Piaggio Gilda, Elbourne Diana, Schulz Kenneth F, Villar José, Pinol Alain P Y, Gülmezoglu A Metin
UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
BMC Med Res Methodol. 2003 Oct 3;3:19. doi: 10.1186/1471-2288-3-19.
The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards.
We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs.
The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios.
Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future.
本文旨在通过一个在发达国家和发展中国家医院产房开展的药物试验实例，探讨在试验中减少和研究选择偏倚与确定偏倚的方法。
我们描述了一种用于包装药物的盒子的创新实用设计，以此作为增强分配隐藏和盲法安全性的一种方式。我们还使用敏感性分析评估确定偏倚，因为其中一种药物的潜在副作用可能导致了一些破盲情况。
敏感性分析表明，即使在不太可能出现的最坏情况下，关于治疗相对效果的结论仍可维持。
对该试验中预防常见偏倚的程序以及确定偏倚评估的详细描述，应能使读者有信心评估和解释所获得的结果。此外，我们的经验将有助于其他人未来规划试验。
