A sample size calculator for SMART pilot studies.
A sample size calculator for SMART pilot studies.
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DOI：
10.1137/15s014058
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发表时间：
2016-01-01
期刊：
影响因子：
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通讯作者：
Almirall, Daniel
中科院分区：
文献类型：
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作者：
Kim, Hwanwoo;Ionides, Edward;Almirall, Daniel
在临床实践中，以及在提供干预措施的其他领域，通常需要连续的个性化治疗方法，从而根据对象的反应调整每种治疗。适应性干预是一系列决策规则，在个人护理的关键决策点正式规定治疗。为了告知适应性干预措施的发展，科学家们对使用序贯多分配随机试验（SMART）越来越感兴趣，这是一种多阶段随机试验，其中个体在关键决策点重复随机分配到一组治疗方案。虽然人们对SMART的使用和适应性干预措施的发展有很大的兴趣，但两者对医学和行为科学来说都是相对较新的。因此，许多临床研究人员将首先实施SMART试点研究（即，SMART的小规模版本），以在进行全面SMART研究之前检查可行性和可接受性考虑因素。本文的主要目的是介绍一种新的方法来计算进行SMART试点所需的最小样本量。
In clinical practice, as well as in other areas where interventions are provided, a sequential individualized approach to treatment is often necessary, whereby each treatment is adapted based on the object's response. An adaptive intervention is a sequence of decision rules which formalizes the provision of treatment at critical decision points in the care of an individual. In order to inform the development of an adaptive intervention, scientists are increasingly interested in the use of sequential multiple assignment randomized trials (SMART), which is a type of multi-stage randomized trial where individuals are randomized repeatedly at critical decision points to a set treatment options. While there is great interest in the use of SMART and in the development of adaptive interventions, both are relatively new to the medical and behavioral sciences. As a result, many clinical researchers will first implement a SMART pilot study (i.e., a small-scale version of a SMART) to examine feasibility and acceptability considerations prior to conducting a full-scale SMART study. A primary aim of this paper is to introduce a new methodology to calculate minimal sample size necessary for conducting a SMART pilot.