Work on developing a core outcome set (COS) for vitiligo began several years ago, and consensus was reached in 2015 on the first core domain set for vitiligo clinical trials (see previous COMET registration). This process involved a global group of physicians, researchers, patients, pharmaceutical companies, payers, and regulatory agencies.
Similar work on a COS for registries and clinical practice, as well as a Core Measurement Set (instruments), remained uncompleted. Furthermore, the Core Domain Set for clinical trials has not been updated since then.
Based on this, the project VITAL was launched in 2020 to continue the work (Vitiligo International Task force for an Agreed List of core data). This project aims to advance the development of a COS for vitiligo clinical trials and to establish internationally accepted COS for registries and clinical practice. These COS will include a core domain set, a core measurement instrument set, and contextual factors such as baseline and treatment-related characteristics.
Our stakeholder group will include over 100 people, including patients. Our stakeholders will be invited from various countries across five continents, making our collaboration truly global.
VITAL project steering committee members (=part of VOICE: Vitiligo Outcome Instruments and Consensus for Evidence) :
Nanja van Geel
Khaled Ezzedine
Amit Pandya
Albert Wolkerstorfer
Viktoria Eleftheriadou
Iltefat Hamzavi
Julien Seneschal
Amit Garg
COSMIN support
Caroline Terwee
CS-COUSIN/CHORD collaboration (C3) methods group adviser
Phyllis Spuls
Collaborative network:
1. Vitiligo Outcome Instruments and Consensus for Evidence (VOICE)
2. Vitiligo Task force (VTF)
3. Vitiligo Global Issue Consensus Conference (VGICC) group
4. Global Vitiligo Foundation (GVF)
5. Vitiligo International Patient Organizations Conference (VIPOC)
6. Global Vitiligo Foundation Support Community (GVFSC)
7. Cochrane Skin - Core Outcome Set Initiative (CS-COUSIN) - Consortium for Harmonizing Outcomes Research in Dermatology (CHORD)-Collaboration (C3)
Disease Category: Skin
Disease Name: Vitiligo
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- COS for registry
- Recommendations for outcome measures (measurement/how)
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Survey
- Systematic review
We will use recognized methodological standards in the field: The Core Outcome Measures in Effectiveness Trials (COMET) Handbook, Harmonising Outcome Measures for Eczema (HOME)-roadmap and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations will be used as a guidance for designing our study. For the quality assessment of the instruments we will rely on the COSMIN-checklist (˜OMERACT filter). Cochrane Skin - Core Outcome Set Initiative and Consortium for Harmonizing Outcomes Research in Dermatology (CHORD) collaboration (C3) will further support our methodology.
This project will consist of two parts. Part 1 will focus on the selection of a core domain set, or ”what to measure” and contextual factors, for each setting based on electronic surveys (e-Delphi technique) and a conclusive consensus meeting by a large group of international stakeholders. Part 2 will include selection of core measurement instruments, or ”how to measure”, and measurement details (e.g., scale and timing) for the core domain sets and contextual factors agreed upon in part 1. Part 2 will be based on consensus meetings.