NHS Digital Data Release Register - reformatted
Nuffield Department Of Primary Health Sciences projects
18 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
Establishing predictors of long-term health outcomes in the NewKI CKD cohort — DARS-NIC-384326-R9V7S
Type of data: information not disclosed for TRE projects
Opt outs honoured: Anonymised - ICO Code Compliant, Identifiable, No (Consent (Reasonable Expectation))
Legal basis: Health and Social Care Act 2012 s261(2)(c)
Purposes: No (Academic)
Sensitive: Sensitive, and Non-Sensitive
When:DSA runs 2021-03-15 — 2024-03-14 2021.09 — 2023.12.
Access method: One-Off
Data-controller type: UNIVERSITY OF OXFORD
Sublicensing allowed: No
Datasets:
- Civil Registration (Deaths) - Secondary Care Cut
- HES:Civil Registration (Deaths) bridge
- Hospital Episode Statistics Admitted Patient Care
- Civil Registrations of Death - Secondary Care Cut
- Hospital Episode Statistics Admitted Patient Care (HES APC)
- Cancer Registration Data
- Civil Registrations of Death
Objectives:
The University of Oxford requires data for the purpose of a longitudinal observational study: Establishing predictors of long-term health outcomes in the New Onset Kidney Impairment Study (NewKI) Chronic Kidney Disease (CKD) cohort. The aim of this study is to identify predictors of adverse health outcomes in an older primary care population with chronic kidney disease or transiently impaired renal function. The investigators at the Nuffield Department of Primary Care Clinical Trials Unit aim to identify which people with CKD are most likely to develop health problems, to help to plan preventive treatments.
CKD is a worldwide health problem associated with high morbidity and mortality and its prevalence is increasing. Decreased renal function is a well-known predictor of hospitalisation, cognitive dysfunction and poor quality of life. Cardiovascular disease (CVD) is the primary cause of morbidity and mortality in this population. Glomerular Filtration Rate (GFR) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the glomeruli each minute. Glomeruli are the tiny filters in the kidneys that filter waste from the blood. Usually GFR is estimated using an equation and a simple blood test to calculate the estimated GFR (eGFR). As GFR decreases, and CKD progresses, the risk of poor health outcomes increases, including end stage renal disease, cardiovascular events and mortality. CKD is characterised by decreased kidney function, measured as a GFR of less than 60 ml/min/1·73 m2 or markers of kidney damage present for at least 3 months duration. CKD prevalence increases with age, therefore older people may be those who benefit most from screening for CKD or closer monitoring of other health conditions. However, despite how common CKD is, and the inevitable decline in renal function over time, little is known about what predicts more rapid decline in renal function seen by some people, and therefore which patients should be monitored more closely or when interventions should be considered. This study will provide novel data in this area.
The Oxford Renal Longitudinal Cohort Study (OxRen) is a prospective observational longitudinal cohort study established in 2013 in the Thames Valley area of the UK. It recruited 3200 primary care participants aged 60 years and older from 13 GP Practices across the Thames Valley region. The study collected data on prevalence of CKD through a targeted screening programme. During the study, participants without a diagnosis of CKD were re-screened after two years to collect data on incidence. Patients who were diagnosed with CKD or had transiently impaired renal function (n=902) received baseline assessment visits where detailed information on participants health and lifestyle were collected. Blood and urine samples were also collected for analysis. Since then, these participants have attended study visits every year to monitor their general health and kidney function.
OxRen closed in 2017, but the population has been followed up in the NewKI study (New Onset Kidney Impairment Study) to continue to collect data on CKD incidence and disease progression through annual follow-up visits or two yearly screening visits for CKD. Now, the investigators want to establish whether any of these participants have gone on to develop more serious health problems, were admitted to hospital or died. The investigators will use statistical models to identify the people who went on to develop health problems or died, at an earlier stage. This work will help the investigators to understand which people are at greatest risk of poor health outcomes, so their doctors can monitor their health more closely and make sure they are taking the right medications.
The study has now been awarded funding from the National Institute for Health Research School for Primary Care Research (NIHR SPCR) towards linking NewKI participants with NHS Digital data. This will enable the investigators to establish predictors of adverse health outcomes in the NewKI CKD cohort by obtaining data on new diagnoses, hospital admissions and death.
Annual follow-up visits will continue to collect data on progression of CKD through laboratory measurements. In addition to scheduled study visits, the study team have begun linking NewKI participant data with the Royal College of General Practitioners Research Surveillance Centre (RCGP RSC) database in a feasibility study. Full linkage with the RCGP RSC will allow the investigators to prospectively follow up participants using their routine primary care records, and will be able to continue to follow up participants who are no longer able to attend study visits.
As the NewKI population continues to age, the risk of adverse health outcomes will increase. In 2020 it will be seven years since the first participant was recruited to the study. However, in order to capture data on hard outcomes, such as new diagnoses, end stage renal disease, hospitalisations, cardiovascular events and death, the investigators now need to link patient data with NHS Digital and Civil Registration mortality data.
Collecting these data will allow the investigators to:
1) provide objective estimates of the mortality rate and CVD incidence of CKD patients,
2) estimate and compare the mortality rates and CVD incidence for CKD patients identified routinely by clinical practice, and for CKD patients identified by means of screening, and
3) identify predictors for mortality and CKD incidence in order to help clinicians identify those at greatest risk for closer monitoring, medication review or other medical interventions.
It will also identify people at the lowest risk of adverse outcomes who do not need close follow up. Over the long term this will help to guide the clinical management of people with CKD, especially those with early stage renal disease in primary care.
Ethical approval for NHS Digital follow-up was received in July 2019 by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 17/YH/0429), and participants have now consented to share their NHS Digital data to allow follow-up for life.
This is a consented study and Article 6 (1) (e) and 9 (2) (j) are used as this work is research in the public interest as it aims to improve care for patients with CKD in the future. It will also help GPs to identify patients at greater risk so they can be monitored more closely.
The data will be pseudonymised when stored and analysed at the University of Oxford Nuffield Department of Primary Care Health Sciences (data controller and processor).
Only aggregated data with small numbers suppressed will be used in publications; no identifiable individual level data will be published. Patients will have provided fully informed written consent for the data linkage. Patients can withdraw their consent for these activities at any time. In such cases no further data will be requested for the patient. Existing data will continue to be used, in accordance with the consent provided.
Expected Benefits:
The planned dissemination will help to guide the clinical management of people with early stage renal disease in primary care. This work will establish predictors of adverse health outcomes and identify those at greatest risk to be prioritised for closer monitoring, medication review or other medical interventions. It will also provide evidence as to whether CKD screening helps to identify additional patients at risk of death, CVD or other poor health outcomes, who may otherwise have been missed.
Dissemination is in the public interest as CKD affects around 3 million people in the United Kingdom and some patients with CKD are more likely to go on to develop adverse health outcomes, including cardiovascular disease, than the general population. Despite how common CKD is, and the inevitable decline in renal function over time, little is known about what predicts more rapid decline in renal function seen by some people, and therefore which conditions should be monitored more closely or when interventions should be considered. Publications focussing on predictors of long term adverse health outcomes in patients with CKD will help raise awareness amongst general practitioners and may lead to changes in practice so that those who are most at risk can be prioritised for closer monitoring and preventative treatments.
Collecting these data will allow the investigators to 1) provide objective estimates of the mortality rate and CVD incidence of CKD patients, 2) estimate and compare the mortality rates and CVD incidence for CKD patients identified routinely by clinical practice, and for CKD patients identified by means of screening, and 3) identify predictors for mortality and CKD incidence in order to help clinicians identify those at greatest risk for closer monitoring, medication review or other medical interventions. It will also identify people at the lowest risk of adverse outcomes who do not need close follow up. Over the long term this will help to guide the clinical management of people with CKD, especially those with early stage renal disease in primary care.
The research aims to benefit patients with CKD and the investigators will also carry out a more limited analysis of the remainder of the cohort who did not have CKD on screening (n=1709) to establish whether the screening data the study team have collected (age, sex, estimated GFR and urinary albumin-creatinine ratio) has any associations with adverse events. This does not include NHS Digital data.
The controller will benefit from recognition associated with the peer review publications.
Outputs:
Apart from direct outputs in terms of new evidence to help identify predictors of adverse health outcomes in an older primary care population with CKD, other outputs will be generated which may include, reports, submissions to peer reviewed journals such as the BMJ, presentations and dashboards. There are 3 potential conferences for presenting the outputs from this work in 2022, Society for Academic Primary Care conference in the UK, NAPCRG North America Primary Care Research Group conference Arizona, US and WONCA Europe (World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians), London 2022. A lay summary of results will also be made available to participants.
All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
The study team will facilitate the dissemination of the research and/or scientific work to stakeholders during the project and after its completion. It is expected that the NewKI study will generate a high number of high impact manuscripts to include the following: Progression and rapid decline of CKD, Biomarkers for the progression of renal decline, Biomarkers for the identification of CVD risk and cost effectiveness of screening for CKD. Dissemination mechanisms will be used appropriate to the relevant audience.
The investigators will ensure that the results of the study are communicated with all relevant parties using multiple channels. The investigators have support from the University of Oxford media team to maximise reach and impact. The study team have also produced a study newsletter for participants to outline key findings from the baseline paper. Participants can also request for a copy of the lay summary of results at the end of the study.
The NIHR SPCR as funders have clear (standard) expectations for data sharing which the University of Oxford are contractually obliged to follow, any onward sharing of data will only be data which is aggregated with small numbers suppressed.
Publications will continue throughout the study.
Two PPI representatives have been involved in the NewKI study steering committee to monitor recruitment and oversee the management of the study. At each stage, the study team have discussed overall study findings, recruitment figures, any planned changes to data collection and the proposed publications with the PPI representatives. The plain English summary of the funding application for this current project to link patient data with NHS Digital was reviewed by the two PPI representatives and they were involved in identifying outcomes which are important to patients.
As the study team generate results from the NewKI study, they have been sharing results with study participants in regular newsletters.
For this current analysis, the study team will be sharing results with the PPI representatives at the regular NewKI study steering committee meetings. When the analysis is complete, the study team will share results in a newsletter to all NewkI study participants.
Processing:
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).
University of Oxford will submit a file containing the identifiers of the consented participants who had a diagnosis of CKD and were recruited to the study (minus any patients that withdraw from the study) to NHS Digital using its secure electronic file transfer system. Identifiers will include: DOB, NHS number. Each participant record will also contain the unique study participant ID number. The CKD cohort will include 902 patients.
HES and mortality data to include date and cause of death for each participant identified in the file submitted by the study team will be returned to the study team. The HES and mortality data flowing from NHS Digital is pseudonymised, however the study team has a participation ID to link the HES and mortality data to data the study team already holds. By means of this re-identification, the HES and mortality data is therefore considered identifiable.
The returned data will be processed and stored by the study team at the University of Oxford who will be undertaking the study analyses to achieve the stated purpose. Access to this data will be limited to authorised personnel from the study team.
The flow of data would involve University of Oxford securely transferring name, NHS number and date of birth to NHS digital to link records.
Linked data from NHS Digital would be transferred back to study team.
Pseudonymised data is processed and only aggregate data will be used to describe the population.
No record level data falling under this agreement will be shared with any third-party.
Only substantive employees of the University of Oxford will undertake data processing activities. Standard employment contractual agreements are in place to cover general data confidentiality requirements of all staff. In addition staff will be required to undergo specific data protection training in accordance with relevant local policies