학술논문

Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)
Document Type
article
Source
Clinical Infectious Diseases. 61(5)
Subject
Patient Safety
Clinical Trials and Supportive Activities
Clinical Research
Anti-Bacterial Agents
Bacterial Infections
Clinical Trials as Topic
Drug Resistance
Bacterial
Humans
Research Design
Risk
Treatment Outcome
DOOR
RADAR
antibiotic use strategies
Biological Sciences
Medical and Health Sciences
Microbiology
Language
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.