Hyperkalaemia describes abnormally high blood potassium levels and without appropriate treatment can lead to poor clinical outcomes and increased use of health resources. Accurate information on the impact of hyperkalaemia on patient outcomes and costs can be used to improve the delivery of healthcare services for individuals with the condition.
In this study we will analyse a group of patients with hyperkalaemia and a group of patients without the condition. We will then investigate whether the group of individuals with hyperkalaemia uses the healthcare system more frequently than the group without hyperkalaemia. We will also investigate whether any differences in the frequency of use of the health system lead to differences in the costs of treating the two groups of patients. Finally, we will investigate whether the frequency of significant events, including heart diseases and death, differ between the two groups. Our analysis will attempt to account for reasons other than hyperkalaemia that may lead to differences in outcomes between the two groups such as changes in the dose of renin-angiotensin-aldosterone system inhibitors (treatment used for common comorbidities such as chronic kidney disease and heart failure) and the analysis will also explore these research questions within specific groups of patients in whom the results may differ, namely those with long term kidney disease and those with heart failure.
Hyperkalaemia describes abnormally high blood potassium levels above 5.0mmol/L and without appropriate treatment can lead to adverse clinical outcomes and increased utilisation of health resources. Accurate information on the incremental risk to patients and cost to the healthcare system associated with the condition allows for the appropriate planning of healthcare resources and accurate assessment of the benefits of new technologies designed to treat the condition. This study will analyse hyperkalaemia and non-hyperkalaemia patients and compare healthcare resource utilisation and costs between the two patient groups.
Annual utilisation counts (such as GP visits, hospitalisations and outpatient visits) and costs in the year prior to the serum potassium test and in the subsequent 10 years will be captured and compared using generalised linear models and generalised estimating equations. Analyses will also be stratified by setting (i.e. primary care, outpatient visit). The hazard of clinical outcomes including time to subsequent hyperkaliaemic event, major adverse cardiac event, dialysis and death will be compared between the hyperkalaemia and non-hyperkalaemia patients groups using Cox proportional hazard regression. We will seek to account for differences in the demographic and clinical profile of patients in the two groups by including a number of key prognostic variables available in the databases in the analyses.
Subgroup analyses will repeat the above analyses in individuals with (a) a prior diagnosis of stage 3-5 non-dialysis chronic kidney disease (stage 3-5 ND-CKD) and no prior diagnosis of heart failure (HF), (b) a prior diagnosis of HF and no diagnosis of stage 3-5 ND-CKD and (c) a prior diagnosis of HF and stage 3-5 ND CKD.
Health Care Resource Utilisation (HCRU) outcomes
GP visits
Outpatient visit
Hospitalisations
Prescriptions
Emergency admissions
Clinical outcomes
Time to subsequent hyperkalaemia
Major adverse cardiac event (MACE)
Death
Dialysis
Michele Intorcia - Chief Investigator - Vifor Pharma
Cormac Sammon - Corresponding Applicant - PHMR Associates Limited ( UK )
Megan Besford - Collaborator - PHMR Associates Limited ( UK )
Mihail Samnaliev - Collaborator - Maverex Ltd
Nadav Zadok - Collaborator - Vifor Pharma
Sharada Weir - Collaborator - Maverex Ltd
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data