The aim of this project is to develop an international consensus on a Core Outcome Set (COS) for clinical effectiveness trials of bordered foam dressings in the treatment of chronic wounds, regardless of the study population. Certain subgroups (children, older adults, palliative care, etc.) that comprise this patient population may require a separate COS. This decision will be made following identification and attribution of outcomes in our systematic review, interviews with key stakeholders, including patients, a two-stage online Delphi consensus study with a global stakeholder group and a consensus meeting.
ContributorsCharlotte Raepsaet, Paulo Alves, Breda Cullen, Amit Gefen, José Luis Lázaro-Martínez, Hadar Lev-Tov, Bijan Najafi, Nick Santamaria , Andrew Sharpe, Terry Swanson, Kevin Woo, and Dimitri Beeckman
Disease Category: Skin, Wounds
Disease Name: Chronic wounds (non-healing wounds)
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Other
- Clinical experts
- Consumers (patients)
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
The methods used are those described in the initiative Core Outcome Measures in Effectiveness Trials (COMET).The methods of this investigation involve two steps.
STEP 1: Prepare and establish background and process
STEP 2: Develop a set of core outcomes
Step 2 comprises four phases
1. Literature review
2. Qualitative study
3. Delphi consensus study
4. Consensus meeting