《临床医学》16年随机对照试验文献的方法学评价

Evaluation of Papers with Randomized Control Trials Published in《Clinical Medicine》in Recent 16 years

目的:评价《临床医学》临床治疗文献中随机对照试验论文的研究质量。方法:逐期逐页手工检索《临床医学》1985-2001年中发表的治疗性试验论文,按Cochrane协作网RCT、CCT资料库中的判定标准进行严格分析评价。结果:近16年21卷136期杂志中,共检出随机对照试验的治疗性文献338篇,半随机对照试验的治疗性文献170篇,发表数量呈逐年增加趋势。正确使用随机分配方法的13篇,占3.85%,无一篇文献提到实施随机方案的隐藏。各试验选择了对照。20篇(5.92%)文献中显示采用盲法试验,并且2.96%应用的双盲。结论:《临床医学》临床随机对照试验论文逐年增多,但仍存在一些问题,质量有待提高加强。

Objective： To evaluate the quality of papers with randomized controlled trials published in Clinical Medicine Journal during 1985- 2001. Methods： According to Cochrane Center hand - search guideline in 1997, all of the papers related to clinical therapeutic trials were searched, screened, and Randomized controlled trials （RCT） was identified by hand. Results： Of 136 issues in the recent sixteen years, there research papers 338 were of RCTs and CCTs 170. Among them, randomized methods were used correctly in 13 trials, all of the paper did not showed allocation concealment. All of the trials selected correct measurement. Twenty trials adopted blind test with 2.96% double blinded trials. Conclusion： The number of RCTs papers publisbed in Clinical Medicine Journal were increasing year hy year. However, there remained some problems, and the quality needed to be improved.