七种军队医学期刊临床随机对照试验的报告质量评价

Assessment of Reporting Quality of Randomized Controlled Trials in Seven Journals Using the CONSORT Statement

目的调查7种军队综合性医学期刊2007年发表的随机对照试验(RCT)的报告质量,了解当前军队医学期刊临床试验报告质量的现状。方法手工检索2007年《解放军医学杂志》、《南方医科大学学报》、《第二军医大学学报》、《第三军医大学学报》、《第四军医大学学报》、《军事医学科学院院刊》和《军医进修学院学报》发表的文献,纳入声明采用"随机"方法分组的RCT,并采用国际公认的CONSORT标准进行报告质量评价。结果共纳入99篇RCT,其中6篇随机方法错误。根据CONSORT条目对随机方法正确的93篇RCT进行评价,其中62篇(66.7%)描述了各组的基线情况和临床特征;16篇(17.2%)提及了产生随机分配序列的方法,其中5篇(5.4%)提及用计算机产生随机分配序列;9篇(9.7%)采用盲法的文献中2篇仅提及"盲法"二字,1篇采用单盲,6篇采用双盲(其中2篇盲法正确);仅1篇文献采用意向治疗分析法;1篇分配方案隐藏充分。99篇均未提及样本含量的计算,且样本量多较小。结论目前军队综合性医学期刊发表的RCT报告质量与CONSORT标准比较尚有较大差距,今后应进一步进行规范报告。

Objective To evaluate the reporting quality of randomized controlled trials （RCTs） in seven military medical journals. Methods Seven journals in 2007, including Medical Journal of Chinese People’s Liberation Army, Journal of South Medical University, Journal of Second Military Medical University, Journal of Third Military Medical University, Journal of Fourth Military Medical University, Bulletin of the Academy of Military of Medical Sciences and Academic Journal of PLA Postgraduate Medical School, were handsearched. We identified RCTs labeled “random” and assessed the quality of these reports using the Consolidated Standards for Reporting of Trials （CONSORT） statement. Results We identified 99 RCTs, but found an incorrect randomized method was used in 6 RCTs. According to the items in the CONSORT statement in 93 RCTs, 62 （66.7%） RCTs described baseline demographic and clinical characteristics in each group. Sixteen （17.2%） RCTs mentioned the method of random sequence generation, with 5 （5.4%） using a computer allocation. Only 1 RCT had adequate allocation concealment. Only 9 （9.7%） RCTs used blinding, with 2 mentioning blinding, 1 using single blinding and 6 described as double-blind （2 were correct）. Zero （0%） reported the sample size calculation and 1 RCT reported the intention-to-treat （ITT） analysis. Conclusion The reporting quality of RCTs in seven journals is poor. The CONSORT statement should be used to standardize the reporting of RCTs.