摘要
[目的]评价CNKI数据库中肿瘤治疗的临床随机对照试验（RCT）文献的质量。[方法]检索2006~2011年CNKI数据库中发表的有关肿瘤治疗的临床随机对照试验的期刊文献,并参考2010年版报告随机临床试验的CONSORT声明,对文献质量进行评价。[结果]共纳入合格文献696篇。其中列举了具体纳入和排除标准的占82.04%;报告了随机分配方法的占14.37%;运用盲法的占0.43%;简单描述随机分配隐藏的占1.15%;具体描述基线资料的占1.87%;有受试者流程图的占0.72%;所有文献中,提及样本量计算的占0.29%;有试验注册的占0.14%;所有文献中均没有记载试验方案和商业资助的内容。[结论]目前肿瘤治疗的临床随机对照试验质量普遍较低,还有待进一步提高,尤其是盲法的使用和样本量的估算方面。
[ Purpose ] To assess the quality of randomized controlled trials reports on the treatment for tumor in China. [Methodsl All primary reports of randomized controlled trials for tumor treatment pub- lished in CNKI from 2006 to 2011 were enrolled. The quality of reporting was assessed according to consolidated standards of reporting trials statement in 2010. [ Results ] A total of 696 articles which met the inclusion criteria were analyzed. Reports with inclusion and exclusion criteria accounted for 82.04%. Reports describing randomization allocation method, blinding methods, random allocation con- cealment, baseline data, flow figure, sample size evaluation and trial registration accounted for 14.37%, 0.43%, 1.15%, 1.87%,0.72%,0.29% and 0.14% of all reports respectively. [Conclusionl The quality of randomized controlled trials of cancer treatment is generally low,which needs to be further im- proved, especially the use of blinding and sample size calculation.
出处
《肿瘤学杂志》
CAS
2013年第8期639-643,共5页
Journal of Chinese Oncology
基金
福建省自然科学基金(2013J01379)
