UCL Eastman Dental Institute, London, UK.
Department of Oral Medicine, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.
Clin Oral Investig. 2021 Jun;25(6):3699-3709. doi: 10.1007/s00784-020-03695-6. Epub 2020 Nov 17.
To establish thresholds of pain and quality of life scores corresponding to patient acceptable symptom state (PASS) in patients with oral lichen planus (OLP) and to assess demographic and clinical factors associated with achieving the PASS.
Prospective data from baseline and 4-month follow-up including Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), 14-item Oral Health Impact Profile (OHIP-14) and 15-item and 26-item Chronic Oral Mucosal Disease Questionnaire (COMDQ-15; COMDQ-26) were collected from 281 patients with OLP. An anchoring approach based upon the patient's opinion on acceptability of OLP status was applied. Associated factors for achieving the PASS were analysed using multivariate logistic regression.
About two-thirds (68.7%) of participants rated their OLP status as acceptable. Cut-off thresholds for PASS were as follows: ≤ 28 mm for VAS, ≤ 3 for NRS, ≤ 18 for total OHIP-14, ≤ 26 for total COMDQ-15 and ≤ 48 for total COMDQ-26. Based upon results of multivariate logistic analysis, factors associated with being in PASS were lower pain intensity, lower depressive symptoms and lower disease activity of OLP.
The present study established PASS cut-off thresholds as a tool facilitating interpretation of pain and quality of life outcomes relevant to individuals with OLP.
Identified PASS estimates could be utilised as clinically important endpoints in clinical practice of OLP as well as eligibility criteria for recruiting participants in clinical trials assessing effectiveness of symptomatic intervention of OLP.
确定口腔扁平苔藓(OLP)患者达到可接受症状状态(PASS)的疼痛和生活质量评分阈值,并评估与达到 PASS 相关的人口统计学和临床因素。
从基线和 4 个月随访中收集了 281 例 OLP 患者的视觉模拟量表(VAS)、数字评分量表(NRS)、14 项口腔健康影响量表(OHIP-14)、15 项和 26 项慢性口腔黏膜疾病问卷(COMDQ-15;COMDQ-26)的前瞻性数据。采用基于患者对 OLP 状态可接受性的观点的锚定方法。使用多变量逻辑回归分析达到 PASS 的相关因素。
约三分之二(68.7%)的参与者认为他们的 OLP 状态是可以接受的。PASS 的截止阈值如下:VAS≤28mm、NRS≤3、OHIP-14 总分≤18、COMDQ-15 总分≤26、COMDQ-26 总分≤48。基于多变量逻辑分析的结果,与处于 PASS 相关的因素是疼痛强度较低、抑郁症状较低和 OLP 疾病活动度较低。
本研究确定了 PASS 截止阈值,作为与 OLP 患者相关的疼痛和生活质量结果解释的工具。
确定的 PASS 估计值可作为评估 OLP 症状干预效果的临床试验中招募参与者的资格标准,也可作为 OLP 临床实践中重要的临床终点。