Eldridge Sandra M, Lancaster Gillian A, Campbell Michael J, Thabane Lehana, Hopewell Sally, Coleman Claire L, Bond Christine M
Centre for Primary Care and Public Health, Queen Mary University of London, London, United Kingdom.
Department of Mathematics and Statistics, Lancaster University, Lancaster, Lancashire, United Kingdom.
PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.
我们描述了一个用于定义试点研究和可行性研究的框架，重点关注为随机对照试验做准备而开展的研究。为了制定该框架，我们进行了一项德尔菲调查；在一次试验方法学会议上召开了一次公开会议；对健康研究背景之外的定义进行了综述；在一次国际共识会议上咨询了专家；并审查了27项实证试点研究或可行性研究。我们最初采用了试点研究和可行性研究相互排斥的定义。然而，一些德尔菲调查的受访者以及大多数公开会议的与会者不同意相互排斥定义的观点。健康研究背景之外的定义、文献中对“试点”和“可行性”术语的使用以及国际共识会议的参与者均支持他们的观点。在我们的框架中，试点研究是可行性研究的一个子集，而非两者相互排斥。可行性研究要探讨某件事是否可行、我们是否应该着手进行，如果是，该如何进行。试点研究也提出同样的问题，但还有一个特定的设计特点：在试点研究中，未来的一项研究或未来研究的一部分会在较小规模上进行。我们建议，为便于识别，这些研究应根据情况适当使用“可行性研究”或“试点研究”等术语予以明确标识。这应包括主要为定性研究的可行性研究；我们发现这类研究在电子检索中很难识别，因为研究人员很少在这类研究的标题或摘要中使用“可行性”一词。研究人员还应报告与可行性相关的适当目标和方法；并明确确认其研究是在为未来旨在评估一项干预措施效果的随机对照试验做准备。
