Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus

    Authors

    J. T. Connor; J. J. Elm; K. R. Broglio;Esett Adapt-It Investigators

    Comments

    Authors: contact us about adding a copy of your work at STARS@ucf.edu

    Abbreviated Journal Title

    J. Clin. Epidemiol.

    Keywords

    Comparative effectiveness research; Bayesian adaptive trials; Response; adaptive randomization; Adaptive sample size; Status epilepticus; Emergency medicine; PHARMACEUTICAL PRODUCT DEVELOPMENT; CLINICAL-TRIALS; DESIGNS; Health Care Sciences & Services; Public, Environmental & Occupational; Health

    Abstract

    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.

    Journal Title

    Journal of Clinical Epidemiology

    Volume

    66

    Issue/Number

    8

    Publication Date

    1-1-2013

    Document Type

    Article

    Language

    English

    First Page

    S130

    Last Page

    S137

    WOS Identifier

    WOS:000322207400017

    ISSN

    0895-4356

    Share

    COinS