Department of Occupational Therapy, Tufts University, Medford, MA 02155, USA.
Am J Occup Ther. 2013 Mar-Apr;67(2):171-6. doi: 10.5014/ajot.2013.006270.
Many factors can affect the successful implementation and validity of intervention studies. A primary purpose of feasibility and pilot studies is to assess the potential for successful implementation of the proposed main intervention studies and to reduce threats to the validity of these studies. This article describes a typology to guide the aims of feasibility and pilot studies designed to support the development of randomized controlled trials and provides an example of the studies underlying the development of one rehabilitation trial. The purpose of most feasibility and pilot studies should be to describe information and evidence related to the successful implementation and validity of a planned main trial. Null hypothesis significance testing is not appropriate for these studies unless the sample size is properly powered. The primary tests of the intervention effectiveness hypotheses should occur in the main study, not in the studies that are serving as feasibility or pilot studies.
许多因素会影响干预研究的成功实施和有效性。可行性和初步研究的主要目的是评估拟议的主要干预研究成功实施的可能性，并降低这些研究有效性的威胁。本文描述了一种分类法，以指导旨在支持随机对照试验发展的可行性和初步研究的目标，并提供了一个支持一项康复试验发展的研究示例。大多数可行性和初步研究的目的应该是描述与计划的主要试验的成功实施和有效性相关的信息和证据。除非样本量适当，否则不适合对这些研究进行零假设显著性检验。干预效果假设的主要检验应在主要研究中进行，而不是在作为可行性或初步研究的研究中进行。
