The prompted optional randomization trial: A new design for comparative effectiveness research Academic Article uri icon


MeSH Major

  • Comparative Effectiveness Research
  • Randomized Controlled Trials as Topic


  • 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 date

  • December 2012



  • Academic Article



  • eng

PubMed Central ID

  • PMC3519302

Digital Object Identifier (DOI)

  • 10.2105/AJPH.2012.301036

PubMed ID

  • 23078493

Additional Document Info

start page

  • e8

end page

  • 10


  • 102


  • 12