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Design and analysis of pilot studies: recommendations for good practice

Research output: Contribution to journalJournal article

Published

Journal publication date05/2004
JournalJournal of Evaluation in Clinical Practice
Journal number2
Volume10
Number of pages6
Pages307-312
Original languageEnglish

Abstract

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.