NHS Digital Data Release Register - reformatted

University of Birmingham

Project 1 — DARS-NIC-02544-M7M7G

Opt outs honoured: No - data flow is not identifiable (Does not include the flow of confidential data)

Sensitive: Non Sensitive

When: 2018/06 — 2018/12.

Repeats: One-Off

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

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Accident and Emergency

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.

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.

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.


Project 2 — DARS-NIC-121849-W0T5C

Opt outs honoured: No - data flow is not identifiable (Does not include the flow of confidential data)

Sensitive: Non Sensitive

When: 2019/04 — 2019/04.

Repeats: One-Off

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

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care

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.

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).


Project 3 — DARS-NIC-147797-45YHZ

Opt outs honoured: Yes - patient objections upheld

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/07.

Repeats: Ongoing

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)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Cohort Event Notification Report

Objectives:

The prinicpal aim of the research is to establish a database of aproximately 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.


Project 4 — DARS-NIC-147805-HDHWM

Opt outs honoured: Yes - patient objections upheld (Does not include the flow of confidential data)

Sensitive: Sensitive

When: 2016/12 — 2019/07.

Repeats: Ongoing, One-Off

Legal basis: Health and Social Care Act 2012, 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)

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

  • MRIS - Scottish NHS / Registration
  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

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.

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

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.


Project 5 — DARS-NIC-147812-77TZR

Opt outs honoured: Y, N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2017/05.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • 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.


Project 6 — DARS-NIC-147927-8K193

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/09.

Repeats: Ongoing

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)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

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


Project 7 — DARS-NIC-147932-B9FG1

Opt outs honoured: Yes - patient objections upheld

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/07.

Repeats: Ongoing, One-Off

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)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Cohort Event Notification Report

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.


Project 8 — DARS-NIC-148063-6YT63

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2017/03 — 2018/05.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

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.


Project 9 — DARS-NIC-148121-LZNC5

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/09.

Repeats: Ongoing

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)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification 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 10 — DARS-NIC-148286-3RWRG

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

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/07.

Repeats: Ongoing

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)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

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.

Objectives:

The data supplied to the University of Birmingham will be used only for the approved medical research project.

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).


Project 11 — DARS-NIC-148313-G56YY

Opt outs honoured: Yes - patient objections upheld

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/09.

Repeats: Ongoing

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)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Cohort Event Notification Report

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.


Project 12 — DARS-NIC-148379-5VSG8

Opt outs honoured: Y, No - consent provided by participants of research study

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/03.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • 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


Project 13 — DARS-NIC-148380-Q4H3D

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • 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.


Project 14 — DARS-NIC-148425-R38F2

Opt outs honoured: Y, N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2017/02.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Members and Postings 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. "


Project 15 — DARS-NIC-152807-J9T1B

Opt outs honoured: Y

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • 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 16 — DARS-NIC-156412-QY9WM

Opt outs honoured: Y, N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2016/11.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

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


Project 17 — DARS-NIC-178135-HJSFF

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2017/05.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cohort Event Notification Report
  • MRIS - Cause of Death 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


Project 18 — DARS-NIC-230509-D4R8J

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2016/11.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • 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 19 — DARS-NIC-24810-Q6T3B

Opt outs honoured: N

Sensitive: Non Sensitive, and Sensitive

When: 2017/06 — 2018/05.

Repeats: One-Off

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)

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients
  • Hospital Episode Statistics Critical Care
  • Office for National Statistics Mortality Data
  • Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics

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.

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.


Project 20 — DARS-NIC-309500-F4X1B

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

Sensitive: Non Sensitive, and Sensitive

When: 2016/04 (or before) — 2019/04.

Repeats: Ongoing, One-Off

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)

Categories: Identifiable

Datasets:

  • MRIS - Flagging Current Status Report
  • MRIS - Cause of Death Report

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.

Objectives:

This is a follow up study to a 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 we 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.

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). 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.

Outputs:

The original BAFTA trial led to publications in a number of journals, including Lancet, BMJ, and Stroke. The University would anticipate that this analysis would lead to publications in similar high impact journals and are expecting to publish towards the end of the year. 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. All outputs will contain aggregate data only and no data will be shared with a third party. 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.

Processing:

The data will be used to establish who is now deceased and the cause of death. The deceased data will also be used to establish overall mortality rate. The data will be stored in a secure database, no third parties will be accessing it and it will not be made available to anyone outside of the University of Birmingham.


Project 21 — DARS-NIC-324388-L6C2Q

Opt outs honoured: Yes - patient objections upheld (Does not include the flow of confidential data)

Sensitive: Sensitive, and Non Sensitive

When: 2019/02 — 2019/08.

Repeats: One-Off

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

Categories: Anonymised - ICO code compliant

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

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.

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).

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).


Project 22 — DARS-NIC-81519-G1T5F

Opt outs honoured: Y

Sensitive: Sensitive, and Non Sensitive

When: 2017/09 — 2018/02.

Repeats: One-Off

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

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

  • Office for National Statistics Mortality Data (linkable to HES)
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients
  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Critical Care
  • Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics
  • Office for National Statistics Mortality Data

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.

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.