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Clin Infect Dis. 2014 Oct 15;59(8):1142-7. doi: 10.1093/cid/ciu486. Epub 2014 Jun 30.

Difficulties in demonstrating superiority of an antibiotic for multidrug-resistant bacteria in nonrandomized studies.

Author information

1
Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.
2
Department of Biostatistics and Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
3
Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore VA Maryland Health Care System, Baltimore.

Abstract

The discovery and development of new antimicrobials is critically important, especially as multidrug-resistant bacteria continue to emerge. Little has been written about the epidemiological issues in nonrandomized trials aiming to evaluate the superiority of one antibiotic over another. In this manuscript, we outline some of the methodological difficulties in demonstrating superiority and discuss potential approaches to these problems. Many of the difficulties arise due to confounding by indication, which we define and explain. Epidemiological methods including restriction, matching, stratification, multivariable regression, propensity scores, and instrumental variables are discussed.

KEYWORDS:

antibiotics; epidemiology; nonrandomized studies; research design; superiority

PMID:
24982037
PMCID:
PMC4271096
DOI:
10.1093/cid/ciu486
[Indexed for MEDLINE]
Free PMC Article

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