Introduction
Venous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual's health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU.
Aim
To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment.
Method
Two sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry).
Results
Five outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting.
Recommendations
We recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).
To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment.
ContributorsCo-PI Dr. Georgina Gethin, National University of Ireland, Galway, Ireland.
Co-PI Prof. Andrea Nelson, School of Healthcare, University of Leeds, United Kingdom.
Co-Investigators
Prof Jane Nixon, Leeds Institute for Clinical Trials Research, University of Leeds, United Kingdom
Dr Susan O’Meara, School of Healthcare, University of Leeds, United Kingdom.
Dr Una Adderley, School of Healthcare, University of Leeds, United Kingdom.
Prof. Stewart Walsh, National University of Ireland, Galway, Ireland
Dr. Mary Madden, School of Healthcare, University of Leeds, United Kingdom
Disease Category: Wounds
Disease Name: Venous leg ulceration , Chronic wounds (non-healing wounds)
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Academic research representatives
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Pharmaceutical industry representatives
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
Two sequential, two round e-Delphi surveys were completed. The first stage, a scoping review to identify outcomes reported in VLU RCTs, has been published previously. The results of the scoping review informed the content of the two Delphi studies (stage 2 and 3) reported
here.