Epidemiology and reporting of randomised trials published in PubMed journals
Epidemiology and reporting of randomised trials published in PubMed journals
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DOI：
10.1016/s0140-6736(05)71879-1
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发表时间：
2005-03-01
期刊：
影响因子：
168.9
通讯作者：
Altman, DG
中科院分区：
文献类型：
--
作者：
Chan, AW;Altman, DG
尽管随机试验对循证医学很重要，但对其总体特征知之甚少。我们对2000年12月发表的所有519项PubMed索引的随机试验（383项[74%]平行组，116项[22%]交叉）的流行病学和方法学细节报告进行了评估。482篇（93%）发表在专业期刊上。平行组试验招募了中位数为80名受试者（第10 - 90百分位数25-369）。309例（60%）为盲法。把握度计算、主要结局、随机序列生成、分配隐藏和损耗处理均在不到一半的出版物中得到充分描述。样本量小令人担忧，方法学特征的报告不足将妨碍对许多已发表试验进行可靠的质量评估。
Although randomised trials are important for evidence-based medicine, little is known about their overall characteristics. We assessed the epidemiology and reporting of methodological details for all 519 PubMed-indexed randomised trials published in December, 2000 (383 [74%] parallel-group, 116 [22%] crossover). 482 (93%) were published in specialty journals. A median of 80 participants (10th-90th percentile 25-369) were recruited for parallel-group trials. 309 (60%) were blinded. Power calculation, primary outcomes, random sequence generation, allocation concealment, and handling of attrition were each adequately described in less than half of publications. The small sample sizes are worrying, and poor reporting of methodological characteristics will prevent reliable quality assessment of many published trials.