Practical guidelines for economic evaluations alongside equivalence trials
Practical guidelines for economic evaluations alongside equivalence trials
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DOI：
10.1111/j.1524-4733.2007.00245.x
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发表时间：
2008-03-01
期刊：
影响因子：
4.5
通讯作者：
van Tulder, Maurits W.
中科院分区：
文献类型：
--
作者：
Bosmans, Judith E.;de Bruijne, Martine C.;van Tulder, Maurits W.
许多疾病已经有了有效的治疗方法。在这些情况下，新治疗的有效性可以通过证明新治疗与旧治疗一样有效（即，等效）或至少与旧治疗一样有效（即，不逊色于旧治疗）来确定。对于伴随临床等效或非劣效性试验的经济评价，在研究开始前确定适当的研究问题是很重要的。在许多情况下，经济评价的目标将是显示治疗的成本效益的等效性或非劣效性。这对经济评估的设计和分析具有重要意义。在本文中，我们提出了类似于临床等效性和非劣效性试验的方法来分析经济等效性和非劣效性研究。此外，成本效益面被证明是解释经济等效或非劣效性试验结果的有价值的工具。文中所描述的概念是用一项经济非劣效性试验的结果来说明的。
An effective treatment already exists for many diseases. In these cases the effectiveness of a new treatment may be established by showing that the new treatment is as effective as (i.e., equivalent to) or at least as effective as (i.e., noninferior to) the old treatment. For an economic evaluation accompanying a clinical equivalence or noninferiority trial it is important to decide before the start of the study on the appropriate research question. In many cases the objective of the economic evaluation will be to show equivalence or noninferiority of the cost-effectiveness of the treatments. This has major implications for the design and analysis of the economic evaluation. In this article we propose methods for the analysis of economic equivalence and noninferiority studies that are similar to the methods applied to clinical equivalence and noninferiority trials. Furthermore, cost-effectiveness planes prove to be a valuable tool in the interpretation of the results in an economic equivalence or noninferiority trial. The concepts described in the article are illustrated using the results from an economic noninferiority trial.