Design and analysis of pilot studies:recommendations for good practice

Lancaster, Gillian and Dodd, Susanna and Williamson, Paula R (2004) Design and analysis of pilot studies:recommendations for good practice. Journal of Evaluation in Clinical Practice, 10 (2). pp. 307-312. ISSN 1356-1294

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Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.

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Journal Article
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Journal of Evaluation in Clinical Practice
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19 Nov 2012 11:10
Last Modified:
21 Nov 2022 23:05