Step | Content and intermediate goals (in bold) of each step | Who? | |
---|---|---|---|
Part 1 | 1 | Discussion with and approval of the protocol by steering committee and methodological collaborators [e.g. COSMIN, C3 (CHORD/COUSIN Collaboration)] | SC, M, ST |
2 | Definition of scope and applicability for each setting | SC | |
3 | Information, selection, and invitation of participant [including advisory panels/patient (focus) groups]: e.g., health care professionals/researchers, patients, industry representatives and subsequent comprehensive explanation of the protocol to participants | SC, M | |
4 | Development provisional lists for outcome domains/domain items and contextual factors by steering committee and advisory panel based on preparative exercise: revision previous (2015) core domains for trials; definitions (patient focus groups/patient surveys), literature search + items used in existing clinical practice/registries + expert/patient opinions. | SC, PFG, AP | |
5 | Electronic surveys according to e-Delphi technique to score the importance of outcome domain items and contextual factors (maximum 3 rounds) by all participants. | APT | |
6 | A conclusive meeting will be organized to solve remaining disagreements or items with “no consensus.” | APT | |
7 | Process (steps 4–6) will be repeated for each setting to construct 3 core domain sets (clinical trials; registries; clinical practice) | APT | |
Part 2 | 8 | Quality assessment (evaluation of measurement properties) of available instruments for vitiligo (PROMs, ClinROM, and imaging techniques) by COSMIN checklist (updated systematic review). | CG |
9 | Selection of measurement instruments and measurement details (e.g., scale and timing) during consensus meetings guided by HOME and COSMIN recommendations for each setting. | APT | |
10 | A final meeting will be organized to present an overview of the composed 3 dataset and to define the dissemination plan and implementation goals. | APT |