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Stroke ; 54(7): 1909-1919, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37078281

RESUMEN

From 2016 to 2021, the National Institutes of Health Stroke Trials Network funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke initiated ten multicenter randomized controlled clinical trials. Optimal subject randomization designs are demanded with 4 critical properties: (1) protection of treatment assignment randomness, (2) achievement of the desired treatment allocation ratio, (3) balancing of baseline covariates, and (4) ease of implementation. For acute stroke trials, it is necessary to minimize the time between eligibility assessment and treatment initiation. This article reviews the randomization designs for 3 trials currently enrolling in Stroke Trials Network funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke, the SATURN (Statins in Intracerebral Hemorrhage Trial), the MOST (Multiarm Optimization of Stroke Thrombolysis Trial), and the FASTEST (Recombinant Factor VIIa for Hemorrhagic Stroke Trial). Randomization methods utilized in these trials include minimal sufficient balance, block urn design, big stick design, and step-forward randomization. Their advantages and limitations are reviewed and compared with traditional stratified permuted block design and minimization.


Asunto(s)
National Institute of Neurological Disorders and Stroke (U.S.) , Accidente Cerebrovascular , Humanos , Hemorragia Cerebral/terapia , Estudios Multicéntricos como Asunto , National Institutes of Health (U.S.) , Distribución Aleatoria , Accidente Cerebrovascular/tratamiento farmacológico , Estados Unidos , Ensayos Clínicos Controlados Aleatorios como Asunto
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