[Interpretation and consideration of core outcome set in clinical intervention study of oral lichen planus]

Zhonghua Kou Qiang Yi Xue Za Zhi. 2024 Oct 9;59(10):998-1003. doi: 10.3760/cma.j.cn112144-20240307-00099.
[Article in Chinese]

Abstract

Oral lichen planus (OLP), as a chronic inflammatory disease of oral mucosa, cannot be completely cured at present. OLP can develop into oral squamous cell carcinoma and reduce the life quality of patients. The development of high-quality evidence-based strategies for OLP clinical management can effectively alleviate the clinical symptoms and reduce the risk of cancerization, thus to improve the life quality of patients. However, there is a wide variety of outcomes and a lack of uniform standards in previous OLP clinical intervention studies. Therefore, evidence-based analysis of relevant studies cannot be conducted to provide more convincing guidance for clinical diagnosis and treatment. To reduce the heterogeneity of clinical intervention studies, form a data pool for meta-analysis, and provide higher quality evidence-based OLP clinical management protocols, the World Workshop on Oral Medicine Ⅷ identified a core outcome set (COS) for OLP in three steps from March 2022 to January 2023. This article introduces the process of COS formulation, interprets OLP COS, and puts forward the advantages and drawback of OLP COS in this paper. We encourage researchers to use this COS in their future OLP clinical studies for improving the clinical significance and evidence-based value of studies.

口腔扁平苔藓(OLP)是口腔黏膜慢性炎症性疾病,尚无法治愈。OLP病情易反复,影响患者生活质量且有癌变风险。制订OLP临床管理循证方案并规范执行可缓解OLP患者的临床症状,降低癌变风险,提升其生活质量。但已有的OLP临床干预研究,研究者报告的结局指标种类繁多,缺乏统一标准,无法对不同研究进行循证分析并为临床诊疗提供循证意见。为此,第8届世界口腔医学工作组于2022年3月至2023年1月间分3个步骤确定了OLP核心结局指标集(COS),以降低OLP临床干预研究数据的异质性,形成可用于循证分析的数据池,为制订OLP临床管理循证方案提供必要条件。本文对本次COS的制订过程进行介绍,并对OLP COS进行解读,明确COS的意义与不足。同时帮助国内学者理解并使用OLP COS,以进一步提升我国OLP临床研究质量和循证价值。.

Publication types

  • English Abstract

MeSH terms

  • Humans
  • Lichen Planus, Oral* / diagnosis
  • Lichen Planus, Oral* / therapy
  • Mouth Neoplasms / therapy
  • Quality of Life