国内男性泌尿生殖系统结核文献中随机对照试验的质量评价

Quality assessment of randomized controlled trials of the male genitourinary tuberculosis in China

目的评价国内男性泌尿生殖系统结核文献中随机对照试验(RCT)的方法学质量。方法检索截至2015年8月收录于中国生物医学文献数据库(CBM)、万方、CNKI、维普以及Pub Med中的关于国内男性泌尿生殖系统结核的文献,纳入所有随机对照试验文献,依据CONSORT 2010声明对文献质量进行评价,由两名研究者独立进行文献质量评价。结果共纳入9篇中文文献。质量评价结果显示,大多数文献与CONSORT 2010声明符合率不高。纳入文献对样本量确定、随机序列产生、分配隐藏、盲法、意向性治疗分析等条目的报道不详尽或未见报告,同时在试验局限性、可推广性、试验解释以及其他信息(试验注册、试验方案以及资助)等条目的报告上也不够重视。结论国内男性泌尿生殖系统结核文献中RCT的报告质量较低,与CONSORT 2010声明符合率不高,建议RCT的报告尽量采用CONSORT 2010声明来规范,以提高临床随机对照研究的质量。

Objective To assess the quality of randomized controlled trials associated with the male genitourinary tuberculosis in China.Methods Literatures of the male genitourinary tuberculosis in China were searched from the database of CBM,Wan fang,CNKI,VIP and Pub Med.We researched randomized controlled trials associated with the male genitourinary tuberculosis in China up to August,2015.CONSORT 2010 statement was used to assess the quality of literatures by two researchers independently. In case of disagreement,discuss was performed to solve the disagreement. Results A total of nine Chinese literatures were included and assessed without any English literature.We found that most of the studies didn＇t meet with CONSORT 2010 statement.In the included literatures,the report was not in detail or not shown in the report on sample size estimation,random sequence generation,distribution of hidden,blindness and intention-to-treat analysis.Meanwhile,trial limitations,generalizability,test interpretation and other information（ registration,protocol and funding） were also not reported in detail.Conclusion The quality of reports of randomized controlled trials associated with male genitourinary tuberculosis in China was low-quality,and the articles don＇t meet well with CONSORT 2010 statement.To improve the quality of randomized controlled trials,it is suggested that CONSORT 2010 statement should be used to report randomized controlled trials.