Pilot and feasibility studies: extending the conceptual framework

Pilot and Feasibility Studies

Methodology

Claire Chan¹  Saskia Eddy²  Sandra Eldridge²  Lehana Thabane³  Gillian A. Lancaster⁴  Sally Hopewell⁵  Katie Mellor⁵  Christine Bond⁶  Mike Campbell⁷ 

[1] Barts and the London Pragmatic Clinical Trials Unit Centre for Evaluation and Methods Wolfson Institute of Population Health, Queen Mary University of London, London, UK;Centre for Evaluation & Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK;Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada;St Joseph’s Healthcare—Hamilton, Hamilton, ON, Canada;Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa;Keele Clinical Trials Unit, School of Medicine, Keele University, Keele, UK;Oxford Clinical Trials Research Unit/Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK;Primary Care, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK;School of Health and Related Research, University of Sheffield, Sheffield, UK;

关键词: Internal pilot;    External pilot;    Definitions;    Concepts;    Uncertainties;    Randomised controlled trial (RCT);    Feasibility;    Reporting;    Framework;   

DOI  :  10.1186/s40814-023-01233-1

 received in 2022-07-05, accepted in 2022-12-30,  发布年份 2022

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 1