Developing core outcome set for vitiligo clinical trials: international e-Delphi consensus

The purpose of this study is to determine a set of core outcomes to be used in trials for the treatment of vitiligo that are acceptable to the research, clinical community and patients internationally.
This will be a moderated, international, multi-perspective web-based Delphi (eDelphi) exercise involving experts from stakeholder groups. These groups will include dermatologists and researchers with interest in vitiligo, patients with vitiligo (and their carers) and representatives of regulatory agencies and journal editors.

The e-Delphi process will utilise both paper questionnaires and a web-based survey tool (‘Survey Monkey’) and will be completed in three rounds.
‘Consensus’ will be defined if at least 75% of participants’ responses in two stakeholder groups match on the questionnaire items.


This study aimed to develop international consensus over a core outcome set for vitiligo trials that is acceptable to healthcare professionals, patients and their care-givers, researchers and regulatory bodies.


Viktoria Eleftheriadou
Kim Thomas
Nanja vanGeel
Iltefat Hamzavi
Henry Lim
Tamio Suzuki
Ichiro Katayama
Tag Anbar
Marwa Abdallah
Laila Benzekri
Yvon Gauthier
John Harris
Caio Cesar Silva de Castro
Amit Pandya
Boon Kee Goh
Cheng-Che E. Lan
Naoki Oiso
Ahmed Al Issa
Samia Esmat
Caroline Le Poole
Ai-Young Lee
Davinder Parsad
Alain Taieb
Mauro Picardo
and Khaled Ezzedine
on behalf of the Vitiligo Global Issues Consensus Group (VGICG)


Journal: Pigment Cell and Melanoma Research
Volume: 28
Issue: 3
Pages: 363 - 369
Year: 2015
DOI: 10.1111/pcmr.12354

Further Study Information

Current Stage: Not Applicable
Date: January 2013 - December 2014
Funding source(s): National Institute for Health Research

Health Area

Disease Category: Skin

Disease Name: Vitiligo

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Regulatory agency representatives
- Researchers

Study Type

- COS for clinical trials or clinical research


- Delphi process

An international web-based electronic-Delphi (e-Delphi) consensus was conducted between January 2013 and September 2013. A total of 101 self-selecting participants from three stakeholder groups took part from 24 countries: healthcare professionals with an interest in vitiligo (dermatologists: n = 51 and dermatology nurse: n = 1); patients (or their caregivers) with vitiligo (n = 32); and representatives of regulatory agencies (n = 2), journal editors (n = 14) and vitiligo researchers (n = 1). The survey was administered in English language, and all participants were fluent English speakers. This e-Delphi study included three rounds; each taking approximately 2–4 weeks to complete. The first round was conducted using
a questionnaire distributed by e-mail to the leaders of each subgroup of the International Federation of Pigment Cell Societies (IFPCS) (American, Asian, European, Japanese and Mediterranean). Subsequent rounds were conducted using electronic questionnaires via Survey Monkey software ( Reminders were sent by e-mail 10 days prior to the submission deadline. No financial incentives were provided to any of the participants and completion of round one was taken as consent to participate. Participants were strongly encouraged to continue participation
throughout all three rounds, as this was important for maintaining the validity of the consensus approach. Ethical approval was not required for this study.