COMET Initiative | Study protocol for the development of a core outcome set (COS) for clinical effectiveness trials of bordered foam dressings in the treatment of complex wounds

Study protocol for the development of a core outcome set (COS) for clinical effectiveness trials of bordered foam dressings in the treatment of complex wounds

No abstract

Aim

The study aims to develop a COS, which recommends what outcomes should be measured and reported as a minimum, for clinical effectiveness trials of bordered foam dressings in the treatment of complex wounds

Contributors

Charlotte Raepsaet, Paulo Alves, Breda Cullen, Amit Gefen, Jose Luis Lazaro-Martínez, Hadar Lev-Tov, Bijan Najafi, Nick Santamaria, Andrew Sharpe, Terry Swanson, Kevin Woo, Dimitri Beeckman

Publication

Journal: Journal of Tissue Viability
Volume: 31
Issue:
Pages: 625 - 629
Year: 2022
DOI: 10.1016/j.jtv.2022.09.004

Further Study Information

Current Stage: Ongoing
Date:
Funding source(s): The current work of the International Wound Dressing Technology Expert Panel was supported by an educational grant from M ¨olnlycke Health Care (Gothenburg, Sweden).

Health Area

Disease Category: Wounds

Disease Name: Complex wounds

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Device

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Researchers
- Service providers

Study Type

- COS for clinical trials or clinical research

Method(s)

- 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