The Prompted Optional Randomization Trial: A New Design for Comparative Effectiveness Research.

• Autores: James Flory, Jason Karlawish
• Localización: American journal of public health, ISSN 0090-0036, Vol. 102, Nº. 12, 2012, págs. 8-10
• Idioma: inglés
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• Resumen

  • 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. [ABSTRACT FROM AUTHOR]