Randomization in clinical trials of titrated therapies: unintended consequences of using fixed treatment protocols.

@article{Deans2007RandomizationIC,
  title={Randomization in clinical trials of titrated therapies: unintended consequences of using fixed treatment protocols.},
  author={Katherine J. Deans and Peter C. Minneci and Anthony F. Suffredini and Robert L Danner and William D. Hoffman and Xizhong Ciu and Harvey G. Klein and Alan N Schechter and Steven M. Banks and Peter Q Eichacker and C Natanson},
  journal={Critical care medicine},
  year={2007},
  volume={35 6},
  pages={1509-16}
}
OBJECTIVE Clinical trial designs that randomize patients to fixed treatment regimens may disrupt preexisting relationships between illness severity and level of therapy. The practice misalignments created by such designs may have unintended effects on trial results and safety. METHODS To illustrate this problem, the Transfusion Requirements in Critical Care (TRICC) trial and the Acute Respiratory Distress Syndrome Network low tidal volume (ARMA) trial were analyzed. RESULTS Publications… CONTINUE READING
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