NHS Digital Data Release Register - reformatted
NHS Blood And Transplant (nhsbt)
Project 1 — DARS-NIC-338242-C8Z8M
Opt outs honoured: Y
Sensitive: Non Sensitive, and Sensitive
When: 2016/12 — 2017/02.
Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012)
Categories: Anonymised - ICO code compliant, Identifiable
- Hospital Episode Statistics Admitted Patient Care
- Office for National Statistics Mortality Data
A significant proportion of patients initially listed for deceased donor kidney transplantation end up being suspended from the national waiting list. The vast majority of these patients are suspended on the basis of clinically accepted criteria. The outcomes of those patients who remained suspended are predictably poor however the scale of their morbidity and mortality remains alarmingly unknown or underreported. It can be argued these patients represent a forgotten cohort of renal transplant candidates not specifically analysed. However with transplantation known to offer a survival benefit over haemodialysis, attributable in the main to reduction in cardiovascular risk, it is conceivable that earlier allocation of a kidney transplant to these patients could have prevented the development of the clinical deterioration that led to their suspension. Inevitably this leads to difficult questions regarding allocation policy especially as at present there are no current clinical criteria that contribute to the prioritisation of deceased donor kidneys to potential recipients. Based on research already presented at the 2014 World Transplant Conference, NHS Blood and Transplant (NHS BT) wish to link data from patients suspended on the National Kidney Waiting List with outcome data (number and cause of individual hospital admissions and cause of death) from HSCIC to determine the ‘Outcome of potential recipients of a kidney transplant suspended from the national waiting list’ Using the linked outcome data NHS BT aim to address 6 separate objectives: 1) To assess the validity of two linked national databases as a data source for kidney transplant research. 2) To determine the true mortality rate of patients both activated and suspended on the national kidney transplant waiting list over a 10 year period 3) To identify potentially modifiable clinical factors that independently contribute to the mortality of patients activated and suspended on the national kidney waiting list. 4) To perform a literature review identifying whether the clinical factors independently contributing to the death of patients activated or suspended on the waiting list have been proven to be modifiable by earlier renal transplantation. 5) To help NHS BT build a validated survival benefit model that prioritises deceased donor kidney transplantation based proven clinical criteria thus leading to a reduction in waiting list deaths and an overall fairer allocation policy. 6) To determine the economic benefit of earlier transplantation for those with greater clinical need, achieved through cost of renal failure related hospital admissions whilst suspended on the national kidney transplant waiting list. Organisations Involved: i) NHS Blood and Transplant (NHSBT) NHS BT is a Special Health Authority of the Department of Health. It has the responsibility of and raising the quality, effectiveness and efficiency of blood and transplant services in the UK. Amongst its remit is managing both the national transplant waiting lists and national databases containing all organ transplant outcome data. NHS BT is also committed to improving outcome through research and encourages the secure release of its data for research purposes. The project lead (an employee of NHS BT), retains close links to the NHS BT and acts as their Associate National Clinical Lead for Organ Retrieval.
The proposed research will make six fundamental contributions to measurably improving the health of patients suspended on the national kidney waiting list. 1) To increase national awareness of this patient cohort and encourage consultant nephrologists, transplant surgeon, specialist nurses and patients and their families to monitor closely status while active on the national kidney transplant waiting list. 2) To decrease waiting list morbidity and mortality and reduce the number of patients suspended on the list by prioritising those with the greatest clinical need to receive a kidney first. 3) To reduce the number of renal failure related hospital admissions from patients on the waiting list by prioritising those with the greatest clinical need. 4) To aid in the development of a statistical model to dictate NHS BT’s allocation policy for deceased donor kidney transplantation. 5) To produce a reliable data source for future research into improving outcomes in this patient cohort. 6) To encourage the tighter regulation of the national deceased donor kidney waiting list and encourage optimal deceased donor and recipient allocation. In order to determine the full impact of these potential benefits the applicant will first need to use the linked databases to determine how many patients are suspended on the national waiting list, what proportion die whilst suspended from the list and the rate of renal failure related hospital admissions. Once this baseline information is established the applicant can then calculate the true impact of the research in terms of total life years saved and total cost saved through potential implementation of an allocation system based on clinical need.
During the course of this research the applicant would look to publish a minimum of four to five high quality research papers in high impact transplant specific journals. Selected journals include; Transplantation, Transplant International and the American Journal of Transplantation. Intended dates of publication: Submission of Abstract by December 2016 to: January 2017 (allowing for data linkage, validation and analysis) Presentations: Research outputs will be presented at national and international meetings, aiming for yearly presentations at the British Transplant Society (BTS) Conference with international presentations focussed on conferences hosted by the European Society of Transplantation (ESOT); also an oral presentation at the two-yearly World Transplant Conference (WTC). Intended Dates of Presentation: British Transplant Society (BTS): 2017 European Society of Transplantation: 2016 – 2018 World Transplant Congress; 2016 (preliminary work) and 2018 NHS BT: As the national governing body for transplantation in the UK NHS BT will present results to the NHS BT’s Kidney Advisory Group. Intended initial presentation: November 2016 (introduction to the project). Projected updates: 3 months intervals Presentations will be continually given throughout the study as NHSBT generate interesting results - these presentations will be given on a local, regional, national and international basis. The results will also be published in any transplant specific or well recognised international journal. A monthly newsletter containing relevant updates is circulated to the cohort.
NHS BT will use the two linked national databases, the NHS BT national kidney waiting list to identify all patients in the UK activated and suspended from the waiting list and the HSCIC outcome data to determine the number and length of hospital admissions and the cause of death of patients both suspended and activated on the list. The validity of this linked data will be checked prior to addressing NHS BT's main research objectives. Data handling and statistical analysis will be led by the Head of Organ and Donation Studies at NHS BT. NHSBT will be providing a study ID within the cohort to enable them to re-identify the data from the pseudonymised output provided to them from the HSCIC. Linking the datasets enhances NHSBT's project by providing information on patient outcome data. In addition linking the data sets allows NHSBT to adjust for more variables during regression analysis thus increasing the internal validity of NHSBT's study by reducing the effect of known confounding variables. NHS BT confirm that all individuals with access to the record level data are employed by NHSBT
Project 2 — DARS-NIC-147815-X5CHM
Opt outs honoured: Y
When: 2016/04 (or before) — 2018/09.
Legal basis: Section 251 approval is in place for the flow of identifiable data
- MRIS - Flagging Current Status Report
- MRIS - Cause of Death Report
- MRIS - Scottish NHS / Registration
- MRIS - Cohort Event Notification Report
The data supplied by the NHS IC to NHS Blood and Transplant will be used only for the approved Medical research project
Project 3 — DARS-NIC-14342-Q8W0X
Opt outs honoured: Y
Sensitive: Non Sensitive
When: 2018/03 — 2018/05.
Legal basis: Health and Social Care Act 2012
Categories: Anonymised - ICO code compliant
- Hospital Episode Statistics Outpatients
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Admitted Patient Care
The Access to Transplant and Transplant outcome measures (ATTOM) study is a UK-wide cohort study of patients with kidney disease receiving dialysis or with a kidney transplant. Its aim is to investigate patient-specific factors which influence progress and outcomes. Baseline data were collected from 2011-2013 and include the results from patient surveys and case notes review for 6842 patients (which included 1139 patients from Wales, Northern Ireland and Scotland, who are not included in the proposed data linkage, ie: cohort size 6842-1139=5703). Study data contain details of patients’ comorbidities, markers of socioeconomic status such as education, employment, marital status and accommodation, demographics and health literacy (as defined by the Single-item literacy screener: a validated measure of individual health literacy, which is the question ‘How often do you need to have someone help you when you read instructions, pamphlets or other written material from your doctor or pharmacy’, answered on a 5-point scale, with responses 1-Never, 2-Rarely, 3-Sometimes, 4-Often and 5-Always. Responses ‘Sometimes’, ‘Often’ and ‘Always’; See Taylor et al Kidney International Issue 90; vol 3; Pages 685-695). Patients with advanced kidney disease such as those included in ATTOM have high rates of comorbidity, especially in the form of cardiovascular disease. Because of these comorbidities as well as complications of dialysis or transplantation, they have a high rate of contact with hospital services (emergency care, admissions, outpatients). Data from HES contain details recorded as a result of hospital care, which can be used to examine healthcare use, expenditure and comorbidity, and its relationship to patient-specific factors such as socioeconomic status and health literacy. ATTOM data will be linked to HES (ONS mortality data will be linked at a later date subject to the legal basis being gained) data to allow: a) Analysis of variations in healthcare utilisation and cost (admission rate, hospital bed days, HRG tariff remuneration, clinic attendance, Emergency Department attendance) in relation to health literacy, socioeconomic status and comorbidity. b) Comparison of comorbidity data from HES (derived from diagnoses and procedural entries before and during the ATTOM study period, hence start point in 2006) to comorbidity data from the ATTOM dataset (collected by a research nurse from patients’ medical notes), to establish if HES-derived comorbidity data is equal in quality and scope to researcher-collected data from the ATTOM dataset. c) Survival analysis (from HES initially and linked to ONS mortality data at a later date) in relation to health literacy, socioeconomic status and comorbidity. Although the linkage of HES data was not specified in the original ATTOM study protocol, the above analyses fit within the first overarching aim of the ATTOM study: to improve equity of access to kidney and pancreas transplantation across the UK. These analyses are primarity concerned with equity of access to treatment and equity of outcome by socioeconomic status and associated factors (including health literacy). By analysing hospital admissions data in this patient group we aim to develop insight into the ways in which socioeconomic factors and health literacy influence patient pathways and may limit access to transplantation. Part b) of the above relates to a specific question about analysis of socioeconomic status in prospective studies (specifically in CKD). Low socioeconomic status is associted with higher comorbidity but also independently with adverse health outcomes. It may be that these factors interact: patients with the same reported baseline comorbidity data but with differing socioeconomic status may develop further comorbidities more quickly (or baseline comorbidities may be more severe in those with low socioeconomic status). In analyses of outcomes, it is difficult to differentiate the effects of comorbidity from the effects of socioeconomic status. This analysis will allow us to compare the consequences of similar comorbidities between patients in different socieoconomic groups. It will be of relevance to the interpretation of our results and to the wider research community. The data will only be used for this purpose. When the application for data was submitted the data was expected to be available to be analysed and reported a in the doctorate thesis. At the time of CAG application, the data were still expected to contribute to the above doctorate thesis, so the CAG approval makes reference to this doctorate. However, because data were not available, they were not able to be included in the doctorate thesis, which has now been completed. Data from this linkage will therefore not contribute to a doctorate thesis, but the aim is (and always was) for the analyses to be performed as previously planned. The primary aim of this linkage was not to support a doctorate (as evidenced by the above, adequate data were already available to do so), but to advance knowledge of Chronic Kidney Disease and disseminate these findings as set out in the later sections of this application. The research protocol was amended to include the addition of HES linkage to ATTOM data-set to evaluate outcomes based on health literacy.
Research using ATTOM/HES data (and future ONS mortality data pending legal basis obtained) examining variations in healthcare use and expenditure in the context of health literacy, socioeconomic status and comorbidity will expand current knowledge. For example, results from ATTOM have shown that socioeconomic inequity in access to kidney transplantation appears to be driven in part by health literacy differences. Analysis of healthcare service use data allows more detailed examination of mechanisms underlying this association, and would inform policy changes to reduce inequity (possibly by targeting low health literacy groups). Demonstration of higher healthcare costs (from PbR data) among those with low health literacy would add weight to the promotion of initiatives to improve access to care for this group (with resulting reductions in inequity). Benefits to health and social care will be measureable at the point of dissemination of results, target date August 2020. Achievement of these objectives will be of relevance to the population of NHS patients receiving dialysis treatment, or living with a kidney transplant (the number of patients in these groups in 2013 was 56,940 (UK Renal Registry 17th Annual Report 2014)). Benefit to these patients will come from research-driven change in policy to improve equity of access to treatment (as described above). Direct communication of results to patient groups will happen as part of ATTOM's Public and Patient Involvement commitment.
When processing of the linked ATTOM-HES data has been completed, the ATTOM study will have analysed variations in hospital resource use and outcomes associated with health literacy, socioeconomic status and comorbidity. Without linked data from NHS Digital these analyses would not be possible.The target date for completion of the work is August 2020. As specified in the ATTOM study protocol, all published output will be open-access (available without charge to the public). All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide. Dissemination of results will be as follows: 1) The results of these analyses will form part of planned academic publications in nephrology and public health journals, and presentations at national/international academic meetings (nephrology, public health). This will allow dissemination of the results of these analyses to clinicians and policymakers in nephrology communities worldwide, with subsequent influence on policy. 2) Because the analysis concerns UK patients, the results will be of direct relevance to UK NHS policy. Analyses using ATTOM data have shown that people with low health literacy have reduced access to kidney transplantation, and that this effect is likely to promote socioeconomic inequity in transplant access. Interventions to support people with low health literacy therefore have potential to reduce this inequity and improve outcomes, but have not yet been developed. NHSBT aim to apply for research funding to develop and test such a complex intervention. The proposed HES analysis will provide further evidence in support of this application. In other healthcare settings (eg: USA nephrology, UK and USA non-nephrology medicine), low health literacy has been associated with increased non-routine healthcare use, but reduced use of preventative healthcare. The suggested analysis of HES data is expected to identify differences in patterns of healthcare use among those with low health literacy- most likely higher expenditure and more use of emergency care. These findings would support interventions to ameliorate the effects of low health literacy in the UK Chronic Kidney Disease population. This analysis will contribute to the development and of a complex intervention as described above. 3) The NIHR-funded ATTOM study has established routes for dissemination of results which include: a) Presentation at the annual NHS Blood and Transplant Renal Transplant Services Meeting (which invites transplant lead clinicians UK-wide) b) Stakeholder meetings (which invite clinical leads from UK renal units) Patient/public representation is required by the NIHR at ATTOM meetings.
1) NHSBT will create a copy of the ATTOM dataset and assign a unique person ID not present in the master ATTOM dataset. 2) NHSBT will send NHS Digital the NHS Numbers, DoBs and unique IDs 3) NHSBT will destroy the NHS Numbers, DoBs and any other identifiers except the unique ID in the copy ATTOM 4) NHS Digital will provide pseudonymised HES data with the unique ID enabling linkage with the copy ATTOM dataset but not with the master dataset. NHSBT will not attempt to re-link or re-identify individuals to the data received from NHS Digital 5) All record-level data from the returned dataset will be stored only on the NHS Blood and Transplant(NHSBT) server in a directory with permissions specific to the research team within NHSBT. No data will be accessed by anyone outside of NHS BT. 6) Data will be transferred to statistical packages within the NHSBT server to allow data analysis. 7) Aggregated data with small numbers suppressed in line with the HES analysis guide will be used in draft reports and publications. This data will be made available to the editing team within the ATTOM group. These members are from several institutions listed in the ATTOM protocol. 8) HES ID will be provided to the applicant through this agreement to allow for any future ONS linkage. Any data used in these draft reports and publications referred to above will be used aggregated with small numbers suppressed in line with the HES Analysis Guidelines. Data analysis will test the following hypotheses: a) Healthcare utilisation (admission rate, hospital bed days, HRG tariff remuneration) and patient outcomes (survival from the start of RRT, from transplantation, hospital associated mortality) vary by patient health literacy (defined by responses to the Single Item Literacy Screener), individual-level markers of socioeconomic status and comorbidity in patients from the ATTOM cohort. b) Comorbidity data derived from diagnoses and procedural information recorded by admissions (prior to the time point of interest) by HES is equal in quality and scope to data collected in the ATTOM study by researchers - this may inform the use of HES data in future observational cohort studies. No data will be used for commercial purposes, provided in any form to any third party (except when published as aggregate data) or used for marketing of any kind. All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide. No ONS data will flow under this agreement. A future amendment will be required to seek approval for the ONS data to flow to NHSBT. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).