Assignment: Randomized Controlled Trial

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Assignment: Randomized Controlled Trial

Assignment: Randomized Controlled Trial

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We searched MEDLINE, CINAHL, EMBASE, and the Cochrane Library for studies published from January 1985 to April 2010. The search terms used included terms to identify the organism (eg, Enterobacteriaceae),

the Department of Medicine, University of Toronto, Toronto, daa; and Division of Infectious Diseases, St. Michael’s Hospital, to, Canada.b

ess correspondence to Matthew P. Muller, MD, PhD, FRCPC, ichael’s Hospital, 30 Bond St, 4CC wing, room 4-178, Toronto, M5B 1W8, Canada. E-mail:

icts of interest: None to report.


right ª 2011 by the Association for Professionals in Infection rol and Epidemiology, Inc. Published by Elsevier Inc. All rights ved.


the mechanism of resistance (eg, ESBL), and the inter- vention (eg, contact precautions). The complete search strategy is available from the authors on request.

Studies were included if the study was designed as a randomized controlled trial (RCT), time series analysis, or quasi-experimental study; if they included an infection control intervention designed to reduce the person-to-person transmission of ESBL-E; and if they reported total or nosocomial ESBL-E incidence as an outcome. Studies were excluded if third-generation cephalosporin resistance was not confirmed to be due to ESBL production; if the intervention was con- ducted during a defined clonal outbreak; if the inter- vention focused on antibiotic stewardship or digestive tract decolonization; or if the study was not published in a peer-reviewed journal or not published in English.

Articles were reviewed independently by both au- thors to determine eligibility; differences of opinion were resolved through consensus. Studies were not ex- cluded because of poor quality if the inclusion criteria were met. Instead, the strength of the study design was assessed using a guidelines for the evaluation of quasi- experimental studies of infection control interventions (no RCT were identified).2

Table 1. Recommendations for future trials of infection control interventions for ESBL-E

Study design Interventions should be evaluated using time series analysis or prospective controlled quasi-experimental studies with

repeated, removed, or crossover designs that will strengthen the internal validity of the results.

Interventions that are effective in well-designed quasi-experimental studies should be prioritized for testing using a cluster

randomized design, which minimizes bias because of unmeasured confounders.

Interventions Studies should focus on isolation and/or contact precautions with and without active surveillance for ESBL-E colonization

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