A new pan-European initiative, the European Venous Registry, was launched at this years European Venous Forum (EVF) meeting in London. This registry has been designed to focus on patients with venous insufficiency, recording data at the individual patient record level, to include the patients pre-treatment risk factors and comorbidities, both medical and surgical treatment modalities and the final outcome. It is the result of close collaboration between the European Vascular Forum, the Vascular Independent Research and Education European Organisation (VAS), based in Italy, and Dendrite Clinical Systems.
In the past, vascular surgery audit largely focused on the treatment of arterial disease, even though symptomatic venous insufficiency is known to affect up to 15% of men and around 25% of women in the UK. Recent years have seen significant changes in the way venous disease is managed: advances in technology such as endoluminal laser treatment, radio-frequency ablation and foam sclerotherapy have added a string of new weapons to the clinicians armoury. The significant changes in treatment methodologies and in clinical pathways have all driven a renewed interest in using routine data-collection across Europe to compare and contrast treatments.
For example, it is widely believed that there is a great deal of variation in the use of compression hosiery for this patient-group. Early analyses of data from the European Venous Registry could be used to determine the extent of such variation and to examine any relationship between this treatment and patients outcome.
The Registry is a web-based system, which means that clinicians can use any computer that has internet access to enter data. There is no upper limit on the number of cases that you can add to the registry,and the Database Committee would like to encourage all those who are interested and motivated to input any historical data that they might have recorded elsewhere.
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At present adding data to the registry is entirely voluntary and the Database Committee hope that all who have an interest in this area of patient-care would be keen to participate. However, recently published National Institute for Health & Clinical Excellence (NICE, United Kingdom)guidelines stated that any clinician using techniques such as laser therapy, sclerotherapy or radio-frequency ablation (RFA) must follow the normal arrangements in place for consent,audit and clinical governance which amounts to a forceful suggestion that clinicians enter data into a registry.
Speaking at the European Venous Forum, Mr Alun Davies, President of the EVF, commented We hope that by establishing the Venous Registry we can collate information on the natural history of venous disease and the treatment patterns across Europe. Participation is voluntary and we would hope to generate interest and have at least 1,000 contributors.
The Venous Registry should see the first test cases entered into the system by Autumn of 2007. It will initially cover seven treatments and procedures:
compression therapy
deep vein reconstruction
drug therapy
endoluminal laser ablation
foam sclerotherapy
traditional surgery
radio-frequency ablation
If you would like to view the registry homepage in the meantime, please visit http://ivr.e-dendrite.com to see a demonstration version.
The Committees aspiration is that the registry will eventually expand to include all treatments and procedures for patients with venous disorders. As Alun Davies went on to say Thusfar, the Registry has the support of the EVF, the Venous Forum at the Royal Society of Medicine [United Kingdom] and the American Venous Forum, in principle; and the response from industry, as well as clinicians, has been very positive indeed.
A key aim of the Venous Registry is to produce an annual publication similar to the National Vascular Database Reports and Adult Cardiac Surgical Database Reports collaborations between Dendrite Clinical Systems and the Vascular Society of Great Britain & Ireland and between Dendrite and the European Association for Cardio-Thoracic Surgeons respectively.
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The intention is that the report will describe the patientpopulation in terms of demographic, risk factors and comorbidities and the treatments methodologies that are being deployed in each country that is represented in the database. Dr Peter Walton, Dendrites Managing Director, said at the launch meeting;
...Initially, the data will be published as simple analyses to demonstrate that the whole project is feasible. It is designed to give us broad demographic comparisons.
For example, in France we think there is much more drug therapy prescribed for venous disease than in England - so just looking at the most basic comparisons of treatment patterns should be interesting.
In addition, we will also be able to look at the demographics and risk factors in different populations...
Dr Walton went on to stress that the EVR is subject to the same caveats as any other observational database: it is not a controlled trial and therefore any results from the database must be treated with great caution, especially concerning the differences in outcomes from different treatments, from country to country. One key aspiration for the registry is that it will drive the focus for future randomised controlled trials in this arena. Dr Walton summarised these viewpoints succinctly as:
conclusions reached by analyses generated from data in the European Venous Registry will be hypothesis generators, rather than hypothesis solvers...
As with all of Dendrites collaborations with local hospitals, National and International Specialist Societies, it is crucial that the data in the EVR will be owned by the Societies involved and the participants.
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