The Prompted Optional Randomization Trial: A New Design for Comparative Effectiveness Research
- 1 December 2012
- journal article
- Published by American Public Health Association in American Journal of Public Health
- Vol. 102 (12), e8-e10
- https://doi.org/10.2105/ajph.2012.301036
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. 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.Keywords
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