Division of Biostatistics and Bioinformatics, Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
Fertil Steril. 2024 Jun;121(6):899-901. doi: 10.1016/j.fertnstert.2024.01.040. Epub 2024 Feb 6.
Pilot studies, when properly designed and implemented, are an important tool that provide critical information for the development and potential success of a subsequent, larger trial. In fact, these small-scale studies are commonly used to assess the feasibility of whether a larger trial should be initiated. A popular investigator question is whether a pilot study requires a formal statistical power calculation. In general, the answer is "no"; however, the sample size needs to be justified on the basis of the goal of the pilot study.
初步研究,如果设计和实施得当,是一个重要的工具,可以为后续更大规模试验的开发和潜在成功提供关键信息。事实上,这些小规模研究通常用于评估是否应该启动更大规模的试验。一个常见的研究人员问题是,初步研究是否需要进行正式的统计功效计算。一般来说,答案是否定的;然而,样本量需要根据初步研究的目标来证明。