Table 1.
Phase 1: Development and validation |
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Stages |
1. Agreement of the research methodologies that could be developed for international use in complex health care systems |
2. Literature review of prevalence study methods and epidemiology |
3. Development of questionnaires for the core and module specialist tools |
4. Development and validation of a classification for chronic edema |
5. Interrater reliability studies (pitting test and classification of chronic edema in different populations) |
6. Construction and testing of the online database |
7. Development of an international protocol and sampling frameworks |
8. Development of a support manual and educational tools |
9. Establishment of quality control mechanisms |
Phase 2: Main study |
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Stages |
1. Epidemiology studies undertaken in all participating sites |
2. Data quality monitoring |
3. Data analysis and reporting |