LAUSR

Improvement of vitiligo in clinical studies has usually been measured by assessing repigmentation of individual lesions as well as overall reduction of body surface area affected by vitiligo. However, even after achieving significant repigmentation, vitiligo lesions may still be quite noticeable to others, contributing to the considerable psychological impact of this disorder. Statistically significant improvement in trials may not be meaningful to affected individuals, especially those with lesions in exposed areas and darker skin types. Successful repigmentation as defined by an investigator does not always correlate with perceived improvement by affected individuals. Patient-reported outcome measures (PROMs) can improve this gap, complementing traditional investigatorassessed measures. In this issue of the BJD, Batchelor and colleagues report the results of a study aiming to further investigate the Vitiligo Noticeability Scale (VNS). The VNS was first validated by the same group in 2016. This scale assesses cosmetic acceptability of repigmentation of individual lesions of vitiligo. In the present study, the authors asked individuals with vitiligo participating in a phototherapy trial to assess the noticeability of a single patch of vitiligo after 9 months of treatment, compare it with a baseline photo and score improvement using the VNS. They compared this score with a patient-reported global treatment success score for validation. Three other individuals with vitiligo rated the before and after images using the same scales. Additionally, three clinicians rated the images for global treatment success and percentage repigmentation. The VNS showed good construct validity and the results were the same in all ages and skin types. The authors found that subjects did associate global treatment success with higher VNS values. Interestingly, this conclusion was not shared by the raters with vitiligo and clinicians. This discrepancy between clinicians and patients should prompt new approaches on selection of main outcome measure in randomized controlled trials for patients with vitiligo. At the very least, the present study argues for using dual main outcomes that take into account the opinions of patients and clinicians. These results have important implications when interpreting VNS results from previous clinical trials and will be useful in implementing this PROM in future studies. The fact there was a significant difference in the assessment of improvement in subjects compared with investigators and independent raters with vitiligo emphasizes the importance of including validated PROMs in vitiligo studies. Small improvements in noticeability may be important to people with vitiligo, as any improvement indicates the condition is no longer worsening. Furthermore, stabilization and cessation of spreading have been shown to be important outcomes for individuals with vitiligo in past consensus studies. Indeed, 14 6% of subjects in the present study valued a VNS score of only 2, corresponding to no change in noticeability. The improvement in noticeability in this study depends on the eye of the beholder, as the raters with vitiligo and clinicians did not share this enthusiasm with the subjects. Unlike the initial study to validate the VNS by the same authors, which used digitally created images of vitiligo lesions from other patients, this study used the patients’ own lesions to investigate the VNS, which is how it was intended to be used and is in line with a real-world setting. The authors obtained valuable information from face-to-face focus groups and online discussion groups to further understand and refine the VNS. The results of this study will be beneficial to researchers planning trials for new treatments. As with previous studies, a level of 75% or greater repigmentation of a target lesion was confirmed to be significant in this study. The VNS helps us to answer some important questions about vitiligo: What type of improvement in vitiligo is meaningful to patients? How should that improvement be interpreted? As the VNS is used more frequently, it will be easier to compare treatments and we will learn even more about this PROM as it is used in wider, more diverse groups in the future. An important limitation pointed out by the authors is that the VNS relates to single lesions of vitiligo. Furthermore, it is a dynamic measure, relying on baseline images, which adds to its complexity. Further research should be performed to develop PROMs that are static and measure improvement in all vitiligo lesions in a single patient.