The Chronic Oedema Outcome Measure (ILF-COM) project is aiming to develop an internationally agreed set of outcome measures for patients with chronic oedema.
Background
The ILF has identified a number of key priority areas that are inhibiting the recognition of chronic oedema as a major, emerging public health care problem. These include the need for international epidemiology to provide evidence of the size and impact on health care services. This topic amongst others have been addressed in the LIMPRINT study.
A second aspect that has not received sufficient attention is the lack of agreed international standards and methods for assessing and reporting the outcome of treatment of patients with different forms of chronic oedema.
Challenges of measuring outcome in chronic oedema
The most commonly used primary outcome measure in chronic oedema or lymphoedema trials or studies is changes in limb volume. There are many different methods used and a lack of standardisation. Some studies, particularly in breast cancer, adopt other methods including symptom rating and mixed methods. The diversity of approaches means that it is almost impossible to compare studies. This issue is particularly difficult for reimbursement and healthcare agencies for which limb volume change currently has little or no meaning.
The overall goal for the ILF-COM endeavour is to agree and validate international measures to be used by the lymphoedema community in both clinical practice and research. This should assist in providing robust guidance for reimbursement agencies.
Twelve countries have agreed to be part of the ILF-COM project and all first interviews with each country are now completed. A number of interviews with industry representatives have also taken place about issues surrounding chronic oedema and reimbursement.
International survey
During 2018 and 2019 an international survey is being conducted by active involvement of identified key stakeholders. The survey is currently available in English, Italian, Dutch, Danish, and Turkish and we expect to have French, French Canadian and German translations available in the near future. We invite all interested patients, health care professionals and industry representatives to take part in the survey which can be accessed via this link: https://www.surveymonkey.com/r/CYSCKKT
Please contact for the ILF Secretariat contact@lympho.org for surveys in one of the mentioned translations.
Undertaking the international survey serves several purposes including identifying:
- The range of outcome measures used in different countries and how these are viewed by the reimbursement and/or health care systems.
- The issues that are important to patients as outcomes of care.
- The challenges faced by the medical device industry in gaining reimbursement of products.
- Outcome measures appropriate for use by reimbursement and health agencies, and for use in chronic oedema research.
The international survey has been elaborated by active involvement of key stakeholders during international meetings held during 2018.
Literature Study
Currently taking place is furthermore a comprehensive literature search and review to identify measures used in chronic oedema studies and their limitations, in order to inform the wider methodology of development of the outcome measures.
Publications
The Journal of Wound Care has agreed to publish the findings of the survey, literature search, and issues around reimbursement. Expected publication in late 2019.
Future activities
At the ILF 2019 conference in Chicago between 13 and 15 June, a international poster exhibition will present findings from the project.
Industry support
The ILF-COM project is being developed with support from unrestricted educational grants by 3M, BSN, Thuasne, Sigvaris, Specialbandager, and Tactile Medical.
