CAJ | 학술논문

背景按照循证医学(EBM)的理念对医学临床研究进行随机对照试验(RCT)能够为医疗决策提供重要证据,国际编辑组织提供的临床试验报告统一标准(CONSORT)是医学临床研究者正确撰写RCT报告的指南.目前中国临床研究人员对RCT的评价和使用方法了解的还不够. 目的采用2010版CONSORT对中国大陆地区眼科研究者在SCI期刊上所发表的有关眼科疾病的RCT报告的方法学质量进行评价,为RCT报告的正确撰写提供方法学介绍.方法在PubMed平台检索中国大陆眼科研究者在SCI期刊上发表的眼科RCT研究文章,检索文献截止至2013年3月,由2位评阅者对检索的文献独立评分,统计所纳入文献对于CONSORT各项条目的符合率,根据CONSORT的发表和修订年份对文章进一步分层分析. 结果共纳入60篇眼科研究相关的RCT文献,研究中的干预措施以手术类为主(34/60),共有44篇文献设立了2个研究组,样本量的中位数为76.0.纳入的文献中,仅有22％的文章(13/60)在文题中标注了RCT.绝大多数文章在摘要和背景部分进行了合理描述,仅4篇文章提出了试验的假设,占7％.在方法部分,仅12篇文章报告了如何计算样本量,有41篇报告了资料收集的场所和地点,仅6篇文章提到了中期分析和中止原则.2010版CONSORT声明发表后,中国大陆地区所发表的RCT报告对随机化的描述并未显著改善(RR=1.06,95％ CI:0.62 ～ 1.82),对盲法进行描述的报告仅占42％ (25/60). 结论中国大陆地区发表在SCI期刊上的RCT报告还存在较多问题.严格按照CONSORT声明设计并报告高质量的RCT有助于真实、客观地反映中国眼科临床研究的现状,提高中国大陆地区眼科临床试验的质量,并为眼科临床工作提供指导.
배경 안조순증의학(EBM)적이념대의학림상연구진행수궤대조시험(RCT)능구위의료결책제공중요증거,국제편집조직제공적림상시험보고통일표준(CONSORT)시의학림상연구자정학찬사RCT보고적지남.목전중국림상연구인원대RCT적평개화사용방법료해적환불구. 목적 채용2010판CONSORT대중국대륙지구안과연구자재SCI기간상소발표적유관안과질병적RCT보고적방법학질량진행평개,위RCT보고적정학찬사제공방법학개소.방법 재PubMed평태검색중국대륙안과연구자재SCI기간상발표적안과RCT연구문장,검색문헌절지지2013년3월,유2위평열자대검색적문헌독립평분,통계소납입문헌대우CONSORT각항조목적부합솔,근거CONSORT적발표화수정년빈대문장진일보분층분석. 결과 공납입60편안과연구상관적RCT문헌,연구중적간예조시이수술류위주(34/60),공유44편문헌설립료2개연구조,양본량적중위수위76.0.납입적문헌중,부유22％적문장(13/60)재문제중표주료RCT.절대다수문장재적요화배경부분진행료합리묘술,부4편문장제출료시험적가설,점7％.재방법부분,부12편문장보고료여하계산양본량,유41편보고료자료수집적장소화지점,부6편문장제도료중기분석화중지원칙.2010판CONSORT성명발표후,중국대륙지구소발표적RCT보고대수궤화적묘술병미현저개선(RR=1.06,95％ CI:0.62 ～ 1.82),대맹법진행묘술적보고부점42％ (25/60). 결론 중국대륙지구발표재SCI기간상적RCT보고환존재교다문제.엄격안조CONSORT성명설계병보고고질량적RCT유조우진실、객관지반영중국안과림상연구적현상,제고중국대륙지구안과림상시험적질량,병위안과림상공작제공지도.
Background Randomized controlled trial (RCT) can offer high quality of evidence for the medical decisions.Consolidated standards of reporting trials (CONSORT) statement,an international criteria for RCT report,is a guideline and methodology of RCT report.However,the assessment and application of RCT according to CONSORT are dissatisfactory in China.Objective This study was to evaluate the reporting quality of ophthalmic diseases related RCTs published in SCI journals from mainland China and offer a good methodology of RCT report.Methods The RCT literature were searched on PubMed database according to "Ophthalmology"," Eye" and all of their inferior subjective terms,and the published papers were limited in mainland China and before March,2013.Included papers were evaluated independently and checked by two searchers.The methodology and results of all retrieved papers were stratifiedly analyzed by the year of CONSORT published and revised.Results Sixty eligible RCTs were assessed,and the intervention methods were primarily surgery trials (34/60).Forty-four papers presented the comparison study of two groups with the median sample size of 76.0.Only 22％ (13/60) trial reports gave the clear identification of RCT in the title.Majority of papers described trial design,eligibility criteria for participants,detail of interventions and outcome measures.Twelve pieces of articles reported how sample size was determined,and 41 pieces referred settings and locations,but only 6 pieces recorded interim analyses and stopping guidelines.After CONSORT 2010 Statement was published,the proportion of trial reports that included details of the randomization had little improvement (RR=1.06,95％ CI:0.62-1.82).Only 42％ trial reports (25/60) offered a description about blinding method.Conclusions RCT reports related to ophthalmic diseases from mainland China in SCI journals are still flawed with certain shortcomings.Following the guidance of the CONSORT statement can improve the quality of ophthalmic diseases related RCT from mainland China.