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

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Over the past few decades, there has been a substantial increase in the development, validation and application of patient‐reported outcome measures (PROMs) for research and/or clinical practice.1 A PROM is a standardised instrument (usually a questionnaire) for patients to directly evaluate one or more aspects of their own health.2 The aim was to quantify, evaluate and monitor the subjective perception of the impact of the disease from patient's perspective in a standardised way and to incorporate the patient's voice regarding the perception of their health condition and related treatment into clinical practice and research.2 PROMs are required to have adequate psychometric properties as well as good evidence for interpretability for the specific patient population. From the perspective of clinical research, a vital step in the design of clinical trial is to select a PROM with appropriate psychometric properties to ensure that the instrument is suitable for its proposed application, valid (measure what it is intended to measure), reliable (produce consistent results on repeated measurement under identical conditions) and responsive (able to detect change over time) in a specific group of patients.3 Further to the psychometric properties, it is necessary that scores or outcomes generated by the PROMs are interpretable or clinically meaningful.3
Little is known regarding the use of PROMs in patients with oral lichen planus (OLP), a common chronic inflammatory disease4 that can cause long‐standing painful ulceration of the oral mucosa6 and is also known to increase the risk of oral cancer development.8 The persistent painful symptoms of OLP can have significant negative impact on daily activities (eg eating, swallowing, speaking) but can also impair psychosocial functioning as well as patient's quality of life.9 Therefore, medical treatment, often in the form of long‐term use of topical corticosteroids or immunosuppressants, is required to reduce patient's painful symptoms.10
Clinical scoring systems (CSS) used in OLP have been comprehensively addressed in a recent review.11 Some of these CSS demonstrated good measurement properties for use in clinical studies of patients with OLP including Escudier severity scale (ESS)12 and reticulation‐erythema‐ulceration (REU) scoring system13 . However, very few studies focus mainly on the use and psychometric evidence of PROMs in OLP patients. Two reviews have previously investigated the use of PROMs in patients with oral mucosal diseases,15 but there remains no comprehensive assessment of the instruments used specifically in studies of OLP patients. The purposes of this study are to i) review the range of PROMs used for the assessment of oral symptoms, psychosocial status and quality of life in the OLP population and ii) assess their psychometric properties and interpretability.

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