EWMA Document on evidence and outcome measures

Project period: 2009–2010

The document "Outcomes in controlled and comparative studies on non healing wounds – Recommendations to improve quality of evidence in wound management" is written by Finn Gottrup, Jan Apelqvist and Patricia Price. It was published in the June 2010 issue of the Journal of Wound Care.

The initiative to produce this document was taken by the EWMA Patient Outcome Group (EWMA POG)

The document is summarized in a pixi version.

Document aim

The aim of the document is to provide recommendations on the accepted level of rigour for studies in wound management and to develop a consistent and reproducible approach to define, evaluate and measure appropriate and adequate outcomes in RCTs as well as clinical studies.

The document provide statements on how to improve evaluations of new treatment strategies with regards to outcome to meet the need for evidence based information in wound management. It also describes the particular considerations that have to be recognised when evaluating treatment strategies in non healing wounds.

Appendix and extended literature lists

A list of literature included in the statistics on use of endpoints in comparative studies and RCTS (2003-2009) can be downloaded here

Appendix referred to in the document can be downloaded here:

Appendix 1: Norms and parameters for wound dressings (selection)

Appendix 2: International regulations for clinical investigation with medical devices

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