Novel Oral Lichen Planus Symptom Severity Measure for assessing patients’ daily symptom experience

Abstract

Objective A novel Oral Lichen Planus Symptom Severity Measure was developed as a clinical outcome assessment of the daily symptom experience of patients with oral lichen planus. Methods A literature review and expert input were followed by open‐ended concept elicitation interviews with 17 adults with oral lichen planus in the United States and Ireland. Item content was generated, and the interviews continued until input saturation was reached. The final electronic version of the measure was cognitively debriefed in 6 US patients and subsequently translated and linguistically validated in Germany and Denmark. Results Concept elicitation interviews demonstrated content validity and saturation in identifying symptoms and daily activities that generate symptoms in patients with oral lichen planus. The content and electronic daily diary format demonstrated content validity during cognitive debriefing interviews. Linguistic validation of the 7‐item Oral Lichen Planus Symptom Severity Measure in Germany and Denmark confirmed the content validity of the German and Danish versions. Conclusions Qualitative research methods generated evidence that the 7‐item Oral Lichen Planus Symptom Severity Measure version 1.0 is a well‐defined assessment tool to characterize the severity, specificity and variations of symptoms in patients with oral lichen planus.

Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial

“…Improvement in patient‐reported outcomes was demonstrated, using an established generic pain measure (pain on a 0–10 NRS) and quality of life measures (COMDQ). Additionally, a new disease‐specific instrument (OLPSSM), 8 demonstrated reduction and relief of OLP symptoms while patients performed activities of daily living. Improvements in patient‐reported outcomes resulted from successful targeted delivery of clobetasol propionate to the OLP lesions as demonstrated by clinical assessments (ulcer area, lesion size, erythema severity, and the DAS of ODSS).…”

“…Diagnosis relies on characteristic clinical findings, often confirmed by biopsy. Chronic symptomatic OLP is often painful, which compromises oral functions, like talking and eating, 7,8 and quality of life 9 …”

“…[4][5][6] Diagnosis relies on characteristic clinical findings, often confirmed by biopsy. Chronic symptomatic OLP is often painful, which compromises oral functions, like talking and eating, 7,8 and quality of life. 9 Treatment of OLP varies based on the severity of the symptoms; however, there are limited options; and there is no approved treatment.…”

Health-Related Quality of Life and Its Associated Predictors in Patients with Oral Lichen Planus: A Cross-Sectional Study

“…Currently there are a number of specific instruments developed with the input from patients with OLP. These include the Oral Lichen Planus Symptom Severity Measure to assess daily experience of physical symptoms of OLP 32 , the COMDQ to quantify the level of QoL specific to chronic oral mucosal conditions, and the OPMDQoL to measure QoL specific to oral potentially malignant disorders 12 . Utilising these instruments could help clinicians and researchers assessing subjective constructs specific to patients with OLP with confidence.…”

Validation of the HADS and PSS‐10 and psychological status in patients with oral lichen planus

“…The measurement of subjective oral symptoms in the present study was recorded using both VAS and NRS, which measure overall symptom intensity alone. The incorporation of other self-report symptom instruments such as the short-form McGill Pain Questionnaire (SF-MPQ), which measures both quality and quantity of subjective symptoms, or the novel Oral Lichen Planus Symptom Severity Measure (OLP-SSM) would provide better profile of oral symptoms as reported by patients with OLP (Burke, Brennan, Ni Riordain, & Madsen, 2019;Main, 2016).…”