Observational research--opportunities and limitations.
Observational research--opportunities and limitations.
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DOI：
10.1016/j.jdiacomp.2013.07.007
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发表时间：
2013-11
影响因子：
3
通讯作者：
Boyko EJ
中科院分区：
文献类型：
--
作者：
Boyko EJ
医学研究在识别与益处和不良结果相关的治疗方法和特征方面不断取得进展。治疗有效性评价的主要引擎是随机对照试验（RCT）。由于成本和其他因素，RCT无法解决所有临床重要决策。观察性研究通常用于解决RCT未解决或无法解决的问题。本文概述了观察性研究的益处和局限性，以指导糖尿病调查中这类研究设计的解释。在观察性研究中，偏倚的可能性更高，但有一些设计和分析功能可以解决这些问题，尽管不能完全消除它们。药物流行病学研究可以提供关于糖尿病药物的相对安全性和有效性的重要信息。此类研究必须有效解决适应症混淆的重要问题，才能产生有临床意义的结果。其他方法，如工具变量分析，正在使用，以实现更强的因果推理，但这些方法也需要履行几个关键的假设，可能是或可能不是现实的。几乎所有的临床决策都涉及概率推理和面对不确定性，因此观察性研究的现实目标可能不是RCT设定的高标准，而是影响诊断或治疗决策所需的确定性水平。
Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principle engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision.
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影响因子：
158.5
作者：
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影响因子：
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通讯作者：
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