• Am J Public Health · Dec 2012

    The prompted optional randomization trial: a new design for comparative effectiveness research.

    • James Flory and Jason Karlawish.
    • Department of Medicine, Weill Cornell School of Medicine, New York, NY, USA. jaf9052@nyp.org
    • Am J Public Health. 2012 Dec 1;102(12):e8-10.

    AbstractRandomized 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.

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