Altman D G, Doré C J
Medical Statistics Laboratory, Imperial Cancer Research Fund, London, UK.
Lancet. 1990 Jan 20;335(8682):149-53. doi: 10.1016/0140-6736(90)90014-v.
80 reports of randomised clinical trials in four leading general medical journals were reviewed. The reporting of the methodology of randomisation was inadequate. In 30% of trials there was no clear evidence that the groups had been randomised. Among trials that used simple randomisation the sample sizes in the two groups were too often similar, and there was an unexpected small bias in favour of there being fewer patients in the experimental group. The handling of comparisons of baseline characteristics was inadequate in 41% of the trials. Suggestions are made for improving standards.
对四种主要的普通医学期刊上的80篇随机临床试验报告进行了综述。随机化方法的报告不够充分。在30%的试验中，没有明确证据表明分组是随机的。在采用简单随机化的试验中，两组的样本量常常相似，而且存在一种意外的小偏差，即实验组的患者较少。41%的试验对基线特征比较的处理不充分。文中提出了提高标准的建议。
