A systematic review on outcomes in vitiligo trials showed that 25 different outcomes had been measured in 54 randomised controlled trials.2 Although repigmentation was measured in 94% of trials, 48 different scales were used to measure it, making comparison among trials impossible. A second systematic review on outcome measures was conducted in order to summarize and critically appraise the evidence on the measurement properties of clinician-, patient-, and observer-reported outcomes measures scales. The Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) 4-point checklist, combined with quality criteria for measurement properties, was used to calculate the overall level of evidence per measurement property of each instrument. The authors of the review concluded that none of the scales used was validated.
Scope of the intended COS
- Study types: e.g. RCTs
- Region, e.g. global scope
An international e-Delphi consensus on core outcomes set (COS) for vitiligo was conducted. One hundred and one participants from 25 countries worldwide took part. The following outcomes were identified: Core outcomes set (essential): Repigmentation; Side effects and harms; Maintenance of gained repigmentation. Core outcomes set (recommended): Cosmetic acceptability of the results; Quality of life; Cessation of spreading of vitiligo; Tolerability or burden of treatment.
A second e-Delphi consensus, with an aim to gain agreement on how to best measure repigmentation in target lesions in future randomised controlled trials (RCTs), was conducted. This international e-Delphi involved 94 panellists (patients, clinicians, journal editors) and reached a response rate of 94%; however, no agreement was reached on the best outcome measure to assess target repigmentation. The results of the second e-Delphi were presented at the International Pigment Cell Conference (Singapore) and following a prolonged face to face meeting and confidential voting amongst the Vitiligo Global Issues Consensus group (VGICG)of international experts (clinicians, researchers, journal editors), an agreement was reached on the definition of successful percentage of repigmentation as being greater that 80%. Following the above, the VGICG in collaboration with the Cochrane Skin Group- Core Outcome Set Initiative (CSGS-COUSIN) recommended that a workshop with patients needed to be conducted in order to overcome the disagreement amongst stakeholders’ groups (patients, clinicians and journal editors).
We conducted 3 workshops with vitiligo patients and their parents/care givers. Workshop 1: World Vitiligo Day (Detroit, MI); Workshop 2: the University of Texas Southwestern Medical Centre; Workshop 3: Vitiligo and Pigmentation Institute of Southern California, University of California. Seventy three participants were recruited. Consensus on the following questions was achieved unanimously:
- Definition of “successful repigmentation” was 80-100% of repigmentation of a target lesion.
- Both an objective and a subjective scale to measure repigmentation should be used.
This was the largest patients’ outcomes workshop. We followed the HOME roadmap, guidance from the CSG-COUSIN and the Vitiligo Global Issues Consensus Group (VGICG). Our recommendation to use of percentage of repigmentation quartiles (0-25%, 26-50%, 51-79%, 80-100%) and the vitiligo noticeability scale are based on the best available current evidence.
Involvement of stakeholders
patients, clinicians, journal editors
COS defined, scale to measures repigmentation
Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Colombia, Egypt, France, Germany, Greece, India, Italy, Mexico, Morocco, Netherlands, Saudi Arabia, Spain, Taiwan, Tunis, United Arab Emirates, United Kingdom, and United States of America.
Date of updates
- Dr Viktoria Eleftheriadou
- Prof Khaled Ezzedine
Project team members
- I. Hamzavi
- A. Pandya
- P. Grimes
- J.E. Harris
- R.H. Huggins
- H.W. Lim
- N. Elbuluk
- A. Tovar-Garza
- A.F. Nahhas
- T. Braunberger
- N. van Geel
- M. Picardo
- A. Taieb
Responsible member of Methods group (as assigned by CS-COUSIN)
- Dr. Jan Kottner
1. Eleftheriadou V, Hamzavi I, Pandy AG, Grimes P, Harris JE, Huggins RH, Lim HW, Elbuluk N, Bhatia B, Tovar-Garza A, Nahhas AF, Braunberger T, Ezzedine K. International Initiative for Outcomes (INFO) for vitiligo: workshops with patients with vitiligo on repigmentation. Brit J Dermatol. 2019;180(3):574-579.
2. Eleftheriadou V, Thomas K, van Geel N, Hamzavi I, Lim H, Suzuki T, Katayama I, Anbar T, Abdallah M, Benzekri L, Gauthier Y, Harris J, de Castro CCS, Pandya A, Goh BK, Lan CCE, Oiso N, Al Issa A, Esmat S, Le Poole C, Lee AY, Parsad D, Taieb A, Picardo M, Ezzedine K, G VGIC. Developing core outcome set for vitiligo clinical trials: international e-Delphi consensus. Pigm Cell Melanoma R. 2015;28(3):363-369.
3. Eleftheriadou V, Thomas KS, Batchelor JM, Ravenscroft JC, Whitton ME. Core outcomes in vitiligo trials: progress and challenges. Clinical Investigation. 2013;3(5):417-419.
4. Eleftheriadou V, Thomas KS, Whitton ME, Batchelor JM, Ravenscroft JC. Which outcomes should we measure in vitiligo? Results of a systematic review and a survey among patients and clinicians on outcomes in vitiligo trials. Br J Dermatol. 2012;167(4):804-814.