Sequential Multiple Assignment Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS).
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, decision-rules that guides 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 ultimate patient outcomes. SMART COMPASS is valuable in the setting of antibiotic resistance when therapeutic adjustments may be necessary due to resistance.
Evans, SR; Follmann, D; Liu, Y; Holland, T; Doernberg, SB; Rouphael, N; Hamasaki, T; Jiang, Y; Lok, JJ; Tran, TTT; Harris, AD; Fowler, VG; Boucher, H; Kreiswirth, BN; Bonomo, RA; van Duin, D; Paterson, DL; Chambers, H
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