Zucker D M, Lakatos E, Webber L S, Murray D M, McKinlay S M, Feldman H A, Kelder S H, Nader P R
Biostatistics Research Branch, National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA.
Control Clin Trials. 1995 Apr;16(2):96-118. doi: 10.1016/0197-2456(94)00026-y.
This paper describes some statistical considerations for the Child and Adolescent Trial for Cardiovascular Health (CATCH), a large-scale community health trial sponsored by the National Heart, Lung, and Blood Institute. The trial involves randomization of entire schools rather than individual students to the experimental arms. The paper discussed the implications of this form of randomization for the design and analysis of the trial. The power calculations and analysis plan for the trial are presented in detail. The handling of outmigrating and immigrating students is also discussed.
本文描述了儿童和青少年心血管健康试验(CATCH)的一些统计学考量,该试验是由美国国立心肺血液研究所发起的一项大规模社区健康试验。该试验涉及将整个学校而非个别学生随机分配至各试验组。本文讨论了这种随机化形式对试验设计和分析的影响。详细介绍了该试验的效能计算和分析计划。还讨论了转学学生和转校学生的处理方法。