Skip to main content

ETHNOS_APP

Home • Search • Journals • List 0

The Prompted Optional Randomization Trial

A New Design for Comparative Effectiveness Research

Bibliographic Data

ID11024931
AuthorsJames Flory (0000-0001-9936-1962, James Flory is with the departments of Medicine and Public Health, Weill Cornell School of Medicine, New York, NY. Jason Karlawish is with the departments of Medicine and Medical Ethics and Health Policy and the Alzheimer's Disease Core Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.), Jason Karlawish (0000-0002-6880-2865, James Flory is with the departments of Medicine and Public Health, Weill Cornell School of Medicine, New York, NY. Jason Karlawish is with the departments of Medicine and Medical Ethics and Health Policy and the Alzheimer's Disease Core Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.)
Year2012
Volume102
Issue12
Pagese8-e10
Publication date2012-12-01
Open AccessNo
TypeARTICLE
VenueAmerican Journal of Public Health (JOURNAL)
Journal identifiersISSN: 0090-0036 • E-ISSN: 1541-0048
PublisherAmerican Public Health Association (PUBLISHER • US)
DOI10.2105/ajph.2012.301036
PMID23078493
PMCIDPMC3519302
OpenAlexW2150622596
LanguageEN
References cited8

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

Alternative medicine · Clinical trial · Comparative effectiveness research · Confounding · Family medicine · Gold standard (test) · Informed consent · Medical physics · Random assignment · Randomization · Randomized controlled trial · Research design · Restricted randomization · Statistics · Ethics in Clinical Research · Health Systems, Economic Evaluations, Quality of Life · Mathematics · Medicine · Statistical Methods in Clinical Trials · Surgery

  • What Makes Clinical Research Ethical?

    Ezekiel J Emanuel•JAMA•2000

  • Equipoise and the Ethics of Clinical Research

    Benjamin Freedman•New England Journal of Medicine•1987

Highly citedNo

Tools

Open DOISci-HubOpen Access
Ethnos_APP • Open Source Project • MIT License • Frontend v2.0.0 • Privacy and Cookies • API Documentation: api.ethnos.app/docs • API Source Code: GitHub • DOI: 10.5281/zenodo.17049435 • Frontend Source Code: GitHub • DOI: 10.5281/zenodo.17050053 • cruz.rio.br • Expectantes Misericordiae