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

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  • Flory, J.
  • Karlawish, J.

Abstract

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.Adifferentmethod 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 decisionmaking 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-gradeinformedconsent.

Suggested Citation

  • Flory, J. & Karlawish, J., 2012. "The prompted optional randomization trial: A new design for comparative effectiveness research," American Journal of Public Health, American Public Health Association, vol. 102(12), pages 8-10.
    • Handle: RePEc:aph:ajpbhl:10.2105/ajph.2012.301036_0
    DOI: 10.2105/AJPH.2012.301036
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