Group sequential design for comparative diagnostic accuracy studies: Implications and guidelines for practitioners
Group sequential design for comparative diagnostic accuracy studies: Implications and guidelines for practitioners
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DOI：
10.1177/0272989x04269240
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发表时间：
2004-09-01
影响因子：
3.6
通讯作者：
Mazumdar, M
中科院分区：
文献类型：
--
作者：
Mazumdar, M
目的。比较诊断准确性（CDA）研究通常是小型回顾性研究，支持一种模式比另一种模式更高的准确性，无论是对特定疾病的分期还是评估对治疗的反应，它们被用来为更大规模的前瞻性试验产生假设。本文的目的是介绍组序贯设计（GSD）方法来规划这些大型试验。方法。在CDA研究中使用GSD所需的方法是最近发展起来的。本文描述了具有OBF停止规则的GSD，并提供了样本量计算指南。模拟数据用于演示GSD在CDA研究环境中临床试验设计/分析中的应用。结果。计划GSD试验所需的预期样本量（在OBF停止规则下）略有夸大，但最终可能会节省更多的患者资源。结论。GSD是一种专门的统计方法，有助于在早期停止研究的道德和经济优势与错误结论的风险之间取得平衡，应该在规划CDA研究时采用。
Purpose. Comparative diagnostic accuracy (CDA) studies are typically small retrospective studies supporting a higher accuracy for one modality over another for either staging a particular disease or assessing response to therapy, and they ore used to generate hypotheses for larger prospective trials. The purpose of this article is to introduce the group sequential design (GSD) approach in planning these larger trials. Methods. Methodology needed for using GSD in the CDA studies is recently developed. In this article, GSD with the O'Brien and Fleming (OBF) stopping rule is described and guidelines for sample size calculation are provided. Simulated data is used to demonstrate the application of GSD in the design/analysis of a clinical trial in the CDA study setting. Results. The expected sample size needed for planning a trial with GSD (under the OBF stopping rule) is slightly inflated but may ultimately result in greater savings of patient resources. Conclusion. GSD is a specialized statistical method that is helpful in balancing the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion and should be adopted for planning CDA studies.