四种口腔专业期刊十年正畸临床论著循证医学质量评估

Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals

目的对四种口腔专业期刊十年的正畸临床论著进行循证医学质量评估，为国内口腔正畸临床试验设计以及论著写作提供参考。方法手工检索1999至2008年《中华口腔医学杂志》、《华西口腔医学杂志》、《实用口腔医学杂志》和《口腔正畸学》发表的正畸临床论著，提取分析论著的基本信息，对临床试验的设计进行分类评价，采用临床试验统一报告标准（consolidated standards of reporting trials，CONSORT）建立的临床试验评价标准进行质量评估。结果共提取494篇正畸临床论著，其中有基金支持的占21．3％（105／494）。所有论著中前瞻性试验占26．1％（129／494），随机对照临床试验仅有3．8％（19／494）。大多数论著由于方法学部分相关信息缺失，无法进行全面的方法学质量评价。即使是随机对照临床试验，其随机方法、分配方式的隐藏、盲法的采用以及应用基线数据分析等方面也不完善。结论口腔正畸临床试验应在试验设计及论著写作两方面进一步提高。

Objective To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. Methods All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials （CONSORT） was assessed. Results Four hundrend and ninty-four clinical trials were retrieved, and 21.3 % （105/494） of them were supported by grants. For the study design, only 26. 1% （129/494） were prospective studies, and 3.8% （19/494） were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intension to treat compromised the quality. Conclusions The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.