Chronic kidney disease (CKD) is a long-term condition in which the functioning of the kidneys is impaired. Patients with CKD are treated using haemodialysis (HD), which is a method of replacing the kidney’s blood filtering abilities through use of an external machine. Patients undergoing HD often report an unpleasant itching of the skin, known as pruritus. Severe pruritus can interfere with daily life, leading to loss of sleep, emotional distress, and infections which occur due to persistent scratching. The treatments available for pruritus are often not effective. This study plans to analyse patients with CKD who are receiving HD who report associated pruritus, and explore their risk of death, skin infection, depression, cardiovascular disease (CVD), and sleep disorders. In addition, this study will calculate the costs associated with pruritus in HD patients, as well as the number of medical notes issued, phosphate binding medications prescribed (medications to lower blood levels of phosphate), and HD sessions received. These results will be compared to CKD patients on HD of similar characteristics, who do not develop pruritus. This study will improve patient care by helping healthcare professionals understand the health, resource, and cost impact of CKD-aP in the UK.
Chronic kidney disease associated pruritus (CKD-aP) is common, affecting an estimated 20% of patients with CKD, and 40% of patients with end stage renal disease. CKD-aP has been associated with increased mortality, reduced quality of life, sleep disturbances, mental health conditions, and skin infections as a result of persistent scratching. The treatments available at present for CKD-aP are often not sufficiently effective.
The primary purpose of this study is to characterise the risk of mortality, skin infection, depression, Major Adverse Cardiovascular Events and sleep disorders, in patients from the UK who are receiving HD and suffer from CKD-aP. In addition, this study will calculate the NHS resource use and costs of care associated with HD patients with CKD-aP, and compare the number of fit notes issued, phosphate binding medications prescribed, and number of dialysis sessions attended between the two cohorts.
To achieve this, data from the GOLD and aurum primary care datasets linked to that from HES admitted patient care, HES outpatient, and HES A&E to accurately determine exposures, outcomes, and co-variates. HD patients with CKD-aP will be matched by age (± 2 years), gender, Charlson Comorbidity Index (CCI), ethnicity, duration of HD (± 1 years), route of vascular access, and Index of multiple deprivation, to CKD patients receiving HD without a diagnosis of pruritus. Rates of progression to each primary outcome will be presented and compared using Kaplan Meier curves and Cox proportional hazard models. Generalized linear models will be constructed to compare resource use and costs (Poisson/binomial) and cost (Gamma) between treatments. All multivariable models will be adjusted for baseline characteristics.
This work will increase understanding of the mortality and morbidity risks, and healthcare resource use and costs, associated with development of pruritus in CKD patients on HD.
All-cause mortality (primary);
incidence of skin infections (primary) ;
incidence of depression (primary);
incidence of sleep disorders (primary);
incidence of Major Adverse Cardiovascular Events (MACE) outcomes (primary);
rate of issuance of fit notes (secondary);
rate of HD sessions attended (secondary);
primary care resource use and costs (secondary);
secondary care resource use and costs (secondary);
cost of primary care prescriptions (secondary);
rate of prescriptions for phosphate binders (secondary).
- Chief Investigator -
Benjamin Heywood - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Garth Baxter - Collaborator - Vifor Pharma
Jeevan Virdi - Collaborator - Vifor Pharma
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Practice Level Index of Multiple Deprivation