期刊
JOURNAL OF CLINICAL EPIDEMIOLOGY
卷 66, 期 8, 页码 S130-S137出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2013.02.015
关键词
Comparative effectiveness research; Bayesian adaptive trials; Response adaptive randomization; Adaptive sample size; Status epilepticus; Emergency medicine
资金
- NIH Common Fund
- FDA
- National Institutes of Neurological Disorders and Stroke (NINDS) [U01NS073476, U01NS056975, U01NS059041]
Objective: We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping. Study Design and Setting: The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design. Results: The trial design is compared to a trial without adaptive randomization and produces an efficient trial in which a higher proportion of patients are likely to be randomized to the most effective treatment arm while generally using fewer total patients and offers higher power than an analogous trial with fixed randomization when identifying a superior treatment. Conclusion: When one treatment is superior to the other two, the trial design provides better patient care, higher power, and a lower expected sample size. (C) 2013 Elsevier Inc. All rights reserved.
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