Morbidity, mortality, resource use, and financial cost of pruritus in chronic kidney disease patients in the UK general population: a retrospective matched cohort study

Date of Approval
Application Number
21_000469
Technical Summary

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.

Health Outcomes to be Measured

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).

Collaborators

- Chief Investigator -
Melissa Perry - Corresponding Applicant - 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

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Practice Level Index of Multiple Deprivation