NHS Digital Data Release Register - reformatted

Barts Health NHS Trust

Project 1 — DARS-NIC-07205-H2D1K

Opt outs honoured: Y, N

Sensitive: Sensitive

When: 2016/12 — 2017/02.

Repeats: Ongoing

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)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report

Objectives:

1. To establish whether women who should have been recalled for breast screening and were not, have died from breast cancer, possibly resulting from inappropriate ceasing of screening. 2. To establish whether any women who are recorded as having died are in fact still alive and not being offered breast screening and are at risk of an undetected cancer progressing. Following the identification of an SUI in 2011 relating to the incorrect removal (‘inappropriate ‘ceasing’) of a woman from the breast screening programme by the Central and East London Breast Screening Service (CELBSS) it was agreed that an audit should be undertaken of all women with a ‘ceased’ status for breast screening within the Central and East London Breast Screening Service and related Exeter databases. The total number of women in the audit was 2299. That audit has been completed, with the exception of those women recorded as being deceased, a number of whom were ceased from the programme before their death. 1019 were recorded as deceased by the breast screening programme. Barts are seeking more information on that cohort, to confirm they have deceased and whether they died of breast cancer. Barts will provide the complete details of those women to HSCIC. Once Central East London Breast Screening Service receive the data set from HSCIC, it will pseudonymised (Pseudo-ID, fact and cause of death) and pass it to PHAST to produce a dataset specifying those who died, those who died of breast cancer and those still alive. PHAST is a not-for-profit consultancy and they have identified a clinician and an analyst who have honorary contracts with Barts Health and will only view anonymised data within the location specified in this agreement. Once Central East London Breast Screening Service has completed the audit the data will be disposed of appropriately. The legal basis for the data in the cohort is covered under direct care pathway due to the clinical relationship that Barts have with the patients.

Expected Benefits:

The avoidance of harm to women who should have been offered breast screening, but remain outside the programme. These women could be offered screening as soon as they are identified with the data provided. Establishing whether significant harm resulted from the incorrect removal from the programme, such that women had an undetected cancer which killed them. Not only is this important information for the service, patient’s families have a right to know. There will be no commercial benefits from this work. It is not research and will not be published in a scientific journal.

Outputs:

Barts will receive from PHAST a database that will include pseudo ids and the categories the patients fall into. For those patient still alive, the data will be re-identified to ensure screening is taking place. Given the time that has elapsed seeking these data, the sooner the better to minimise the chance of continuing harm to patients.

Processing:

Barts NHS Trust to provide a cohort of patients through to the HSCIC where the HSCIC will provide back patient status from the ONS Mortality database matching only to those persons who are in the originally supplied cohort.


Project 2 — DARS-NIC-151212-B5Z3R

Opt outs honoured: Y

Sensitive: Non Sensitive, and Sensitive

When: 2018/03 — 2018/05.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012, 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: Anonymised - ICO code compliant, Identifiable

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Office for National Statistics Mortality Data

Objectives:

The National Institute for Cardiovascular Outcomes Research (NICOR) hosted at Barts Health NHS Trust require HES Admitted Patient Care and ONS Mortality data for use in an audit of patients who have undergone one of three procedures. Percutaneous mitral valve leaflet repair for mitral regurgitation using MitraClip; Left Atrial Appendage Occlusion (LAAO); and Patent Foramen Ovale Closure (PFOC) procedures. Previous service provision has been unstructured and delivered by providers who had attempted to establish services through negotiation with local specialised commissioners. In April 2013, NHS England became responsible for directly commissioning specialised services and published a clinical commissioning policy statement which stated that percutaneous mitral valve leaflet repair for mitral regurgitation using MitraClip, LAAO and PFOC procedures would not be routinely funded as the current evidence base had been of insufficient quality. NHS England developed ‘Commissioning through Evaluation’ (CtE) to support the commissioning of clinical activity around an evaluation programme to add to the current evidence base for designated technologies. The overall aim was to provide a clinical and economic evaluation of the MitraClip and the other two procedures. Funding was provided for a limited number of high risk patients as determined by an appropriately constituted Multi-disciplinary Team (MDT) process. Prior to 2013 service provision was unstructured and delivered by providers who attempted to establish services through negotiation with local specialised commissioners. The majority of procedures were commissioned through individual funding requests or by individual Trusts funding treatments by other means. In April 2013 NHS England became responsible for commissioning specialised services. However as the evidence base for percutaneous mitral valve leaflet repair for mitral regurgitation using MitraClip, LAAO and PFOC procedures was of insufficient quality the procedures were not to be routinely funded. Because of the remit of NICE in terms of developing evidence based guidance NHSE, the principal funder, commissioned NICE to establish the ‘Commissioning through Evaluation’ (CTE) programme in order to gather further evidence to support commissioning of designated technologies. The overall aim was to develop a model for both clinical and economic evaluation of the three procedures which could be used in future for other similar new health technology procedures. NICE contracted with the Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH) which hosts one of the NICE External Assessment Centres (EAC) with the task of establishing this programme. The NUTH EAC houses a team of scientists, economists and engineers, who provide an independent assessment of evidence for innovative medical devices and associated economic analysis. The team are substantive employees of NUTH. With its extensive experience and excellent reputation in conducting national cardiovascular audits and registries, the National Institute for Cardiovascular Outcomes Research (NICOR) was commissioned by NUTH to develop, host and maintain the three cardiovascular registries. NICOR are acting as sole data controller for the CtE datasets because these datasets contain variables over and above those needed for the NUTH purposes, which might be of interest to other applicants for the audit data. The NUTH/NICE would not be expected to have to be part of the approvals process for such applications, should they occur. The national CtE Steering Group and a number of Working Groups were established to define the datasets. The Working Groups deemed that the datasets should be designed to answer as many questions as was felt clinically and administratively relevant for the purposes of evaluating the technology in more detail. The datasets were approved by the Working Groups and the Steering Group. As well as determining the datasets and defining the audit questions, NICOR is also responsible for managing all aspects of the data collection process, data security, data storage, cleaning/validation of data, data linkage with ONS/HES and reporting. The reporting function includes providing pseudonymised data extracts to NUTH as per its requirements, receiving all variables needed for the purposes of the agreed independent analyses. A key deliverable of this contract is to provide NUTH with a pseudonymised linked clinical PFOC, MitraClip and LAAO raw data with ONS and HES data extract. ONS and HES linked data are required from NHS Digital to allow analysis of future clinical events rates after the initial treatment (principally rates of strokes/cerebrovascular events and death). The work aims to gather more data on the safety and effectiveness of three complex cardiology procedures which are not currently routinely funded by the NHS, but nonetheless may show significant promise as a future treatment. The data gathered from centres undertaking these procedures is to be analysed to inform future commissioning intentions. This is not an experimental research project, but an evaluation of service delivery. There is no specific hypothesis being tested. NICOR have defined 11 specific questions to frame the CtE evaluation programme: 1) Can UK clinical teams undertaking MitraClip reproduce the reduction in mitral regurgitation seen in the early clinical trials? 2) Is reduction in mitral regurgitation mediated by MitraClip associated with improvements in quality of life? 3) Does MitraClip improve survival rates? 4) Does MitraClip reduce the frequency of subsequent hospital admissions? 5) Are the early benefits in reduction in mitral regurgitation maintained in the medium-term? Is there a need for repeat treatment over time (either by a repeat percutaneous procedure or surgery)? 6) What proportion of patients referred to a specialist Mitraclip service as defined in the CtE documents were assessed by the MDT as suitable for the intervention? What proportion of the patients considered suitable for the procedures received it and what proportion of them benefited? 7) What are the short and medium term risk of complications from MitraClip use? 8) Are clinical outcomes with MitraClip associated with particular patient characteristics (clinical or demographic)? 9) What are the full procedural costs of using MitraClip to the NHS? 10) What costs savings might occur in the NHS as a result of MitraClipTM therapy? 11) Is MitraClip cost-effective from the perspective of the NHS? It is intended that the data reported from the registries will be used to part inform an update of IPG 309 (The NICE Interventional Procedures Guidance on MitraClip), which will be reviewed by NICE, in light of the CtE registry findings. Separately, NHS England Commissioning Policies for all 3 cardiac procedures will also be reviewed, with a view to future patient access to these treatments.

Expected Benefits:

There are a number of expected benefits: 1) The ability to look at cardiovascular admissions which may be related to, and affected by, the medical management of a patient’s condition. This will provide a much more detailed and complete picture of readmissions, and help determine the full impact of the original treatment on readmission rates and mortality outcomes. 2) The ability to evaluate readmission rates and reasons for readmission will be extremely beneficial to commissioners, healthcare economists and regulatory bodies such as NICE in terms of assessing the long term effects on patients undergoing the various cardiac procedures. It will allow assessment of the effect of different variables on these outcomes and the assessment of the total burden of care, thereby aiding an analysis of cost effectiveness. 3) To provide additional insight into outcomes (especially adverse reactions such as stroke) which Barts Health (NICOR)/NUTH can then include in any reports used to inform quality improvement work/evaluation of new health technology. Linkage to the HES dataset would allow further exploration of the geographic, socio-economic and organisational data of patients in much more detail. This may lead to a better understanding of commissioning patterns within the UK. In addition, the HES dataset collects information on augmented care and the patient care pathway. 4) To identify relevant safety and efficacy outcomes that were not known to the clinicians undertaking the procedures in the tertiary centres because the relevant episodes of care took place in other hospitals. Should these treatments become routinely commissioned, these types of outputs will be useful for future reports derived from data collected by NICOR. The NUTH will perform an updated literature review and analysis of the clinical data and will provide a report to NHS England aimed at answering the specific service evaluation questions. The answer to some of these questions is dependent on the ONS and HES linked data. At present, for LAAO and PFOC, two reports have been submitted to NHS England using registry data alone, describing patient outcomes such as mortality and post-procedure neurological events, which have been reported by the centres following up their patients. The MitraClip report will be submitted to NHS England in February 2018 and will describe patient outcomes such as mortality and post-procedure events requiring hospital readmission. At present, this too will contain registry data alone. However, ONS and HES data, linked to each registry, are vital to: (i) confirm that all deaths and post-procedure hospital readmissions (for neurological / cardiac events) have been captured in the registry. NICOR do not have 100% follow up of CtE cases - so do not know if there is missing information for many patients post-procedure. (ii) where additional events are identified in ONS and HES, the combination of registry-reported outcomes and ONS / HES recorded outcomes will validate the mortality rates and efficacy measures (stroke prevention rates and cardiac outcomes) of these 3 procedures and provide more robust data to NHS England. These data will directly inform NHS England's commissioning policy decision-making, which will determine patient access to these procedures in future. NHS England has scheduled the review of all 3 procedures as part of their annual commissioning round and has funded these CtE procedures (2014-2017) to obtain "real world" data on outcomes for patients treated in the NHS setting. The review of the initial NHS experience with these treatments aligned to an updated review of the world literature will enable NHS England Specialised Commissioning to update its commissioning policies regarding the use of the MitraClip, LAAO and PFOC procedures.

Outputs:

Aggregate data with small numbers suppressed in line with the HES Analysis Guide which has been derived from the data in this application will be contained within reports published in 2018. These reports are presented to NICE and NHS England. They may also be made available to other stakeholders. The reported data may also be visualised in various formats on-line, as relevant to the stakeholders. No record level data or patient identifiable data will be released in any report. The publication date for these outputs is early 2018. (Results from authorised work may also be subsequently published in peer-reviewed journals). NICOR already receive data under DARS-NIC-359940-W1R7B to complete six national cardiovascular audits. Specific outputs from that agreement include: 1) Making the comparisons of disease/treatment outcome by hospital as well as any relevant comparisons between journeys of care. 2) Adjust the analysis used for 1 (above) to ensure that 'risk' is taken correctly into account. 3) As part of the registry dataset, national data is added on the treatment/disease the researcher is interested in to ensure that they have data for all patients. 4) Analysis is also provided directly to NICE to enable them to make a decision as the whether the device/treatment should be included in national guidelines. It is hoped that similar outputs will be achieved with the data requested in this agreement. Please note that the data under this agreement NIC-151212 will not be linked to the NHS Digital data held under other agreements. NICOR provides monthly reports to NUTH. The primary purpose of the ONS/HES linked data is to inform the CtE programme. All published reports are made available on the NICOR website. This only happens once the funder has reviewed and approved the report for publication. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

Through a specifically designed database, NICOR receives patient identifiable data collected by NHS Hospital Trusts about patients who have had a Mitraclip, LAAO and PFOC together with data about the treatment itself and outcomes both to hospital discharge and during predetermined follow-up periods. From the agreed dataset, those fields needed to answer the specific evaluation questions are provided to the NUTH. No patient identifiable data is shared with NUTH. The datasets for the three registries are available on the NICOR website. NICOR will send the following identifiers to NHS Digital for NHS Digital to provide NICOR with linked ONS mortality and HES data: Member Number Name (both forename & surname) Postcode NHS Number Gender Date of Birth This data is then linked to HES Admitted Patient Care data. HES APC data will be used to evaluate frequency and duration of re-admissions and pre-admissions for patients recorded in the above mentioned registries. The OPCS4 and ICD10 codes are requested for each linked patient. These will be used to search for any episodes of stroke/cardiovascular event, postcardiac CtE procedure etc. and also linked to HES ONS data to find out if any of the cohort has died. ONS data will be used, firstly, to identify patients who have died out of hospital, or in between follow-up appointments, where their deaths may not be known by their treating centre (therefore missing from the registry follow up data). This will validate the mortality rate found using registry data alone. Secondly, to confirm registered cause of death and determine whether this is of neurological or cardiac origin. This will allow the study to determine how many of the deaths in these patients may be attributed to failure of the procedure, or another cause. The ONS/HES linked data (returned to NICOR). Member number is the only identifiable data returned. The senior developer will then re-link the member number to the identifiers. Once the initial analysis has taken place, all identifiers are stripped from the data. All data are securely stored on a departmental shared drive, which is restricted to staff working on the project. The nominated staff (substantive employees of NICOR) have varying levels of permissions to view and access the data depending on their position and involvement. The ONS/HES linked data transferred from NICOR to NUTH contains no patient identifiers and will be stored securely within the NUTH network which has access protected in accordance with the NUTH ‘Network Security & Access Control Policy’. Access to the data will be restricted to authorised staff working on the project. The York Health Economics Consortium (YHEC) is not involved in any data processing - they will only receive aggregated (in line with the HES analyses guide) outputs of the analyses from NUTH such as mortality rates and hospital readmission rates, to be used as inputs to their economic modelling work for NHS England. 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). All processing of ONS data will be in line with ONS standard conditions.


Project 3 — DARS-NIC-226652-N1G2N

Opt outs honoured: Y

Sensitive: Non Sensitive, and Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

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)

Categories: Identifiable

Datasets:

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

Objectives:

1. To establish whether women who should have been invited for breast screening and were not, have died from breast cancer, possibly resulting from inappropriate ceasing of screening. 2. To establish whether any women who are recorded as having died are in fact still alive and not being offered breast screening and are at risk of an undetected cancer progressing. Background Following the identification of an SUI in 2011 relating to the incorrect removal (‘inappropriate ‘ceasing’) of a woman from the breast screening programme by the Central and East London Breast Screening Service (CELBSS) it was agreed that an audit should be undertaken of all women with a ‘ceased’ status for breast screening within the Central and East London Breast Screening Service and related Exeter databases. The total number of women in the audit was 2299. That audit has been completed, with the exception of those women recorded as being deceased, a number of whom were ceased from the programme before their death. 1019 were recorded as deceased by the breast screening programme. We are seeking more information on that cohort, to confirm they have deceased and whether they died of breast cancer. We can provide the complete details of those women to HSIC.

Expected Benefits:

The avoidance of harm to women who should have been offered breast screening, but remain outside the programme. These women could be offered screening as soon as they are identified with the data provided. Establishing whether significant harm resulted from the incorrect removal from the programme, such that women had an undetected cancer which killed them. Not only is this important information for the service, patient’s families have a right to know. There will be no commercial benefits from this work. It is not research and will not be published in a scientific journal.

Outputs:

A dataset providing name, date of death, and cause of death if it was breast cancer. Given the time that has elapsed seeking these data, the sooner the better to minimise the chance of continuing harm to patients.

Processing:

Once we receive the data set, we will anonymise it and pass it to PHAST to produce a dataset identifying those who died and date of death, of those, those who died of breast cancer and date of death and those still alive. PHAST is a not-for-profit consultancy and they have identified a clinician and an analyst who have honorary contracts with Barts Health and will only view anonymised data. Once we have completed the audit the data will be disposed of appropriately.


Project 4 — DARS-NIC-291938-R6V3V

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

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2019/03.

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 - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Flagging Current Status Report
  • MRIS - Members and Postings Report

Yielded Benefits:

The DARE study has contributed to the recruitment of over 25 ethically approved NIHR portfolio studies to date and has involved the participation of over 2,200 people registered on the database. These studies are aimed at either finding a cure for diabetes or improving health of those with diabetes. Having this database has accelerated the research process and provided evidence which has improved health care provision. For example, the team recently searched for a study called REVITA-2. This study for over weight people with type 2 diabetes (T2D) is trialling a new investigative procedure in the small intestine (duodenum). The study is designed to safely alter the inner surface of the duodenum to improve control of blood sugar. The study was very difficult to recruit to. Using DARE the Team were able to identify nearly 200 people meeting the criteria with 5% of these going on to be screened into the study. The benefit for DARE members is that they have access to some of the latest research studies which they may be interested in. The yielded benefit to the company is that they will now be undertaking another study - REVITA -3 which will improve the health of many others with T2D. In another completely different study DARE members were also contacted about a questionnaire - the Diabetes Essential Care Study - which asked their opinion about Diabetes Care provision in primary care. So far nearly 2000 people have responded and presentations have been made on preliminary findings to the study steering committee. The next yielded benefit is to make reports to local CCGs on the findings which could have a beneficial affect on service provision. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Objectives:

The aim of this study is to establish an epidemiologically based sample of all patients with diabetes within the regions included in the Diabetes Research Network (DRN). By collecting the same non-invasive samples as per clinical care it will be possible to perform tests to look for markers of the complications of diabetes. DNA will be taken from all consenting patients and molecular and genetic information will be combined with clinical information to provide a resource to look for gene/environment interaction in the development of Type 1, Type 2 and other forms of diabetes and their associated complications. Data access is restricted to those named in section 7 of this agreement. Any changes will be notified to the HSCIC.

Expected Benefits:

The expected benefit of the DARE database is that study team can continue to offer people registered the opportunity to take part in diabetes research. Recruitment is sometimes a difficult aspect of any research and can be costly in terms of searching and advertising. Studies using the database can expect to have an increased chance of recruiting more efficiently and quickly. This speeds up the evidence gained from the research and may lead to prompt changes in treatment and care, improving self management etc. The indirect expected benefit of being on the DARE database is that many members are likely to attend outreach events organised by the study team and have access to new information about their diabetes which in turn improves health and well being for people with diabetes.

Outputs:

The main output is an up-to-date database for the DARE study which means that the study team can contact their members about research opportunities when they become available. They will also be holding a series of public engagement events with researchers and clinicians. The first such event was on 13th November 2018 where they invited people from the database to listen to presentations on diabetes research which they may be interested in. The event was also attended by the charity Diabetes UK and latest information on diabetes and self management was distributed. Members were also allowed to vote on future presentations and make recommendations. The day was highly evaluated and a report was sent to all invited members. The study team also have a twitter account to promote such events. Another large event is being planned in the autumn of 2019. The study team also intend to email and post a twice yearly newsletter giving latest information on diabetes research and other relevant material to members. The first newsletter is anticipated to be in Spring 2019. It is the study team's intention to submit abstracts and presentations for relevant diabetes professional conferences e.g. Diabetes UK and International Diabetes Federation and publish our findings in appropriate journals e.g. Diabetic Medicine. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

No contact will be made with any individual(s) who could be identified from the information supplied, other than as specified in the protocol and associated documents. Use of the data supplied is for the sole purpose set out above. The Data must not be shared with any other organisation or named individual not explicitly referred to within this agreement. If the information referred to herein is subject to an FOI or other request to share the Data, then agreement from the HSCIC must be sought before undertaking this. The Dataset must not be shared with any third party in the format in which it is provided to you by the HSCIC. Information tools derived from this Dataset will not be provided to any organisations without the specific consent of the HSCIC. Any publications derived from this Data by any party must be subject to ONS confidentiality guidance on the release of birth and death and Health Statistics: The National Statistician sets standards for protecting confidentiality, including a guarantee that no statistics will be produced that are likely to identify an individual unless specifically agreed with them, where the guarantee is judged against the standard that ‘it would take a disproportionate amount of time, effort and expertise for an intruder to identify a statistical unit to others, or to reveal information about that unit which is not already I the public domain.’ Specifically, undertake to ensure that appropriate controls are in place, to ensure compliance with the HSCIC’s, Small Numbers Special Terms and Conditions. Such controls will, as a minimum, meet the requirements of condition 3.3 of the Small Numbers Special Terms and Conditions and more generally satisfy Section 5 of the ONS confidentiality guidance.