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

ObjectiveTo establish and test a clinician-reported outcome measure of oral lichen planus (OLP): OLP Investigator global assessment (IGA). MethodsOLP 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. ResultsClinical 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. ConclusionsThe 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.

Automated summary

This study establishes and tests the OLP Investigator Global Assessment (IGA) as a clinician-reported outcome measure for oral lichen planus (OLP). The OLP IGA scale is found to be suitable for assessing changes in symptomatic OLP lesions across a wide range of severity and can be used in both clinical practice and clinical trials.