TY - JOUR
T1 - Clinician-reported outcome measures for the assessment of vitiligo
T2 - A scoping review
AU - van Geel, Nanja
AU - Duponselle, Jolien
AU - Delbaere, Liesbeth
AU - Herbelet, Sandrine
AU - Eleftheriadou, Viktoria
AU - Ezzedine, Khaled
AU - Forman, Maxine
AU - Garg, Amit
AU - Hamzavi, Iltefat H.
AU - Seneschal, Julien
AU - Spuls, Phyllis
AU - Terwee, Caroline B.
AU - Wolkerstorfer, Albert
AU - Speeckaert, Reinhart
AU - Pandya, Amit G.
N1 - Funding Information: The research activities of N. van Geel and R. Speeckaert are supported by the Scientific Research Foundation‐Flanders (FWO Senior Clinical Investigator: 1831512N and 18B2721N respectively). This VITAL project was supported by a grant from Incyte Biosciences International Sàrl, Abbvie and CHORD COUSIN Collaboration (C3). Funding Information: NvG: Consultancy and/or investigator: Pfizer, Incyte, Sunpharma, Abbvie and MSD/Merck. NvG and RS were involved in the development and/or validation of several scores summarized in this article. PS received a departmental independent research grants for TREAT NL registry from Pharma since December 2019 for the TREAT NL registry, is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of, for example, psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and, is Chief Investigator (CI) of the systemic and phototherapy atopic eczema registry (TREAT NL) for adults and children and one of the main investigator of the SECURE‐AD registry. PS was involved in the development of the PtDA investigated in this study. And was involved in the development of one of the HOME core outcome instruments (Recap of atopic eczema (RECAP)). IHH has served as a Consultant to Abbvie, Pfizer, Incyte, UCB, BoerhingerIngelheim, Sonoma, Union therapeutics, Novartis, Jansen, Avita, Galderma, Vimela Investigator for Lenicura, Pfizer, Incyte, Avita, Loreal/Laroche Posay, ITN. Board member and Past‐president of the HS foundation and Global Vitiligo foundation. AG is an advisor for AbbVie, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, UCB, Union Therapeutics, Ventyx Biosciences and Viela Biosciences, and receives honoraria. AG receives research grants from AbbVie, UCB, National Psoriasis Foundation and CHORD COUSIN Collaboration (C3). He is co‐copyright holder of the HS‐IGA and HiSQOL instruments. KE is a consultant for AbbVie, Incyte, La Roche‐Posay, Pfizer, Pierre Fabre, Sanofi and Viela Bio. AW is consultant for InCyte, Novartis, AvitaMedical, Candela and Lumenis. JS received grants and/or honoraria from AbbVie, Bristol Myers Squibb, Calypso Biotech, Eli Lilly, Incyte, LEO Pharma, Novartis, Pfizer, Pierre Fabre, Sanofi, Sun Pharmaceuticals and Viela Bio; and has a patent on MMP9 inhibitors and uses thereof in the prevention or treatment of a depigmenting disorder and three‐dimensional model of depigmenting disorder. CB Terwee is one of the founders of the COSMIN initiative. VE is a Consultant for Incyte, Abbvie, Pfizer and Almirall. AGP has served as an investigator for Immune Tolerance Network, Incyte and Pfizer; a consultant for AbbVie, Arcutis, Avita Medical, Chromaderm, Immune Tolerance Network, Incyte, Pfizer, TWi, Viela Bio, Villaris, Vyne, Thalocan and Trifecta; and holds stock options for Tara Medical and Zerigo Health. All other authors have no disclosure. Funding Information: We thank Terence Aspeslagh (Ghent University, Belgium), Emma De Sutter† (Ghent University, Belgium), Amy Van Buggenhout (Ghent University, Belgium), and Nele Pauwels (Knowledge Centre for Health Ghent, Ghent University, and Ghent University Hospital, Ghent, Belgium) for their assistance in the literature search. We are grateful for the support and collaboration with CHORD COUSIN Collaboration (C3) within the context of the VITAL project. Publisher Copyright: © 2023 European Academy of Dermatology and Venereology.
PY - 2023/11
Y1 - 2023/11
N2 - Clinician-reported outcome measures (ClinROMs) are essential for assessment of vitiligo in clinical trials and daily practice. Several instruments have been developed and tested to measure, for example, vitiligo extent, repigmentation and activity. The goal of this review was to identify all introductory publications of ClinROMs for vitiligo that include at least some aspects of validation and to describe the instruments' characteristics, intention for use and practical strengths and limitations. A search strategy was conducted in PubMed, Embase and Cochrane Library (CENTRAL) from inception to July 2022. Based on the literature search (n = 2860), 10 articles were identified, describing 14 different ClinROMs. Six ClinRoms measured disease extent and/or repigmentation, seven evaluated disease activity and one was a composite score. The Vitiligo Area Scoring Index (VASI), and Vitiligo Extent Score (VES and VESplus) measure overall disease extent and/or repigmentation. The VASI relies on hand units (1% body surface area), whereas the VES and VESplus use a picture-based scoring technique. The Vitiligo Extent Score for a Target Area (VESTA) measures repigmentation percentage for target lesions. One global assessment score for extent has been validated. Vitiligo disease activity scores included a static measure of clinical activity signs (Vitiligo Signs of Activity Score [VSAS]) and two measures assessing dynamic evolution (Vitiligo Disease Activity Score [VDAS] and Vitiligo Disease Improvement Score [VDIS]). The Vitiligo European Task Force assessment tool (VETFa) is a composite score. Depending on the practical strengths and limitations as well as the research question and setting (clinical trials vs. daily practice), the choice of an appropriate ClinROM may differ. Fourteen ClinROMs in vitiligo were identified to measure vitiligo extent, repigmentation, and activity. Further research evaluating the validity, reliability, and responsiveness of each instrument and worldwide consensus on which instrument to use for a specific outcome (domain) is greatly needed.
AB - Clinician-reported outcome measures (ClinROMs) are essential for assessment of vitiligo in clinical trials and daily practice. Several instruments have been developed and tested to measure, for example, vitiligo extent, repigmentation and activity. The goal of this review was to identify all introductory publications of ClinROMs for vitiligo that include at least some aspects of validation and to describe the instruments' characteristics, intention for use and practical strengths and limitations. A search strategy was conducted in PubMed, Embase and Cochrane Library (CENTRAL) from inception to July 2022. Based on the literature search (n = 2860), 10 articles were identified, describing 14 different ClinROMs. Six ClinRoms measured disease extent and/or repigmentation, seven evaluated disease activity and one was a composite score. The Vitiligo Area Scoring Index (VASI), and Vitiligo Extent Score (VES and VESplus) measure overall disease extent and/or repigmentation. The VASI relies on hand units (1% body surface area), whereas the VES and VESplus use a picture-based scoring technique. The Vitiligo Extent Score for a Target Area (VESTA) measures repigmentation percentage for target lesions. One global assessment score for extent has been validated. Vitiligo disease activity scores included a static measure of clinical activity signs (Vitiligo Signs of Activity Score [VSAS]) and two measures assessing dynamic evolution (Vitiligo Disease Activity Score [VDAS] and Vitiligo Disease Improvement Score [VDIS]). The Vitiligo European Task Force assessment tool (VETFa) is a composite score. Depending on the practical strengths and limitations as well as the research question and setting (clinical trials vs. daily practice), the choice of an appropriate ClinROM may differ. Fourteen ClinROMs in vitiligo were identified to measure vitiligo extent, repigmentation, and activity. Further research evaluating the validity, reliability, and responsiveness of each instrument and worldwide consensus on which instrument to use for a specific outcome (domain) is greatly needed.
UR - http://www.scopus.com/inward/record.url?scp=85170578389&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/jdv.19448
DO - https://doi.org/10.1111/jdv.19448
M3 - Review article
C2 - 37602494
SN - 0926-9959
VL - 37
SP - 2231
EP - 2242
JO - Journal of the European Academy of Dermatology and Venereology
JF - Journal of the European Academy of Dermatology and Venereology
IS - 11
ER -