Power Analysis for Cluster Randomized Trials

描述（由申请人提供）：整群随机试验是将完整的单位（如医院、诊所或学校）随机分配到治疗或对照等条件下的试验。聚类随机试验在医学、健康和社会政策研究中发挥着重要作用，在这些领域约有11，000项试验，近年来这些试验的使用正在加速。计划和分析整群随机试验所需的统计程序比简单随机试验所用的统计程序复杂得多。流行的软件包，如SPSS，SAS和Stata包括用于分析聚类随机试验的模块，约80%的这些试验使用这些模块进行分析。相比之下，没有商业软件可以计算这些试验的功率。因此，只有约20%的试验在计划这些研究时使用适当的技术来计算功效。这是一个严重的问题，因为与具有相同总样本量的简单随机设计相比，群集随机设计的功效通常下降至少50%，并且通常更多。这个项目的目标是开发软件来计算群集随机试验的功效。该计划将与包括层次结构中的两个、三个或四个级别的研究合作。它将包含一个复杂的用户界面，以解决在功耗分析中必须解决的各种现实问题。在输入端，它将允许用户输入他们可能拥有的数据类型，并使用清晰直观的界面进行输入。在输出端，程序将创建表格和图形，允许用户快速评估所有假设的影响，并确定设计中的变化将如何影响功率和成本。公共卫生相关性群集随机试验是将医院、诊所或学校等完整单位随机分配到治疗或对照等条件下的试验。这类试验在医学、健康和社会政策研究中发挥着重要作用，每年计划进行多达1,000项此类试验。该项目的目标是开发软件来执行群集随机试验的功效分析，并使研究人员能够以最小成本产生最大功效的方式设计这些试验。

DESCRIPTION (provided by applicant): Cluster randomized trials are trials in which intact units such as hospitals, clinics, or schools, are randomly assigned to a condition such as Treatment or Control. Cluster randomized trials play a prominent role in medicine, health, and social policy research, accounting for some 11,000 trials in these areas, and the use of these trials has been accelerating in recent years. The statistical procedures required to plan and to analyze a cluster randomized trial are substantially more complex than those used for simple randomized trials. Popular software packages such as SPSS, SAS, and Stata include modules for the analysis of cluster randomized trials, and some 80% of these trials are analyzed using these kinds of modules. By contrast, no commercial software exists to compute power for these trials. Therefore, only about 20% of these trials use the proper techniques to compute power when these studies are being planned. This is a serious problem, since power for the cluster randomized design typically drops by at least 50%, and often by more, as compared with a simple randomized design with the same total sample size. The goal of this project is to develop software to compute power for cluster randomized trials. The program will work with studies that include two, three or four levels in the hierarchy. It will incorporate a sophisticated user interface to address the kinds of real-world issues that must be addressed in a power analysis. On the input side, it will allow users to enter the kinds of data that they are likely to have, and to do so using a clear and intuitive interface. On the output side the program will create tables and graphs that allow the user to quickly assess the impact of all assumptions, and to determine how changes in the design would affect power and costs. PUBLIC HEALTH RELEVANCE Cluster randomized trials are trials in which intact units such as hospitals, clinics, or schools, are randomly assigned to a condition such as Treatment or Control. These kinds of trials play a prominent role in medicine, health, and social policy research, with as many as 1,000 such trials being planned each year. The goal of this project is to develop software to perform a power analysis for cluster randomized trials, and enable researchers to design these trials in a manner that yields maximum power for the smallest cost.