Chapter

16. Experimental studies: clinical trials, field trials, community trials, and intervention studies

Barrie M. Margetts and Ian L. Rouse

in Design Concepts in Nutritional Epidemiology

Second edition

Published in print April 1997 | ISBN: 9780192627391
Published online September 2009 | e-ISBN: 9780191723704 | DOI: http://dx.doi.org/10.1093/acprof:oso/9780192627391.003.0016
16. Experimental studies: clinical trials, field trials, community trials, and intervention studies

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Experimental studies set out to alter, rather than just observe, relevant exposures of interest, and to assess over time their impact on health status or disease outcomes. This chapter begins with an historical perspective, and goes on to define experimental studies with tables illustrating the differences between the types of study. This is followed by an outline of the practical approaches to study design, including selection of study populations, allocation of treatment regimes, length of follow up, observer and participant effects, compliance, ascertainment of exposure and outcome, and sample size and power. The chapter concludes with a consideration of analysis and interpretation, some useful variations in design (e.g., factorial designs), and the role of systematic review and meta-analysis.

Keywords: experimental studies; clinical trials; field trials; community trials; intervention studies; hypothesis testing; compliance; confounding; bias; sample size

Chapter.  11230 words.  Illustrated.

Subjects: Public Health and Epidemiology

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