Evans M, Pollock A V
Arch Surg. 1984 Jan;119(1):109-13. doi: 10.1001/archsurg.1984.01390130091016.
The ability of a small-scale random-control clinical trial comprising less than 500 patients to disclose clinically important differences between treatment groups depends on the event rate in the control group. The high rate of wound infection after abdominal operations has attracted many trials of methods of antibiotic prophylaxis. We reviewed all of the pertinent English literature recorded in Index Medicus in 1980 and 1981. We examined 45 articles for defects in design, analysis, and presentation. Of the 45 articles, 25 reported statistically significant differences between treatment groups and 20, no significant differences. Unsatisfactory methods of randomization were used in four trials, ethics were questionable in 22, statistical methods were incorrect in 31, and presentation was inadequate in 40. We concluded that there is room for improvement in the conduct of clinical trials.
一项包含不到500名患者的小规模随机对照临床试验揭示治疗组间临床重要差异的能力取决于对照组中的事件发生率。腹部手术后伤口感染的高发生率引发了许多抗生素预防方法的试验。我们查阅了1980年和1981年《医学索引》中记录的所有相关英文文献。我们检查了45篇文章在设计、分析和呈现方面的缺陷。在这45篇文章中，25篇报告了治疗组间具有统计学显著差异，20篇报告无显著差异。四项试验采用了不令人满意的随机方法，22项试验的伦理问题存疑，31项试验的统计方法不正确，40项试验的呈现不充分。我们得出结论，临床试验的实施还有改进空间。
