National and local perspectives in venous leg ulceration: estimating prevalence and mapping referral pathways

Study type
Protocol
Date of Approval
Study reference ID
19_249
Lay Summary

Venous leg ulceration (VLU) describes open wounds caused by poorly functioning veins. These abnormal veins can cause blood pooling, skin damage and open ulcers, which can last many years. People with VLU are at risk of depression and have difficulty with daily activities like work. VLU also costs £2.5 billion every year.VLU is estimated to affect 1 in every 100 people, increasing to 2 out of every 100 in the elderly, however, these figures are outdated or the research was not performed in England.
Most ulcers are managed by community doctors and nurses. Ulcers heal quicker and stay healed longer if patients are referred to hospital for early treatment, which is cost-effective. It is advised that doctors refer patients to hospital if the ulcer has not healed within 2 weeks. The referral often does not happen meaning patients may not receive best treatment. Referral rates across the country vary, the reasons for these differences are unknown. Investigating these may help improve referrals to hospital and patient treatment.

To help explore this, we will use CPRD to describe how many VLU patients are in the community and how many are referred to hospital in different regions in England. This will form part of a larger project that will investigate barriers to referral by evaluating GP questionnaires, nursing and patient focus groups. We will use this information to develop a plan to improve access to hospital care for VLU patients.

Technical Summary

The aim is to investigate the burden of VLU in primary care across different regions in England. To do this we will use a retrospective population-based cohort study design to calculate the 12-month period prevalence, every year, over a 10-year period in CPRD. The study population will be all patients in the CPRD-HES linkage subset within each 12-month interval over the 10-year period. Prevalent cases will be all patients with a Read code corresponding to VLU (see Appendix). Prevalence will then be stratified to deprivation and the geographical region of the patient which will be determined through the Patient Level Index of Multiple Deprivation Domains in CPRD.
Through this retrospective cohort study design, we also aim to estimate the proportion of patients referred for their VLU from primary care to secondary care in each region. Patients who have been referred to secondary care will be defined as patients who either have referral codes in CPRD linked to a VLU encounter or who, through HES data linkage, are found to have been seen in hospital outpatients for their VLU. The number of patients who were referred to secondary care for their VLU will be expressed as a percentage of all VLU patients within that time frame. The proportion of referred patients will be stratified to geographical region.
A further aim is to assess how the referral patterns of VLU has changed since National Institute for Health and Care Excellence (NICE) published guidance on the management of varicose veins and VLU in 2013. The percentage of patients who have been referred to secondary care for their VLU will be calculated for each 12-month period over the 10-year interval of 2008-2018; this represents 5 years before and after publication of the NICE guidance.

Health Outcomes to be Measured

Venous leg ulceration (VLU). This is defined by the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) stages of chronic venous disease as stages C5 and C6, corresponding to healed and active ulceration respectively. Read codes corresponding to these CEAP stages have been identified (see Appendix)
- VLU secondary care referrals

Collaborators

Alun Davies - Chief Investigator - Imperial College London
Safa Salim - Corresponding Applicant - Imperial College London
Aoife Molloy - Collaborator - NHS England
Azeem Majeed - Collaborator - Imperial College London
Layla Bolton - Collaborator - Imperial College Healthcare NHS Trust
Sarah Onida - Collaborator - Imperial College London
Toqir Mukhtar - Collaborator - Imperial College London

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation