Batchelor J M, Tan W, Tour S, Yong A, Montgomery A A, Thomas K S
Centre of Evidence Based Dermatology, King's Meadow Campus, Lenton Lane, Nottingham, NG7 2NR, U.K.
Nottingham Clinical Trials Unit, Queen's Medical Centre, C Floor, South Block, Nottingham, NG7 2UH, U.K.
Br J Dermatol. 2016 Feb;174(2):386-94. doi: 10.1111/bjd.14208. Epub 2015 Dec 14.
Patient-reported outcome measures are rarely used in vitiligo trials. The Vitiligo Noticeability Scale (VNS) is a new patient-reported outcome measure assessing how 'noticeable' vitiligo patches are after treatment. The noticeability of vitiligo after treatment is an important indicator of treatment success from the patient's perspective.
To evaluate the construct validity, acceptability and interpretability of the VNS.
Clinicians (n = 33) and patients with vitiligo (n = 101) examined 39 image pairs, each depicting a vitiligo lesion pre- and post-treatment. Using an online questionnaire, respondents gave a global assessment of treatment success and a VNS score for treatment response. Clinicians also estimated percentage repigmentation of lesions (< 25%; 25-50%; 51-75%; > 75%). Treatment success was defined as 'yes' on global assessment, a VNS score of 4 or 5, and > 75% repigmentation. Agreement between respondents and the different scales was assessed using kappa (κ) statistics.
Vitiligo Noticeability Scale scores were associated with both patient- and clinician-reported global treatment success (κ = 0·54 and κ = 0·47, respectively). Percentage repigmentation showed a weaker association with patient- and clinician-reported global treatment success (κ = 0·39 and κ = 0·29, respectively). VNS scores of 4 or 5 can be interpreted as representing treatment success. Images depicting post-treatment hyperpigmentation were less likely to be rated as successful.
The VNS is a valid patient-reported measure of vitiligo treatment success. Further validation of the VNS is required, using larger sets of clinical pre- and post-treatment images, affecting a wider range of anatomical sites.
患者报告的结局指标在白癜风试验中很少使用。白癜风显著程度量表(VNS)是一种新的患者报告结局指标,用于评估治疗后白癜风斑块的“显著程度”。从患者角度来看,治疗后白癜风的显著程度是治疗成功的重要指标。
评估VNS的结构效度、可接受性和可解释性。
33名临床医生和101名白癜风患者检查了39对图像,每对图像分别描绘了白癜风皮损治疗前后的情况。通过在线问卷,受访者对治疗成功进行整体评估,并对治疗反应给出VNS评分。临床医生还估计皮损的色素恢复百分比(<25%;25 - 50%;51 - 75%;>75%)。治疗成功定义为整体评估为“是”、VNS评分为4或5且色素恢复>75%。使用kappa(κ)统计量评估受访者与不同量表之间的一致性。
白癜风显著程度量表评分与患者和临床医生报告的整体治疗成功均相关(κ分别为0.54和0.47)。色素恢复百分比与患者和临床医生报告的整体治疗成功的相关性较弱(κ分别为0.39和0.29)。VNS评分为4或5可解释为代表治疗成功。描绘治疗后色素沉着过度的图像被评为成功的可能性较小。
VNS是一种有效的患者报告的白癜风治疗成功指标。需要使用更多的临床治疗前后图像集,涵盖更广泛的解剖部位,对VNS进行进一步验证。