| Objective: To review the quality of Chinese clinical research papers on urinary tuberculosis and male genital tuberculosis, furthermore, to provide reference for the quality improvement of research, the normative report of the papers and clinical practice, we evaluated the quality of Chinese clinical research papers on urinary tuberculosis and male genital tuberculosis.Methods: The papers on urinary tuberculosis and male genital tuberculosis in China were searched from Chinese Biomedical database(CBM), Wanfang database and Chinese Science and Technology Periodical database(VIP),Chinese National Knowledge Infrastructure(CNKI) and Pub Med up to August,2015. Note Express was used to conduct preliminary management of the papers,which were further screened, according to the proposed inclusion and exclusion criteria. Based on the principles and methods of evidence-based medicine, thegeneral characteristics of the included papers, such as the year distribution, the regional distribution, the researcher's unit distribution, the journals distribution and the types of the papers and so on, were summarized and analyzed. The list of quality assessment of Joanna Briggs Institute(JBI) was used to evaluate the quality of the case series. The consolidated standards of reporting trials(CONSORT) 2010 statement was used to evaluate the quality of the randomized controlled trials. A cochrane risk of bias assessment tool(ACROBAT) was used to evaluate the quality of the non-randomized studies of interventions. The quality assessment of diagnostic accuracy studies(QUADAS) was used to evaluate the quality of the diagnostic accuracy studies. Epi Data 3.1 was used to establish evaluation table database for data entry, and the data acquired was imported into Excel to analysis the relevant contents. The quality assessment of the papers was mainly performed by researcher group, If we didn't reach an agreement for the quality assessment,we consulted with the instructor to make judgments.Results:(1)A total of 6416 papers were retrieved by computer, after screening, 1437 papers were ultimately included.(2)As to the year distribution of the papers, the amount of papers began to maintain a growth trend from the beginning of the 90's. As to the total amount of papers, since 2000, the amount of papers increased rapidly, and the papers growth reached a peak in the period between 2006 and 2010(400 articles, 27.8%).(3) As to the regional distribution of the papers, 1409 Chinese papers were distributed in all regions of the country,the five regions were Shandong, Guangdong, Hubei, Beijing and Hebei,respectively, which had the most papers, a total of 445 articles(31.6%) were published.(4) As to the researcher's unit distribution of the papers, 1409 Chinese papers were reported from 881 units, the seven hospitals were the Xinjiang Uygur Autonomous Region People's Hospital, the Affiliated Hospital of Zunyi Medical College, the Affiliated Hospital of Chengde Medical College,the 309 th Hospital of Chinese People' Liberation Army, the First Affiliated Hospital of China Medical University, the Tongji Hospital of Tongji Medical College, the West China Hospital of Sichuan University, respectively, which published the most papers.(5) As to the types of the papers, most of the 1437 papers on urinary tuberculosis and male genital tuberculosis were narrative papers(1290 papers, 89.8%), which concluded 870 case series(60.5%) and 420 case reports(29.3%). The other types of the papers were relatively small, 13non-randomized controlled trials(0.9%), 9 randomized controlled trials(0.6%),36 diagnostic accuracy studies(2.5%).(6)As to the periodical distribution of the papers, 1437 papers were distributed in 439 kinds of periodicals. The 7 journals were Journal of Clinical Urology, Chinese Journal of Urology, Chinese Journal of Misdiagnostics, Clinical Misdiagnosis and Mistherapy, Chinese Tuberculosis, Shandong Medical Journal and Journal of Modern Department of Urology, which published the most papers.(7)Quality evaluation of case series:863 papers(99.2%) didn't define the inclusion and exclusion criteria. 465papers(53.4%) reported the objective evaluation indexes, 274 papers(31.5%)reported the subjective evaluation indexes, 854 papers(98.2%) didn't elaborate on baseline data, defined as "missing" in this item.(8)Quality evaluation of randomized controlled trials: The sample size of 5 articles was 20-50, and the sample size of 4 articles was 50-80. Both sample size estimation and calculation method weren't mentioned in the papers. All of the 9 papers didn't describe the method of random sequence generation. All of the 9 papers didn't explain the specific process of the randomization implementation, also failed to implement the allocation concealment and blinding.(9)Quality evaluation of non-randomized controlled trials: The risk of bias due to confounding in the 9papers was "high". The risk of bias due to confounding in the 4 papers was "extremely high". The risk of bias in measurement of outcomes in the 8 papers was "high". The risk of bias in measurement of outcomes in the 5 papers was "moderate". The risk of bias in selection of the reported result in the 13 papers was "high".(10)Quality evaluation of diagnostic accuracy studies: 20papers(55.6%) didn't conclude various types of cases and the disease easily confused. The criteria of selection of 28 papers(77.8%) weren't clear enough.25 papers(69.4%) weren't sure if they were aware of each other in the interpretation of the index tests or reference standard results.Conclusions:(1)The types of clinical studies on urinary tuberculosis and male genital tuberculosis in China were extremely uneven. The narrative researches accounted for the most, which were the lowest level of evidence.While randomized controlled trials, non-randomized controlled trials anddiagnostic accuracy studies were very few.(2) From the beginning of the 90 s,the papers on urinary tuberculosis and male genital tuberculosis in China maintained growth trend, since 2000, the papers were into a stable stage of rapid growth, the researcher's unit distribution and the periodical distribution of the papers were relatively scattered, the papers were mainly concentrated in the central and eastern regions, the papers in the western regions were relatively few.(3) Chinese clinical research papers on urinary tuberculosis and male genital tuberculosis were generally low quality. Case series needs to be improved in the following aspects, such as inclusion and exclusion criteria,evaluation and follow-up of outcome, statistical analysis and so on.Randomized controlled trials were mainly in title, sample size, random sequence generation, allocation concealment, implementation, blinding,intention to treat analysis which were not detailed or not reported.Non-randomized controlled trials were at high risk of bias due to confounding,bias in measurement of outcomes, and bias in selection of the reported result.Diagnostic accuracy studies were at high risk of case selection, reference standard selection, trial repeatability and blinding.(4) In this study, the general characteristics of the papers and the quality of the papers had been retrospectively evaluated. The specific content of the papers needs to be further evaluated, and the conclusions needs to be further confirmed. |
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