Assessing the content validity of the 2015 core domain set for vitiligo clinical trials: preliminary investigations for developing an updated version

Abstract Background The 2015 core domain set (CDS) for vitiligo defines outcomes for clinical trials, comprising three essential and four recommended outcome domains/domain items. Periodic reassessment is required to ensure its continued relevance. Objectives To evaluate the content validity (relevance, comprehensiveness and comprehensibility) of the 2015 vitiligo CDS to inform a consensus-based update as part of a core outcome set, including core outcomes and core measurement instruments. Methods A roundtable discussion and three surveys reassessed the 2015 vitiligo CDS regarding relevance (≥ 70% agreement for ‘essential’), comprehensiveness (identification of missing domain items) and comprehensibility (clarity of terminology and descriptions). Results Fifty-three patients with vitiligo (group 1) and 37 experts (36 dermatologists and 1 researcher; group 2) participated. Two previously essential domains (‘Repigmentation’ and ‘Side effects/harms’) were re-endorsed as essential by both groups. ‘Maintenance of gained repigmentation’ was rated essential by patients only. Among previously recommended domains, ‘Quality of life’ was considered essential by both groups, whereas ‘Cosmetic acceptability of repigmentation’ and ‘Cessation of spreading of vitiligo’ were rated essential by patients only. ‘Tolerability/burden of treatment’ was not considered essential by either group. Frequently suggested missing items (outcomes and contextual factors) included psychological impact, treatment session duration, overall treatment duration, treatment costs, patient education and evaluation of associated auto­immune diseases. Proposed updates included refining domain terminology (e.g. vitiligo-specific/health-related quality of life; replacing ‘harms’ with ‘adverse events’) and addressing feasibility-related timeframes. Conclusions While the 2015 vitiligo CDS retains content validity for several domains, meaningful updates are warranted. These findings will inform the development of a revised and updated CDS.

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Journal
Skin Health and Disease
Published
2026-10-28
DOI
https://doi.org/10.1093/skinhd/vzag150
Primary Topic
Delphi Technique in Research
Type
article
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article

Assessing the content validity of the 2015 core domain set for vitiligo clinical trials: preliminary investigations for developing an updated version

Henry W. Lim, Davinder Parsad, Sandrine Herbelet, Liesbeth Delbaere et al.
2 links
Skin Health and Disease
Delphi Technique in Research
article

Assessing the content validity of the 2015 core domain set for vitiligo clinical trials: preliminary investigations for developing an updated version

Henry W. Lim, Davinder Parsad, Sandrine Herbelet, Liesbeth Delbaere, Victor Huang, Samia M. Esmat, Mehdi Rashighi, David M. Rosmarin, Marwa Abdallah, Harvey Lui, Deepti Ghia, Jung Min Bae, Albert Wolkerstorfer, Noufal Raboobee, Thierry Passeron, Hyun Jeong Ju, Nanja van Geel, Amit Garg, Laïla Benzekri, Somesh Gupta, Giovanni Leone, Nicoline F. Post, John F. Ferguson, Iltefat H. Hamzavi, I. Caroline Le Poole, Michelle A. Rodrigues, J.‐M. Meurant, Andrea Tovar‐Garza, Phyllis Ira Spuls, Mauro Picardo, Martha Alejandra Morales‐Sánchez, Steven Tien Guan Thng, Amit G. Pandya, Caroline Barbara Terwee, Reinhart Speeckaert, Julien Sénéschal, Marloes Zuidgeest, Wedad Zoheir Mostafa, Jolien Duponselle, Georg Pliszewski, Nicolle Maquignon, Youwen Zhou, Markus Böhm, Stephen Taylor, Emma Rush, Paul Monteiro
article en

Abstract

Abstract Background The 2015 core domain set (CDS) for vitiligo defines outcomes for clinical trials, comprising three essential and four recommended outcome domains/domain items. Periodic reassessment is required to ensure its continued relevance. Objectives To evaluate the content validity (relevance, comprehensiveness and comprehensibility) of the 2015 vitiligo CDS to inform a consensus-based update as part of a core outcome set, including core outcomes and core measurement instruments. Methods A roundtable discussion and three surveys reassessed the 2015 vitiligo CDS regarding relevance (≥ 70% agreement for ‘essential’), comprehensiveness (identification of missing domain items) and comprehensibility (clarity of terminology and descriptions). Results Fifty-three patients with vitiligo (group 1) and 37 experts (36 dermatologists and 1 researcher; group 2) participated. Two previously essential domains (‘Repigmentation’ and ‘Side effects/harms’) were re-endorsed as essential by both groups. ‘Maintenance of gained repigmentation’ was rated essential by patients only. Among previously recommended domains, ‘Quality of life’ was considered essential by both groups, whereas ‘Cosmetic acceptability of repigmentation’ and ‘Cessation of spreading of vitiligo’ were rated essential by patients only. ‘Tolerability/burden of treatment’ was not considered essential by either group. Frequently suggested missing items (outcomes and contextual factors) included psychological impact, treatment session duration, overall treatment duration, treatment costs, patient education and evaluation of associated auto­immune diseases. Proposed updates included refining domain terminology (e.g. vitiligo-specific/health-related quality of life; replacing ‘harms’ with ‘adverse events’) and addressing feasibility-related timeframes. Conclusions While the 2015 vitiligo CDS retains content validity for several domains, meaningful updates are warranted. These findings will inform the development of a revised and updated CDS.

Skin Health and Disease
Ain Shams University (EG), Mohammed V University (MA), Northwell Health (US), Royal Children's Hospital (AU), Vancouver Coastal Health (CA), University of British Columbia (CA), Cairo University (EG), Henry Ford Health System (US), Inserm (FR), Mexican Social Security Institute (MX), King's College London (GB), Ghent University Hospital (BE), Jaslok Hospital (IN), Henry Ford Hospital (US), University of California System (US), Centre Hospitalier Universitaire de Bordeaux (FR), Centre Hospitalier Universitaire de Nice (FR), The Catholic University of Korea St. Vincent's Hospital (KR), Ain Shams University Hospital (EG), University Hospital Münster (DE), Hôpital Saint-André (FR), Istituto Dermopatico dell'Immacolata (IT), King's College School (GB), Amsterdam Public Health (NL), Ospedale Israelitico (IT), Vancouver Coastal Health Research Institute (CA), Amsterdam University Medical Centers (NL), Indiana University School of Medicine (US), Servicios de Salud del Instituto Mexicano del Seguro Social para el Bienestar (MX), Post Graduate Institute of Medical Education and Research (IN), All India Institute of Medical Sciences (IN), Vrije Universiteit Amsterdam (NL), The University of Texas Southwestern Medical Center (US), University of Amsterdam (NL), Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
Incyte, Fonds Wetenschappelijk Onderzoek, Universiteit Gent, Vlaamse regering, AbbVie Canada
Good health and well-being
Openalex Percentile: Top 6%
Delphi Technique in Research
DOIOpen Access PDFOpenAlex
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