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The Typical Nail lichen planus severity index (tNLPSI):an outcome instrument for typical nail lichen planus.

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. To develop and validate a measurement instrument (tNLPSI - typical nail lichen planus severity index) for typical nail lichen planus that could be used in clinical trials.

METHODS: 48 patients with typical NLP diagnosed pathologically and 5 dermatologists participated. The physicians were trained to use the tNLPSI activity scale and Physician's Global Assessment (PGA). Using both tools, 5 physicians scored samples independently to estimate inter-rater reliability and intra-rater reliability in two sessions. In addition, tNLPSI activity scores were compared with physician global assessment (PGA) scores.

RESULTS: The tNLPSI activity scale had excellent internal consistency and interrater 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 consistent (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).

CONCLUSIONS: The tNLPSI activity scale was demonstrated to be consistent, reliable, reproducible, and feasible. It may prove to be a valuable tool in evaluating the treatment response in typical NLP clinical trials.

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