ORALMED Research Group, Department of Dental Clinical Specialties, School of Dentistry, Complutense University, Madrid, Spain.
Special Care Unit, OMEQUI Research Group, School of Medicine and Dentistry, Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela University, Santiago de Compostela, Spain.
Oral Surg Oral Med Oral Pathol Oral Radiol. 2023 Jun;135(6):772-780. doi: 10.1016/j.oooo.2023.01.014. Epub 2023 Mar 3.
There is a lack of consensus regarding clinician- and patient-reported oral lichen planus (OLP) outcomes. The World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research (WONDER) Project aims to develop a core outcome set (COS) for OLP, which would inform the design of clinical trials and, importantly, facilitate meta-analysis, leading to the establishment of more robust evidence for the management of this condition and hence improved patient care.
Ovid MEDLINE, Embase, CINAHL, CENTRAL, and Clinicaltrials.gov were searched for interventional studies (randomized controlled trials, controlled clinical trials, and case series including ≥5 participants) on OLP and oral lichenoid reactions published between January 2001 and March 2022 without language restriction. All reported primary and secondary outcomes were extracted.
The searches yielded 9,135 records, and 291 studies were included after applying the inclusion criteria. A total of 422 outcomes were identified. These were then grouped based on semantic similarity, condensing the list to 69 outcomes. The most frequently measured outcomes were pain (51.9%), clinical grading of the lesions (29.6%), lesion size/extension/area (27.5%), and adverse events (17.5%).
As a first step in developing a COS for OLP, we summarized the outcomes that have been used in interventional studies over the past 2 decades, which are numerous and heterogeneous.
临床医生和患者报告的口腔扁平苔藓（OLP）结局缺乏共识。世界口腔医学成果倡议方向研究（WONDER）项目旨在为 OLP 制定核心结局集（COS），这将为临床试验的设计提供信息，重要的是，促进荟萃分析，从而为该疾病的治疗建立更有力的证据，进而改善患者护理。
在没有语言限制的情况下，对 2001 年 1 月至 2022 年 3 月期间发表的关于 OLP 和口腔类扁平苔藓反应的干预性研究（随机对照试验、对照临床试验和包括≥5 名参与者的病例系列研究），在 Ovid MEDLINE、Embase、CINAHL、CENTRAL 和 Clinicaltrials.gov 中进行了检索。提取所有报告的主要和次要结局。
检索结果得到 9135 条记录，在应用纳入标准后，有 291 项研究被纳入。共确定了 422 个结局。然后根据语义相似性对这些结局进行分组，将列表简化为 69 个结局。测量最多的结局是疼痛（51.9%）、病变的临床分级（29.6%）、病变大小/延伸/面积（27.5%）和不良事件（17.5%）。
作为制定 OLP COS 的第一步，我们总结了过去 20 年干预性研究中使用的众多且多样的结局。
