Assignment: Quasi-experimental Studies

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Assignment: Quasi-experimental Studies

Assignment: Quasi-experimental Studies

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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

rather than on routine practices that are already required (eg, hand hygiene).

The intervention should be described in sufficient detail as to be reproducible.

Preintervention infection control strategies for ESBL-E should be clearly described.

Cointerventions Cointerventions with the potential to impact ESBL-E incidence (eg, initiation of an antibiotic stewardship program,

intervention to improve hand hygiene) should be avoided; if cointerventions occur, they should be described and their

impact assessed (eg, report change in antimicrobial usage patterns, change in hand hygiene compliance over study period).

Outcome measures Nosocomial ESBL-E incidence per patient day or per admission should be the preferred outcome.

Surveillance cultures on admission should be used to help distinguish patients with colonization at admission from those who

develop colonization following hospitalization because in-hospital interventions can only influence the latter group.

ESBL-E production should be confirmed using standard phenotypic methods; additional molecular data should be presented

to exclude both clonal and plasmid outbreaks (eg, PFGE, plasmid typing).

Confounding factors Potential confounding factors including changes in the incidence risk factors for ESBL-E acquisition should be monitored (eg,

antibiotic use, length of hospital or ICU stay, hand hygiene compliance, severity of illness).

ESBL-E, extended-spectrum b-lactamase (ESBL)-producing Enterobacteriaceae; ICU, intensive care unit; PFGE, pulsed-field gel electrophoresis.

600 Goddard and Muller

American Journal of Infection Control September 2011

excluded following full review because ESBL-E inci- dence was not measured at baseline (n 5 2),3,4 no in- tervention was studied (n 5 2),5,6 the study was

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