The prompted optional randomization trial: a new design for comparative effectiveness research.
Randomized controlled trials are the gold standard for medical evidence because randomization provides the best-known protection against confounding of results.  Randomization has practical and ethical problems that limit the number of trials that can be conducted, however. A different method for collecting clinical data retains the statistically useful properties of randomization without incurring its practical and ethical challenges.  A computerized prompt introduces a random element into clinical decision-making that can be instantly overridden if it conflicts with optimal patient care. This creates a weak form of randomization that still eliminates the effect of all confounders, can be carried out without disturbing routine clinical care, and arguably will not require research-grade informed consent.
Department of Medicine, Weill Cornell School of Medicine, New York, NY, USA. jaf9052@nyp.org
James
J
Flory
Jason
J
Karlawish
D057186:Comparative Effectiveness Research / Q000941:ethics / Q000379:methods*; D003627:Data Interpretation, Statistical; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D050316:Medical Order Entry Systems; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods*