The Typical Nail Lichen Planus Severity Index: An Outcome Instrument for Typical Nail Lichen Planus.

IF 3 3区医学 Q2 DERMATOLOGY

Dermatology Pub Date : 2024-01-01 Epub Date: 2024-06-08 DOI:10.1159/000539687

Juan He, Tengyu Weng, Wei Zhang, Anqi Li, Xianfu Meng, Wenwei Zhu, Jia Bai, Yonghong Hao, Yi Yang, Chengxin Li

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引用次数: 0

Abstract

Introduction: Despite numerous treatment options for nail lichen planus (NLP), a validated method for measuring the severity of NLP and therapeutic response in clinical trials is absent. The aim of the study was to develop and validate a measurement instrument, Typical Nail Lichen Planus Severity Index (tNLPSI), for typical NLP that could be used in clinical trials.

Methods: A total of 48 patients pathologically confirmed with typical NLP were enrolled in this study. Five dermatologists were trained to use the tNLPSI activity scale and the Physician's Global Assessment (PGA) scale to score samples independently to estimate inter-rater and intra-rater reliability across two sessions. In addition, tNLPSI activity scores were compared with PGA scores to assess the construct validity.

Results: The tNLPSI activity scale had excellent internal consistency and inter-rater reliability (Cronbach's alpha 0.990; ICC = 0.954; 95% CI = 0.930-0.971), and the correlations between the different graders' scores indicate good consistency (rp = 0.934-0.968). In addition, the tNLPSI activity scale demonstrated high intra-rater reliability (ICC = 0.996; 95% CI = 0.993-0.998), showing good reproducibility. And tNLPSI activity scores and PGA scores showed good construct validity (Spearman's rho = 0.941 and Spearman's rho = 0.903-0.935, respectively; p < 0.01).

Conclusion: The tNLPSI activity scale was demonstrated to be consistent, reliable, reproducible, and feasible, making it a potential valuable tool for evaluating the treatment response in typical NLP clinical trials.

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典型甲沟炎严重程度指数（tNLPSI）：典型甲沟炎的结果工具。

导言：尽管治疗甲扁平苔藓（NLP）的方法很多，但在临床试验中却缺乏一种有效的方法来测量NLP的严重程度和治疗反应。方法：48 名经病理诊断为典型 NLP 的患者和 5 名皮肤科医生参与了这项研究。医生们接受了使用tNLPSI活动量表和医生总体评估（PGA）的培训。使用这两种工具，5名医生在两次会议中独立对样本进行评分，以评估评分者之间的可靠性和评分者内部的可靠性。此外，还将 tNLPSI 活动量评分与医生总体评估（PGA）评分进行了比较：tNLPSI活动量表具有良好的内部一致性和评分者之间的可靠性（Cronbach's alpha 0.990；ICC= 0.954；95% CI=0.930-0.971），不同评分者的评分之间的相关性也显示出良好的一致性（rp=0.934-0.968）。此外，tNLPSI 活动量表的评分者内部信度很高（ICC=0.996；95% CI=0.993-0.998），显示了良好的再现性。tNLPSI活动量评分和PGA评分显示出良好的建构效度（Spearman's rho=0.941和Spearman's rho=0.903-0.935；P < 0.01）：tNLPSI活动量表具有一致性、可靠性、可重复性和可行性。结论：tNLPSI 活动量表具有一致性、可靠性、可重复性和可行性，在典型的 NLP 临床试验中可能被证明是评估治疗反应的重要工具。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Dermatology 医学-皮肤病学

CiteScore

6.40

自引率

2.90%

发文量

审稿时长

1 months

期刊介绍： Published since 1893, ''Dermatology'' provides a worldwide survey of clinical and investigative dermatology. Original papers report clinical and laboratory findings. In order to inform readers of the implications of recent research, editorials and reviews prepared by invited, internationally recognized scientists are regularly featured. In addition to original papers, the journal publishes rapid communications, short communications, and letters to ''Dermatology''. ''Dermatology'' answers the complete information needs of practitioners concerned with progress in research related to skin, clinical dermatology and therapy. The journal enjoys a high scientific reputation with a continually increasing impact factor and an equally high circulation.