Randomized and Observational Studies in Nephrology: How Strong Is the Evidence?
Randomized and Observational Studies in Nephrology: How Strong Is the Evidence?
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DOI：
10.1053/j.ajkd.2008.12.001
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发表时间：
2009-03-01
影响因子：
13.2
通讯作者：
Greene, Tom
中科院分区：
文献类型：
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作者：
Greene, Tom
从观察性研究和随机临床试验（RCT）中获得的证据的强度已被广泛讨论。本报告批判性地探讨了在肾脏病学临床研究中讨论的两个观点，这些研究的目的是确定治疗干预的有效性。第一种观点强调随机化在支持因果推断中的基本作用，主张RCT在显示疗效方面具有严格的优越性，并强调观察性研究对偏倚的敏感性，如果不引用不可检验的假设，这种偏倚就无法纠正。我们还研究反驳这种严格的等级观点，支持更大的作用，观察性研究。反驳者引用了随机对照试验的局限性、观察性研究和随机对照试验结果一致性的系统评价以及方法学的进步，这些进步加强了从观察性数据中得出的推论。最终，我们支持一种综合方法，该方法基于各自的优势和劣势，在研究过程的不同阶段针对观察性研究和RCT的使用，并寻求最大限度地利用通过联合评估两种类型的证据获得的信息。
The strength of the evidence that can be obtained from observational studies and randomized clinical trials (RCTs) has been widely discussed. This report critically examines 2 perspectives of this discussion in the setting of clinical studies in nephrology that have the objective of determining the efficacy of therapeutic interventions. Emphasizing the fundamental role of randomization in supporting causal inference, the first perspective asserts the strict superiority of RCTs for showing efficacy and emphasizes the susceptibility of observational studies to bias that cannot be corrected without invoking untestable assumptions. We also examine counterarguments to this strictly hierarchical perspective that support a greater role for observational research. The counterarguments cite limitations of RCTs, systematic reviews of the concordance between results of observational studies and RCTs, and methodological advances that have strengthened the inferences that can be made from observational data. Ultimately, we support an integrative approach that targets the use of observational studies and RCTs at different stages of the research process based on their respective strengths and weaknesses and seeks to maximize the information gained by joint evaluation of both types of evidence.