Yang Chun-Song, Zhang Ling-Li, Zeng Li-Nan, Liang Yi, Han Lu, Lin Yun-Zhu
BMC Pediatr. 2013 Aug 2;13:113. doi: 10.1186/1471-2431-13-113.
Quality assessment of pediatric randomized controlled trials (RCTs) in China is limited. The aim of this study was to evaluate the quantitative trends and quality indicators of RCTs published in mainland China over a recent 10-year period.
We individually searched all 17 available pediatric journals published in China from January 1, 2002 to December 30, 2011 to identify RCTs of drug treatment in participants under the age of 18 years. The quality was evaluated according to the Cochrane quality assessment protocol.
Of 1287 journal issues containing 44398 articles, a total of 2.4% (1077/44398) articles were included in the analysis. The proportion of RCTs increased from 0.28% in 2002 to 0.32% in 2011. Individual sample sizes ranged from 10 to 905 participants (median 81 participants); 2.3% of the RCTs were multiple center trials; 63.9% evaluated Western medicine, 32.5% evaluated traditional Chinese medicine; 15% used an adequate method of random sequence generation; and 10.4% used a quasi-random method for randomization. Only 1% of the RCTs reported adequate allocation concealment and 0.6% reported the method of blinding. The follow-up period was from 7 days to 96 months, with a median of 7.5 months. There was incomplete outcome data reported in 8.3%, of which 4.5% (4/89) used intention-to-treat analysis. Only 0.4% of the included trials used adequate random sequence allocation, concealment and blinding. The articles published from 2007 to 2011 revealed an improvement in the randomization method compared with articles published from 2002 to 2006 (from 2.7% to 23.6%, p = 0.000).
In mainland China, the quantity of RCTs did not increase in the pediatric population, and the general quality was relatively poor. Quality improvements were suboptimal in the later 5 years.
中国儿科随机对照试验（RCT）的质量评估有限。本研究旨在评估中国大陆近10年发表的RCT的数量趋势和质量指标。
我们逐一检索了2002年1月1日至2011年12月30日期间在中国出版的所有17种儿科期刊，以确定18岁以下参与者的药物治疗RCT。根据Cochrane质量评估方案对质量进行评估。
在包含44398篇文章的1287期期刊中，共有2.4%（1077/44398）的文章纳入分析。RCT的比例从2002年的0.28%增加到2011年的0.32%。个体样本量从10名至905名参与者不等（中位数为81名参与者）；2.3%的RCT为多中心试验；63.9%评估西药，32.5%评估中药；15%采用了适当的随机序列生成方法；10.4%采用准随机方法进行随机化。仅1%的RCT报告了适当的分配隐藏，0.6%报告了盲法。随访期为7天至96个月，中位数为7.5个月。8.3%的研究报告了不完整的结局数据，其中4.5%（4/89）采用意向性分析。仅0.4%的纳入试验采用了适当的随机序列分配、隐藏和盲法。与2002年至2006年发表的文章相比，2007年至2011年发表的文章在随机化方法上有所改进（从2.7%至23.6%，p = 0.000）。
在中国大陆，儿科人群中RCT的数量没有增加，总体质量相对较差。后5年质量改善未达最佳状态。
