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Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship: Randomized Controlled Trials

Published online by Cambridge University Press:  25 April 2016

Deverick J. Anderson*
Duke University Medical Center, Division of Infectious Diseases, Durham, North Carolina
Manisha Juthani-Mehta
Yale University School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, New Haven, Connecticut
Daniel J. Morgan
VA Maryland Healthcare System and University of Maryland School of Medicine, Baltimore, Maryland
Address correspondence to Deverick J. Anderson, MD, MPH, Associate Professor of Medicine, Division of Infectious Diseases, Box 102359, Duke University Medical Center, Durham, NC 27710 (


Randomized controlled trials (RCT) produce the strongest level of clinical evidence when comparing interventions. RCTs are technically difficult, costly, and require specific considerations including the use of patient- and cluster-level randomization and outcome selection. In this methods paper, we focus on key considerations for RCT methods in healthcare epidemiology and antimicrobial stewardship (HE&AS) research, including the need for cluster randomization, conduct at multiple sites, behavior modification interventions, and difficulty with identifying appropriate outcomes. We review key RCTs in HE&AS with a focus on advantages and disadvantages of methods used. A checklist is provided to aid in the development of RCTs in HE&AS.

Infect Control Hosp Epidemiol 2016;37:629–634

SHEA White Paper
© 2016 by The Society for Healthcare Epidemiology of America. All rights reserved 

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