Chronic kidney disease (CKD) is a global health burden associated with adverse clinical consequences, some of which include heart or blood vessel (cardiovascular) disease, high potassium levels, low red blood cells, increased cardiovascular death, and progression to worsened outcomes resulting in high healthcare costs and reduced health-related quality of life. Currently, real-life data on the patient journey, including clinical outcomes, disease progression, treatment patterns, healthcare resource utilisation and management of CKD patients is limited. DISCOVER CKD is a novel hybrid observational study which aims to create a global population of high-quality CKD patient data. This includes assessment of the patients historic and future outcomes data that would be captured via mobile and web-based technology, including patient interviews to assess their journey. It will involve patients from the UK, US, China, Japan, Sweden and Italy. Utilising UK clinical practice research database (CPRD) data for the historic anonymised patients records will allow us to evaluate and describe: patient characteristics and diseases, treatment patterns, disease progression, clinical outcomes, healthcare resource use, laboratory tests, care pathway and risk factors in patients with CKD across the UK, then where possible, combine aggregated data with data from other countries to assess differences in clinical management of CKD across the countries. DISCOVER CKD will add value to patients by giving them a voice to tell us of their experiences and may impact clinical guidelines, optimizing management of CKD.
CKD constitutes a major cost burden to healthcare systems worldwide, in the UK costing approximately £1.45 billion annually for patients with CKD stages 3 to end stage renal disease (ESRD). The health burden caused by CKD is likely to grow sharply over the next several years due to an increasing elderly population and the escalating prevalence of comorbid conditions such as type 2 diabetes (T2D). The Global Burden of Disease 2015 study estimated that, in 2015, 1.2 million people died from kidney failure, an increase of 32% since 2005(1). Analysing patient data from several countries (including the UK using the CPRD) will provide regional insights into the real-world patient journey and clinical management of CKD patients. The ambition is that the DISCOVER CKD study will provide the foundation and infrastructure for a large multinational cohort of patients with CKD for pooled or country specific analysis. Additionally, subgroups including but not limited to CKD stage, dialysis status, comorbidity status (e.g. anaemia) and treatment status will be evaluated and described by pooled analysis or country specific analysis.
Methods and analysis plan
All individuals with CKD fulfilling the inclusion criteria and who have at least 1 year of medical history prior to baseline (index) date will be considered. The index date will be either the first documented code of CKD or renal replacement therapy (RRT) on or after 2008 or the 2nd eGFR measure from eligible patients. For analytical purposes, we will include patients in CPRD alone, those also linked to HES data and patients with linkages to other data sources described in section K. CPRD will be combined with retrospective data from other data sources for pooled analysis where time-period coverage and data linkages allow or analysed separately for UK specific analyses and combined with results from other countries.
Clinical outcomes and hospitalisation (for example: incidence, prevalence, time to event and risk [hazard ratios] of clinical events).
Death and cause of death (where available).
Disease progression (for example: eGFR decline, time to ESRD, time to incident anaemia).
Healthcare resource use and cost (using NHS reference cost tables) (for example describe number of hospital visits).
Treatment practice, patterns, medications, and medication adherence (for example: number and percentage of patients on CKD related treatments).
Biochemical (laboratory value) monitoring and trajectories
Risk factors associated with CKD progression, dialysis initiation, comorbidities and clinical outcomes.
Eric Wittbrodt - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Eric Wittbrodt - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Anubhav Kumar - Collaborator - ZS Associates
Chirag Dhawan - Collaborator - ZS Associates
David Wheeler - Collaborator - University College London ( UCL )
Eleni Rapsomaniki - Collaborator - AstraZeneca Ltd - UK Headquarters
Hungta Chen - Collaborator - Astra Zeneca Inc - USA
Jil Billy Mamza - Collaborator - AstraZeneca Ltd - UK Headquarters
Katarina Hedman - Collaborator - AstraZeneca Ltd - UK Headquarters
Matthew Arnold - Collaborator - AstraZeneca Ltd - UK Headquarters
Mina Khezrian - Collaborator - AstraZeneca Ltd - UK Headquarters
Ping Sun - Collaborator - AstraZeneca Ltd - UK Headquarters
Saanidhya Srivastava - Collaborator - ZS Associates
Saheba Kaur Vasdev - Collaborator - ZS Associates
Sanchita Porwal - Collaborator - ZS Associates
Saurabh Sohlot - Collaborator - ZS Associates
Supriya Kumar - Collaborator - AstraZeneca Ltd - UK Headquarters
Tanmoy Bose - Collaborator - ZS Associates
Zoe (Zhuoxin) Jiang - Collaborator - AstraZeneca Ltd - UK Headquarters
Alyshah Abdul Sultan - Collaborator - AstraZeneca Ltd - UK Headquarters
Gabriel Rosenfeld - Collaborator - AstraZeneca Ltd - UK Headquarters
HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation