The CoreVen project aims to determine what outcomes are really important and should be included as core for any trial evaluating treatment effectiveness in venous leg ulceration. An outcome is a measurement used to assess the effect of a treatment such as the assessment of effectiveness (benefits) or side effects (risk). The current problem is that the types of outcomes reported vary considerably across trials and as a result it is very difficult to determine treatment effectiveness from the overall body of evidence. The application of a core outcome set has the potential to facilitate the comparing, contrasting and synthesising of outcome data across trials. This can make research evidence accessible to those involved in clinical decision making. The advantage of easier decision making will benefit patients’ treatments by enabling a clearer judgement on the intervention that is being provided.
A two-round online survey has explored consensus on which domains are important. Domains are broad, descriptive categories under which several, more specific, outcomes might be grouped. We now need to decide which specific outcomes, falling within the domains, are important.
We would like to invite you to contribute to a two-round online survey so that we can gain agreement on which outcomes should be presented in future venous leg ulcer trials. The domains that were rated as important are as follows:
- Patient reported symptoms
- Clinician reported symptoms
- Life impacts
- Clinical signs
- Clinical measurement
- Performance of the intervention
- Resource use: supplies
- Resource use: clinician time
- Adverse events
It will take approximately 25 minutes to complete the round 1 survey and approximately 20 minutes to complete the round 2 survey. Details of the round 2 survey will be sent via email once the results from the round 1 survey have been analysed.
The School of Healthcare Research Ethics Committee, University of Leeds, UK, has granted approval (HREC17-028). A copy of the ethics approval documentation can be forwarded to you on request.
If you would like to take part or would like more information please contact Sarah Hallas (PhD student on the project) by sending an email to firstname.lastname@example.org.