Weill Cornell Medical College, Department of Psychiatry, Box 140, 525 East 68th Street, New York, NY 10065, USA.
J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
Pilot studies represent a fundamental phase of the research process. The purpose of conducting a pilot study is to examine the feasibility of an approach that is intended to be used in a larger scale study. The roles and limitations of pilot studies are described here using a clinical trial as an example. A pilot study can be used to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, new methods, and implementation of the novel intervention. A pilot study is not a hypothesis testing study. Safety, efficacy and effectiveness are not evaluated in a pilot. Contrary to tradition, a pilot study does not provide a meaningful effect size estimate for planning subsequent studies due to the imprecision inherent in data from small samples. Feasibility results do not necessarily generalize beyond the inclusion and exclusion criteria of the pilot design. A pilot study is a requisite initial step in exploring a novel intervention or an innovative application of an intervention. Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study. Investigators should be forthright in stating these objectives of a pilot study. Grant reviewers and other stakeholders should expect no more.
初步研究是研究过程的基础阶段。进行初步研究的目的是检验拟用于更大规模研究的方法的可行性。本文以临床试验为例，阐述了初步研究的作用和局限性。初步研究可用于评估招募、随机化、保留、评估程序、新方法和新干预措施实施的可行性。初步研究不是假设检验研究。安全性、疗效和有效性不在初步研究中评估。与传统观念相反，由于小样本数据固有的不精确性，初步研究无法为后续研究提供有意义的效应量估计。可行性结果不一定超出初步设计的纳入和排除标准而具有普遍性。初步研究是探索新干预措施或干预措施创新应用的必要初始步骤。初步研究结果可提供可行性信息，并确定在更大规模后续假设检验研究设计中需要进行的修改。研究人员应如实陈述初步研究的这些目标。资助评审员和其他利益相关者也不应期望更多。
