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

Am J Public Health. 2012 Dec;102(12):e8-10. doi: 10.2105/AJPH.2012.301036. Epub 2012 Oct 18.


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Comparative Effectiveness Research / ethics
  • Comparative Effectiveness Research / methods*
  • Data Interpretation, Statistical
  • Humans
  • Informed Consent / ethics
  • Medical Order Entry Systems
  • Random Allocation
  • Randomized Controlled Trials as Topic / ethics
  • Randomized Controlled Trials as Topic / methods*