NHS Digital Data Release Register - reformatted

University Of Nottingham

Project 1 — DARS-NIC-148215-CQWFM

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/05. breached contract — audit report.

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:

Does the presence of thrombophilia increase the risk of developing idiopathic pulmonary fibrosis? a) Are defects associated with an increased tendency to clot a risk factor for developing IPF. b) Does the presence of a thrombophillia modify the association of environmental risk factors for IPF? c) Does thrombophillia worsen the prognosis of patients with IPF?


Project 2 — DARS-NIC-148233-2MP49

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/09 — 2018/05. breached contract — audit report.

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
  • MRIS - Personal Demographics Service

Objectives:

The data supplied will be used only for the approved medical research project MR1105 - SNAP (Nicotine replacement therapy in pregnancy)


Project 3 — DARS-NIC-148262-PR6G1

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2016/04 (or before) — 2017/05. breached contract — audit report.

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

Objectives:

The TARDIS trial will assess the safety and efficacy of intensive antiplatelet therapy, as compared with guideline antiplatelet therapy in patients at high-risk of stroke recurrence.The TARDIS trial will assess the safety and efficacy of intensive antiplatelet therapy, as compared with guideline antiplatelet therapy in patients at high-risk of stroke recurrence.


Project 4 — DARS-NIC-160361-NDZKG

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/08. breached contract — audit report.

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 overall aim of this study is to use a prospective cohort study of IPF to validate a panel of published biomarkers and to discover novel candidate biomarkers that can be used in subsequent intervention studies in order to provide proof of mechanism for novel interventions. As such, this is an enabling study which will provide robust biomarkers which can be used in the clinical development of novel therapeutic interventions.


Project 5 — DARS-NIC-376367-M5V9H

Opt outs honoured: Y, N

Sensitive: Non Sensitive

When: 2016/04 (or before) — 2018/05. breached contract — audit report.

Repeats: Ongoing

Legal basis: Health and Social Care Act 2012

Categories: Anonymised - ICO code compliant

Datasets:

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

Benefits:

The results of research undertaken continues to result in new knowledge and understanding regarding disease epidemiology, health inequalities, drug safety, methods of identifying patients at high risk of serious illnesses. Every year new research is published in high impact international research journals such as the British Medical Journal and the British Journal of General Practice. The research is ongoing with target dates for individual projects rather than one overall target date. A complete list of research papers using QResearch database is published at http://www.qresearch.org/SitePages/publications.aspx Research arising for the QResearch database including the linked data has been used to inform national policy. For example, research findings have been included in NICE guidelines on fragility fracture, diabetes, suspected cancer and lipid modification. Research findings have informed the NHS Health Checks programme and Department of Health guidelines on health checks. Examples of ongoing research include assessment of the safety of antidepressant drugs and novel anticoagulants; investigation of potential links between diabetes drugs and cancer; quantification of the risk of thrombosis associated with various types of the oral contraceptive pill.

Outputs:

The outputs are research papers which are published in peer reviewer academic scientific journals and presented at academic conferences. The results tables within the papers will only contain statistical information with cell counts of > 5, being suppressed in line with the ICO code on anonymisation. Outputs will contain aggregate level data with small numbers suppressed in line with the HES analysis guide. No indicators are produced which show performance of an organisation – indeed the identity of the GP practices contributing to QResearch are not shared with any third party.

Processing:

The HES data is linked to the QResearch database at individual patient level using a pseudonymised version of the NHS number which has been supplied in both GP data and the HES data. No strong patient identifiers are received by QResearch as the data is pseudonymised-at-source and at HSCIC. Date of birth is rounded to year of birth The resulting data are then used for undertaking primary research. The linked HES-GP data are not accessible by third party organisations or across multiple locations within the same organisation. The linked HES data is only processed on site on secure servers at the University of Nottingham. Only approved research staff with substantive contracts with the University of Nottingham access the linked HES data. No individual level data will be shared outside the University of Nottingham or supplied to any third party. As described in the section above, the QResearch database is also linked to ONS mortality and cancer registration data. The database was first linked to ONS mortality data in 2007 and ONS cancer data in 2011. The data fields received from ONS mortality data are: pseudonymised NHS number; year of birth, date of death; ICD10 cause of death. The ONS cancer data includes pseudonymised NHS number; sex; year of birth; date of death; diagnosis date; cancer site and type; cancer stage and grade; cancer behaviour; cancer diagnosed only on death certificate; cancer treatment (surgery, hormone, chemotherapy, other) In theory it would be possible to link additional datasets to the QResearch database though this would require consultation with the QResearch advisory board, the ethics committee, the confidentiality advisory group. It would also require amendment to the data sharing agreement with the HSCIC.

Objectives:

The HES data are requested to link to the existing QResearch database so that it can be used for medical research. The HES patient level data linked to QResearch is only accessed by academics employed by University of Nottingham on site at the University of Nottingham. However the researchers involved in a given project (contributing to the research question, design, interpretation and writing of the paper for publication but not handling the data) may be employed by other UK universities. The HES data stays on site at the University of Nottingham and are only handled by University of Nottingham staff. The University of Nottingham may have a collaborator at another university on the project team advising on clinical aspects or interpretation of findings, but they will not receive any data. In addition, the external research may initiate a project but the analysis will be done by University of Nottingham staff with the data located at the University of Nottingham. Only University of Nottingham staff will have access to HES record level data and outside researchers will only have access to tabular outputs. HES record level data are not shared with researchers outside of the University of Nottingham. Small numbers are suppressed in line with the ICO guidance. The QResearch database consists of the coded pseudonymised electronic health records from primary care patients registered with approximately 1,000 general practices spread throughout the UK. The QResearch organisation is a not for profit collaboration between the University of Nottingham and EMIS. The database is widely used for medical research into the causes of disease, its natural history, treatment and outcomes. QResearch was started in 2003 and will continue for the foreseeable future. In addition to coded data from the GP electronic record, the QResearch database also contains the linked cause of death derived from the death certificate data and cancer registration data supplied by the Office of National Statistics following approval by Trent MREC and Secretary of State for Health. The data linkages for QResearch were extended in 2011 to include additional health information from secondary care including HES. The additional HES linked data enables researchers to analyse additional information on patient characteristics, treatment and outcomes which will improve the epidemiological analyses of studies since the data will be more complete. Without the data linkage, for example, research studies may under-estimate the risk and benefits associated with interventions such as prescribed medicines. The QResearch database linked to HES data is used for research to develop and validate risk prediction algorithms such as QRISK2. QRISK2 is a risk prediction algorithm which calculates an individual’s risk of a heart attack or stroke taking account of their individual risk factors such as age, sex, ethnicity, clinical values and diagnoses. The research describing the derivation and validation of QRISK2 has been published in the BMJ (2008). The software implementing QRISK2 is available as open and closed source software. QRISK2 is recommended by NICE as the risk score for use in its guidance on lipid modification (2014). It is also recommended for use in the NHS Health Check. Research undertaken using the extended database continues to be processed using the existing arrangements with respect to scientific review and annual reports to Trent MREC. Research has to be peer reviewed, original, hypothesis driven or hypothesis testing, intended for publication in an academic peer reviewed journal. All research undertaken using the QResearch database and linked data are subject to independent peer review and the results of all research are published. The criteria and process for access to the QResearch database are published on the QResearch website (http://www.qresearch.org/SitePages/Informationforresearchers.aspx). Applications for linked HES data linked to QResearch GP data are restricted to academics employed by University of Nottingham to undertake research. At least one member of the research team must be a medically qualified academic registered with the General Medical Council who signs the guarantee. Eligibility of applications is assessed according to the following criteria. • You agree NOT to attempt to identify patient(s) or practice(s)? • You undertake to provide a copy of the final report of the project and copies of any publications within one year of the project completion? • You agree NOT to release the data to any third party including the funder, sponsor or other such body? • You agree not to use the data for any other project except that which is expressly described in your protocol • Do you have a statistician on the project team who has contributed to the design of the study and will advise on the analysis? • Is the research a benefit to the UK Health and Social care system If an application does not meet these criteria it would mean that application would be rejected and the data would not be shared. For studies requiring access to the QResearch primary care data linked to HES, then the same eligibility criteria are applied. However the linked HES data are not disclosed but remain on the server at the University of Nottingham with analyses undertaken by the core team at the university. Researchers originate a research question or hypothesis; write an outline protocol; and contact QRESEARCH to discuss the feasibility of undertaking the study. If the study is feasible, QRESEARCH will give a broad estimate of the costs of providing the data and will provide a letter to accompany any application for funding. The researcher then secures the necessary funding and completes the QRESEARCH application form, including a detailed protocol and data specification. This application is sent for scientific review and feedback is given to the researcher. The researcher makes any necessary modifications to the protocol and approval is obtained, the researcher is given a timescale for the data extraction. Once the researcher has the data, they have to approve it within one month of receipt.


Project 6 — DARS-NIC-389320-R4M6Z

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/02. breached contract — audit report.

Repeats: One-Off, Ongoing

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

Categories: Identifiable

Datasets:

  • Office for National Statistics Mortality Data
  • Hospital Episode Statistics Admitted Patient Care
  • Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics

Benefits:

The cost of admission and hospital stay for a bleeding peptic ulcer is likely to be approximately £15,000 for the population that will be analysed. Based on calculations for patients participating in the proposed trial (assuming all ultimately undergo eradication treatment) the trial would lead to the projected prevention of 585 hospitalisations at a saving of approximately £5.85 million, and prevention of ~59 deaths, potentially making the trial itself a cost effective therapeutic intervention. Though cost savings in relation to the trial particpants is not the primary purpose of the study, these figures are illustrative of potential savings should the trial results have the expected impact on NHS policy. If the hypothesis of the trial is correct, patients would benefit medically from the study, and the NHS would make significant cost savings. The results would be presented to NICE and other policy makers, who may deem that any patient taking aspirin regularly (25% of over 65 years) should be breath tested, and their H. pylori eradicated if present, as the University of Nottingham believe this will halve the bleeding risk for patients.

Outputs:

The trial will proceed until there are 87 adjudicated cases and will then be analysed to test the hypothesis that H.pylori eradication reduces the incidence of peptic ulcer bleeding. The main primary outputs of the analysis will be scientific papers/posters covering both the medical and procedural aspects of the study. The University of Nottingham intends to publish the results of the HEAT Study in a major scientific journal (such as The Lancet), and will also present details of the study at relevant scientific meetings. For example, the methodology for the study presented at the Digestive Diseases Federation Conference in London in June 2015 and at the United Gastroenterology Week Conference in Barcelona in October 2015. The final results of the study, for which the HSCIC data will be used, will be expected in early 2017 for publication in The Lancet, and these results would be presented at BSG national (and potentially international) meetings. As this study is endpoint-driven, the University of Nottingham require hospitalisation / ulcer bleed data regularly throughout the course of the study, as this will help to determine a more accurate end date, based on event rates. There will also be a report for the funder and sponsor at the end of the trial, which is currently due in September 2017. All outputs from the study would only include aggregated summaries, with small numbers suppressed in line with the HES Analysis Guide and no patient-level identifiable data would be used.

Processing:

Suitable patients identified from GP records are invited to participate. Those who respond are invited to attend a screening visit at their GP practice. Following consent they undergo a brief baseline health assessment and perform a H. pylori breath test. H. pylori positive patients will be randomised to receive eradication treatment or matching placebo. Treatment is dispatched to the patients by post. The trial data are owned by University of Nottingham but managed and held under contract by TCR Nottingham on the HEAT database. The HEAT database is stored on an N3 server within the N3 network based at Nottinghamshire Health Informatics Service (formally King’s Mill Hospital Data Centre). Authorised University of Nottingham staff can access the data via remote access to the server but the data is not removed from the server. TCR Nottingham manages all access permissions which are set on a per-person basis. Only relevant members of the study team would have access to the data provided by HSCIC. TCR Nottingham provides two levels of access to the data for staff at University of Nottingham: (i) the full identifiable data is accessible only to 2 individuals for the purpose of facilitating follow-up contact, and (ii) data stripped of identifiers except for initials and study screening number is assessable to the research team and only this level of data is used in analyses. The practice of retaining initials is to mitigate risks of quality errors arising from transposition errors if using only a study screening number. This is consistent with established operating procedures within the University based on published opinion of what is classed as identifiable data. The methodology has been reviewed by the Ethics Committee and study sponsor with both supporting the approach. The University is satisfied that amongst up to 40,000 patients, the use of initials would not render an individual at risk of reidentification by those accessing the data. All patient follow-up is electronic. Patients make no follow up visits but can notify trial office of any relevant [or indeed irrelevant] events. Follow up data is obtained by interrogation of GP electronic records and by routine linkage via the HSCIC to ONS data on deaths and from HES data. The University of Nottingham will be making several sequential applications for data from the HSCIC to support follow up activities. GP records will be interrogated 6-12-monthly by searching for relevant read codes to identify any hospital admission possibly due to acute GI bleeding, as well as current health and prescribing information. These will be cross-checked against HES. The study uses all routinely available data to detect events. As HES data is transmitted to GPs in the form of a discharge summary, it is likely that the primary hospital data will contain detail that does not appear in the GP record but that is not known. The main purpose in collecting from both sources is to minimise the chance of missing information but a secondary analysis of the trial includes an assessment of whether electronic interrogation of GP practice records is a reliable form of patient follow-up. The trial will not directly link GP records and HES data. At individual patient level, the HES data will be compared with the HEAT database to determine the extent of discrepancies between the detail in the HES data and the data derived from the GP records. The primary endpoint for this trial is a hospitalisation for an ulcer bleed therefore; details of hospitalisation that trial patients experience are required from the HSCIC to ensure that no potential endpoints are missed. Data on hospitalisations will be reviewed and, if it is deemed that a potential endpoint has occurred, then further details will be collected (directly from the source) and the event will be adjudicated by a blinded Adjudication Committee (like the trial subjects and investigators (see above)) members of the committee do not know the identity of each subject’s randomised treatment. The University of Nottingham require all the fields within HES because as part of the secondary analysis of this study, a health economic analysis will be performed comparing many quality of life factors in both arms of the trial (e.g. the cost effective benefit of intervention; length of hospital stay types of services accessed, and other related medical events). For the secondary analysis HES data on all reasons for admissions are required in order to study the impact on other health conditions. To inform the economic analysis it is important to consider the route of admission (elective investigation versus emergency). Data minimisation has been considered and as part of that process, a health economist has reviewed the list of fields available from HES and confirmed which are required.

Objectives:

Helicobacter Eradication Aspirin Trial (HEAT) is a large double-blind (i.e. neither subject nor trialist knows the identity of their randomised treatment), placebo-controlled randomised multi-centre study set in primary care. There are three primary objectives: 1. Medical: To test the hypothesis that a one week course of Helicobacter pylori (H. pylori) eradication in patients using aspirin ≤325mg daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding that results in hospitalisation. 2. Economic: To test the hypothesis that the intervention has a positive net monetary benefit. 3. Methodological: To establish a methodology for large simple outcomes studies using electronically extracted Primary Care follow-up data, to reduce costs to a level that enables outcomes studies of clinically important questions to be done without the need for industry support. The data is required as part of the process of endpoint detection. This is a large ultra-simple trial which attempts to use electronic data sources to capture possible trial endpoints (primary endpoint admission to hospital with peptic ulcer bleeding). Other sources of data will be via electronic scrutiny of GP records, ONS mortality data and patient alerts. Cases deemed to have possibly reached an endpoint will have detailed hospital data collated and an Adjudication Committee will evaluate whether patients have had a definite or probable ulcer bleed using the criteria of the TARGET study. Study patients give permission for subsequent scrutiny of their records and any death certification. GP data are repetitively uploaded to a bespoke database/management system which has also been prepared to detect and store disease and procedure codes from HES. Permissions are also already in place for access to all the major hospitals where the trial is being conducted (Southampton & the South West, London, Nottingham & East Midlands / South Yorkshire, Durham and the North, Oxford and South East, Birmingham and the West Midlands) to allow nurse access to gather information on possible cases.


Project 7 — DARS-NIC-50919-D5R5D

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2017/09 — 2017/11. breached contract — audit report.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care

Benefits:

The National Institute for Health and Care Excellence (NICE) have developed public health guidance on home injury prevention in children: PH29 (unintentional injuries: prevention strategies for under 15s) and PH30 (Unintentional injuries in the home: interventions for under 15s). In these publications NICE recommend that commissioners of health and social care services provide local safety equipment schemes for families most in need (on low incomes and with children under 5). The results from this analysis will inform future updates of this guidance and will provide additional health economic / cost effectiveness data that does not currently exist. This will be achieved by members of the study team sharing the results of the study with the National Accident Prevention Strategy Group which they sit on with Public Health England who are reviewing the child accident prevention guidance, in conjunction with NICE. Members of the study team also sit on the advisory group for this work. This is in addition to usual publication in peer reviewed journals and media engagement when the studies are published. The results will also inform the commissioning of home safety equipment schemes via the direct dissemination methods to CCGs and Local Authorities. This dissemination will happen via the Faculty of Public Health (individuals from the study team are members and will share the findings via special interest groups in child health and injury prevention) and via the Royal Society for the Prevention of Accidents who are part of the study group and have access to a large practitioner audience nationally and internationally. The results may indicate that the scheme is not likely to be effective, in which case NHS and Public Health funding should be used to commission alternative injury prevention programmes that are shown to be effective. If however the study indicates that provision is effective and cost effective it would inform a strong case for local areas to commission schemes in the future. After national funding ended, most areas stopped providing equipment at that time.

Outputs:

The project described in this application will lead to at least two published papers (a 'clinical' effectiveness paper and a cost effectiveness paper) in peer reviewed journals, plus dissemination at the National Society for Academic Primary Care and Safety 2018 world conferences and other professional networks (e.g. via RoSPA). It is anticipated that the papers will be submitted for publication by July 2018 as this is a 12 month study, commencing summer/autumn 2017. Papers will be submitted to British Medical Journal, BMJ Injury Prevention, and Journal of Public Health. There is funding for at least one open access publication which would be free for anyone to read. Research summaries/briefings will be specifically targeted at commissioners within CCGs and Local Authorities who are the most likely to commission population-level safety equipment schemes and work with Public Health England and the National Institute for Health and Care Excellence to disseminate their findings in evidence reviews that they produce. A lay summary of the research will also be produces and, via the communications teams at the universities of Nottingham and Swansea disseminate this to the media and to RoSPA for their dissemination to parents. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guide. Results will be presented at Local Authority and Clinical Commissioning Group level as these are the footprints for current commissioning arrangements for health (NHS), Public Health and Social Care services. It would be aimed at Public Health Consultants, GPs, Commissioners and third sector organisations who may provide equipment on a charitable basis. The study team will work with patient public representatives and the 3rd sector (e.g. The Royal Society for the Prevention of Accidents (RoSPA) and Child Accident Prevention Trust (CAPT) to develop dissemination materials for local authorities and CCGs to help them ensure that commissioned services are designed to maximise injury prevention. The findings will also be used by the applicant to support an NIHR programme grant application in 2018 on the implementation of child injury prevention programmes. The dataset itself used in the analysis will not be made publically available and no analysis tools will be generated.

Processing:

Pseudonymised, non-sensitive record level HES data will be transferred from NHS Digital to the SAIL databank/UK Secure e-Research Platform (UKSeRP) for secure storage, processing and statistical/health economic analysis. The legal basis for this is Section 261(1) of the Health and Social Care Act. The SAIL Databank is now powered by the UK Secure e-Research Platform (UKSeRP), developed by the Health Informatics Group at Swansea University, with support from the Farr Institute of Health Informatics Research funded by Medical Research Council. UKSeRP, a is high powered data management and sharing technology, is infinitely scalable to suit a range of use cases including imaging, genomics and analysis of free text. It benefits from carefully designed Information Governance to ensure person-based data with high privacy risk is managed to the highest standards, and is ISO 27001 certified. The HES data will be merged in SAIL with home safety equipment supply data using Lower Super output area fields in both datasets. PEDW data from Wales, available in SAIL, will be used also to provide some of the control population. The home safety equipment dataset contains no individually identifiable level data. It is non-sensitive scheme activity data supplied by RoSPA to the SAIL databank. There will be no record level linkage and we are not asking NHS Digital to do the aggregated linkage of RoSPA LSOA level data and HES data. There will be no attempts by the study to identify any individual. The primary analysis is a controlled interrupted time series analysis with injury rate data points at Lower Super Output Area (LSOA) level. Because injuries are more common in deprived areas, differ between boys and girls and by child age, control areas will be matched on how rural or urban the area is (using Office for National Statistics classification at LSOA level), deprivation, sex and age profiles. As the scheme was implemented in England only and in households with the lowest income and in areas with the highest injury rates, the study will need to supplement the pool of potential control areas with areas of similar levels of deprivation and injury rates in Wales using the PEDW data (the scheme was not implemented in Wales). Intervention (England) areas will therefore be matched at LSOA level to control areas (England and Wales) on rurality (ONS classification), deprivation, sex and age profiles. The rates of injury-related hospital admission will be compared in the intervention and control areas before, during and after the scheme’s implementation using an interrupted time series analysis. The applicant will undertake a cost-effectiveness analysis, estimating the incremental cost per hospital admission averted and determine if the cost-effectiveness of the scheme varies according to the level of deprivation of the areas it is implemented in. The hypothesis is that provision of home safety equipment prevents injuries in children that require hospitalisation and that the provision is cost effective to the public sector. Data will not be accessible by any parties other than substantive employees of the Swansea University (SAIL databank/UKSeRP) and substantive employees of the University of Nottingham (accessed via remote secure platform connection).

Objectives:

During 2009-2011, the Department for Education funded an £18 million scheme in England to provide safety education and equipment to the poorest families with children under 5. The scheme (Safe At Home) was overseen by the Royal Society for the Prevention of Accidents (RoSPA) and led by local authorities. It included the provision of equipment such as stair gates, fire guards and cupboard locks to over 66,000 families. To date, the effectiveness of this scheme in preventing child injuries from occurring has not been analysed on a national scale. The aim of the study is to determine if the Safe at Home scheme was associated with the following in children under age 5: 1) a reduction in hospital admissions due to unintentional injuries of any type likely to have occurred within the home 2) a reduction in hospital admissions due to unintentional injuries likely to have occurred within the home that could plausibly be prevented by the equipment provided by the scheme (e.g. falls down stairs, fire burns, poisoning) The study will also determine if the scheme: 1) was cost-effective as delivered (targeted at the most deprived areas) and 2) would be cost-effective if implemented in ‘lower risk’ populations e.g. those with lower baseline injury incidence or residing in more affluent areas The HES data will be transferred in full, by NHS Digital, to the SAIL databank/UK SeRP at the Swansea University, where data will be processed and analysed. The HES data will be merged with home safety equipment supply data using Lower Super output area fields in both datasets. PEDW data from Wales, available in SAIL, will be used also to provide some of the control population. Access to the HES/PEDW/equipment supply data by researchers at the University of Nottingham will be via the secure platform connection to SAIL databank/UK SeRP. Results will only contain aggregated data with small numbers suppressed in line with the HES analysis guide. The analysis will be undertaken at Lower Super Output Area (LSOA) level and results we be presented at LSOA, Clinical Commissioning Group (CCG) and Local Authority level. This is because CCGs and Local Authorities (Public Health and Social Care) commission health and social care interventions and so the results will need to be presented in a way that is relevant to them. Outputs will be reported in peer-reviewed academic journals and then disseminated further through professional publications, conferences and public dissemination routes. The number of years of data requested is from 2003/4 to 2015/16. This number of years will provide adequate study power and achieve a sample size of 72 time points recorded on each lower super-output area; that is 6 times per year for the 5.25 years prior to the intervention, 2 years during the intervention delivery and 4.75 years after the intervention between January 2004 to December 2015. This sample provides at least 85% power to detect an effect size of 0.5 for autocorrelations up to values of 0.5. The data fields requested are restricted to those that are specific to the analysis that will be undertaken, with the primary outcome of injury admission rates in the intervention versus the control areas. The data requested is only the episode where age at start of the episode is under the age of five. The HES data from NHS Digital will enhance what the applicant knows about the effectiveness of this type of scheme. Until now effectiveness of home safety equipment provision has only been assessed at the local level (e.g. local evaluations) and as such, there is no robust effectiveness and cost effectiveness data. The National Institute for Health and Care Excellence, NICE, currently recommend that local areas commission home safety equipment provision schemes for families with young children and on the lowest income levels, based on local evaluation data. The results may therefore inform future NICE guidance, depending on the outcome of the analyses. None of the work will take place outside of England and Wales. These data will not be used for commercial purposes. Data will not be provided, at record level, to any third parties and will not be used for direct marketing. HES data from NHS digital will only be used for the purposes stated within this agreement.