国内泌尿男性生殖系统结合文献中诊断试验性研究的文献质量评价

Quality assessment of the diagnostic accuracy studies of the male genitourinary tuberculosis in China

目的评价国内关于泌尿男性生殖系统结核中诊断试验性研究的文献质量。方法检索收录于中国生物医学文献数据库（CBM）、pubmed中的关于国内泌尿男性生殖系统结核的文献，截至时间为2015年8月，纳入所有诊断试验性研究文献，应用QUADAS（Quality Assessment of Diagnostic Accuracy Studies）质量评价标准进行评价，由两名研究者独立进行文献质量评价，如遇分歧，讨论解决。结果共纳入36篇相关文献，其中，中文文献35篇，英文文献1篇。质量评价结果显示，大多数文献与QUADAS质量评价标准符合率不高；20篇文献病例谱未包含各种病例及易混淆病例，7篇病例谱不清楚是否包含各种病例及易混淆病例，28篇未清楚描述研究对象的选择标准，21篇“金标准”不能准确区分有病无病状态，仅10篇文献都以病理诊断作为“金标准”，26篇采用多个诊断“金标准”或以综合性诊断作为“金标准”，24篇不能确定是否所有研究对象均经“金标准”核实，25篇不清楚诊断试验和“金标准”结果的解释是否采用盲法，36篇未描述难以解释的结果，35篇未描述有退出病例。结论国内关于泌尿男性生殖系统结核文献的诊断试验性研究文献质量在病例选择、金标准选择、试验重复性、盲法比较、偏倚控制等方面还有待提高。

Objectives To assess the quality of the diagnostic accuracy studies of the male genitourinary tuberculosis in China. Methods Literatures of the male genitourinary tuberculosis in China were searched from the database of FubMed and Chinese biomedical literature database （CBM）. The diagnostic accuracy studies on the male genitourinary tuberculosis in China up to August, 2015 were researched. The quality assessment of diagnostic accuracy studies （QUADAS） was used to assess the quality of literatures by two researchers independently, in case of disagreement, discuss solutions. Resuits A total of thirty - six articles were included and assessed, including thirty - five Chinese literatures and one English literatures. We found that most of the studies were not met with QUADAS items. Twenty studies didn＇t contain correct cases which included miscellaneous cases and confused cases. Seven studies were not clear whether they contained a variety of cases and confused cases or not. Twenty - eight studies didnt describe internalized or exclusive references clearly. The gold standard in twenty - one studies could not accurately distinguish whether the diagnosis of patients were confirmed or not. Only ten studies regarded pathologic diagnosis as gold standard. Twenty - six studies used multiple diagnostic gold standard or regarded comprehensive diagnosis as the gold standard. Twenty - four studies didnt confirm whether all the research objects were verified by the gold standard. Twenty - five studies were not clear whether they used blind trial to compare the diagnostic test and the gold standard. Thirty - six studies didnt describe uninterpretable test results. Thirty - five studies didnt describe withdrawals from the study. Conclusions The quality of the diagnostic accuracy studies of the male genitourinary tuberculosis in China should be improved in patients selection, the gold standard selection, test repeatability, comparison of blind trial and bias control.