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.
A qualitative study to explore the challenges faced by the medical device industry in the development of compression and reimbursement were conducted. Twelve countries agreed to be part of the ILF-COM project and all first interviews with each country are now completed. Furthermore, eight companies who produce compression therapy and have expertise in reimbursement took part in 11 individual semi-structured interviews. Data was analysed using Interpretative Phenomenological Analysis (IPA). Results are presented in a special supplement to the Journal of Wound Care published in November 2021.
International survey
During 2018 and 2019 an international survey was conducted by active involvement of identified key stakeholders. The survey was available in several translations and was completed with 8,014 respondents including patients, healthcare professionals and industry representatives from 61 countries including 12 framework countries. The international survey was elaborated by active involvement of key stakeholders during international meetings held during 2018.
Undertaking the international survey served 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 Challenges faced by the medical device industry in gaining reimbursement of products
- The issues that are important to patients as outcomes of care.
- Outcome measures appropriate for use by reimbursement and health agencies, and for use in chronic oedema research.
Scoping review
A scoping review mapping current chronic oedema and lymphoedema outcome measures is currently being undertaken. The project team completed abstract screening (7,818 studies) and is currently reviewing full texts. The review is expected to be completed in 2022. Results from the scoping review will be presented at the 2023 ILF Conference.
Phase 2
ILF-COM project phase 2 is focused on developing a chronic oedema and wound care tool based on the results of phase 1. Phase 2 includes the following steps:
- 2-round Delphi study
- Ethical approval UK July 2020 of inter-rater reliability study (to be undertaken when possible after COVID-19)
- Ethical approval for a repeat study in Copenhagen (Autumn 2020
- Validation of a chronic oedema/complex wound outcome measure
- International development and validation within the national frameworks.
The validation of a chronic oedema/complex wound outcome measure will include an international development and validation within the national frameworks.
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