To evaluate the management of varicose veins in clinical practice in the UK

Study type
Protocol
Date of Approval
Study reference ID
19_081
Lay Summary

The objectives are to estimate the patterns patient care, healthcare resource use and corresponding costs attributable to managing patients with symptoms from, and signs of, prominent veins in their legs (varicose veins) over 10 years from the time the symptoms and signs are first noted by a doctor or nurse.

The study population will comprise patients who were older than 18 years of age at the time of the first mention of varicose veins in their records and who had at least 10 years follow-up in their clinical record following diagnosis. Patients will be excluded if they were pregnant or had any type of leg ulcer or had any form of cancer when their prominent veins were first noted.

Information will be systematically extracted from the patients’ records including baseline characteristics, other illnesses, healthcare resource use, prescribed medication and the results of managing patients’ symptoms arising from their prominent veins.

The analysis would estimate the percentage of patients who were referred to hospital or a specialist clinic to manage the problem with their veins, the percentage who received treatment for their prominent veins, mean time to referral from first seeing a doctor or nurse about their prominent veins, mean time to treatment from initial diagnosis of the problems with their veins, the frequency of healing and development of any leg ulcers and the NHS cost of managing patients with these prominent veins over 10 years from initial recognition of the problem who were/were not referred to a hospital or specialist clinic.

Technical Summary

The objectives are to estimate the patterns of care, clinical outcomes, healthcare resource use and corresponding costs attributable to managing patients with varicose veins over 10 years from initial presentation.

The study population will comprise patients who were ?18 years of age at the time of initial presentation with varicose veins and who had at least 10 years follow-up in their clinical record following initial presentation. Patients will be excluded if they were pregnant or had any type of leg ulcer or had any form of cancer at the time of initial presentation.

Information to be extracted from the patients’ records includes baseline characteristics, comorbidities, healthcare resource use, prescribed medication and clinical outcomes. Analysis of covariance will be used to adjust for any differences in patients’ baseline characteristics between patients who were/were not referred to a vascular service.

In addition to descriptive statistics, any differences between patients who were/were not referred to a vascular service would be tested for statistical significance using appropriate non-parametric tests. Multivariate logistic regression would investigate relationships between patients’ baseline variables and clinical outcomes. Kaplan–Meier analyses might be undertaken to compare the healing distribution between the two groups.

The analysis would estimate the percentage of patients who were referred to a vascular service, the percentage who received treatment for their varicose veins, mean time to referral and mean time to treatment from initial presentation, and the incidence of a range of clinical outcomes including healing and development of venous ulceration of the lower limb.

NHS reference costs would be assigned to the quantity of healthcare resources utilised to estimate the NHS cost of managing patients with varicose veins over 10 years from initial presentation who were/were not referred to a vascular service, followed by sensitivity analyses to assess uncertainty.

Health Outcomes to be Measured

Baseline characteristics of patients who develop varicose veins; Comorbidities of patients who develop varicose veins; Percentage of patients who were referred to a vascular service; Percentage of patients who received treatment and the time to the start of treatment following initial presentation/diagnosis of varicose veins; Distribution of healthcare costs associated with managing varicose veins; Clinical outcomes associated with managing a cohort of patients with varicose veins who were referred to a vascular service; Clinical outcomes associated with managing a cohort of patients with varicose veins who were not referred to a vascular service.

Collaborators

Julian Guest - Chief Investigator - Catalyst Health Economics Consultants
Julian Guest - Corresponding Applicant - Catalyst Health Economics Consultants
Graham Fuller - Collaborator - Catalyst Health Economics Consultants
Peter Vowden - Collaborator - Bradford Teaching Hospitals Foundation Trust (bthft)
Robert Bawden - Collaborator - Lindsay Leg Club Foundation

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient