Villar J, Carroli G
Special Programme of Research, World Health Organization, Geneva, Switzerland.
Prev Med. 1996 May-Jun;25(3):365-75. doi: 10.1006/pmed.1996.0067.
Randomized controlled trials proved the most valid basis for comparing alternative treatment modalities. Unfortunately, the quality of many such trials has not been as high as our patients deserve. We offer here methodological and practical insights to key issues related to the design, implementation, and analysis of randomized controlled trials in obstetrics and gynecology, based on our experience in exploring research hypotheses in this field. Specifically, we present randomization as a method for the prevention of confounding; we discuss the process of randomization and the bias that can be introduced to randomized controlled trials by some popular methods of randomization. The strategies for presenting baseline comparisons and evaluating the impact of a treatment or intervention are also reviewed. We hope to contribute to a more rigorous selection of treatments for our clinical and public health armamentarium.
随机对照试验被证明是比较不同治疗方式最有效的依据。不幸的是，许多此类试验的质量并未达到我们患者应得的水平。基于我们在该领域探索研究假设的经验，我们在此提供与妇产科随机对照试验的设计、实施和分析相关的关键问题的方法学和实践见解。具体而言，我们将随机化作为一种预防混杂的方法进行介绍；我们讨论随机化过程以及一些常用随机化方法可能给随机对照试验带来的偏差。还回顾了呈现基线比较以及评估治疗或干预效果的策略。我们希望有助于更严格地选择用于临床和公共卫生手段的治疗方法。
