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

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 col...

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Bibliographic Details
Published in:American journal of public health (1971) 2012-12, Vol.102 (12), p.e8-e10
Main Authors: Flory, James, Karlawish, Jason
Format: Article
Language:English
Subjects:
Clinical decision making
Clinical outcomes
Clinical trials
Cohort analysis
Comparative Effectiveness Research - ethics
Comparative Effectiveness Research - methods
Confounding (Statistics)
Data Interpretation, Statistical
Decision making
Diabetes
Disease
Ethics
Humans
Informed consent
Informed Consent - ethics
Medical Order Entry Systems
Order entry
Patients
Physicians
Prescription drugs
Public health
Random Allocation
Randomized Controlled Trials as Topic - ethics
Randomized Controlled Trials as Topic - methods
Studies
Variables
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Summary: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.
ISSN:0090-0036
1541-0048
DOI:10.2105/AJPH.2012.301036