Bond Christine, Lancaster Gillian A, Campbell Mike, Chan Claire, Eddy Saskia, Hopewell Sally, Mellor Katie, Thabane Lehana, Eldridge Sandra
Primary Care, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Keele Clinical Trials Unit, School of Medicine, Keele University, Keele, UK.
Pilot Feasibility Stud. 2023 Feb 9;9(1):24. doi: 10.1186/s40814-023-01233-1.
In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies. We consider, with examples, when different approaches to feasibility and pilot studies are more effective and efficient, taking into account the pragmatic decisions that may need to be made. The ethical issues involved in pilot studies are discussed. We end with a consideration of the funders' perspective in making difficult resource decisions to include feasibility work and the policy implications of these; throughout, we provide examples of the uncertainties and compromises that researchers have to navigate to make progress in the most efficient way.
2016年，我们发表了一个概念框架，概述了我们在界定预试验和可行性研究方面的工作结论。自那时以来，随机预试验和可行性试验的CONSORT扩展版已发布，并且预试验领域有了进一步发展。在本文中，我们重新审视并扩展我们的框架，以纳入研究人员可采用的各种可行性途径，其中包括内部预试验研究。我们结合实例，考虑在何时不同的可行性和预试验研究方法更有效率，同时考虑到可能需要做出的务实决策。文中讨论了预试验研究中涉及的伦理问题。我们最后从资助者的角度考虑做出艰难的资源决策以纳入可行性工作及其政策影响；在整个过程中，我们提供了研究人员为以最有效的方式取得进展而必须应对的不确定性和折衷情况的实例。
