Linking the UK Renal Registry and Hospital Episode Statistics for research

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Civil Registrations of Death

Objective for processing

The UK Renal Registry (UKRR) is part of the Renal Association, a not-for-profit organisation registered with the Charity Commission (https://register-of-charities.charitycommission.gov.uk/charity-search/-/charity-details/800733). The Renal Association is the data controller of the UKRR database and was established in 1995 to improve the care of patients with kidney disease. The registry collects data from the United Kingdom’s 70 adult and 13 paediatric renal centres, as well as hospital laboratories in England. The UKRR has a current agreement (DARS-NIC-94250-L8W8T) with NHS Digital for Hospital Episode Statistic (HES) and Civil Registration Mortality data which is for audit purposes to enhance benchmarking of renal centres against national audit standards. DARS-NIC-94250-L8W8T states: "Other agreements between the Renal Association and NHS Digital may permit re-use of this data for further purposes." This agreement (DARS-NIC-406158-Q2J0X) is being submitted separately for the purpose of research only. To strengthen the UKRR’s corresponding research programme, the UKRR is applying to link the UKRR database to HES and Civil Registration Mortality data released under DARS-NIC-94250-L8W8T for the research purposes detailed below, namely to: The UK Renal Registry (UKRR) is part of the Renal Association, a not-for-profit organisation registered with the Charity Commission (charity no. 800733). The Renal Association was established in 1995 to improve the care of patients with kidney disease and is the data controller for the UKRR database. 1) Investigate risk factors (including the impact of renal treatment, morbidities and infections such as COVID-19) for clinical outcomes of adults and children with kidney disease. The UKRR has an ongoing separate agreement (DARS-NIC-94250-L8W8T) with NHSE for Hospital Episode Statistic (HES) and Civil Registration Mortality data for audit purposes to enhance benchmarking of renal centres against national audit standards. These data are used in the Chronic Kidney Disease (CKD) annual report to adjust survival for case-mix to identify kidney centres with significantly poorer patient survival – the most recent annual report was published in Spring 2024 and all annual reports are available to view here: https://www.ukkidney.org/audit-research/annual-report HES data also supports an annual Acute Kidney Injury (AKI) report to identify which people with an AKI required hospital treatment and to investigate the degree of correlation between AKI coding in the UKRR database and AKI coding in HES. The UKRR’s study team (henceforth 'study team') comprises approximately 15 people (medical director, research director, clinical research fellows and statisticians). The linkage will enable the study team to better understand the reasons why some patients with kidney disease progress faster towards kidney failure and/or have worse clinical outcomes than others. This will help the study team to understand how risk factors could be managed to slow the progression of kidney disease and to have a targeted quality improvement approach to better patient outcomes. For patients with established kidney failure, understanding risk factors that can be modified will be valuable in ensuring they experience the best outcomes and quality of life. For clarity, this agreement - DARS-NIC-406158-Q2J0X – is for the purpose of research only. Having HES and Civil Registration Mortality data for research purposes allows the research team to use powerful statistical methods and to generalise findings. The key differences to the audit work is our ability to generalise findings to other kidney populations and investigate causal associations. 2) Predict future outcomes for adults and children with kidney disease using novel statistical modelling methods on big datasets, including the impact of infections such as COVID-19 and changing underlying morbidities. The UKRR collects data from the 67 adult and 13 paediatric kidney centres in the UK, as well as hospital laboratories in England. Participation of kidney centres in England is mandated through NHS commissioning specialised services A06 Renal Services (www.england.nhs.uk/commissioning/spec-services/npc-crg/group-a/a06/). Participation of hospital laboratories is mandated by NHS England following a level 3 patient safety alert (www.england.nhs.uk/akiprogramme/aki-algorithm). Modelling outcomes of kidney disease in various scenarios, e.g. different renal replacement therapy (RRT) modalities or for those with diabetes as a morbidity versus those without (HES morbidities data), can help clinicians offer treatments to patients that might slow progression and/or improve their clinical outcomes. Understanding how morbidities change over time in the kidney patient population is vital for predicting future outcomes and care needs for kidney patients. Initially, the UKRR only collected data on people receiving kidney replacement therapy (KRT – dialysis (haemodialysis and peritoneal dialysis) or a kidney transplant), but in recent years data collection has been expanded to also include: 3) Understand trends and variations (geographical, socio-economic, ethnic, seasonal, time and by renal centre) in the care and outcomes of adults and children with kidney disease, including the impact of infections such as COVID-19 and changing underlying morbidities. – all cases of acute kidney injury (AKI) in people in primary and secondary care in England from 2015 (following a level 3 patient safety alert issued by NHS England – see above). Approximately 550,000 cases are alerted per year. Understanding variation in outcomes in relation to demographic and other factors can help to address inequalities in kidney care – see the recent report the UKRR jointly authored with Kidney Research UK – kidneyresearchuk.org/wp-content/uploads/2019/09/Health_Inequalities_lay_report_FINAL_WEB_20190311.pdf. Being able to add in the hospitalisation, length of stay and morbidities in future analyses of inequalities would help to further understand and quantify inequalities in access to care for kidney patients. Seasonality of AKI mortality in community and hospital acquired AKI and trends in excess mortality in patients starting RRT will be studied. – all cases of pre-dialysis chronic kidney disease (CKD – stages 4 to 5) in people in secondary care in England and Wales from 2016 (at the request of the National Clinical Reference Group). There were approximately 72,575 individual cases in total, from ~17 kidney centres between 2016-2022. – Though the Renal Association approvals cover CKD stages 1-5, for the purpose of this linkage, only stages 4-5 are included. Research at the UKRR relies on having good completeness and quality of data on co-morbidity. The UKRpre-defined 6 research areas/questions are as follows: 1) Investigate risk factors (including the impact of kidney treatment, co-morbidities and infections) for clinical outcomes of adults and children with kidney disease. The UKRR research team is made up of approximately 15 people (medical director, research director, senior project manager, clinical research fellows and statisticians). Linkage with NHSE data will enable the research team to better understand and share the reasons why some patients with kidney disease progress faster towards kidney failure and/or have worse clinical outcomes than others. Research will help create new knowledge of how risk factors could be managed to slow the progression of kidney disease and to have a targeted quality improvement approach to better patient outcomes. For patients with established kidney failure, understanding risk factors that can be modified will be invaluable in ensuring they experience the best outcomes and quality of life. 2) Predict future outcomes for adults and children with kidney disease using novel statistical modelling methods on big datasets. Modelling outcomes of kidney disease in various scenarios, e.g. different kidney replacement therapy (KRT) modalities or for those with diabetes as a morbidity versus those without (HES morbidities data), can help clinicians offer treatments to patients that might slow progression and/or improve their clinical outcomes. Understanding how morbidities change over time in the kidney patient population is vital for predicting future outcomes and care needs for kidney patients. 3) Understand trends and variations (geographical, socio-economic, ethnic, seasonal, time and by kidney centre) in the care and outcomes of adults and children with kidney disease, including the impact of infections and changing underlying morbidities. Understanding variation in outcomes in relation to demographic and other factors can help to address inequalities in kidney care – see the recent report the disparities in patients on KRT: https://www.ukkidney.org/audit-research/disparities-report Being able to add in the hospitalisation, length of stay and morbidities in future analyses of inequalities would help to further understand and quantify inequalities in access to care for kidney patients. Seasonality of Acute Kidney Injury (AKI) mortality in community and hospital acquired AKI and trends in excess mortality in patients starting KRT will be studied. [1 paragraph unchanged] Kidney disease is not just about clinical outcomes – it is also [16 words unchanged] www.who.int/healthinfo/survey/whoqol-qualityoflife/en/). The UKRR collects various PREM, PAM and PROM data about patients – renal.org/audit-research/data-permissions/data/ukrr-ckd-patient-measures-dataset, which (https://www.ukkidney.org/audit-research/data-permissions/data/ukrr-ckd-patient-measures-dataset )which the quality improvement arm of the Renal Association uses to work with [31 words unchanged] data will be linked to the HES data. Using HES data, the study research team will be able to better understand and describe the association between [9 words unchanged] quality of life, which is very important to patients with kidney disease. 5) Quantify the financial cost to the healthcare system of kidney disease in adults and children, taking into account considering morbidities. The burden of kidney disease in the UK is substantial and the cost of providing RRT, KRT, in particular, is high. The linkage will enable us to quantify this [5 words unchanged] time, not only for England, but also by trust and kidney centre. Understanding the financial impact of infection for example COVID-19 on kidney care is anticipated to help the research team to quantify the burden of this pandemic and potential future pandemics on kidney services. [1 paragraph unchanged] Being able to validate UKKR data using HES and Civil Registration Mortality data, particularly cause of death and morbidities, which have long proved difficult to collect from renal kidney centres, will allow the Renal Association to highlight issues with the data [53 words unchanged] data will add greatly to the understanding of referral patterns in England. Having HES and Civil Registration Mortality data for the above 6 research questions would allow the study research team to use powerful statistical methods and to generalise the findings. findings beyond individual kidney centres. This has potential benefits for the thousands of people with kidney disease in England and further afield. The UKRR holds secondary use permissions under section 251 of the NHS Act (2006) for collecting patient data for both audit and research purposes without consent and relies on the following legal [16 words unchanged] Regulation as incorporated into UK law under the Data Protection Act 2018). [1 paragraph unchanged] For processing of special category personal data, the UKRR relies on article [31 words unchanged] portion of the article, because the analysis of the data received from renal kidney centres and hospital laboratories is a vital component of research studies. As [20 words unchanged] Article 89(1) of the UK GDPR and is in the public interest. The linkage between the UKRR database and HES and Civil Registration Mortality data will strengthen the research analyses and will allow the study research team to be able to conduct research at the UKRR to address [8 words unchanged] crucially on information on morbidities and if/when patients were admitted to hospital. [1 paragraph unchanged] – Identify underlying morbidities in patients (this is currently not possible because UKRR morbidity data are about 50% incomplete, with considerable variation between renal kidney centres) [5 paragraphs unchanged] – Have a better understanding of where patients die [1 paragraph unchanged] – Understand the quality and consistency of renal kidney care given by morbidity profile of patients and to what extent some centres appear to avoid complications. Participation of renal centres in England is mandated through NHS commissioning specialised services A06 Renal Services (www.england.nhs.uk/commissioning/spec-services/npc-crg/group-a/a06/). Participation of hospital laboratories is mandated by NHS England following a level 3 patient safety alert (www.england.nhs.uk/akiprogramme/aki-algorithm). Initially, the UKRR only collected data on people receiving renal replacement therapy (RRT – dialysis (haemodialysis and peritoneal dialysis) or a kidney transplant), but in recent years data collection has been expanded to also include: – all cases of acute kidney injury (AKI) in people in primary and secondary care in England from 2015 (following a level 3 patient safety alert issued by NHS England – see above). Approximately 550,000 cases are alerted per year. – all cases of pre-dialysis chronic kidney disease (CKD – stages 4 to 5) in people in secondary care in England and Wales from 2016 (at the request of the National Clinical Reference Group). There were approximately 50,000 individual cases in total, from ~17 renal centres between 2016-2020. Though the Renal Association approvals cover CKD stages 1-5, for the purpose of this linkage, only stages 4-5 are included. The study team analyses the UKRR data for audit and research purposes (under separate Agreements) and publishes the results in various reports and medical journals – see renal.org/audit-research/annual-report and renal.org/audit-research/publications-presentations. Research at the UKRR relies on having good data on morbidity. Since 2018 the UKRR has had permission to link the UKRR with HES and Civil Registration Mortality data for audit purposes. These data are used in the CKD annual report to adjust survival for case-mix to identify renal centres with significantly poorer patient survival – the most recent annual report was published in August 2021 (https://ukkidney.org/audit-research/annual-report/23rd-annual-report-data-31122019). HES data were also recently used in the UKRR’s inaugural AKI report to identify which people with an AKI required hospital treatment and to investigate the degree of correlation between AKI coding in the UKRR database and AKI coding in HES. This report was published in July 2020 (renal.org/audit-research/publications-presentations/report/acute-kidney-injury-aki-england-report-nationwide). HES data was also used in the 'Getting It Right First Time' (GIRFT) report that described hospitalisation and length of stay for hospitalised patients with AKI (https://ukkidney.org/resource/renal-girft-national-report) . Possessing HES and Civil Registration Mortality data for the above 6 research questions will enable the study team to generalise findings beyond individual renal centres, which has potential benefits for the thousands of people with kidney disease in England and further afield. Aside from the audit work, having HES and Civil Registration Mortality data for research purposes will allow the study team to use powerful statistical methods and to generalise the findings. The key differences to the audit work are that these six research questions seek to generalise to other renal populations and investigate causal associations. [1 paragraph unchanged] (i) Adults and children in England who are on RRT KRT (kidney transplant or dialysis). (ii) Adults and children in England with CKD (stages 1-5), CKD, including those with ESKD who do not receive RRT. KRT. [1 paragraph unchanged] The UKRR is not permitted to hold individual data about people without kidney disease. Analyses are therefore designed to identify the risk factors associated with various outcomes for patients with kidney disease. (iv) Adults and children in the above categories who have completed PAM and/or PROM surveys The purpose of the project is to conduct research only for the 6 research questions described above for the benefit of patients with kidney disease. Purpose The purpose of the project is to conduct research that falls within the remit of the 6 research questions described above for the benefit of patients with kidney disease. [2 paragraphs unchanged] – HES Admitted Patient Care, period 1997/98 to 2020/21 or most recent, with further annual data releases. The UKRR commenced collection of new patients starting RRT KRT in 1997 and so to identify variation and improvement over time, data are requested from 1997 onwards. – HES Critical Care, period 2014/15 to 2020/21 or most recent, with further annual data releases. The UKRR began collecting AKI data in 2015 and so the study research team have only requested critical care data from 2015 onwards. [1 paragraph unchanged] – Civil Registration (Deaths) Secondary Care cut, annual quarterly data releases requested. [1 paragraph unchanged] The UKRR started collecting data about people on RRT KRT in 1997 and has therefore requested HES and Civil Registration Mortality data [67 words unchanged] about 100 new cases per million of the population each year start RRT KRT – there can often be a degree of uncertainty or noise in [24 words unchanged] and hospital acquired AKI and trends in excess mortality in patients starting RRT KRT will be studied (research question 3). ESKD also has a high mortality [28 words unchanged] term survival further (a key metric for people with ESKD), which the study research team need to understand outcomes in the oldest patients (research question 1, and to project future health needs – research question 2). The UKRR collects data from every kidney centre in the UK and so collects data on 100% of people on RRT KRT in the UK. This includes patients in the 50 adult and 10 paediatric renal kidney centres in England. To enable the UKRR to include all English patients treated in England in analyses the UKRR are requesting HES and Civil Registration Mortality data for all kidney patients in England. The UKRR can confirm that there is no alternative, less intrusive way [23 words unchanged] Despite many efforts at national meetings and correspondence with clinical directors and renal kidney centres, the completeness of many data items submitted to the UKRR is not improving and in some instances is declining. All data items requested in the UKRR-HES-Civil Registration Mortality linkage have been specifically chosen to answer the questions described above and the UKRR have not requested any data items which are not required. Over 20 years of data is requested because several renal kidney conditions are rare and therefore many years of data are required to yield clinically meaningful results. The organisations involved with the storage and management of the UKRR database are the Renal Association and North Bristol NHS Trust. Arrow Business Solutions. Their roles are explained below. The data controller of the UKRR database is the Renal Association (the [24 words unchanged] collection, through validation, to analysis and publication. The Renal Association also engages North Bristol NHS Trust and AIMES Arrow Business Solutions (formerly AIMES) as an additional data processors processor for the purposes described in 'Processing Activities'. The Renal Association has a Patient Council that meets every 2-3 months. The Patient Council propose research questions of interest to patients. The Renal Association annual research strategy is discussed with the Patient Council before it gets approved approval and implemented. implementation. The Patient Council annually reviews all patient information, such as the privacy notice, information on who describing what the UK Renal Registry is, how patient data are used and information on patient opt-out. The ‘opt-out’. Members of the Patient Council also reviews all review submitted data applications and approved data applications. can put questions to applicants directly. Any substantial changes in data access procedures and data flows will be are discussed by the Patient Council before a Confidentiality Advisory Group amendment is [16 words unchanged] that will give patients a further voice in what research to undertake. The UKRR are re-presented A new patient facing research newsletter, to be published in joint annual patient meetings with NHS Blood and Transplant where 2025 will allow patients to submit research are discussed. ideas directly to the research team. It is recognised that UK renal kidney centres are the respective data controllers of the data submitted to the UKRR and that the renal kidney IT system providers, who assist renal kidney centres, are data processors on their behalf. The role of data controller for the respective patient care data sets is transferred from the renal kidney centres to the Renal Association at the point of data submission.

Processing activities

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). [1 paragraph unchanged] - For linkage of the UKRR database with HES and Civil Registration [10 words unchanged] of English kidney patients will be securely uploaded by the UKRR to NHS Digital’s NHSE’s Secure Electronic File Transfer (SEFT) data portal. Patient identifiers will be limited [10 words unchanged] ID will also be uploaded, but this is an anonymised study ID. - Upon receipt of the UKRR patient identifiers, NHS Digital NHSE will send back to the UKRR the agreed clinical and mortality data [26 words unchanged] with access to identifiers limited to the UK Renal Registry Systems Team. - An extract of linked data up to 2021/22 the most recent financial year will be sent to the UKRR at the start of the Data Sharing Agreement (DARS-NIC-94250-L8W8T-v2). A further dissemination of linked HES/Civil Registration Mortality data from 2022 - 2024 – will be sent to the UKRR on an annual basis. basis for HES data and quarterly for Mortality data The data is held on UKRR servers in two one separate data centres. centre. The data centres centre host the hardware and provide connectivity. AIMES Arrow Business Solutions host the physical hardware in a Secure Datacentre. AIMES Arrow Business Solutions have ISO27001 certification (UK8000045), NHS Data Security and Protection Toolkit Compliance and [30 words unchanged] encrypted with access to the keys limited to the UKRR Systems Team. North Bristol Trust Arrow Business Solutions hosts the physical hardware in a purpose built purpose-built secure data centre. The data centre is a controlled environment and access [15 words unchanged] security zones is logged. Physical access to this room is restricted by hospital security protocols to senior IT staff and substantive employees/ honorary contract holders [7 words unchanged] in the UKRR function. Any access to the servers is logged. The computer server has its own tape backup system, with servers are regularly backed up on back-up servers stored separately and securely from the tape rotated on a daily basis by the hospital IT staff. These tapes are encrypted and stored along with the hospital system backups, in the hospital’s fire proof safe. main servers. Employees of North Bristol NHS Trust Arrow Business Solutions do not have access to data held on the Renal Association’s server. [2 paragraphs unchanged] – whether a patient was seen by kidney or other specialities prior to RRT KRT or after sustaining an AKI episode [7 paragraphs unchanged] – care and outcomes of patients incident to RRT, KRT, i.e. people starting dialysis or receiving a first kidney transplant in England, and those already on RRT KRT – survival of new and existing patients on RRT. KRT. HES and Civil Registration Mortality data will only be linked with UKRR-held data for specific research analyses. (The UKRR annually collects patient outcomes and experience measures (PREM, PAM and PROM data) for the kidney patients for whom the UKRR hold data. PAM and PROM data forms part of the renal dataset that will be linked to the HES and Civil Registration Mortality data.) Aside from that HES and Civil Registration Mortality data will be kept separately from any other UKRR-held data. HES and Civil Registration Mortality data will only be linked with UKRR-held data for specific research analyses. The UKRR’s legal basis for research allows routine linkage, not only with NHS Digital, NHSE but also with NHS Blood and Transplant (NHSBT) and UK Health Security Agency (UKHSA) for the UKRR to receive a small number of data items: [1 paragraph unchanged] (ii) UKHSA to enable the UKRR to monitor levels of the following infections and bacteraemias bacteraemia’s in kidney patients in England: E. coli, MRSA, MSSA, C. difficile and [23 words unchanged] UKHSA and they return the bacteraemia and infections data to the UKRR. In order to effectively analyse e.g. kidney transplant patients or RRT KRT patients highly susceptible to infections, HES and Civil Registration Mortality data may [69 words unchanged] then transplanted could be compared with those too sick to be eligible. Being UK-wide, the UKRR also holds data about kidney patients who are treated in renal kidney centres in Northern Ireland, Scotland and Wales. The Renal Association confirm that these data will be kept entirely separate from HES and Civil Registration Mortality data. [1 paragraph unchanged] Any analyses that plan to include HES and Civil Registration Mortality data [10 words unchanged] Group approved data use process, which is documented on the Renal Association website (renal.org/audit-research/how-access-data/ukrr-data/apply-access-ukrr-data). website: https://www.ukkidney.org/audit-research/how-access-data/ukrr-data . All research must fall within the scope of the six research questions stated in this Agreement. [1 paragraph unchanged] (i) For each analysis, the UKRR research fellow or statistician applying researcher must submit an expression of interest (EoI) to the UKRR’s Data Release [46 words unchanged] as well as representatives from the British Association for Paediatric Nephrology (BAPN). The DRG also has four voting patient members representing the RA’s Patient Council and patient voice. [1 paragraph unchanged] (iii) At the DRG, DRG meeting, the group collectively completes an assessment form, one section of which is [78 words unchanged] or if the cohort is from a particularly small or specialised population. [5 paragraphs unchanged] Only members of the Renal Association’s statistics research team (substantive employees and honorary contract holders) will have access to the pseudonymised HES and Civil Registration Mortality data [31 words unchanged] of the statistics team use a virtual private network (VPN) via a North Bristol Trust laptop to access data on the Renal Association server. The statistics programme [75 words unchanged] honorary contracts are expected to respect the terms of access they sign. [1 paragraph unchanged] There will be no data linkage undertaken with NHS Digital NHSE data provided under this agreement that is not already noted in the agreement.

Expected output

The UKRR’s study team work together to plan and conduct analyses, and write up the findings for publication in reports, medical journals and patient information, and for presentation at various national and international meetings. The study team works closely with the Renal Association’s Patient Council, a group comprising approximately 15 people with kidney disease that meets four times per year with representatives of the UKRR (renal.org/patients/patient-council). The UKRR’s research team work together to plan, conduct, analyse and disseminate outputs with the overarching aim of improving the lives of patients living with kidney disease. Our main audience includes multidisciplinary healthcare professionals, kidney doctors and nurses, patients and their families, the public, NHS commissioners and National Clinical Directors. There is no lay person on the Data Release Group (DRG), however the outcomes of the DRG meeting (i.e. approved data releases) are included in the agenda of the Renal Association Patient Council for review. Patient Council is always scheduled a week or two after the DRG. This allows for lay review and feedback on proposed data releases. Planned analyses/reportable outputs including HES and Civil Registration Mortality data include (numbers in parentheses relate to the six research questions detailed in the ‘Objective for processing’ section): Planned analyses using HES and Civil Registration Mortality data include (numbers in parentheses relate to the six research questions detailed in the ‘Objective for processing’ section): [1 paragraph unchanged] – Long-term outcomes of COVID-19 survivors on RRT kidney replacement therapy (KRT) (1) and variation of this by time/centre (3) – Impact of morbidity on COVID-19 ethnic disparities in renal kidney care (1) and variation of this by time/centre (3) – Development of a prognostic model for dialysis patients starting RRT KRT (2) [1 paragraph unchanged] – Seasonality of AKI Acute Kidney Injury (AKI) mortality in community and hospital acquired AKI (3) – Trends in excess mortality in patients starting RRT KRT (3) – Impact of morbidity on self-reported symptom clusters on RRT KRT (4) – Impact Quantification of COVID-19 on the cost of renal care kidney disease, considering morbidities (5) – Validation of dates of first referral to renal kidney care (6). (6) From these analyses the study team will produce: – Reports e.g. renal.org/audit-research/publications-presentations/reports – Peer reviewed publications, as many as possible open access, information about which is available through the Renal Association’s website, renal.org/audit-research/publications-presentations. Potential journals include Nephrology Dialysis Transplantation and Kidney International. – Presentations at meetings and conferences – examples at which the UKRR study team regularly presents are: o UK Kidney Week o The British Renal Society's annual conference o European Renal Association-European Dialysis and Transplant Association annual conference o American Society of Nephrology annual conference o British Transplant Society annual conference o Clinical directors’ annual forum. – Webinars, e.g. renal.org/audit-research/publications-presentations/presentations – Newsletters – the Renal Association produces monthly newsletters that are used to disseminate new analyses and publications to the UK’s renal community. Only aggregate data will be published in research papers or other outputs, with small numbers suppressed. [1 paragraph unchanged] Working with the Renal Association’s communications officer and the Renal Association’s Patient Council, the study team will strive to disseminate results of analyses containing HES and Civil Registration Mortality data as widely as possible. The audience is clinicians, patients, commissioners and clinical directors. Findings will be disseminated through the many channels already routinely used at the UKRR by the study team. These channels are those listed above (reports, publications, conferences etc) as well as: Research team members work closely with the Renal Association’s Secretariat Team, annual conference Program Committee, Clinical Director for Research, Communications and Marketing Officer and Education Project Manager to ensure outputs are disseminated effectively and are as far reaching as possible. The Renal Association’s Patient Council (a group comprising approximately 15 people with kidney disease) assist with ensuring outputs are also disseminated to patients via appropriate routes and in an appropriate language style. https://www.ukkidney.org/patients/patient-council . – Patient Council – key analyses are discussed at quarterly meetings and participants are encouraged to distribute and promote findings through their local networks. The Patient Council also has close links with Kidney Care UK, with whom the Renal Association works closely Output types and dissemination channels include: – Website – www.renal.org – the UKRR is one of the largest and longest standing registries in the world and so the website receives a lot of traffic, both nationally and internationally. The website was overhauled this year and relaunched in October 2020 and includes various sections aimed at health professionals, researchers, commissioners and patients - Written reports: https://www.ukkidney.org/audit-research/reports – Website – https://ukkidney.org/audit-research/projects/ukrr - projects that use UKRR data are published here - Peer reviewed publications https://www.ukkidney.org/audit-research/publications-presentations – Social media (Twitter) - Research Briefs within our newly formed Education Hub: https://education.ukkidney.org/ – Press releases - Posters and presentations at meetings and conferences https://www.ukkidney.org/audit-research/publications-presentations By making the findings of the research accessible to as broad an audience as possible, the study team expect this will encourage further research and, if of benefit, changes to clinical guidelines. - News posts https://www.ukkidney.org/ - Webinars - Newsletter articles - Press releases and social media posts - Via stakeholder channels (Kidney Research UK, Kidney Care UK etc) In 2025, a new research newsletter for patients will be published in partnership with the Patient Council. The Renal Association is the oldest continuously active nephrology society in the world and as such, its website receives a continual stream of traffic, both nationally and internationally. The website was renewed and relaunched in December 2024 and includes sections aimed at health professionals, researchers and patients. By placing our research outputs on the website we ensure they are presented to as broad an audience as possible. Only aggregate data is ever shared, with small numbers suppressed. [1 paragraph unchanged] Two-way communication with key stakeholders takes place with commissioners, clinicians and patients. The UKRR works closely with the Patient Council each year to produce, for example, patient summaries of the UKRR CKD annual report (https://ukkidney.org/audit-research/annual-report/23rd-annual-report-data-31122019) and an infographic summarising the impact of COVID-19 on patients on haemodialysis (renal.org/health-professionals/covid-19/covid-19-data). Patients influence the way dissemination of audit and research findings are achieved and also have the opportunity to highlight which research questions are of key importance to them. Two-way communication takes place with key stakeholders and audiences. Commissioners, clinicians and researchers actively engage with the Renal Association on the research being conducted at the UKRR, and the UKRR works closely with the renal community on a number of research ideas and projects. Communication channels that specifically target two-way communication are webinars and dedicated meetings with key stakeholders. The UKRR works closely with the Patient Council each year to produce, for example, patient summaries of the UKRR Chronic Kidney Disease (CKD) annual report, the AKI annual report and an infographic summarising the impact of infections on patients undergoing haemodialysis. Patients influence the way dissemination of audit and research findings are achieved and also have the opportunity to highlight which research questions are of key importance to them. In 2024 the Patient Council Chair co-published 4 disparities sub reports with members of the research team: https://www.ukkidney.org/audit-research/disparities-report In 2025 individual patients throughout the UK will be able to directly communicate with the research team via the new patient research newsletter. Research ideas and input into current projects and initiatives will be encouraged. Commissioners, clinicians and researchers actively engage with Renal Association on research ideas and approved projects. Communication channels that specifically target two-way communication are webinars, dedicated research project meetings, conferences and presentations, attendance at a 6 monthly Research Methods and Strategy Group meetings (involving key stakeholders and representation from other kidney registries within the devolved nations) and via the data application/review process. The UK Renal Registry produces lay summaries of all research projects. These lay summaries are written in plain English and published for public viewing via Health Data Research UK Innovation Gateway. [1 paragraph unchanged] Whilst the study research team strive to carry out research for these 6 questions, they are [21 words unchanged] work on research questions 2 or 6 that should be embedded in renal kidney software systems, the study research team will make these this open access to achieve maximum benefit and quick effective, timely, implementation. The Renal Association aim aims to start publishing publish results of analyses within 12 months of receipt of HES and Civil Registration Mortality data.

Expected measurable benefits

Kidney disease is common, affecting 1 in 8 people at some point in their life (kidneycareuk.org/about-kidney-health/conditions/ckd/). life. The research that the HES and Civil Registration Mortality data would make [65 words unchanged] cost of treatments; and (vi) improve the quality of the data the study research group collect at the UKRR to enhance the audit function. [1 paragraph unchanged] 1) Patients. All UKRR research in conducted with the goal of improving the quality of treatments, care and outcomes for patients. Using UKRR and NHS Digital NHSE data minimises the impact on patients because most of the research can [13 words unchanged] especially important for those on dialysis who already require regular visits to renal kidney centres. 2) The NHS. NHS and commissioners of kidney services. Any major research finding should inform and impact on the way on the way care is delivered, and therefore also benefits the NHS, and any health systems providing renal kidney care to patients. 3) The UKRR UK Renal Registry directly benefits from the processing of patient data for research by allowing its staff, namely its employed statisticians and research fellows staff to carry out research projects using the data. Not only does this [36 words unchanged] improving the quality of care and outcomes of patients with kidney disease. Dissemination of the results of analyses addressing these the 6 questions posed is key to improving the care of people with kidney disease, because the study team need to reach key stakeholders to enable implementation disease. Below are examples of changes in care and how each question can achieve outputs that can benefit patient management (or data management for question 6). care: Below are examples of how research outputs are hoped can benefit patient care for each of the 6 research questions: 1. Investigate risk factors (including the impact of kidney treatment, morbidities and infections for clinical outcomes of adults and children with kidney disease. 1. Investigate risk factors (including the impact of renal treatment, morbidities and infections such as COVID-19) for clinical outcomes of adults and children with kidney disease. The specific analysis of long-term outcomes of infection survivors on KRT will help both patients and healthcare providers understand the long-term consequences of current and new diseases and infections. This will ensure kidney patients receive the most appropriate care and will enable planning of services for any future pandemics. The specific analysis of long-term outcomes of COVID-19 survivors on RRT and the resulting publication it is anticipated will help both patients and healthcare providers understand the long-term consequences of this new disease, and it is hoped will ensure kidney patients receive the most appropriate care and will also enable planning of services. 2. Predict future outcomes for adults and children with kidney disease using novel statistical modelling methods on big datasets. 2. Predict future outcomes for adults and children with kidney disease using novel statistical modelling methods on big datasets, including the impact of infections such as COVID-19 and changing underlying morbidities. The development of a prognostic model for dialysis patients starting KRT will inform patient choice, as well as policies related to patient choice, for example it may allow development of an algorithm that is anticipated will be made available to physicians. The development of a prognostic model for dialysis patients starting RRT will hopefully inform patient choice, as well as policies related to patient choice, for example it may allow development of an algorithm that is anticipated will be made available to physicians. 3. Understand trends and variations (geographical, socio-economic, ethnic, seasonal, time and by kidney centre) in the care and outcomes of adults and children with kidney disease, including the impact of infections and changing underlying morbidities. 3. Understand trends and variations (geographical, socio-economic, ethnic, seasonal, time and by renal centre) in the care and outcomes of adults and children with kidney disease, including the impact of infections such as COVID-19 and changing underlying morbidities. Any trend and variation of care requires investigation with regards to potential inequalities that may need to be addressed. Variation in outcomes of care means that there is a potential worst and best practice of care that should be investigated to inform uniformly better patient care. HES data are essential to this to adjust for case-mix. Outputs in the form of papers and reports to commissioners are essential to change care processes. Any trend and variation of care requires investigation with regards to potential inequalities that may need to be addressed. Variation in outcomes of care means that there is a potential worst and best practice of care that should be investigated to inform uniformly better patient care. HES data are essential to this to adjust for casemix. Outputs in the form of papers and reports to commissioners are essential to change care processes. 4. Use patient reported measures, such as patient activation (PAM), patient reported outcome (PROM) and patient reported experience (PREM), to understand the impact of kidney disease on adults and children, considering morbidities. 4. Use patient reported measures, such as patient activation (PAM), patient reported outcome (PROM) and patient reported experience (PREM), to understand the impact of kidney disease on adults and children, taking into account morbidities. Kidney disease is not just about clinical outcomes – it is also about the wellbeing and quality of life experienced by people with kidney disease (World Health Organization www.who.int/healthinfo/survey/whoqol-qualityoflife/en/). The UKRR collects various PREM, PAM and PROM data about patients (https://www.ukkidney.org/audit-research/data-permissions/data/ukrr-ckd-patient-measures-dataset ) which the quality improvement arm of the Renal Association uses to work with renal centres to make changes that enhance the activation, outcomes and experiences of patients receiving treatment for kidney disease. PREM data is fully anonymised and cannot be linked. PAM and PROM data will be linked to the HES data. Using HES data, the research team will be able to better understand and describe the association between morbidities and their impact on patient reported measures and quality of life, which is very important to patients with kidney disease. Dissemination of these findings will inform quality improvement initiatives to help patients cope with their chronic medical condition. HES morbidity data is expected to help the study team to understand the impact of a patient’s morbidities on their experience of kidney disease, something that up to now hasn’t been possible. Dissemination of these findings through papers, conferences, and dedicated webinars will hopefully inform quality improvement initiatives to help patients cope with their chronic medical condition. 5. Quantify the cost of kidney disease in adults and children, considering morbidities. 5. Quantify the cost of kidney disease in adults and children, taking into account morbidities. The burden of kidney disease in the UK is substantial and the cost of providing KRT, in particular, is high. The linkage will enable us to quantify this cost and the change over time, not only for England, but also by trust and kidney centre. Understanding the financial impact of infection for example COVID-19 on kidney care is anticipated to help the study research team to quantify the burden of the this pandemic and potential future pandemics on renal services, so it is hoped that they can be better prepared for future such outbreaks. Key outputs will be papers and a dedicated report to inform commissioners. kidney services. [1 paragraph unchanged] The validation of dates of first referral to renal kidney care is hoped to help determine if those who present late to renal kidney services have worse outcomes, which will be fed back to commissioners. It is expected to inform future data capture by the UKRR. Also, a research paper is key because external External researchers use a range of different data sources on renal kidney care and the our research will hopefully help them the community to interpret the positive predictive value of a given variable. Four members of the UKRR’s study team (statisticians and clinical fellows) are currently undertaking PhDs. The two statisticians are substantive employees of the Renal Association, and the two clinical fellows are on honorary contracts (their substantive employer is the University of Bristol). University of Bristol will ensure that both clinical fellows and their substantive employers sign the NHS Digital honorary contract that applies specifically to the use of NHS Digital data by a non-substantive employee of the Renal Association. In collaboration with senior members of the study team, the PhD students plan to conduct some analyses for their PhDs that include the HES data. All UKRR statisticians and clinical fellows who are undertaking PhDs have appropriate training in data security and information governance. The objectives of these PhDs are as follows: The UK Renal Registry supports and encourages members of its research team in conducting and publishing research projects that relate to the work of the registry. Where applicable, these research projects may also support individual’s pursuit of academic qualifications (i.e. MSc, PhD, etc.). 1) Address the issue of missing data in the CKD and AKI datasets held by the registry in order to improve the quality of these data The research team is made up of approximately 15 people (medical director, research director, senior project manager, clinical research fellows and statisticians). The statisticians are substantive employees of the Renal Association, and the clinical fellows hold honorary contracts. Honorary contract holders and their substantive employers sign a contract that refers specifically to the use of NHSE data by a non-substantive employee of the Renal Association. 2) Determinants of unplanned dialysis start Due to funding and operational capacity, the UKRR will support at any given time 2-3 PhDs projects for its substantive employees as well as up to 3 MSc projects, 4 PhDs, and 2 clinical fellows, as holders of honorary contracts. o Investigate the impact of AKI to unplanned dialysis start In collaboration with senior members of the research team, the members of the research team plan to conduct some analyses for their research projects and academic studies that include HES data. All UKRR statisticians and clinical fellows who are undertaking research have appropriate training in data security and information governance. The objectives of these research projects conducted by the research team are aligned to the six research questions highlighted both in this application and the UKRR’s research ethics permissions. o Examine the association between late referral and unplanned dialysis start in CKD and RRT cohort o Examine the effect of multi-morbidity on dialysis start 3) Develop statistical methods to capture diverse health needs/treatment pathways The PhD projects also explore and quantify the potential underestimation of coverage of the UKRR AKI Master Patient Index (MPI) dataset, to uncover the limitations in AKI algorithm, and the gap between the AKI algorithm and clinical assessment through the help of Hospital Episode Statistics (HES) data. Through multilevel modelling, with the help of geographical epidemiology, the PhD will use statistical techniques to quantify the missing data problems with the AKI-MPI, to get a better estimate of AKI rates in each area. Linking the HES data with the AKI-MPI, it should be possible to compare the difference between hospitalised patients who also had AKI (N17) coded in the HES data and those who did not, to understand the clinical characteristics of the latter AKI patients in more depth. This will help to achieve a better understanding of the clinical diagnosis and AKI algorithm, which could potentially explain part of the variation in each area’s AKI rate. AKI is a common and heterogeneous syndrome with a high short-term mortality rate. Improving the AKI-MPI will provide more confidence in the interpretation of area AKI rates. This will help identify areas that are outliers with the greatest need, for potential prevention interventions or quality of clinical care improvement. This facilitates prioritisation of resource allocation, to achieve positive impacts on patient outcomes.

Benefits reported

Yielded Benefits is not a requirement for new applications. Analyses using HES and Civil Registration Mortality data that are either published or in progress are as follows, with numbers in parentheses relate to the six research questions detailed in the ‘Objective for processing’ section: Acute kidney injury in a national cohort of children who have undergone a kidney transplant. epidemiology and outcomes . UK Kidney Week poster 2023. This work showed that AKI was a common event in a 5-year period with most AKI episodes being initially detected outside of hospital settings and most requiring subsequent hospitalisation and almost 10% with an AKI episode required dialysis within 30 days. This finding improves our understanding of the risk of AKI and associated outcomes in transplanted children. (1) (3) Modelling the determinants of unplanned dialysis initiation; A UK Renal Registry analysis. In progress. This work is looking at risk factors for unplanned dialysis initiation using the UKRR data linked to HES, including nephrology appointment attendance and comorbidity data. It is hoped that this work will provide suggestions on modifiable risk factors for unplanned dialysis initiation, and improve our understanding of inequity of access to treatment modalities across the population. (1) (3) The spectrum of co-existing disease in children with established kidney failure using registry and linked electronic health record data . Paper published 2024. Benefit to patients: This study examined the prevalence of comorbidities in children on kidney replacement therapy, comparing what is captured in the electronic hospital record versus the UK Renal Registry (UKRR), to ascertain validity and quality of data which are fundamental when auditing patient care. (1) (6) A comparative analysis of the starting modality of kidney replacement therapy amongst UK children and the association with all-cause mortality. UK Kidney Week oral presentation 2024. This study was the first to report estimates of long-term survival amongst UK children starting KRT, finding that those starting on dialysis had higher mortality in the earliest chronological time period, these differences reduced and were not statistically significant in later periods. Information on long-term survival is helpful for clinicians when counselling children, young adults and their caregivers. (1) (3) What is the clinical background of individuals starting dialysis? A UKRR analysis. Paper submitted. This work found that those with a failing transplant appear similar to those who present late to kidney services. This might be due to a reluctance amongst this group to plan for dialysis start and being in denial that their transplant could fail. Improved understanding of this group of patients could lead to increased support for dialysis preparation. (1) Parkinson’s disease is overrepresented in people with acute kidney injury – A UKRR cross-sectional study. UK Kidney Week poster presentation 2023. This study showed that Parkinson disease is overrepresented in people with AKI, especially in younger age-groups, indicating the need to evaluate kidney function in people with Parkinsons to understand long-term implications of AKI on their health outcomes (1) Acute Kidney Injury does not explain sex-differences in kidney replacement therapy initiation or death amongst individuals with chronic kidney disease reported to the UK Renal Registry. Paper submitted. This work found that accounting for events of higher stage AKI in the CKD population does not explain the higher KRT initiation seen in males compared to females, and only in part lowers the difference in mortality between males and females. More research is needed to explain the difference between sexes in progression to KRT to support management strategies. (3) People coded with delirium are overrepresented in people in hospital with acute kidney injury – A UKRR cross-sectional study. UK Kidney Week oral presentation 2023. Benefit to patients: This study showed that delirium is a common co-morbidity in hospitalised patients with AKI which impacts considerably on the subsequent length of stay, readmission rates and mortality. The findings demonstrate that addressing delirium should be a key target for quality improvement initiatives amongst people with AKI. (1) Ethnicity differences in the impacts of ambient heat exposure on Acute Kidney Injury. In progress. This work will examine differences in susceptibility to temperature dependent AKI across ethnic groups. Understanding such variation is important for ensuring services and prevention strategies are planned equitably. (1) (3) The impact of the COVID-19 pandemic on UK dialysis modality use and its relation to demographic factors including ethnicity. In progress. The objective is to examine the impact of the COVID 19 pandemic on dialysis data and modality use including centre variation. HES data will provide associated mortality and hospitalisation and allow us to examine the factors that influence that risk including demographic, ethnic, comorbidity and socioeconomic factors. It is crucial to understand these practice patterns to deliver on targets for growth in home therapies such as home dialysis. (1) (2) (3) KFRE for predicting allograft failure in those with an eGFR<30. A UKRR External Validation Study and Recalibration study. Submitted. This study externally validated and subsequently recalibrated the easily accessible Kidney Failure Risk Equation (KFRE) for a prevalent transplant population with an eGFR <30 mL/min/1.73m². The revised model is easily accessible, robust to temporal and case-mix differences, demonstrates clinical utility. It has potential to improve daily clinical practice by guiding timely communication and reducing unplanned dialysis starts. (2) The impact of COVID19 on AKI in the UK - a descriptive analysis from the UKRR. In progress. This study will clarify the challenges around care delivery for people with AKI during the pandemic and aims to prove that the post-pandemic data is not at all comparable with the pre-pandemic data. As such, this analysis will clarify challenges of using existing indicators in a post COVID world. (3) Seasonal mortality trends for hospitalised patients with acute kidney injury across England . Paper published 2023. The excess mortality risk in winter may reflect higher pressure on NHS services. Trusts that were identified as high outliers in the analysis may benefit from further review to better understand and address factors that may be contributing to excess winter mortality risk for their AKI patients. Conversely, trusts without excess winter AKI mortality could share their experience and best practice in order to improve performance of less well performing trusts. (3) Do outcomes for hospitalized patients with an Acute Kidney Injury (AKI) vary across specialties in England? Published 2023. The aim was to determine if 30-day mortality differ by speciality. Results show that treatment specially was associated with mortality of patients who develop an AKI post admission. This finding contributes to better management of patients in hospital and improvements in AKI patient care. (3) Inequality of PD Initiation based on Ethnicity and Socio-Economic Status. In progress. This study sought to examine differences in PD update by ethnicity and socio-economic status, including differences in trends over time and centre variation. This will help address variation and issues of home dialysis access among underserved groups. (1) (3) Hospitalisation after paediatric kidney transplant: a multicentre retrospective review. In progress. This study aims to better understanding the reasons for re-hospitalisation in paediatric kidney transplant (PKT) recipients. This will benefit patients by helping to reduce its occurrence, associated healthcare costs and inequities in this population. (1) (5) Centre variation in length of stay following post-hospitalisation acute kidney injury: analysis of a large national cohort. Poster at UKKA AKI meeting 2023, publication in progress. Routine monitoring of outcomes for patients with acute kidney injury is important to drive ongoing quality improvement in patient care. This work identified unwarranted variation inlength of stay that was not explained by patient characteristics, readmission rates or delayed transfer of care. Centres identified as outliers need to interrogate local care pathways to understand and address reasons for the high mortality. (3) Waitlist activation and transplantation for patients with kidney failure This study will explore country-level differences in access to kidney transplantation. Specifically, this study will examine which patients are waitlisted and which patients receive a kidney transplant. This study will facilitate greater understanding of current international clinical practice and inform discussions on observed variations in access to kidney transplantation. (1) (3) Uncovering the uncaptured: Exploring characteristics and outcomes of Acute Kidney Injury cases overlooked by the NHS England AKI algorithm due to missing baseline creatinine. UK Kidney Week poster 2024. The study found that while one-third of patients were rechecked as recommended within 14 days, another third did not undergo rechecking within a year, highlighting a gap in care. (6) Validation of cause of death in the UKRR data against hospitalisation data for kidney replacement therapy patients in England and Wales. In progress. Cause of death (COD) data in the UKRR is about 55% complete with the leading cause of death cardiac disease and infections. Linkage of the UKRR data with hospitalisation data in England and Wales has been performed and existing COD data can be validated against the hospitalisation mortality data. Understanding the causes of death can help formulate policies for addressing certain causes like infections.