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    Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

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    1745-6215-15-169.pdf
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    Author
    Witt, Claudia
    Aickin, Mikel
    Cherkin, Daniel
    Che, Chun
    Elder, Charles
    Flower, Andrew
    Hammerschlag, Richard
    Liu, Jian-Ping
    Lao, Lixing
    Phurrough, Steve
    Ritenbaugh, Cheryl
    Rubin, Lee
    Schnyer, Rosa
    Wayne, Peter
    Withers, Shelly
    Zhao-Xiang, Bian
    Young, Jeanette
    Berman, Brian
    Collaborators
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    Affiliation
    Institute for Complementary and Integrative Medicine, University Hospital Zurich, Zurich, Switzerland
    Center for Integrative Medicine, University of Maryland, School of Medicine, Baltimore, MD, USA
    Department of Family and Community Medicine, University of Arizona, Tucson, AZ, USA
    Group Health Research Institute, Seattle, WA, USA
    Department of Medicinal Chemistry and Pharmacognosy, University of Illinois at Chicago, Chicago, IL, USA
    Kaiser Permanente Northwest, Center for Health Research, Portland, OR, USA
    Complementary and Integrated Medicine Research Unit, Department of Primary Care, University of Southampton, Southampton, UK
    Research Department, Oregon College of Oriental Medicine, Portland, Oregon, USA
    Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
    Complementary Medicine Program and Integrative Medicine, University of Maryland Medical Center, Baltimore, MD, USA
    Centers for Medicare and Medicaid Services, Baltimore, Maryland, USA
    School of Nursing, The University of Texas at Austin, Austin, TX, USA
    Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
    The Institute for Integrative Health, Baltimore, MD, USA
    School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, China
    Patient stakeholder, New York, NY 10001, USA
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    Issue Date
    2014
    Keywords
    Comparative effectiveness research
    Effectiveness guidance document
    Chinese medicine research
    
    Metadata
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    Publisher
    BioMed Central
    Citation
    Witt et al. Trials 2014, 15:169 http://www.trialsjournal.com/content/15/1/169
    Journal
    Trials
    Rights
    © 2014 Witt et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)
    Collection Information
    This item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.
    Abstract
    BACKGROUND:There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.METHODS:The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.RESULTS:Recommendations were developed for "using available data" and "future clinical studies". The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.CONCLUSION:The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.
    EISSN
    1745-6215
    DOI
    10.1186/1745-6215-15-169
    Version
    Final published version
    Additional Links
    http://www.trialsjournal.com/content/15/1/169
    ae974a485f413a2113503eed53cd6c53
    10.1186/1745-6215-15-169
    Scopus Count
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    UA Faculty Publications

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