Impact case study database

The research impacts are multifaceted, manifesting in the development of improved national and International guidelines ( 4.1), significant improvements in patient treatment and the provision of these services ( 4.2), whilst delivering economic benefits to medical device companies providing minimally-invasive interventions for varicose veins (VV) and vascular leg ulcers (VLU) (4.3).

4.1 Supporting National & International treatment guidelines

UoH research has been used to underpin national and international treatment guidelines both promoting an increase in the number of patients offered treatment and shaping the recommendations of what that treatment should be. Four UoH studies were cited (including References 1 and 4) as significant sources of evidence for the NICE guidelines updated in 2016 on diagnosis and management of varicose veins (CG168) ( Evidence 1i, ii). Prior to this, there was inconsistency about which patients were referred for treatment and about which treatments were most appropriate. The 2001 guidance provided the basis for referral only when VV resulted in complications, and at that point open surgery was the standard intervention. The new guidelines, based on UoH work, introduced two key changes: Endothermal ablation (ETA) is now the preferred first line intervention for VV; and that the QoL and cost effectiveness benefits, mean that the recommendation is for all symptomatic patients to be referred for vascular treatment, irrespective of complications.

In 2015 the European Society for Vascular Surgery released its own practice guidelines for Europe. The UoH studies were again used to support the preferential use of endothermal techniques over all other treatment options ( Evidence 2). In 2018 The Royal Society of Medicine released guidelines on the management of VLUs, and using evidence from the EVRA trial (Reference 7), for the first time these guidelines incorporated a recommendation that all patients amenable for endovenous treatment should receive this, and that it should be delivered expeditiously ( Evidence 3).

4.2 Impact on clinical care and policy implementation

In the UK in 2000 open surgery for VV or VLU accounted for 97% of the surgical procedures undertaken in the UK NHS. By 2019/20 this had dropped to 23%, and ETA had risen to 50% ( Evidence 4). The revised guidelines, based on UoH work, also served to increase the total number of procedures performed. These had fallen from 55,609 in 1998 to 24,300 in 2012, but rose again to 33,439 by 2016. The global trend has mirrored these findings, but with a significantly higher rate of growth overall than seen in the UK NHS ( Evidence 5).

The NHS introduced the mandatory collection of Patient Reported Outcome Measures (PROMs) for a number of treatments in 2009, this included for the treatment of VV. This real-world data demonstrated that following the NICE-approved, minimally-invasive, venous treatment discussed above in section 4.1, over 80% (5,260 of 6,575) patients reported significant improvements in QoL in 2018. This compares very favourably against other healthcare interventions and was not only reflected in disease-specific measures, but also the generic health questionnaire, EQ5D, which demonstrated a significant gain in Quality Adjusted Life Years ( Evidence 6i, ii). These outcomes clearly demonstrate the impact of UoH research on patients, through the adoption into guidelines and thus clinical practice.

UoH policy research has highlighted the barriers in access to care that are present across the UK. This work was included in a recent publication by the All Party Parliamentary Group on Vascular and Venous Disease ( Evidence 7) and the evidence was quoted during a debate on the floor of the House of Commons on 23^rd July 2019 by Ann Clwyd MP. These events and the evidence based guidelines from the Royal Society of Medicine, co-authored by Dr Carradice, resulted in efforts by NHS England to incentivise the care of these patients through the establishment of an NHS CQUIN (Commissioning for Quality and Innovation) scheme. This will support further improvements in the care of patients with VLU nationally ( Evidence 8).

4.3 Benefits to the healthcare technologies sector

The evidence from UoH has helped unlock brand new markets for minimally-invasive technology in the management of VV and VLU, especially through working with Medtronics, the world’s leading medical technology company. The Senior Director of Global Medical Science | Endovenous states “ Minimally-invasive endovenous treatments of varicose veins for chronic venous disease have revolutionized the treatment of patients globally. The University of Hull’s research helped to outline these benefits and drive changes in national guidelines culminating in a change of practice. This technology has subsequently improved the quality of life and outcomes of a large population of patients. As a market leader in catheter based endovenous technologies for treating chronic venous disease, we are focused on innovation and research to expand minimally invasive innovation to improve the quality of life for all patients with venous disease…....Our market estimates that the global opportunity for Chronic Venous Insufficiency (CVI) is over 7 million patients per year, of which nearly 4 million are within the US and Europe.” (Evidence 9) Medical device Industries have continued to refine existing products, Medtronics offer ClosureFast™ and the VenaSeal™, and there has been a proliferation of new companies and technologies all aiming to improve the outcomes and applicability of this treatment paradigm. Thus, there has been a tremendous growth in the global market for these new technologies from a negligible base at the commencement of UoH’s research programme in 2006; the revenue from a single modality of treatment (EVLA) in 2016 was US$ 273.6 million and market analysis predicts that this will grow to an estimated US$ 550 million by 2026 ( Evidence 10).