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Clin Infect Dis. 2015 Sep 1;61(5):800-6. doi: 10.1093/cid/civ495. Epub 2015 Jun 25.

Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR).

Author information

1
Harvard University, Boston, Massachusetts.
2
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring.
3
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
4
Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
5
Division of Pediatric Infectious Diseases, Mayo Clinic, Rochester, Minnesota.
6
George Washington University School of Medicine, Washington D.C. Leidos Biomedical Research in support of the Division of Clinical Research, National Institutes of Health, Bethesda, Maryland.
7
Massachusetts General Hospital, Boston.
8
Pfizer, Inc, Groton, Connecticut.
9
Johns Hopkins University, Baltimore, Maryland.
10
Duke University, Durham, North Carolina.
11
University of Pennsylvania, Philadelphia.
12
University of California, San Francisco.

Abstract

Clinical trials that compare strategies to optimize antibiotic use are of critical importance but are limited by competing risks that distort outcome interpretation, complexities of noninferiority trials, large sample sizes, and inadequate evaluation of benefits and harms at the patient level. The Antibacterial Resistance Leadership Group strives to overcome these challenges through innovative trial design. Response adjusted for duration of antibiotic risk (RADAR) is a novel methodology utilizing a superiority design and a 2-step process: (1) categorizing patients into an overall clinical outcome (based on benefits and harms), and (2) ranking patients with respect to a desirability of outcome ranking (DOOR). DOORs are constructed by assigning higher ranks to patients with (1) better overall clinical outcomes and (2) shorter durations of antibiotic use for similar overall clinical outcomes. DOOR distributions are compared between antibiotic use strategies. The probability that a randomly selected patient will have a better DOOR if assigned to the new strategy is estimated. DOOR/RADAR represents a new paradigm in assessing the risks and benefits of new strategies to optimize antibiotic use.

KEYWORDS:

DOOR; RADAR; antibiotic use strategies

PMID:
26113652
PMCID:
PMC4542892
DOI:
10.1093/cid/civ495
[Indexed for MEDLINE]
Free PMC Article

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