from the new follow-up file into the main study file if a matching pseudonymised ID is found and if there are no death data already present in the master file for that ID. If death data are already present in the master file, new and old data are reviewed to establish whether this is just a case of duplicate data or whether there is a genuine clash of data (death details for two separate individuals have become confused). In the very few instances of genuine clashes of data, assistance of NHS Digital staff will be sought. Cancer registration data are transferred from the new follow-up file into the main study file if a matching pseudo ID is found. A separate program seeks evidence of duplicate entries. For any cases where it is not possible to resolve discrepancies between data in the main study file and new data from NHS Digital, the new data will be destroyed.

Analyses of individual level data are used to calculate standardised mortality ratios (SMRs) for different causes of death, using national mortality rates as a basis of comparison. These SMRs are adjusted for age, sex and calendar year. Analyses of individual level data are used to calculate standardised registration ratios (SRRs) for different sites of cancer death, using national registration (incidence) rates as a basis of comparison. These SRRs are also adjusted for age, sex and calendar year. Estimates of cumulative occupational exposure to magnetic fields have also been calculated for each study member and, in separate analyses, Poisson regression is used to calculate relative risks for cumulative exposure categories, using risks in the lowest exposure group as a baseline or reference category. Such analyses seek evidence of dose-response effects i.e. does the risk of a disease increases with increasing exposure.

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 data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement.

MR1262 - Teenage and Young Adult Cancer Survivor Study (TYACSS) — DARS-NIC-147797-45YHZ

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes, No

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

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2011-09-28 — 2026-09-27 2016.05 — 2020.03.

Access method: Ongoing

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The principal aim of the research is to establish a database of approximately between 170,000 to 200,000 individuals diagnosed with cancer aged 15 to 39 years, in England and Wales, between 1971 and 2006 and who survived for at least 5-years from original cancer diagnosis. This database of teenage & young adult cancer survivors would be used to investigate the observed and expected risks of: specific causes of death, specific types of subsequent primary cancer, and specific types of non-cancer morbidity (including cardiovascular, pulmonary, urological, hepatic and endocrine conditions). Evidence for the cure of specific types of cancer would also be assessed. Record linkages between the established database and NHS-IC (for deaths and subsequent primary cancers), the Hospital Episode Statistics (HES) for England, the Patient Episode Database for Wales (PEDW) in Wales and the Myocardial Ischaemia National Audit Project (MINAP) would be undertaken. From such linkages it will be possible to identify subgroups of patients (defined in terms of type of cancer, age at treatment, calendar year of diagnosis, period of follow-up, attained age and sex) at a substantially increased risk of specific adverse health outcomes.

MR321: Cohort study of mortality and cancer incidence in UK oil refinery and petroleum distribution workers (1951-2016) — DARS-NIC-324388-L6C2Q

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Yes (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: Sensitive, and Non Sensitive, and Non-Sensitive

When:DSA runs 2016-01-01 — 2020-04-30 2019.02 — 2019.08.

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

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:

In the 1970s the Institute of Petroleum (IP) (now known as the Energy Institute (EI)) developed epidemiological cohort studies into the mortality and cancer morbidity experience of male employees from eight oil refineries and 476 petroleum distribution centres in the UK


The Energy Institute (EI) is the chartered professional membership body bringing global energy expertise together. It is an independent, not-for-profit, safe space for evidence-based collaboration, an honest broker between industry, academia and policy makers. A registered charity, incorporated by Royal Charter in 2003, the EI is licensed by the Engineering Council (UK) to offer Chartered, Incorporated and Engineering Technician status to engineers, the Science Council to award Chartered Scientist status, and also licensed by the Society for the Environment to award Chartered Environmentalist status. The EI was set up in 2003 as a result of a merger between the Institute of Petroleum (IP) and the Institute of Energy (InstE).

The objectives of this study (carried out by the University of Birmingham (UoB) as sole Data controller who also processes the data) are to summarise the available mortality and cancer incidence data in relation to the cohorts and to determine whether any part of this experience might be related to occupational exposures; in which event further analyses capable of investigating the potential role of occupational exposures might be needed.

UoB requires mortality and cancer registration data for use in the cohort mortality study of UK oil refinery and petroleum distribution workers. The cohort size is 55-60,000 participants. However, these are split geographically, so the size of the cohort in England is 35-40,000 (data for the remaining participants will be sought by UoB directly from Information Services Division (ISD) Scotland). The cohort details were previously held in identifying form by UoB, but UoB no longer hold identifying fields and now use pseudonymised data.

All these male employees had a minimum period of employment of 12 months in the period 1950-75, and incidence of death/cancer are being followed-up long-term.

The numbers of deaths and cancers identified in the cohort will be compared to deaths and cancers in the general population to identify whether there appears to be an excess risk of cancers (overall and by specific type of cancer) and deaths (overall and by specific cause) in the cohort when compared to the general population. Information on the rates of cancer/deaths in the general population does not require data from NHS Digital.

The findings of the study will help the UK Health and Safety Executive (HSE) and the EU Scientific Committee for Occupational Exposure Limits (SCOEL) in assessing whether current national and EU regulations provide adequate protection to workers exposed to benzene. The benefits of the work will be felt by current and future workers occupationally exposed to benzene, particularly in relation to risks of acute myeloid leukaemia and myelodysplastic syndrome (the latter has been suggested by others to be a major problem at low-level benzene exposure).

Yielded Benefits:

A previous analysis and publication from this study (Tom Sorahan, 2007. https://doi.org/10.1093/occmed/kql168) found clear evidence of an occupational cancer hazard for mesothelioma in oil refinery workers and it was present in all periods of follow-up. This was unexpected given that asbestos was only present as a ‘background’ exposure and provided further evidence that asbestos is a highly potent carcinogen. An international pooled study by Schnatter et al (https://doi.org/10.1093/jnci/djs411) suggested that low-level benzene exposure might be an important risk factor for myelodysplastic syndrome (MDS). The previous analysis of the UK oil refinery and petroleum distribution workers cohort (to 2011) provided no support for this hypothesis (Tom Sorahan and Nuredin Mohammed, 2016. DOI:10.3390/ijerph13050474); as no convincing evidence of occupational cases of acute myeloid leukaemia (AML) from benzene exposure was seen. An update on the cohort analysis will update the knowledge in this field of research in particular for benzene exposure and incidental exposure to asbestos in the refineries. The findings will provide an up-to-date assessment of cancer risks in the cohort of UK oil industry workers hired in the period 1946-74. If there is no evidence of an excess of acute myeloid leukaemia it will be safe to assume that more recent hires will not have been influenced by the even lower levels of benzene found in recent years. Please note the previous publications which have been available to academics, industry, regulatory bodies and the general public: Rushton, L. and M. Alderson, An epidemiological survey of eight oil refineries in Britain. Occupational and Environmental Medicine, 1981. 38(3): p. 225-234. 2. Rushton, L. and M. Alderson, Epidemiological survey of oil distribution centres in Britain. Occupational and Environmental Medicine, 1983. 40(3): p. 330-339. 3. Rushton, L., Further follow up of mortality in a United Kingdom oil refinery cohort. Occupational and Environmental Medicine, 1993. 50(6): p. 549-560. 4. Rushton, L., Further follow up of mortality in a United Kingdom oil distribution centre cohort. Occupational and Environmental Medicine, 1993. 50(6): p. 561-569. 5. Sorahan, T., Mortality of UK oil refinery and petroleum distribution workers, 1951–2003. Occupational Medicine, 2007. 57(3): p. 177-185. 6. Sorahan, T., L. Nichols, and J. Harrington, Mortality of United Kingdom oil refinery and petroleum distribution workers, 1951–1998. Occupational Medicine, 2002. 52(6): p. 333-339. 7. Energy Institute, An investigation of mortality and cancer incidence in United Kingdom petroleum distribution workers 1951-2011. 2016. 8. Energy Institute, An investigation of mortality and cancer incidence in United Kingdom oil refinery workers 1951-2011. 2016.

Expected Benefits:

Workers, management and regulatory authorities will be able to see whether there are unrecognized serious health problems in the UK petroleum industry, and to understand the size of the health effects of previous occupational hazards such as benzene exposure and incidental asbestos exposure.

Publications from this study are used routinely by agencies such as the International Agency for Research on Cancer (IARC) to classify those chemicals that are carcinogenic to humans. Perhaps more importantly they are used by regulatory authorities such as the UK Health and Safety Executive (HSE) and the EU Scientific Committee for Occupational Exposure Limits (SCOEL) to set appropriate occupational hygiene standards in the current workplace. The publications are published typically in medical journals read by medical specialists in Occupational Health.

A previous analysis and publication from the cohort study (Tom Sorahan, 2007. https://doi.org/10.1093/occmed/kql168) found clear evidence of an occupational cancer hazard for mesothelioma in oil refinery workers and it was present in all periods of follow-up. This was unexpected given that asbestos was only present as a ‘background’ exposure and provided further evidence that asbestos is a highly potent carcinogen.

An international pooled study by Schnatter et al (https://doi.org/10.1093/jnci/djs411) suggested that low-level benzene exposure might be an important risk factor for myelodysplastic syndrome (MDS). The previous analysis of the UK oil refinery and petroleum distribution workers cohort (to 2011) provided no support for this hypothesis (Tom Sorahan and Nuredin Mohammed, 2016. DOI:10.3390/ijerph13050474); as no convincing evidence of occupational cases of acute myeloid leukaemia (AML) from benzene exposure was seen. An update on the cohort analysis will update the knowledge in this field of research in particular for benzene exposure and incidental exposure to asbestos in the refineries. The findings will provide an up-to-date assessment of cancer risks in the cohort of UK oil industry workers hired in the period 1946-74. If there is no evidence of an excess of acute myeloid leukaemia it will be safe to assume that more recent hires will not have been influenced by the even lower levels of benzene found in recent years.

The research team also reported that the workers had a significantly elevated risk of melanoma. This information has been presented in the reports to the Energy Institute (EI) and disseminated to the EI Health Technical Committee who may advise the oil refinery and petroleum workers of a potentially higher risk for this type of cancer and symptoms to check for. Please see the following for activities of the EI health technical committee (includes a report on this cohort): https://www.norskoljeoggass.no/globalassets/dokumenter/drift/presentasjonerarrangementer/34th-joint-international-meeting-2014/11b-hildenbrand-energy-institute-htc_statusupdate_jointinternationalmtg.pdf

The research team found for all the other cancer and death registrations examined no significantly elevated risks were seen. This would have provided reassurance to the workers in this industry. To continue the surveillance and potential advice to workers and regulatory bodies in the oil refinery and petroleum distribution industry of the risks of cancer and specific causes of death, continued follow-up is needed on this cohort. The workers will be reaching an age when their background risk of cancer increases greatly it is important to examine if this particular group of workers are not at a further elevated risk from specific types of cancer against this increasing background risk of cancer with increasing age.

Using the updated cancer and death registrations will enable the research team to investigate if the risks for specific cancers and deaths have changed with longer follow-up, especially since asbestos exposure can have a considerable lag period (10-40 years) before mesothelioma develops. The research team will use the updated observed number of cause-specific deaths and site-specific incident cancers and compare with expected numbers based on national mortality and cancer registration rates, taking sex, age, calendar year and country into account. These values will be compared to provide standardised mortality (SMRs) and cancer registration ratios (SIRs) for the UK oil and petroleum industry. These SMRs and SIRs will also be calculated by period from hire, by decade of hire, by period from leaving employment and by job category to seek possible patterns indicating occupational involvement.
The results of these analyses will form the basis of annual reports to the study funder, the Energy Institute (http://www.energyinst.org, registered charity number: 1097899). All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide. The results will also be published in a peer-reviewed, open access journal which will be accessible by the general public, academics and regulatory authorities; the research team plan to publish two manuscripts on this updated analysis.

Dependent on the results from this continued analysis on the cohort, if increased risk are seen it would be expected that the Health Technical Committee (HTC) will take action with Occupational Health in the companies to reduce further risks and aid surveillance among workers for cancer symptoms. Also these results will continue to assist the regulatory agencies IARC, HSE and SCOEL in classifying chemicals that are carcinogenic to humans and setting appropriate occupational hygiene standards in the current workplace. If no increased risks for cancer and specific causes of death are seen in this continued follow-up this will provide reassurance to workers and the industry. The benefit is ultimately for the workers in the oil refinery and petroleum distribution industry, safeguarding their health. Currently the UK oil sector comprises over 200 companies involved in the refining, distribution and marketing of petroleum products. Although this cohort of workers was established in 1946-1971, the results will still have health benefits for the current work sector in maintaining a safe work environment.

Outputs:

The research team at the University of Birmingham would like to update cancer incidence and mortality notifications for a UK cohort of oil refinery and petroleum workers. Previously published work on this cohort used cancer and death registrations to the end of 2011.

The research team plan to publish updated study findings (on cancer incidence and mortality) in medical peer-reviewed journals that specialise in Occupational Health. The team plan to use mortality registration data for the period 1951-2018 and cancer registration data for the period 1971-2018. They will investigate if this particular cohort are at an increased risk, compared to the general population, of specific types of deaths and specific types of cancers. The research team expect to produce two manuscripts based on the cancer and death registrations for the oil refinery and the petroleum distribution workers. The results will be published in a peer-reviewed, open access journal which will be accessible by the general public, academics and regulatory authorities.

The results of these analyses will also form the basis of annual reports to the study funder, the Energy Institute (http://www.energyinst.org, registered charity number: 1097899). These are available to the public. The last two reports written for the Energy Institute by the researchers on this project were:
- An investigation of mortality and cancer incidence in United Kingdom petroleum distribution workers 1951-2011. 2016. (please see: https://publishing.energyinst.org/topics/health/medical/an-investigation-of-mortality-and-cancer-incidence-in-united-kingdom-petroleum-distribution-workers-1951-2011)
- An investigation of mortality and cancer incidence in United Kingdom oil refinery workers 1951-2011. 2016. (please see: https://publishing.energyinst.org/topics/health/medical/an-investigation-of-mortality-and-cancer-incidence-in-united-kingdom-oil-refinery-workers-1951-2011)

During the course of the project regular project steering group meetings will be held with key stakeholders in the project, and minutes reported back to the Energy Institute. Meetings on the progress of the work will also be held with the Health Technical Committee at the Energy Institute. When appropriate conferences on Occupational Health are run, the team plan to submit the revised analysis for discussion (either through an oral presentation or a poster presentation) at such conferences, which consist of industry, academia and public members.

The final reports and publications in medical journals will also be used by policy markers. The findings of the study will help the UK Health and Safety Executive (HSE) and the EU Scientific Committee for Occupational Exposure Limits (SCOEL) in assessing whether current national and EU regulations provide adequate protection to workers exposed to benzene. This is an on-going review process and copies of the study reports will be sent to both organisations.
In October 2017 the International Agency for Research on Cancer (IARC) held a new monograph meeting on benzene. This new development was discussed with the Energy Institute Health Technical Committee (HTC). The outcome of this meeting increased even further the importance and the imperative for a comprehensive analysis of the cohort data.

The study will only be used to make comparison of cause-specific mortality and site-specific cancer incidence in the cohort with expected numbers based on national rates.

All outputs will only contain results in highly aggregated format and as statistical summaries and measures of association. Small numbers will be suppressed in line with the HES Analysis Guide. Record level information will not be released to any third party.

The final reports to the EI need to have been completed by the research team by 30th April 2020. Also specific milestones on the project before April 2020 need to be met.

Processing:

The cohort is already flagged with NHS Digital, who will supply only pseudonymised data to UoB (Member ID, Exits and re-entries to the NHS, Cancer data including the cancer registration number (restricted to 6 digits only), fact of death, date of death, cause of death and ICD coding. ) The last data received from NHS Digital was in August 2015, therefore UoB now require data from September 2015. UoB also request to retain all previously-supplied data.

This is an occupational cohort study and will compare the occupational cohort with the general population. The University of Birmingham have sets of mortality rates and cancer registration rates for England and Wales, and for Scotland. The University of Birmingham calculate how many cause-specific deaths and site-specific cancers would be expected to occur in the cohort, if the cohort suffered the same disease rates as the general population, taking sex, age, calendar year and country into account. The University of Birmingham then compare these expected numbers with the numbers that have actually occurred, the so-called observed numbers. The ratio of these two quantities (observed and expected numbers) provide the summary standardised mortality ratios (SMRs) and standardised incidence ratios (SIRs).

UoB will produce data for reports to the funders (the Energy Institute) and peer-reviewed open access journals, specifically in relation to Occupational Health. Any such publications will be accessible to the general public, academics and regulatory authorities. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide. In accordance with the technical project specification, the Energy Institute will not have influence on the outcomes nor suppress any of the findings of the research.

Data will only be accessed by individuals within the UoB department who have authorisation from the Principal Investigator to access the data described, all of whom are substantive employees of the University of Birmingham. Data is never shared with third parties or to other locations within the University.

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

MR363 - RUBBER FACTORY EMPLOYEES — DARS-NIC-147932-B9FG1

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes, No

Legal basis: 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(7), , 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 2012-08-07 — 2027-08-07 2016.06 — 2019.07.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The aims of the study are:

~ To describe the mortality and cancer morbidity experience of recent entrants to the UK rubber industry
~ To determine if recent and proposed measures to reduce and control exposure levels of dust and fume have had the effect of removing (completely or largely) the excess occurrence of lung and stomach cancer which has been identified in recent years (assuming that occupational exposures were involved in these excess risks)
~ To determine, by means of continuing surveillance, if any other part of the mortality and cancer morbidity experience of the study cohort may be due to occupational exposures in the rubber industry.

MR730 - Bespoke data linkage — DARS-NIC-309500-F4X1B

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2017-12-01 — 2020-11-30 2019.04 — 2019.04.

Access method: One-Off, Ongoing

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. MRIS - Cause of Death Report

Objectives:

The University of Birmingham requires Current Status and Cause of Death data for use in the BAFTA 2 study. This study will be undertaken in Birmingham Clinical Trials Unit which sits within the University Of Birmingham's Institute of Applied Health Research. The University of Birmingham set up Birmingham Clinical Trials Unit to undertake health research in response to calls from a variety of funders including the National Institute of Health Research. The University of Birmingham responded to a call for research in this area.

BAFTA 2 is a follow up study to the BAFTA project that was closed 8 years ago (MR730). The aim of the study is to investigate the longer term effects of anticoagulation in terms of overall mortality and risk of stroke and cardiovascular events. The University also aims to report the longer term adherence to anticoagulation therapy in this age group. All patients that were involved in the original study are patients that the University aim to collect data from (1440).
The original cohort of patients has been used and no new patients have been recruited. Therefore, the University of Birmingham has permission from CAG to gain access to these records without further consent; it was decided that the consent originally given met the guidelines for collecting this additional data.

In the original BAFTA trial, the average length of follow up was 2.7 years, and the average age on entry to the study was 81, With the increasing numbers of very elderly people in the UK, it is of great relevance to understand whether the benefits of anticoagulation persist in this very elderly group. The long term follow up of the BAFTA cohort offers the opportunity to explore this.
This follow up study will provide invaluable information about the long term outcomes for this population. Additionally, with the introduction of new anticoagulants, such as rivaroxaban, this data will assist the University in addressing the cost effectiveness of the new anticoagulants by providing answers on long term harms and benefits that will be important for economic modelling.

Yielded Benefits:

As well as being incorporated into national guidelines, and providing data on the safety and effectiveness of anti-coagulation in people over the age of 75 in atrial fibrillation (a major cause of stroke in this age group), a number of publications have arisen from the original BAFTA study, thus allowing its findings to have an impact on health care globally. These publications include: Mant J, Hobbs FD, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Murray E; BAFTA investigators; Midland Research Practices Network (MidReC). Lancet. 2007 Aug Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Hurley V, Ireson R, Fletcher K, Lip GY, Hobbs FD, Mant J; BAFTA Investigators. Int J Cardiol. 2007 Apr 25;117(2):152-6. Epub 2006 Aug 2. PMID: 16887213A cross-sectional study of hypertension in an elderly population (75 years and over) with atrial fibrillation: secondary analysis of data from the Birmingham Atrial Fibrillation in the Aged (BAFTA) randomised controlled trial. Fletcher K, Mant J, Roalfe A, Hobbs FD. Fam Pract. 2010 Dec;27(6):691-7. doi: 10.1093/fampra/cmq050. Epub 2010 Jul 7. PMID: 20610490 Impact of study design on recruitment of patients to a primary care trial: an observational time series analysis of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study. Roalfe AK, Bryant TL, Davies MH, Hackett TG, Saba S, Fletcher K, Lip GY, Hobbs FD, Mant J; BAFTA investigators. Europace. 2012 Oct;14(10):1420-7. Epub 2012 May 10. PMID:22581625A cross-sectional study of quality of life in an elderly population (75 years and over) with atrial fibrillation: secondary analysis of data from the Birmingham Atrial Fibrillation Treatment of the Aged study. Hobbs FD, Roalfe AK, Lip GY, Fletcher K, Fitzmaurice DA, Mant J; Birmingham Atrial Fibrillation in the Aged Investigators and Midland Research Practices Consortium Network. BMJ. 2011 Jun 23;342:d3653. doi: 10.1136/bmj.d3653. PMID:21700651 Performance of stroke risk scores in older people with atrial fibrillation not taking warfarin: comparative cohort study from BAFTA trial. Yiin GS, Howard DP, Paul NL, Li L, Mehta Z, Rothwell PM; Oxford Vascular Study.J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):12-18. doi: 10.1136/jnnp-2015-311947. Epub 2015 Oct 20. PMID:26487646 Recent time trends in incidence, outcome and premorbid treatment of atrial fibrillation-related stroke and other embolic vascular events: a population-based study. Tanislav C, Milde S, Schwartzkopff S, Misselwitz B, Sieweke N, Kaps M. BMC Res Notes. 2015 Jun 25;8:262. doi: 10.1186/s13104-015-1237-2. PMID:26108787 Baseline characteristics in stroke patients with atrial fibrillation: clinical trials versus clinical practice.

Expected Benefits:

The original BAFTA trial was a landmark study that has had significant impact on management of stroke prevention in older people and has been incorporated into national guidelines. The original trial provided key data on the safety and effectiveness of anticoagulation in people over the age of 75 in atrial fibrillation (a major cause of stroke in this age group). This follow up study will provide invaluable information about the long term outcomes for this population. Additionally, with the introduction of new anticoagulants, such as rivaroxaban, this data will assist the University in addressing the cost effectiveness of the new anticoagulants by providing answers on long term harms and benefits that will be important for economic modelling.

Outputs:

The original BAFTA trial led to publications in a number of journals, including Lancet, BMJ, and Stroke.
As well as these papers, the results arising from BAFTA have been presented at numerous international conferences.

The University would anticipate that this further analysis of long-term outcomes would lead to publications in similar high impact journals and are expecting to publish towards the end of the 2019. The analysis would have an immediate impact on policy, as it would help clinicians and their very elderly patients reach informed decisions about whether or not to continue anticoagulation. The University will present the data at relevant conferences, e.g. Society for Academic Primary Care (SAPC), UK Stroke Forum (UKSF), and make the results available to The National Institute for Health and Care Excellence (NICE) and alert relevant charities, such as the Stroke Association, of the findings.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. Record level information will not be released to any third party.

Processing:

The data will be used to establish who is now deceased and the cause of death. The mortality data will also be used to establish overall mortality rate. The original cohort of 622 participants held by NHS Digital will be added to, giving a total cohort of 1440. Data previously supplied by NHS Digital will not need to be re-supplied.

Data will only be accessed by individuals within Birmingham Clinical Trials Unit who have the authorisation from the Professor of Biostatistics and Deputy Unit Director, to access the data for the purposes described, all of whom are substantive employees of the University of Birmingham. The core dataset will only be accessed by two individuals within Birmingham Clinical Trials Unit. They will produce pseudonymised subsets of the data that will be accessed by the statisticians from Birmingham Clinical Trials Unit in the University of Birmingham. Access to the data supplied by NHS Digital, including subsets, will be restricted to substantive employees of the University of Birmingham.

Only the named researchers employed by the University of Birmingham will have access to these data. No third parties will be accessing the data and it will not be made available to anyone outside of the University of Birmingham. Researchers from the University of Cambridge will assist with preparing the algorithms for the analysis of the database holding the combined BAFTA 2 data. These algorithms will be designed by the University of Cambridge against a database with the same field architecture as the BAFTA 2 database but which only contains dummy data. Once these analysis algorithms are correct they will be passed to researchers in the University of Birmingham who will run them against the database which contains the BAFTA 2 data supplied by NHS Digital. The University of Cambridge will not analyse or process any data in relation to this study and are only supplying the algorithm that will be used by Personnel from The University of Birmingham.

Once downloaded onto the secure University of Birmingham servers dedicated to hold data supplied by NHS Digital, any necessary decryption will take place. A member of the IT team from Birmingham Clinical Trials unit will ensure that the data provided only contains the Unique Study ID and no other identifiers. Any analysis of data for BAFTA2 will only be undertaken on this pseudonymised data set.

There will be no requirement nor attempt to re-identify individuals from the 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).

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.

Supporting health services research activity in the School of Health and Population Sciences at the University of Birmingham — DARS-NIC-02544-M7M7G

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

Purposes: No (Academic)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2020-01-01 — 2020-12-31 2018.06 — 2018.12.

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Critical Care
  3. Hospital Episode Statistics Accident and Emergency
  4. Hospital Episode Statistics Accident and Emergency (HES A and E)
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)
  6. Hospital Episode Statistics Critical Care (HES Critical Care)

Objectives:


Project (1) To deliver a programme of applied health services research under the Collaboration for Leadership in Applied Health Research and Care programme (CLAHRC). This is an NIHR-funded programme in which the leading academic health care institutions in the UK work with the NHS and other providers of health and social care, in a programme of multiple themed research streams (the themes which require data from NHS Digital are "Maternity and Child Health", and "Research Methods"). In the case of the West Midlands CLAHRC, this involves answering research questions about patient flows through secondary care systems and the resulting outcomes in the West Midlands population. To do this, the University of Birmingham ("the University") needs contextual data on the English acute hospital population to make valid comparisons, using metrics such as length of stay, in-hospital mortality rates and readmission applied to various groups of patients, determined by epidemiology, demography or service use derived from HES data. To achieve this, the University need to look at longitudinal trends in hospital use in the population. Pragmatically, the University decided that, owing to data quality and completeness, 2007/8 would be used as the first year of observation, so data from that point on is required to complete this work.
Much of the work undertaken is traditional academic research, principally cross-sectional observational studies resulting in peer reviewed publications. However, the University will also be undertaking 'action research' and service evaluation in response to changes in service configuration. This activity will generate outputs whose main aim is to communicate assessments of service quality safety and cost-effectiveness to stakeholders, such as monograph reports and other forms of 'grey' literature. There is a deliberate degree of permeability in the University’s NIHR work programmes between research and service evaluation in accordance with the wishes of the commissioner and the guiding philosophy of CLAHRC. Examples of research questions are given in the Processing Activities section below. This project is funded until 31st December 2019.


Project (2) The University of Birmingham is leading an NIHR-funded project, the High Level Specialist Led Acute Care project to determine the impact of different models of consultant working at weekends on the excess mortality in acute hospitals that occurs in patients admitted during these times. This project started in 2014 with a proposed conclusion date of 31st January 2019. It will evaluate the roll out of the Government’s seven day services initiative. It will include an analysis of trends in hospital mortality from 2007-2008 onwards and will examine the association between a measure of specialist intensity captured in approximately 120 acute trusts in England, and in-hospital mortality in financial year 2013/14 to provide a baseline analysis. The University of Birmingham will go on to repeat the analysis until the end of the project to measure how this association changes over time as the Seven Day Services implementation extends throughout the service. None of these above activities are commercial. None involve for-profit work, commercialisation of research outputs or the development of intellectual property.

Record level data will not be shared with any third party and only used by the University of Birmingham. No commercial organisation is involved in any of this work.

Yielded Benefits:

For (1 - CLAHRC) above: The University has produced a study showing that there has been a significant growth in neonatal admissions between 2007/8 and 2014/15, however nearly 80% of the increase consists of potentially avoidable conditions. The study is currently out for review. The University has produced a comprehensive report on the emergency care needs of the population of Worcestershire which has been used by both commissioners locally and NHS England to inform the development of acute services in the area. For (2 - HiSLAC) above: The University has published a paper in The Lancet has published a paper which, to The University's knowledge, is the first study in a national health system to quantify specialist involvement in the care of emergency admissions at weekends and weekdays, and to analyse this with weekend and weekday admission mortality rates. The University has found no correlation across different Trusts between the mortality risk for emergency admissions at weekends and the relative levels of specialist involvement on Sundays and Wednesdays. This provides the context for phase 2 of the study which will evaluate the whole-system secular change during the implementation of 7 day services from 2014 to 2018. For the NIHCE Evidence Assessment Centre (a purpose on the original application, which ended in 2017). The commissioners of this project, felt that HES analysis could be used instead of specialist registries in a number of initiatives to monitor diffusion of novel technologies, and felt this to be an effective low-cost alternative. We were able to demonstrate in case studies in areas such as extra corporal carbon dioxide removal in intensive care and in the use of ultra-radical surgery in treating advanced ovarian cancer, that this was not the case, and that coding lag meant that OPCS coding lacked both the sensitivity and specificity for this task. In the case of extracorporeal carbon dioxide removal made this clear in the peer reviewed literature. See A United Kingdom Register study of in-hospital outcomes of patients receiving extracorporeal carbon dioxide removal (ECCO2R). Cummins, Carole; Bentley, Andrew; McAuley, Danny; McNamee, James; Patrick, Hannah; Barrett, Nicholas, Journal of the Intensive Care Society, 19.10.2017.

Expected Benefits:

For (1) CLAHRC above
The CLAHRC is funded by the NIHR, and the importance and benefit of undertaking this work was described to NIHR as follows:
“
** Service Theme: Maternity and child health
** Please describe the proposed outputs from the research and the impacts anticipated (including the intended audience, how the impacts will be achieved and the likely timeframe):

We intend to publish our findings in peer reviewed papers in internationally respected journals over years 3-5. We will present our work at local, national and international conferences: the first being done in such a way as to encourage collaboration and networking. We will promote uptake of our findings through the AHSN [Academic Health Science Network] and other communities of practice and through the national network of specialist children's hospitals of which BCH [Birmingham Children’s Hospital] is a member.


** Please describe the proposed implementation of applied health research into clinical practice across the health community that will be pursued within the proposed Theme using the matched funding, including an overview of how these relate to the overall strategy:

The IOS [Implementation and Organisational Studies] theme is embedded in the maternal and child health theme as follows: one of the four IOS Research Fellows will be part of the theme, working alongside our theme Research Fellows, Leadership & Diffusion Fellows and Patient Leaders. The IOS affiliated Research Fellow will carry out applied research in absorptive capacity, leadership and use of patient experience for service development within one or more of the studies. This will provide situated education on implementation science methodology and implementation issues as the need arises. The theme will draw on behavioural science expertise through an additional Research Fellow within IOS, who is an expert in such matters. Finally, we will draw upon management consultancy expertise from Warwick Business School and Health Services Management Centre (Birmingham) e.g. to engineer a more integrated service along lean methodology or to develop distributed leadership for innovation

** Please describe the proposals for activities to facilitate the implementation of research findings across the health community, including the rationale and an outline of the process and methodology by which this approach to implementation will be evaluated:

The rationale is to improve care to women and children by both supporting changes in practice identified from evidence and evaluating service change as robustly as possible. Identification of topic areas is a dialogue between CLAHRC researchers and service leads. We will use similar methodologies to those used in CLAHRC pilot. For example the Birthplace findings around safety of place of birth were co-written in a language clinical staff understood: changes in the configuration of services will take longer but have been facilitated by this initiative. The Trusts identified that membrane sweeping to reduce labour induction (NICE recommendation) was not being done as recommended. Training for clinical staff was co-designed and evaluated using a step-wedge design. The introduction of an induction of labour suite was supported by CLAHRC researchers, together with evaluation of the current move to enable women to go home during the early phase of induction of labour. We have both fed back evaluations of service innovations locally and disseminated findings at national conferences and workshops (innovations include advice and guidance referrals, location of care, barriers to discharge, hospital delivery of health promotion advice). Some of our work and future programmes impact on mental health and we will therefore collaborate with the Centre for Public Mental Health and Applied Healthcare Research described under the next theme.


** Support and Cross-cutting Theme: Research methods
** Please describe the proposed outputs from the research and the impacts anticipated (including the intended audience, how the impacts will be achieved and the likely timeframe):
The outputs will be grant applications and papers but equally importantly we will incorporate learning from this theme in the leadership courses for which both the Health Services Management Centre and Warwick Business School conduct on a large scale. An example of a key audience that we can reach through these courses is boards of NHS hospitals including non-executive directors who must assimilate quality related data. Our PPI representative machinery will form another highly relevant audience as will clinicians and managers that can be reached through the AHSN. We also wish to erode the epistemic wall that sometimes separates qualitative and quantitative researchers and will do so through the integrated model for service development and evaluation.”




For (2) HiSLAC above:
The research is funded by the NIHR, and the importance and benefit of undertaking this was described as follows:
“**Why is the research important in terms of improving the health of the public and/or to patients and the NHS?

This research is important because of the large number of patients who stand to benefit and because the research literature indicates the need for a large-scale study to provide secure evidence about the best way to improve care out of hours.

Patients admitted to hospital out-of-hours are exposed to greater risk of error and adverse events because they experience multiple transitions in the location of care (for example, from the Emergency Department to the Acute Medical Unit to general acute wards, or to the Intensive Care Unit (Fig 3)), each transition involving discontinuities and gaps in communication. In the Royal College of Physicians’ specialist survey, 28% reported that they considered continuity of care to be poor in their own hospital [RCP London 2012 (2)]. The impact of poor process control is amplified at weekends because of reduced specialist input and lack of supporting resources, particularly in ordinary acute wards. The putative week-end effect can thus be plausibly explained by suboptimal specialist staffing of hospitals out-of-hours and during the continuum of care after acute admission.

Acutely ill patients represent a major challenge for health services in terms of volume, risk, safety, costs, and impact on elective care pathways. They also cross traditional disease-specific boundaries of specialist practice as many have multiple co-morbid diseases. As stated above, they experience multiple transitions and discontinuities in care. The acutely ill patient pathway is presented conceptually in Fig 3 with approximate numbers of patients and outcomes.

Emergency admissions are estimated to cost the NHS around £11bn per year [Blunt 2010]. In 2008-9 there were 5m emergency admissions to hospitals in England, a rise of 11.8% since 2004/5, and representing 35% of all hospital admissions [Blunt 2010]. This has increased to 5.2M emergency admissions for 2010 and 2011 [Hospital Episode Statistics 2011-2012]. Given the additional (unquantified) numbers of elective hospital admissions who become acutely ill during their hospital stay and require urgent or enhanced levels of care (such as admission to intensive care units), the acutely ill patient population is the single largest group of patients in NHS hospitals. The overall mortality rate at hospital discharge or 30 days is 0.7% for elective hospital admissions but a recent report from the Information Centre for Health and Social Care, reported that the 30 day mortality rate following non-elective (urgent and emergency) admission was approximately 3.7% in the period 1 April 2011 to 31 March 2012. Of these, 75.7% of these deaths occurred in hospital and the remainder after discharge [Information Centre 2013].for emergency admissions is reported to range from 3.6% [HES data 2011] to 5% [Blunt 2010]. Mortality risk is much higher for specific conditions such as myocardial infarction (12.5% mortality for hospitalised patients with acute MI) [Smolina BMJ 2012], stroke (around 20%) [McKinney 2011], fractured proximal femur (10%) [Wu 2011], and septic shock (30-40%) [Levy 2010]. These patients should not be additionally burdened by avoidable morbidity and mortality associated with admission to hospital out-of-hours.

The deficiencies in structure and care processes described above are those over which specialists can exert the greatest effect – diagnosis, critical thinking, organisation of care, and access to timely investigation and treatment. The study by Baines et al (2013) that greatest avoidable harm came from diagnostic errors adds weight to the principle of specialist-led care. It is notable that acute care interventions which have been specifically designed to substitute for specialist involvement such as critical care outreach [McGaughey 2007] and ‘hospital at night’ [Hospital at Night 2010] have not impacted strongly on patient outcomes. The ‘weekend effect’ may be diminished when the disease process has a well-defined care pathway likely to include 7-day specialist input [Byun 2012; Kazley 2010; Kevin 2010; Myers 2009, Smolina 2012, Al-Lawati 2012, Jneid 2008, McKinney 2011] (Appendix 1). The Royal College of Physicians (RCP) evaluation of specialist input into acute medical admissions [Lambourne 2012] found that amongst the 61% of responding Trusts, case mix-adjusted mortality rates were lower in hospitals with specialists dedicated to the on-call work, working in blocks of several days, and offering two formal patient reviews a day. A single centre study has shown that improving structures and processes by integrating the medical assessment unit with the emergency department to permit higher intensity specialist-led care is associated with a sustained and significant reduction in overall hospital standardised mortality ratios [Boyle 2012]. In summary, the majority of studies show that weekend admission to hospital is associated with an increased case mix-adjusted mortality risk and more errors in care. The impact may be even more adverse for patients perceived initially as low-risk who subsequently deteriorate, either from misdiagnosis or systemic failure to track physiology and trigger a prompt response. The feature which distinguishes hospitals at nights and weekends from weekdays is the reduction in intensity of specialist input.


** Plans for disseminating the findings of this research
The main research outputs will be presented through the collaborating NHS, professional and public organisations to their respective constituencies and networks through regular reports, peer-reviewed scientific publications and presentations at scientific meetings. We will translate information on the link between process quality and outcomes into generalisable learning and sustained change in practice through the competency-based training programmes for acute care medical specialities. An example of this approach is the international training programme for intensive care medicine (www.CoBaTrICE.org)the development of which was led by the chief investigator (JB)in a highly successful Ledonardo programme funded project.

The impact of the research outputs (below) will be of value to health service policy makers and funders, patients and the public, the professions, and to quality improvement and human factors scientists. The findings will be of interest internationally as well as in the UK. We have ensured that the key constituencies are represented in the project team, including PPI reps, the clinical communities and professional organisations, the Department of Health and Medical Directorate, health services and sociology researchers, and groups focussed on promoting professional leadership (Faculty of Medical Leadership & Management).

The combination of objective and experiential data is a powerful method for engendering change. We expect to engender shared understanding between clinicians and managers of the barriers to and facilitators of major service reconfiguration through the triangulation of quantitative and qualitative data on process and outcome.

Generalisable experiential learning from the adopting hospitals lends itself to a peer-support model of diffusion and sustainability [Woolhouse 2012]. While not the immediate focus of this application, in contingent Phase 3 the Academy of Medical Royal Colleges may take the opportunity to develop a collaborative support network through the professional lead organisations and with the additional guidance of the Advisory Board, so that HiSLAC-Adopting hospitals will act as Promoters for others in their immediate proximity through the development of partnerships.

To enhance dissemination and impact, we will take into account the evidence synthesis published by the Health Foundation on challenges in quality improvement research [Dixon-Woods 2012]. We will invest substantial project time in stakeholder engagement, and in developing consensus on the correct metrics for measuring the impact of HiSLAC. We will minimise ‘top-down’ approaches to project management, capitalising on existing networks of clinicians with experience in front-line acute care and building on that community; and we will use ethnographic observations to promote reflective learning and to identify and minimise unintended consequences.


** Expected Output of Research/Impact:
The main research outputs will include:
• Information on current provision of specialist-led care throughout NHS acute hospitals in England, the extent of national variation, the use of physician assistants, and plans for change.
• National standards and definitions of quality of specialist-led care, and measurement metrics.
• Development of a generic framework for acutely ill patient pathways
• Novel data on the relationship between specialist-led care and specific patient outcomes, for example on CPR rates or length of stay.
• A better understanding of the interplay between weekend and weekday admission and the intensity of specialist-led care.
• Insights into the mechanisms for the link between weekend admission and suboptimal outcomes. • Evidence for improvement in patient outcomes with the introduction of higher-intensity specialist-led care during national roll-out in Phase 3.
• An economic model to determine whether the impact of the intervention justifies or even fully offsets the workforce costs.
• A more detailed and nuanced understanding from the ethnographic study of the relationship between contextual factors and innovation uptake.

If the theory that increasing the amount of care provided by specialists at the weekend will improve patient outcomes to a level in-line with those for weekday admissions is correct, developing a solid evidence base and implementation guidance material will significantly assist hospitals in making the business case for, and implementing, high-intensity specialist-care. The combination of objective and experiential data this project will deliver is a powerful method for engendering change. The decision-making processes and change management activities for each Trust can be streamlined by using the reference and guidance material from this project, saving money and effort. The subsequent outcomes from implemented changes, both within the project in Phase 3, and inspired by the results of the project, will benefit a substantial number of patients.
Each phase of the Stepping Up project will deliver beneficial outputs, from clarity on the current situation to a support network of hospitals implementing changes.
We anticipate building additional research alliances as the project unfolds, with particular emphasis on the development of care pathway mapping tools, and educational interventions to promote reflective learning. The PPI representatives will be key players in these developments.“

Outputs:

For (1 - CLAHRC) above:
• A report on urgent care provision in Worcestershire has been written. This compares the relationship between urgent care needs and socio-economic status (as measured by neighbourhood income deprivation) in a number of diagnostic groups. It also undertook comparison of the epidemiology of unplanned emergency care needs between the Worcestershire population and its statistical neighbours. The report was delivered in December 2015.

• An evaluation of how three natural experiments arising from three changes in service configuration change affect demand for Emergency Department (ED) attendance namely an ED closure, an ED relocation and the opening of a Minor Injury Unit. This builds on existing work carried out in the Department which has been published in peer-reviewed scientific literature by the applicant.

• A report on bariatric surgery uptake in the Region compared to the rest of England. Specifically modelling uptake and assessing the differential association between estimates population obesity, socio-economic status, proximity to provider and demographic factors. Submitted for peer reviewed publication mid-year 2018

• A study of patient pathways for paediatric allergy services, including a systematic review, and assessment of current use of and demand for allergy services and a health economic assessment of different models of service delivery. This will include assessment of demand, temporal trends and current patterns of service contact using HES. This will include of design of a West Midlands service pathway. Outputs will include peer review publication and reports and feedback to regional and national stakeholders between the present and 31st December 2018.

• A study of the Frequency of obesity as a diagnostic code in paediatric admissions in the West Midlands.

• A longitudinal observational study into the outcomes associated with early discharge following childbirth in England. The first of three papers intended for publication in peer reviewed scientific journals has been started. This paper reports the results of a readmission risk model. A second paper reporting the validation of an obstetric co-morbidity index is under discussion. The University plans a paper reporting the results of a risk prediction model for completion by 31st January 2019.

For (2 - HiSLAC) above:
• A statistical model estimating the correlation between a measure of intensity of specialist care cove and case-mix adjusted mortality rates in English Hospitals for financial 2013/14.This has been completed and published in the Lancet ( Aldridge et al, 2016, Weekend specialist intensity and admission mortality in acute hospital trusts in England: a cross-sectional study, Lancet, 388,10040, 178–186)
• Interim reports to the project steering committee have been presented at regular intervals and will continue to be produced until the project end date.
• A full report to the project steering committee and then for wider stakeholder distribution will be completed by 31st January 2019
• A paper intended for publication in a peer reviewed scientific journal on the association between specialist led care intensity and hospital mortality, including ethnographic research and analysis of case note reviews is expected to be submitted towards the end of calendar year 2018. The main content of this paper will concern data which is not captured from HES, however it will contain for an analysis of temporal trends in English hospital mortality from 2003 to 2018 in 140 Trusts providing non-specialist acute care which will be based on admitted patient care data.
• Econometric modelling will also be done to evaluate the extent to which changes in policy result in cost savings as well as patient outcomes. Results of this will be included in the final report. It is likely that they will be separately submitted to a peer-reviewed scientific journal at or around the project end date.

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).

The University of Birmingham will not link the data provided by NHS Digital to anything other than aggregated data, and only where this does not increase the risk of re-identification.

HES Admitted Patient Care data was originally supplied (2007/07 to 2014/15) without a 30-day mortality flag. The additional data (2015/16 to 2017/18) being supplied will include this flag, and it will be supplied as a single field which can be linked back to the earlier years of HES data. This will greatly assist with the mortality analysis.

For (1 - CLAHRC) above:
• Use the HES Inpatient, Outpatient and A&E data to derive directly standardised rates of admissions in various diagnostic groups defined by HRGs, main diagnostic profiles or surgical procedures. This will be done in a SQL server database using T-SQL. Aggregate data will then be presented in tabular form and as graphs and charts either as background and context setting in academic papers or as the substantive output where the objective is simply to present descriptive data.

• Use the HES admitted patient care and A&E data to construct statistical models to test specific hypotheses about the association between changes to service configuration in uses (see next section for specific examples of studies). Processing will consist of building analysis data sets using T-SQL from raw HES data in our SQL server warehouse, in flat file format, and then performing statistical analysis (typically generalised linear modelling, logistic regression and in the case of less common outcomes, Poisson regression using STATA and R).

• Use the HES admitted patient care and A&E data to construct statistical models to test specific hypotheses about the association between environmental, spatial and demographic characteristics of specific populations and localities and service use and outcome (see next section for specific examples of studies). Processing will consist of building analysis data sets using T-SQL from raw HES data in our SQL server warehouse, in flat file format, and then performing statistical analysis (typically generalised linear modelling, logistic regression and in the case of less common outcomes, Poisson regression using STATA and R. Some use of spatial analysis involving analysis sets produced as above, will be performed using ArcGIS geographical information systems software and R.

• For clarity, no other organisations which are involved in the CLAHRC are permitted to access or process the data from NHS Digital, other than where it is aggregated (with small numbers suppressed in line with the HES Analysis Guide).


For (2 - HiSLAC) above:
• A multi-level model of hospital mortality and its association with a range of variables captured in the HES Inpatient and A&E data sets and a measure of specialist intensity captured by a point prevalence survey in a sample of approximately 120 hospitals. For context, the University of Birmingham will also be building a more general model of mortality based on the supplied HES data. This will require historical data going back to financial year 2007/08. analysis sets will be captured from HES data stored in an SQL data warehouse and then used to build logistic regression models of mortality in which co-variates include demographic, clinical (diagnoses, co-morbidities), service (provider as random effect), temporal (before during or after reforms) and staffing as determined by the point prevalence data described above. Analysis sets will be captured from HES data using T-SQL and modelling will be undertaken using STATA.
• Produce counts of emergency admissions by day of week for all non-specialist acute Trusts, and, in some cases sites within Trusts, to provide denominators for a calculation of specialist consultant hours worked per 10 emergency admissions for a number of time periods across the life of the study.

The Birmingham COPD Cohort study — DARS-NIC-24810-Q6T3B

Type of data: information not disclosed for TRE projects

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

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

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

When:DSA runs 2019-01-19 — 2020-01-18 2017.06 — 2018.05.

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Accident and Emergency
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Critical Care
  5. Office for National Statistics Mortality Data
  6. Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics
  7. Civil Registration (Deaths) - Secondary Care Cut
  8. HES:Civil Registration (Deaths) bridge
  9. Civil Registrations of Death - Secondary Care Cut
  10. Hospital Episode Statistics Accident and Emergency (HES A and E)
  11. Hospital Episode Statistics Admitted Patient Care (HES APC)
  12. Hospital Episode Statistics Critical Care (HES Critical Care)
  13. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The Birmingham COPD Cohort study is a three-year longitudinal study of primary care COPD patients; a substantial work package within a NIHR-funded research programme grant (ref: RP-PG-0109-10061, 01/01/2011 – 31/12/2016). Chronic Obstructive Pulmonary Disease (COPD) is an important health problem, accounting for significant health service and societal costs. However the natural history and factors affecting prognosis are poorly understood and interventions for early disease are limited. There is also considerable under-diagnosis, resulting in potential unmet need.

A better understanding of factors that determine prognosis, particularly those that are modifiable, is essential for informing future interventions. In addition, a better understanding of prognosis helps inform patient management decisions, and facilitates doctor patient relationships. A number of prognostic indices have been developed and are currently used, which typically aim to predict either mortality or hospitalisation. The BLISS research team wishes to process data relating to hospitalisation and mortality in order to generate the prognostic indices for the COPD Cohort Study participants. These data are unavailable from other sources and will be more accurate and complete than self-reported information.

The Birmingham COPD Cohort study uses all-cause hospitalisation within three years as the primary outcome, with secondary outcomes including number and duration of hospitalisations, respiratory hospitalisations, healthcare costs and mortality.

COPD patients are at high risk of hospitalisations due to exacerbations, when their symptoms worsen and cannot be adequately controlled at home. However, due to the number of comorbidities common in this patient group (e.g. heart disease) and the complex interactions between them, the cause of hospitalisation is often miscoded. If the data requested were limited to admissions coded as being respiratory-related, a substantial proportion of admissions would be missed, therefore underrepresenting the burden on hospitals associated with COPD. Only age-appropriate variables (e.g. not paediatric or maternity) are requested, hence adhering to data minimisation. The data fields requested were critically reviewed in the initial application leading to a reduction in the number of fields requested.

For the above reasons, the study protocol was written with all-cause hospitalisations as the primary outcome. The study is funded by the NIHR to answer specific research questions; primarily the prediction of all-cause hospitalisation within this patient group. A power calculation was used to determine the number of recruited patients needed to answer the question, and result in statistically significant findings. Now the study is nearing completion the primary outcome cannot be changed, as this would contravene the study protocol and the funding agreement with the NIHR.

The study is also funded to collect and analyse secondary outcomes including A&E admissions and outpatient appointments, to assess how patients’ lung health affects healthcare utilisation overall.

The above explains why A&E attendance, outpatients, admitted patient care and critical care products are requested.

Yielded Benefits:

In line with the above statement, the analyses and measurable benefits for this study are planned for 2019 and beyond. Although the main analyses are completed for the report to the NIHR (the funder), further analyses are ongoing for publication of academic papers and conference presentations at a later date

Expected Benefits:

The funder is an NHS organisation that rigorously peer reviewed the aims of the research and was satisfied that there is a benefit for this work within the health and social care sector.

Prognostic indices are useful for communicating with patients and for planning health services. The existing prognostic indices are based on patients with more advanced COPD but the BLISS research team will use the data collected from this cohort study to examine the validity of these indices in a primary care COPD population, including patients with very early disease. If the current indices do not accurately predict the risk of exacerbations, hospitalisations or death amongst primary care COPD patients, the result could be inappropriate patient care decisions and treatment. More accurate prognostic estimation will also be of use to health service planners and policy makers in predicting the future need for services. Based on the study findings, the team will modify or develop a more appropriate index for use in primary care if required, that would be published in academic peer-reviewed journals and presented at relevant conferences during 2017/18.

Such outputs will address an important evidence gap within respiratory health, leading to improved patient outcomes (e.g. symptoms, hospitalisation rates) and reduced costs to the NHS.

The planned disseminations are expected to lead to evaluation of the findings by NIHR and other interested parties involved in setting national guidelines such as NICE. The BLISS study team hopes its recommendations for new/improved indices will be implemented in primary care within 5 years of study completion. This time frame reflects the fact that the outputs from this study will contribute to a body of evidence from multiple research studies that provide cumulative evidence forming a consensus on which policy and best practice guidelines are based.

Patients will benefit because their COPD will be recognised earlier and treatment options will be available to them. Better treatment decisions will be possible (therefore potentially improving their quality of life and survival) as a result of both the new severity score and the possibility of two new interventions in the future (exercise and occupational assessment) being explored separately within this programme of work. They may also be able to return to, or remain longer in productive work.

Outputs:

A report will be submitted to the funders (NIHR) in January 2018. This will provide a narrative on the methodology, the results, the conclusions and recommendations. If the results indicate that the current indices or uses of indices are not sufficient or could be improved upon, the report will contain evidence-based recommendations for a new index including what factors at what stage of diagnosis indicate levels of risk of future hospitalisation due to COPD and recommendations for earlier treatments to reduce future hospitalisation rates and improve outcomes.

The findings of the overall study and the results of interim analyses during the study period will also be and, in the case of some interim findings, have been be disseminated via academic peer-reviewed papers and conference presentations. Publications and presentations may continue beyond the current study period.

Outputs will present group-level data only (e.g. proportion of patients with specified characteristics/outcomes). All data included in outputs are aggregated with small numbers suppressed in line with the HES Analysis Guide. The funder’s report will be solely for the purposes of the funding body. All academic publications will be ‘open-access’ (available to members of the public without cost) and will be available on the websites of the publishing journal as well as the study website (www.birmingham.ac.uk/bliss).

Processing:

Patients were recruited to the study between June 2012 and June 2014. Following their baseline study assessment, patients were sent six-monthly postal questionnaires until the date of the follow-up study assessment (approx. 2.5 years after baseline). The research team also disseminated newsletters to all patients, providing study updates and notifying patients of relevant information.

Due to the dissemination of postal questionnaires and other study correspondence, the team were able to maintain current contact details for study participants, often receiving returned correspondence or contact from patients’ relatives if they had moved address or died. If patients had moved address, the study team contacted patients’ GP practices to obtain new contact details.

At the time of recruitment, the participants were provided with the Patient Information Leaflet and asked to sign the Consent form. All participants were written to in the summer of 2014, giving further information about the sharing of data with HSCIC (now NHS Digital) for linkage purposes and offering the opportunity for participants to object. This information and clarification of the intention to seek mortality data via the HSCIC was also published on the BLISS study’s website in the section: ‘Information for patients and the public’.

The data requested via NHS Digital will be downloaded to a University of Birmingham computer, saving it in a restricted area of the University server that is only accessible to specified members of the research team. Data within this area of the server will be backed up internally (not on to tape), so that data can be fully deleted within 2 weeks of a deletion request from NHS Digital. All data will be processed and stored at the University of Birmingham and only accessed by substantive employees of University of Birmingham.

The Birmingham COPD Cohort study started in 2012, with patient-level data being obtained from various sources (patient study assessments, patient self-completion questionnaires and general practice clinical systems) between study commencement and the current time. Baseline and 3 year follow-up study assessments are conducted by trained research assistants, with patients returning six-monthly self-completion questionnaire via post between these time points. Routine data (e.g. comorbidities and prior test results) was extracted from general practice clinical systems, covered by the patient informed consent obtained at baseline and signed Data Sharing Agreements with each participating general practice.

The data collected from these sources are stored in pseudonymised form and linked using common participant-specific study ID numbers. Participant identifiers linked to the study ID numbers are stored separately and held only for administrative purposes and for use in facilitating linkage to other data.

2,291 participants have consented to participate in the COPD Cohort Study and HES data plus linked ONS mortality data (supplied under section 42(4) of the Statistics and Registration Service Act 2007) are requested in relation to these participants. The University of Birmingham will send to NHS Digital NHS Number, Surname, Forename, Date of Birth, Postcode, and sex plus a unique study ID for use in linking the data. Pseudonymised data will be returned to the University of Birmingham with the study ID as the only identifier. NHS Digital will supply month and year of death but not full date of death to maintain effective pseudonymisation.

The supplementary HES and ONS data will be merged into the existing pseudonymised dataset using study ID. It will not be re-identified and will be stored separately from the participant identifiers.

Linking the stated data sources will allow the research team to explore health care usage and prognosis of COPD patients. The analyses will use the pseudonymised data only.

Prognostic indices are used in various diseases, such as heart disease, to identify patients at risk of developing a negative health outcome e.g. heart attack. The ability to assess patients’ level of risk is then used to inform the shared decision making process as well as treatment decisions, to optimise patient outcomes. Several multidimensional prognostic indices (PI) for COPD have been developed, mostly based on patients with moderate/severe COPD. PIs have been developed to predict a range of outcomes including mortality, hospitalisations and exacerbations. The Birmingham COPD Cohort study will examine the performance of these indices in a primary care COPD population, and the study team needs HES data to generate these indices. Prognostic indices are based on various components (e.g. the ADO index is based on Age Dyspnoea Obstruction; the DOSE index is based on Dyspnoea, Obstruction Smoking Exacerbations; the HADO-AH index is based on Health Activity Dyspnoea Obstruction Age Hospitalisations, etc.) While the study team has collected much of the data from the study patients, some of the data (e.g. hospitalisations, exacerbations) are only accurately held by HES. For example, although study patients are asked about hospitalisations in study postal questionnaires, not all patients reply and self-reported is subject to recall bias (memory). HES data should be complete and reliable. The study team is examining the performance of the prognostic indices to determine if they accurately predict primary care patients’ risk of events (e.g. hospitalisation or death). If indices are not found to be accurate, the team will modify the indices or develop a new prognostic index to more accurately predict future events.

MR1188 - OPTIMISATION OF THE MANAGEMENT OF STROKE & TIA — DARS-NIC-148063-6YT63

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Identifiable, Yes

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,

Purposes: No (Academic)

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

When:DSA runs 2010-03-10 — 2020-03-09 2017.03 — 2018.03.

Access method: Ongoing

Data-controller type: UNIVERSITY OF BIRMINGHAM

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

Objectives:

To optimise the acute management of people with Transient Ischaemic Attack (TIA) and stroke in Birmingham through identification and breaking down of current barriers to timely and effective treatment. This project will build on our previous work by describing current practice and then the potential effects of implementation of the National Stroke Strategy to local stakeholders, by intervening in the community and primary care to improve timeliness of arrival of patients at the specialist, by feeding back individualized risk factor attainment to patients and clinicians and overall improving stroke and TIA care in Birmingham using a generalisable model.

TargetCOPD: A randomised controlled trial of targeted case finding for COPD versus routine practice in primary care — DARS-NIC-81519-G1T5F

Type of data: information not disclosed for TRE projects

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

Legal basis: Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: No (Academic)

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

When:DSA runs 2019-11-01 — 2020-10-31 2017.09 — 2018.02.

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

  1. Office for National Statistics Mortality Data (linkable to HES)
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Accident and Emergency
  5. Hospital Episode Statistics Critical Care
  6. Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics
  7. Office for National Statistics Mortality Data
  8. Civil Registration (Deaths) - Secondary Care Cut
  9. HES:Civil Registration (Deaths) bridge
  10. Civil Registrations of Death - Secondary Care Cut
  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)

Objectives:

The Birmingham Lung Improvement StudieS (BLISS) programme is a series of connected research studies about Chronic Obstructive Pulmonary Disease (COPD) funded by a five-year programme grant from the National Institute for Health Research. The overall aim of the programme is to evaluate new ways of better identifying and managing patients with COPD in the community.

Background (TargetCOPD trial):
The study for which data is being sought is an extension of TargetCOPD trial (2012-2014), which is a substantial work package within a NIHR-funded research programme grant (ref: RP-PG-0109-10061, 01/01/2011 – 31/12/2016). Chronic Obstructive Pulmonary Disease (COPD) is an important health problem, accounting for significant health service and societal costs. Although diagnosed COPD is estimated at 1.3% of the population, it is widely accepted that under diagnosis may be in the region of 50-80%, where patients with clinically significant disease are unable to access effective treatments as they have not yet presented to their GP.

Section 251 will provide a legal basis for the use of the data under this application, previous trial consent is not being relied on.

The TargetCOPD trial aimed to determine the most effective method of identifying new cases of COPD amongst primary care patients. This trial did not include any data sharing with NHS Digital/HSCIC. Results of the trial showed it was most effective to post screening questionnaires to at-risk patients and invite those reporting respiratory symptoms for an additional lung function assessment at their GP practice.

Study aims and processing activities of TargetCOPD extension (TargetCOPD2):
Patients were recruited to the study between August 2012 and June 2014. At the time of recruitment, the participants were provided with the Patient Information Leaflet and asked to sign the Consent form.

Whilst the evidence from the TargetCOPD is useful, it does not provide information on whether diagnosing people earlier than usual leads to health benefits such as reduced hospital admissions and mortality. The Target COPD2 study will address this question by following-up patients for up to 5 years. Data is being requested from 2011 (to cover from the start of the recruitment period) - 2017/2018 (to allow five years follow-up).

To do this accurately, hospitalisation and mortality data is required for all patients deemed to be at-risk (~75,000) when the TargetCOPD trial started in 2012. It can then be determined if health outcomes differ for the patients receiving earlier COPD diagnoses as a result of the trial. The routine health data requested will include A&E attendance, inpatient and outpatient hospital admissions and ONS mortality. These data are unavailable from other sources and will be more accurate and complete than self-reported information. The research study team only holds data on patients that responded to the initial screening questionnaire (~8,000) thereby consenting to their information being held; hence data on all 75,000 patients can only be obtained by accessing certain patient identifiable data at the GP practices and subsequently sharing this with NHS Digital.

Benefits to health care:
Long-term follow-up of all eligible patients is in the interests of the health of the public. Considerable resources would be required for the primary care sector to adopt methods used in the TargetCOPD trial to diagnose COPD patients earlier. If long-term analysis demonstrates that hospital usage and mortality is not reduced through earlier COPD diagnosis, it would indicate that NHS resources could be better spent in other ways. Evidence from the current study will be produced as a final report for the National Institute for Health Research as well as peer-reviewed academic papers, hence disseminating evidence to policy makers and academic researchers.

Yielded Benefits:

In line with the above statement, the analyses and measurable benefits for this study are planned for 2020 and beyond (while the outputs were originally planned for 2019, due to additional information requested for the funder's report, the academic outputs are now expected in 2020). Although the main analyses are completed for the report to the NIHR (the funder), further analyses are ongoing for publication of academic papers and conference presentations at a later date.

Expected Benefits:

Patients diagnosed with COPD via case finding programmes would be expected to receive treatment, resulting in improved quality of life, increased survival, and reduction in hospital admissions and work-related absences. The requested data will provide robust, generalisable evidence to quantify the long-term patient health outcomes associated with COPD case finding. If the long-term analysis demonstrates that hospital usage and/or mortality is reduced through earlier COPD diagnosis, the findings would feed into the National Screening Committee (NSC). The NSC advises Government regarding implementation of screening programmes; if evidence supported case finding for COPD, expected patient benefits would include improved health and quality of life as a result of appropriate treatment. Considerable resources would be required for the primary care sector to adopt methods used in the TargetCOPD trial to diagnose COPD patients earlier. If the analysis does not demonstrate health benefits for patients, it would indicate that NHS resources could be better spent in other ways.

The planned dissemination is expected to lead to evaluation of the findings by NIHR and other interested parties involved in setting national guidelines such as NICE. The BLISS study team hopes its recommendations regarding COPD case finding are implemented in primary care within 5 years of study completion. This time frame reflects the fact that the outputs from this study will contribute to a body of evidence from multiple research studies that provide cumulative evidence forming a consensus on which policy and best practice guidelines are based.

Policies and guidelines are based on the entire existing evidence base (i.e. all previous research studies on the topic), rather than a single trial. Whilst these other studies are not part of the NIHR programme grant in any way and were conducted by different researchers, it is important to consider all the available evidence to obtain a consensus.

Outputs:

A report will be submitted to the funders (NIHR) in early 2018. This will provide a narrative on the methodology, the results, the conclusions and recommendations. If the results indicate that early COPD diagnosis leads to better health outcomes, the report will contain evidence-based recommendations for COPD case finding to be adopted, to reduce future hospitalisation rates and improve outcomes.

Research findings will be published in relevant peer-reviewed academic journals, with either a respiratory or primary care focus and readership. For example, research findings will be submitted to Lancet Respiratory, Thorax, British Medical Journal, npj Primary Care Respiratory Medicine (but not restricted to these). Outputs will also be presented at relevant academic national and international conferences, such as European Respiratory Society, International Primary Care Research Group, Society for Academic Primary Care. Such dissemination will take place either during or following the study period.

A lay summary of the results for the patients who responded to the questionnaire in the TargetCOPD trial will be produced in the form of a newsletter or similar. The Patient Advisory Group will also be presented with the findings. In addition, a dissemination event will be held for all stakeholders e.g. patients, health care professionals and policy makers. This will be advertised through various patient organisations e.g. British Lung Foundation Breathe Easy groups.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

The funder’s report will be solely for the purposes of the funding body. All academic publications will be ‘open-access’ (available to members of the public without cost) and will be available on the websites of the publishing journal as well as the study website (www.birmingham.ac.uk/bliss).

Processing:

The TargetCOPD trial started in 2012, with patient-level data being obtained from various sources (patient study assessments, patient self-completion questionnaires and general practice clinical systems) over the trial period. Study assessments were conducted by trained research assistants. Routine data (e.g. comorbidities and prior test results) was extracted from general practice clinical systems, covered by patient informed consent and signed Data Sharing Agreements with each participating general practice.

The data collected from these sources are stored in pseudonymised form and linked using study ID numbers. Patient identifiers linked to the study ID numbers are stored separately and held only for administrative purposes and for use in facilitating linkage to other data.

The TargetCOPD trial identified 74,818 patients as potentially eligible and NHS Digital and ONS data is requested in relation to these patients. The University of Birmingham will send the following data extracted from the participating GP Practices (see Section 4) to NHS Digital for linking purposes: NHS Number, date of birth, postcode, sex and study ID number. The study team will destroy the identifiable data previously obtained from the GP practice once it has been shared with NHS Digital.

Patient identifiable data is flowing to NHS Digital with a study ID, and pseudonymised HES data is flowing back to the University of Birmingham with the study ID as the only identifier. As the University of Birmingham holds identifiable data for patients consenting to the TargetCOPD trial (approx 10% of the total sample involved in this application), the HES data is classed as identifiable. However, data obtained from NHS Digital will never be merged with participant identifiers, meaning that the HES/ONS data will remain pseudonymous.

The data requested from NHS Digital will be downloaded to a University of Birmingham computer, and saved in a restricted area of the University server that is only accessible to specified members of the research team who are substantive employees of University of Birmingham. Data within this area of the server will be backed up internally so that data can be fully deleted within 2 weeks of a deletion request from NHS Digital or at the end of the data retention period. All data will be processed and stored at the University of Birmingham.

The NHS Digital data will be merged into the existing pseudonymised dataset, for analysis purposes only, using study ID. It will not be re-identified and will be stored separately from the participant identifiers. Only substantive employees of University of Birmingham will access and analyse the data (individuals names as ONS users later in the application). In addition, it will not be linked to any other data.

Linking the stated data sources will allow the research team to compare health care usage and mortality, according to early COPD diagnosis. The analyses will use the linked pseudonymised data only.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

All processing of ONS data will be in line with ONS standard conditions.

Project 22 — DARS-NIC-147812-77TZR

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Purposes: ()

Sensitive: Sensitive, and Non Sensitive

When:2016.04 — 2017.05.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

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

Objectives:

A randomised controlled trial of extended warfarin treatment versus routine warfarin treatment for the prevention of recurrent VTE and post thrombotic syndrome in patients being treated for a first episode of unprovoked VTE.

This study aims to:
i) Identify patients at highest risk of having a second clot from D-dimer tests and other factors;
ii) See if extended treatment can prevent recurrent clots;
iii) Identify patients at risk of developing post thrombotic syndrome;
iv) Identify the most cost-effective means of both preventing and treating clots;
v) Determine patient preferences and utilities with regard to extended Warfarin.

MR1257: CReST Trial (Role of Endoluminal Stenting in the acute management of obstructing colorectal cancer) Extension Request for Patient Tracking Service — DARS-NIC-178135-HJSFF

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2017-03-17 — 2020-12-16 2016.04 — 2017.05.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

Primary objectives:
To determine if endoluminal stenting for obstructing colonic cancers can result in:
- Reduced perioperative morbidity as assessed by length of hospital stay
- Reduced 30-day mortality

Secondary objectives:
To determine if endoluminal stenting for obstructing colonic cancers:
- Reduces stoma formation
- Improves quality of life
- Increases ability to tolerate adjuvant chemotherapy
- Has demonstrable benefits in the palliative and attempted curative settings
- Improves overall survival

Yielded Benefits:

The data produced to date from the CReST study has significantly changed the recently updated European guidelines for stenting in obstructing colorectal cancer. This guidance has changed form not recommending stenting as a bridge to surgery to; ‘Recommendation 2019 ESGE recommends stent as bridge to surgery to be discussed as a treatment option in patients with potentially curable left-sided obstructing colon cancer as an alternative to emergency resection within a shared decision making process. This discussion should include the following factors: availability of expertise, similar overall survival and postoperative mortality, lower overall complication rates and permanent stoma rates, more laparoscopic one-stage surgery, and higher recurrence rates, technical and clinical failure rates, and risk of perforation (strong recommendation, high quality evidence).’ This guidance is awaiting publication in the journal Endoscopy (Impact factor 6.831) There is increasing recognition for the requirement for long term oncological outcomes after definitive treatments. Ten-year follow up data collected from the sites will provide definitive outcomes on patients presenting acutely with obstructing colorectal cancer. There have been requests for collaborative work with international colleagues from Holland and Italy to share the trial outcomes data for the purpose of meta-analysis of outcomes following stenting for colorectal cancer. Meta-analysis of randomised trials is recognised to provide the highest level of evidence to direct treatment. Retainment of CReST1 data will allow participation in this international collaboration.

Expected Benefits:

Due to the CReST trial, patients admitted acutely with large bowel obstructions arising from colorectal cancer will have appropriate treatment which will now be guided by evidence based medicine. The results from CReST will provide definitive evidence to show how these patients should be treated.

The team were hopeful that NICE will take into account the findings of CReST and amend their guidance accordingly should there be the need.

The team hope that through publication in a high profile journal and presentation at various prestigious conferences the results of CReST will have an effect on the current practice of dealing with patients who present in the emergency setting with a left-sided colonic obstruction.

The study will publish 3 year follow up data. Longer term follow up data will be relevant for the patients recruited into the study. 5-year follow up data represents definitive cure rates which are important in any cancer study. There are residual concerns about increased recurrence rates in patient’s treated with stenting as a bridge to surgery. Longer term follow up data will be important in this regard. CReST remains the largest study of stenting as a bridge to surgery and therefore represents the largest body of evidence in patients presenting with large bowel obstruction secondary to colorectal cancer. Maintaining data in these patients also allows us to participate in collaborative studies with other researchers who have performed similar, albeit smaller studies.

Data generated by the CReST study will have important worldwide application as obstructing colorectal cancer remains an important health care problem in most countries.

Outputs:

The data collected will form part of the basis of the publication of the CReST trial results. The |Trial Management Group are reviewing the trial data and expect to publish the main results of the trial in 2020 in a high impact journal preferably ‘The Lancet’ or ‘Lancet Oncology’.

The results of the trial have also been presented at targeted, specialism-specific conferences, including The Association of Coloproctology of Great Britain and Ireland Annual Meeting in July 2016, The European Society of Coloproctology Annual
Meeting in September 2016 and The British Society of Gastrointestinal and Abdominal Radiology Conference.

There was a CReST Collaborators meeting in June 2016 where all participating Principal Investigators (mostly made up of Surgeons and several Radiologists) were invited to hear the results of the trial from members of the Trials Management Group. CReST had 44 participating centres, across the UK and Ireland, by the end of the study. The results may therefore be presented to a large demographic of clinicians and potentially impact on their clinical practice.

The National Institute for Health and Care Excellence (NICE) – The CReST Chief Investigator and the CReST Lead Radiologist, were on the writing committee for the latest update of NICE guidelines on colorectal cancer in January 2020. The Chief Investigator presented the results at a form NICE committee who were updating the Stenting guidelines for colorectal cancer.

Publication of data and dissemination of results to patients will be important and achieved via the Association of Coloproctology of Great Britain and Ireland (ACPGBI) and their patient groups and also by the colorectal cancer charities (which enjoy a good relationship with ACPGBI). The data will also be shared more widely by presentations at international society meetings.

Processing:

This is a request for an extension of the existing agreement to continue to hold data previously supplied by NHS Digital for archiving purposes only, data will be held for 5 years till 16/12/2025.

As this is a request for an extension of an existing agreement to continue to hold data previously supplied by NHS Digital no further processing activities are envisaged. These data will be held to allow calculations to be repeated should any further queries arise whilst the paper is being prepared.

BCTU provided the patient identifiable data (NHS number and Date of Birth) for consented individuals in the CReST cohort (245) to NHS Digital. NHS Digital linked the cohort to the requested identifiable data relating to the date and cause of death, including the incidence and the outcome of any cancers and disseminated to BCTU.

The data was then downloaded by BCTU via secure file transfer and saved on a secure server dedicated to hold data from NHS Digital at the University of Birmingham. These data supplied by NHS Digital and the Hospital / GP practices were shared with a small number of named researchers at the University of Birmingham who were working on the CReST study and only had access to these data from secure computers on University of Birmingham premises. The staff members who processed the data are substantive employees of the UoB.

All death data received from NHS Digital was compared with the death data that Birmingham Clinical Trials Unit (BCTU) had already collected from Case report Forms (CRFs) and correspondence with individual hospital sites. Any additional data was added to the secure password protected database and relevant spreadsheets for the trial. A death certificate was compiled from a BCTU generic template that contains the patient’s date of death, the cause of death text provided by NHS Digital, the underlying cause of death code and any other multiple cause of death codes provided. This was then filed electronically in the Mortality CReST folder and in the patient’s paper file kept in a lockable filing cabinet, in a secure swipe office.

Similarly, the cancer registrations were checked against the current information that BCTU hold about the relevant patients. If there are any discrepancies between the data that has been collected and the cancer registration data the team would contact the relevant hospital site and amend the records accordingly.

The data supplied by NHS Digital contained sufficient information to ensure that the information is assigned to the correct patient record on the database. Once imported into the database the information used to link the study fields was modified to ensure that it was not sufficient for any researcher on the CReST study, or member of staff of the University of Birmingham, to personally identify anyone who consented to participate in the full trial.

Researchers from the University of Birmingham prepared algorithms for the analysis of the database. Once these analysis algorithms were correct they would be run against the database which contains the Crest data. This allowed the follow up of the original participants in the CReST study to be extended.

The CReST analyses do not identify any individuals, but instead look at the overall patterns of a large set of anonymised records to identify patterns and trends.

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).

Project 24 — DARS-NIC-148121-LZNC5

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

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

Purposes: ()

Sensitive: Sensitive

When:2017.09 — 2017.05.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

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

Objectives:

The data supplied by the NHS IC to University of Birmingham will be used only for the approved Medical Research Project MR792.

Project 25 — DARS-NIC-148379-5VSG8

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research studY

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

Purposes: ()

Sensitive: Sensitive

When:2017.06 — 2017.05.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

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

Objectives:

Fluoropyrimidine, oxaliplatin and targeted-receptor pre-operative therapy for pateints with high-risk, operable colon cancer.

FOxTROT is a multi-centre randomised controlled trial (RCT) with the following objectives:
Primary objectives:
• To determine if neoadjuvant chemotherapy±panitumumab followed by deferred surgery and completion of chemotherapy post-operatively can reduce 2-year recurrence as compared to surgery and postoperative chemotherapy±panitumumab
• To determine if adding panitumumab in the neoadjuvant treatment produces a measurable increase in anti-tumour efficacy as measured by tumour shrinkage.
Secondary objectives:
• To assess the accuracy of pre-treatment CT scan staging
• To assess the tolerability of the neoadjuvant therapies
• To assess the nature and frequency of surgical complications
• To measure the impact of the treatments on participant quality of life and on resource usage

National Register of RF Workers - MR1123 — DARS-NIC-148425-R38F2

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N, Identifiable (Consent (Reasonable Expectation))

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

Purposes: No (Academic)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2019-06-01 — 2021-04-01 2016.04 — 2017.02.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

"This study to obtain important new information on the topic of long-term health effects of occupational RF exposure by examining data from the on-going National Register of RF Workers. Analyses of cancer incidence and cancer mortality will be carried out for each site of cancer (three digit ICD codes) and analyses of non-cancer mortality will be carried out for broad disease categories (ICD chapters).

The National RF Register was first sponsored by the Health and Safety Executive (HSE) for the two-year period 2003-2004. It was always the intention of the HSE to support the start-up costs but then seek industry support for later years of data collection and analysis. Industry support has been made available for the five year period 2005-2009. "

Yielded Benefits:

None to date as the work is not yet completed.

Expected Benefits:

Most of the expected measurable benefits will be felt by more recent and future employees in the industry. This is because UoB are looking at late effect of exposures that have already happened. Measurable effects can only come from improved working conditions experiences by later generations of workers.

Currently the only recognised mechanism for causing adverse health outcomes is the thermal effect, observed when the energy deposited by oscillating electric fields causes an increase in temperature due to the agitation of the mobile ions contained in the body. This causes an electric current, the resistance of which by body tissue leads to heating. The exact nature of this effect is dependent upon the frequency of the signal as this determines the depth to which the RF radiation penetrates the tissue which in turn impacts on whether the temperature receptors in the skin are stimulated, receptors that play an important role in local and whole body thermo-regulation.

The exposure standards for RF are based on the assumption that the primary route of energy absorption is via heat deposition. All current occupational guidelines are devised on this basis.

The largest existing body of evidence of adverse health effects from RF concerns the occurrence of cancer at a number of different sites. The majority of these studies showed that occupational exposure to RF showed no increased risk however isolated studies have shown some potential areas of concern, for example an increased risk for breast cancer in radio operators. In May 2011, the International Agency for Research into Cancer (IARC) convened a meeting of global experts in the subject to review the existing literature and classify the carcinogenic properties of RF; this concluded that the evidence suggested that RF was a possible carcinogen, however the evidence of increased risk of cancer from occupational exposures was judged ‘inadequate’.

The updated linking of mortality and cancer data will allow University of Birmingham to determine if there is a significant health effect as a result of occupational exposure to RF at current levels. Dependent upon the results new limits for occupational exposure will be proposed. These may be in place within two to five years of the release of study results.

Outputs:

The Register provides a valuable long-term framework for research into potential health effects of occupational exposure to RF radiation across a range of industries and has the potential to produce a number of valuable publications. The first of these containing a preliminary analysis of the incidence of cancer within the cohort is expected to be completed by the end of 2019. The manuscript will initially be submitted to the journal Environmental Health Perspectives, the highest ranking journal that publishes work on occupational exposure and health. The journal is open access which will allow all interested parties to read the article free of charge. A lay summary of these findings will be made available on the Register’s website and submitted for publication in trade journals such as ‘Engineering and Technology’ the journal of the Institute of Engineering and Technology. The press office of the University of Birmingham will also provide a media release. In addition they will engage with the research community by presenting the results at the 2020 edition of the (UK and Ireland) Conference on Occupational and Environmental Epidemiology.

There will be at least one further publication following a full analysis of the data set which will also include an investigation of the cause of death this will be conducted once further follow up has been added providing meaningful additional data. The same avenues for dissemination will be followed including publication in the peer-reviewed literature, production of lay-summaries for wider dissemination and the presentation of the results to the scientific community via the appropriate conference. University of Birmingham expect this to be published by 2025.

All outputs will contain only aggregated data with small numbers suppressed, in accordance with NHS Digital’s HES Analysis Guide

Processing:

The following provides background on the processing activities undertaken for the original study:

Identifying data (full name, date of birth, address or postcode) was shared with NHS Digital to carry out the linkage between the study data and civil registration mortality and cancer registration data. Participants records were ‘flagged’ with NHS Digital. NHS Digital notified the study team at the University of Birmingham of participants’ deaths (date and cause) or cancer registrations when they occurred. Data was last supplied in June 2016.

The University of Birmingham (UoB) will now proceed with a unique identifier which NHS Digital will use to provide dates of death, and ICD codes for causes of death, dates of cancer registration and ICD codes for site and type of cancer.

Data will only be accessed by substantive employees of the University of Birmingham.

Data supplied by NHS digital will be linked to individual level study data containing details on dates of birth and work histories (dates of employment, job titles and incidents of acute exposure at the time of joining the Register). 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 HES Analysis guide.

Data is required over such a long timescale (since 2002) because cancer can have very long intervals between exposure to a risk factor and the clinical presentation of a disease. The cohort has been recruited nationally because national data is required: the study has been established as a national study of all employees with the potential to be exposed to radiofrequency radiation (RF) above public guidelines. This national coverage provides maximum statistical power and provides findings that have national application. The study would be weakened if relying on regional sub-sets of data and the credibility of any findings reduced. Because the potential impact of the findings on national policy for occupational exposure to RF it is important that uncertainty is minimised.

The degree to which UoB have filtered the outputs is related to the fact that there is a wide variety of possible harms. The study maintains the original data collected from individuals on their work history and date of birth as this forms an integral part of the analysis allowing for the statistical adjustment of age effects and the development of exposure histories.

The data requested from NHS digital will be downloaded to a University of Birmingham computer, saving it in a restricted area of the University server that is only accessible to the specified member of the research team . Data within this area of the server will be backed up internally so that all data can be fully deleted with two weeks of deletion request from NHS Digital. All data will be stored and processed at the University of Birmingham.

On receiving the NHS Digital datasets data on study ID, dates of death, causes of death, dates of cancer registrations and site and type of cancer will be transferred to a dated spreadsheet and saved into the same restricted area of the server as the master file. The main study file will contain information on the study ID, dates of birth, work histories (this will be added to over time with data on death and cancer registration). Death data will be transferred into the master file if a matching study ID is found. In the event that subsequent data provided by NHS digital contains death data already present in the master file then new and old data will be reviewed to determine if this is duplicate data or if there is a clash of data and two individual files have been confused. In the unlikely incident of the latter then assurances of NHS Digital staff will be sought. Cancer registration data will be transferred from the new follow-up file into the main study file if a matching study ID is found. A separate program seeks evidence of duplicate entries. For any cases where it is not possible to resolve discrepancies between data in the main study file new data from NHS digital the new data will be destroyed.

Analysis of individual level data are used to calculate standardised mortality ratios (SMRs) for different causes of death, using national mortality rates as a basis of comparison. These SMRs are adjusted for age, sex, and calendar year. Analyses of individual level data are used to calculate standardised registration ratios (SRRs) for different sites of cancer death using national registration (incidence) rates as a basis of comparison. These SRRs are also adjusted for age, sex and calendar year. Estimates of cumulative occupational exposure to magnetic fields have also been calculated for each study member and in lowest exposure group as a baseline or reference category. Such analyses seek evidence of dose-response effects i.e. does the risk of a disease increases with increasing exposure.

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).

Echocardiographic Heart of England Screening (ECHOES) - Survive study — DARS-NIC-156412-QY9WM

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N, Identifiable (Consent (Reasonable Expectation), Section 251 NHS Act 2006)

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); Other-Section 251 of NHS Act 2006, Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2019-06-01 — 2020-05-31 2016.04 — 2016.11.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The data supplied to the University of Birmingham will be used only for the approved medical research project - MR685 - ECHOCARDIOGRAPHIC HEART OF ENGLAND SCREENING (ECHOES) STUDY

Yielded Benefits:

The previously published data has benefited patients, clinicians and healthcare commissioners. The 5 and 10-year survival analyses provide estimates of longevity and also likely cause of death following a diagnosis for people with heart failure. The UoB team have heard from clinicians that they have used the survival rate estimates from the ECHOES study when discussing outlook with their patients with heart failure. The figures have also been used to lobby policymakers in the importance of heart failure as a malignant condition and the need to commission appropriate healthcare services, including provision of palliative care.

Expected Benefits:

The natural history of heart failure detected by screening is poorly understood. UoB's previous research reporting the 5 and 10-year survival rates for people with heart failure has been well cited and related work attracted a lot of interest from media globally, and from patient groups, when it was published in January 2017. The need for accurate prognostic information for people with heart failure remains an important priority for patients, clinicians, researchers and commissioner of healthcare. The 20-year survival rates for people with and without heart failure are currently unknown. This information is vital to further UoB's knowledge of the natural course of screen detected heart failure and for patients to understand their outlook following a diagnosis.

Outputs:

No new outputs will be produced under this Data Sharing Agreement.

In any future application, the applicant will be required to provide details of any future outputs planned.

In the original study, 6162 participants were screened for heart failure forming the largest cohort of its kind in England. Using existing linkage with civil registration mortality data, the University of Birmingham (UoB) have been able to report novel findings on how long people with and without screen-detected heart failure lived for following a diagnosis. UoB have also been able to report the cause of death, which isn't always heart failure.

UoB's 5 and 10-year prognosis papers (listed below) have been reported in peer-reviewed journals and widely cited. UoB plan to report 20-year survival rates from the original cohort. The NHS Digital audit team commented on the importance of this prognostic research and were keen for the study to continue and further this work. This type of long-term mortality data from a well-established cohort is not available by any other means.

Hobbs FD, Roalfe AK, Davis RC, Davies MK, Hare R; Midlands Research Practices Consortium (MidReC). Prognosis of all-cause heart failure and borderline left ventricular systolic dysfunction: 5 year mortality follow-up of the Echocardiographic Heart of England Screening Study (ECHOES). Eur Heart J. 2007;28(9):1128-34.

Taylor CJ, Roalfe AK, Iles R and Hobbs FDR. Ten-year prognosis of heart failure in the community: follow up data from the Echocardiographic Heart of England Screening Study (ECHOES). Eur J Heart Fail 2012; 14(2):176-184.

Processing:

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement.

The study data, including data provided by NHS Digital under previous agreements, are currently held by the University of Birmingham. Under this interim extension all devices containing data will be securely locked away in a locked cabinet at the University of Birmingham storage address specified in this Agreement.

The following provides background on the processing activities undertaken for the original study:

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 the University of Birmingham 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 December 2016.

Project 28 — DARS-NIC-230509-D4R8J

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: Sensitive, and Non Sensitive

When:2016.04 — 2016.11.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

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

Objectives:

A prospective cohort observational study to determine the incidence of venous thromboembolism amound care home residents (VTEC)

This study aims to determinefor the first time in UK care homes the incidence of Venous thromboembolism (VTE), the incidence rate of VTE related deaths, the rate of hospital admissions due to VTE amoung care home residents not admitted to hospital.

Dates and causes of death are to be used for research purposes, that is to confirm study endpoints and to collect relevant data on risk factors, prevention and treatment from care home and GP surgery it is achieved.

The data will be held on a secure database within the University of Birmingham and analysed to answer the study questions.

The output of the analysis will be peer reviewed medical journals. The suty aims to ascertain the incidence, examine prevention measures, determine the optimal treatment strategy and to imprve VTE risk assessment which is needed in Care Home because many residents have multiple conditions and complex medication regimes.

Project 29 — DARS-NIC-152807-J9T1B

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, and Non Sensitive

When:2016.04 — 2016.08.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

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

Objectives:

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR)

The primary aim of TASMIN-SR is to compare self-management with usual care in the control of hypertension in patients with stroke and other at-risk conditions.

The trial has four main research questions:
1. Does self-management of blood pressure result in better control of blood pressure in people with stroke and other at-risk conditions compared to usual care?
2. Is self-management of blood pressure in people with stroke and other at-risk conditions achievable in routine practice and is it acceptable to patients?
3. What is the relationship between self-management of blood pressure, self-efficacy, lifestyle behaviours, patients’ attitude to health and health care and use of other self-care strategies in people with stroke and other at-risk conditions?
4. Is self-management of blood pressure in people with stroke and other at-risk conditions cost effective?

Project 30 — DARS-NIC-148380-Q4H3D

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y

Legal basis: Section 251 approval is in place for the flow of identifiable data

Purposes: ()

Sensitive: Sensitive

When:2016.04 — 2016.08.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

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

Objectives:

To define overall mortality and specific mortality secondary to fractured femur and ischaemic heart disease in patients with previous radioiodine treated Throtoxicosis who have or have not subsequently received T4 therapy.