title: Difficulties in demonstrating superiority of an antibiotic for multidrug-resistant bacteria in nonrandomized studies.
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.
authors: Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.
authors: Kristen A
authors: KA
authors: Stafford
authors: Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.
authors: Mallory
authors: M
authors: Boutin
authors: Department of Biostatistics and Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
authors: Scott R
authors: SR
authors: Evans
authors: Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore VA Maryland Health Care System, Baltimore.
authors: Anthony D
authors: AD
authors: Harris
mesh_terms: D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology*; D002986:Clinical Trials as Topic; D024901:Drug Resistance, Multiple, Bacterial; D006801:Humans; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents
keywords: antibiotics; epidemiology; nonrandomized studies; research design; superiority