The aim of this project was to develop a core outcome set (COS) for clinical efficacy studies of bordered foam dressings in the treatment of complex wounds.
Methods:
The research project followed the Core Outcome Measures in Effectiveness Trials (COMET) initiative and consisted of two phases. The first phase prepared the background and process, while the second phase had three steps: outcome list generation via systematic review and qualitative study, Delphi consensus study, and consensus meeting. The study has been registered in the Core Outcome Measures in Effectiveness Trials database.
Results:
The systematic review resulted in 82 outcomes and 20 additional outcomes were obtained during the interviews. After refinement, 111 panellists from 23 countries rated a list of 51 outcomes. In the following consensus meeting, six outcomes were prioritized to be included in the core outcome set.
Conclusion:
The COS for evaluating the effectiveness of bordered foam dressings in treating complex wounds includes 6 outcomes: "ability to stay in place", "leakage", "pain", "dressing related periwound skin changes", and "change in wound size over time". These identified outcomes are correlated with contemporary bioengineering testing and evaluation methods for dressing performance, which underpins the need for a close multidisciplinary collaboration to advance the field of wound dressings. The use of these outcomes is recommended to improve data synthesis and promote evidence-based practice. Future developments in COS development involve creating measurement instruments and relevant endpoints for these outcomes.
The aim of this project was to develop a core outcome set (COS) for clinical efficacy studies of bordered foam dressings in the treatment of complex wounds.
Charlotte 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: Wounds
Disease Name: Complex wounds
Age Range: 18
Sex: Either
Nature of Intervention: Device
- Clinical experts
- Consumers (patients)
- Researchers
- Service providers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
Consensus meeting
- Delphi process
- Interview
- Literature review
The project consists of two phases and three steps including different research methods. Phase one comprises the preparation and establishment of the background and process, and phase two comprises the development of a core outcome set. Phase two is divided into three steps: (1) the generation of a list of outcomes, including a literature review and
a qualitative study, (2) a Delphi consensus study, and (3) a consensus meeting