This analytical observational matched cohort study using CPRD Aurum data and linked HES-ONS data aims to estimate the incidence and prevalence as well as the underlying aetiology, diagnostic procedures, treatments, healthcare resource utilization (HCRU) and costs related with first time vascular ulcers.
The study population will include individuals aged 18 to <90 at risk for an incident vascular ulcer between April 2013 and the most current data available.
The study cohort will consist of patients with a first time vascular ulcer comprising venous ulcers (superficial or deep venous ulcers), arterial ulcers and mixed arterial and venous ulcers. A propensity score and calendar day matched group of patients in the study population without vascular ulcer will be identified and used as reference group for determination of incremental HCRU and costs related with a first time vascular ulcer.
Patient characteristics will be presented using number and proportions for categorical variables and mean, standard deviation for continuous variables. Crude incidence rates for vascular ulcers will be calculated from the number of patients with a first vascular ulcer divided by total sum of person time at risk in the study population. Prevalence rates of vascular ulcers will be calculated assuming exposure to a vascular ulcer from the initial ulcer diagnosis until the end of observational period. HCRU rate differences between the 2 matched patient groups will be calculated for each HCRU component and these differences will be multiplied with HCRU component-specific costs to estimate the additional costs of the vascular ulcer event. Analyses will be stratified by type of vascular ulcer, calendar year, age and gender.
The study outputs will allow clinicians and patients to have a stronger evidence base for the incidence, risk factors and types of vascular ulcers, to plan for prevention and more effective and less costly treatment.
Additional (incremental) costs related with first time vascular ulcers.
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Alexander Cohen - Collaborator - King's College London (KCL)
Carlos Martinez - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Serena Granziera - Collaborator - San Giovanni and Paolo Hospital
Stephan Rietbrock - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Stephen Black - Collaborator - Guy's & St Thomas' NHS Foundation Trust
HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation