NHS Digital Data Release Register - reformatted

University Of Bristol

Project 1 — DARS-NIC-119910-K6W9Q

Opt outs honoured: N

Sensitive: Non Sensitive, and Sensitive

When: 2017/09 — 2018/05. breached contract — audit report.

Repeats: One-Off, Ongoing

Legal basis: Health and Social Care Act 2012, Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Anonymised - ICO code compliant, Identifiable

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Outpatients
  • Diagnostic Imaging Dataset
  • Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

Benefits:

The main outcomes of the trial are the effectiveness of Prostate Specific Antigen (PSA) testing in reducing prostate cancer mortality, and its cost-effectiveness (i.e. comparing the health-related costs in the two groups in combination with the effectiveness of PSA testing, in order to assist policy makers in their decisions about how to achieve the best use of resources). The expected measurable benefits to health arise from the ability of these data to allow an unbiased comparison between men screened for prostate cancer and those not screened. The data generated will provide both clinical and policy relevant data on one of the most controversial issues in health care nationally and internationally: the potential benefits, harms and costs to the UK population of screening for prostate cancer. Research from the University of Bristol led to the Department of Health decision in 1997 that screening for prostate cancer would not be introduced in the UK until there was evidence that benefits outweighed harms. University of Bristol led and collaborative research subsequently provided evidence to support informed decision-making in the NHS. A formal review by DH in 2010 endorsed the policy and confirmed that any change would be based on evidence from the team’s randomised trials. This research has ensured UK men have avoided known harms of prostate cancer screening in the context of uncertain benefits, and saved the UK economy. The median 10 years follow-up will be reached in 2016 and it is anticipated that the first publication will report these results as soon as possible following this, the University would nevertheless wish to apply for additional funding for longer term follow–up. The dataset already held by SAIL has been used to develop the STATA do files, and confirmed the feasibility of extracting unbiased health-related costs for comparison across the two groups.

Outputs:

CAP plan to publish median 10 year results in The New England Journal of Medicine (NEJM) or The Journal of the American Medical Association (JAMA). A statistical analysis plan detailing the analyses that will be included in the publications has been uploaded onto the University of Bristol research information repository (http://hdl.handle.net/1983/6d41509f-ab93-4f96-9869-c320acbc4ae1). Statistics involved in these papers usually refer to measures such as rate ratios and 95% confidence intervals rather than actual numbers of cases. CAP will follow ONS non-disclosure rules for small numbers of cases and will not include any counts of less than 5 in a Table. As stated above the median 10 years follow-up will be reached in 2016, the applicant would nevertheless wish to apply for additional funding for longer term follow–up. As stated above the primary outcome is reached at a median 10 years follow up in 2016 there are however a number of recent publications directly related to the study, listed below: Williams NJ, Hill EM, Ng SY, Martin RM, Metcalfe C, Donovan JL, Evans S, Hughes LJ, Davies CF, Hamdy FC, Neal DE, Turner EL, for the CAP Cause of Death Committee. Standardisation of information submitted to an endpoint committee for cause of death assignment in a cancer screening trial – lessons learnt from CAP (Cluster randomised triAl of PSA testing for Prostate cancer). BMC Medical Research Methodology (2015) 15:6 (doi:10.1186/1471-2288-15-6) Turner EL, Metcalfe C, Donovan JL, Noble S, Sterne JAC, Lane A, Avery K, Down L, Walsh E, Davis M, Ben-Shlomo Y, Oliver S, Evans S, Brindle P, Williams N, Hughes LJ, Hill E, Davies C, Ng SY, Neal DE, Hamdy FC, Martin RM. Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP). British Journal of Cancer (2014) 110; 2829-36 (doi: 10.1038/bjc.2014.242) Lane JA, Donovan JL, Davis M, Walsh E, Dedman D, Down L, Turner EL, Mason MD, Metcalfe C, Peters TJ, Martin RM, Neal DE, Hamdy FC, for the ProtecT study group. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncology (2014) 15: 1109-18 (http://dx.doi.org/10.1016/ S1470-2045(14)70361-4) Hill EM, Turner EL, Martin RM & Donovan JL. "Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study. BMC Medical Research Methodology (2013) 13:72 (doi: 10.1186/1471-2288-13-72) Williams NJ, Hughes LJ, Turner EL, Donovan JL, Hamdy FC, Neal DE, Martin RM, Metcalfe C. Prostate-specific antigen testing rates remain low in UK general practice: A cross-sectional study in six English cities. British Journal of Urology International (2011) 108:9; 1402-08 (doi:10.1111/j.1464-410X.2011.10163.x) Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL. Latest results from the UK trials evaluating prostate cancer screening and treatment: The CAP and ProtecT studies. European Journal of Cancer (2010) 46; 3095-3101 (doi:10.1016/j.ejca.2010.09.016) Outputs will also be fed directly to funders, Cancer Research UK and Department of Health. Other appropriate bodies such as NICE or the Cochrane Centre will also be informed. The papers will be available on the University of Bristol PURE pages https://research-information.bris.ac.uk/ - these publications are available to download with open access allowing anyone to access publications. We also publish with open access rights when submitting to journals, ensuring we maintain CRUKs publication ethos of ensuring research funded by them is available to all. Publications are also uploaded to 'researchfish' allowing the research community to clearly see what has been published.

Processing:

In this renewal request, the linked HES data would be accessible to investigators at the University of Bristol in the form of a pseudonymised dataset housed at the Secure Anonymised Information Linkage (SAIL) Databank. This means that it is totally separate to the identifiable data and can never be linked to it. Processing steps - 1.NHS Digital will utilise the identifier (unique study ID) for MR738A and link these data from the HES dataset held at NHS Digital. The HES data extract and unique study ID for the cohort will be sent to SAIL by NHS Digital. 2.The applicant will transfer a study ID and the following primary and secondary mortality outcome variables to SAIL: month and year of birth; date of prostate cancer diagnosis; prostate cancer stage and grade, if present; month and year of death, if deceased; prostate cancer attributed death, if deceased; date of censor, if no longer in follow up; month and year of censor. 3.SAIL will then link these data to the HES extract from NHS Digital. SAIL will also encrypt the unique study ID to create a unique pseudo anonymised ID number for each individual, area identifiers will also be pseudonymised HES data will be used to identify all inpatient and outpatient resources used by men in CAP. Costs will be assigned to the identified events and used alongside the linked outcome data to conduct the CAP cost-effectiveness analysis from the perspective of the UK NHS (secondary care). This dataset will be remotely accessed from Bristol for analysis and only aggregated results tables (verified by SAIL to be unidentifiable) would be extracted from the dataset. Only individuals substantively employed by the University of Bristol will have access to the data. All processing of ONS data will be in line with standard ONS terms and conditions. All outputs will be restricted to aggregate data with small numbers suppressed in line with the HES Analysis Guide. The funding organisation, CRUK, has confirmed in writing that it agrees that no NHS Digital data will be shared with it or with 3rd parties, and that in the unlikely event that they would wish to share the data they would direct any request through NHS Digital.

Objectives:

Cluster randomised trial of testing for Prostate cancer (CAP) is a pragmatic, cluster Randomised Clinical Trial (RCT) that compares an invitation to attend for population-based Prostate Specific Antigen (PSA)-testing for prostate cancer (intervention arm) with standard NHS care (control arm) amongst men aged 50 to 69 years registered with GP practices in eight centres in England and Wales. Recruitment to the DH/CRUK-funded CAP trial was completed in 2009 and it is currently in the follow-up phase. Over 415,000 men are being followed-up for incident and fatal prostate cancer via NHS Digital. Where cost implications of any national screening programme are considerable, and where survival is relatively good whatever form of management is adopted, it is essential to incorporate analysis of cost-effectiveness. To obtain timely and comprehensive UK-wide coverage to estimate the cost effectiveness of prostate cancer screening in the UK CAP are applying for permission to perform record linkage for all 415,000 men in the CAP trial with NHS Digital for the provision of resource use information.


Project 2 — DARS-NIC-147773-9G6ZN

Opt outs honoured: Y, N

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/11. breached contract — audit report.

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 - Members and Postings Report
  • MRIS - Flagging Current Status Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Bespoke
  • MRIS - Personal Demographics Service

Objectives:

The purpose of the proposed research is to evaluate the effectiveness and cost-effectiveness of population-based screening for prostate cancer. This study will allow an unbiased comparison between men screened for prostate cancer and those not screened. The data generated will provide policy relevant data for one of the most controversial issues in health care: the potential impact on the UK population of screening for prostate cancer


Project 3 — DARS-NIC-147806-M11MB

Opt outs honoured: Y, N

Sensitive: Sensitive

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

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
  • MRIS - Bespoke
  • MRIS - Scottish NHS / Registration

Benefits:

Research in the UK and elsewhere has repeatedly shown that drug users have an increased risk of death immediately following release from prison, most commonly due to overdose after loss of a previous tolerance to opiates. The IDTS aims to provide a more integrated and comprehensive system of treatment for drug users. A significant aspect of this has been the increased use of OST in prisons, the aims of which are to lessen the likelihood of illegal drug use in prison, opiate related overdose upon release, and disengagement from community services upon release. We have been funded by the English Department of Health and the Ministry of Justice to evaluate the effectiveness of this aspect of the IDTS.

Outputs:

Data will be collected from various databases one year after recruitment and again at ten years, and linked to the participant identifying information. Mortality data provided by the MRIS is crucial, a comparison of short-term mortality rates between cases and control participants being our primary outcome. This mortality data will be modelled using multivariable regressions, adjusting for baseline covariates available to us from the Drug Intervention Record (DIR), completed on entry to prison. In addition, we will examine the prevalence of different causes of death within prison or in the first year after prison release. As such, we also require information on causes of deaths from the MRIS. Our other analyses will rely on data from other sources, including the Police National Computer (PNC) and National Drug Treatment Monitoring System (NDTMS). Of particular interest in addition to mortality is a comparison of re-conviction rates / time to re-conviction between cases and controls and also of rates of engagement with community drug services.

Processing:

We aim to recruit a total of 20,000 adult opiate dependent participants from 42 prisons in England, over a period of 13 months: 10,000 cases released from prison opiate tolerant due to Opiate Substitution Therapy (OST) and 10,000 controls released from prison detoxified. Each prisoner entering a participating prison who is triaged as being opiate dependent will be invited to participate in the study by a member of the prison’s Health Care or Psychosocial team. Once a prisoner signs the study consent form or refuses to participate, that is the end of his / her active participation. The consent will allow information to be collected about a participant from a number of national databases. An individual’s participation in the study will be confirmed upon his / her release from prison, at which time his / her opiate tolerance status (detoxified / still in receipt of OST and therefore opiate tolerant) will be recorded, based on the prison’s OST dispensing data. These data will be collected and conveyed to the researchers using either encrypted data disks or sealed hard copy transferred using a secure parcel service. Participant prison release dates will be confirmed from dispensing data and the Local Inmate Database System (LIDS).

Objectives:

This study is part of an evaluation of the Integrated Drug Treatment System (IDTS), which has recently been introduced to prisons in England. The primary purpose of the study is to assess whether differences occur in relation to short-term mortality rates, engagement with treatment services, and offending behaviour between 10,000 IDTS clients released from prison while still receiving Opiate Substitution Treatment (OST) (e.g. methadone or buprenorphine) and 10,000 IDTS clients released after detoxification from opiate dependence.


Project 4 — DARS-NIC-147901-2XMLG

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

Benefits:

Head and neck cancer (H&N) is one of the commoner cancers with around 7,000 cases per year in England and Wales. The incidence appears to be increasing. The two year all cause mortality is around 35%. A person with H&N requires care from a range of disciplines. These include surgical teams to resect the tumour, dissect the neck and reconstruct the defect; radiotherapists and oncologists to provide radiotherapy and chemotherapy; clinical nurse specialists to offer pre and postoperative support; nutritionists to help with postoperative feeding and nutrition; speech therapists to assist with speech and swallowing; restorative dentists to fit and maintain prostheses and treat dental caries; palliative care physicians to support patients in the terminal stages of H&N and psychologists to provide psychological support. In an attempt to move beyond clinical outcomes, such as the surgical result or survival, quality of life scores have been developed for people with H&N and are being used to guide and monitor response to treatment. Despite their importance there is limited evidence on the modifiable psychological and social determinants of coping for people with H&N. There is thus a need to assess a broad range of patient centred outcomes in studies of H&N.

Outputs:

We will continue the follow up through flagging so participants that survive remain in the study for 10+ years. The MRIS will enable us to trace and identify those that have died to ensure that we do not send out further questionnaires. Furthermore, the flagging will provide ongoing notifications about our participants and will allow the study to compare morbidity and mortality outcomes across different centres. We will also be able to analyze the broad range of patient centred outcomes collected in the study in relation to morbidity and mortality.

Processing:

The overall objective of the study is to recruit a clinical cohort of 5,000 people with H&N and then follow up this cohort for two years. This study will be large enough to compare groups by age, site and stage. Specifically, the objectives are to: 1. Compare morbidity and mortality outcomes across different centres. 2. Compare quality of life outcomes across different centres. 3. Describe the individual economic cost of head and neck cancer care. 4. Identify prognostic indicators for head and neck cancer. 5. Create a resource for translational and applied research in head and neck cancer. Research nurses at each participating H&N cancer centre together with the research team will recruit and collect data: • Obtain consent • Baseline collection - Collect blood, saliva and tissue sample accordance with the established biological sample protocol - Administer the base line questionnaire at the clinic - Provide the additional baseline questionnaire pack to be completed at home which should be sent back to the research team in the provided prepaid envelope. • The patients will be flagged with the NHS Information Centre (NHSIC) and followed for two years. • At 4 months, the research team will send out the 4 month questionnaire pack to the participants enrolled for self completion at their home together with a prepaid envelope to return the questionnaire pack. • At 12 months, the research team will send out the 12 month questionnaire pack to the participants enrolled for self completion at their home together with a prepaid envelope to return the questionnaire pack.

Objectives:

The overall aim of the programme is evaluate and disseminate the outcome of centralization in Head and Neck cancer (H&N). In order to accomplish this we will create a clinical cohort of 5,000 people with H&N and follow up this cohort. This study will be large enough to compare groups by age, site and stage. Data are already collected on the care provided to patients with H&N as part of an ongoing National Head and neck cancer audit. The proposed studies will complement these National audit data by investigating the role of patient characteristics not recorded as part of routine care and by examining a broader range of patient centred and clinical outcomes. We will collect data on people with H&N that would include age, sex, diagnosis and treatment. Additional data will be collected on socioeconomic status (including occupation, education and housing): lifestyle (including smoking and alcohol intake); questions on psychological status and general and cancer specific quality of life questions. We will collect a venous blood, saliva and tissue sample for use in future translational studies. The outcome of the study will allow clinicians and managers to design effective patient centred multidisciplinary centralised services for people with H&N.


Project 5 — DARS-NIC-148033-FMST7

Opt outs honoured: Y

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

Objectives:

The Avon Longitudinal Study of Parents and Children (ALSPAC) is a prospective birth Cohort study with detailed biological and behavioral data from before birth through till late adolescence and is organised as a resource for the whole scientific community (www.alspac.bris.ac.uk). Past assessments of ALSPAC participants have substantially been based on postal questionnaires, study clinics and increasingly through information obtained through linkage to routinely collected data. The data collected via this arrangement will be processed and provided in a suitably secure and non-disclosive form to our research collaborators. The ALSPAC resource is used extensively to investigate a wide range of research questions. To date there have been over 450 publications (http://www.bristol.ac.uk/alspac/sci-com/pubs/) with many more topics being actively investigated. Additionally these data will be used in an administrative function to help prevent causing distress to our study families through contacting them if there has been a bereavement. Embarkation and health authority data are used in our cohort tracking and tracing initiatives. ALSPAC conduct many data extraction and linkage projects in order to answer our research questions. The use of NHS ID number allows for greater efficiency and accuracy. ALSPAC will provide full information and seek prior approval from NHS IC before commencing any research projects using the NHS ID number.


Project 6 — DARS-NIC-148336-V4SL1

Opt outs honoured: Y

Sensitive: Sensitive

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

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 examine behavioural, social,physiological and clinical factors determine healthy,ageing and disease risk. The Caerphilly Prospective Study (CaPS) is one of the oldest epidemiological cohort studies in the UK. It was set up by Prof. Peter Elwood, Director of the MRC Epidemiological Unit South Wales in 1979 and the male subjects who have been followed up ever since having been seen on five occasions and we are currently planning to do one final clinical assessment. The original cohort was established to examine risk factors for cardiovascular disease. However over the years the scope and breadth of interest has expanded so it is now focussing on cognitive decline, dementia and ageing. It has an extensive breadth of phenotypic dat including specialised clotting tests as we well as DNA and a range of biochemical results. The cohort is actively engaged in research particulary the Halcyon collaboration (http://www.halcyon.ac.uk/) which is a multicohort collaboration studying healthy ageing across the life course. It also contributes to large international genetic consortia as part of the validation set which have identified new genetic variants for disease and traits such as obsesity.


Project 7 — DARS-NIC-17875-X7K1V

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2016/04 (or before) — 2017/11. breached contract — audit report.

Repeats: Ongoing

Legal basis: Health and Social Care Act 2012

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients

Benefits:

Estimating the magnitude of variation UOB-SSCM will disseminate lists of the most variable conditions / procedures using journal articles. These articles will be aimed at research funders, commissioners and clinicians. The output will help research funders identify where the most important treatment uncertainties exists and prioritise research to these clinical areas. For example, in previous work high variation in transluminal and combined varicose vein procedures flagged up the clinical uncertainty about the use of minimally invasive techniques and the criteria for when each procedure is appropriate. This research has the potential to reduce treatment uncertainties and lead to more standardised and better quality care, and improved patient outcomes. Although the immediate impact of this research will be difficult to measure, UOB-SSCM would expect benefits from 2017 onwards. Ref: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0081522/ Investigating the causes of variation Work exploring the causes of geographic variation will be aimed at NHS commissioners. The output will help NHS commissioners by providing insight into the influence of population and organisational factors on admission rates / procedure use. For example, in current work UOB-SSCM identified continuity of GP care, rather than accessibility of GP care, as a key factor in reducing unplanned hospital admission rates. UOB-SSCM has previously used HES data to investigate how demographic, geographic and NHS institutional factors affect emergency hospital admissions which has added to the debate around the most appropriate structure of English general practice. This type of observational evidence has played a crucial role in the design of the NHS and has directly influenced recent government-led initiatives to provide 7-day primary care access and increase hospital staffing levels at weekends. UOB-SSCM expects the analysis to have an effect on NHS policy and, although the effect will be difficult to evaluate, UOB-SSCM would expect benefits from 2017 onwards. Identifying opportunities for disinvestment Work identifying opportunities for disinvestment will be aimed at commissioners in the seven partner CCGs of the CLAHRC West. UOB-SSCM will collaborate with individual partner CCGs to better understand the causes of high admission rates or procedure use and, where appropriate, help design interventions to reduce utilisation to more appropriate levels. Helping commissioners appropriately disinvest from poor-value healthcare will free up resources for more cost-effective treatments and will result in patient benefit. In a previous project UOB-SSCM undertook a benchmarking process with Suffolk PCT to identify clinical areas where disinvestment was necessary. UOB-SSCM identified high utilisation of carpal-tunnel surgery, which was centered on one of the two hospitals in the area, leading to the PCT to change the provider of these services which reduced costs and released funds for other healthcare activity.

Outputs:

Estimating the magnitude of variation 1) Publish national-level analysis of variations in procedure rates in peer-reviewed medical journal by December 2017. 2) Publish national-level analysis of variations in unplanned admissions and outpatient care in peer-reviewed medical journal by December 2017. Investigating the causes of variation 1) Explore temporal and geographic variations in specific procedures and medical admissions in a series of peer-reviewed medical journals by December 2018. Identifying opportunities for disinvestment 1) Benchmark local CCG unplanned admission and procedure rates against the national average. Provide report to each local CCG by December 2016. All outputs will include only aggregate data with small numbers suppressed in line with the HES analysis guide. No record level data will be shared with third parties including the partner CCGs.

Processing:

The data will be processed in the following way: Data preparation Upon receiving the data from the HSCIC, UOB-SSCM will store it on its secure server located Canynge Hall, Bristol. The data can only be accessed by authorized personnel with user accounts on UOB-networked computers. The network can be accessed remotely but all processing is logically on the server based at Canynge Hall and no data is removed from that server and the authorised personnel are all employees of UOB. UOB-SSCM will take following steps to create analysis datasets for the programme of research. 1. Analysis datasets will be created using an SQL query. UOB-SSCM will use filters (e.g. procedure codes, diagnosis codes), and restrict the data fields to those that are strictly required, to ensure the size of the analysis dataset is minimised. 2. Identify the finished consultant episodes to be included in the analysis based on diagnosis or procedure codes. 3. Count the number of unplanned hospital admissions / procedures within each CCG and GP practice. 4. Use appropriate methods (e.g. indirect standardisation, Poisson regression) to adjust for differences in need (e.g. age, deprivation) between CCGs and practices. Descriptive analysis This analysis will use the data produced from the ‘Data Preparation’ phase. Descriptive analysis will involve all ten years of data, to understand how the characteristics of patients has changed over time. 1. Describe the characteristics of patients admitted for each condition / procedure including demographics (e.g. age), admission details (e.g. source, method) and discharge details (e.g. source, method). Estimating the magnitude and understanding the causes of variation This analysis will use the data produced from the ‘Data Preparation’ phase. UOB-SSCM will calculate estimates of variation for each of the ten years of data. 1. Use appropriate methods (e.g. hierarchical models) to quantify variation in unplanned admission rates / procedure use between CCGs. 2. Rank conditions / procedures from the most to least variable. 3. Use appropriate methods (e.g. regression) to calculate trends in variability over time. 4. Use appropriate methods (e.g. Poisson regression) to investigate how demographic, geographic and NHS institutional factors affect unplanned hospital admissions and procedure use. Identifying opportunities for disinvestment This analysis will use the data produced from the ‘Data Preparation’ phase. UOB-SSCM will use the most recent year’s data to identify opportunities for disinvestment and will supplement this with a time trend analysis describing how local and national have differed over the previous ten years. 1. Rank conditions / procedures based on the difference between the local and national rate for each partner CCG. This will provide a starting point for conversations around potential opportunities for disinvestment. 2. Calculate time trends in the difference between national and local rates to understand if local high utilisation is a recent phenomenon or if differences are more entrenched.

Objectives:

University of Bristol (UOB) School of Social and Community Medicine (SSCM) will use the data for a programme of work based around identifying the magnitude and causes of variations in outpatient care, unplanned admission rates and procedure use. The work is funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West) (see: http://clahrc-west.nihr.ac.uk/). The CLAHRC West brings together a collaboration of the local providers of NHS services and NHS commissioners, universities (including UOB-SSCM), patients and members of the public. It conducts applied health research and implements research evidence, to improve health and healthcare across the West of England. The purpose of this programme of work is threefold: 1. Estimating the magnitude of variation UOB-SSCM aims to identify the clinical areas where outpatient care, unplanned admission rates and procedure use differ substantially across England. High variation is likely to be the result of clinical uncertainty in the optimal pathway of care including: when to refer patients for a specialist opinion; when to admit patients, and which procedures they should receive once admitted. Identifying high variations in care allows research funders and NHS managers to prioritise research towards the areas where additional evidence has the greatest potential to improve and standardise healthcare. For example, UOB-SSCM have previously demonstrated that admissions for hip fracture, where the diagnosis and need for admission are clear cut, vary much less than admissions for senility/dementia where making a diagnosis and judging the need for admission is more difficult. As the aim of this analysis is to identify new areas of exploration, rather than simply confirm that variation is present in clinical areas where it is already known to exist (e.g. mental health care, tonsillectomy), it is essential that it starts from a broad base. UOB-SSCM previously used the HES data from 200708-2011/12 to identify the most geographically variable therapeutic procedures. This study considered the 154 most common procedures which were recorded in 17.8 million finished consultant episodes. UOB-SSCM’s proposed analysis of the latest data will be at least as large and will require an unfiltered dataset. UOB-SSCM requires data on patients admitted in the previous ten years to investigate how geographic variation has evolved over time. Ref: www.ncbi.nlm.nih.gov/pubmed/25879119 2. Investigating the causes of variation UOB-SSCM aims to explore the causes of variation in hospital outpatient care, admission rates and procedure use. UOB-SSCM will use other freely available datasets (e.g. quality and outcomes framework, GP patient survey) to better understand how the characteristics of an area (e.g. age-sex composition, deprivation) or an organisation (e.g. availability and continuity of primary care) are related to hospital admission rates / procedure use. Understanding the causes of geographic variation will help inform the design of interventions that may be most successful in standardising care around best practice. UOB-SSCM has previously used HES data to demonstrate the associations between unplanned hospital admissions, GP proximity to A&E departments and hospital bed availability. This type of observational evidence has played a crucial role in current initiatives to co-locate GP services with A&E departments to triage and prevent unnecessary admissions. Refs: http://www.ncbi.nlm.nih.gov/pubmed/21719477; http://www.ncbi.nlm.nih.gov/pubmed/21183192 3. Identifying opportunities for disinvestment UOB-SSCM will work with the seven partner CCGs of the CLAHRC West to identify clinical areas where there may be an over-use of care locally. Identifying and reducing over-utilisation to free up resources for other, more productive activities is commonly termed ‘disinvestment’. For example, in previous work UOB-SSCM worked with a local CCG to explore why local rates of laser capsulotomy (to improve 'cloudy' vision after initial cataract surgery) were apparently much higher than the national average. Analysis revealed that locally procedures were performed as (more expensive) day cases, whereas elsewhere the procedure was done in the (cheaper) outpatient setting, therefore identifying an opportunity for CCG savings. Part of these investigations will include a time trend analysis to identify if local high utilisation is a recent phenomenon or if differences are more entrenched over time which will require multiple years of inpatient and outpatient data. UOB-SSCM’s plans for this programme of work have been strongly supported by local NHS organisations through the Bristol Health Partners (a strategic collaboration between the city's three NHS trusts, three clinical commissioning groups, two universities and its local authority) and the West of England Academic Health Science Network (a collaboration of healthcare organisations, industry, universities, research bodies and patients). Ref: www.ncbi.nlm.nih.gov/pubmed/25879119 UOB-SSCM require multiple years of data to investigate if geographic variation has increased over time. Having previously received only inpatient data, UOB-SSCM requires outpatient data because many minor procedures may be performed in the outpatient clinic or as day cases. In accordance with the Data Protection Act, UOB-SSCM are minimising the data held by requesting a smaller amount of outpatient data, excluding earlier years when data were considered experimental. UOB-SSCM will be requesting their HES extracts to be updated annually. With each update, UOB-SSCM will destroy the oldest year of data on its server meaning that only ten years of data will be held on the server and be available for active data analysis at any time. UOB-SSCM will follow established best practice by archiving the dataset underpinning work published in medical journals for five years after publication to ensure that queries or disputes can be appropriately addressed.


Project 8 — DARS-NIC-207953-Q9H2M

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2016/11. breached contract — audit report.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

  • MRIS - Cohort Event Notification Report
  • MRIS - Flagging Current Status Report
  • MRIS - Personal Demographics Service

Objectives:

The Cleft Collective project's aim is to create the infrastructure, capacity and resources necessary to gain important new knowledge that will advance our understanding of the causes of cleft lip and/or palate, inform treatment and ultimately improve the lives of children, adolescents and adults with the condition through the creation of a Birth cohort study and a Five-Year cohort study.   We are conscious of the fact that a member of our cohort may die while we are out of contact with the study family and we wish to minimise the risk of upsetting them by attempting to make contact without knowing the circumstances. We also believe that learning of an individual's cancer registration will provide vital health information for this research project. Through continued notification of these data, The Cleft Collective will accumulate data that will enable studies to be undertaken on the environmental and genetic factors related to cleft. To clarify, we would like to receive the full range of data provided by the IC Flagging and Tracing service. Statistical analysis will take place at such times as the numbers in any particular group suggest that this would be feasible. Statisticians and researchers do not have access to the personal details of the study participants. Disclosure control mechanisms will be employed to limit the risk of disclosure through small cell counts.


Project 9 — DARS-NIC-30560-W4V1T

Opt outs honoured: N

Sensitive: Non Sensitive

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

Repeats: One-Off

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

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care

Benefits:

Infants born prematurely are at high risk of brain injury and major disabilities/neurodevelopmental impairments later in life. Bleeding into the ventricles of the brain is one of the most common consequences of being born very early and has a very high rate of serious disability such as cerebral palsy and learning difficulties. Drainage, irrigation and fibrinolytic therapy (DRIFT) was developed as a method of washing out the ventricles to clear the effects of the bleeding. The DRIFT randomised trial was conducted in 2003-2006 among 74 premature babies (with parental consent) with bleeding into the ventricles. Babies were randomly allocated to get either DRIFT or standard therapy. When neurodevelopment was assessed by “blinded” observers at 2 years, severe disability or death was significantly reduced in the DRIFT group. There was a large reduction in severe learning difficulties from 59% to 31% in the DRIFT group compared to the control group. However longer term follow up at school age is needed as cognitive testing at 2 years is limited and can be difficult in children with motor impairment. In its current guidance to the NHS, NICE currently does not recommend drainage, irrigation and fibrinolytic therapy (DRIFT) because there is insufficient evidence. If the DRIFT school age follow up study demonstrates that DRIFT is effective for children and cost-effective for the NHS, NICE will update its recommendations. If so, measurable health benefits among thousands of premature infants with bleeding into the ventricles of the brain treated with DRIFT would be expected from 2017 onwards. Expected benefits range from saving babies' lives to improving lives (e.g. by enabling children to attend ordinary schools rather than specialised schools). Results will also be relayed to the patient group via newsletters and will be shared with relevant charities such as Bliss.

Outputs:

1) Final report to the NIHR HTA which will contain a chapter including a comparison of the use and cost of hospital care among participants in the DRIFT trial. It is anticipated that the final report based on the HES data will be submitted in Autumn 2016. 2) Peer reviewed article reporting on the cost effectiveness of the DRIFT procedure in a high impact medical journal. Target date late 2016. 3) Results of the DRIFT school age trial will be presented at the European Academy of Paediatric Societies, Geneva October 2016. 4) The University of Bristol will notify the NICE interventional procedure advisory committee of its findings so that they can update the NICE guidance, should the evidence support this. All outputs will include only aggregate data with small numbers suppressed in line with the HES Analysis Guide. No record level data will be shared with any third parties.

Processing:

1. The DRIFT project team at University Hospitals Bristol (UHB) will prepare a file containing the DRIFT study participant ID and patient identifiers (NHS number, date of birth and postcode at birth) to allow linkage to HSCIC data. Parents have provided informed consent for hospital episode statistics to be used in this research project. This file will be securely transferred to the HSCIC. 2. The HSCIC will use the identifiers to link to non-sensitive HES data on hospital admissions since birth. The HSCIC will prepare a file containing the DRIFT study participant ID linked to HES Pseudo ID (where a match has been found) and HES data. This file will be securely transferred to the DRIFT project team at the University of Bristol under the provisions of the Health & Social Care Act 2012. 3. All data analysis will be performed by the DRIFT project team at the School of Social Medicine, University of Bristol (UOB-SSCM) according to its System Level Security Policy (SLSP) for HES data. 4. Upon receiving the data from the HSCIC, UOB-SSCM will store it on its secure server located at Canynge Hall, Bristol. The data can only be accessed by authorized personnel with user accounts on UOB-networked computers. The network can be accessed remotely but all processing is logically on the server based at Canynge Hall and no data is removed from that server. Data will only be accessed by substantive employees of University of Bristol. 5. The data will be used to compare the use of hospital care between children who received the DRIFT procedure and those who received standard care. The pseudonymised data supplied by the HSCIC will not be reidentified nor linked with the UHB’s identifiable data or any other data.

Objectives:

Between 2003 and 2006 the DRIFT study recruited premature infants with post-haemorrhagic ventricular dilatation. Infants were randomised to receive a novel treatment (drainage, irrigation and fibrinolytic therapy [DRIFT]) or standard therapy which consisted of lumbar punctures and if needed a ventricular reservoir to drain cerebrospinal fluid. Initial results (at age 2) were promising. In 2014, the NIHR Health Technology Assessment programme funded the DRIFT research team (based at University Hospitals Bristol and the University of Bristol) to conduct long term follow up of children at school age (i.e. 9 to 11 years). The aims of this long term follow up were to: 1) To compare cognitive function, visual function, sensorimotor ability and emotional wellbeing, between the two treatment groups in the DRIFT trial at school age. 2) To quantify functional status and use of community and specialist health and educational services. 3) To estimate the economic cost and outcomes of the DRIFT intervention by age 11, and model long-term costs and outcomes. 4) To quantify degree of ventricular dilatation and neurosurgical sequelae in the two treatment groups by clinical neuroimaging. As part of aim 3, the University of Bristol requests data from HSCIC on hospital care received by DRIFT participants since birth. The specific requirement is for Hospital Episode Statistics (HES) data on the subset of DRIFT participants who were born in England and whose parents have provided consent for us to access routinely collected health data. The analysis of HES data is taking place solely at the University of Bristol. The data will not be made available to any third party. Without these data from the HSCIC it would not be possible to judge whether the initial cost of the DRIFT procedure results in subsequent savings to the NHS through reduced hospital care during the first 11 years of life. If the initial costs of DRIFT are justified by NHS savings and improved health outcomes for children, this procedure will become used widely across the NHS.


Project 10 — DARS-NIC-30645-Z2Z2K

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2017/06 — 2017/11. breached contract — audit report.

Repeats: One-Off

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

Datasets:

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

Benefits:

Reducing health inequalities is a fundamental health care goal. This proposal is important as currently the extent of regional variation on hip fracture incidence is not known, nor the impact of social deprivation across the different regional healthcare economies on fundamental health outcomes after hip fracture such as a death, mobility, institutionalization, and readmissions which carry such a high financial burden. Benefits to patients and the health system: Around 60,000 older adults fracture a hip each year in England. As our population ages, fracture numbers are predicted to rise. Fractures represent a major trauma for individuals and a significant societal burden, both through direct medical costs (UK predicted £2.2 billion by 2025), and important social sequelae. Details regarding 95% of hip fractures are now routinely recorded through the National Hip Fracture Database (NHFD); after adjusting for case-mix, by 30-days between 3 and 17% of patients will have died and 5 to 75% will have returned home; percentages vary across the 186 NHS hospitals. Mean acute hospital length of stay varies from 9 to 32 days. Health and healthcare inequalities still persist. Previous research has established lower socioeconomic status is a predictor of poorer health outcomes, associated with increased rates of incident hip fracture in Nottingham, whilst regional variation across the country is unknown. Previous research also shows that nationally there are identified geographic and socioeconomic variation in the provision of elective hip replacement , found that socioeconomic deprivation predicts poorer post-operative outcomes, and showed socioeconomic deprivation reduces the chance of returning to one’s own home following a hospital admission with a fall. Recent results suggest patients from deprived areas in southwest England, despite being younger, are more likely to be transferred to community rehabilitation hospitals following hip fracture, than be discharged directly home, with consequently longer lengths of stay in the NHS. A third of hospital expenditure is spent on those in the last year of life, with 58% of UK citizens dying in hospital. Hip fracture is the commonest cause of injury related death. One-year mortality following hip fracture is approximately 30%. Lower socioeconomic status predicts higher inpatient mortality after hip fracture in England; however, the relationship with 30-day and one year mortality has not been defined nationally. This research will investigate and quantify the true impact of deprivation on hip fracture outcomes and to identify deprived healthcare regions, with potentially the poorest outcomes, where peri-operative inpatient care may not be optimal. Emergency 30-day readmissions following hip fracture have risen progressively over 10 years in England from 8.3% to 12.0%. The extent to which survival, co-morbidity, geographic and socioeconomic factors influence this trend has not been assessed. Given the high financial burden of readmissions, such data will have high utility to policy makers (e.g. Public Health England) and those commissioning local hip fracture services (e.g. Clinical Commissioning Groups (CCGs) in England). Understanding the effects of deprivation on the incidence of hip fracture, the outcomes after hip fracture and the cost implications, and how this all varies across different parts of the country, will identify those health systems with greatest need, in greatest need of reform, and potentially those to be high-lighted as ‘gold-standards’. This research will ensure these patterns can be understood in order to design and implement change, to drive down the current health inequalities, improve patient health outcomes and reduce the economic burden on the health system.

Outputs:

The intention is for each of the 4 aims to produce at least one peer-reviewed published paper (target journals include: The BMJ, Osteoporosis International, Journal of Bone and Mineral Research) and at least one conference abstract for national/international presentation (target conferences: The National Osteoporosis Society conference, the European Fragility Fracture Network conference, The Bone Research Society, the American Society of Bone and Mineral Research). These will be delivered sequentially over the course of the 3-year programme with the first publication targeted for submission by the end of 2016. The types of journals to be targeted will depend on the nature of the findings. All outputs will contain only aggregated data, with small number suppressed in line with the HES analysis guide. As part of this programme, a systematic review assessing the effects of deprivation on hip fracture incidence will also be completed and published. In preparing this proposal advice was obtained from a Commissioner at NHS England, advisor to the National Osteoporosis Society (NOS) and RCP Fracture Liaison Service Database committee representative. He is well positioned, and with a vested interest, to help to disseminate our research findings in the interests of improving models of hip fracture care. He has a voice amongst NHS commissioners which will permit this research a direct path so that the findings directly influence national commissioning and hence lead to improved patient care. The rates at which patients need to move to care homes and the costs incurred through hospital readmissions are of crucial importance to commissioners. This research is funded by the NOS and hence we will work with the NOS’ publicity office to disseminate our research findings. The data produced by this study will inform Public Health England (PHE), for whom elimination of health inequalities is a priority target: PHE direct local organisations towards appropriately commissioned services. Given current political priorities, it is also planned that findings will be disseminated directly to Westminster MPs. Furthermore, the Welsh Assembly clearly prioritized the tackling of health inequalities in its publication ‘Fairer Health Outcomes for All: Reducing Health Inequalities in Health Strategic Action Plan’; stating that currently there is little evidence of differential impacts on different socio-economic groups. One of the leaders of the study is well placed as National Hip Fracture Database (NHFD) clinical lead to feedback the findings to key stakeholders, such as the Royal College of Physicians. . Findings will further be disseminated by the NHFD Publications and Scientific Committee which the applicant takes over as chair of this committee in May 2017.

Processing:

Only substantive employees of Bristol University will access the disseminated data and only for the purposes described in this document . Under this application/Agreement, a pseudonymised extract of linked NHFD and HES/ONS data will supplied by NHS Digital to University of Bristol. The data will be exclusively stored on University of Bristol’s servers and will not be accessible to any third parties. Data flow: 1. The cohort will be provided for linkage from Crown Informatics (who are the DP for the NHFD but play no other role in this application and receive no linked data) who will supply NHS number, DOB and postcode. 2. NHS Digital will link HES and ONS data to the cohort and patients with related ICD/diagnosis codes. 3. NHS Digital will supply the linked pseudonymised data to Bristol (replacing date of death with death status at various stages in one year). Over the course of a 3-year programme, the data will be analysed to produce research outputs in relation to the four aims listed above. The processing activities for each aim will take place in sequential order but there will be overlaps between the processing activities for different aims. The analyses and statistical programmes written will differ for each aim and different variables will be used. For the 4 study aims, the respective processing activities are as follows: 1. Three years of data will be analysed to calculate rates of different types of hip fracture for different age groups amongst men and women across 11 geographical regions in England and Wales. Then the study will look at how these rates vary according to levels of social deprivation. Social deprivation will be measured using the Index of Multiple Deprivation (IMD). 2. The study will determine how levels of social deprivation relate to a range of outcomes after hip fracture, including: a. A patient’s ability to walk indoors and outdoors 30 days after sustaining a hip fracture b. Rates of death 2 days, 14 days, 21 days, 30 days, 60 days, 90 days, 120 days, 182 days, 274 days and 365 days after sustaining a hip fracture c. How long patients stay in hospital, and afterwards in rehabilitation hospitals, after sustaining a hip fracture d. How often patients are able to return to their own home, or whether they need to move to live in a care home, after a hip fracture How often patients need to be readmitted to hospital having been discharged after an admission with hip fracture; calculating the total number of days spent in hospital in the year following a hip fracture. 3. The study will investigate how the relationships established in Aim 2, between social deprivation and hip fracture outcomes, vary across 11 different geographical regions (and smaller subgroups within these regions) in England and Wales. It will be determined whether these relationships vary according to whether patients live in rural or urban environments, or whether they are treated in larger teaching hospitals or smaller district general hospitals). The study will determine to what extent hospital characteristics explain difference in patient outcomes after hip fracture, such as delays in operating, access to medical assessment, specialist geriatricians, a full multidisciplinary team, fracture liaison services 4. The study will calculate the total costs associated with hospital readmissions following a hip fracture for each region and clinical commissioning group. The study will also perform a detailed review of the scientific literature to assess measures to avoid hospital readmission after hip fracture so that both the financial impact and the current evidence based can be presented to commissioners and policy makers.

Objectives:

This request is necessary to enable a new study which will determine how much social deprivation affects outcomes after hip fracture in terms of death, recovery, institutionalisation, and readmission. The study will identify areas in the UK where hip fracture patients receive inequitable health care which is below the expected standard. The findings are designed to drive equal access to high quality services for all hip fracture patients across the country by influencing policy and the commissioning of services. This 3 year program aims to establish: 1. Variation in the incidence of hip fractures across the different regional healthcare economies in England and Wales, and how deprivation relates to incident hip fractures within these regions. 2. After sustaining a hip fracture, the effect of individual social deprivation on; (i) Day 7, Day 14, Day 21, Day 30, Day 60, Day 90, Day 120, Day 182, Day 274, Day 365 mortality, (ii) length of hospital stay, (iii) walking ability (iv) return home (vs. need for institutionalised care), (v) 30-day readmissions and (vi) days spent in hospital over the next 12 months. 3. Whether the effect of social deprivation on the outcomes in Aim 2 varies across different regional healthcare economies in England and Wales; identifying healthcare providers/CCGs with suboptimal outcomes necessitating revision to commissioned services. 4. The financial cost to the NHS, by healthcare provider/CCG and deprivation, of readmissions (all and fracture-related) over the 12 months after hip fracture, or until death; generating valuable intelligence for NHS commissioners, supported by a systematic review of readmission avoidance post hip fracture. Reducing health inequalities is a fundamental health care goal. This proposal is important as it will address the lack of information on the extent of regional variation on hip fracture incidence, or the impact of social deprivation across the different regional healthcare economies on fundamental health outcomes after hip fracture such as a death, mobility, institutionalization, and readmissions which carry such a high financial burden. Results are intended to influence national commissioning of hip fracture services and thus reduce health inequalities.


Project 11 — DARS-NIC-319171-G7H8K

Opt outs honoured: N, Y

Sensitive: Non Sensitive, and Sensitive

When: 2016/04 (or before) — 2018/05. 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, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Categories: Anonymised - ICO code compliant, Identifiable

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Outpatients
  • Diagnostic Imaging Dataset
  • Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Benefits:

The main outcomes of the trial are the effectiveness of Prostate Specific Antigen (PSA) testing in reducing prostate cancer mortality, and its cost-effectiveness (i.e. comparing the health-related costs in the two groups in combination with the effectiveness of PSA testing, in order to assist policy makers in their decisions about how to achieve the best use of resources). The expected measurable benefits to health arise from the ability of these data to allow an unbiased comparison between men screened for prostate cancer and those not screened. The data generated will provide both clinical and policy relevant data on one of the most controversial issues in health care nationally and internationally: the potential benefits, harms and costs to the UK population of screening for prostate cancer. Research from the University of Bristol led to the Department of Health decision in 1997 that screening for prostate cancer would not be introduced in the UK until there was evidence that benefits outweighed harms. University of Bristol led and collaborative research subsequently provided evidence to support informed decision-making in the NHS. A formal review by DH in 2010 endorsed the policy and confirmed that any change would be based on evidence from the team’s randomised trials. This research has ensured UK men have avoided known harms of prostate cancer screening in the context of uncertain benefits, and saved the UK economy. The median 10 years follow-up will be reached in 2016 and it is anticipated that the first publication will report these results, the University would nevertheless wish to apply for additional funding for longer term follow–up.

Outputs:

CAP plan to publish median 10 year results in The New England Journal of Medicine (NEJM) or The Journal of the American Medical Association (JAMA) in 2016. A statistical analysis plan detailing the analyses that will be included in the publications has been uploaded onto the University of Bristol research information repository (http://hdl.handle.net/1983/6d41509f-ab93-4f96-9869-c320acbc4ae1). Statistics involved in these papers usually refer to measures such as rate ratios and 95% confidence intervals rather than actual numbers of cases. CAP will follow ONS non-disclosure rules for small numbers of cases and will not include any counts of less than 5 in a Table. As stated above the median 10 years follow-up will be reached in 2016, the applicant would nevertheless wish to apply for additional funding for longer term follow–up. As stated above the primary outcome is reached at a median 10 years follow up in 2016 there are however a number of recent publications directly related to the study, listed below: Williams NJ, Hill EM, Ng SY, Martin RM, Metcalfe C, Donovan JL, Evans S, Hughes LJ, Davies CF, Hamdy FC, Neal DE, Turner EL, for the CAP Cause of Death Committee. Standardisation of information submitted to an endpoint committee for cause of death assignment in a cancer screening trial – lessons learnt from CAP (Cluster randomised triAl of PSA testing for Prostate cancer). BMC Medical Research Methodology (2015) 15:6 (doi:10.1186/1471-2288-15-6) Turner EL, Metcalfe C, Donovan JL, Noble S, Sterne JAC, Lane A, Avery K, Down L, Walsh E, Davis M, Ben-Shlomo Y, Oliver S, Evans S, Brindle P, Williams N, Hughes LJ, Hill E, Davies C, Ng SY, Neal DE, Hamdy FC, Martin RM. Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP). British Journal of Cancer (2014) 110; 2829-36 (doi: 10.1038/bjc.2014.242) Lane JA, Donovan JL, Davis M, Walsh E, Dedman D, Down L, Turner EL, Mason MD, Metcalfe C, Peters TJ, Martin RM, Neal DE, Hamdy FC, for the ProtecT study group. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncology (2014) 15: 1109-18 (http://dx.doi.org/10.1016/ S1470-2045(14)70361-4) Hill EM, Turner EL, Martin RM & Donovan JL. "Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study. BMC Medical Research Methodology (2013) 13:72 (doi: 10.1186/1471-2288-13-72) Williams NJ, Hughes LJ, Turner EL, Donovan JL, Hamdy FC, Neal DE, Martin RM, Metcalfe C. Prostate-specific antigen testing rates remain low in UK general practice: A cross-sectional study in six English cities. British Journal of Urology International (2011) 108:9; 1402-08 (doi:10.1111/j.1464-410X.2011.10163.x) Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL. Latest results from the UK trials evaluating prostate cancer screening and treatment: The CAP and ProtecT studies. European Journal of Cancer (2010) 46; 3095-3101 (doi:10.1016/j.ejca.2010.09.016) Outputs will also be fed directly to funders, Cancer Research UK and Department of Health. Other appropriate bodies such as NICE or the Cochrane Centre will also be informed. The papers will be available on the University of Bristol PURE pages https://research-information.bris.ac.uk/ - these publications are available to download with open access allowing anyone to access publications. We also publish with open access rights when submitting to journals, ensuring we maintain CRUKs publication ethos of ensuring research funded by them is available to all. Publications are also uploaded to 'researchfish' allowing the research community to clearly see what has been published.

Processing:

In this amendment request, the linked HES data would be accessible to investigators at the University of Bristol in the form of a pseudonymised dataset housed at the Secure Anonymised Information Linkage (SAIL) Databank. This means that it is totally separate to the identifiable data and can never be linked to it. Processing steps - 1.HSCIC will utilise the identifier (unique study ID) for MR783 and MR738A and link these data from the HES dataset held at the HSCIC. The HES data extract and unique study ID for the cohort will be sent to SAIL by the HSCIC. 2.The applicant will transfer a study ID and the following primary and secondary mortality outcome variables to SAIL: month and year of birth; date of prostate cancer diagnosis; prostate cancer stage and grade, if present; month and year of death, if deceased; prostate cancer attributed death, if deceased; date of censor, if no longer in follow up; month and year of censor. 3.SAIL will then link these data to the HES extract from the HSCIC. SAIL will also encrypt the unique study ID to create a unique pseudo anonymised ID number for each individual, area identifiers will also be pseudonymised HES data will be used to identify all inpatient and outpatient resources used by men in CAP. Costs will be assigned to the identified events and used alongside the linked outcome data to conduct the CAP cost-effectiveness analysis from the perspective of the UK NHS (secondary care). This dataset will be remotely accessed from Bristol for analysis and only aggregated results tables (verified by SAIL to be unidentifiable) would be extracted from the dataset.

Objectives:

Cluster randomised trial of testing for Prostate cancer (CAP) is a pragmatic, cluster Randomised Clinical Trial (RCT) that compares an invitation to attend for population-based Prostate Specific Antigen (PSA)-testing for prostate cancer (intervention arm) with standard NHS care (control arm) amongst men aged 50 to 69 years registered with GP practices in eight centres in England and Wales. Recruitment to the DH/CRUK-funded CAP trial was completed in 2009 and it is currently in the follow-up phase. Over 415,000 men are being followed-up for incident and fatal prostate cancer via the Health and Social Care Information Centre (HSCIC). Where cost implications of any national screening programme are considerable, and where survival is relatively good whatever form of management is adopted, it is essential to incorporate analysis of cost-effectiveness. To obtain timely and comprehensive UK-wide coverage to estimate the cost effectiveness of prostate cancer screening in the UK CAP are applying for permission to perform record linkage for all 415,000 men in the CAP trial with the HSCIC for the provision of resource use information.