School of Chinese Medicine
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.
Chinese medicine research, Comparative effectiveness research, Effectiveness guidance document
Source Publication Title
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
The workshop was funded by The Institute for Integrative Health (TIIH), Baltimore MD, USA, a non-profit organization.
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Witt, Claudia M., Mikel Aickin, Daniel Cherkin, Chun T. Che, Charles Elder, Andrew Flower, Richard Hammerschlag, Jian-Ping Liu, Lixing Lao, Steve Phurrough, Cheryl Ritenbaugh, Lee H. Rubin, Rosa Schnyer, Peter M. Wayne, Shelly R. Withers, Bian Zhao-Xiang, Jeanette Young, Brian M. Berman, Alan Bensoussan, Benno Brinkhaus, Francesco Cardini, Kevin Chen, George Lewith, Klaus Linde, Hugh MacPherson, Richard L. Nahin, and Jed Weissberg. "Effectiveness guidance document (EGD) for Chinese medicine trials: A consensus document." Trials 15 (2014): 169.