Gao Jie, Deng Gaopi, Hu Yunyun, Huang Yanxi, Lu Liming, Huang Dandan, Li Yadi, Zhu Lin, Liu Xiaojing, Jin Xin, Luo Songping
Department of Gynecology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, Guangdong, China.
Trials. 2015 Apr 18;16:172. doi: 10.1186/s13063-015-0665-6.
Despite increasing numbers of RCTs done in China, detailed information on the quality of Chinese RCTs is still missing. The aim of this study was to assess the reporting quality of RSA RCTs and to identify significant predictors of reporting quality.
A literature review was conducted with the aim of identifying published RCTs on RSA conducted in China. In order to rate the report quality, we scored 1 for the item of CONSORT 2010 if it was reported and 0 if it was not stated or unclear. An overall quality score (OQS) with a range of 0-15 and a key methodological index score (MIS) with a range of 0-3 were calculated for each trial.
A total of 98 relevant RCTs were included in the final analysis. The median OQS was 7, with a minimum of 1 and maximum of 12. The general level of OQS was not high, especially among 'sample size,' 'baseline data,' 'outcomes and estimation,' and 'ancillary analyses,' all of which had a positive rate of less than 10%. The median MIS was 1 with a minimum of 0 and maximum of 1. 'Allocation concealment,' 'blinding,' and 'intention-to-treat analysis' were mentioned in 1 (1%), 1 (1%) and 69 (70%) of the studies, respectively. In univariate analysis, funding was the only factor associated with an increased OQS. Specifically, the mean OQS increased by approximately 1.52 for manuscripts supported by funding (95% CI: 0.12 - 2.92; p = 0.03). With regard to the MIS, no association was found for any variable.
RCTs of RSA conducted in China need improvement in order to meet the level of "reporting quality" required by the CONSORT statement.
尽管中国开展的随机对照试验（RCT）数量不断增加，但关于中国RCT质量的详细信息仍然缺失。本研究的目的是评估随机序贯分配（RSA）RCT的报告质量，并确定报告质量的重要预测因素。
进行文献综述，旨在识别在中国开展的关于RSA的已发表RCT。为了对报告质量进行评分，如果CONSORT 2010的项目被报告则计1分，如果未提及或不清楚则计0分。为每个试验计算了范围为0至15的总体质量评分（OQS）和范围为0至3的关键方法学指标评分（MIS）。
最终分析共纳入98项相关RCT。OQS的中位数为7，最小值为1，最大值为12。OQS的总体水平不高，特别是在“样本量”“基线数据”“结局与估计”以及“辅助分析”方面，所有这些方面的阳性率均低于10%。MIS的中位数为1，最小值为0，最大值为1。分别有1项（1%）、1项（1%）和69项（70%）研究提及了“分配隐藏”“盲法”和“意向性分析”。在单变量分析中，资金是与OQS增加相关的唯一因素。具体而言，由资金支持的手稿的平均OQS增加约1.52（95%置信区间：0.12 - 2.92；p = 0.03）。关于MIS，未发现任何变量与之相关。
在中国开展的RSA RCT需要改进，以达到CONSORT声明要求的“报告质量”水平。
