Heterogeneity of Outcome Measures Used in Randomized Controlled Trials for the Treatment of Oral Lichen Planus: A Methodological Study

Yu-Rong Yan; Fang Hua; Ming-Jing He; Tong Lei; Ya-Qin Tan; Gang Zhou

doi:10.1016/j.jebdp.2020.101468

Heterogeneity of Outcome Measures Used in Randomized Controlled Trials for the Treatment of Oral Lichen Planus: A Methodological Study

J Evid Based Dent Pract. 2020 Sep;20(3):101468. doi: 10.1016/j.jebdp.2020.101468. Epub 2020 Jun 20.

Authors

Yu-Rong Yan¹, Fang Hua², Ming-Jing He³, Tong Lei¹, Ya-Qin Tan³, Gang Zhou⁴

Affiliations

¹ The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China.
² The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China; Centre for Evidence-Based Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China; Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, Division of Dentistry, School of Medicine Sciences, University of Manchester, Manchester, UK.
³ The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China; Department of Oral Medicine, School and Hospital of Stomatology, Wuhan University, Wuhan, China.
⁴ The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China; Department of Oral Medicine, School and Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: zhougang@whu.edu.cn.

PMID: 32921388
DOI: 10.1016/j.jebdp.2020.101468

Abstract

Objective: Oral lichen planus (OLP) is a chronic inflammatory immune disease, recognized as an oral potentially malignant disorder by the World Health Organization. There is considerable controversy over the standardized treatment of OLP, with great diversities in the outcome measures in clinical trials. This methodological study aimed to estimate the degree of consensus on outcome measures in randomized controlled trials (RCTs) for OLP treatment.

Methods: PubMed, Embase, and Cochrane databases were searched to identify RCTs published from 2004 to 2018 about OLP treatment. All the outcome measures and measurement methods mentioned in the trials were extracted and analyzed.

Results: After identification of 1087 articles, 88 RCTs were included. A total of 193 single-outcome measures and 119 composite outcome measures were classified into 11 different domains, the chief of which consisted of clinical symptom (78 trials; 88.6%) and clinical score (58 trials; 65.9%). Visual analog scale (65 trials; 73.9%) and Thongprasom scoring system (38 trials; 43.2%) were the predominant measurement methods. Oral health-related quality of life (except for clinical symptoms) accounted for 4.8% of all the outcome measures.

Conclusions: There was high heterogeneity in outcome measures of RCTs for OLP treatment, making it difficult to make valid comparisons between different clinical trials. A core outcome set should be developed and adopted in future trials for OLP treatment.

Keywords: Measurement methods; Oral lichen planus; Outcome measure; Randomized controlled trial.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Humans
Lichen Planus, Oral* / drug therapy
Outcome Assessment, Health Care*
Quality of Life
Randomized Controlled Trials as Topic*