Jager K J, Stel V S, Wanner C, Zoccali C, Dekker F W
ERA-EDTA Registry, Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Kidney Int. 2007 Sep;72(6):671-5. doi: 10.1038/sj.ki.5002397. Epub 2007 Jun 27.
In studies on the effects of therapy (or other interventions), the randomized controlled trial (RCT) is an almost unbeatable standard in clinical research. The value of RCTs leaves unabated the valuable contributions of observational studies to medicine. This paper discusses some limitations of RCTs providing examples where these are not possible, inappropriate, inadequate, or unnecessary. Thereafter, it focuses on observational studies and gives a number of examples of studies on etiology, diagnosis, prognosis, and adverse effects, where observational designs have provided answers to research questions that could not have been answered by RCTs. Strengths and weaknesses of the different observational study designs are discussed. Finally, it is concluded that both observational studies and RCTs fulfill a complementary and valuable role in nephrology.
在关于治疗（或其他干预措施）效果的研究中，随机对照试验（RCT）在临床研究中几乎是无可匹敌的标准。RCT的价值并未削弱观察性研究对医学的宝贵贡献。本文讨论了RCT的一些局限性，并给出了一些实例，说明在哪些情况下RCT不可行、不合适、不充分或不必要。此后，本文重点关注观察性研究，并给出了一些病因学、诊断、预后和不良反应研究的实例，在这些研究中，观察性设计为RCT无法回答的研究问题提供了答案。文中还讨论了不同观察性研究设计的优缺点。最后得出结论，观察性研究和RCT在肾脏病学中都发挥着互补且有价值的作用。
