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    Do Surgical Trials Meet the Scientific Standards for Clinical Trials?

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    Author
    Wenner, Danielle M.; Brody, Baruch A.; Jarman, Anna F.; Kolman, Jacob M.; Wray, Nelda P.; More... Ashton, Carol M. Less...
    Date
    2012
    Abstract
    Unlike medications, the dissemination of surgical procedures into practice is not regulated. Before marketing, pharmaceutical products are required to be shown safe and efficacious in comparative clinical trials that use bias-reducing strategies designed to reduce the distortion of estimates of treatment effect by predispositions toward the investigational intervention or control. Unless an investigational device is involved, the corresponding process for surgical innovations is usually unregulated and therefore may not be based on adequate evidence. Given these differences, we sought to evaluate the state of clinical research on invasive procedures. We conducted a systematic review of publications from 1999 through 2008, which reported the results of studies evaluating the effects of invasive therapeutic procedures, focusing on trials that appeared to influence practice. Our objective was to determine what proportion of studies evaluating surgical procedures use a comparative clinical trial design and methods to control bias. This article reports our results and raises concerns about the methodologic, and therefore the ethical, quality of clinical research used to justify the implementation of surgical procedures into practice.
    Citation
    Wenner, Danielle M., Brody, Baruch A., Jarman, Anna F., et al.. "Do Surgical Trials Meet the Scientific Standards for Clinical Trials?." Journal of the American College of Surgeons, 215, no. 5 (2012) Elsevier: 722-730. https://doi.org/10.1016/j.jamcollsurg.2012.06.018.
    Published Version
    https://doi.org/10.1016/j.jamcollsurg.2012.06.018
    Type
    Journal article
    Publisher
    Elsevier
    Citable link to this page
    https://hdl.handle.net/1911/96161
    Rights
    This is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by Elsevier.
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    • Faculty Publications [4990]
    • Philosophy Department publications [12]

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    Home | FAQ | Contact Us | Privacy Notice | Accessibility Statement
    Managed by the Digital Scholarship Services at Fondren Library, Rice University
    Physical Address: 6100 Main Street, Houston, Texas 77005
    Mailing Address: MS-44, P.O.BOX 1892, Houston, Texas 77251-1892
    Site Map