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Design and analysis of pilot studies: recommendations for good practice
Author(s) -
Lancaster Gillian A.,
Dodd Susanna,
Williamson Paula R.
Publication year - 2004
Publication title -
journal of evaluation in clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.737
H-Index - 73
eISSN - 1365-2753
pISSN - 1356-1294
DOI - 10.1111/j..2002.384.doc.x
Subject(s) - rigour , randomized controlled trial , work (physics) , research design , plan (archaeology) , quality (philosophy) , management science , engineering ethics , medicine , medical education , computer science , sociology , engineering , surgery , mechanical engineering , social science , philosophy , geometry , mathematics , archaeology , epistemology , history
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.