CAJ | 학술논문

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.
목적 대<구강정기학>근10년소유발표적림상론저진행순증의학질량평고,료해발표적림상론저적질량,위금후적국내구강정기림상시험、문헌발표이급구강전업기간질량공제제공삼고.재료여방법수공검색1999～2008년<구강정기학>발표적림상론저,제취분석론저적기본신식,대림상시험적설계진행분류평개,채용CONSORT(림상시험통일보고표준)건립적림상시험평개표준래진행질량평고.결과 십년공발표론저295편,림상론저점69.8%(206/295편).유기금지지론저점29.5%(87/295편),림상론저중기금지지비례위18.0%(37/206편).림상론저중,원교서명점85%(175/206편),비원교서명부점15.0%(31/206편).재시험설계중,21.8%(45/206편)위전첨성연구,수궤대조시험부점3.4%(7/206편).대우방법학질량적평개,대다수론저유우방법학부분상관신식적결실,무법진행전면적평개.즉사대우수궤대조림상시험,재명학수궤방법,분배방식적은장、맹법이급기선수거분석등주요질량공제표준야불완선.결론 정기림상시험응해재시험설계급론저사작량방면진행제고.
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.