子宫内膜癌随机对照试验摘要报告质量评价

Assessment of quality of randomized controlled trials research papers among Chinese abstracts for Endometrial cancer

目的使用CONSORT声明评价中文发表的子宫内膜癌随机对照试验(RCT)摘要报告质量。方法通过计算机检索中国生物医学文献数据库(1978年~2017年3月)、万方(1997年~2017年3月)、中国知网(1994年~2017年3月)和维普(1989年~2017年3月)数据库纳入的以中文发表的子宫内膜癌领域的RCT,依据摘要CONSORT标准对所纳入RCT摘要进行质量评价,采用Meta-Analyst和RevMan5.1软件进行统计分析。结果最终纳入符合标准的研究共171篇,全部为中文,发文量主要集中在四川、黑龙江、广东、河南、山东5省。参文作者数量以1~3位居多,共计131篇(76.6%)。自2008年“摘要CONSORT”发布之后发表文章数量明显增长,达到164篇(95.9%),且纳入的RCT中11个条目报告质量得到明显改善;被CSCD收录的5篇(2.9%)文献的完整报告率明显高于非CSCD收录的164篇文献(95.9%)。但在“标题随机[RR(95%CI)0.3(0,4.5)]、研究对象[RR(95%CI)7.0(4.0,11.9)]、结局指标[RR(95%CI)0.3(0,4.5)]、随机化[RR(95%CI)12.3(8.1,18.1)]、盲法[RR(95%CI)1.2(0.3,4.6)]、统计方法[RR(95%CI)5.8(3.2,10.5)]、分析的例数[RR(95%CI)4.1(2.0,8.3)]、试验注册[RR(95%CI)0.3(0,4.5)]和资助来源[RR(95%CI)10.5(6.7,16.1)]9个方面仍存在严重不足。结论目前中文发表子宫内膜癌RCT摘要质量存在严重缺陷,本研究采用CONSORT对这些RCT的摘要报告质量进行了评价,以期了解目前的现状,从而提高中文发表子宫内膜癌RCT的摘要报告质量。

Objective To evaluate the reported quality of randomized controlled trials (RCTs) literature abstract of endometrial cancer published in Chinese using the abstract CONSORT statement. Methods Endometrial-cancer-related RCTs were searched in CNKI, CBM, VIP and WF databases from inception to March 2017. the literature abstracts were conducted quality assessment in accordance with the abstract CONSORT standard. Meta-Analyst and RevMan5.1 software were used for statistical analysis. Results A total of 171 Chinese RCTs were included which the published areas were mainly Sichuan, Heilongjiang, Guangdong, Henan and Shandong. The number of reference writers ranged from 1 to 3, with a total of 131 articles (76.6%). Statistical data showed that the number of published articles has increased significantly and reached to 164 (95.9%) since the publication of the abstract CONSORT in 2008. The quality of the 11 entries in the RCTs has been significantly improved. In addition, the complete reporting rate of 5 articles (2.9%) collected by CSCD was significantly higher than that of the 164 non-CSCD articles (95.9%).The serious reporting flaws were appeared for RCT abstract of endometrial cancer regarding following items: title randomized, subject, investigated outcome indes, randomization, blinding, statistical methods, numbers analysised, trial registration, funding. The pooled RR with 95%CI were 0.3(0, 4.5), 7.0(4.0, 11.9), 0.3(0, 4.5), 12.3(8.1, 18.1), 1.2(0.3, 4.6), 5.8(3.2, 10.5), 4.1(2.0, 8.3), 0.3(0, 4.5), 10.5(6.7, 16.1), respectivly. Conclusion At present, Chinese published endometrial cancer RCT abstract quality is poor. In this study, the quality of these RCT reports are evaluated by CONSORT in order to understand the current status and to improve the quality of Chinese abstracts published for endometrial cancer RCTs.