Oral lichen planus clinician reported outcome measure: Development, content validity, and further development

OBJECTIVE: To establish and test a clinician-reported outcome measure of oral lichen planus (OLP): OLP Investigator global assessment (IGA). METHODS: OLP IGA scale was tested with retrospective data from clinical practice and a phase II clinical trial. A comparison of the OLP IGA score with patient-reported outcomes was completed. RESULTS: Clinical Practice: The mean (SD) OLP IGA score (0-4) in 107 OLP patients was 1.8 (1.0) with correlation of 0.25-0.48 (p value 0.01 - <0.0001) with symptom scores. There was a significant increase in OLP symptoms based on OLP IGA score. CLINICAL TRIAL: The mean (SD) OLP IGA score in 137 research participants was 2.5 (1.2) with correlation of 0.43-0.52 (all p values <0.0001) with symptoms scores. There was a significant increase in OLP symptoms based on OLP IGA score. Forty-seven (35%) participants in the phase 2 study had an improvement in the OLP IGA score of ≥2. There were significant improvements in all symptoms scores in relation to the change in IGA score. CONCLUSIONS: The OLP IGA is designed to assess changes in symptomatic OLP lesions and is appropriate for use across the full range of symptomatic OLP severity and represents a scale with utility in clinical practice and clinical trials.