Development and validation of the Oral Lichen Planus-Disease Activity Scale: a novel tool for comprehensive clinical assessment.

Abstract

To develop and validate the Oral Lichen Planus-Disease Activity Scale (OLP-DAS) for assessing overall disease activity of OLP. The OLP-DAS was created by refining the Thongprasom criteria, incorporating inputs from the literature and expert review, and integrating pain assessment. Content validity was evaluated in a virtual meeting with 8 Oral Medicine specialists. Reliability and validity of the final version were examined. Seventeen OLP subjects were assessed for disease activity by 10 investigators using the OLP-DAS, Oral Disease Severity Score (ODSS), OLP-Investigator Global Assessment (OLP-IGA), and Reticular-Erythema-Ulcerative (REU) scale. Convergent validity was assessed by rating 160 OLP subjects using the OLP-DAS, ODSS, and OLP-IGA. Inter-rater and intra-rater reliability, along with convergent validity, were analyzed using intraclass correlation coefficients (ICCs) and Spearman's rank correlation coefficients (rs). The final OLP-DAS achieved excellent content validity indices. Inter-rater and intra-rater ICCs for total OLP-DAS scores were 0.93 and 0.96, respectively. Total OLP-DAS scores exhibited strong positive correlations with the ODSS and OLP-IGA (rs = 0.94 and rs = 0.76; P < 0.001, respectively). The OLP Severity Index (OLP-SI), a component of the OLP-DAS, showed very strong positive correlations with OLP disease activity parameters of the ODSS (rs = 0.90; P < 0.001). The OLP-DAS is a valid and reliable clinician-reported outcome measure (CROM) for evaluating OLP disease activity. The OLP-DAS, as a standardized CROM for OLP, is valuable for both routine clinical assessments and research applications.