Improving chronic kidney disease identification and assessing its association with health inequalities in coding practices
| ISRCTN | ISRCTN16150211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16150211 |
| Integrated Research Application System (IRAS) | 357027 |
| Sponsor | Lancashire Teaching Hospitals NHS Foundation Trust |
| Funder | Lancashire Teaching Hospitals NHS Foundation Trust |
- Submission date
- 16/04/2026
- Registration date
- 22/04/2026
- Last edited
- 21/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Chronic Kidney Disease (CKD) is a global public health problem. It is a long-term condition that gradually damages the kidneys and can lead to serious health problems if not detected early. It is defined as a sustained reduction in the glomerular filtration rate (GFR) of less than 60 ml/min/1.73m2 for 3 months or more, and/or urinary abnormalities or structural abnormalities of the kidney tract. All patients with CKD should be coded in their primary care electronic health records. Accurate coding supports pathways that ensure regular review and monitoring through the CKD register and enhance safe prescribing via automated decision-support alerts.
However, CKD is often under-recorded in primary care because systems may lack reliable disease detection tools, and GPs may not have full access to hospital blood and urine results. As a result, some patients miss essential care, while others are incorrectly coded as having CKD when they do not. These issues are more common in socially deprived areas and among ethnic minority groups, where CKD prevalence is higher.
This project aims to transform CKD detection through a data-driven tool that addresses coding inaccuracies, health inequities, and economic burdens. The early stage of the study consists of three parts:
1) Development and pilot testing of a novel CKD detection algorithm designed to identify undiagnosed CKD cases and incorrect CKD coding.
2) Optimisation and validation of the algorithm to improve CKD classification accuracy by enhancing its sensitivity and specificity.
3) Analysis of kidney care inequalities by comparing coded and uncoded CKD groups, stratified by socioeconomic status, age, sex, ethnicity, other health conditions (comorbidities) and major complications related to CKD (sequelae) including cerebrovascular disease.
Who can participate?
Adult volunteers aged 18 or over (and no upper age limit) who are registered with GP practices located within Lancashire & South Cumbria (L&SC).
What does the study involve?
This study uses existing health records and does not involve any direct patient contact activity. The study comprises the collection of information that is already routinely recorded as part of standard care. Once the CKD detection algorithm is validated in the real-world population, the next step will be to implement it across Lancashire and South Cumbria. The algorithm will then be compared against current practice to assess its impact on clinical outcomes and economic implications. For example, improved CKD coding could prompt timely medication reviews, ensuring that patients receive appropriate treatments, such as sodium–glucose co-transporter 2 (SGLT2) inhibitors, to help slow disease progression. By identifying and coding patients who were previously missed from CKD registers, the tool may also help reduce the financial burden associated with CKD complications, including late presentation with kidney failure requiring urgent dialysis, unplanned hospital admissions, and mortality. Additionally, it may support earlier referral to secondary care services when needed.
What are the possible benefits and risks of participating?
The study aims to improve the detection and coding of CKD in primary care electronic health records. Conversely, patients who have been incorrectly coded as having CKD could be identified and removed from the register, avoiding unnecessary interventions. This would reduce the workload for GPs and provide reassurance to patients. A cost analysis will also be conducted to estimate savings resulting from fewer unnecessary or duplicated appointments and investigations.
As there will be no direct patient contact for research purposes, there will be no risk of intrusion, inconvenience, or any change in the relationship between participants and their general practitioner or kidney specialists (if they are under specialist care).
The main potential risk relates to data confidentiality. To minimise this risk, strict measures will be in place throughout the study:
- Participating GP practices will provide only the NHS numbers of their registered patients and their CKD registers to enable the CKD detection algorithm to run. No other identifiable information will be required from primary care providers.
- The research team will only access identifiable information on a strict need-to-know basis.
- All data will be stored and shared securely using approved platforms within Lancashire Teaching Hospitals NHS Foundation Trust (LTHTR), such as secure email and Microsoft shared folders linked to LTHTR accounts.
- Lower-layer Super Output Area (LSOA), rather than postcode, will be used to assess socioeconomic status to better maintain anonymity.
With these safeguards in place, the risk to participants is considered very low.
Where is the study run from?
Renal Department, Royal Preston Hospital, UK.
When is the study starting and how long is it expected to run for?
April 2026 to July 2028.
Who is funding the study?
Lancashire Teaching Hospitals NHS Foundation Trust, UK.
Who is the main contact?
Dr Wing Yin Leung, w.leung@nhs.net.
Contact information
Principal investigator, Scientific, Public
Renal Department
Royal Preston Hospital
Preston
PR2 9HT
United Kingdom
| 0000-0003-4191-2762 | |
| Phone | +44 1772 716565 |
| wingyin.leung@lthtr.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Data-only observational study |
| Scientific title | Algorithm-based approach to CKD identification and its association with health inequalities in coding practices |
| Study acronym | CKD-ID |
| Study objectives | Objectives This study aims to answer the key question: Can a new algorithm improve the identification of Chronic Kidney Disease (CKD) in primary care? Primary objective 1. To develop, test and refine a novel CKD detection algorithm using longitudinal kidney test data to accurately identify CKD and optimise coding accuracy in primary care electronic health record. Secondary objective 1. To analyse inequalities in kidney care by comparing patients who have CKD correctly recorded (“coded”) in their primary care records with those who do not. The comparison will consider factors such as socioeconomic status, age, sex, ethnicity and comorbidities. We are particularly interested in whether missing CKD coding is linked to major complication related to CKD (sequelae), such as stroke or heart-related problems. |
| Ethics approval(s) |
1. Approved 05/03/2026, North East - Newcastle & North Tyneside 1 Research Ethics Committee (REC) (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +442071048384; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 26/NE/0030 2. Approved 05/03/2026, Confidentiality Advisory Group (CAG) (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44207 104 8353; cag@hra.nhs.uk), ref: 26/CAG/0026 |
| Health condition(s) or problem(s) studied | Chronic Kidney Disease |
| Methodology | This project aims to transform CKD detection through a data-driven tool that addresses coding inaccuracies, health inequities, and economic burdens. The early stage of the study consists of three parts: 1. Development and pilot testing of a novel CKD detection algorithm designed to identify undiagnosed CKD cases and incorrect CKD coding. 2. Optimisation and validation of the algorithm to improve CKD classification accuracy by enhancing its sensitivity and specificity. 3. Analysis of kidney care inequalities by comparing coded and uncoded CKD groups, stratified by socioeconomic status, age, sex, ethnicity, other health conditions (comorbidities) and major complications related to CKD (sequelae), including cerebrovascular disease. The study does not involve any patient contact and uses existing health records only. There is no additional sample or collection of data beyond what is routinely generated during standard care. How the participants' data is handled during the study (full details can also be found in the Protocol 6.4 Overview of data): GP practices securely send NHS numbers and CKD registers for all registered patients to the research team under Section 251 approval. No other identifiers are shared. Once received, NHS numbers are immediately converted into unique pseudo IDs within secure LTHTR systems. After conversion, all processing and analysis use only pseudo IDs. The original NHS number file is stored separately in an encrypted, access-restricted area. Laboratory results from the OMOP database are linked using pseudo IDs to combine serial tests for each patient. All data processing takes place within the Lancashire and South Cumbria Secure Data Environment. A pseudonymised analysis dataset is then created containing pseudo IDs, lab results, demographics, and comorbidity information. This dataset supports CKD algorithm development, performance testing, and inequalities analysis. All analyses use pseudonymised data only. Algorithm outputs remain pseudonymised unless clinical verification is required. When verification is needed, secure re-linkage to NHS numbers occurs within the SDE so GP practices and specialists can review results. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 19/07/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 60000 |
| Key inclusion criteria | 1. Adults aged 18 or over (and no upper age limit) 2. Patients registered with GP practices located within Lancashire & South Cumbria (L&SC) participating in the study 3. No other specific inclusion criteria apply |
| Key exclusion criteria | 1. Patients under the age of 18 2. Patients registered with GP practices outside Lancashire & South Cumbria (L&SC) 3. No other exclusion criteria apply |
| Date of first enrolment | 20/04/2026 |
| Date of final enrolment | 19/04/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
England
Adlington Medical Centre, Chorley PR6 9NW
Chorley
PR7 7HZ
England
Longridge
Preston
PR3 3AP
England
Kepple Lane
Garstang
Preston
PR3 1PB
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | version 1.1 | 10/02/2026 | 21/04/2026 | No | No |
| Protocol file | version 1.1 | 10/02/2026 | 21/04/2026 | No | No |
Additional files
- 49377_Data Flow Chart_v1.1_10Feb2026.pdf
- Other files
- 49377_Protocol_v1.1_10Feb2026.pdf
- Protocol file
Editorial Notes
17/04/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).