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

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 A...

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Bibliographic Details
Published in:Clinical infectious diseases 2015-09, Vol.61 (5), p.800-806
Main Authors: Evans, Scott R., Rubin, Daniel, Follmann, Dean, Pennello, Gene, Huskins, W. Charles, Powers, John H., Schoenfeld, David, Chuang-Stein, Christy, Cosgrove, Sara E., Fowler, Vance G., Lautenbach, Ebbing, Chambers, Henry F.
Format: Article
Language:English
Subjects:
Anti-Bacterial Agents - administration & dosage
Anti-Bacterial Agents - therapeutic use
Antibiotics
Bacterial Infections - drug therapy
Clinical outcomes
Clinical Trials as Topic
Drug Resistance, Bacterial
HEALTHCARE EPIDEMIOLOGY
Humans
Invited
Patient Safety
Probability
Research Design
Risk
Risk factors
Treatment Outcome
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Summary: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.
ISSN:1058-4838
1537-6591
1537-6591
DOI:10.1093/cid/civ495