The trial's investigators had 2 goals: to develop approaches for embedding large randomized trials into the routine delivery of clinical care, and to determine whether patients benefit from hemodialysis sessions that are longer than usual. In the Time to Reduce Mortality in ESRD (TiME) trial, 266 dialysis facilities randomized to the intervention adopted a default hemodialysis session duration of at least 4.25 hours for new dialysis patients; those randomized to usual care had no trial-specified approach to duration. Trial implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data.
The team demonstrated that a trial embedded into clinical care delivery with no on-site research personnel could efficiently enroll a large number of participants using an opt-out approach to informed consent. (The trial enrolled 7,035 patients.) The trial was also able to obtain useful treatment and outcomes data from...
Wake Up To Breaking News!
Never argue with an idiot, the spectators may not be able to differentiate between you.