《口腔正畸学》十年临床论著质量评估

目的 对<口腔正畸学>近10年所有发表的临床论著进行循证医学质量评估,了解发表的临床论著的质量,为今后的国内口腔正畸临床试验、文献发表以及口腔专业期刊质量控制提供参考.材料与方法手工检索1999～2008年<口腔正畸学>发表的临床论著,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CONSORT(临床试验统一报告标准)建立的临床试验评价标准来进行质量评估.结果 十年共发表论著295篇,临床论著占69.8%(206/295篇).有基金支持论著占29.5%(87/295篇),临床论著中基金支持比例为18.0%(37/206篇).临床论著中,院校署名占85%(175/206篇),非院校署名仅占15.0%(31/206篇).在试验设计中,21.8%(45/206篇)为前瞻性研究,随机对照试验仅占3.4%(7/206篇).对于方法学质量的评价,大多数论著由于方法学部分相关信息的缺失,无法进行全面的评价.即使对于随机对照临床试验,在明确随机方法,分配方式的隐藏、盲法以及基线数据分析等主要质量控制标准也不完善.结论 正畸临床试验应该在试验设计及论著写作两方面进行提高.

Quality assessment of clinical trials published in the Journal of Orthodontics in the past ten years

Objective To assess the quality of clinical trials published in Chinese Journal of Orthodontics in the past 10 years. Methods We hand searched all the clinical trials published in Chinese Journal of Orthodontics. We extracted the major information of the papers and assessed the quality of the clinical trials according to the CONSORT (Consolidated Standards of Reporting Trials).Results Two hundred and ninety-five papers were published in the past 10 years in Chinese Jounal of Orthdontics. We retrieved 206 clinical trials (69.8%). Among the clinical trials, 37 studies (18.0%)were supported by grants. There were 175 papers (85.0%) were submitted by university hospitals and only 31 (15.0%) papers belonged to hospitals not affiliated with university. For the study design,only 45 studies (21.8%) were progressive and 7 studies (3.4%) were randomized. It was hard to evaluate precisely due to lack of information about the details of the study designs. For the randomized clinical trials, lack of precise randomization, allocation concealment, blinding and intension to treat compromised the quality. Conclusions Clinical study design and the paper writing needed to be improved.