Patient selection bias in randomized controlled trials

Clyman et al recently published an international multicenter patent ductus arteriosus (PDA) trial —the Tolerate Trial—to evaluate routine PDA pharmacologic treatment of PDA or delayed treatment for increasing findings of PDA related abnormalities (J Pediatr 2019:205:41–8.e6). The early treatment to achieve closure did not improve overall outcomes, a clear indication that a conservative app roach may be preferable. However, despite agreement at the clinical sites that there was equipoise for the 2 approaches to PDA management, 137 infants were not enrolled into the trial that included 202 enrolled infants because of physician choice to not offer enrollment.

Source: The Journal of Pediatrics - September 25, 2019 Category: Pediatrics Authors: Alan H. Jobe Tags: The Editors' Perspectives Source Type: research