Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Clinical trials:randomization before consent

P W Armstrong, D G Watts

    Biomedicine / [Publiee Pour L'A.A.I.C.I.G.]
    |September 1, 1981
    PubMed
    Summary
    This summary is machine-generated.

    Related Concept Videos

    You might also read

    Related Articles

    Articles linked to this work by shared authors, journal, and citation graph.

    Sort by
    Same author

    The hospital frailty risk score in patients with heart failure is strongly associated with outcomes but less so with pharmacotherapy.

    Journal of internal medicine·2019
    Same author

    Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease.

    Journal of internal medicine·2017
    Same author

    Effect of nesiritide in patients with acute decompensated heart failure.

    The New England journal of medicine·2011
    Same author

    Benefit of angiographic spontaneous reperfusion in STEMI: does it extend to diabetic patients?

    Heart (British Cardiac Society)·2009
    Same author

    Short- and long-term outcomes following atrial fibrillation in patients with acute coronary syndromes with or without ST-segment elevation.

    Heart (British Cardiac Society)·2008
    Same author

    It's a matter of time: contemporary pre-hospital management of acute ST elevation myocardial infarction.

    Heart (British Cardiac Society)·2005
    Same journal

    Characterization of a major natural killer activity in rat lungs.

    Biomedicine / [publiee pour l'A.A.I.C.I.G.]·1981
    Same journal

    Decreased phagocytosis and antibody-dependent cellular cytotoxicity (ADCC) in type-1 diabetes.

    Biomedicine / [publiee pour l'A.A.I.C.I.G.]·1981
    Same journal

    [Alveolar macrophages in asthmatic patients: study of their phagocytic function].

    Biomedicine / [publiee pour l'A.A.I.C.I.G.]·1981
    Same journal

    Effect of salbutamol, a putative cerebral beta agonist on sleep stages and interictal epileptic discharges.

    Biomedicine / [publiee pour l'A.A.I.C.I.G.]·1981
    Same journal

    Ganglioside content and pattern in tumor tissue of human neuroblastomas.

    Biomedicine / [publiee pour l'A.A.I.C.I.G.]·1981
    Same journal

    Protective effect of levamisole on carbon tetrachloride-induced lipid peroxidation and hepatotoxicity.

    Biomedicine / [publiee pour l'A.A.I.C.I.G.]·1981
    See all related articles

    Obtaining consent after randomization in clinical trials improves study power. Analyzing patients who refuse treatment post-randomization validates randomization and enhances efficiency.

    Area of Science:

    • Clinical Trials Methodology
    • Biostatistics
    • Medical Ethics

    Background:

    • Conventional randomized trials require consent before randomization, potentially reducing participant numbers.
    • Obtaining consent after randomization can increase study power by isolating refusal effects to treatment arms.
    • This approach addresses challenges in recruiting participants for control groups in open-label trials.

    Purpose of the Study:

    • To propose and analyze a method for handling consent refusal after randomization in clinical trials.
    • To validate the randomization process by comparing patients who refuse treatment with the control group.
    • To test the hypothesis that patients refusing consent behave similarly to the control population.

    Main Methods:

    • Patients randomized to treatment but refusing experimental therapy will be analyzed as a separate group.

    Related Experiment Videos

  • This refuser group will be compared to the control population to assess randomization efficacy.
  • If no significant difference is found, refuser and control groups will be combined for analysis against the treatment group.

    • Main Results:

    • Analysis of outcomes for patients refusing post-randomization consent is proposed.
    • Comparison between refusers and controls will validate randomization and assess refuser behavior.
    • Potential for combining refuser and control groups enhances statistical power.

    Conclusions:

    • Post-randomization consent offers a more efficient use of patient material in clinical trials.
    • This strategy validates randomization and allows for robust hypothesis testing regarding patient behavior.
    • Combining refuser and control groups, when appropriate, strengthens comparative analyses.