학술논문
Sequential, Multiple-Assignment, Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS).
Document Type
article
Author
Evans, Scott R; Follmann, Dean; Liu, Ying; Holland, Thomas; Doernberg, Sarah B; Rouphael, Nadine; Hamasaki, Toshimitsu; Jiang, Yunyun; Lok, Judith J; Tran, Thuy Tien T; Harris, Anthony D; Fowler, Vance G; Boucher, Helen; Kreiswirth, Barry N; Bonomo, Robert A; Van Duin, David; Paterson, David L; Chambers, Henry
Source
Clinical Infectious Diseases. 68(11)
Subject
Language
Abstract
Patient management is not based on a single decision. Rather, it is dynamic: based on a sequence of decisions, with therapeutic adjustments made over time. Adjustments are personalized: tailored to individual patients as new information becomes available. However, strategies allowing for such adjustments are infrequently studied. Traditional antibiotic trials are often nonpragmatic, comparing drugs for definitive therapy when drug susceptibilities are known. COMparing Personalized Antibiotic StrategieS (COMPASS) is a trial design that compares strategies consistent with clinical practice. Strategies are decision rules that guide empiric and definitive therapy decisions. Sequential, multiple-assignment, randomized (SMART) COMPASS allows evaluation when there are multiple, definitive therapy options. SMART COMPASS is pragmatic, mirroring clinical, antibiotic-treatment decision-making and addressing the most relevant issue for treating patients: identification of the patient-management strategy that optimizes the ultimate patient outcomes. SMART COMPASS is valuable in the setting of antibiotic resistance, when therapeutic adjustments may be necessary due to resistance.