Gore S M
MRC Biostatistics Unit, Cambridge, United Kingdom.
Lipids. 1999 Feb;34(2):185-97. doi: 10.1007/s11745-999-0353-0.
Infant nutrition trials usually require developmental follow-up, often to 18 mon, and sometimes beyond reading ability at age 7 yr. They are therefore logistically complex and costly, and should be conducted to a high statistical standard. With examples, we focus on: good practice in nutrition trials and the goal of a common protocol; how to set plausible trial targets and to work out trial size accordingly; statistical observations on assessing visual maturation; and methods of randomization, including the method known as minimization, which can be adapted to select more appropriately a comparison cohort of breast-fed infants. We end with discussion of analysis and reporting standards, including the give-aways (or tell-tale signs) to be on the look out for. A Cochrane Collaboration for systematic review of randomized trials of infant nutrition is proposed.
婴儿营养试验通常需要进行发育随访，随访时间往往长达18个月，有时还要考察7岁时的阅读能力。因此，这类试验在组织实施上较为复杂且成本高昂，应按照较高的统计标准开展。我们结合实例重点讨论：营养试验的良好做法及通用方案的目标；如何设定合理的试验目标并据此确定试验规模；评估视觉成熟度的统计学观察方法；随机化方法，包括所谓的最小化法，该方法可用于更恰当地选择母乳喂养婴儿作为对照队列。最后，我们讨论分析和报告标准，包括需要留意的破绽（或蛛丝马迹）。本文提议成立一个Cochrane协作组，对婴儿营养随机试验进行系统评价。
