Patient-reported outcome measures in oral lichen planus: A comprehensive review of the literature with focus on psychometric properties and interpretability.

OBJECTIVE: To review the range of patient-reported outcome measures (PROMs) used in clinical studies of patients with oral lichen planus (OLP) and to assess their psychometric properties and interpretability. METHODS: Literature searches were performed on MEDLINE, EMBASE and Web of Science databases (1990-September 2016) to retrieve relevant studies related to the development, psychometric testing and/or use of PROMs assessing oral symptoms, psychosocial status and quality of life in individuals with OLP. The identified PROMs were then categorised by concept measured and assessed for instrument characteristics and evidence for psychometric properties and interpretability. RESULTS: We identified a total of 41 PROMs used in clinical studies for the assessment of patient-reported outcomes in patients with OLP. There were three PROMs of oral symptoms, 30 PROMs of psychosocial status and eight PROMs of quality of life. Six instruments (Visual Analog Scale, Numerical Rating Scale, Change in Symptom Scale, Oral Health Impact Profile-14, Oral Health-related Quality of Life-UK and Chronic Oral Mucosal Disease Questionnaire) demonstrated some evidence of psychometric properties but no evidence for interpretability of their results in the OLP population. CONCLUSION: The range of PROMs used in clinical studies of patients with OLP is wide and include instruments for oral symptoms, psychosocial status and quality of life. The vast majority of these instruments have no evidence of psychometric properties and interpretability for patients with OLP. Further qualitative and validation studies are required to investigate whether these instruments are appropriate for use in this patient population.