【摘要】：目的了解近年來國內(nèi)具有代表性的三本麻醉學(xué)專業(yè)期刊隨機(jī)對照試驗(yàn)(RCT)文獻(xiàn)的質(zhì)量。方法本研究采用CONSORT清單對《中華麻醉學(xué)雜志》、《臨床麻醉學(xué)雜志》和《國際麻醉學(xué)與復(fù)蘇雜志》2011~2013年發(fā)表的所有RCT文獻(xiàn)質(zhì)量進(jìn)行評價(jià)。結(jié)果本研究共納入RCT文獻(xiàn)1024篇,占發(fā)表文獻(xiàn)總數(shù)的29.9%。納入的文獻(xiàn)中,科學(xué)背景、試驗(yàn)設(shè)計(jì)描述、受試者合格標(biāo)準(zhǔn)、干預(yù)措施的描述、統(tǒng)計(jì)學(xué)方法和不良反應(yīng)等報(bào)告率達(dá)100%。而在重要方法的改變、設(shè)定主要和次要結(jié)局指標(biāo)、主要指標(biāo)的效應(yīng)估計(jì)值等方面報(bào)告率為0。僅有13篇(1.3%)文獻(xiàn)可以從文題中看出是否為RCT文獻(xiàn)。僅有3篇(0.3%)文獻(xiàn)有介紹如何計(jì)算樣本量。有464(45.3%)文獻(xiàn)報(bào)道了隨機(jī)序列的產(chǎn)生方法。但僅有5篇(0.5%)有對隨機(jī)方法類型的描述。只有9篇(0.9%)文獻(xiàn)能在方法中看出使用了分配隱藏機(jī)制。盲法的使用要多一些,有69篇(6.7%)。介紹招募時(shí)間的文獻(xiàn)只有148篇(14.5%)�；�表格的使用超過半數(shù),有559篇(54.6%)。討論中提及試驗(yàn)的局限性的文獻(xiàn)有855篇(83.5%)。結(jié)論國內(nèi)麻醉學(xué)期刊的RCT文獻(xiàn)報(bào)告質(zhì)量與CONSORT聲明要求相比有較大差距,國內(nèi)期刊應(yīng)盡快采納CONSORT,提高麻醉學(xué)文獻(xiàn)的報(bào)告質(zhì)量和科研水平。
[Abstract]:Objective to investigate the quality of (RCT) literature in three representative journals of anesthesiology in recent years. Methods the quality of all RCT literatures published in the Chinese Journal of Anesthesiology, the Journal of Clinical Anesthesiology and the International Journal of Anesthesiology and Resuscitation from 2011 to 2013 was evaluated by CONSORT list. Results A total of 1024 RCT papers were included in this study, accounting for 29. 9% of the published literature. In the literature, the scientific background, the design description of the experiment, the qualification criteria of the subjects, the description of the intervention measures, the statistical method and the adverse reaction, the reporting rate was 100%. However, the reporting rate is 0. 5% in terms of the change of important methods, the setting of primary and secondary outcome indicators, and the estimation of the effects of the main indicators. Only 13 articles (1.3%) can be identified as RCT. Only 3 articles (0.3%) showed how to calculate the sample size. 464 (45.3%) literature reported the method of generating random sequences. However, only 5 (0.5%) have a description of the type of random method. Only 9 articles (0.9%) showed the use of allocation hiding mechanism in the method. Blind methods were used more frequently, 69 (6.7%). There were only 148 articles (14.5%) on the time of recruitment. More than half of the baseline tables were used, with 559 articles (54.6%). There were 855 articles (83.5%) referring to the limitations of the experiment in the discussion. Conclusion compared with the requirement of CONSORT, the quality of RCT literature report in domestic anesthesiology journals is much lower than that of CONSORT. CONSORT, should be adopted as soon as possible to improve the reporting quality and scientific research level of anesthesiology literature.
【作者單位】： 南京醫(yī)科大學(xué)第一附屬醫(yī)院麻醉科;《臨床麻醉學(xué)雜志》編輯部;
【分類號】：R614

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