NHS Digital Data Release Register - reformatted

University Of Birmingham

Project 1 — DARS-NIC-147797-45YHZ

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/05.

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

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 2 — DARS-NIC-147805-HDHWM

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/12 — 2018/05.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

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

Objectives:

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


Project 3 — 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 4 — DARS-NIC-147927-8K193

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 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
  • 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 5 — DARS-NIC-147932-B9FG1

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/05.

Repeats: Ongoing

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

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 6 — 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 7 — DARS-NIC-148121-LZNC5

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/02.

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

Objectives:

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


Project 8 — DARS-NIC-148286-3RWRG

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/05.

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

Categories: Identifiable

Datasets:

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

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).

Objectives:

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


Project 9 — DARS-NIC-148313-G56YY

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/05.

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

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 10 — DARS-NIC-148379-5VSG8

Opt outs honoured: Y, N

Sensitive: Sensitive

When: 2016/04 (or before) — 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
  • 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 11 — 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 12 — 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 13 — 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 14 — 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 15 — 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 16 — 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 17 — 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

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.

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.


Project 18 — DARS-NIC-309500-F4X1B

Opt outs honoured: N

Sensitive: Non Sensitive, and 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 - Flagging Current Status Report
  • MRIS - Cause of Death Report

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.

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.


Project 19 — 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

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.

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.