The EWMA Patient Outcome Group has a clinical scientific platform, including both clinicians and representatives from companies working within wound healing.
Discussions and objectives of the group touch upon topics such as structure of treatment as well as more traditional clinical trials and approval and reimbursement of wound care products.
Meetings
The group will meet 2-3 times a year.
For more information about the EWMA Patient Outcome Group please contact EWMA Secretariat at ewma@ewma.org
Primary objectives of the group are to:
- Identify barriers:
- With a starting point in the current debate on evidence in wound healing and the Cochrane levels of evidence, the group will define the primary barriers (as experienced by clinicians and companies) related to creating and implementation of evidence based guidelines in wound healing.
- Propose guidelines for clinical data collection:
- The objective will be to define how existing guidelines for clinical trials (e.g. RCTs or more “practical” studies (real life studies etc.)) can be adapted to wound management, e.g. by including other end points such as number of dressing changes, health economics, QOL, education of staff and structure of treatment.
- Participate in the public debate / policy making:
- The working group should present a common viewpoint on clinical trials of wound management products in relation to the debate on both national and European level. A primary goal will be to influence the decision making processes concerning approval and reimbursement of wound management products. EWMA will act as shareholder and work to influence the national agendas in order to put chronic wounds on the agenda.
- A central European HTA unit is assumed to be established. The working group should approach involved institutions in order to present the work and conclusions of the group in relation to evidence in HTA of wound management products.
- Create and implement consensus:
- Other interested parties (clinicians, companies, reimbursement authorities, European collaborative groups and institutions) should be involved in order to create consensus within the area. A pan European consensus with a national implementation strategy has been proposed.
Members
Clinicians/Individual
Finn Gottrup (Chair)
Jan Apelqvist
Luc Gryson
Zena Moore
Patricia Price
Hugo Partsch
John Posnett
Industry representatives from
Abbott Nutrition
BBraun
ConvaTec
Covidien
KCI
Lohmann & Rauscher
Paul Hartmann AG
Mölnlycke Healthcare
Publications - "Outcomes in controlled and comparative studies on non healing wounds – Recommendations to improve quality of evidence in wound management"
By Finn Gottrup, Jan Apelqvist and Patricia Price
The document was published in the June 2010 issue of the Journal of Wound Care and can be downloaded here
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
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. - The challenge of using randomized trials in wound healing
By Finn Gottrup and Jan Apelqvist
Published in British Journal of Surgery 2010; 97: 303–304
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